What changed in this filing

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Item 1. Business

2025-02-14 compared with 2024-02-14 · 360 added, 354 removed, 557 unchanged (56% of the section changed)

(including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease.

We focus on areas of high unmet medical need and leverage our expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease.

We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies.

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Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987.

Amgen operates in one business segment:

Amgen operates in one operating segment:

human therapeutics.

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

Acquisition of Horizon Therapeutics plc

In October 2023, we completed our acquisition of Horizon for $116.50 per share in cash, representing a total transaction price of $27.8 billion.

Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs of patients impacted by rare, autoimmune and severe inflammatory diseases.

The acquisition aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for thyroid eye disease (TED), KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder.

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 .

Products/Pipeline

In October 2023, we announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 (DLL3) targeting BiTE ® (bispecific T-cell engager) molecule, in patients with advanced stage small cell lung cancer (SCLC) who had failed two or more prior lines of treatment.

With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an objective response rate (ORR;

primary endpoint) of 40%.

For key secondary endpoints, median progression-free survival (mPFS) was 4.9 months, and median overall survival (mOS) was 14.3 months.

There were no new safety signals observed compared to the Phase 1 study.

Additionally in October 2023, the FDA granted tarlatamab Breakthrough Therapy Designation for the treatment of adult patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy.

In December 2023, we announced the FDA accepted and granted Priority Review for the Company’s BLA for tarlatamab, with a PDUFA date of June 12, 2024.

LUMAKRAS/LUMYKRAS

In December 2023, we announced that the FDA completed its review of our supplemental New Drug Application seeking full approval of LUMAKRAS, resulting in a Complete Response Letter.

The review was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.

Additionally, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS’s accelerated approval has been fulfilled.

LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.

In October 2023, we announced positive data from the global Phase 3 CodeBreaK 300 trial.

This global Phase 3 study evaluated two doses of LUMAKRAS/LUMYKRAS (960 mg or 240 mg) in combination with Vectibix versus investigator’s choice of therapy (trifluridine and tipiracil, or regorafenib) in patients with chemorefractory G12C-mutated mCRC.

In June 2023, based on data from the previous CodeBreaK 101 study, the FDA granted Breakthrough Therapy Designation to LUMAKRAS in combination with Vectibix for the treatment of patients with metastatic KRAS G12C-mutated CRC, as determined by an FDA approved test, who have received prior chemotherapy.

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.

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.

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

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Together with our collaborators, we market our products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies.

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

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

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.

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

Outside the United States, we sell principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country.

In the Asia Pacific region, we also sell our products in partnership with other companies, including Astellas Pharma Inc., BeiGene, Takeda Pharmaceutical Company Limited, Daiichi Sankyo Co., Ltd.

and Kyowa Kirin.

Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc.

(formerly AmerisourceBergen) and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2023, 2022 and 2021.

and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2024, 2023 and 2022.

On a combined basis, these wholesalers accounted for 77%, 79% and 82% of worldwide gross revenues for 2024, 2023 and 2022, respectively.

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Total $ 32,026 100 % $ 26,910 100 % $ 24,801 100 %

(1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales from the acquisition date through December 31, 2023.

(2) Consists of product sales of our non-principal products, as well as sales prior to the divestiture of our Bergamo and Gensenta subsidiaries in the second quarter of 2023 and fourth quarter of 2022, respectively.

(1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.

(2) Consists of product sales of our non-principal products.

We market Prolia in many countries around the world.

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

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

Prolia was launched in the United States and Europe in 2010.

In the United States, it is used primarily in the indication for the treatment of postmenopausal women with osteoporosis at high risk of fracture and for treatment to increase bone mass in men with osteoporosis at high risk of fracture.

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

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

Otezla was acquired from Bristol Myers Squibb Company in November 2019 after their acquisition of Celgene.

Otezla is an oral therapy approved for the treatment of adults with plaque psoriasis across all severities (in the United States, Japan and Australia) and moderate-to-severe plaque psoriasis (in other global markets, including Europe), for adults with active psoriatic arthritis and for adults with oral ulcers associated with Behçet’s disease.

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.

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 CV disease.

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).

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.

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

Otezla was acquired from Bristol-Myers Squibb Company in November 2019 after its acquisition of Celgene Corporation.

for adults with active psoriatic arthritis;

for adults with oral ulcers associated with Behçet’s disease;

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).

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

EVENITY was launched in the United States and Japan in 2019.

In the United States, it is used in the indication for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture;

or patients who have failed or are intolerant to other available osteoporosis therapy.

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 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.

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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.

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

EVENITY was launched in the United States and Japan in 2019.

or patients who have failed or are intolerant to other available osteoporosis therapy.

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

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).

RAS status is determined by an FDA-approved test.

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 precursor acute lymphoblastic leukemia (ALL), including those who are MRD(–) or MRD(+) in frontline consolidation, and those with relapsed or refractory (R/R) disease.

ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

Subsequent to the closing of our Horizon acquisition, we market TEPEZZA primarily in the United States.

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 FDA approved medicine for the treatment of thyroid eye disease (TED).

TED is a serious, progressive and vision-threatening rare autoimmune condition.

While TED often occurs in people living with hyperthyroidism or Graves’ disease, it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.

This leads to a cascade of negative effects, which may cause long-term, irreversible eye damage.

As TED progresses, it causes serious damage, including proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision), and in some cases can lead to blindness.

Historically, patients have had to live with TED until the inflammation subsides, after which they are often left with permanent and vision-impairing consequences and may require multiple surgeries that do not completely return the patient to their pre-disease state.

