Amgen (AMGN) Risk Factor Changes

•tariffs or other trade barriers that increase costs, limit availability, or disrupt the flow of goods; and/or

Our stock price, like that of our peers in the biotechnology and pharmaceutical industries, is volatile.

We maintain a significant portfolio of investments on our consolidated balance sheets.

We continue to work towards operating our business in a sustainable manner.

Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives.

There have also been legislative and administrative proposals seeking to incentivize greater drug manufacturing in the United States with the stated goal of improving supply reliability in the United States.

In addition, regulatory agencies conduct routine monitoring and inspections of our manufacturing facilities and processes as well as those of our third-party contract manufacturers and service providers.

If any of these or other problems affect production in one or more of our facilities or those of our third-party contract manufacturers, or if we do not accurately forecast demand for our products or the amount of our…

Manufacturing biologic and small molecule human therapeutic products is difficult, complex and highly regulated.

For example, in prior years we have experienced shortages in certain components necessary for the formulation, fill and finish of certain of our products in our Puerto Rico facility, and we have also experienced short…

We rely on unaffiliated third-party suppliers for certain raw materials, medical devices and components necessary for the manufacturing of our commercial and clinical products.

Many of our products and product candidates may be used in combination with a drug delivery device, such as an injector or other delivery system.

Regulatory authorities also require that our products are tested and controlled for impurities.

Regulatory authorities have questioned, and may in the future question, the sufficiency for approval of the endpoints we select for our clinical trials.

Obtaining and maintaining regulatory approvals have been, and will continue to be, increasingly difficult, time-consuming and costly.

Clinical trials must generally be designed based on the current standard of medical care.

Further, to increase the number of patients available for enrollment in our clinical trials, we have opened, and will continue to open, clinical sites and enroll patients in a number of locations where our experience…

Before a product may be sold, we must conduct clinical trials to demonstrate that our product candidates are safe and effective for use in humans.

Certain of our distributors, customers and payers have substantial purchasing leverage, due to the volume of our products they purchase or the number of patient lives for which they provide coverage.

While we are unable to predict the precise effects and timing of biosimilars and generics on our products, we are currently facing and expect to face greater competition in the United States, Europe and elsewhere as a…

Upon the expiration or loss of patent protection and/or applicable exclusivity for one of our products, we can lose the majority of revenues for that product in a very short period of time.

In the United States, the BPCIA authorizes the FDA to approve biosimilars via a separate, abbreviated pathway.

In the EU, biosimilars are evaluated for marketing authorization pursuant to a set of general and product class-specific guidelines.

We currently face competition from biosimilars and generics in most of the territories in which we operate, including the United States and Europe, and we expect to face increasing biosimilar and/or generics competiti…

examples of and information related to our patent litigation, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.

Our success depends in part on our ability to obtain and defend patent rights and other intellectual property rights that are important to the commercialization of our products and product candidates.

We operate in a highly competitive environment.

We expect to access the capital markets, from time to time, to supplement our existing funds and cash generated from operations to satisfy our needs for working capital; capital expenditure and debt service requiremen…

We are subject to fluctuations in foreign currency exchange rates relative to the U.S.

business dealings with Russia, certain regions of Ukraine and certain entities and individuals.

As we continue our expansion efforts in emerging markets around the world, through acquisitions and licensing transactions as well as through the development and introduction, both independently and through collaborat…

Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets.

We are adopting and exploring the use of AI in our business, and as an emerging and rapidly evolving technology, our use of AI introduces potential opportunities but also presents risks that could adversely affect our…

Domestic and global government regulators, our business partners, suppliers with whom we do business, companies that provide us or our partners with business services and companies we have acquired or may acquire face…

Cyberattackers are also increasingly exploiting vulnerabilities in commercially available software from shared or open-source code.

Our systems also contain and use a high volume of sensitive data, including intellectual property, trade secrets and other proprietary business information, financial information, regulatory information, strategic pla…

We have also experienced denial of service attacks against our network, and, although such attacks did not succeed, there can be no assurance that our efforts to guard against the wide and growing variety of potential…

present in many non-corporate and home networks.

Our information technology systems, including AI-enabled tools and systems are highly integrated into our business, including our R&D efforts, our clinical and commercial manufacturing processes and our product sales…

We may pay substantial amounts of cash, incur debt or issue equity securities to pay for acquisition activities, which could adversely affect our liquidity or result in dilution to our stockholders, and could adversel…

We seek innovation through significant investment in both internal R&D and external transactions, including collaborations, partnerships, alliances, licenses, joint ventures, mergers and acquisitions (collectively, ac…

Changes to existing tax law in the United States, the U.S.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations—Income Taxes, and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements.

We are currently also under examination by the IRS for the years 2016–2018 with respect to issues similar to those for the 2010 through 2015 period.

We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit.

In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United S…

One or more of our legal entities file income tax returns in the U.S.

