Q1 '25 Earnings Call May 1, 2025 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 outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (a ...

Core Insights - Amgen's UPLIZNA has received FDA approval as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet medical need in this chronic and debilitating condition [1][2][8] Company Developments - The approval of UPLIZNA is a pivotal moment for patients and healthcare providers, offering a proven treatment that targets a key driver of IgG4-RD, thereby reducing the risk of flares and reliance on long-term steroid use [2][3] - UPLIZNA's efficacy is supported by data from the MITIGATE trial, which demonstrated an 87% reduction in the risk of IgG4-RD flares compared to placebo [9] - UPLIZNA is also indicated for the treatment of AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) and has received Orphan Drug Designation for generalized myasthenia gravis (gMG), with regulatory filings for gMG expected to be completed in H1 2025 [1][8] Clinical Trial Insights - The MITIGATE trial was the first randomized, double-blind, placebo-controlled trial for IgG4-RD, showing significant reductions in disease activity and flares among patients treated with UPLIZNA [4][5] - Key findings from the trial include that 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, and complete remission at Week 52, compared to 22.4% in the placebo group [9] - UPLIZNA-treated patients experienced a ten-fold reduction in mean total glucocorticoid use for disease control compared to those on placebo [9] Disease Background - IgG4-RD is a chronic, systemic, immune-mediated disease that can affect multiple organs and lead to fibrosis and permanent organ damage [6] - The disease is characterized by unpredictable inflammatory flares and can mimic other conditions, complicating timely diagnosis [6][7] - The prevalence of IgG4-RD is estimated at 20,000 people in the U.S., with a higher incidence in men and typical onset between ages 50 and 70 [6]