Subsequent to the closing of our Horizon acquisition, we market KRYSTEXXA in the United States.

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.

We market KRYSTEXXA in the United States.

KRYSTEXXA was acquired through our Horizon acquisition in October 2023.

KRYSTEXXA is the first and only FDA-approved medicine for the treatment of chronic refractory gout.

Chronic refractory gout occurs in patients who have failed to normalize serum uric acid (sUA) and whose signs and symptoms are inadequately controlled with conventional therapies, such as xanthine oxidase inhibitors (XOIs), at the maximum medically appropriate dose, or for whom these drugs are contraindicated.

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.

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 Neulasta, MVASI, AMJEVITA/AMGEVITA, TEZSPIRE, Parsabiv, Aimovig, LUMAKRAS/LUMYKRAS, EPOGEN, KANJINTI, TAVNEOS, RAVICTI, UPLIZNA and PROCYSBI.

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.

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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Europe RANKL antibodies, including sequences (1)

Product Territory General subject matter Expiration

Enbrel ® (etanercept)

Formulations and methods of preparing formulations 10/19/2037

Fusion protein and pharmaceutical compositions 11/22/2028

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

Otezla ® (apremilast)

Compositions and compounds 2/16/2028

Europe Compositions, compounds and methods of treatment (1)

Formulations and methods of preparing formulations 10/19/2037

Product Territory General subject matter Expiration

Repatha ® (evolocumab)

Antibodies (2)

Methods of treatment 11/22/2030

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Europe Formulation 5/3/2033

Nplate ® (romiplostim)

Formulation 2/12/2028

Europe Thrombopoietic compounds (1)

Europe Formulation 4/20/2027

KYPROLIS ® (carfilzomib)

Otezla ® (apremilast) (2)

Compositions and compounds (3)

TEPEZZA ® (teprotumumab-trbw)

IGF-1R antibodies (4)

Methods of treatment

Methods of making 5/8/2033

Europe Compositions, compounds and methods of treatment (1)

Aranesp ® (darbepoetin alfa)

Glycosylation analogs of erythropoietin proteins 5/15/2024

EVENITY ® (romosozumab-aqqg)

Antibodies 4/25/2026

Methods of treatment 4/9/2033

Formulation and methods of using formulation 5/11/2031

Methods of treatment 4/9/2033

Europe Antibodies (1)

Europe Methods of treatment 4/18/2032

Europe Formulation and methods of using formulation 5/11/2031

Europe Methods of treatment 4/18/2032

KYPROLIS ® (carfilzomib)

Methods of treatment 4/14/2025

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)

Pharmaceutical compositions and bifunctional polypeptides 4/6/2030

Method of administration 9/28/2027

Method of treatment

Europe Bifunctional polypeptides (1)

Europe Method of administration 11/6/2029

Europe Method of treatment

KRYSTEXXA ® (pegloticase)

Polypeptides and pharmaceutical compositions

Methods of treatment

TEZSPIRE ® (tezepelumab-ekko)

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Europe Polypeptides (1)

TEPEZZA ® (teprotumumab-trbw)

IGF-1R antibodies (3)

UPLIZNA ® (inebilizumab-cdon)

CD19 antibodies and pharmaceutical compositions

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

Parsabiv ® (etelcalcetide)

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Europe Formulation 6/27/2034

Aimovig ® (erenumab-aooe)

CGRP receptor antibodies 5/17/2032

Methods of treatment 4/22/2036

Compositions and pharmaceutical formulations 4/1/2039

Europe CGRP receptor antibodies (1)

Europe Methods of treatment 8/10/2035

Europe Methods of making

LUMAKRAS ® /LUMYKRAS™ (sotorasib)

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

KRYSTEXXA ® (pegloticase)

Polypeptides and pharmaceutical compositions

Aimovig ® (erenumab-aooe)

Polynucleotides encoding CGRP receptor antibodies and methods of making antibodies

CGRP receptor antibodies 5/17/2032

Methods of treatment 4/22/2036

Compositions and pharmaceutical formulations 4/1/2039

Europe CGRP receptor antibodies (1)

Europe Methods of treatment 8/10/2035

TAVNEOS ® (avacopan)

Compounds and pharmaceutical compositions (5)

Crystalline and amorphous forms and pharmaceutical compositions 5/29/2041

UPLIZNA ® (inebilizumab-cdon)

CD19 antibodies and pharmaceutical compositions (2)

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

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 2025

• apremilast — France, Germany, Italy, Spain and the United Kingdom expiring in 2028

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

• evolocumab — France, expiring in 2030 and Spain and the United Kingdom, expiring in 2031

• romiplostim — France, Germany, Italy, Spain and the United Kingdom, expiring in 2024

• 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

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

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

• 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

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

• tezepelumab — France and Italy, expiring in 2033

• inebilizumab — Italy and Spain, expiring in 2032

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

• 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.

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

We operate in a highly competitive environment.

A number of our marketed products are indicated for disease areas in which other products or treatments are currently available or are being pursued by our competitors through R&D activities.

Additionally, some competitor-marketed products target the same genetic pathways as our recently launched marketed products or are currently in development.

Additionally, some competitor-marketed products target the same genetic pathways as our recently launched marketed products or product candidates.

This competition could impact the pricing and market share of our products.

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ENBREL biosimilars approved but not launched.

Once multiple biosimilar versions of one of our originator products have launched, competition has intensified rapidly, resulting in greater net price declines for both the reference and the biosimilar products and a greater effect on product sales.

