Amgen Inc. · NASDAQ:AMGN
Amgen — Investor Presentation (September 2024)
20 slides from Amgen's investor presentation, Sep 24, 2024
Slide 1: Driving Long-Term Growth: Rocatinlimab and UPLIZNA Update
Driving Long-Term Growth: Rocatinlimab and UPLIZNA® Update September 24, 2024
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 outco
Slide 3: Participants
Participants Jay Bradner, MD Exec. VP, Research & Development, Amgen Murdo Gordon Exec. VP, Global Commercial Operations, Amgen Vikram Karnani Exec. VP, Rare Disease, Amgen 3 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, a
Slide 4: Four Therapeutic Area Pillars Driving Long-term Growth
Four Therapeutic Area Pillars Driving Long-term Growth GENERAL MEDICINE ONCOLOGY INFLAMMATION RARE DISEASE Y Marketed Products Innovative Pipeline Biosimilars 4 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results
Slide 5: Rocatinlimab ROCKET Phase 3 Program Update
Rocatinlimab ROCKET Phase 3 Program Update
Slide 6: Atopic Dermatitis (AD) Impacts Over 30 Million Individuals Globally
Atopic Dermatitis (AD) Impacts Over 30 Million Individuals Globally • AD is complex and heterogeneous, presenting with a broad range of symptoms that significantly affects patients’ quality of life ◦ Impacts ~15%–20% of children and up to 10% of adults in the U.S. ◦ Approximately 40% of U.S. adults
Slide 7: Rocatinlimab Rebalances T-cells by Targeting OX40 Receptor
Rocatinlimab Rebalances T-cells by Targeting OX40 Receptor T-cell Imbalance T-cell Rebalance Driven by increased activity and number of pathogenic T-cells Achieved by inhibition and reduction of pathogenic T-cells Resting OX40 T-cell Rocatinlimab Receptor Pathogenic Rocatinlimab T-cell rebalances pa
Slide 8: ROCKET Phase 3 Program in Atopic Dermatitis Well Underway with Potential in Other Diseases
ROCKET Phase 3 Program in Atopic Dermatitis Well Underway with Potential in Other Diseases HORIZON: placebo-controlled monotherapy rocatinlimab (N = 726) IGNITE: placebo-controlled monotherapy evaluating two rocatinlimab doses (N = 769) Adult SHUTTLE: placebo-controlled trial evaluating two rocatinl
Slide 9: HORIZON Phase 3 Trial: Investigation of Rocatinlimab in Atopic Dermatitis
HORIZON Phase 3 Trial: Investigation of Rocatinlimab in Atopic Dermatitis (AD) Monotherapy Treatment (24 Weeks) 20210146 N = 543 Rocatinlimab Dose 1 Q4W Long-term Randomization + loading dose at W2 Maintenance Trial Screening N = 726 (3:1) N = 183 Placebo Q4W + loading dose at W2 Safety Follow-Up We
Slide 10: HORIZON Phase 3 Trial: Primary & Key Secondary Endpoints
HORIZON Phase 3 Trial: Primary & Key Secondary Endpoints • Co-primary endpoint: • EASI 75: ≥ 75% improvement in the Eczema Area and ◦ For US: EASI-75 and rIGA 0/1 at week 24 Severity Index (EASI), a detailed and objective ◦ Ex-US: EASI-75 and vIGA-AD 0/1 at week 24 measure that quantifies the extent
Slide 11: HORIZON Phase 3 Trial: Summary of Results
HORIZON Phase 3 Trial: Summary of Results • Statistically significant improvement observed in co-primary endpoints: o 32.8% of rocatinlimab treated subjects achieved an EASI-75 response at week 24 vs. 13.7% placebo (19.1% difference, p<0.001) o 19.3% of rocatinlimab treated subjects achieved a vIGA-
Slide 12: The Robust ROCKET Phase 3 Program Is Designed to Provide a Complete Understanding of Rocatinlimab's Profile
The Robust ROCKET Phase 3 Program Is Designed to Provide a Complete Understanding of Rocatinlimab’s Profile • The HORIZON trial readout is the first of eight pivotal study readouts in atopic dermatitis, building our understanding of rocatinlimab’s profile • We continue to pursue studies in asthma an
Slide 13: UPLIZNA (inebilizumab-cdon) Update
UPLIZNA® (inebilizumab-cdon) Update IgG4 Related Disease Generalized Myasthenia Gravis
Slide 14: UPLIZNA Is an Anti-CD19, Humanized Monoclonal Antibody
UPLIZNA® Is an Anti-CD19, Humanized Monoclonal Antibody Optimized for CD19 binding • CD19 targeted agent with potential in multiple autoimmune diseases ◦ Glycoengineered design to provide efficacy - in those that may have diminished responses to other monoclonal antibodies • Provides targeted, rapid
Slide 15: IgG4-Related Disease Is a Serious Illness Often Resulting in Permanent Organ Damage
IgG4-Related Disease Is a Serious Illness Often Resulting in Permanent Organ Damage IgG4-Related Disease is Caused by Characteristics and Symptoms Multiple Mechanisms of B-Cell Dysfunction • Chronic, debilitating rare disease characterized by tumor-like inflammatory and fibrotic mass formation in af
Slide 16: Landmark MITIGATE Phase 3 Trial Demonstrated Impressive Results in IgG4-RD
Landmark MITIGATE Phase 3 Trial Demonstrated Impressive Results in IgG4-RD; Granted Breakthrough Therapy Designation by FDA • First global placebo controlled, randomized controlled trial in IgG4-RD. • Met primary endpoint, demonstrating a clinically meaningful and statistically significant 87% reduc
Slide 17: Evaluating UPLIZNA to Address Unmet Needs in a Broad Generalized Myasthenia Gravis Patient Population
Evaluating UPLIZNA® to Address Unmet Needs in a Broad Generalized Myasthenia Gravis Patient Population • gMG is a chronic, rare autoimmune neuromuscular disorder ◦ Two main types of gMG: AChR+ and MuSK+ • Symptoms include weakness in voluntary muscles, especially those that control the eyes, mouth,
Slide 18: MINT: A Phase 3 Trial of UPLIZNA in Generalized Myasthenia Gravis
MINT: A Phase 3 Trial of UPLIZNA® in Generalized Myasthenia Gravis (gMG) Double-blind Randomized Control Period (RCP) Optional Open (AChR+ & MuSK+) N = 119 IV Inebilizumab (300mg)1 Label Period (OLP) Randomization Treatment: Day 1, Day 15, and Day 183 Q6M dosing Screening (1:1) N = 238 N = 119 IV pl
Slide 19: Potential Practice-Changing Phase 3 Results in Generalized Myasthenia Gravis from MINT Trial
Potential Practice-Changing Phase 3 Results in Generalized Myasthenia Gravis from MINT Trial • Clinically meaningful and statistically significant MG-ADL score improvement after two doses of UPLIZNA® compared to placebo at Week 26: -4.2 overall improvement, -1.9 placebo adjusted (p < 0.0001, primary
Slide 20: Questions?
Questions? AMGEN