What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-02-13 compared with 2025-02-14 · 329 added, 321 removed, 596 unchanged (52% of the section changed)

10 unchanged sentences

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.

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.

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.

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.

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.

In August 2025, we announced that the FDA broadened the approved use of Repatha to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), removing the previous requirement that a patient have been diagnosed with cardiovascular (CV) disease.

In November 2025, we announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha achieved statistically significant and clinically meaningful reductions in MACEs in high-risk adults without a prior heart attack or stroke, when added to statins or other LDL-C–lowering treatments.

Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and a 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE).

Repatha also reduced the risk of heart attack by 36%.

In a cohort of patients included in a lipid sub-study, the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo arm.

No new safety signals were identified, and tolerability was consistent with the current prescribing information in the United States.

In April 2025, we announced the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

UPLIZNA is the first and only FDA approved treatment for adults living with IgG4-RD.

In December 2025, we announced the FDA approved UPLIZNA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

IMDELLTRA/IMDYLLTRA

In June 2025, we announced interim results from the global Phase 3 DeLLphi-304 trial evaluating IMDELLTRA/IMDYLLTRA in patients with small cell lung cancer (SCLC) who had progressed on or after one line of platinum-based chemotherapy.

The study demonstrated that IMDELLTRA/IMDYLLTRA significantly reduced the risk of death by 40% compared to standard-of-care chemotherapy, with a median overall survival of 13.6 months compared to 8.3 months.

Additionally, IMDELLTRA/IMDYLLTRA showed a statistically significant improvement in median progression-free survival of 4.2 months compared to 3.7 months and enhanced patient-reported outcomes related to cancer-associated symptoms, including dyspnea and cough.

The safety profile of IMDELLTRA/IMDYLLTRA was consistent with prior studies.

In November 2025, we announced that the FDA granted full approval for IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy, converting its prior accelerated approval to full approval based on results from the global Phase 3 DeLLphi-304 study.

In October 2025, we announced that the FDA approved TEZSPIRE as an add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.

In June 2025, the European Commission granted marketing authorization approval of TEPEZZA for treatment of adults with moderate-to-severe thyroid eye disease (TED).

Maridebart cafraglutide (MariTide ™ )

In March 2025, we announced the initiation of two global Phase 3 studies to evaluate MariTide, a differentiated antibody-peptide conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR), in chronic weight management:

one study in adults living with obesity or overweight without Type 2 diabetes and another study in adults living with obesity or overweight with Type 2 diabetes.

In June 2025, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85 th Scientific Sessions and simultaneously published in The New England Journal of Medicine .

In November 2025, we announced that, in addition to the two global Phase 3 studies announced in March 2025, four global Phase 3 studies were underway, with studies in adults living with established atherosclerotic cardiovascular disease and obesity or overweight;

in adults living with heart failure with preserved or mildly reduced ejection fraction and obesity;

in adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight;

and in adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.

In January 2026, we announced that Part 2 of the Phase 2 chronic weight management study, an exploratory evaluation of MariTide treatment for an additional 52 weeks in people who lost at least 15% of their body weight in the 52-week Part 1 of the Phase 2 chronic weight management study, is complete.

Key findings included the following:

the large majority of participants maintained the weight loss achieved in Part 1 for an additional 52 weeks on a lower monthly dose or quarterly dose of MariTide;

the second year of MariTide treatment was very well tolerated, including at quarterly doses, with a very low incidence of nausea and vomiting and no new safety signals observed;

and improvements in cardiometabolic parameters were sustained with MariTide at effective maintenance doses for a full second year.

In January 2026 we also announced that a Phase 2 study of MariTide for the treatment of Type 2 diabetes in adults living with and without obesity has completed the 24-week timepoint.

Key findings included the following:

robust and clinically meaningful reduction in both hemoglobin A1c (HbA1c) and weight with monthly MariTide at 24 weeks, which is in line with results seen in the Type 2 diabetes population in Part 1 of the Phase 2 chronic weight management study, at 24 weeks;

safety and tolerability profile consistent with the GLP-1 class, where the most common side effects were gastrointestinal-related, predominantly mild-to-moderate in nature, and occurred primarily during dose escalation;

and favorable improvement in cardiometabolic parameters.

TAVNEOS was approved by the FDA in October 2021 for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids.

TAVNEOS was developed by ChemoCentryx.

Amgen acquired ChemoCentryx in October 2022, after TAVNEOS had been on the market for a year.

On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S.

The FDA raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial.

Hepatotoxicity, which is a known infrequent risk of TAVNEOS treatment for AAV, was also raised in the context of the benefit-risk profile of the medicine.

Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial, and after review of the relevant clinical data and years of real-world evidence, Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile.

On January 28, 2026, following FDA regulatory process, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market.

Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront.

Bemarituzumab

In February 2026, we announced that, based upon data from the FORTITUDE-101 and FORTITUDE-102 Phase 3 studies, the Company does not intend to pursue regulatory approval of bemarituzumab in first-line gastric cancer.

In January 2026, we and Kyowa Kirin agreed to terminate the rocatinlimab collaboration agreement and to transition control of the global development and commercialization program to Kyowa Kirin, subject to receipt of clearance under the

Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In February 2026, we received such regulatory clearance.

In the first quarter of 2026, Kyowa Kirin will assume full responsibility for rocatinlimab worldwide, except that Amgen will continue to manufacture rocatinlimab and perform other transition activities for an agreed upon period of time.

Marketing, Distribution and Selected Marketed Products

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We also commercialize and market our products into other geographic territories, including Japan, China and other parts of Asia, Latin America and the Middle East by using our own affiliates, by acquiring existing third-party businesses or product rights or by collaborating with third parties.

In the Asia Pacific region, we also sell our products in partnership with other companies, including Astellas Pharma Inc., BeiGene, Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Kirin and Mitsubishi Tanabe Pharma Corporation.

In the Asia Pacific region, we also sell our products in partnership with other companies, including Astellas Pharma Inc., BeOne, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd.

and Kyowa Kirin.

This international footprint allows us to deliver our medicines to more patients globally.

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In the United States, substantially all of our sales are to pharmaceutical wholesale distributors, which is the principal means of distributing our products to healthcare providers.

We market certain products through direct-to-consumer channels, including print, television and online media.

We market certain products through direct-to-patient channels, including print, television and online media.

For further discussion, see Government Regulation— Regulation in the United States — Regulation of Product Marketing and Promotion .

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In Europe, Prolia is used primarily for the treatment of osteoporosis in men and postmenopausal women at increased risk of fracture.

Our patents for RANKL antibodies, including sequences, for Prolia expire in February 2025 in the United States and November 2025 in select countries in Europe.

See Patents table below.

We market ENBREL, a tumor necrosis factor blocker, in the United States and Canada.

ENBREL was launched in 1998 and is used primarily in indications for the treatment of adult patients with moderately to severely active rheumatoid arthritis, patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and patients with active psoriatic arthritis.

We market XGEVA in many countries around the world.

Prolia and XGEVA contain the same active ingredient but are approved for different indications, patient populations, dose and frequency of administration.

XGEVA was launched in 2010 and is used primarily in the indication for prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with bone metastases from solid tumors and multiple myeloma.

Our patents for RANKL antibodies, including sequences, for XGEVA expire in February 2025 in the United States and November 2025 in select countries in Europe.

See Patents table below.

Our patents for RANKL antibodies, including sequences, for Prolia expired in February 2025 in the United States and in November 2025 in select countries in Europe.

We market Repatha, a PCSK9 inhibitor, in many countries around the world.

Repatha was launched in 2015 and is indicated to reduce the risks of myocardial infarction, stroke and coronary revascularization in adults with established cardiovascular disease.

Repatha is also indicated to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

Repatha was launched in 2015 and is indicated to reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.

Repatha is also indicated to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

See Significant Developments for additional information regarding regulatory developments.

We market Otezla, a small molecule that inhibits phosphodiesterase 4 (PDE4), in many countries around the world.

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and for pediatric patients six years of age and older and weighing at least 20 kilograms with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

We market TEPEZZA primarily in the United States.

TEPEZZA was acquired through our Horizon acquisition in October 2023.

TEPEZZA is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is the first and only approved medicine for the treatment of thyroid eye disease (TED).

Otezla is also approved in Japan for the treatment of palmoplantar pustulosis (PPP).

We market ENBREL, a tumor necrosis factor blocker, in the United States and Canada.

ENBREL was launched in 1998 and is used primarily in indications for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis, patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and patients with active psoriatic arthritis.

Together with our collaboration partners, we market EVENITY in many countries around the world.

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In Japan, EVENITY is used primarily in the indication for the treatment of osteoporosis in men and postmenopausal women at high risk of fracture.