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.

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

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

In 2019, Amgen launched MVASI, a biosimilar to Avastin, and KANJINTI, a biosimilar to Herceptin;

and in 2018, Amgen launched AMGEVITA, a biosimilar to HUMIRA, in markets outside the United States.

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.

and in 2021, we launched RIABNI, a biosimilar to Rituxan.

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, Amgen received FDA approval for Wezlana, a biosimilar to STELARA, which we expect to launch in the United States in 2025.

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

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For example, following loss of exclusivity of patents directed to cinacalcet, the active ingredient in our small molecule calcimimetic Sensipar, we lost a significant share of the market and corresponding revenues in a very short period of time.

See Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.

The introduction of new products, the development of new processes or technologies by competitors or the emergence of new information about existing products may result in (i) increased competition for our marketed products, even for those protected by patents and/or (ii) reductions in the prices we receive from selling our products.

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

Sandoz Group AG

Xeljanz Pfizer Inc.

Etanercept biosimilars

Canada Etanercept biosimilars Various

& Europe Zoledronate generics

U.S., Europe & Asia Pacific PRALUENT

& Europe LEQVIO

Novartis Pharma AG

& Europe Skyrizi AbbVie Inc.

& Europe HUMIRA (2)

& Europe Cosentyx Novartis

& Europe Tremfya Johnson & Johnson Innovative Medicine (3)

& Europe Taltz Lilly

& Europe Tremfya Janssen (2)

& Europe Skyrizi AbbVie

& Europe SOTYKTU Bristol Myers Squibb (BMS)

& Europe Cosentyx Novartis Pharma AG

& Europe SOTYKTU Bristol Myers Squibb Company

& Europe Topical products Various

& Europe Zoledronate generics

U.S., Europe & Asia Pacific PRALUENT

Regeneron Pharmaceuticals, Inc.

& Europe PROMACTA/REVOLADE Novartis

Bisphosphonates, including generics Various

Japan Teribone Asahi Kasei Pharma

KYPROLIS U.S.

Millennium Pharmaceuticals, Inc.

& Europe REVLIMID (4)

& Europe POMALYST/IMNOVID

& Europe DARZALEX

Johnson & Johnson Innovative Medicine (3)

& Europe POMALYST/IMNOVID

Celgene Corporation (4)

& Europe REVLIMID (5)

Takeda Oncology (6)

& Europe PROMACTA/REVOLADE Novartis Pharma AG

Johnson & Johnson Innovative Medicine (3)

& Europe Epoetin alfa biosimilars

Bisphosphonates, including generics Various

Japan Teribone Asahi Kasei Pharma

Hoffmann-La Roche Ltd (Roche)

Merck & Co., Inc.

& Europe ERBITUX

Chemotherapy regime Various

† Approved biosimilars available.

& Europe Chemotherapy regime Various

Vectibix U.S.

& Europe Avastin F.

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.

(3) A subsidiary of Johnson & Johnson.

(3) A subsidiary of Takeda Pharmaceutical Company Limited.

(4) REVLIMID also includes generics.

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

(5) REVLIMID also includes generics.

(6) A subsidiary of Takeda Pharmaceutical Co., Ltd.

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

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Drugs remain heavily scrutinized for cost containment.

As a result, payers are becoming more restrictive regarding the use of biopharmaceutical products and are scrutinizing the prices of these products while requiring a higher level of clinical evidence to support the benefits such products bring to patients and the broader healthcare system.

As a result, payers have been and continue to be more restrictive regarding the use of biopharmaceutical products and are scrutinizing the prices of these products while requiring a higher level of clinical evidence to support the benefits such products bring to patients and the broader healthcare system.

For example, as discussed below, payers are increasingly using stricter utilization management criteria, such as prior authorization and step therapy, to contain or reduce costs.

These pressures become intensified when our products become subject to competition, including from biosimilars.

In the United States, healthcare providers and other entities such as pharmacies and PBMs are reimbursed for covered services and products they deliver through both private-payer and government healthcare programs such as Medicare and Medicaid.

We provide negotiated rebates to healthcare providers, private payers, government payers and PBMs.

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 federal 340B Drug Pricing Program.

We provide negotiated rebates or discounts to healthcare providers, private payers, government payers and PBMs.

Further, inappropriate 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.

A drug’s inclusion and favorable positioning on a formulary are essential to ensure patients have access to a particular drug.

A drug’s inclusion and favorable positioning on a formulary are essential to ensure patients have full access to a particular drug.

Even when access is available, some patients abandon their prescriptions for economic reasons.

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The use of such measures by PBMs and insurers has continued to intensify and has thereby limited Amgen product usage and sales.

Furthermore, during the past few years, many PBMs and insurers have consolidated, resulting in a smaller number of PBMs and insurers overseeing a large portion of total covered lives in the United States.

Furthermore, in the United States, the top six integrated health plans and PBMs controlled about 94% of all pharmacy prescriptions.

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.

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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 .

Although the IRA was enacted in August 2022, the environment remains dynamic, and the Administration and Congress continues to consider drug pricing legislation.

The IRA includes provisions requiring that beginning on January 1, 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.

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).

In August 2023, ENBREL, a product in which the rights to the BLA are held by our wholly owned subsidiary Immunex Corporation, was selected for the first round of 10 drugs subject to price setting that will be applicable beginning January 1, 2026.

