Amgen Inc. · NASDAQ:AMGN
Amgen — Investor Presentation (October 2021)
71 slides from Amgen's investor presentation, Oct 4, 2021
Slide 1: Growing Our Leadership in Inflammation
GROWING OUR LEADERSHIP IN INFLAMMATION OCTOBER 4, 2021
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward- looking statements, including any statements on the outc
Slide 3: Agenda
AGENDA David Reese, M.D.—Executive Vice President, Introduction Research and Development Rob Lenz, M.D., Ph.D.—Senior Vice President, Global Data Review Development Commercial Murdo Gordon—Executive Vice President, Global Landscape Commercial Operations Q&A All Provided October 4, 2021, as part of a
Slide 4: Introduction
INTRODUCTION DAVID REESE, M.D. EXECUTIVE VICE PRESIDENT, RESEARCH AND DEVELOPMENT
Slide 5: We Expect Inflammation to Be a Meaningful Growth Driver
WE EXPECT INFLAMMATION TO BE A MEANINGFUL GROWTH DRIVER • Building on decades of established research, development, and commercial expertise • Pursuing under-served markets with significant growth potential • Launching first-in-class molecules, new indications and quality biosimilars in each of the
Slide 6: Steady Flow of Inflammation Launches and Late Stage Clinical Data Through 2025
STEADY FLOW OF INFLAMMATION LAUNCHES AND LATE STAGE CLINICAL DATA THROUGH 2025 2021 2022 2023 2024 2025 December 2021 Q1 2022 January 31, 2023 H1 2024 March 1, 2025 Otezla® Tezepelumab AMJEVITA™ Tezepelumab ABP 959 U.S. approval U.S. approval U.S. launch* Phase 3 completion* U.S. launch Mild-to-mode
Slide 7: Steady Flow of Inflammation Launches and Late Stage Clinical Data Through 2025
STEADY FLOW OF INFLAMMATION LAUNCHES AND LATE STAGE CLINICAL DATA THROUGH 2025 2021 2022 2023 2024 2025 December 2021 Q1 2022 January 31, 2023 H1 2024 March 1, 2025 Otezla® Tezepelumab AMJEVITA™ Tezepelumab ABP 959 U.S. approval U.S. approval U.S. launch* Phase 3 completion* U.S. launch Mild-to-mode
Slide 8: Pursuing Differentiated Approaches to the Treatment Landscape
WE ARE PURSUING DIFFERENTIATED APPROACHES TO THE TREATMENT LANDSCAPE Rebalancing the immune system Block Deplete Tolerize Repair Inhibit well-validated Remove cells or Enhance population of Regenerate cells that targets using innovative molecules that cause antigen-specific are damaged due to modali
Slide 9: Leveraging Industry-Leading Human Genetics Platform
WE ARE LEVERAGING OUR INDUSTRY-LEADING HUMAN GENETICS PLATFORM TO ADVANCE INNOVATIVE NEW THERAPIES Genomics Transcriptomics Proteomics Chip typed WGS mRNA sequence data Plasma proteome >2.5M 300K 18K 60K and 5,000 proteins Imputation ~ 10,000 Phenotypes Variant mRNA Variant Protein Phenotype Variant
Slide 10: Broad Portfolio of Inflammation Products
BROAD PORTFOLIO OF INFLAMMATION PRODUCTS* Respiratory and Allergy Gastrointestinal Dermatology Rheumatology • Tezepelumab • AMGEVITA™† • Enbrel® • Enbrel® – Asthma • AVSOLA™ • Otezla® • Otezla® – Chronic obstructive Biosimilar to Remicade®* – Psoriasis – Psoriatic arthritis pulmonary disease • Efava