We market XGEVA in many countries around the world.

Prolia and XGEVA contain the same active ingredient but are approved for different indications, patient populations, dose and frequency of administration.

Our patents for RANKL antibodies, including sequences, for XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe.

We market TEPEZZA for the treatment of TED in multiple countries globally, including the United States, Japan, Brazil, among others.

TEPEZZA was acquired through our Horizon acquisition in October 2023.

TEPEZZA is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is the first and only approved medicine for the treatment of TED.

See Significant Developments for additional information regarding regulatory developments.

We market BLINCYTO in many countries around the world.

BLINCYTO was launched in 2014 and has proven efficacy in a wide range of patients with CD19-positive B-cell acute lymphoblastic leukemia (B-ALL), including those who are MRD(–) or MRD(+) in frontline consolidation, and those with relapsed or refractory (R/R) disease.

Acute lymphoblastic leukemia (ALL) is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

We market Nplate in many countries around the world.

Nplate was launched in 2008 and is indicated to treat thrombocytopenia in patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

Together with our collaboration partner, we market TEZSPIRE in many countries around the world.

TEZSPIRE is currently approved for the treatment of severe uncontrolled asthma (SUA) in the United States, Europe, Japan and more than 70 countries across the globe.

In addition, TEZSPIRE is approved for chronic rhinosinusitis with nasal polyps (CRSwNP) in the United States, Europe and several additional countries.

TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation:

the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults.

See Significant Developments for additional information regarding regulatory developments.

We market KYPROLIS primarily in the United States and Europe.

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It is also approved as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous therapies.

We market Nplate in many countries around the world.

We market Aranesp primarily in the United States and Europe.

Aranesp was launched in 2001 and is indicated to treat a lower-than-normal number of red blood cells (anemia) caused by chronic kidney disease (CKD) in both patients on dialysis and patients not on dialysis.

Aranesp is also indicated for the treatment of anemia due to concomitant myelosuppressive chemotherapy in certain patients with nonmyeloid malignancies and when chemotherapy will be used for at least two months after starting Aranesp.

We market BLINCYTO in many countries around the world.

BLINCYTO was launched in 2014 and has proven efficacy in a wide range of patients with CD19-positive B-ALL, including those who are MRD(–) or MRD(+) in frontline consolidation, and those with relapsed or refractory (R/R) disease.

Acute lymphoblastic leukemia (ALL) is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

Aranesp is also indicated for anemia in certain patients with non-myeloid malignancies who are receiving concomitant myelosuppressive chemotherapy.

We market KRYSTEXXA in the United States.

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We market Vectibix in many countries around the world.

Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, cancer that has spread outside the colon and rectum) and in the United States, in combination with LUMAKRAS, for the treatment of adult patients with KRAS G12C-mutated mCRC, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, which is a cancer that has spread outside the colon and rectum) and in the United States, in combination with LUMAKRAS, for the treatment of adult patients with KRAS G12C-mutated mCRC, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

RAS status is determined by an FDA-approved test.

Together with our collaboration partner, we market TEZSPIRE in many countries around the world.

TEZSPIRE is currently approved for the treatment of severe asthma in the United States, Europe, Japan and more than 50 countries across the globe.

TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation:

the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults.

Other Marketed Products

We also market a number of other products in various markets worldwide, including but not limited to AMJEVITA/AMGEVITA, MVASI, Neulasta, RAVICTI, UPLIZNA, Parsabiv, LUMAKRAS/LUMYKRAS, Aimovig, TAVNEOS, PROCYSBI, EPOGEN and IMDELLTRA.

We also market a number of other products in various markets worldwide, including but not limited to MVASI, PAVBLU, UPLIZNA, IMDELLTRA/IMDYLLTRA, AMJEVITA/AMGEVITA, TAVNEOS, Neulasta, LUMAKRAS/LUMYKRAS, RAVICTI, Parsabiv, Aimovig, WEZLANA/WEZENLA and PROCYSBI.

The following table lists our outstanding material patents for the indicated product by territory, general subject matter and latest expiry date.

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Product Territory General subject matter Expiration

Prolia ® /XGEVA ® (denosumab)

RANKL antibodies, including sequences 2/19/2025

Europe RANKL antibodies, including sequences (1)

Enbrel ® (etanercept)

Fusion protein and pharmaceutical compositions 11/22/2028

DNA encoding fusion protein and methods of making fusion protein 4/24/2029

Formulations and methods of preparing formulations 10/19/2037

Product Territory General subject matter Expiration

Repatha ® (evolocumab)

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Europe Formulation 5/3/2033

Otezla ® (apremilast) (2)

Otezla ® /Otezla XR™ (apremilast)

Compositions and compounds (2)

TEPEZZA ® (teprotumumab-trbw)

IGF-1R antibodies (4)

Methods of treatment

Oral dosage forms for extended release and methods of treatment

Enbrel ® (etanercept)

Fusion protein and pharmaceutical compositions 11/22/2028

DNA encoding fusion protein and methods of making fusion protein 4/24/2029

Formulations and methods of preparing formulations 10/19/2037

Methods of treatment using formulations

EVENITY ® (romosozumab-aqqg)

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Europe Methods of treatment 4/18/2032

KYPROLIS ® (carfilzomib)

TEPEZZA ® (teprotumumab-trbw) (3)

IGF-1R antibodies

Methods of treatment

Compositions and compounds 12/7/2027

Methods of making 5/8/2033

Europe Compositions, compounds and methods of treatment (1)

Nplate ® (romiplostim)

Formulation 2/12/2028

Europe Formulation 4/20/2027

BLINCYTO ® (blinatumomab)

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Europe Method of treatment

KRYSTEXXA ® (pegloticase)

Polypeptides and pharmaceutical compositions

Methods of treatment

Nplate ® (romiplostim)

Formulation 2/12/2028

Europe Formulation 4/20/2027

TEZSPIRE ® (tezepelumab-ekko)

Polypeptides (5)

Methods of treatment 8/23/2038

Europe Polypeptides (1)

KYPROLIS ® (carfilzomib)

Compositions and compounds (4)

Methods of making 5/8/2033

Europe Compositions, compounds and methods of treatment (1)

Pharmaceutical compositions and methods of making 5/8/2033

KRYSTEXXA ® (pegloticase)

Polypeptides and pharmaceutical compositions

Methods of treatment, including combination therapy

UPLIZNA ® (inebilizumab-cdon)

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Europe CD19 antibodies, pharmaceutical compositions and methods of treatment (1)

IMDELLTRA ® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab)

Bifunctional polypeptides (5)

Bifunctional polypeptides 8/1/2036

TAVNEOS ® (avacopan)

Compounds and pharmaceutical compositions

Amorphous forms and pharmaceutical compositions and uses thereof

Europe Compounds, pharmaceutical compositions, and methods of treatment (1)

Europe Formulations

LUMAKRAS ® /LUMYKRAS™ (sotorasib)

Compounds and pharmaceutical compositions 5/21/2038

Crystalline form, pharmaceutical compositions and methods of treatment 5/20/2040

Methods of treatment 9/15/2040

Europe Compounds, pharmaceutical compositions and methods of treatment 5/21/2038

Product Territory General subject matter Expiration

Parsabiv ® (etelcalcetide)

5 unchanged sentences

Europe Methods of making

LUMAKRAS ® /LUMYKRAS™ (sotorasib)

Compounds and pharmaceutical compositions 5/21/2038

Crystalline form, pharmaceutical compositions and methods of treatment 5/20/2040

Methods of treatment 9/15/2040

Europe Compounds, pharmaceutical compositions and methods of treatment 5/21/2038

Aimovig ® (erenumab-aooe)

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Europe Methods of treatment 8/10/2035

TAVNEOS ® (avacopan)

Compounds and pharmaceutical compositions (5)

Amorphous forms and pharmaceutical compositions

Europe Compounds, pharmaceutical compositions, and methods of treatment (1)

Europe Formulations

IMDELLTRA ® (tarlatamab-dlle)/IMDYLLTRA ® (tarlatamab)

Bifunctional polypeptides (5)

Bifunctional polypeptides

(1) A European patent with this subject matter may also be entitled to supplemental protection in one or more countries in Europe, and the length of any such extension will vary by country.