As of January 1, 2024, Medicare Part D has been redesigned to cap beneficiary out-of-pocket costs and, beginning January 1, 2025, Federal reinsurance will be 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, beginning October 1, 2022, manufacturers owe rebates on drugs reimbursed under Medicare Part D if price increases outpace inflation, and beginning January 1, 2023, owe rebates on drugs reimbursed under Medicare Part B if price increases outpace inflation.

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.

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

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

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using third-party value assessments to determine drug prices;

referencing foreign prices;

and changes to government rebate programs.

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

The Infrastructure Investment and Jobs Act, signed into law on November 15, 2021, requires manufacturers of certain Part B–covered drugs packaged in single-use containers to give refunds to the government starting in 2023 for discarded amounts.

CMS also issued a proposed Medicaid Drug Rebate Program rule that, if finalized, would require 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.

Further, at the state level, seven states (Colorado, Maine, New Hampshire, Maryland, Minnesota, 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.

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 mandates, incentives for generic substitution and biosimilar usage and government-mandated price cuts.

In this regard, many countries have health technology assessment organizations that use formal economic metrics such as cost-effectiveness to determine prices, coverage and reimbursement of new therapies;

and these organizations are expanding in both established and emerging markets.

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 countries will continue taking aggressive actions to seek to reduce expenditures on drugs and biologics.

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 possible revision of its pharmaceutical legislation.

Various proposals are now being considered with a possible first reading in the EU Parliament in the first quarter of 2024, with full implementation not expected until 2027 or possibly later.

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

There are both positive and negative aspects to the current proposals being debated within the EU Commission and Parliament, including various proposals which could alter the intellectual property protection regime in Europe.

Nevertheless, the legislation, if implemented, is unlikely to significantly impact the difficult financial situation facing many Member States and is, therefore, not likely to improve the overall business climate for biopharmaceutical firms operating in the EU.

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.

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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Highly specialized knowledge and extensive process and product characterization are required to transform laboratory-scale processes into reproducible commercial manufacturing processes.

Further, our expertise in the manufacture of biologics positions us well for leadership in the global biosimilars market.

Further, our expertise in the manufacture of biologics has positioned us well for leadership in the global biosimilars market.

For additional information regarding manufacturing facilities, see Item 2.

We have been innovating our manufacturing facilities designed to extend our manufacturing advantage by optimizing our manufacturing network and/or by mitigating risks while continuing to ensure adequate supply of our products.

For example, our licensed next-generation biomanufacturing plants operating in Singapore and West Greenwich, Rhode Island, incorporate multiple innovative technologies into a single facility.

Next-generation biomanufacturing plants require smaller manufacturing footprints and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

Within such plants, the equipment is portable and smaller, which provides greater flexibility and speed in the manufacture of different medicines simultaneously.

This enables Amgen to respond to changing demands for its medicines with increased agility.

The Singapore site also has a plant that has been approved by several agencies, including the FDA and EMA, to produce small molecule drugs for commercial manufacturing.

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

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

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.

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.

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.

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.

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

To support our clinical trials, we manufacture product candidates primarily at our California facilities.

We also use third-party contract manufacturers to supplement the capacity or capability of our overall clinical manufacturing network.

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.

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Manufacturing Initiatives

As discussed above, we have been expanding capacity and advancing new innovations with multiple ongoing projects.

Our next-generation biomanufacturing plant at our West Greenwich, Rhode Island, campus, the first of its kind in the United States, has been approved by the FDA and EMA.

This plant expands our capacity to manufacture certain products for U.S.

and global markets, as we receive regulatory approval in those markets.

In November 2021, we broke ground for our newest biomanufacturing plant located in New Albany, Ohio, which received FDA licensure for commercial production in January 2024.

This final product assembly and packaging plant will support the growing demand for Amgen’s medicines and will use state-of-the-art technologies.

In March 2022, we broke ground for our new multi-product drug substance manufacturing facility in Holly Springs, North Carolina.

The new plant will support both traditional stainless steel-fed batch manufacturing and next-generation single-use technologies, allowing flexibility in the production of multiple products in one plant.

Subsequent to the Horizon acquisition, we are evaluating Horizon’s supply chains and pursuing activities to further improve resiliency and efficiency.

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.

Amgen continues to embed environmental sustainability into the upfront design, development and execution of our new facilities.

The new facility under construction in North Carolina and our recently FDA approved facility in Ohio contain many examples of environmental advances, including on-site photovoltaic renewable energy generation at both sites.

We expect our North Carolina facility’s carbon, waste and water footprints to be substantially lower than those at a traditional drug substance

manufacturing plant, and we expect lower footprints per unit produced as well at our Ohio facility compared with existing similar facilities.

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

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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 also monitor the financial condition of certain suppliers and their ability to supply our needs.

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

Risk Factors— We rely on third-party suppliers for certain of our raw materials, medical devices and components.

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We continue to work toward reducing cycle times by applying our expertise in human genetics and innovation in technology, clinical trials and real-world evidence.

See Research and Development and Selected Product Candidates section below.

After laboratory analysis and preclinical testing in animals, we file an IND with the FDA to begin human testing.

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• In phase 3, we conduct clinical trials to 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.

The FDA monitors the progress of each trial conducted under an IND and may, at its discretion, reevaluate, alter, suspend or terminate the testing based on data accumulated to that point and the FDA’s risk–benefit assessment with regard to the

patients enrolled in the trial.

The results of preclinical and clinical trials are submitted to the FDA in the form of either a BLA for biologic products or a New Drug Application for small molecule products.

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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 acquired in connection with the Horizon acquisition, have orphan drug exclusivity under this framework.

