Amgen (AMGN) 10-K risk factor changes: FY2021 vs FY2020

- The COVID-19 pandemic, and the public and governmental effort to mitigate against the spread of the disease, have had, and are expected to continue to have, an adverse effect, and may have a material adverse effect, on our clinical trials, operations, [added: manufacturing,] supply chains, distribution systems, product development, product sales, business and results of operations.

- Our stock price is [removed: volatile][added: volatile.]

*The COVID-19 pandemic, and the public and governmental effort to mitigate against the spread of the disease, have had, and are expected to continue to have, an adverse effect, and may have a material adverse effect, on our clinical trials, operations, [added: manufacturing,] supply chains, distribution systems, product development, product sales, business and results of operations.*

The COVID-19 pandemic and the resulting measures implemented in response to the pandemic are adversely affecting, and [removed: is] [added: are] expected to continue to adversely affect, our business (including our R&D, clinical trials, operations, [added: manufacturing,] supply chains, distribution systems, product development and sales activities), the business activities of our suppliers, customers, third-party payers and our patients.

See *Our current products and products in development cannot be sold without regulatory [removed: approval*, and] [added: approval*;] see also *We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications*.

Due to the pandemic and these measures and their effects, we have experienced, and expect to continue to experience, unpredictable reductions in demand for certain of our products, [removed: and] [added: exacerbated by COVID-19 surges resulting] in [removed: some cases, have experienced, and could continue to experience, unpredictable increases] [added: repeated shutdowns and/or disruptions] in [removed: demand for] certain [removed: of our products.][added: geographies.]

[removed: Additionally,] [added: Due to the COVID-19 pandemic,] there [removed: may be] [added: have been] delays in ongoing or new patent office [removed: or patent] [added: and court] proceedings in the United States [removed: or internationally] [added: and abroad] that [removed: may delay] [added: have delayed] the outcome of such proceedings.

[removed: Such delays] [added: This competition has had,] and [removed: disruptions] could [removed: have] [added: increasingly have,] a [removed: significant] [added: material] adverse effect on our product [removed: development and launches, product] sales, business and results of operations.

Federal, state and local, and international governmental policies and initiatives designed to reduce the transmission of COVID-19 also have resulted in the cancellation or delay of diagnostic, elective, specialty and other procedures and [removed: appointments to avoid non-essential patient exposure to medical environments and potential infection with COVID-19 and to focus limited resources and personnel capacity toward the treatment of COVID-19.]

For example, [removed: Prolia® is a product requiring] [added: Prolia requires] administration by a healthcare provider in doctors’ offices or other healthcare settings that are affected by COVID-19.

The U.S. label for [removed: Prolia®] [added: Prolia] instructs healthcare professionals who discontinue [removed: Prolia®] [added: Prolia] to transition the patient to an alternative antiresorptive, including oral treatments that do not require administration by a healthcare provider.

Further, as a result of COVID-19, oncology patients, in consultation with their doctors, may be selecting [added: therapies that are] less immunosuppressive [removed: therapies] or therapies that do not require administration in a hospital setting, potentially adversely affecting [added: sales of] certain of our products.

Once the pandemic subsides, we anticipate there [removed: will] [added: could] be a [removed: substantial] backlog of patients seeking appointments with physicians relating to a variety of medical conditions, and as a result, patients seeking treatment with certain of our products may have to navigate [removed: limited] [added: lower] provider capacity, and this [removed: limited] [added: lower] provider capacity could have a continued adverse effect on our sales following the opening up of various geographies and/or the end of the pandemic.

See *Concentration of sales at certain of our wholesaler distributors and at one free-standing dialysis clinic business and consolidation of private payers may negatively affect our business.* [removed: The COVID-19 pandemic has also resulted in a significant increase in unemployment and underemployment which may continue after the pandemic.]

See *Our sales depend on coverage and reimbursement from [added: government and commercial] third-party payers, and pricing and reimbursement pressures [removed: may affect] [added: have affected, and are likely to continue to affect,] our profitability.* [added: As a result of global economic conditions, some third-party payers may delay or be unable to satisfy their reimbursement obligations.]

As the pandemic continues, and if conditions worsen or if the duration of the pandemic extends significantly, we expect to experience additional adverse effects on our [added: development,] operational and commercial activities, customer purchases and our collections of accounts receivable.

It [removed: is unclear which adverse effects may be material, and it] remains uncertain the degree to which these adverse effects would impact our future operational and commercial activities, customer purchases and our collections [removed: even if] [added: as] conditions begin to improve.

There was a resurgence in COVID-19 infections in numerous jurisdictions in [removed: the autumn of 2020 and winter of 2020-2021,] [added: 2021,] resulting in the reinstatement of stricter restrictions and shutdowns in a number of [removed: jurisdictions.][added: jurisdictions, including in the United States, Europe and Asia Pacific regions.]

[removed: In addition to existing travel restrictions, jurisdictions may continue or reinstate border closures, impose or reimpose prolonged quarantines and further restrict travel and business activity, which] [added: These measures] could significantly affect our ability to support our operations and customers and the ability of our employees to get to their workplaces to discover, study, develop and produce our product candidates and products, disrupt the movement of our products through the supply chain, and [added: further] prevent or discourage patients from [added: participating in our clinical trials,] seeking healthcare services and the administration of certain of our products.

In the [removed: U.S.,] [added: United States,] on January 21, 2021, President Biden issued an Executive Order instructing federal agencies to use all available legal authorities, including the Defense Production Act, to improve current and future pandemic response and biological threat preparedness.

The rapid reallocation of resources for the treatment and prevention of [removed: COVID-19, including] [added: COVID-19 (including] the production of COVID-19 vaccinations or related therapies, such as our agreement to contribute to the production of [removed: one of Lilly’s potential] COVID-19 antibody [removed: therapies,] [added: therapies for Lilly) and/or disruptions and shortages in the global supply chain caused by the pandemic,] could also result in increased competition for, or reduced availability of, materials [added: or components] used in the [removed: manufacturing] [added: development, manufacturing, distribution,] or [removed: distribution] [added: administration] of our products.

The COVID-19 pandemic and the volatile global economic conditions stemming from it may precipitate or amplify the other risks described in this “Risk Factors” section, which could materially adversely affect our business, operations and [removed: financial conditions and results.]

If relations between the United States and [removed: China or] other governments [removed: deteriorates,] [added: deteriorate,] our business and investments [removed: in China or other] such markets may also be adversely affected.

The rapid development and fluidity of the pandemic [removed: preclude] [added: precludes] any prediction as to the ultimate effect of COVID-19 on us.

The duration of the measures being taken by the authorities to mitigate against the spread of COVID-19 (including the distribution [added: and/or availability] of [removed: vaccines),] [added: vaccines] and [added: boosters), and] the extent to which such measures are effective, if at all, remain highly uncertain.

The magnitude and degree of COVID-19’s adverse effect on our business (including our product development, product sales, operating [removed: results,] [added: results] and resulting cash flows) and financial condition will be driven by the severity and duration of the pandemic, the pandemic’s effect on the United States and global economies and the timing, scope and effectiveness of federal, state, local and international governmental responses to the pandemic.

If [removed: the spread continues at or near its current trajectory or] mitigation [added: of the pandemic] continues to require [removed: similar levels of] [added: further] shelter-in-place and [removed: shut-down orders,] [added: shutdown orders and/or restrictions on individual and/or group conduct,] any adverse effects of [added: the] COVID-19 [added: pandemic] will likely grow and could be [removed: enduring] [added: enduring,] and our business and financial position could be materially adversely affected.

As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and [removed: intensity] [added: intensity,] and are becoming increasingly difficult to detect.