For example, supplementary protection certificates have been issued related to the indicated products for patents in at least the following countries:

• denosumab — France, Germany, Italy, Spain and the United Kingdom, expiring in November 2025

• evolocumab — France, Italy, Spain and the United Kingdom, expiring in 2031

• romosozumab — France, Germany, Italy, Spain and the United Kingdom, expiring in 2031

• carfilzomib — France, Germany, Italy, Spain and the United Kingdom, expiring in 2030

• blinatumomab — France, Germany, Italy, Spain and the United Kingdom, expiring in 2029

• tezepelumab — France, Italy and Spain, expiring in 2033

• inebilizumab — France, Italy and Spain, expiring in 2032

• carfilzomib — France, Germany, Italy, Spain and the United Kingdom, expiring in 2030

• inebilizumab — France, Germany, Italy and Spain, expiring in 2032

• avacopan — France, Italy, Spain and the United Kingdom, expiring in 2034

• etelcalcetide — France, Germany, Italy, Spain and the United Kingdom, expiring in 2031

• erenumab — France, Germany, Italy, Spain and the United Kingdom, expiring in 2033

• avacopan — France, Italy, Spain and the United Kingdom, expiring in 2034

(2) Regulatory data exclusivity for apremilast in Europe expires in 2026.

(3) Pediatric exclusivity granted to 8/16/2028 for a patent with this subject matter.

(4) We have biologic exclusivity in the United States covering teprotumumab-trbw that will expire in 2032.

(2) Pediatric exclusivity granted to August 16, 2028 for a patent with this subject matter.

(3) We have biologic exclusivity in the United States and regulatory exclusivity in Europe covering teprotumumab-trbw that will expire in 2032 and 2035, respectively.

(4) Pediatric exclusivity granted to June 7, 2028 for a patent with this subject matter.

(5) A patent with this subject matter may be entitled to patent term extension in the United States.

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ENBREL biosimilars approved but not launched.

Our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expire in February 2025 in the United States and November 2025 in select countries in Europe, and we expect sales erosion driven by biosimilar competition.

Once multiple biosimilar versions of one of our originator products have launched, competition intensifies rapidly, resulting in accelerated net price declines for both the reference and the biosimilar products.

For example, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe, and we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW.

See also Government Regulation— Regulation in the United States — Approval of Biosimilars .

We also have our own biosimilar products both in the United States and outside of U.S.

markets that are competing against branded and biosimilar versions of our competitors’ products.

In 2018, we launched AMGEVITA, a biosimilar to HUMIRA, in markets outside the United States.

In 2019, we launched MVASI, a biosimilar to Avastin, and KANJINTI, a biosimilar to Herceptin.

In 2020, we launched AVSOLA, a biosimilar to Remicade.

In 2021, we launched RIABNI, a biosimilar to Rituxan.

In 2023, we launched AMJEVITA, a biosimilar to HUMIRA, in the United States, and BEKEMV, a biosimilar to SOLIRIS, in the EU.

Additionally, in 2023, we received FDA approval for WEZLANA, a biosimilar to STELARA, and in 2024, we received FDA approval for BKEMV, a biosimilar to SOLIRIS, and in the fourth quarter of 2024, we launched PAVBLU, a biosimilar to EYLEA, in the United States.

In January 2025, we launched WEZLANA in the United States.

We also have our own biosimilar products both in the United States and ROW that are competing against branded and biosimilar versions of our competitors’ products.

Since 2018, we have launched eight biosimilars, including the 2025 U.S.

launches of WEZLANA, a biosimilar to STELARA ® , and BKEMV, a biosimilar to SOLIRIS ® .

We expect additional biosimilar competition against both our branded and biosimilar products in the future across markets.

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U.S., Europe & Asia Pacific Bisphosphonates, including generics

Sandoz Group AG

Xeljanz Pfizer Inc.

Canada Etanercept biosimilars Various

& Europe Zoledronate generics

U.S., Europe & Asia Pacific PRALUENT

& Europe LEQVIO

Novartis Pharma AG

& Europe Skyrizi AbbVie Inc.

U.S., Europe & Asia Pacific Denosumab biosimilars

U.S., Europe & Asia Pacific LEQVIO ®

U.S., Europe & Asia Pacific

Regeneron Pharmaceuticals, Inc.

& Europe Skyrizi ®

& Europe Taltz ®

Eli Lilly and Company

& Europe Tremfya ®

Johnson & Johnson Innovative Medicine (1)

& Europe HUMIRA ® (2)

& Europe Tremfya Johnson & Johnson Innovative Medicine (3)

& Europe Taltz Lilly

& Europe Cosentyx Novartis Pharma AG

& Europe SOTYKTU Bristol Myers Squibb Company

& Europe Cosentyx ®

& Europe SOTYKTU ®

Bristol Myers Squibb Company

& Europe Topical products Various

Bristol Myers Squibb Company

Canada Etanercept biosimilars Various

Bisphosphonates, including generics Various

Japan Teribone Asahi Kasei Pharma

Asahi Kasei Pharma

& Europe Zoledronate generics

U.S., Europe & Asia Pacific

Denosumab biosimilars

& Europe Chemotherapy regimen

& Europe PROMACTA ® /REVOLADE ™

Regeneron Pharmaceuticals, Inc.

Genentech, Inc.

KYPROLIS U.S.

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Takeda Oncology (5)

& Europe PROMACTA/REVOLADE Novartis Pharma AG

Johnson & Johnson Innovative Medicine (1)

Legend Biotech

PROCRIT ® (6)

Johnson & Johnson Innovative Medicine (1)

& Europe Epoetin alfa biosimilars

& Europe Chemotherapy regime Various

Vectibix U.S.

& Europe Avastin F.

& Europe Avastin ®

Hoffmann-La Roche Ltd.

KEYTRUDA Merck & Co., Inc.

& Europe ERBITUX Lilly

& Europe Chemotherapy regime Various

Genentech, Inc.

Novartis Pharma AG

(1) Approved biosimilars available for Prolia and XGEVA in Asia Pacific only.

Other biosimilars under regulatory review in the United States, Europe and Asia Pacific.

(2) Approved biosimilars for HUMIRA available.

& Europe ERBITUX ®

Eli Lilly and Company

Merck & Co., Inc.

& Europe Chemotherapy regimen

(1) A subsidiary of Johnson & Johnson.

(2) Approved biosimilars for HUMIRA ® available.

(3) A subsidiary of Bristol-Myers Squibb Company.

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(6) PROCRIT ® competes with Aranesp in supportive cancer care and predialysis settings.

TEPEZZA and KRYSTEXXA currently do not face any direct competitors in the United States or Europe.

TEPEZZA and KRYSTEXXA currently do not face any direct competitors in the United States, Europe or Japan.

TEPEZZA faces competition from other therapies, such as corticosteroids, which have been used on an off-label basis to alleviate some of the symptoms of TED.

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In addition, we are required to (i) provide rebates or discounts on our products that are reimbursed through certain government programs, including Medicare and Medicaid, and (ii) provide discounts to qualifying healthcare providers under the 340B Program.

Further, inappropriate expanded utilization of the 340B Program has had a negative impact on the Company’s financial performance.

There has been an increase in the number of entities participating in the 340B Program and in the volume of our medicines dispensed through 340B channels.

As a result, this expanded utilization of the 340B Program has had a negative impact on the Company’s financial performance.

Both private and some government payers use formularies to manage access to and utilization of drugs.

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As a result, PBMs and insurers have greater market power and negotiating leverage to mandate stricter utilization criteria and/or exclude drugs from their formularies in favor of competitor drugs or alternative treatments.

In highly competitive treatment markets such as the markets for ENBREL, Otezla, Repatha and Aimovig, PBMs are also able to exert negotiating leverage by requiring incremental rebates from manufacturers in order for them to gain and/or maintain their formulary position.

In highly competitive treatment markets such as the markets for ENBREL, Otezla, Repatha and

Aimovig, PBMs are also able to exert negotiating leverage by requiring incremental rebates from manufacturers in order for them to gain and/or maintain their formulary position.

In addition to market actions taken by private and government payers in the United States, policy makers in both of the major U.S.

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For example, in 2022, the IRA was enacted and includes provisions requiring that beginning in 2026, mandatory price setting be introduced in Medicare for certain drugs paid for under Parts B and D, whereby manufacturers must accept a price established by the government or face penalties on all U.S.

sales (starting with 10 drugs in 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that by 2031 approximately 100 drugs could be subject to such set prices).

The Medicare price setting process began in August 2023 when CMS announced the first 10 drugs for Medicare price setting, which includes ENBREL, currently a product that generates considerable revenue for the Company.

On July 30, 2024, CMS set a price for ENBREL in Medicare Part D that is significantly lower than the currently applicable price, effective beginning on January 1, 2026.

We expect this will negatively impact

ENBREL’s profitability in Medicare.

In January 2025, CMS announced the next 15 drugs for Medicare price setting that will be applicable beginning on January 1, 2027, which includes Otezla.

