AMGEN INC

We focus our R&D on novel human therapeutics for the treatment of serious illness. We capitalize on our strengths in human genetics, novel biology and protein engineering. We leverage our biologic expertise and seek to choose the optimal modality for a drug target and disease. And we use cutting-edge science and technology to study subtle biological mechanisms in search of therapies that will improve the lives of those who suffer from diseases. See Government Regulation—Clinical Development and Product Approval section above.

Our discovery research programs may therefore yield targets that lead to the development of human therapeutics delivered as large molecules, small molecules, other combination modalities or new modalities. We have reshaped our portfolio and have increasingly focused our efforts on human genetics when possible to enhance the likelihood of success. We have major R&D centers in the United States in Thousand Oaks and San Francisco, California; Iceland; and the United Kingdom, as well as smaller research centers and development facilities globally. See Item 2. Properties.

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; and we are evaluating the impact in all relevant countries. We remain focused on supporting our active clinical sites in their providing care for patients and in our providing investigational drug supply. Our clinical trial activities are conducted by both our internal staff and third-party contract clinical trial service providers. To increase the number and diversity of patients available for enrollment in our clinical trials, we have opened clinical sites and will continue opening clinical sites and enrolling patients in a number of geographic locations. See Government Regulation—Regulation in the United States—Clinical Development and Product Approval for a discussion of government regulation over clinical development. Also see Item 1A. 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. For example, we compete with other clinical trials for eligible patients, which may limit the number of available patients who meet the criteria for certain clinical trials. The competitive marketplace for our product candidates is greatly dependent on the timing of entry into the market. Early entry may have important advantages in gaining product acceptance, thereby contributing to a product’s eventual success and profitability. Accordingly, we expect that in some cases, the relative speed with which we can develop products, complete clinical testing, receive regulatory approval and supply commercial quantities of a product to the market will be important to our competitive position.

In addition to product candidates and marketed products generated from our internal R&D efforts, we acquire companies, acquire and license certain product and R&D technology rights and establish R&D arrangements with third parties to enhance our strategic position within our industry by strengthening and diversifying our R&D capabilities, product pipeline and marketed product base. 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 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, 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.

Phase 3 Product Candidate Program Changes

As of January 31, 2024, we had 24 phase 3 programs studied in investigational indications. As of February 4, 2025, we have 25 phase 3 programs being studied in investigational indications, as five programs initiated phase 3 studies, three programs were approved by the FDA and one program was approved in Japan. These changes are set forth in the following table.

Phase 3 Product Candidate Patent Information

The following table describes our composition-of-matter patents that have been issued thus far for our product candidates in phase 3 development that have yet to be approved for any indication in the United States or the EU. Patents for products already approved for one or more indications in the United States or the EU but that are currently undergoing phase 3 clinical trials for additional indications have been previously described. See Marketing, Distribution and Selected Marketed Products—Patents.

(1)Patent expiration estimates are based on issued patents, which may be challenged, invalidated or circumvented by competitors. The estimates do not include any term adjustments, extensions or supplemental protection certificates that may be obtained in the future and thereby extend these dates. Corresponding patent applications are pending in other jurisdictions. Additional patents may be filed or issued and may provide additional exclusivity for the product candidate or its use. In addition to patent exclusivity, the product candidates may be protected by regulatory exclusivities upon approval in some countries. For example, new chemical entities would receive a five year exclusivity period and new molecular entities would receive a 12 year exclusivity period in the United States, whereas new chemical and molecular entities would receive a 10 year exclusivity period in Europe.

Phases 2 and 3 Program Descriptions

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

AMJEVITA

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

Bemarituzumab

Bemarituzumab is a monoclonal antibody that inhibits fibroblast growth factor receptor 2b (FGFR2b). It is being investigated for the treatment of gastric and gastroesophageal junction cancer and advanced solid tumors other than advanced squamous NSCLC.

Blinatumomab

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 for the treatment of newly diagnosed adults with B-ALL.

Daxdilimab

Daxdilimab is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells. It is being investigated for the treatment of both dermatomyositis and anti-synthetase inflammatory myositis and discoid lupus erythematosus.

Dazodalibep

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 disease.

EVENITY

EVENITY is a monoclonal antibody that inhibits the action of sclerostin. It is being evaluated as a treatment for male osteoporosis. EVENITY is being developed in collaboration with UCB.

IMDELLTRA

IMDELLTRA is an anti-DLL3 x anti-CD3 BiTE® molecule. It is being investigated for the treatment of small cell lung cancer.

Inebilizumab

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 in NSCLC, colorectal cancer and other solid tumor cancers.

Maridebart cafraglutide

MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR). It is being investigated for the treatment of obesity and type 2 diabetes. See Significant Developments for additional information regarding clinical trial updates.

Nplate

Nplate is a thrombopoietin receptor agonist (TPO-RA). It is being investigated for the treatment of chemotherapy-induced thrombocytopenia (CIT).

Olpasiran

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

Ordesekimab is a monoclonal antibody that inhibits the action of IL-15. It is being investigated for the treatment of celiac disease and is being developed in collaboration with Provention Bio, Inc.

Otezla

Otezla is a small molecule that inhibits PDE4. It is being investigated in phase 3 studies for the treatment of palmoplantar pustulosis.

Repatha

Repatha is a human monoclonal antibody that inhibits PCSK9. It is being investigated in patients at high cardiovascular risk without a prior myocardial infarction or stroke.

Rocatinlimab

Rocatinlimab is a monoclonal antibody that inhibits OX-40. 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. See Significant Developments for additional information regarding clinical trial updates.

TEPEZZA

TEPEZZA is a monoclonal antibody against IGF-1R. It is being investigated in phase 3 studies for subcutaneous administration for the treatment of TED and chronic/low clinical activity score (CAS) TED in Japan.

TEZSPIRE is a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin. It is being evaluated in phase 3 studies as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis and severe asthma. It is also being investigated in phase 2 studies as a treatment for chronic obstructive pulmonary disease (COPD). TEZSPIRE is being developed in collaboration with AstraZeneca. See Significant Developments for additional information regarding clinical trial updates.

UPLIZNA

UPLIZNA is a humanized, affinity-optimized, afucosylated IgG1 kappa (IgG1κ) monoclonal antibody that binds to the B cell-specific surface antigen CD19. It is being investigated in phase 3 studies for the treatment of generalized myasthenia gravis and flares in patients with IgG4-related disease. See Significant Developments for additional information regarding clinical trial updates.

Xaluritamig

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

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 234

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

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

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

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

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.