See *The COVID-19 pandemic, and the public and governmental effort to mitigate against the spread of the disease, have had, and are expected to continue to have, an adverse effect, and may have a material adverse effect, on our clinical trials, operations, [added: manufacturing,] supply chains, distribution systems, product development, product sales, business and results of [removed: operations* for a discussion of the cyberattack on the EMA.][added: operations.* Third parties have challenged and may continue to challenge, invalidate or circumvent our patents and patent applications relating to our products, product candidates and technologies.]

Intentional or inadvertent data privacy or security breaches (including cyberattacks) [added: resulting from attacks] or lapses by employees, service providers (including providers of information technology-specific services), nation states (including groups associated with or supported by foreign intelligence agencies), organized crime organizations, “hacktivists” or others, create risks that our sensitive data may be exposed to unauthorized persons, our competitors, or the public.

Domestic and global government regulators, our business partners, suppliers with whom we do business, companies that provide us or our partners with business [removed: services] [added: services,] and companies we [added: have or] may acquire [removed: may] face similar risks, and security breaches of their systems [added: or service outages] could adversely affect our security, leave us without access to important systems, products, raw materials, components, services or information or expose our confidential [removed: data.][added: data or sensitive personal information.]

For example, in 2019, two vendors that perform testing and analytical services that we use in developing and manufacturing our products [removed: have] experienced cyberattacks, and in April and September of 2020, vendors that provide us with information technology services and clinical data services, respectively, each experienced ransomware attacks.

[removed: Each] [added: Although there was no breach] of [added: our systems, each of] these incidents required us to disconnect our systems from those vendors’ systems.

While we were able to reconnect our systems following restoration of these [removed: vendor’s] [added: vendors’] capabilities without significantly affecting product availability, a more extended service outage affecting these or other vendors, particularly where such vendor is the single source from which we obtain the services, could have a material adverse effect on our business or results of operations.

However, there can be no assurances that our efforts will detect, prevent or fully recover systems or data from all breakdowns, service interruptions, [removed: attacks,] [added: attacks] and/or breaches of our systems that could adversely affect our business and operations and/or result in the loss or exposure of critical, proprietary, private, confidential or otherwise sensitive data, which could result in material financial, legal, business or reputational harm to us or negatively affect our stock price.

For example, we are subject to the [removed: EU’s GDPR,] [added: European Union’s General Data Protection Regulation,] which became effective in May 2018, and the California Consumer Privacy Act of [removed: 2018,] [added: 2018 (CCPA),] which became effective in January 2020, both of which provide for substantial penalties for non-compliance.

Other jurisdictions where we operate have [removed: enacted] [added: passed,] or [removed: proposed] [added: continue to propose,] similar legislation and/or regulations.

Failure to comply with these current and future laws could result in significant penalties and [added: reputational harm and] could have a material adverse effect on our business and results of operations.

We may also be required to increase our reliance on third-party agents and unfamiliar operations and arrangements including those previously utilized by companies we partner with or acquire [removed: in emerging markets.]

Our expansion efforts in China and emerging markets around the world is dependent upon the establishment of an environment that is predictable, navigable and supportive of biopharmaceutical innovation, sustained access for our products and [removed: limited] [added: predictable] pricing controls.

- Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives.

- The effects of global climate change and related natural disasters could negatively affect our business and operations.

appointments to avoid non-essential patient exposure to medical environments and potential infection with COVID-19 and to focus limited resources and personnel capacity toward the treatment of COVID-19.

For example, an NPR/Harvard poll in 2021 found that, with hospitals crowded from COVID-19, one in five U.S. households has had to delay care for serious illnesses.

Also, new patients have been, and are expected to continue to be, less likely to be diagnosed and/or to start therapeutics during the pandemic, and these effects, together with the lower treatment rates during the pandemic, have had, and are expected to continue to have, a cumulative negative effect on the commercial performance of our business.

The decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business.

New variants of the SARS-CoV-2 virus have emerged, including the delta and omicron variants, and have been shown to be present in many geographies and appear to spread more easily and quickly than other variants.

Further, although some studies suggest that antibodies generated with currently authorized vaccines may be effective against these variants, it remains uncertain whether currently available vaccines will retain their efficacy against future variants of the virus.

Further, even while vaccine booster shots are available for certain patients, persistent vaccine hesitancy may result in under-vaccinated populations which may prolong the duration of the COVID-19 pandemic and continue to disrupt the availability of healthcare services to the patients we serve.

Jurisdictions may implement, continue or reinstate border closures, impose or reimpose prolonged quarantines and further restrict travel and business activity.

The increased availability of remote working arrangements in response to the COVID-19 pandemic has expanded the pool of companies that can compete for our employees and employment candidates.

For example, during the second quarter of 2021, an industry-wide shortage of certain lab kit supplies necessary for some activities that support our clinical trials has developed that we are actively monitoring and managing.

We have also experienced challenges in obtaining certain COVID-19-related supplies, including COVID-19 antigen rapid test kits for our staff, as a result of high demand and limited supplies during the omicron variant surge.

financial condition and results.

Upgrades or changes to our systems or the software that we use may result in the introduction of new cybersecurity vulnerabilities and risks.

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 attack techniques will be successful in the future.

For example, a supplier recently experienced a data breach in which an unauthorized third party acquired access to certain information provided to the supplier in the course of its provision of services to us, including business documents and certain personally identifiable patient information (not including social security or other financial or health insurance information).

As required, we promptly notified the applicable state attorneys general and the individuals whose personally identifiable information was affected of this data breach at the supplier.

Although the supplier data breach did not result in a material adverse effect on our business, there can be no assurance that a similar

future cybersecurity incident would not result in a material adverse effect on our business or results of operations.

Another vendor experienced a cyberattack and, while initially reporting that our information was not involved, the vendor subsequently informed us that the attacker had accessed limited, non-significant information.

Although this breach did not have a significant adverse effect on us, we may not receive timely reporting of future breaches.

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

We rely on third party commercial software that may have such vulnerabilities, but as use of open-source code is frequently not disclosed, our ability to fully assess this risk to our systems is limited.

For example, in December 2021, a remote code execution vulnerability was discovered in a widely used software library that is used in a variety of commercially available software and services.

Although this vulnerability has not resulted in any significant adverse effects on us, there can be no assurances that a similar future vulnerability in the software and services that we use would not result in a material adverse effect on our business or results of operations.

The CCPA was amended in late 2020, to create the California Privacy Rights Act to create opt-in requirements for the use of sensitive personal data and the formation of a new dedicated agency for the enforcement of the law, the California Privacy Protection Agency.

Since then, Virginia and Colorado both passed similar consumer privacy laws that will go into effect in 2023.

in emerging markets.

Additional proposals would require a rebate to the government for any price increase in excess of the Consumer Price Index for All Urban Consumers and/or to shift some of the costs of these Medicare Part D reforms to manufacturers to offset the cost.

Congress has been focused on drug pricing reforms and oversight since 2018, and this activity is still ongoing and has intensified.

In 2019, 2020 and 2021, a number of Congressional committees debated drug pricing reform proposals and, in 2020, Amgen participated in House Oversight and Reform Committee hearings on drug pricing practices.

In 2019, the Senate Finance Committee advanced a bill that would, among other things, penalize pharmaceutical manufacturers for raising prices on drugs

In 2021, proposals from H.R. 3 were incorporated and adapted into other proposed legislation.

These proposals, which included penalties if drug price benchmarks rise faster than inflation, Medicare price setting for certain drugs paid for under Parts B and D (whereby manufacturers must accept a price established by the government or face a penalty on all U.S. sales), and Part D redesign including a cap on beneficiary spending and a new manufacturer discount program, are also likely to be considered in a reconciliation bill that remains to be further debated between the Senate, House and White House.

This framework remains in discussion with policymakers in Congress and the Administration.