Slide 11: Inflammation Portfolio Review
INFLAMMATION PORTFOLIO REVIEW ROB LENZ, M.D., PH.D. SENIOR VICE PRESIDENT, GLOBAL DEVELOPMENT MURDO GORDON EXECUTIVE VICE PRESIDENT, GLOBAL COMMERCIAL OPERATIONS
Slide 12: AMG 451 / KHK4083
AMG 451 / KHK4083 A FIRST-IN-CLASS ANTI-OX40 MONOCLONAL ANTIBODY WITH POTENTIAL ACROSS INFLAMMATORY DISEASES
Slide 13: Atopic Dermatitis Is a Prevalent Disease with Significant Unmet Need
ATOPIC DERMATITIS IS A PREVALENT DISEASE WITH SIGNIFICANT UNMET NEED • Atopic dermatitis (AD) affects > 30 million people in major global markets, with particular unmet need in patients with moderate to severe disease – ~ 15%-30% of children and up to 3% of adults – ~ 1/3 have moderate to severe AD
Slide 14: AMG 451 / KHK4083: Phase 3-Ready for Atopic Dermatitis
AMG 451 / KHK4083: PHASE 3-READY FOR ATOPIC DERMATITIS • Activation of Th2 and other T cell subsets is central in Naïve T cells atopic dermatitis MHC I TCR CD28 B7 • The OX40–OX40L axis plays a critical role in long-lasting Activated APC Primed T cell T cell responses KHK4083, mAb – OX-40 ligand bin
Slide 15: Efficacy and Safety Results of KHK4083/AMG 451 in Atopic Dermatitis
Efficacy and Safety Results of KHK4083/AMG 451 (Anti-OX40 mAb) in Subjects With Moderate to Severe Atopic Dermatitis: A Phase 2, Multicentre, Randomized, Double-blind, Parallel-Group, Placebo-Controlled Study Emma Guttman-Yassky,1 Eric Simpson,2 Kristian Reich,3 Kenji Kabashima,4 Ken Igawa,5 Hidetos
Slide 16: Phase 2 Study Design (NCT03703102)
PHASE 2 STUDY DESIGN (NCT03703102) Treatment A Treatment B Follow- Primary efficacy endpoint Screening (Up to Week 18) (Week 18-Week 36) up ▪ Percentage change in EASI score from baseline to Week Adults with Placebo KHK4083 600 mg SC Q2W 16 chronic AD EASI ≥16; IGA ≥3; BSA ≥10%; Secondary efficacy I
Slide 17: Baseline Demographics and Disease Characteristics
BASELINE DEMOGRAPHICS AND DISEASE CHARACTERISTICS (SAFETY ANALYSIS SET) All baseline parameters were generally well-balanced among the treatment groups Placebo/ KHK4083 KHK4083 KHK4083 KHK4083 KHK4083 150 mg Q4W 600 mg Q4W 300 mg Q2W 600 mg Q2W 600 mg Q2W Total Characteristics* N=54 N=53 N=55 N=54 N
Slide 18: Primary Endpoint: % Change in EASI Scores (Week 16)
PRIMARY ENDPOINT: % CHANGE IN EASI SCORES (WEEK 16) FROM BASELINE (LAST OBSERVATION CARRIED FORWARD, FULL ANALYSIS SET) All KHK4083-treated groups achieved the primary endpoint KHK4083 KHK4083 KHK4083 KHK4083 150 mg Q4W 600 mg Q4W 300 mg Q2W 600 mg Q2W Placebo n=52 n=52 n=52 n=54 n=57 0 –10 LS mean
Slide 19: Proportion of Patients Who Achieved EASI-75
PROPORTION OF PATIENTS WHO ACHIEVED EASI-75 (NON-RESPONDER IMPUTATION, FULL ANALYSIS SET) Proportions of EASI-75 responders at Week 16 were significantly higher in all KHK4083-treated cohorts versus placebo Treatment period A Treatment period B (Placebo-controlled period) (All groups received KHK408