Also under the IRA, starting on January 1, 2024, Medicare Part D was redesigned to cap beneficiary out-of-pocket costs and, beginning on January 1, 2025, Federal reinsurance will become reduced in the catastrophic phase (resulting in a shift and increase of such costs to Part D plans and manufacturers, including by requiring manufacturer discounts on certain drugs).

Further, the IRA created a mechanism for CMS to collect rebates from manufacturers if price increases outpace inflation.

sales (starting with 10 drugs effective January 1, 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that by 2031 approximately 100 drugs would be subject to such set prices).

CMS has set Medicare Part D prices for ENBREL, effective January 1, 2026, and Otezla, effective January 1, 2027, in each case at significantly lower prices that are expected to negatively impact their profitability in Medicare.

See Part IV—Note 13, Goodwill and other intangible assets, to the Consolidated Financial Statements for additional information related to the Otezla intangible asset impairment charges.

Also under the IRA, starting on January 1, 2024, Medicare Part D was redesigned to cap beneficiary out-of-pocket costs and reduce Federal reinsurance in the catastrophic phase, increasing cost-sharing obligations for Part D plans and manufacturers, including by requiring manufacturer discounts.

Further, the IRA created a mechanism for CMS to collect rebates from manufacturers if Medicare price increases outpace inflation.

We began to accrue for rebate obligations on October 1, 2022 for Medicare Part D and on January 1, 2023 for Medicare Part B.

In addition to the IRA, other proposed U.S.

policy actions focus on drug pricing, including the Most-Favored-Nations Prescription Drug Pricing Executive Order (MFN EO) that is aimed at using price benchmarks from other developed countries to set U.S.

pricing targets, and the July MFN Letter that was delivered to a number of pharmaceutical companies, including Amgen.

The July MFN Letter called for drug manufacturers to:

1) extend MFN pricing to Medicaid;

2) guarantee MFN pricing to Medicaid, Medicare and commercial payers on all newly launched drugs;

3) use future increased revenues from outside the U.S.

to lower U.S.

and 4) participate in direct-to-patient models to provide MFN pricing for certain drugs.

In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests.

We also announced the expansion of our direct-to-patient program, AmgenNow TM , to include Aimovig and AMJEVITA, supplementing our existing offering of Repatha, all of which are available through AmgenNow TM and are expected to be available through TrumpRx following the platform’s launch.

Risk Factors— Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability .

Other potential policies cover a wide range of areas, including allowing the importation of drugs from other countries;

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For example, on January 5, 2024, the FDA authorized Florida to move forward with its importation program proposal, which excludes biologics.

CMS also issued a proposed Medicaid Drug Rebate Program rule that would have required manufacturers to aggregate or “stack” all rebates, discounts or other price concessions made to separate, unrelated entities across the pharmaceutical supply chain on a given unit of product to determine the “Best Price,” a metric that is used to determine Medicaid rebates and 340B statutory rates.

This proposal was not finalized but remains a policy that could be reconsidered in the future.

Further, at the state level, eight states (Colorado, Maine, Maryland, Minnesota, New Hampshire, New Jersey, Oregon and Washington) have enacted laws that establish PDABs to identify drugs that pose affordability challenges, and in four states (Colorado, Maryland, Minnesota and Washington) include authority for the state PDAB to set upper payment limits on certain drugs for in-state patients, payers and providers.

In many countries other than the United States, government-sponsored healthcare systems are the primary payers for drugs and biologics.

With increasing budgetary constraints and/or difficulty in understanding the value of medicines, governments and payers in many countries are applying a variety of measures to exert downward price pressure.

These measures can include mandatory price controls, price referencing, therapeutic-reference pricing, increases in rebates, incentives for generic substitution and biosimilar usage and government-mandated price cuts.

In this regard, many governments use health technology assessment organizations to judge the added benefit of new treatments over existing ones, metrics which are then used to set reimbursement prices and/or set coverage limits.

Many countries also limit coverage to populations narrower than those specified on our product labels or impose volume caps to limit utilization.

We expect that governments will continue taking aggressive actions to seek to reduce expenditures on drugs and biologics.

Similarly, fiscal constraints may also affect the extent to which countries are willing to approve new and innovative therapies and/or allow access to new technologies.

The EU is currently undergoing a review and revision of its pharmaceutical legislation.

Various proposals are under consideration with the EU Council, followed by a negotiation among the EU government to agree to a final law.

Full implementation is not expected until 2027 or later.

The new legislation, if implemented, will likely have a significant impact on the landscape for access and pricing decisions within EU Member States.

In many countries outside the United States, government-sponsored healthcare systems are the main payers for drugs and biologics.

Governments and payers are using a range of tools to drive prices down, including mandatory price controls, international reference pricing, therapeutic-reference pricing, higher rebates, incentives for generics and biosimilars, and mandated price cuts.

Pricing and reimbursement reforms under consideration in the United States—including proposals to expand government negotiation and increase payer leverage—may further amplify global pricing pressures, as many countries reference or react to U.S.

pricing dynamics.

Health technology assessment bodies increasingly evaluate the added benefit of new therapies, and these judgments shape reimbursement levels and coverage terms.

Many countries also narrow coverage relative to product labels or impose volume caps to limit use.

We expect governments to continue taking aggressive steps to reduce spending on drugs and biologics, and fiscal constraints may limit willingness to approve or provide access to innovative therapies and new technologies.

Potential EU pharmaceutical legislation may also influence pricing and reimbursement frameworks, which could affect patient access.

The dynamics and developments discussed above create pressures on the pricing and potential usage of our products and on the industry.

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• providing patient support and education programs;

• expanding patient access to our medicines, including through direct-to-patient channels;

• continuing to deliver a reliable supply of medicines through our additional investments in U.S.

manufacturing;

• helping patients in financial need access our medicines;

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For additional information regarding manufacturing facilities, see Item 2.

We are expanding our manufacturing capacity and incorporating state-of-the-art technologies, allowing us to optimize our manufacturing network and mitigate risks while continuing to ensure adequate supply of our products to patients worldwide.

Our new state-of-the-art biomanufacturing plants, including our facility in North Carolina and FDA-approved facility in Ohio, have been constructed at a lower cost and with greater speed as compared to traditional facilities.

We are expanding our manufacturing capacity and incorporating state-of-the-art technologies to allow us to optimize our manufacturing network and mitigate risks while working to continue to ensure adequate supply of our products to patients worldwide.

See Manufacturing Initiatives below for additional discussion of our manufacturing expansion efforts.

Our new state-of-the-art biomanufacturing facilities, including our facility in North Carolina and FDA-approved facility in Ohio, have been constructed at a lower cost and with greater speed as compared to traditional facilities.

For example, our facility in North Carolina has equipment that is portable and smaller, which provides greater flexibility and speed in the manufacture of different medicines simultaneously, allowing us to respond to changing demands for our medicines with increased scale and agility.

Furthermore, such state-of-the-art plants incorporate multiple innovative technologies, automation solutions and environmental sustainability into a single facility, thus requiring smaller manufacturing footprints and offering greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

Furthermore, such state-of-the-art facilities incorporate multiple innovative technologies, automation solutions and environmental sustainability, thus requiring smaller manufacturing footprints and offering greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

For example, our facility in North Carolina and our FDA-approved facility in Ohio contain many examples of environmental commitments, including on-site photovoltaic renewable energy generation at both sites.

We expect our North Carolina facility’s carbon footprint, water usage and waste disposed to be substantially lower than that of a traditional drug substance manufacturing plant.

We expect our North Carolina facility’s carbon footprint, water usage and waste disposed to be substantially lower than that of a traditional drug substance manufacturing facility.

Similarly, we expect lower carbon footprint, water usage and waste disposed per unit at our Ohio facility as compared to traditional packaging and assembly facilities.

Our internal manufacturing network has commercial production capabilities for bulk manufacturing, formulation, fill, finish, tableting and final device assembly.

These activities are performed within the United States and its territory, including in our Puerto Rico, Rhode Island, Ohio and California facilities, as well as internationally in our Ireland, Netherlands and Singapore facilities.

These activities are performed within the United States, including in the U.S.

territory of Puerto Rico, Rhode Island, Ohio and California facilities, as well as internationally in our Ireland, Netherlands and Singapore facilities.

In addition, we use third-party contract manufacturers to supplement the capacity or capability of our commercial manufacturing network.

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We also use third-party contract manufacturers, including contract manufacturers that were added to our clinical manufacturing network from the Horizon acquisition, to supplement the capacity or capability of our overall clinical manufacturing network.

Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products.

We operate distribution centers in Puerto Rico, Kentucky, California and the Netherlands for worldwide distribution of the majority of our commercial and clinical products.