In July 2021, the Administration issued an Executive Order designed to address anticompetitive behavior across multiple sectors, and for the healthcare sector, called for, among other things, the FDA to work with states and Indian Tribes to develop prescription drug importation programs, more scrutiny of anticompetitive activity by the FTC, emphasized the need for actions to allow for greater competition from generics and biosimilars, and included a process and timeline for federal agencies to deliver ideas to address drug pricing to the Administration.

Subsequently, in September 2021, HHS released a report that presented guiding principles for the Administration’s drug pricing proposals, including changes to promote competition throughout the prescription drug industry, highlighting potential legislative policies that Congress could pursue (including drug price negotiation in Medicare Parts B and D, making those negotiated prices available to commercial plans and legislation to speed the entry of biosimilar and generic drugs) and examples of potential administrative tools available to the HHS (including testing various models and enhanced focus of the FTC and the USPTO to address impediments to generic drug and biosimilar competition).

Also, in response to the July 2021 Executive Order, the FDA sent a letter to the USPTO describing ways to strengthen coordination between the two agencies, offering training to help identify prior art, and seeking USPTO’s views on practices that extend market exclusivities, whether pharmaceutical patent examiners need additional resources, and the effect of post-grant challenges at the PTAB on drug patents.

Legislation enacted in 2021 has also contained drug pricing reforms, including the Infrastructure Investment and Jobs Act and the American Rescue Plan Act of 2021 that include provisions requiring, starting in 2023, manufacturers to provide refunds to the government for discarded amounts of drugs from single use containers under Medicare Part B, and starting in 2024, increases the Medicaid rebate liability for certain medicines that raise prices in excess of inflation, respectively.

Our clinical trials have been, and are expected to continue to be, adversely affected by the COVID-19 pandemic.

We have clinical work ongoing at investigational sites across the globe.

A number of clinical trial sites, including those in regions experiencing new or resurgent outbreaks of COVID-19, have restricted site visits and imposed restrictions on the initiation of new clinical trials and/or patient visits to protect both site staff and patients from possible COVID-19 exposure that has stopped or slowed clinical trial activities.

In response to the safety concerns related to COVID-19, we have suspended, and will continue to suspend, enrollment and screening in clinical trials where sites are unable to perform clinical trial work due to COVID-19 or there is uncertainty around the ability of sites to ensure subject safety or data integrity.

Further, the COVID-19 pandemic has adversely affected, and may continue to adversely affect, our ability to enroll or to continue to enroll certain required post-marketing studies, including pediatric studies.

While many of our clinical trial activities have recommenced over the course of 2020, the initial disruption caused by the COVID-19 pandemic to our clinical trials and our clinical trial plans and timelines, and any similar future disruptions (including as a result of the current surge and lockdowns in numerous regions), may have a significant adverse effect on our product development and launches, and, in turn, on future product sales, business and results of operations.

For example, to ensure patient safety we initially paused enrollment of our sotorasib Phase 1 combination cohort with Keytruda® and Phase 3 lung cancer study, and such interruptions in enrollment may ultimately affect the timeline of these or other studies.

Additionally, while we are investing in research, collaborations and operational support to potentially develop and/or produce treatments for COVID-19, such activities may not result in therapeutic candidates, product approvals, successful production and/or significant commercial value being derived from potential COVID-19-related medicines.

As a result of the COVID-19 pandemic, we have experienced, and expect to continue to experience, regulatory delays, including delays in receiving regulatory advice, reviews of applications, or performance of inspections required for approvals.

The pandemic may also result in greater regulatory uncertainty.

For example, the FDA and the EMA have issued guidance to provide biopharmaceutical manufacturers greater flexibility in certain regulatory areas, including protocol deviations and adverse event reporting.

However, such flexibility may result in greater uncertainty regarding the expectations of such health authorities in relation to this guidance.

In response to COVID-19, we have activated our applicable business continuity plans, including suspending U.S. in-person meetings and interactions with the healthcare community and professionals in a substantial number of states, suspending, as a general matter, all international business travel and the majority of domestic travel within the United States, and U.S. employees who are able to work from home have been doing so since mid-March 2020.

Our ability to perform critical functions and maintain operations have been adversely affected and could continue to be adversely affected as a result of such workforce restrictions, and the COVID-19-related support programs we have put into place for our staff, suppliers and customers have increased, and are expected to continue to increase, our operating expenses and reduce the efficiency of our operations.

Notwithstanding such support programs, the COVID-19 pandemic’s effects on the health and availability of our workforce, as well as those of the third parties on which we rely, could have an adverse effect on our business.

If members of our management and other key personnel in critical functions across our organization are unable to perform their duties or have limited availability due to COVID-19, we may not be able to execute on our business strategy and our operations may be adversely affected.

Additionally, disruptions in public and private infrastructure, including transportation and supply chains, have adversely affected, and continue to adversely affect, the efficiency of our business operations.

Also, the transition of the majority of our workforce to a remote work environment in response to COVID-19, as well as that of our third-party service providers, have exacerbated certain risks to our business, including, but not limited to, those associated with an increased demand for information technology resources, increased risk of cybersecurity attacks (including social engineering attacks), and increased risk of unauthorized dissemination of sensitive personal information or our proprietary or confidential information.

As the pandemic continues to progress, we have observed an increase in cybersecurity incidents, predominantly ransomware and social engineering attacks, experienced by our third-party service providers.

Further, government entities have also been the subject of cyberattacks.

The EMA disclosed in December 2020 that it had been the subject of a cyberattack that targeted and accessed third-party documents relating to regulatory submissions, and that such documents were published on the internet (some of which were manipulated prior to publication).

Such third-party and governmental incidents have created the risk of the loss of availability and/or control of information (including information related to our clinical trials) important to the operation of our business.

See *A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our information technology systems, network-connected control systems and/or our data, interrupt the operation of our business and/or affect our reputation.* In the future, as the pandemic progresses and afterwards, we may experience significant adverse effects on our commercial and clinical manufacturing activities, our operations, and our cybersecurity, and our suppliers and vendors may also experience significant disruptions to their activities and operations on which we depend, as a result of these cybersecurity incidents.

Also, new patients are less likely to be diagnosed and/or to start therapeutics during the pandemic.

The legislative and regulatory environment governing our businesses is dynamic and changing frequently in response to COVID-19.

For example, the COVID-19 pandemic has resulted in increased interest in compulsory licenses, march-in rights or other governmental interventions, both in the United States and internationally, related to the procurement of drugs, such as the WHO’s COVID-19 Technology Access Pool initiative, which provides an approach for sharing all intellectual property, information and clinical trial data necessary to enable generic drug manufacturing.

*See Our intellectual property positions may be challenged, invalidated or circumvented, or we may fail to prevail in current and future intellectual property litigation*.

Further, the challenges of the pandemic have resulted in the exploration of signification legislation to address the need to supply medicines to address COVID-19.

Pursuant to the declaration of a national emergency in the United States in March 2020 under the Stafford Act, state and local governments may request access to discounted pricing for certain items related to the COVID-19 response.

The Coronavirus Aid, Relief and Economic Security (CARES) Act implements initiatives to provide advanced payments from Medicare to healthcare providers, clinics and physicians and to require Medicare plans to provide up to a 90-day supply of Part D drugs.

However, despite such initiatives and government support, there may be adverse effects on the timing and collectability of our customer receivables as a result of the COVID-19 pandemic.

Such a significant increase in unemployment or other disruptions in the labor market have led to a substantial reduction in disposable income and, in the U.S., access to healthcare insurance, including reductions in the commercially insured population that has led to growth (and is expected to continue to lead to growth) in Medicaid enrollment, which has adversely affected our product sales.

See *Global economic conditions may negatively affect us and may magnify certain risks that affect our business*.

Such reduction in healthcare insurance could be compounded by any full or partial repeal of the ACA by the U.S. Supreme Court.