Slide 20: Proportions of Patients Achieving IGA Score of 0/1
PROPORTIONS OF PATIENTS WHO ACHIEVED AN IGA SCORE OF 0/1 AND A REDUCTION OF ≥2 POINTS FROM BASELINE (NON-RESPONDER IMPUTATION, FULL ANALYSIS SET) In all KHK4083 groups, the proportion of subjects who achieved IGA score 0/1 gradually increased up to Week 36 Treatment period A Treatment period B (Plac
Slide 21: Durability of EASI-75 Response After Treatment Discontinuation
DURABILITY OF EASI-75 RESPONSE AFTER TREATMENT DISCONTINUATION IN SUBJECTS WHO ACHIEVED EASI-75 AT WEEK 36 EASI-75 response was durable even after discontinuation of KHK4083 at Week 36 +: censored; Note: Subjects in the placebo group were switched to KHK4083 600 mg Q2W after Treatment A period. The
Slide 22: TEAEs – Treatment A Period
TEAES – TREATMENT A PERIOD (SAFETY ANALYSIS SET) In Treatment A period, 81% TEAEs occurred in KHK4083 groups versus 72% in the placebo group KHK4083 KHK4083 KHK4083 KHK4083 KHK4083 Placebo Category 150 mg Q4W 600 mg Q4W 300 mg Q2W 600 mg Q2W Total N=57 N=54 N=53 N=55 N=54 N=216 Any TEAEs 37 (68.5) 4
Slide 23: TEAEs in >5% of Subjects by Preferred Term
TEAES IN >5% OF SUBJECTS IN THE TOTAL KHK4083 GROUP BY PREFERRED TERM - TREATMENT A PERIOD (SAFETY ANALYSIS SET) • The most frequent TEAEs in KHK4083 groups were pyrexia, nasopharyngitis, worsening of AD, and chills • Events of pyrexia and chills were mild to moderate in intensity and were mostly ob
Slide 24: AMG 451/KHK4083: First-in-Class Anti-OX40 Antibody
AMG 451/KHK4083: A FIRST-IN-CLASS ANTI OX40 ANTIBODY WITH POTENTIAL ACROSS INFLAMMATORY DISEASES • Novel mechanism of action blocks OX40 signaling and depletes OX40-expressing T cells • Significant improvements in signs and symptoms of AD compared with placebo, across primary and secondary efficacy
Slide 25: Otezla
OTEZLA® POTENTIAL TO BE FIRST AND ONLY SYSTEMIC ORAL TREATMENT FOR ACTIVE PSORIATIC ARTHRITIS AND MILD TO SEVERE PSORIASIS
Slide 26: Burden of Disease in Mild-to-Moderate Psoriasis
BURDEN OF DISEASE IN MILD-TO-MODERATE PSORIASIS PATIENTS IS PERCEIVED TO BE THE SAME AS IN SEVERE PSORIASIS • Systemic therapy-naïve patients with mild-to-moderate psoriasis were associated with – Bothersome symptoms, such as fatigue and psoriasis in special areas – Substantial quality-of-life burde
Slide 27: Efficacy of Otezla in Mild-to-Moderate Psoriasis Patients
EFFICACY OF OTEZLA® IN MILD-TO-MODERATE PSORIASIS PATIENTS REGARDLESS OF DISEASE EXTENT AT BASELINE • More than half of patients achieved target of BSA<3 at Week 16 • No new safety signals were identified ADVANCE study inclusion: Adults with mild-to-moderate plaque psoriasis (static Physician Global
Slide 28: Mild-to-Moderate Indication Could Move Otezla into Earlier Lines
MILD-TO-MODERATE PSORIASIS INDICATION COULD HELP OTEZLA® MOVE INTO EARLIER LINES OF TREATMENT Otezla® Has Potential to Address Patients Across the Psoriasis Continuum Mild Moderate Severe • Biologics • Biosimilars • Topicals • JAK / TYK2 inhibitors Oral PDE4 Inhibitor Based on current moderate – sev
