AMGEN INC

Manufacturing

We believe we are a leader in the manufacture of biologics and that our manufacturing capabilities represent a competitive advantage. The products we manufacture consist of both biologics and small molecule drugs. The majority of our products are biologics that are produced in living cells and that are inherently complex due to naturally occurring molecular variations. 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 has positioned us well for leadership in the global biosimilars market. For additional information regarding manufacturing facilities, see Item 2. Properties.

We are expanding our manufacturing capacity and incorporating state-of-the-art technologies to allow us to optimize our manufacturing network and mitigate risks while working to continue to ensure adequate supply of our products to patients worldwide. See Manufacturing Initiatives below for additional discussion of our manufacturing expansion efforts. Our new state-of-the-art biomanufacturing facilities, including our facility in North Carolina and FDA-approved facility in Ohio, have been constructed at a lower cost and with greater speed as compared to traditional facilities. For example, our facility in North Carolina has equipment that is portable and smaller, which provides greater flexibility and speed in the manufacture of different medicines simultaneously, allowing us to respond to changing demands for our medicines with increased scale and agility. Furthermore, such state-of-the-art facilities incorporate multiple innovative technologies, automation solutions and environmental sustainability, thus requiring smaller manufacturing footprints and offering greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions. For example, our facility in North Carolina and our FDA-approved facility in Ohio contain many examples of environmental commitments, including on-site photovoltaic renewable energy generation at both sites. We expect our North Carolina facility’s carbon footprint, water usage and waste disposed to be substantially lower than that of a traditional drug substance manufacturing facility. Similarly, we expect lower carbon footprint, water usage and waste disposed per unit at our Ohio facility as compared to traditional packaging and assembly facilities.

Our internal manufacturing network has commercial production capabilities for bulk manufacturing, formulation, fill, finish, tableting and final device assembly. These activities are performed within the United States, including in the U.S. territory of Puerto Rico, Rhode Island, Ohio and California facilities, as well as internationally in our Ireland, Netherlands and Singapore facilities. In addition, we use third-party contract manufacturers to supplement the capacity or capability of our commercial manufacturing network.

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

See Item 1A. Risk Factors for a discussion of the factors that could adversely impact our manufacturing expansion operations and the global supply of our products.

Distribution

We operate distribution centers in the U.S. territory of Puerto Rico, Kentucky, California and the Netherlands for worldwide distribution of the majority of our commercial and clinical products. We also use third-party distributors to supplement distribution of our products worldwide.

Other

In addition to the manufacturing and distribution activities noted above, each of our manufacturing locations includes key manufacturing support functions such as quality control, process development, engineering, procurement, production scheduling and warehousing. Certain of those manufacturing and distribution activities are highly regulated by the FDA as well as international regulatory agencies. See Government Regulation—Regulation in the United States—Regulation of Manufacturing Standards.

Manufacturing Initiatives

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 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 at this location. This second facility will incorporate state-of-the-art technologies and sustainable practices. The result is a more flexible and efficient facility, with a smaller physical footprint, reduced consumption of water and energy, and lower levels of carbon emissions than a traditional facility.

Additionally, in 2025 we announced expansions of our manufacturing network in New Albany, Ohio and the U.S. territory of Puerto Rico, further strengthening our U.S.-based manufacturing capabilities. Our Ohio expansion builds on our existing biomanufacturing facility, which received FDA licensure for commercial production in January 2024 and supports final product assembly and packaging using state-of-the-art technologies and automation.

These expansion initiatives further enhance our manufacturing network to support reliable and efficient supply of our medicines to patients worldwide. We continue evaluating our manufacturing network to ensure we maintain appropriate levels of operational flexibility and risk management needed to support our global operations.

Numerous tariffs and trade protection measures have been proposed and, in some cases, implemented by the United States and other countries. We continue to evaluate our global supply chains, sourcing strategies and manufacturing network and to implement measures to minimize the impact of existing and potential future tariffs. See Item 1A. Risk factors—Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets, and Part II—Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview.

See Item 1A. Risk Factors—Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.

Raw Materials and Medical Devices

Certain raw materials, medical devices (including companion diagnostics) and components necessary for the commercial and/or clinical manufacturing of our products are provided by and are the proprietary products of unaffiliated third-party suppliers, certain of which may be our only source for such materials. We work to manage the risk associated with such sole suppliers by means of inventory management, relationship management and evaluation of alternative sources when feasible. We also monitor the financial condition and manufacturing quality and compliance of key suppliers and their ability to supply our needs. See Item 1A. Risk Factors—We rely on third-party suppliers for certain of our raw materials, medical devices and components.

We perform various procedures to help authenticate the sources of raw materials, including intermediary materials used in the manufacture of our products; the procedures are incorporated into the manufacturing processes we and our third-party contract manufacturers perform and include verification of country of origin.

To better ensure supply, Amgen has a risk mitigation strategy that uses a combination of methods, including multiple sources or backup inventory of critical raw materials. As part of our ongoing business continuity efforts, we continue to closely monitor our inventory levels and have taken additional measures to mitigate against raw material supply interruption. We also continue to assess the potential impacts of existing and proposed tariffs on our raw material and medical device supply chains and implement sourcing and inventory strategies intended to minimize the impacts from existing and potential future tariffs. See

Item 1A. Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products.