Further, globally, the substantial pressures placed on governmental and payor budgets as a result of the COVID-19 pandemic and the projected governmental budget shortfalls caused by significantly reduced economic activity during and potentially after the COVID-19 pandemic, together with the long-term impact from the pressures on healthcare systems, may result in greater and continued downward price pressure on biopharmaceutical products and increased intensity of stakeholder negotiations across the biopharmaceutical value chain.

Further, the global pandemic has exacerbated geopolitical tensions, and some countries, such as China, may be especially vulnerable to such dynamics.

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

Since late 2018, Congressional focus on drug pricing has increased, placing our industry under greater Congressional scrutiny.

For example, in early 2019, the chair of the House Oversight and Reform Committee sent letters to twelve different biopharmaceutical manufacturers, including Amgen, seeking documents and detailed information about such companies’ drug pricing practices.

Subsequently, in the fall of 2020, the House Oversight and Reform Committee released staff reports and held hearings with executives from six biopharmaceutical manufacturers, including Amgen, about their companies’ drug pricing practices.

The following [removed: management’s discussion and analysis (MD&A)] [added: MD&A] is intended to assist the reader in understanding Amgen’s business.

Our results of operations discussed in MD&A are presented in conformity with [removed: U.S. generally accepted accounting principles (GAAP).][added: GAAP.]

Reference is made in particular to forward-looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, [removed: earnings per share (EPS),] [added: EPS,] liquidity and capital resources, trends, planned dividends, stock repurchases, collaborations and effects of pandemics.

Our principal [removed: products—those with the most significant annual commercial sales—are] [added: products are] ENBREL, [removed: Prolia®, Neulasta®, Otezla®, XGEVA®, Aranesp®, KYPROLIS®] [added: Prolia, Otezla, XGEVA, Neulasta, Aranesp, Repatha, KYPROLIS] and [removed: Repatha®.][added: Nplate.]

We also market a number of other products, including [removed: Nplate®, Vectibix®, MVASI®, Parsabiv®, EPOGEN®, KANJINTI®, BLINCYTO®, Aimovig®, EVENITY®, AMGEVITATM, Sensipar®/Mimpara®, NEUPOGEN®, IMLYGIC®, Corlanor®] [added: MVASI, Vectibix, KANJINTI, EVENITY, EPOGEN, BLINCYTO, AMGEVITA, Aimovig, Parsabiv, NEUPOGEN, LUMAKRAS/LUMYKRAS, Sensipar/Mimpara] and [removed: AVSOLA®.][added: TEZSPIRE.]

We focus on six commercial areas: inflammation, oncology/hematology, bone health, CV disease, nephrology and [removed: neuroscience, and we conduct discovery research primarily in three therapeutic areas: inflammation, oncology/hematology and CV/metabolic diseases.][added: neuroscience.]

We accomplished these objectives while maintaining a strategic and disciplined approach to capital [removed: allocation,] [added: allocation] and [added: while] advancing our [removed: environmental, social and governance] [added: ESG] efforts.

During [removed: the year,] [added: 2021,] while meeting the challenges of a global pandemic and facing increased competition from biosimilars and generics, total product sales [removed: increased 9%, driven by] [added: were relatively flat as] volume growth [removed: primarily from Otezla®, partially] [added: was] offset by lower net selling prices.

We also continued to advance our biosimilar program with the launch of [removed: AVSOLA® and the approval of RIABNITM] [added: RIABNI] in the United [removed: States.][added: States and introduced our other biosimilars into new markets.]

Our biosimilars are expected to [removed: launch] [added: continue launching] in new markets throughout [removed: 2021.][added: 2022.]

Cash flows from operating activities totaled [removed: $10.5] [added: $9.3] billion, [removed: enabling us to invest] [added: which supported investment] in our business while returning capital to shareholders through the payment of cash dividends and stock repurchases.

For [removed: 2020,] [added: 2021,] we increased our quarterly cash dividend by 10% to [removed: $1.60] [added: $1.76] per share of common stock.

In December [removed: 2020,] [added: 2021,] we declared a cash dividend of [removed: $1.76] [added: $1.94] per share of common stock for the first quarter of [removed: 2021,] [added: 2022,] an increase of 10% for this period, to be paid in March [removed: 2021.][added: 2022.]

We also repurchased [removed: 15.2] [added: 21.7] million shares of our common stock [removed: throughout 2020,] [added: during 2021] at an aggregate cost of [removed: $3.5] [added: $5.0] billion.

Amgen’s approach to, and investment in, human capital resource management is directed at attracting, [removed: motivating] [added: motivating, developing] and retaining talent to tackle the challenges of running an enterprise focused on the discovery, [removed: development,] [added: development] and commercialization of innovative medicines.

Our compensation, benefits and development programs are designed to encourage performance, promote accountability and adherence to Company values, and [removed: in alignment] [added: align] with the interests of the Company’s shareholders.

In 2020, we met or exceeded our environmental sustainability targets set out in 2013 that called for reducing fleet carbon output by up to 20%, facility carbon output by 10%, water consumption by 10% and waste disposal by [removed: 35%2.][added: 35%.2 We achieved our 2020 targets while growing revenues, increasing production capacity and expanding to approximately 100 countries over the same 2013–20 period.]

To continue on our path to greater environmental sustainability, in January 2021 we announced a new set of long-term environmental targets to achieve by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by [removed: 75%.][added: 75%.2, 3]

Our long-term success [removed: depends] [added: depends,] to a great [removed: extent] [added: extent,] on our ability to continue to discover, develop and commercialize innovative products and acquire or collaborate on therapies currently in development by other companies.

We must develop new products to achieve revenue growth and to offset revenue losses [added: from] when products lose their exclusivity or when competing products are launched.

As a result of public and private healthcare-provider focus, the industry continues to [removed: experience significant pricing pressures and other] [added: be subject to] cost containment [removed: measures.][added: measures and significant pricing pressures, including net price declines.]

These [removed: effects] [added: buying patterns] can cause fluctuations in quarterly product sales [removed: and] [added: but] have generally not been significant [added: to date] when comparing full-year product performance to the prior year.

Business—Marketing, Distribution and Selected Marketed [removed: Products] [added: Products,] and Part I, Item 1A.

Since the onset of the pandemic in [removed: early] 2020, we have been [removed: carefully] [added: closely] monitoring [removed: its impact] [added: the pandemic’s effects] on our global operations.

[removed: A significant number of our employees have been working remotely, with the exception of certain staff that require] [added: Employee] access to [removed: our manufacturing and laboratory research facilities,] [added: company facilities has been] in accordance with applicable government health and safety protocols and guidance issued in response to the COVID-19 pandemic.

To date, our remote working arrangements have not significantly affected our ability to maintain critical business operations, and we have not experienced disruptions [added: to] or shortages of our supply of medicines.

As a result, we expect to see continued volatility [removed: through] [added: for] at least the duration of the pandemic as governments respond to current local conditions.

We remain focused on supporting our active clinical sites in [removed: providing] [added: their provision of] care [removed: for these] [added: to] patients and in [removed: providing] [added: our provision of] investigational drug supply.

[removed: We continue to] [added: Despite the ongoing pandemic and business impacts noted above, we] believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditures and debt service requirements as well as to engage in [removed: the] capital-return and other business initiatives that we plan to [removed: strategically] pursue.

For a discussion of the risks [removed: presented by] the COVID-19 pandemic [added: presents] to our results, see [added: Risk Factors in] Part I, Item 1A.

