AMGEN INC

Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2023.

Products/Pipeline

Maridebart cafraglutide

In November 2024, we announced positive data at 52 weeks in part 1 of a double-blind, dose-ranging Phase 2 study with MariTide, a differentiated peptide-antibody conjugate subcutaneously administered monthly or less frequently. In people living with obesity or overweight without type 2 diabetes, MariTide demonstrated up to approximately 20% average weight loss at week 52 without a weight loss plateau. The study also showed people living with obesity or overweight and type 2 diabetes achieved up to approximately 17% average weight loss without a weight loss plateau and lowered their average hemoglobin A1C (HbA1c) by up to 2.2 percentage points at week 52. MariTide also demonstrated robust and clinically meaningful improvements in cardiometabolic parameters, including blood pressure, triglycerides and high-sensitivity C-reactive protein (hs-CRP) across doses.

The most common adverse events (AEs) in part 1 of the Phase 2 study were gastrointestinal (GI) related, including nausea, vomiting and constipation. The incidence of nausea and vomiting was substantially reduced with dose escalation. The discontinuation rate in the dose escalation arms due to any AE was approximately 11% and less than 8% for GI-related AEs.

IMDELLTRA

In May 2024, we announced IMDELLTRA received accelerated approval from the FDA for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

In June 2024, we announced BLINCYTO received approval from the FDA in frontline consolidation for patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).

In December 2024, we announced new data from a Phase 3 trial demonstrating that adding BLINCYTO to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-ALL of average or higher risk of relapse. The study met its primary endpoint of DFS. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At three years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone. Safety results are consistent with the known safety profile of BLINCYTO.

TEPEZZA

In September 2024, we announced TEPEZZA was approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan.

UPLIZNA

In June 2024, we announced positive top-line results from our Phase 3 registrational trial evaluating UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD). The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period. All key secondary endpoints were also met, which were annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission. No new safety signals were identified. The FDA has accepted our submission under priority review, with a Prescription Drug User Fee Action (PDUFA) date of April 3, 2025.

In September 2024, we announced top-line results of the Phase 3 MINT trial of UPLIZNA. MINT is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis (gMG). The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared with placebo at week 26 of the combined patient population. UPLIZNA demonstrated a statistically significant and clinically meaningful change from baseline compared to placebo for four out of five key secondary endpoints. Overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of UPLIZNA.

Rocatinlimab

In September 2024, we announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor and one of eight studies in the rocatinlimab Phase 3 clinical trial program for atopic dermatitis. HORIZON, a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate-to-severe atopic dermatitis, met its co-primary endpoints and reached statistically significant difference from placebo for all key secondary endpoints. Overall safety findings in the study were comparable to those seen in the Phase 2b study. Rocatinlimab is being developed in collaboration with Kyowa Kirin.

In November 2024, we announced positive top-line results from the Phase 3 WAYPOINT trial, a double-blind, multi-center, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of TEZSPIRE in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP). The trial demonstrated patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo with safety and tolerability profiles consistent with the known profile of the medicine. TEZSPIRE is being developed in collaboration with AstraZeneca.