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

Regulation outside the United States

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In the decentralized procedure , identical applications for marketing authorization are submitted simultaneously to the national regulatory agencies.

Regulatory review is led by one member state (the reference-member state), and its assessment—based on safety, quality and efficacy—is reviewed and approved (assuming there are no concerns that the product poses a serious risk to public health) by the other member states

from which the applicant is seeking approval (the concerned-member states).

The decentralized procedure leads to a series of single national approvals in all relevant countries.

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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.

On April 25, 2019, we entered into a settlement agreement with the DOJ and the OIG of the HHS to settle certain allegations related to our support of independent charitable organizations that provide patients with financial assistance to access medicines.

Additionally, we entered into a corporate integrity agreement that requires us to both maintain a corporate compliance program and undertake a set of defined corporate integrity obligations for a period of five years.

Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or court decisions addressing some of our practices, it is possible that in the future, our practices might be further challenged under antikickback or similar laws.

Risk Factors—Our business may be affected by litigation and government investigations.

The FCPA prohibits U.S.

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and China’s Personal Information Protection Law, which became effective on November 1, 2021.

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.

Consumer privacy laws were also passed in 11 other states, with the earliest effective dates later this year, and proposed in three additional states.

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.

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.

Both these new consumer health privacy laws become effective March 31, 2024.

Failure to comply with these current and future laws could result in significant penalties.

Both these new consumer health privacy laws became effective on March 31, 2024.

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.

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

High-risk AI systems are subject to stringent requirements such as mandatory risk assessments, technical documentation, bias mitigation and explainability standards.

Non-compliance with these current and future laws could result in significant penalties.

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

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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.

With regard to our clinical trial activities, we are continuously monitoring the possible impacts from health-related events, including changes from new COVID-19 variants;

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.

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

We are working to mitigate effects on future study enrollment in our clinical trials;

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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.

For the years ended December 31, 2023, 2022 and 2021, our R&D expenses were $4.8 billion, $4.4 billion and $4.8 billion, respectively.

We have major R&D centers in Thousand Oaks and San Francisco, California, and Deerfield, Illinois;

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

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

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Risk Factors— We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications.

For the years ended December 31, 2024, 2023 and 2022, our R&D expenses were $6.0 billion, $4.8 billion and $4.4 billion, respectively.

We expect to continue allocating significant resources to our R&D activities.

Some of our competitors are actively engaged in R&D in areas in which we have products or in which we are developing product candidates or new indications for existing products.

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In pursuing these R&D arrangements and licensing or acquisition activities, we face competition from other pharmaceutical and biotechnology companies that also seek to license or acquire technologies, product candidates or marketed products from those entities performing the R&D.

The following table shows a selection of certain of our product candidates by phase of development in our therapeutic areas of focus as of January 31, 2024, unless otherwise indicated.

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 4, 2025, 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 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 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.

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.

Molecule Investigational indication

Phase 3 programs

Investigational indications (programs)

AMJEVITA Interchangeability

Bemarituzumab GEJ adenocarcinoma

BLINCYTO Ph-negative B-cell precursor acute lymphoblastic leukemia

Sjögren’s Syndrome

Bemarituzumab Gastric and gastroesophageal junction cancer

BLINCYTO Ph-negative B-ALL

Investigational indications (programs)

Sjögren’s disease

EVENITY Male osteoporosis

Small cell lung cancer

LUMAKRAS/LUMYKRAS Advanced colorectal cancer

Non-small cell lung cancer

Nplate Chemotherapy-induced thrombocytopenia

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Repatha Cardiovascular disease

Rocatinlimab Atopic dermatitis

Small cell lung cancer

Active TED in Japan;

Chronic/Low CAS TED in Japan

Rocatinlimab Moderate-to-severe atopic dermatitis

Prurigo nodularis

Subcutaneous administration for TED

Chronic/low clinical activity score TED in Japan

TEZSPIRE Chronic rhinosinusitis with nasal polyps

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Severe asthma

Generalized myasthenia gravis

IgG4-related disease

Myasthenia gravis

Investigational biosimilar to STELARA (ustekinumab)

Metastatic castrate resistant prostate cancer

Investigational biosimilar to OPDIVO (nivolumab)

ABP 938 Investigational biosimilar to EYLEA (aflibercept)

ABP 959 Investigational biosimilar to SOLIRIS (eculizumab)

Phase 2 programs

Investigational biosimilar to KEYTRUDA (pembrolizumab)

Investigational biosimilar to OCREVUS (ocrelizumab)

Bemarituzumab

Dermatomyositis or anti-synthetase inflammatory myositis;

Systemic lupus erythematosus with nephritis

Dermatomyositis and anti-synthetase inflammatory myositis

Discoid lupus erythematosus

Efavaleukin alfa

Ulcerative colitis

Fipaxalparant

Diffuse cutaneous systemic sclerosis;

idiopathic pulmonary fibrosis

LUMAKRAS/LUMYKRAS Other solid tumors with KRAS G12C mutations

Systemic lupus erythematosus with nephritis

LUMAKRAS/LUMYKRAS

Maridebart cafraglutide

Type 2 diabetes

Celiac disease

Moderate-to-severe asthma

TEZSPIRE Chronic obstructive pulmonary disease

Chronic spontaneous urticaria

Phase 1 programs

Bemarituzumab NSCLC

Tarlatamab Neuroendocrine prostate cancer

Subcutaneous administration for TED

Prostate cancer

AMG 104 Asthma

AMG 193 Solid tumors

Autoimmune disease

Non-small cell lung cancer

Sjögren’s disease

Neuroendocrine prostate cancer

Prostate cancer

AMG 193 Solid tumors

AMG 355 Solid tumors

AMG 786 Obesity

AMG 651 Solid tumors

Investigational indications (programs)

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.