[removed: Risk Factors] of this Form 10-K.

| | | | Year ended December 31, [added: 2021 | | | | | | Change | | | | | | Year ended December 31,] 2020 | | | | | | Change | | | | | | Year ended December 31, 2019 | | |

| [added: Total] U.S. | | | $ | [added: 17,286 | | | | | (4) | | % | | | | $ |] 17,985 | | | | | 9 | | % | | | | $ | 16,531 | |

| [removed: Rest-of-world (ROW)] [added: Total ROW] | | | [added: 7,011 | | | | | | 12 | | % | | | |] 6,255 | | | | | | 10 | | % | | | | 5,673 | | |

| Total product sales | | | [removed: 24,240] [added: $] | [added: 24,297] | | | | | [added: — | | % | | | | $ | 24,240 | | | | |] 9 | | % | | | | [removed: 22,204] [added: $] | [added: 22,204] | |

| Other revenues | | | [removed: 1,184] [added: 1,682] | | | | | | [removed: 2] [added: 42] | | % | | | | [removed: 1,158] [added: 1,184] | | |

| Total revenues | | | $ | [removed: 25,424] [added: 25,979] | | | | | [removed: 9] [added: 2] | | % | | | | $ | [removed: 23,362] [added: 25,424] | |

| [removed: Operating] [added: Total operating] expenses | | | $ | [added: 18,340 | | | | | 13 | | % | | | | $ |] 16,285 | | | | | 19 | | % | | | | $ | 13,688 | |

| Operating income | | | $ | [removed: 9,139] [added: 7,639] | | | | | [removed: (6)] [added: (16)] | | % | | | | $ | [removed: 9,674] [added: 9,139] | |

| Net income | | | $ | [removed: 7,264] [added: 5,893] | | | | | [removed: (7)] [added: (19)] | | % | | | | $ | [removed: 7,842] [added: 7,264] | |

And we conduct discovery research primarily in three therapeutic areas: inflammation, oncology/hematology and general medicine.

In 2021, we advanced our innovative pipeline, launched new products, completed several strategic transactions to augment our pipeline and research capabilities, and continued providing uninterrupted supplies of our medicines globally through the second year of the COVID-19 pandemic.

In 2021, we continued to advance our pipeline, including achieving key regulatory approvals for LUMAKRAS and TEZSPIRE.

Our external business development activities for 2021 included: (i) acquiring Five Prime, including a later-stage gastric cancer bemarituzumab program; (ii) entering into a license agreement with KKC to develop a later-stage molecule for atopic dermatitis and other diseases; and (iii) acquiring Teneobio for its proprietary technologies and oncology programs in development.

Product sales decreased 4% in the United States, driven by lower net selling prices, partially offset by volume growth, and increased 12% ROW, driven by volume growth, partially offset by lower net selling prices.

Total operating expenses increased 13%, driven by IPR&D expense from the Five Prime acquisition and the upfront payment associated with the KKC licensing agreement.

In 2021, we issued $4.9 billion and repaid $4.2 billion of debt that was coming due in 2022.

3 Carbon neutrality goal refers to Scope 1 and 2.

We continue to take appropriate steps to minimize risks to our employees, a significant number of whom have continued to work virtually.

Since the beginning of the COVID-19 pandemic, we have seen changes in demand for some of our products driven by changes in the frequency of patient visits to doctors’ offices that has impacted the provision of treatments to existing patients and reduced diagnoses in new patients.

During 2021, there was gradual recovery in both patient visits and diagnoses that approached pre-COVID-19 levels early in the fourth quarter.

However late in 2021, the Omicron variant began to impact the healthcare sector and as a result we expect ongoing variability in demand patterns in the first half of 2022.

The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business.

We will continue to closely monitor the effects of emerging COVID-19 variants on patient behavior and access to care.

Since early 2021, global vaccination efforts have been under way to control the pandemic.

However, uncertainty remains as to the length of time required for vaccination of a meaningful portion of the population and as to the efficacy of such vaccinations with regard to the trajectory of the pandemic.

Challenges to vaccination efforts, new variants and other causes of virus spread may require governments to issue additional restrictions and/or order shutdowns in various geographies.

With respect to our drug development activities, we are continuously monitoring COVID-19 infection rates, including changes from new variants, and working to mitigate effects on future study enrollment in our clinical trials and evaluating the impacts in all countries where our clinical trials occur.

| | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

| U.S. | | | $ | 17,286 | | | | | (4) | | % | | | | $ | 17,985 | |

| ROW | | | 7,011 | | | | | | 12 | | % | | | | 6,255 | | |

| Total product sales | | | 24,297 | | | | | | — | | % | | | | 24,240 | | |

Total product sales were relatively flat for 2021, as volume growth was offset by declines in net selling prices.

In general, declines in the sales of our products that were impacted by the dynamics of the pandemic were most significant in the early months of the pandemic with product demand beginning to show some recovery in late 2020.

During 2021, we observed gradual recovery from the COVID-19 pandemic, with patient visits and diagnosis rates that approached pre-pandemic levels early in the fourth quarter.

However, late in the year, the Omicron variant began to impact the healthcare sector and as a result, we have seen some shift back to virtual engagement by our field staff and variability in demand patterns.

The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business.

For example, changes in U.S. employment have led to changes to the insured population.

Growth in numbers of Medicaid enrollees and uninsured individuals may have a negative impact on product demand and sales.

See Risk Factors in Part I, Item 1A.

Other revenues increased for 2021, primarily driven by the sale of COVID-19 antibody material resulting from our manufacturing collaboration.

Operating expenses increased for 2021, driven by IPR&D expense related to the bemarituzumab program acquired as part of the Five Prime acquisition and by the upfront payment associated with the KKC licensing agreement.

| Nplate | | | 1,027 | | | | | | 21 | | % | | | | 850 | | | | | | 7 | | % | | | | 795 | | |

| Other products | | | 5,851 | | | | | | 2 | | % | | | | 5,724 | | | | | | 21 | | % | | | | 4,743 | | |

The decrease in ENBREL sales for 2021 was driven by lower net selling price, unit demand and unfavorable changes in inventory.

| | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | | | | | Change | | | | | | Year ended December 31, 2019 | | |

| | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | | | | | Change | | | | | | Year ended December 31, 2019 | | |

| | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | | | | | Change | | | | | | Year ended December 31, 2019 | | |

The increase in global XGEVA sales for 2021 was primarily driven by higher unit demand, partially offset by lower net selling price.

| | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | | | | | Change | | | | | | Year ended December 31, 2019 | | |

In 2020, we celebrated our 40th anniversary, continuing our history of focusing on innovative medicines that have the potential to be first-in-class molecules and that have a large-effect size on serious diseases.

In 2020, we advanced our innovative pipeline, successfully integrated Otezla®, acquired in November 2019, into our inflammation portfolio, advanced our international expansion and continued to provide uninterrupted supply of our medicines globally through the COVID-19 pandemic.

Product sales increased 9% and 10% in the United States and rest of the world, respectively.

Total operating expenses increased 19%, driven by expenses related to Otezla®.

We continued to advance our pipeline, including sotorasib and tezepelumab—two molecules with respect to which we have achieved positive registration enabling data from our clinical trial activities.

Lastly, we broadened our international reach, particularly in the Asia Pacific region with our investment in and strategic collaboration with BeiGene to expand our oncology presence in China, as well as the establishment of our wholly owned affiliate in Japan.

During the year, we had proceeds from the issuance of debt of $8.9 billion and repayments of debt of $6.5 billion.

In addition, we exchanged some of our higher interest rate debt for newly issued debt with a lower interest rate and a later maturity date.

We also believe our global presence is strengthened by having a workforce that reflects the diversity of the patients we serve.

It is with these beliefs in mind that we have continued to strengthen and grow our culture of diversity, inclusion and belonging.

Our internal efforts include, in 2019, establishing a Diversity, Inclusion and Belonging Council.

We achieved our 2020 targets while growing revenues, increasing production capacity, and expanding to more than 100 countries over the same 2013 to 2020 period.

The COVID-19 pandemic has had a moderate impact to our business in 2020.

We have taken appropriate steps to minimize the risk to our employees.