Risk Factors for a discussion of the factors that could adversely impact our manufacturing expansion operations and the global supply of our products.

We operate distribution centers in the U.S.

territory of Puerto Rico, Kentucky, California and the Netherlands for worldwide distribution of the majority of our commercial and clinical products.

We also use third-party distributors to supplement distribution of our products worldwide.

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As discussed above, we are expanding our capacity and advancing new innovations to support anticipated patient demand for our current and future products.

In January 2024, our biomanufacturing plant located in New Albany, Ohio received FDA licensure for commercial production.

This final product assembly and packaging plant supports the growing demand for Amgen’s medicines and uses state-of-the-art technologies and automation.

In January 2025, we opened our Holly Springs, North Carolina site, a cutting-edge drug substance facility.

Upon FDA approval, this facility will increase our biologics manufacturing capacity.

Also in January 2025, we broke ground on a second drug substance manufacturing facility in Holly Springs, North Carolina.

This second facility will incorporate state-of-the-art technologies and sustainable practices, further enhancing our manufacturing network to support reliable and efficient supply of our medicines to patients worldwide.

Subsequent to the Horizon acquisition, we continue to evaluate our supply chains and pursue activities to further improve resiliency and efficiency.

Additionally, in 2024, we have initiated actions to consolidate the commercial production of select acquired Horizon products into our existing manufacturing network.

Risk factors— Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions.

Also in January 2025, we broke ground on a second drug substance manufacturing facility at this location.

This second facility will incorporate state-of-the-art technologies and sustainable practices.

The result is a more flexible and efficient facility, with a smaller physical footprint, reduced consumption of water and energy, and lower levels of carbon emissions than a traditional facility.

Additionally, in 2025 we announced expansions of our manufacturing network in New Albany, Ohio and the U.S.

territory of Puerto Rico, further strengthening our U.S.-based manufacturing capabilities.

Our Ohio expansion builds on our existing biomanufacturing facility, which received FDA licensure for commercial production in January 2024 and supports final product assembly and packaging using state-of-the-art technologies and automation.

These expansion initiatives further enhance our manufacturing network to support reliable and efficient supply of our medicines to patients worldwide.

We continue evaluating our manufacturing network to ensure we maintain appropriate levels of operational flexibility and risk management needed to support our global operations.

Numerous tariffs and trade protection measures have been proposed and, in some cases, implemented by the United States and other countries.

We continue to evaluate our global supply chains, sourcing strategies and manufacturing network and to implement measures to minimize the impact of existing and potential future tariffs.

Risk factors— Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets , and Part II—Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview.

Risk Factors— Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales .

Raw Materials and Medical Devices

Certain raw materials, medical devices (including companion diagnostics) and components necessary for the commercial and/or clinical manufacturing of our products are provided by and are the proprietary products of unaffiliated third-party suppliers, certain of which may be our only sources for such materials.

We currently attempt to manage the risk associated with such suppliers by means of inventory management, relationship management and evaluation of alternative sources when feasible.

We work to manage the risk associated with such sole suppliers by means of inventory management, relationship management and evaluation of alternative sources when feasible.

We also monitor the financial condition and manufacturing quality and compliance of key suppliers and their ability to supply our needs.

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We perform various procedures to help authenticate the sources of raw materials, including intermediary materials used in the manufacture of our products;

the procedures include verification of country of origin and are incorporated into the manufacturing processes we and our third-party contract manufacturers perform.

the procedures are incorporated into the manufacturing processes we and our third-party contract manufacturers perform and include verification of country of origin.

To better ensure supply, Amgen has a risk mitigation strategy that uses a combination of methods, including multiple sources or backup inventory of critical raw materials.

As part of our ongoing business continuity efforts, we continue to closely monitor our inventory levels and have taken additional measures to mitigate against raw material supply interruption.

We also continue to assess the potential impacts of existing and proposed tariffs on our raw material and medical device supply chains and implement sourcing and inventory strategies intended to minimize the impacts from existing and potential future tariffs.

Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products.

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Our product promotions for approved product indications must comply with the statutory standards of the FDCA and the FDA’s implemented regulations and guidance.

The FDA’s review of marketing and promotional activities encompasses but is not limited to direct-to-consumer advertising, healthcare-provider-directed advertising and promotion, sales representative communications to healthcare professionals, promotional programming and promotional activities involving electronic media.

The FDA’s review of marketing and promotional activities encompasses but is not limited to direct-to-patient advertising, healthcare-provider-directed advertising and promotion, sales representative communications to healthcare professionals, promotional programming and promotional activities involving electronic media.

The FDA may also review industry-sponsored scientific and educational activities that make representations regarding product safety or efficacy in a promotional context.

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Orphan drugs are defined by the FDA as products intended to treat a rare disease or condition that affects less than 200,000 persons in the United States.

A company must request orphan drug designation prior to filing and, if granted for being the first medicine to treat such a rare disease, means the FDA will not approve another sponsor’s marketing application for the same drug for the same indication for seven years.

A company must request orphan drug designation prior to filing, and if the product is ultimately approved for the designated rare disease or condition, it may qualify for seven years of orphan drug exclusivity during which the FDA will not approve another sponsor’s marketing application for the same drug for the same indication.

Orphan drug exclusivity will not bar approval of another medicine for the same indication if it is shown to be clinically superior.

In the United States, a number of our products, including products such as TEPEZZA and UPLIZNA, have orphan drug exclusivity under this framework.

In the United States, a number of our products, including products such as BLINCYTO and UPLIZNA, have orphan drug exclusivity under this framework for specific indications.

Regulation Outside the United States

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Approved orphan drugs in the EU receive 10 years of market exclusivity for the approved indication in all EU member states.

We currently have orphan medicinal product designation for BLINCYTO in the EU and intend to seek medicinal product designation for a number of our products in the future.

We currently have orphan medicinal product designation for BLINCYTO in the EU and may seek medicinal product designation for a number of our products in the future.

Other countries such as those in Latin America and the Middle East have review processes and data requirements similar to those of the EU and in some cases can rely on prior marketing approval from U.S.

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In Asia Pacific, a number of countries such as China, Japan, South Korea and Taiwan may require local clinical-trial data for bridging purposes as part of the drug registration process in addition to global clinical trials, which can add to overall drug development and registration timelines.

In most of the Asian markets, registration timelines depend on marketing approval in the United States or the EU.

In some markets in Asia, such as China, Indonesia and Thailand, regulatory timelines can be less predictable.

In many Asian markets, registration timelines may be influenced by prior marketing approvals in reference jurisdictions (e.g.

the United States or the EU).

In some markets in Asia, such as China, Indonesia and Thailand, regulatory timelines can be more variable.

The regulatory process may also include manufacturing/testing facility inspections, testing of drug product upon importation and other domestic requirements.

Countries such as Australia and Japan have more-mature systems that would allow for submissions under more-competitive time frames.

With regard to biosimilars, several of these countries have pathways to register biosimilars (e.g., Australia, India, Singapore, South Korea and Taiwan), and biosimilar products are already present on the markets (e.g., Australia and South Korea).

Countries such as Australia and Japan have more mature regulatory systems which may allow for submissions under comparatively more predictable time frames.

With regard to biosimilars, several of these countries have pathways to register biosimilars (e.g., Australia, India, Singapore, South Korea and Taiwan), and biosimilar products in market (e.g., Australia, Japan, South Korea and Taiwan).

In some countries, such as Japan and those in the EU, medical devices may be subject to regulatory regimes whereby manufacturers must establish that their medical devices conform to essential requirements set out in the law for the particular device category.

For example, in the EU, with limited exceptions, medical devices placed on the market must bear the Conformité Européenne marking to indicate their conformity with legal requirements.

Postapproval Phase

Post-approval Phase

After approval, we continue to monitor adverse events and product complaints reported following the use of our products through routine postmarketing surveillance and studies when applicable.

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False-claims laws prohibit knowingly and willingly presenting, or causing to be presented, for payment to third-party payers (including Medicare and Medicaid) any claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services.

Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as by the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid).

Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as by the possibility

of exclusion from federal healthcare programs (including Medicare and Medicaid).

Liability under false-claims laws may also arise when violation of certain laws or regulations related to the underlying product (e.g., a violation regarding improper promotional activity or unlawful payments) contributes to the submission of a false claim.

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Other jurisdictions where we operate have enacted or proposed similar legislation and/or regulations, such as consumer privacy laws that went into effect in Virginia, Colorado, Utah, Connecticut and Florida in 2023 and Oregon, Texas and Montana in 2024.

Consumer privacy laws were also passed in other states, including Iowa, Delaware, New Hampshire, Nebraska, New Jersey, Tennessee, Minnesota, Maryland, Indiana, Kentucky and Rhode Island and will be effective beginning in 2025 through 2026.