Slide 29: Otezla Is Well-Positioned for Continued Growth
OTEZLA® IS WELL-POSITIONED FOR CONTINUED GROWTH • Potential to be the first and only systemic oral treatment indicated for active psoriatic arthritis (PsA) as well as mild-to-severe psoriasis (PsO) • Long-term safety profile, with no required lab monitoring or prescreening • Over 90% of commercially
Slide 30: Tezepelumab
TEZEPELUMAB A FIRST-IN-CLASS INVESTIGATIONAL ANTI-TSLP MONOCLONAL ANTIBODY WITH DEMONSTRATED EFFICACY ACROSS A BROAD POPULATION OF PATIENTS WITH SEVERE UNCONTROLLED ASTHMA
Slide 31: Significant Unmet Medical Need Remains in Severe Asthma
SIGNIFICANT UNMET MEDICAL NEEDS REMAINS IN TREATING SEVERE ASTHMA of patients started on biologic therapy continue 40%–60% to experience ≥ 1 exacerbations per year1 have EOS < 300 in which have multiple drivers 50% 50%–60% current biologics have of inflammation2,3 sub-optimal efficacy4 EOS = eosinop
Slide 32: Significant Unmet Need in Severe Uncontrolled Asthma
SIGNIFICANT UNMET NEED IN PATIENTS WITH SEVERE UNCONTROLLED ASTHMA • Patients with severe uncontrolled asthma experience significant symptoms that impact their quality-of-life – Frequent exacerbations requiring systemic/oral corticosteroids1 – Serious exacerbations requiring 1.6M emergency room visi
Slide 33: Tezepelumab: Differentiated, First-in-Class Investigational Therapy
TEZEPELUMAB: A DIFFERENTIATED, FIRST-IN-CLASS INVESTIGATIONAL THERAPY FOR SEVERE ASTHMA • Tezepelumab is the first human monoclonal antibody that specifically blocks TSLP, a key epithelial cytokine at the top of the inflammatory cascade • In response to insults, the airway epithelium releases alarmi
Slide 34: Tezepelumab Reduced Exacerbations Irrespective of Eosinophil Counts
TEZEPELUMAB REDUCED EXACERBATIONS IRRESPECTIVE OF BASELINE EOSINOPHIL COUNTS AND ALLERGIC STATUS 3.00 2.50 Tezepelumab 210 mg Q4W Placebo 2.50 2.66 2.00 AAER Over 52 Weeks AAER Over 52 Weeks 2.00 Percentage reduction in 1.73 Percentage reduction in AAER versus placebo 1.50 AAER versus placebo 1.50 7
Slide 35: Tezepelumab Reduced Exacerbations Requiring Hospitalizations or ER Visits
TEZEPELUMAB SIGNIFICANTLY REDUCED EXACERBATIONS REQUIRING HOSPITALIZATIONS OR ER VISITS AAER associated with hospitalizations and ER visits AAER associated with hospitalizations 0.30 0.30 0.28 0.28 0.26 0.28 0.26 Tezepelumab 210 mg Q4W 0.24 0.24 Placebo 0.22 0.22 AAER over 52 weeks AAER over 52 week
Slide 36: Tezepelumab Has Potential to Transform Care for Severe Asthma
TEZEPELUMAB HAS THE POTENTIAL TO TRANSFORM CARE FOR PATIENTS WITH SEVERE ASTHMA • First and only biologic to demonstrate significant and clinically meaningful reductions in exacerbations irrespective of: – Eosinophil counts – Fractional exhaled nitric oxide levels – Allergic status • No clinically m
Slide 37: Approximately 1 Million Patients May Be Eligible in the U.S.