Since the beginning of the COVID-19 pandemic, we have seen changes in demand trends for some of our products, including lower demand for certain products as continuing patient access to those products has been affected by COVID-19, particularly in the early phases of the pandemic.

For example, near the end of March, we began to observe a decline in sales of Prolia®, as elderly patients, who are relatively more vulnerable to COVID-19, avoided doctors’ offices.

Demand has since recovered to varying degrees by product as local conditions improved in certain geographies that opened after an initial improvement in COVID-19 infection rates, allowing patients to resume receiving their treatments.

During the second half of the year, our own efforts remain focused on assisting patients with improving their continuity of care to increase product access as compared to what they experienced during the earlier stages of the pandemic.

Recently, higher rates of infection have been observed in certain geographies, including the United States and Europe, which may further restrict demand, similar to early phases of the pandemic.

The majority of clinical trials that were paused at the onset of the pandemic to ensure subject safety or data integrity have resumed.

Study enrollment was affected negatively the most in the second quarter of the year and by the end of 2020 resumed to around pre-pandemic levels.

However, going forward COVID-19 infection rates and related vaccination activities may impact future study enrollment.

We continuously monitor our ability for study enrollment on an institution by institution basis and reevaluate the status of studies, pausing when uncertainty arises with regard to the trial sites’ ability to ensure safety or data integrity.

In addition, our R&D organization is supporting efforts to combat the COVID-19 pandemic in a number of ways, including by (i) working to support production of therapeutic antibodies that could diminish the impact of COVID-19 on patients, (ii) joining a public–private partnership between leading companies in our industry and U.S. government health agencies to develop a strategy for a coordinated research response and (iii) participating in platform studies to investigate treatments in adult patients hospitalized with severe COVID-19 infections.

Total product sales increased for 2020, primarily driven by unit demand increases from newer brands including Otezla®, acquired in November 2019, MVASI®, KANJINTI® and Repatha®.

These unit demand increases were partially offset by declines in net selling prices for certain products, unit demand declines for mature brands that face biosimilar or generic competition and the effects of the COVID-19 pandemic.

We also expect increasing competition against our biosimilar products.

In general, sales of negatively affected products fell the most in the early part of the second quarter, with product demand beginning to show some recovery in the second half of the year but still below pre-pandemic levels.

For example, changes in U.S. employment could lead to changes to the insured population, with growth in Medicaid enrollees and uninsured individuals having a negative impact on revenues.

Other revenues increased for 2020, primarily driven by higher royalties.

Operating expenses increased for 2020, primarily driven by acquisition- and commercial-related expenses for Otezla®.

| Other products | | | 6,574 | | | | | | 19 | | % | | | | 5,538 | | | | | | (1) | | % | | | | 5,572 | | |

| Total U.S. | | | $ | 17,985 | | | | | 9 | | % | | | | $ | 16,531 | | | | | (5) | | % | | | | $ | 17,429 | |

| Total ROW | | | 6,255 | | | | | | 10 | | % | | | | 5,673 | | | | | | 11 | | % | | | | 5,104 | | |

Consistent with prior periods, ENBREL has continued to lose market share, and this decline has been compounded by a reduction in the growth rate of the rheumatology market as a result of COVID-19.

In April 2019, the FDA approved a second biosimilar version of ENBREL, and we are involved in patent litigations with the two companies seeking to market their FDA-approved biosimilar versions of ENBREL.

Companies with approved biosimilar versions of ENBREL may seek to enter the U.S. market if we are not successful in our litigations, or even earlier.

Other companies are also developing proposed biosimilar versions of ENBREL.

Disruptions in patient visits as a result of the COVID-19 pandemic affected demand during 2020 by altering the timing of patients receiving their semiannual doses and by lowering the diagnosis of osteoporosis in new patients.

This deceleration of demand has softened the historical growth rates and altered demand patterns of Prolia® experienced in years prior to the pandemic.

In the discussion that follows, we [removed: have] assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, [removed: 2020] [added: 2021] and [removed: 2019.][added: 2020.]

Except as noted below, we [removed: have] also assumed a hypothetical 20% change in foreign currency exchange rates against the U.S. dollar based on its position relative to other currencies as of December 31, [removed: 2020] [added: 2021] and [removed: 2019.][added: 2020.]

Our portfolio of available-for-sale investments as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] was composed [added: almost entirely] of U.S. Treasury securities and money market mutual [removed: funds, and with respect to investments as of December 31, 2019, corporate debt securities and other short-term interest-bearing securities.][added: funds.]

The fair values of our available-for-sale investments were [removed: $9.8] [added: $7.3] billion and [removed: $8.2] [added: $9.8] billion as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] would not have resulted in a material reduction in the fair values of these securities.

In addition, a hypothetical 100 basis point decrease in interest rates as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] would not result in a material effect on income in the respective ensuing year.

As of December 31, [removed: 2019,] [added: 2021,] we had outstanding debt with a carrying value of [removed: $29.9] [added: $33.3] billion and a fair value of [removed: $33.7] [added: $37.9] billion.

Our outstanding debt was composed [removed: almost entirely] of debt with fixed interest rates.

A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] would have resulted in [removed: increases] [added: an increase] of $4.5 billion [removed: and $3.0 billion, respectively,] in the aggregate fair value of our outstanding debt on [removed: each] [added: both] of these dates.

Analysis of the debt does not consider the impact that hypothetical changes in interest rates would have on [removed: the] related interest rate swap contracts and cross-currency swap contracts, discussed below.

Interest rate swap contracts with aggregate notional amounts of [removed: $5.9] [added: $6.7] billion and [removed: $9.6] [added: $5.9] billion were outstanding as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] would have resulted in reductions in fair values of approximately [removed: $230] [added: $330] million and [removed: $380] [added: $230] million, respectively, on our interest rate swap contracts on these dates.

As of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] we had outstanding cross-currency swap contracts with aggregate notional amounts of [removed: $4.8] [added: $3.4] billion [added: and $4.8 billion, respectively,] that hedge our foreign-currency-denominated debt and related interest payments.

A hypothetical 100 basis point adverse movement in interest rates relative to interest rates as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] would have resulted in reductions in the fair values of our cross-currency swap contracts of approximately [removed: $250] [added: $170] million and [removed: $280] [added: $250] million, respectively.

Our international operations are affected by fluctuations in the value of the U.S. dollar [removed: as] compared [removed: to] [added: with] foreign currencies, predominantly the euro.

Increases and decreases in our international product sales from movements in foreign currency exchange rates are partially offset by [removed: the] corresponding increases or decreases in our international operating expenses.

Increases and decreases in our foreign-currency-denominated assets from movements in foreign currency exchange rates are partially offset by [removed: the] corresponding increases or decreases in our foreign-currency-denominated liabilities.

To further reduce our net exposure to foreign currency exchange rate fluctuations on our results of operations, we enter into foreign currency [removed: forward, option] [added: forward] and cross-currency swap contracts.

As of December 31, [removed: 2019,] [added: 2021,] we had outstanding euro-, pound-sterling- and Swiss-franc-denominated debt with a principal carrying value and a fair value of [removed: $4.5] [added: $3.2] billion and [removed: $5.0] [added: $3.6] billion, respectively.

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, [removed: 2019,] [added: 2021,] would have resulted in an increase in fair value of this debt of [removed: $1.0 billion] [added: approximately $710 million] on this date and a reduction in income in the ensuing year of [removed: $900] [added: approximately $640] million.

We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros, pounds sterling and Swiss [removed: francs] [added: francs,] with aggregate notional amounts of [added: $3.4 billion and] $4.8 billion as of [removed: both] December 31, [removed: 2020] [added: 2021] and [removed: 2019.][added: 2020, respectively.]

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would have resulted in reductions in the fair values of these contracts of [removed: $1.1 billion] [added: approximately $700 million] and [removed: $1.0] [added: $1.1] billion on these dates, respectively.