We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and t…

Government agencies promulgate regulations and guidelines directly applicable to us and to our products.

Outside the United States, we expect countries will also continue to take actions to reduce their drug expenditures and to reduce intellectual property protections.

Further, significant consolidation in the health insurance industry has resulted in a few large insurers and PBMs, which places greater pressure on pricing and usage negotiations with biopharmaceutical manufacturers,…

Ultimately, existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations.

At the state level, legislation, government actions and ballot initiatives can also affect how our products are covered and reimbursed and/or create additional pressure on our pricing decisions.

Sales of our products depend on the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans.

•Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives.

•Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets.

•We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and…

perceived safety issues with our products or similar products or unexpected clinical trial results can have an immediate and rapid effect on our stock price, whether or not our operating results are materially affected.

Our operations and performance have been, and may continue to be, affected by global economic conditions.

our products or continue our clinical trials and Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.

We are expanding our manufacturing capabilities to support current and anticipated demand for our products and product candidates.

therapeutics instead of our products, which could have a material adverse effect on our product sales, business and results of operations.

For example, in prior years we have experienced shortages in certain components necessary for the formulation, fill and finish of certain of our products in our Puerto Rico facility, and we have also experienced short…

earthquakes or other natural or man-made disasters or events (including political unrest or labor shortages) could have a more significant effect on our manufacturing operations.

In addition, we currently perform a substantial majority of our commercial manufacturing activities at our facility in the U.S.

development costs; delays in, or failure to obtain or maintain, regulatory approval; and/or associated delays in a product candidate reaching the market or in the addition of new indications for existing products.

outcomes study, as conditions for obtaining approval or obtaining an indication.

Before a product may be sold, we must conduct clinical trials to demonstrate that our product candidates are safe and effective for use in humans.

continue its commercial relationship with us in its present form, it could significantly disrupt our business and adversely affect our product sales, our business and results of operations unless suitable alternatives…

In addition, critics of the 12-year exclusivity period in the biosimilar pathway law may continue to seek to shorten the data exclusivity period and/or to encourage the FDA to interpret narrowly the law’s provisions r…

The U.S.

features.

data.

We are also subject to various laws and regulations globally regarding cybersecurity, privacy and data protection, including laws and regulations relating to the collection, storage, handling, use, disclosure, transfe…

similar cybersecurity breach in which an attacker exfiltrated certain data (including non-significant Amgen data) from the service provider’s systems.

We may not realize the anticipated strategic benefits of our acquisition of Horizon, including our efforts to leverage Amgen’s global presence and commercial and medical capabilities in inflammation and nephrology to…

We seek innovation through significant investment in both internal R&D and external transactions, including collaborations, partnerships, alliances, licenses, joint ventures, mergers and acquisitions (collectively, ac…

As previously reported, the OECD reached an agreement to align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries.

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.

Our business is also affected by policies implemented by private healthcare entities that process Medicare claims, including Medicare Administrative Contractors.

effect on our product sales, business and results of operations.

Payers, including healthcare insurers, PBMs, integrated healthcare delivery systems (vertically-integrated organizations built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, a…

Additionally, on January 5, 2024, the FDA authorized Florida to move forward with its importation program proposal, though the state has not completed any significant steps towards importation within the one-year auth…

expected to continue to have, a negative impact on the Company’s product sales, business and results of operations.

States are also enacting laws referencing the IRA and seeking to regulate and prohibit restrictions on the 340B Program.

years such that, by 2031, approximately 100 drugs could be subject to such set prices).

A substantial proportion of our U.S.

We are unable to predict which or how many policy, regulatory, administrative or legislative changes may ultimately be, or effectively estimate the consequences to our business if, enacted and implemented.

our product sales, business and results of operations.

Our operations and performance have been affected, and may continue to be affected, by uncertain global economic conditions, including those arising from geopolitical and trade policy tensions and market volatility.

sustainability-related regulations across our global business, there could be a material adverse effect on our reputation, business and, ultimately, our stock price.

We are expanding our manufacturing capabilities to support current and anticipated demand for our products and product candidates.

•tariffs or other trade barriers that increase costs, limit availability, or disrupt the flow of goods; and

materials required in the commercial and clinical manufacturing of our products are sourced from other countries and/or derived from biological sources, including mammalian tissues, bovine serum and human serum albumin.

In addition, we currently perform a substantial majority of our commercial manufacturing activities at our facility in the U.S.

the removal of our product from the market.

regulatory filing efforts, delay or prevent us from obtaining regulatory approval for new product candidates or new indications for existing products, or prevent us from maintaining our current product labels.

Recent initiatives to reduce the size and budgets of government agencies, including the HHS, FDA and NIH, may adversely impact our operations.

regulatory approvals may be delayed or we may fail to gain approval for our product candidates or could lose our ability to market existing products in certain therapeutic areas or altogether.

Under the U.S.