APPROXIMATELY 1 MILLION PATIENTS WITH SEVERE ASTHMA MAY BE ELIGIBLE FOR TEZEPELUMAB IN THE U.S. Asthma Prevalence2 25.9M Severe Asthma Prevalence3 4.2M Potential Tezepelumab-target3 ~ 1M Potential eligible patient pool includes both low-EOS (< 300 cells/ul, 50-60% of population)1 and high-EOS patien
Slide 38: Launch Benefits from Amgen and AstraZeneca Shared Capabilities
TEZEPELUMAB LAUNCH WILL BENEFIT FROM AMGEN AND ASTRAZENECA’S SHARED CAPABILITIES • Commercialization of tezepelumab will reflect a “best of both” approach from Amgen and AstraZeneca – 20 years of Amgen contracting and access in inflammation – 50 years of AstraZeneca expertise in respiratory disease
Slide 39: Exploring Tezepelumab in Multiple Indications Beyond Severe Asthma
EXPLORING TEZEPELUMAB IN MULTIPLE INDICATIONS BEYOND SEVERE ASTHMA • Phase 3 study enrolling patients with chronic rhinosinusitis with nasal polyps • Phase 2b study enrolling patients with chronic spontaneous urticaria • Phase 2 study enrolling patients with COPD COPD = chronic obstructive pulmonary
Slide 40: AMG 714 / PRV-015
AMG 714 / PRV-015 FIRST-IN-CLASS INVESTIGATIONAL ANTI IL-15 MONOCLONAL ANTIBODY FOR THE TREATMENT OF CELIAC DISEASE
Slide 41: AMG 714 / PRV-015 – Novel Approach to Treating Celiac Disease
AMG 714 / PRV-015 – NOVEL APPROACH TO TREATING CELIAC DISEASE • Celiac disease is a serious autoimmune disease in genetically predisposed people where ingestion of gluten leads to small intestine damage – Affects ~ 0.7% of adults worldwide—up to 30% of patients have nonresponsive celiac disease (NRC
Slide 42: Efavaleukin Alfa and Rozibafusp Alfa
EFAVALEUKIN ALFA A NOVEL IL-2 MUTEIN DESIGNED TO SELECTIVELY INCREASE REGULATORY T CELLS ROZIBAFUSP ALFA A FIRST-IN-CLASS MULTISPECIFIC BIOLOGIC THAT TARGETS BAFF AND ICOSL SIMULTANEOUSLY
Slide 43: Systemic Lupus Erythematosus Needs New Effective Therapies
SYSTEMIC LUPUS ERYTHEMATOSUS IS AN AUTOIMMUNE DISEASE IN NEED OF NEW EFFECTIVE THERAPIES • Diagnosed prevalence estimate for SLE is ~ 250K in the U.S., ~ 500K in 7 major worldwide markets—expected to grow at 0.5% annually • SLE is > 2X as prevalent in African Americans than other racial groups in th
Slide 44: Efavaleukin Alfa
EFAVALEUKIN ALFA A NOVEL IL-2 MUTEIN DESIGNED TO SELECTIVELY INCREASE REGULATORY T CELLS
Slide 45: Efavaleukin Alfa (AMG 592) Is an IL-2 Mutein
EFAVALEUKIN ALFA (AMG 592) IS AN IL-2 MUTEIN DESIGNED TO ADDRESS AUTOIMMUNE DISORDERS • Regulatory T cells (Tregs) maintain balance in the immune system by negatively regulating other immune cells • Treg impairment or deficiency has been reported in multiple human autoimmune conditions • Phase 1a s
Slide 46: Rozibafusp Alfa
ROZIBAFUSP ALFA A FIRST-IN-CLASS MULTISPECIFIC BIOLOGIC THAT TARGETS BAFF AND ICOSL SIMULTANEOUSLY
Slide 47: Rozibafusp Alfa Targets BAFF and ICOSL Simultaneously
ROZIBAFUSP ALFA IS A FIRST-IN-CLASS, MULTISPECIFIC BIOLOGIC THAT TARGETS BAFF AND ICOSL SIMULTANEOUSLY • T cell ‒ B cell interactions are crucial in the production of autoreactive antibodies, a hallmark of autoimmune diseases such as SLE • Interaction of inducible T cell co-stimulator (ICOS), with i
Slide 48: Amgen's 20 Years of Leadership in Inflammation
AMGEN’S 20 YEARS OF LEADERSHIP IN INFLAMMATION • • AMG 451 / KHK4083 • AMG 714 / PRV-015 • AMG 570 (Rozibafusp alfa) • AMG 592 (Efavaleukin alfa) • Biosimilar candidates to – STELARA® – EYLEA® – SOLIRIS® Provided October 4, 2021, as part of an oral presentation and is qualified by such, contains for
Slide 49: Several Inflammation Biosimilar Launches to Generate Growth
