Amgen (AMGN) investor relations material

Pipeline and clinical development updates

• Plans to initiate phase III studies for UPLIZNA in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy later this year, targeting diseases with significant unmet needs.

• UPLIZNA's broad B-cell depletion mechanism is expected to address a range of autoimmune conditions, with a U.S. CIDP patient pool estimated at 35,000 and AIH likely larger.

• Daxdilimab showed positive phase II results in discoid lupus, meeting primary and key secondary endpoints, and is under consideration for phase III development.

• Dazodalibep, a CD40 ligand inhibitor, is in phase III for Sjögren's syndrome, targeting both moderate-to-severe systemic and high symptomatic burden populations.

• TEZSPIRE received label expansion for chronic rhinosinusitis with nasal polyps, with phase III studies ongoing in COPD and eosinophilic esophagitis.

Mechanistic and competitive insights

• UPLIZNA's CD19 targeting allows depletion of a broad spectrum of B-cells, supporting its use in multiple autoantibody-driven diseases.

• Daxdilimab depletes plasmacytoid dendritic cells, showing efficacy in cutaneous lupus but not in SLE, likely due to differences in disease biology.

• Dazodalibep's inhibition of the CD40/CD40L axis addresses upstream immune activation in Sjögren's, with phase II data showing improvement in disease activity and patient-reported outcomes.

• TEZSPIRE targets TSLP, an upstream driver of inflammation, offering a differentiated profile versus IL-4, IL-5, and IL-13 therapies.

• Inhaled TSLP antibody fragment (AMG 104) is in phase II, with potential to offer an alternative to injected biologics for asthma.

Market opportunity and future outlook

• Expansion into new indications for UPLIZNA and daxdilimab is being considered, with further data review and strategic planning underway.

• TEZSPIRE's broad applicability across asthma, nasal polyps, COPD, and EoE positions it as a durable growth driver beyond 2026.

• The company is focused on execution in large populations before pursuing additional indications for TEZSPIRE, but sees potential in inhaled TSLP agents.

• Upcoming data readouts in the second half of the year for Sjögren's, EoE, and inhaled TSLP are expected to shape future development and market positioning.

• The competitive landscape in Sjögren's and EoE is evolving, with the company aiming to differentiate through mechanistic innovation and clinical outcomes.