The impact of this hypothetical adverse movement in foreign currency exchange rates on ensuing years’ income from these contracts would be fully offset by [removed: the] corresponding hypothetical changes in the carrying amounts of the related hedged debt.

We enter into foreign currency forward [removed: and options] contracts that are designated for accounting purposes as cash flow hedges of certain anticipated foreign currency transactions.

As of December 31, [removed: 2019,] [added: 2021,] the fair values of these contracts were a [removed: $223] [added: $183] million asset and a [removed: $31] [added: $39] million liability.

As of December 31, 2020, we had primarily [removed: euro based] [added: euro-based] open foreign currency forward contracts with notional amounts of $5.1 billion.

As of December 31, [removed: 2019,] [added: 2021,] we had primarily [removed: euro based] [added: euro-based] open foreign currency forward contracts with notional amounts of [removed: $5.0] [added: $5.7] billion.

With regard to [removed: foreign currency forward and option] contracts that were open as of December 31, 2020, a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2020, would have resulted in a reduction in fair value of these contracts of [removed: approximately] $1.1 billion on this date and in the ensuing year, a reduction in income of [removed: approximately] $420 million.

With regard to [added: foreign currency forward] contracts that were open as of December 31, [removed: 2019,] [added: 2021,] a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, [removed: 2019,] [added: 2021,] would have resulted in a reduction in fair value of these contracts of [removed: $930 million] [added: approximately $1.1 billion] on this date and in the ensuing year, a reduction in income of [removed: $400] [added: approximately $390] million.

As of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] we had [removed: open short-duration] [added: open, short-duration,] foreign currency forward contracts that mature in [removed: less than] one [removed: month, with] [added: month or less, that had] notional amounts of [removed: $1.0] [added: $0.7] billion and [removed: $1.2] [added: $1.0] billion, respectively, [added: and] that hedged fluctuations of certain assets and liabilities denominated in foreign currencies but were not designated as hedges for accounting purposes.

These contracts had no material net unrealized gains or losses as of December 31, [removed: 2020] [added: 2021] and [removed: 2019.][added: 2020.]

With regard to these foreign currency forward contracts that were open as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] a hypothetical 5% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would not have a material effect on the fair values of these contracts or related income in the respective ensuing years.

As of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] we were exposed to price risk on equity securities included in our portfolio of investments, which were acquired primarily for the promotion of business and strategic objectives.

These investments include publicly and privately held small-capitalization stocks, limited partnerships that invest in early-stage biotechnology companies and our investment in BeiGene.

A 20% decrease in the aggregate value of our equity investment portfolio as of December 31, 2021 and 2020, would result in losses in fair value of approximately $1.4 billion and $1.2 billion, respectively.

These investments are generally in small-capitalization stocks in the biotechnology industry.

Price risk relative to our equity investment portfolio as of December 31, 2020 and 2019, was not material.

Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is [added: a biotechnology company] committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

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, [removed: 2019.][added: 2020.]

A novel strain of coronavirus (SARS-CoV-2, or severe acute respiratory syndrome coronavirus 2, causing [removed: coronavirus disease 19, or] COVID-19) was declared a global pandemic by the World Health Organization [removed: (WHO)] on March 11, 2020.

[removed: *KYPROLIS®* *(carfilzomib)*][added: *KYPROLIS*]

[removed: - In August 2020,] [added: *•*In December 2021,] we announced that the [removed: U.S. Food and Drug Administration (FDA)] [added: FDA] had approved the expansion of the [removed: KYPROLIS® U.S.] [added: KYPROLIS] prescribing information to include its use in combination with [removed: DARZALEX® (daratumumab) plus dexamethasone in two dosing regimens—once weekly] [added: DARZALEX FASPRO (daratumumab] and [removed: twice weekly—for] [added: hyaluronidase-fihj) and dexamethasone for] the treatment of [added: adult] patients with relapsed or refractory multiple myeloma who have received one to three [removed: previous] lines of therapy.

[removed: - In December 2020,] [added: *•*In May 2021,] we announced that the FDA had [removed: granted Breakthrough Therapy designation for our investigational KRASG12C inhibitor, sotorasib,] [added: approved LUMAKRAS] for the treatment of [added: adult] patients with [added: KRAS *G12C*–mutated] locally advanced or metastatic [removed: NSCLC with *KRAS G12C* mutation,] [added: NSCLC,] as determined by an FDA-approved test, [removed: following] [added: who have received] at least one prior systemic therapy.

[removed: *Otezla®* *(apremilast)*][added: *Otezla*]

See [removed: Note] [added: Part IV—Note] 19, Contingencies and commitments, to the Consolidated Financial [removed: Statements.][added: Statements, Amgen Inc. vs. Sandoz Inc., et al.]

In [removed: addition,] [added: recent years,] we [removed: continue to expand] [added: have expanded] the commercialization and marketing of our products into other geographic territories, including [added: China and Japan and other] parts of Asia, the Middle [removed: East, Canada] [added: East] and Latin America.

This expansion [added: has occurred, and] is [removed: occurring] [added: expected to continue to occur,] by establishing our own affiliates, by acquiring existing third-party businesses or product rights or by collaborating with third parties.

Whether we use our own sales and marketing forces or a third party’s [added: services] varies across these markets.

Our product sales to three large wholesalers, [removed: AmerisourceBergen Corporation,] McKesson [added: Corporation, AmerisourceBergen] Corporation and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018.][added: 2019.]

On a combined basis, these wholesalers accounted for [removed: 83%, 81%] [added: 82%, 83%] and [removed: 84%] [added: 81%] of worldwide gross revenues for [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018,] [added: 2019,] respectively.

Our products are marketed around the world, with the United States [removed: being] [added: as] our largest market.

The following chart shows our product sales by principal product, and the table below (dollar amounts in millions) shows product sales by geography for the years [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018.][added: 2019.]

[removed: ][added: ]

| | | | [removed: 2020] [added: 2021] | | | | | | | | | [removed: 2019] [added: 2020] | | | | | | | | | [removed: 2018] [added: 2019] | | | | | |

| U.S. | | | $ | [removed: 17,985] [added: 17,286] | | [removed: 74] [added: 71] | | % | | | | $ | [removed: 16,531] [added: 17,985] | | 74 | | % | | | | $ | [removed: 17,429] [added: 16,531] | | [removed: 77] [added: 74] | | % |

| Total | | | $ | [removed: 24,240] [added: 24,297] | | 100 | | % | | | | $ | [removed: 22,204] [added: 24,240] | | 100 | | % | | | | $ | [removed: 22,533] [added: 22,204] | | 100 | | % |

We market ENBREL, a tumor necrosis factor blocker, [removed: primarily] in the United [removed: States.][added: States and Canada.]

[removed: *Prolia®* *(denosumab)*][added: *Prolia*]

We market [removed: Prolia®] [added: Aranesp] primarily in the United [removed: States, Europe] [added: States] and [removed: the Asia Pacific region.][added: Europe.]

[removed: Prolia®] [added: Prolia] contains the same active ingredient as [removed: XGEVA® (denosumab)] [added: XGEVA] but is approved for different indications, patient populations, doses and frequencies of administration.

[removed: Prolia®] [added: Prolia] was launched in the United States and Europe in 2010.

In Europe, [removed: Prolia®] [added: Prolia] is used primarily for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

[removed: *Neulasta®* *(pegfilgrastim)*][added: *Neulasta*]

We market [removed: Neulasta®,] [added: Neulasta,] a pegylated protein based on the filgrastim molecule, primarily in the United States and Europe.

[removed: Neulasta®] [added: Neulasta] was launched in 2002 and is used primarily in the indication to help reduce the chance of infection due to a low white blood cell count in patients with certain types of cancer (nonmyeloid) who receive anticancer medicines (chemotherapy) that can cause fever and a low blood cell count.