Phase 2 Clinical trials investigate side-effect profiles and efficacy of product candidates in a larger patient population than phase 1, but still relatively small, who have the disease or condition under study.

Phase 1 Clinical trials investigate the safety and proper dose ranges of product candidates in a small number of human subjects.

Phase 1 Clinical trials investigate the safety and proper dose ranges of product candidates usually in a small number of human subjects.

Phase 3 Product Candidate Program Changes

As of January 31, 2023, we had 18 phase 3 programs.

As of January 31, 2024, we have 24 phase 3 programs, as five phase 3 programs were acquired from Horizon, three programs initiated phase 3 studies, one program was approved by the FDA and one program concluded.

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.

These changes are set forth in the following table.

Molecule Investigational indication Program change

Sjögren’s Syndrome Horizon acquired program

KYPROLIS Weekly dosing for relapsed multiple myeloma Concluded—program did not meet its primary endpoint

LUMAKRAS/LUMYKRAS NSCLC in combination with chemotherapy

Investigational indications (programs)

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

Genital psoriasis

Subcutaneous administration for TED

Initiated phase 3 study

Active TED in Japan Approved in Japan

Investigational biosimilar to STELARA (ustekinumab)

Approved by the FDA

Small cell lung cancer

Metastatic castrate resistant prostate cancer

Initiated phase 3 study

Active TED (OPTIC-J);

Chronic/Low CAS TED in Japan

Horizon acquired programs

IgG4-related disease;

Myasthenia gravis

Horizon acquired programs

Biosimilar to OPDIVO

Investigational biosimilar to KEYTRUDA (pembrolizumab) Initiated phase 3 study

Investigational biosimilar to OCREVUS (ocrelizumab)

Initiated phase 3 study

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Europe Polypeptides 2026

Polypeptides 2036

Europe Polypeptides 2036

(1) Patent expiration estimates are based on issued patents, which may be challenged, invalidated or circumvented by competitors.

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

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

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 advanced gastroesophageal junction (GEJ) adenocarcinoma and advanced solid tumors other than advanced squamous NSCLC.

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.

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

It is being investigated in newly diagnosed adults aged 40 and older with Ph negative B-cell precursor ALL.

It is being investigated for the treatment of newly diagnosed adults with B-ALL.

Daxdilimab is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells.

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Dazodalibep is a fusion protein binding CD40L on T cells, blocking their interaction with CD40-expressing B cells.

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

Efavaleukin alfa

Efavaleukin alfa is an interleukin (IL)-2 mutein Fc fusion protein.

It is being investigated for the treatment of ulcerative colitis.

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

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

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EVENITY is being developed in collaboration with UCB.

Fipaxalparant

Fipaxalparant is a molecule that blocks lysophosphatidic acid receptor 1 (LPAR1).

It is being investigated for the treatment of diffuse cutaneous systemic sclerosis and idiopathic pulmonary fibrosis.

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

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

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.

LUMAKRAS/LUMYKRAS

LUMAKRAS/LUMYKRAS is a KRAS G12C small molecule inhibitor.

It is being investigated as treatment for a variety of solid tumors, including NSCLC, colorectal cancer and other solid tumor cancers.

In October 2023, we announced positive data from the global Phase 3 CodeBreaK 300 trial.

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

Maridebart cafraglutide

Maridebart cafraglutide is a gastric inhibitory polypeptide receptor (GIPR) antagonist and glucagon-like peptide 1 (GLP-1) receptor agonist.

It is being investigated for the treatment of obesity.

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.

See Significant Developments for additional information regarding clinical trial updates.

Nplate is a thrombopoietin receptor agonist (TPO-RA).

It is being investigated for the treatment of chemotherapy-induced thrombocytopenia (CIT).

Olpasiran is an siRNA that lowers Lp(a).

It is being investigated in phase 3 for the treatment of ASCVD.

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.

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Repatha is a human monoclonal antibody that inhibits PCSK9.

It is being investigated as a treatment for ASCVD in high-risk patients with high LDL-C without prior heart attack or stroke.

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

Rocatinlimab is a monoclonal antibody that inhibits OX-40.

It is being investigated for the treatment of moderate-to-severe atopic dermatitis.

It is being investigated in phase 3 studies for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis.

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.

Tarlatamab is a half-life extended (HLE) anti-DLL3 x anti-CD3 BiTE ® molecule.

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

In October 2023, we announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational DLL3 targeting BiTE ® molecule, in patients with advanced stage SCLC who had failed two or more prior lines of treatment.

With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an ORR (primary endpoint) of 40%.

For key secondary endpoints, mPFS was 4.9 months, and mOS was 14.3 months.

There were no new safety signals observed compared to the Phase 1 study.

In December 2023, we announced the FDA accepted and granted Priority Review for the Company’s BLA for tarlatamab, with a PDUFA date of June 12, 2024.

See Significant Developments for additional information regarding clinical trial updates.

TEPEZZA is a monoclonal antibody against IGF-1R.

It is being investigated in phase 3 studies for patients with moderate-to-severe active TED and chronic/low clinical activity score (CAS) TED.

It is also being investigated for subcutaneous administration.

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.

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 severe asthma, chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis.