SEVERAL INFLAMMATION BIOSIMILAR LAUNCHES TO GENERATE GROWTH • We commercialize biosimilars alongside our branded products, which creates a cost-effective selling model • Successfully developed a $2 billion franchise • EU leadership • Broad portfolio that complements our branded products • Sequential
Slide 50: Biosimilars Annualizing at $2 Billion; Growth from Sequential Launches
BIOSIMILARS ARE ANNUALIZING AT $2 BILLION; FUTURE GROWTH TO BE DRIVEN BY SEQUENTIAL LAUNCHES Originator 2020 WW Therapeutic Area Amgen Biosimilar Amgen Biosimilar Status Product Originator Sales AVASTIN® ~$5B Hematology-Oncology MVASI® Launched in U.S. & EU HERCEPTIN® ~$4B Hematology-Oncology KANJIN
Slide 51: Sequential Launches of Biosimilars Will Strengthen Inflammation Presence
SEQUENTIAL LAUNCHES OF BIOSIMILARS WILL STRENGTHEN OUR INFLAMMATION PRESENCE WITH PATIENTS Phase 3 data for Anticipated U.S. launch biosimilar candidates of ABP 959, biosimilar Additional Anticipated candidate to SOLIRIS® biosimilar to STELARA®, AMJEVITA™ U.S. launch EYLEA®, & SOLIRIS® (March 1, 202
Slide 52: Broad Inflammation Portfolio Benefits from Strong Access Capabilities
OUR BROAD INFLAMMATION PORTFOLIO BENEFITS FROM STRONG ACCESS CAPABILITIES Respiratory and Allergy Gastrointestinal Dermatology Rheumatology • Proven success in contracting over 20 years – Enbrel®: > 85% first-line coverage – Otezla®: > 90% first-line coverage • Digital capabilities leveraged through
Slide 53: We Expect Inflammation to Be a Meaningful Growth Driver
WE EXPECT INFLAMMATION TO BE A MEANINGFUL GROWTH DRIVER • Amgen is well-positioned to build on our ~20 years of leadership in inflammation • We have near-term launch opportunities for multiple innovative molecules – Mild-to-moderate indication would allow Otezla® to treat patients across psoriasis c
Slide 54: Q&A
Q&A
Slide 55: AMG 451/KHK4083 Presentation
AMG 451/KHK4083 PRESENTATION
Slide 56: Efficacy and Safety Results of KHK4083/AMG 451 in Atopic Dermatitis
Efficacy and Safety Results of KHK4083/AMG 451 (Anti-OX40 mAb) in Subjects With Moderate to Severe Atopic Dermatitis: A Phase 2, Multicentre, Randomized, Double-blind, Parallel-Group, Placebo-Controlled Study Emma Guttman-Yassky,1 Eric Simpson,2 Kristian Reich,3 Kenji Kabashima,4 Ken Igawa,5 Hidetos
Slide 57: Speaker Disclosures
Speaker Disclosures ▪ Research support, consulting or lecture fees on atopic dermatitis received from Regeneron, Sanofi, Pfizer, Galderma, Celgene, Leo Pharma, Janssen, Medimmune, Dermira, Anacor, AnaptysBio, Glenmark, Novartis, Abbvie, GSK, Sun Pharma, Mitsubishi Tanabe, Vitae, Almirall, Asana Bios
Slide 58: KHK4083/AMG 451 Targets OX40 as Potential Novel Target for AD
KHK4083/AMG 451 targets OX40 as a potential novel target for AD treatment Naïve T cells ▪ Activation of Th2 and other T-cell subsets is central in atopic TCR MHC I CD28 B7 dermatitis (AD) Activated APC Primed T cell ▪ The OX40–OX40L axis plays a critical role in long-lasting T- KHK4083, mAb Activate
Slide 59: Phase 2 Study Design (NCT03703102)
Phase 2 Study Design (NCT03703102) Treatment A Treatment B Follow- Primary efficacy endpoint Screening (Up to Week 18) (Week 18-Week 36) up ▪ Percentage change in EASI score from baseline to Week Adults with Placebo KHK4083 600 mg SC Q2W 16 chronic AD EASI ≥16; IGA ≥3; BSA ≥10%; Secondary efficacy e
Slide 60: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics (Safety Analysis Set) All baseline parameters were generally well-balanced among the treatment groups Placebo/ KHK4083 KHK4083 KHK4083 KHK4083 KHK4083 150 mg Q4W 600 mg Q4W 300 mg Q2W 600 mg Q2W 600 mg Q2W Total Characteristics* N=54 N=53 N=55 N=54 N