Consumer privacy laws were also passed in other states, including Iowa, Delaware, New Hampshire, Nebraska, New Jersey, Tennessee, Minnesota, Maryland, Indiana, Kentucky and Rhode Island, and became effective or are scheduled to become effective in 2025 through 2026.

In April 2023, a new type of state privacy law focused on protection of consumer health data emerged in Washington with the enactment of the My Health My Data Act, with similar legislation passed subsequently in Nevada.

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Further, in 2024, the EU Artificial Intelligence (AI) Act, formally known as Regulation (EU) 2024/1689, was passed into law.

Certain provisions of this regulation, such as transparency obligations and governance structures, will take effect in February and August 2025, with the regulation becoming fully effective on August 2, 2026.

Certain provisions of this regulation, such as transparency obligations and governance structures, became effective in February and August 2025, and the regulation will become fully effective on August 2, 2026.

The regulation establishes a risk-based framework governing the development, deployment and use of AI systems across the EU.

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Our business has been and will continue to be subject to various other U.S.

and foreign laws, rules and regulations, including provisions of the IRA.

and foreign laws, rules and regulations, including provisions of the IRA and OB3.

See Reimbursement section above.

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We capitalize on our strengths in human genetics, novel biology and protein engineering.

We leverage our biologic expertise and seek to choose the optimal modality for a drug target and disease.

And we use cutting-edge science and technology to study subtle biological mechanisms in search of therapies that will improve the lives of those who suffer from diseases.

We leverage our biologic expertise and seek to choose the optimal modality for a drug target and disease, and we use cutting-edge science and technology to study subtle biological mechanisms in search of therapies that will improve the lives of those who suffer from diseases.

See Government Regulation— Clinical Development and Product Approval section above.

Our discovery research programs may therefore yield targets that lead to the development of human therapeutics delivered as large molecules, small molecules, other combination modalities or new modalities.

We have reshaped our portfolio and have increasingly focused our efforts on human genetics when possible to enhance the likelihood of success.

We have increasingly focused our efforts on human genetics when possible to enhance the likelihood of success.

We have major R&D centers in the United States in Thousand Oaks and San Francisco, California;

and the United Kingdom, as well as smaller research centers and development facilities globally.

Additionally, in 2025, we broke ground on a new state-of-the-art R&D facility in Thousand Oaks, California, to further enhance collaboration and innovation across R&D and process development activities.

Our clinical trial activities are conducted by both our internal staff and third-party contract clinical trial service providers.

To increase the number and diversity of patients available for enrollment in our clinical trials and to meet evolving regulatory expectations, we have opened clinical sites and will continue opening clinical sites and enrolling patients in a number of geographic locations.

With regard to our clinical trial activities, we are continuously monitoring the possible impacts from health-related events, geopolitical conflicts and natural disasters.

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We remain focused on supporting our active clinical sites in their providing care for patients and in our providing investigational drug supply.

Our clinical trial activities are conducted by both our internal staff and third-party contract clinical trial service providers.

To increase the number and diversity of patients available for enrollment in our clinical trials, we have opened clinical sites and will continue opening clinical sites and enrolling patients in a number of geographic locations.

See Government Regulation— Regulation in the United States — Clinical Development and Product Approval for a discussion of government regulation over clinical development.

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The following table shows a selection of certain of our product candidates by phase of development in our therapeutic areas of focus as of February 3, 2026, unless otherwise indicated.

Additional product candidate information can be found on our website at www.amgen.com.

(The website address is not intended to function as a hyperlink, and the information contained on our website is not intended to be a part of this filing.) The information in this section does not include, among other things, other, nonregistrational clinical trials that we may conduct for purposes other than for submission to regulatory agencies for their approval of a new product indication.

The information in this section does not include, among other things, other, nonregistrational clinical trials that we may conduct for purposes other than for submission to regulatory agencies for their approval of a new product indication.

We may conduct nonregistrational clinical trials for various reasons, including to evaluate real-world outcomes or to collect additional safety information with regard to the use of products.

Investigational indications (programs)

AMJEVITA Interchangeability

Bemarituzumab Gastric and gastroesophageal junction cancer

BLINCYTO Ph-negative B-ALL

Investigational indications (programs)

Sjögren’s disease

EVENITY Male osteoporosis

IMDELLTRA/IMDYLLTRA

Small cell lung cancer

LUMAKRAS/LUMYKRAS Advanced colorectal cancer

LUMAKRAS/LUMYKRAS Metastatic colorectal cancer

Non-small cell lung cancer

Chronic weight management

Cardiovascular disease

Heart failure

Obstructive sleep apnea

Nplate Chemotherapy-induced thrombocytopenia

Olpasiran Cardiovascular disease

Otezla Palmoplantar pustulosis

Subcutaneous administration for uncontrolled gout

Repatha Cardiovascular disease

Rocatinlimab Moderate-to-severe atopic dermatitis

Rocatinlimab (1)

Moderate-to-severe atopic dermatitis

Prurigo nodularis

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Chronic/low clinical activity score TED in Japan

TEZSPIRE Chronic rhinosinusitis with nasal polyps

TEZSPIRE Chronic obstructive pulmonary disease

Eosinophilic esophagitis

Severe asthma

Generalized myasthenia gravis

IgG4-related disease

Metastatic castrate resistant prostate cancer

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Investigational biosimilar to OCREVUS ® (ocrelizumab)

Bemarituzumab

Systemic lupus erythematosus with nephritis

Investigational indications (programs)

Refractory rheumatoid arthritis

Systemic lupus erythematosus with and without nephritis

Dermatomyositis and anti-synthetase inflammatory myositis

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Systemic lupus erythematosus with nephritis

LUMAKRAS/LUMYKRAS

Maridebart cafraglutide

Type 2 diabetes

Celiac disease

Rocatinlimab (1)

Moderate-to-severe asthma

TEZSPIRE Chronic obstructive pulmonary disease

AMG 104 Asthma

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Sjögren’s disease

Neuroendocrine prostate cancer

Prostate cancer

AMG 193 Solid tumors

AMG 355 Solid tumors

AMG 651 Solid tumors

Investigational indications (programs)

Ewing Sarcoma

(1) See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin.

Phase 3 Clinical trials investigate the short- and long-term safety and efficacy of our product candidates, compared to commonly used treatments, in a large number of patients who have the disease or condition under study.

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Phase 3 Product Candidate Program Changes

As of January 31, 2024, we had 24 phase 3 programs studied in investigational indications.

As of February 4, 2025, we have 25 phase 3 programs being studied in investigational indications, as five programs initiated phase 3 studies, three programs were approved by the FDA and one program was approved in Japan.

As of February 4, 2025, we had 25 Phase 3 programs studied in investigational indications.

As of February 3, 2026, we had 23 Phase 3 programs being studied in investigational indications, as six programs initiated Phase 3 studies, five programs received regulatory approval, one program was stopped, one program was no longer being pursued and one program concluded.

These changes are set forth in the following table.

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Program changes

BKEMV Investigational biosimilar to SOLIRIS (eculizumab) Approved by the FDA

Investigational biosimilar to EYLEA (aflibercept)

Approved by the FDA

Prurigo nodularis

Initiated phase 3 study

Subcutaneous administration for TED

AMJEVITA Interchangeability study Approved by the FDA

Bemarituzumab

Gastric and gastroesophageal junction cancer

EVENITY Male osteoporosis No longer pursued

Chronic weight management

Initiated two global Phase 3 studies

Cardiovascular disease Initiated global Phase 3 study

Heart failure Initiated global Phase 3 study

Obstructive sleep apnea

Initiated two global Phase 3 studies

Otezla Palmoplantar pustulosis Approved in Japan

Subcutaneous administration for uncontrolled gout

Initiated Phase 3 study

Active TED in Japan Approved in Japan

Investigational biosimilar to STELARA (ustekinumab)

Chronic obstructive pulmonary disease Initiated Phase 3 study

Chronic rhinosinusitis with nasal polyps Approved by the FDA and the EC

Severe asthma Concluded

IgG4-RD Approved by the FDA and the EC

Generalized myasthenia gravis

Approved by the FDA

Metastatic castrate resistant prostate cancer

Initiated phase 3 study

Investigational biosimilar to KEYTRUDA (pembrolizumab) Initiated phase 3 study

Investigational biosimilar to OCREVUS (ocrelizumab)

Initiated phase 3 study

Phase 3 Product Candidate Patent Information

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Molecule Territory General subject matter Estimated expiration (1)

Bemarituzumab

Polypeptides 2029

Europe Polypeptides

Antibody-peptide conjugates

Olpasiran U.S.