It is also being investigated in phase 2 studies as a treatment for chronic obstructive pulmonary disease and chronic spontaneous urticaria.

TEZSPIRE is being developed jointly in collaboration with AstraZeneca.

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).

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 for the treatment of flare in patients with IgG4-related disease and myasthenia gravis.

Wezlana, a biosimilar candidate to STELARA, is a monoclonal antibody that inhibits IL-12 and IL-23.

It is being investigated in a phase 3 study for biosimilarity to STELARA.

The reference-product primary conditions are psoriasis, psoriatic arthritis and Crohn’s disease.

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.

It is being investigated for the treatment of prostate cancer.

ABP 206, a biosimilar candidate to OPDIVO, is a monoclonal antibody that binds to the receptor protein called programmed death protein 1 (PD-1).

ABP 938, a biosimilar candidate to EYLEA, is a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein.

It is being investigated in a phase 3 study for biosimilarity to EYLEA.

The reference-product primary conditions are wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

ABP 959, a biosimilar candidate to SOLIRIS, is a monoclonal antibody that specifically binds to the complement protein C5.

It is being investigated in a phase 3 study for biosimilarity to SOLIRIS.

The reference-product primary conditions are paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

ABP 234, a biosimilar candidate to KEYTRUDA, is a monoclonal antibody that binds to the receptor protein (PD-1).

It is being investigated in a phase 3 study for biosimilarity to KEYTRUDA.

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.

AMG 104 is a human anti-TSLP Fab.

It is being investigated for the treatment of asthma and is being developed in collaboration with AstraZeneca.

AMG 193 is a small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.

It is being investigated for the treatment of NSCLC.

AMG 329 is a fully human monoclonal antibody that binds and neutralizes the function of the FLT3-ligand, thereby reducing both conventional and plasmacytoid dendritic cells.

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

Business Relationships

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However, others could either develop independently the same or similar information or unlawfully obtain access to our information.

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 will 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 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 will also pay royalties to BeiGene.

AstraZeneca plc

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1 Under our collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen.

AstraZeneca leads global development, and both Amgen and AstraZeneca jointly commercialize TEZSPIRE in North America.

AstraZeneca leads global development.

In North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada.

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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.

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.

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

1 We are also in a collaboration with AstraZeneca for the development of AMG 104.

See Research and Development and Selected Product Candidates section above.

Human Capital Resources

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We strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.

The way we approach our business is guided by the Amgen Values:

Be Science-Based

Compete Intensely and Win

Create Value for Patients, Staff and Stockholders

Trust and Respect Each Other

Ensure Quality

Work in Teams

Collaborate, Communicate and Be Accountable

Our staff are also guided by, and receive annual training on, the Company’s Code of Conduct, which is designed to help every person who does business on our behalf worldwide (including all staff, management, consultants, contract workers and temporary workers) to understand what is expected of them.

Our industry is subject to a co mplex regulatory and reimbursement environment.

The unique demands of our industry, together with the challenges of running an enterprise focused on the discovery, development, manufacture and commercialization of innovative medicines, requires a highly engaged and committed workforce.

As of December 31, 2023, Amgen had approximately 26,700 staff members in over 50 countries, and we have had relatively low global turnover rates compared to available industry information.

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.

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

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We consider our staff relations to be good, supported by regular assessments of staff engagement surveys on a wide range of topics (including flexible work environments, career development, and maintaining a culture of compliance).

Our engagement scores were above general market benchmarks in 2024.

We discuss the results of these surveys with our workforce and our Board of Directors.

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Compensation, Benefits and Development

Our approach to employee compensation and benefits is designed to deliver cash, equity and benefit programs that are competitive with those offered by leading companies in the biotechnology and pharmaceutical industries, and to attract, motivate and retain talent with a focus on encouraging performance, promoting accountability and adherence to the Amgen Values and alignment with the interests of the Company’s stockholders.

Our approach to employee compensation and benefits is designed to deliver cash, equity and benefit programs that are competitive with those offered by leading companies in the biotechnology and pharmaceutical industries, and to attract, motivate and retain talent with a focus on encouraging performance, promoting accountability and adherence to our values and alignment with the interests of the Company’s stockholders.

Our base pay program aims to compensate staff members relative to the value of the contributions of their role, which takes into account the skills, knowledge and abilities required to perform each position, as well as the experience brought to the job.

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All staff participate in a regular performance measurement process through which staff receive performance and development feedback, and pay is aligned to performance.

The Amgen Values and Leadership Attributes (Inspire, Accelerate, Integrate and Adapt) are an integral part of the performance assessments of our staff members, and these evaluations serve as an important information tool and basis for compensation decisions.

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.

Our values and leadership attributes are an integral part of the performance assessments of our staff members, and these evaluations serve as an important information tool and basis for promotion and compensation decisions.

Our staff receive, and are guided by, regular trainings that help them understand what is expected of them.

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.

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

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staff members are eligible to participate in the same core health and welfare and retirement savings plans.

employee benefits include adoption assistance, paid parental leave programs, access to childcare, employee assistance programs, employee stock purchase plan, flexible spending accounts, life, long-term care and business travel accident insurance, short and long-term disability benefits, wellness benefits and work-life resources and referrals.

employee benefits include adoption assistance, paid parental leave programs, access to childcare, employee assistance programs, employee stock purchase plan, flexible spending accounts, life insurance, long-term care and business travel accident insurance, short and long-term disability benefits, wellness benefits and work-life resources and referrals.

Comparable programs and benefits are available globally, with the same health and well-being intent, and consistent with local statutory requirements.