Slide 61: Primary Endpoint: % Change in EASI Scores (Week 16)
Primary Endpoint: % Change in EASI Scores (Week 16) From Baseline (Last observation carried forward, Full Analysis Set) All KHK4083-treated groups achieved the primary endpoint KHK4083 KHK4083 KHK4083 KHK4083 150 mg Q4W 600 mg Q4W 300 mg Q2W 600 mg Q2W Placebo n=52 n=52 n=52 n=54 n=57 0 LS mean % ch
Slide 62: Proportion of Patients Who Achieved EASI-75
Proportion of Patients Who Achieved EASI-75 (Non-responder Imputation, Full Analysis Set) Proportions of EASI-75 responders at Week 16 were significantly higher in all KHK4083-treated cohorts versus placebo Treatment period A Treatment period B (Placebo-controlled period) (All groups received KHK408
Slide 63: Proportion of Patients Who Achieved EASI-90
Proportion of Patients Who Achieved EASI-90 (Non-responder Imputation, Full Analysis Set) Proportions of EASI-90 responders at Week 16 were significantly higher in most KHK4083-treated cohorts versus placebo Treatment period A Treatment period B (Placebo-controlled period) (All groups received KHK40
Slide 64: Proportions of Patients Achieving IGA Score of 0/1
Proportions of Patients Who Achieved an IGA Score of 0/1 and a Reduction of ≥2 Points from Baseline (Non-responder Imputation, Full Analysis Set) In all KHK4083 groups, the proportion of subjects who achieved IGA score 0/1 gradually increased up to Week 36 Treatment period A Treatment period B (Plac
Slide 65: Proportions Achieving Reduction of ≥4 Points for Pruritus-NRS
Proportions of Patients Who Achieved Reduction of ≥4 Points for Pruritus-NRS (Non-responder Imputation, Full Analysis Set) Proportions of Pruritus-NRS responders at Week 16 were significantly higher in most KHK4083-treated groups versus placebo Treatment period A Treatment period B (Placebo-controll
Slide 66: Durability of EASI-75 Response After Treatment Discontinuation
Durability of EASI-75 Response After Treatment Discontinuation in Subjects who achieved EASI-75 at Week 36 EASI-75 response was durable even after discontinuation of KHK4083 at Week 36 100 80 Probability of not having relapse in EASI-75 (%) 60 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 Time (Weeks
Slide 67: TEAEs – Treatment A Period
TEAEs – Treatment A Period (Safety Analysis Set) In Treatment A period, 81% TEAEs occurred in KHK4083 groups versus 72% in the placebo group KHK4083 KHK4083 KHK4083 KHK4083 KHK4083 Placebo Category 150 mg Q4W 600 mg Q4W 300 mg Q2W 600 mg Q2W Total N=57 N=54 N=53 N=55 N=54 N=216 Any TEAEs 37 (68.5) 4
Slide 68: TEAEs in >5% of Subjects by Preferred Term
TEAEs in >5% of Subjects in the Total KHK4083 Group by Preferred Term - Treatment A Period (Safety Analysis Set) ▪ The most frequent TEAEs in KHK4083 groups were pyrexia, nasopharyngitis, worsening of AD, and chills ▪ Events of pyrexia and chills were mild to moderate in intensity and were mostly ob
Slide 69: Conclusions
Conclusions ▪ KHK4083/AMG 451 represents a novel mechanism of action and its use resulted in significant improvements in signs and symptoms of AD compared with placebo, across primary and secondary efficacy parameters at Week 16 ▪ Importantly, KHK4083/AMG 451 demonstrated progressive improvement in
Slide 70: Acknowledgments
Acknowledgments The authors are grateful to all patients who participated in the trial, the investigators and the staff who helped in trial management, and Dr. Michael Croft at La Jolla Institute for Immunology who identified an important role of OX40 in maintaining T-cell proliferation and survival
Slide 71: Growing Our Leadership in Inflammation
GROWING OUR LEADERSHIP IN INFLAMMATION OCTOBER 4, 2021