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Europe Compounds 2036

Rocatinlimab U.S.

Rocatinlimab (2)

Polypeptides 2028

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For example, new chemical entities would receive a five year exclusivity period and new molecular entities would receive a 12 year exclusivity period in the United States, whereas new chemical and molecular entities would receive a 10 year exclusivity period in Europe.

(2) See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin.

Phases 2 and 3 Program Descriptions

The following provides additional information about selected products and product candidates that have advanced into human clinical trials.

AMJEVITA, a biosimilar to HUMIRA, is a monoclonal antibody that inhibits binding of tumor necrosis factor (TNF) alpha to cell surface TNF receptor / TNF-alpha.

Bemarituzumab

Bemarituzumab is a monoclonal antibody that inhibits fibroblast growth factor receptor 2b (FGFR2b).

It is being investigated for the treatment of gastric and gastroesophageal junction cancer and advanced solid tumors other than advanced squamous NSCLC.

Blinatumomab is an anti-CD19 x anti-CD3 BiTE ® molecule.

It is being investigated for the treatment of systemic lupus erythematosus with nephritis.

It is being investigated for the treatment of both refractory rheumatoid arthritis and systemic lupus erythematosus with and without nephritis.

BLINCYTO is an anti-CD19 x anti-CD3 BiTE ® molecule.

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It is being investigated for the treatment of Sjögren’s disease.

EVENITY is a monoclonal antibody that inhibits the action of sclerostin.

It is being evaluated as a treatment for male osteoporosis.

EVENITY is being developed in collaboration with UCB.

IMDELLTRA is an anti-DLL3 x anti-CD3 BiTE ® molecule.

IMDELLTRA/IMDYLLTRA

IMDELLTRA/IMDYLLTRA is an anti-DLL3 x anti-CD3 BiTE ® molecule.

It is being investigated for the treatment of small cell lung cancer.

See Significant Developments for additional information regarding clinical trial updates.

Inebilizumab is a humanized, affinity-optimized, afucosylated IgG1 kappa (IgG1κ) monoclonal antibody that binds to the B cell-specific surface antigen CD19.

It is being investigated as treatment for patients with systemic lupus erythematosus with nephritis.

It is being investigated as a treatment for patients with systemic lupus erythematosus with nephritis.

LUMAKRAS/LUMYKRAS

LUMAKRAS/LUMYKRAS is a KRAS G12C small molecule inhibitor.

It is being investigated in NSCLC, colorectal cancer and other solid tumor cancers.

It is being investigated in colorectal cancer, NSCLC and other solid tumor cancers.

Maridebart cafraglutide

MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR).

It is being investigated for the treatment of obesity and type 2 diabetes.

MariTide is a differentiated antibody-peptide conjugate that activates the GLP-1 receptor and antagonizes the GIPR.

It is being investigated for the treatment of chronic weight management, cardiovascular disease, heart failure, obstructive sleep apnea and Type 2 diabetes.

See Significant Developments for additional information regarding clinical trial updates.

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Olpasiran is a small interfering RNA (siRNA) that lowers lipoprotein(a) (Lp(a)).

It is being investigated in phase 3 for the treatment of atherosclerotic cardiovascular disease (ASCVD).

Ordesekimab is a monoclonal antibody that inhibits the action of IL-15.

It is being investigated for the treatment of celiac disease and is being developed in collaboration with Provention Bio, Inc.

Otezla is a small molecule that inhibits PDE4.

It is being investigated in phase 3 studies for the treatment of palmoplantar pustulosis.

It is being investigated for the treatment of atherosclerotic cardiovascular disease (ASCVD).

Pegloticase is a PEGylated uricase approved for the treatment of uncontrolled gout by intravenous administration.

It is being investigated for subcutaneous administration when co-administered with methotrexate.

Repatha is a human monoclonal antibody that inhibits PCSK9.

It is being investigated in patients at high cardiovascular risk without a prior myocardial infarction or stroke.

See Significant Developments for additional information regarding clinical trial updates.

Rocatinlimab is a monoclonal antibody that inhibits OX-40.

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It is also being investigated in a Phase 2 study for the treatment of moderate-to-severe asthma.

Rocatinlimab is being developed in collaboration with Kyowa Kirin.

See Significant Developments for additional information regarding clinical trial updates.

See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin.

TEPEZZA is a monoclonal antibody against IGF-1R.

It is being investigated in phase 3 studies for subcutaneous administration for the treatment of TED and chronic/low clinical activity score (CAS) TED in Japan.

It is being investigated for subcutaneous administration for the treatment of TED and chronic/low clinical activity score TED in Japan.

TEZSPIRE is a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin.

It is being evaluated in phase 3 studies as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis and severe asthma.

It is also being investigated in phase 2 studies as a treatment for chronic obstructive pulmonary disease (COPD).

It is being investigated for the treatment of chronic obstructive pulmonary disease and eosinophilic esophagitis.

TEZSPIRE is being developed in collaboration with AstraZeneca.

See Significant Developments for additional information regarding clinical trial updates.

UPLIZNA is a humanized, affinity-optimized, afucosylated IgG1 kappa (IgG1κ) monoclonal antibody that binds to the B cell-specific surface antigen CD19.

It is being investigated in phase 3 studies for the treatment of generalized myasthenia gravis and flares in patients with IgG4-related disease.

See Significant Developments for additional information regarding clinical trial updates.

Xaluritamig is a bivalent T cell engager and is designed using XmAb 2+1 technology.

Xaluritamig is an anti-six transmembrane epithelial antigen of the prostate 1 (STEAP1) x anti-CD3 XmAb ® BiTE ® molecule.

It is being investigated for the treatment of prostate cancer.

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The reference-product primary condition is NSCLC.

ABP 692 is an investigational biosimilar to OCREVUS, which is a monoclonal antibody that binds to CD20, which is a protein found on the surface of B-cells.

ABP 692, a biosimilar candidate to OCREVUS ® , is a monoclonal antibody that binds to CD20, which is a protein found on the surface of B-cells.

AMG 104 is a human anti-TSLP Fab.

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It is being investigated for the treatment of Sjögren’s disease.

AMG 732 is a monoclonal antibody against IGF-1R.

It is being investigated for the treatment of TED.

Business Relationships

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Amgen manufactures and supplies EVENITY worldwide.

BeiGene, Ltd.

In January 2020, we acquired an equity stake in BeiGene for approximately $2.8 billion in cash as part of a collaboration to expand our oncology presence in China.

For additional information regarding our equity investment in BeiGene, see Part IV—Note 10, Investments, to the Consolidated Financial Statements.

Under the collaboration, BeiGene began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in 2022 in China, and Amgen shares profits and losses equally during the initial product-specific commercialization periods;

thereafter, product rights may revert to Amgen, and Amgen would pay royalties to BeiGene on sales in China of such products for a specified period.

Amgen manufactures and supplies the collaboration products to BeiGene.

In addition, we jointly develop a portion of our oncology portfolio with BeiGene, which shares in global R&D costs by providing cash and development services of up to $1.25 billion.

Upon regulatory approval, BeiGene will assume commercialization rights in China for a specified period, and Amgen and BeiGene will share profits and losses equally until certain of these product rights revert to Amgen.

Upon return of the product rights, Amgen will pay royalties to BeiGene on sales in China for a specified period.

For product sales outside China, Amgen also pays royalties to BeiGene.

BeOne Medicines Ltd.

In January 2020, we acquired an equity stake in BeOne for approximately $2.8 billion in cash as part of a collaboration agreement to expand our oncology presence in China.

For additional information regarding our equity investment in BeOne, see Part IV—Note 10, Investments, to the Consolidated Financial Statements.

Under the collaboration, BeOne began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in 2022 in China, and Amgen shares profits and losses equally during the product-specific commercialization periods.

Following entry into an amendment to this collaboration by Amgen and BeOne on November 11, 2025, BeOne will retain the right to commercialize XGEVA, BLINCYTO and KYPROLIS in China for so long as such products are sold in China.

Amgen manufactures and supplies the collaboration products to BeOne.

In addition, we jointly develop a portion of our oncology portfolio with BeOne, which shares in global R&D costs by providing cash and development services of up to $1.25 billion.

Upon regulatory approval, BeOne will assume commercialization rights in China for a specified period, and Amgen and BeOne will share profits and losses equally until certain of these product rights revert to Amgen.

Upon return of the product rights, Amgen will pay royalties to BeOne on sales in China for a specified period.

For product sales outside China, Amgen also pays royalties to BeOne.

For financial information about our significant collaborative arrangements, see Part IV—Note 9, Collaborations, to the Consolidated Financial Statements.