Our Compensation and Management Development Committee provides oversight of our compensation plans, policies and programs.

Safety and Wellness

Total Workforce Health

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, risk management practices and integrating safety throughout our business processes.

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.

We use leading indicators to assess the effectiveness of our safety programs and make course corrections as needed.

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.

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.

Additionally, we perform formal executive management review of functional safety performance for Operations, Global Commercial Operations and R&D on a quarterly basis with a focus on identifying early signals and taking action to drive continuous improvement.

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

We believe that a diverse and inclusive culture fosters innovation, which supports our ability to serve patients.

Further, we also believe our global presence is strengthened by having a workforce that reflects the diversity of the patients we serve (1) .

Our Diversity, Inclusion and Belonging Council is led by our executive leadership and is responsible for overseeing our strategy to further a diverse and inclusive workplace.

We offer a variety of diversity, inclusion and belonging programs and have continued to launch enhanced resources that guide staff on the role they play in creating an inclusive culture.

Further, we continue to incorporate diversity, inclusion and belonging considerations into our business operations, including clinical trial design and procurement, to broaden access to patients and suppliers to the benefit of our business.

Each of Amgen’s Employee Resource Groups is sponsored by senior executive leadership.

Our Employee Resource Groups promote leadership, development and belonging for members while also working to positively impact our business by leading business initiatives and providing diverse perspectives and experience.

(1) Amgen is an equal opportunity employer and does not make employment decisions based on race, gender, ethnicity, or any other protected characteristic.

Global Employee Resource Groups

Amgen Asian Association (AAA) Amgen Black Employee Network (ABEN)

Ability Bettered through Leadership and Education (ABLE), a resource group for those with disabilities, visible and invisible, including those conditions also experienced by the patients that Amgen serves

Amgen Early Career Professionals (AECP) Amgen International Network (AIN)

Amgen Latin Employee Network (ALEN) Amgen PRIDE – LGBTQ and Allies Network (PRIDE)

Amgen South Asian Network (ASAN)

Amgen Veterans Employees Network (AVEN)

Recognition of Indigenous Peoples, Values and Environmental Resources (RIVER)

Women Empowered to be Exceptional (WE2) Women in STEM Enrichment (WISE)

Building on the successful execution of our 2022 ESG goal under our annual incentive plan, our enhanced ESG goal for 2023 was designed to advance our progress on key ESG initiatives, including by driving measurable achievement of our Representation in Clinical Research (RISE) objectives that seek to improve the diversity and representation of racial and ethnic minority populations in our clinical trial research to help us develop medicines that are studied in participants who better reflect the populations affected by serious illness, and further expanding the number of leaders accountable for establishing, documenting and executing on diversity, inclusion and belonging action plans.

As of December 31, 2023, women comprised approximately 53% of our global workforce, and ethnic minorities accounted for approximately 50% of our U.S.

and Puerto Rico-based workforce.

In our effort to attract and retain the best talent, we seek out and support talent across the globe, including in underrepresented populations, consistent with our commitment to equal opportunity.

In 2023, we launched our Apprenticeship Program as part of our multidimensional inclusive hiring and talent development strategy, with the first phase of the program beginning with our Manufacturing and DTI functions.

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.

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.

Through the Apprenticeship Program, we will 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 will provide us with access to a larger pool of highly motivated and productive talent while also providing underrepresented groups greater access to innovation economy careers.

Our 2022 Consolidated EEO-1 Report can be viewed on our website at www.amgen.com (the website address is not intended to function as a hyperlink, and the information contained in our website is not intended to be a part of this filing).

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

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.

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, defense, space and securities systems, since 2016.

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.

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

From 2011 to 2017, Mr.

Bradway was a director of Norfolk Southern Corporation, a transportation company.

Bradner, age 51, became Executive Vice President, Research and Development, and Chief Scientific Officer, in December 2023.

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 was a clinician at the Dana-Farber Cancer Institute.

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.

From 2016 to 2022, Dr.

Bradner served as President of the Novartis Institutes for BioMedical Research, where he was a member of the Executive Committee of Novartis AG.

Bradner served as President of the Novartis Institutes for BioMedical Research, the research and early development organizational unit of Novartis AG, where he was a member of the Executive Committee.

Bradner previously served on the faculty at Harvard Medical School.

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Prior to joining the Company, Mr.

Gordon was Chief Commercial Officer at BMS, a pharmaceutical company, from 2016 to 2018.

Gordon was Chief Commercial Officer at Bristol-Myers Squibb Company (BMS), a pharmaceutical company, from 2016 to 2018.

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

Prior to this, Mr.

Prior to that, Mr.

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

Graham, age 63, became Executive Vice President, General Counsel and Secretary in 2019.

Graham, age 64, became Executive Vice President and General Counsel and Secretary in 2019.

Graham joined the Company in 2015.

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Reese was a cofounder, president, and chief medical officer of Translational Oncology Research International, a not-for-profit academic clinical research organization, and director of Clinical Research at the Breast Cancer International Research Group.

Reese previously served on the faculty at UCLA and the University of California, San Francisco.

Reese previously served on the faculty at the University of California, Los Angeles and the University of California, San Francisco.

Esteban Santos, age 57, became Executive Vice President, Operations, in 2016.

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Prior to joining the Company, Mr.

Santos served as Site General Manager of J&J’s Cordis operation in Puerto Rico.

Santos served as Site General Manager of Johnson & Johnson’s (J&J) Cordis operation in Puerto Rico.

Prior to J&J, 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