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The complexities of our industry along with the challenges of running an enterprise focused on the discovery, development, manufacture and commercialization of innovative medicines, require a highly engaged and committed workforce.

As of December 31, 2024, Amgen had approximately 28,000 staff members in over 50 countries, including approximately 11,000 staff members outside the United States, and we have had relatively low global turnover rates compared to peer companies, based on available industry information.

As of December 31, 2025, Amgen had approximately 31,500 staff members in over 50 countries, including approximately 13,000 staff members outside the United States, and we continue to experience overall low turnover rates.

We also supplement our workforce with independent contractors, contingent workers and temporary workers, as needed.

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Further, to support the development of our staff, we provide a variety of programs, including leadership development programs, classroom-based and virtual instructor-led courses, and self-paced learning options as well as mentoring, networking and coaching opportunities.

In 2025, we invested in general upskilling of our staff on skills for the future, including topics such as AI.

We also maintain a global talent marketplace that enables staff to contribute to work beyond their core responsibilities, providing opportunities to broaden professional networks, support organizational priorities and develop additional skills.

Our benefit programs are generally broad-based, promote health and overall well-being and emphasize saving for retirement.

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Creating a safe and healthy workplace for our staff is an important priority at Amgen.

Our goal is to have a world class safety record through safety leadership, engaged staff, risk management practices and integrating safety throughout our business processes.

We provide job-specific safety training tailored to each role, and to foster our safety culture, we implement a comprehensive safety program and reinforce desired safety behaviors, driving to understand and mitigate the root cause of

safety incidents and manage and control variability.

Our goal is to have a world class safety record through safety leadership, engaged staff, risk management practices and integrating safety throughout our

business processes.

We track injuries and near-miss incidents through our incident tracking system, and we use leading indicators to assess the effectiveness of our safety programs and make course corrections as needed.

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Our CRCC provides general oversight of our safety programs and initiatives.

We believe that an inclusive culture helps attract and retain a strong and engaged workforce informed by the varied backgrounds and experiences represented, which fosters innovation, collaboration and productivity as we execute on our mission to serve patients.

A cross-functional, executive-level council composed of the CEO and his direct reports is responsible for overseeing our strategy to further an inclusive workplace.

We offer a variety of learning programs and have continued to launch enhanced resources and data analytic tools that guide staff and our leadership on the role they play in creating an inclusive culture.

We believe that our culture helps attract and retain a strong and engaged workforce informed by the varied experiences represented, which fosters innovation, collaboration and productivity as we execute on our mission to serve patients.

A cross-functional, executive-level council, which includes our CEO, regularly discusses matters related to workplace culture and, as appropriate, takes actions to support and evolve Amgen’s culture.

In our effort to attract and retain the best talent, we seek out and support talent across the globe.

As part of our multidimensional hiring and talent development strategy, our Apprenticeship Program launched in 2023 in our Manufacturing and ATMOS functions and expanded to include another cohort of apprentices at our North Carolina site in January 2025.

Our Apprenticeship Program is a skills-based approach that proactively seeks to hire candidates from nontraditional sources and backgrounds and is designed to invest in our future workforce through attracting, hiring and upskilling non-four-year degreed talent in the United States.

Our Apprenticeship Program is a skills-based approach and is designed to invest in our future workforce through attracting, hiring and upskilling non-four-year degreed talent in the United States.

Through the Apprenticeship Program, we provide individuals with classroom-based and on-the-job training as well as mentorship opportunities needed to develop proficiency in targeted business areas and roles.

We believe that our Apprenticeship Program and other skills-based approaches to hiring provide us with access to a larger pool of highly motivated and productive talent while also providing underrepresented groups greater access to jobs in innovative sectors of the economy.

Our Compensation and Management Development Committee oversees our labor and employment policies, programs and initiatives, including those relating to our talent strategy and culture of inclusion and belonging.

Multiple cohorts are underway across various sites, including a new 18 month manufacturing apprenticeship at Amgen North Carolina, which serves as a key talent pipeline.

We believe that our Apprenticeship Program and other skills-based approaches to hiring provide us with access to a larger pool of highly motivated and productive talent while also providing greater access to jobs in innovative sectors of the economy.

Our Compensation and Management Development Committee oversees our labor and employment policies, programs and initiatives, including those relating to our talent strategy and culture.

Information about Our Executive Officers

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Bradway was a Managing Director at Morgan Stanley in London, where, beginning in 2001, he had responsibility for the firm’s banking department and corporate finance activities in Europe.

Bradway has been a director of The Boeing Company, an aerospace company and manufacturer of commercial airplanes and defense, space, and securities systems, since 2016.

Bradway has been a director of The Boeing Company, an aerospace company and manufacturer of commercial airplanes, defense, space and securities systems, since 2016.

He has served on the board of trustees of the University of Southern California since 2014.

Bradner, age 52, became Executive Vice President, Research and Development, in 2023 and also served as the Company’s Chief Scientific Officer from 2023 through December 2024.

Prior to joining the Company, from 2022 to 2023, Dr.

Bradner, age 53, became Executive Vice President, Research and Development, in 2023 and also served as the Company’s Chief Scientific Officer from 2023 to 2024.

Prior to joining the Company, in 2023, Dr.

Bradner was a clinician at the Dana-Farber Cancer Institute, a comprehensive cancer treatment and research institution, and a principal teaching affiliate at Harvard Medical School.

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Gordon served as Head of Worldwide Markets at BMS from 2015 to 2016.

Prior to that, Mr.

Prior to this, Mr.

Gordon served in a variety of leadership roles at BMS for more than 25 years.

Graham, age 65, became Executive Vice President and General Counsel and Secretary in 2019.

Graham joined the Company in 2015.

From 2015 to 2019, Mr.

Graham was Senior Vice President, General Counsel and Secretary.

Graham joined the Company in 2015 to serve as Senior Vice President, General Counsel and Secretary.

Prior to joining Amgen, from 2006 to 2015, Mr.

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Grygiel, age 58, became Senior Vice President and Chief Compliance Officer in 2020.

Grygiel joined the Company in 2015.

From 2016 to 2020, Ms.

Grygiel was Vice President, Compliance.

Grygiel joined the Company in 2015 and has held leadership roles within the worldwide compliance and business ethics organization, including as Vice President, Compliance, from 2016 to 2020.

Prior to joining Amgen, from 2011 to 2015, Ms.

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Rachna Khosla, age 53, became Senior Vice President, Business Development, in 2021.

Khosla joined the Company in 2013 as Corporate Development Director.

From 2018 to 2021, Ms.

Khosla was Vice President, Business Development, and from 2016 to 2018, was Executive Director, Business Development.

Khosla joined the Company in 2013 and has held leadership roles in corporate development, licensing, and mergers and acquisitions, including as Vice President Business Development, from 2018 to 2021.

Prior to joining the Company, Ms.

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Derek Miller, age 53, became Senior Vice President, Human Resources, in 2022.

Miller joined the Company in 2003 and has held human resources leadership roles supporting each of the Company’s major business functions.

From 2020 to 2022, Mr.

Miller was Vice President, Global Total Rewards, and from 2018 to 2020, was Vice President, Human Resources.

From 2015 to 2018, Mr.

Miller was an Executive Director, Human Resources.

Prior to 2015, Mr.

Miller served as a Senior Manager in the Human Resources organization, before his promotion to Director, Human Resources, and then to Strategy Director.

Reese, age 62, became the Company’s inaugural Executive Vice President and Chief Technology Officer in December 2023, responsible for accelerating the use of technology and artificial intelligence across the organization.

From 2018 to December 2023, Dr.

Miller joined the Company in 2003 and has held human resources leadership roles of increasing responsibility during his tenure.

Miller’s experience spans each of the Company’s major business functions, including Vice President, Global Total Rewards, from 2020 to 2022 and Vice President, Human Resources, from 2018 to 2020.

Reese, age 63, became the Company’s inaugural Executive Vice President and Chief Technology Officer in 2023, responsible for accelerating the use of technology and artificial intelligence across the organization.

From 2018 to 2023, Dr.

Reese served as Executive Vice President, Research and Development.

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Esteban Santos, age 58, became Executive Vice President, Operations, in 2016.

Santos joined the Company in 2007 as Executive Director, Manufacturing Technologies.

From 2013 to 2016, Mr.

Santos was Senior Vice President, Manufacturing.

From 2008 to 2013, Mr.

Santos held a number of Vice President roles at the Company in engineering, manufacturing, site operations and drug product.

Santos joined the Company in 2007 and has held a number of leadership roles at the Company in engineering, manufacturing, site operations and drug product, including Senior Vice President, Manufacturing, from 2013 to 2016.

Prior to joining the Company, Mr.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business