In 2015, the [removed: Neulasta® Onpro®] [added: Neulasta Onpro] kit became available in the United States.

The [removed: Neulasta® Onpro®] [added: Neulasta Onpro] kit provides physicians the opportunity to initiate [removed: the] administration of [removed: Neulasta®] [added: Neulasta] on the same day as chemotherapy, with drug delivery of the recommended dose of [removed: Neulasta®] [added: Neulasta] at home the day after chemotherapy, thereby saving [removed: patients] [added: the patient] a trip back to the doctor.

[removed: *Otezla*®][added: *Otezla*]

We market [removed: Otezla®, a small molecule that inhibits phosphodiesterase 4 (PDE4),] [added: KYPROLIS] primarily in the United States and Europe.

[removed: Otezla®] [added: Otezla] was acquired from [removed: Bristol-Myers Squibb Company (BMS)] [added: BMS] in November [removed: 2019, post] [added: 2019 after] their acquisition of [removed: Celgene Corporation (Celgene).][added: Celgene.]

[removed: Otezla®] [added: Otezla] is an oral therapy approved for the treatment of adult patients with [removed: moderate-to-severe] plaque psoriasis [added: across all severities] for whom phototherapy or systemic therapy is appropriate, patients with active psoriatic arthritis and patients with oral ulcers associated with Behçet’s disease.

In Europe, [removed: Otezla®] [added: Otezla] is approved for second-line use in the treatment of psoriatic arthritis and [removed: psoriasis.][added: psoriasis and for patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.]

[removed: *XGEVA®*][added: *XGEVA*]

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

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

[removed: Aranesp®] [added: 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 [removed: Aranesp®.][added: Aranesp.]

[removed: *KYPROLIS®*][added: *KYPROLIS*]

*Business Development*

*Five Prime Therapeutics acquisition*

- On April 16, 2021, Amgen completed its acquisition of Five Prime, a public clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, for approximately $1.6 billion in cash, net of cash acquired.

- In April 2021, the FDA granted Breakthrough Therapy designation for bemarituzumab as first-line treatment for patients with FGFR2b overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with fluoropyrimidine, leucovorin and oxaliplatin based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.

*KKC collaboration*

*•*We and KKC entered into an agreement, effective July 30, 2021, to jointly develop and commercialize KKC’s potential first-in-class, phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases.

*Teneobio acquisition*

*•*On October 19, 2021, Amgen completed its acquisition of Teneobio, a privately held, clinical-stage biotechnology company developing a new class of biologics called human heavy-chain antibodies, which are single-chain antibodies composed of the human heavy-chain domain, for $900 million as well as future contingent milestone payments potentially worth up to an additional $1.6 billion upon the achievement of certain developmental and regulatory events.

- In December 2021, we announced that the FDA had approved the expanded indication for Otezla for the treatment of adult patients with plaque psoriasis, who are candidates for phototherapy or systemic therapy, across all severities.

*TEZSPIRE*

- In December 2021, we and AstraZeneca announced that the FDA had approved TEZSPIRE for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

*LUMAKRAS/LUMYKRAS*

LUMAKRAS received accelerated approval based on ORR and DoR.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.

- In January 2022, we announced that the EC had granted conditional marketing authorization for LUMYKRAS for the treatment of adults with advanced NSCLC with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

We also announced that LUMAKRAS had been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent NSCLC that has progressed after systemic anticancer therapy.

*Operations*

*New manufacturing facilities*

We announced plans to expand our United States–based manufacturing footprint.

- In August 2021, we announced plans to build a drug substance plant in North Carolina that will increase our manufacturing network capacity to reliably supply more medicines for patients.

*•*In November 2021, we broke ground to build an advanced assembly and packaging plant in Ohio.

The new facility will assemble and package vials and syringes to support the growing demand for our medicines.

We expect that both of these facilities will be built faster and at lower cost than traditional plants.

Once completed, both will also utilize cutting-edge technologies to be more efficient and environmentally friendly than traditional plants.

Since the onset of the pandemic in 2020, we have been closely monitoring the pandemic’s effects on our global operations.

To date, we have not experienced disruptions to or shortages of our supply of medicines.

We continue to take appropriate steps to minimize risks to our employees.

Employee access to company facilities has been in accordance with applicable government health and safety protocols and guidance issued in response to the COVID-19 pandemic.

The pandemic has shifted how we work as an organization and in the fourth quarter of 2021, we enabled our U.S. based workforce to return to the workplace for work that benefits from face-to-face interaction, while maintaining appropriate safety measures to ensure staff well-being.

In the Asia Pacific region, we also sell our products in partnership with other companies, including BeiGene, Daiichi Sankyo, KKC and Takeda.

| ROW | | | 7,011 | | | 29 | | % | | | | 6,255 | | | 26 | | % | | | | 5,673 | | | 26 | | % |

We market Prolia in many countries around the world.

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

We market XGEVA in many countries around the world.

*Aranesp*

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

Repatha is also indicated to reduce LDL-C in adults with primary hyperlipidemia, including HeFH; in pediatric patients aged 10 years and older with HeFH; and in adults and pediatric patients aged 10 years and older with HoFH.

We market Nplate in many countries around the world.

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

| Product | | | | | | Territory | | | | | | General subject matter | | | | | | Expiration | | |

Since the first quarter of 2020 and continuing into 2021, we have seen some impact of the pandemic to our operations.

We continue to monitor and respond as the pandemic evolves to ensure the continued development, manufacture and distribution of our medicines.

Also see the remainder of Item 1.

Business for discussion of pandemic-related impacts to our overall business.

*Sotorasib (formerly AMG 510)*

- In September 2020, we announced updated phase 1 data evaluating sotorasib in 129 patients across multiple advanced solid tumors with Kirsten rat sarcoma viral oncogene homolog (*KRAS) G12C* mutation, which were published in the New England Journal of Medicine.

Data from 59 patients with advanced non-small cell lung cancer (NSCLC) were also featured in an oral presentation at a September 2020 medical conference.

In the patients with advanced NSCLC who were treated with the 960 mg daily dose, the confirmed objective response rate (ORR) was 35.3%.

Across all dose levels, the confirmed ORR was 32.2%, with median duration of response of 10.9 months and median progression-free survival (PFS) of 6.3 months; 10 of 19 responders were still in response as of the data cutoff.

- In October 2020, we announced top-line phase 2 results in 126 patients with *KRAS G12C*\-mutant advanced NSCLC.

Sotorasib demonstrated an ORR (primary endpoint) consistent with previously reported phase 1 data in patients taking the 960 mg daily dose.

Other measures of efficacy, including duration of response, were promising, and more than half of the responders were still on treatment and continuing to respond as of the data cutoff date.

The results of this phase 2 study are potentially registrational, and a phase 3 confirmatory study comparing sotorasib to docetaxel is currently recruiting patients with *KRAS G12C*\-mutant advanced NSCLC.

Following this announcement, we submitted a New Drug Application (NDA) to the FDA.

The sotorasib NDA is being reviewed by the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.

Later in December, we also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).

- In January 2021, we announced results from the phase 2 cohort of the clinical study evaluating sotorasib in 126 patients with *KRAS G12C*\-mutant advanced NSCLC.

Sotorasib demonstrated a confirmed ORR and disease control rate of 37.1% and 80.6%, respectively, a median duration of response of 10 months and median progression-free survival of 6.8 months.

In addition, sotorasib was granted Breakthrough Therapy designation by the Center for Drug Evaluation of the National Medical Products Administration in China.

*RIABNITM* *(rituximab-arrx) (formerly ABP 798)*

*•*In December 2020, we announced that the FDA had approved RIABNITM, a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.

RIABNITM launched in the United States in January 2021.

- In May 2020, we announced positive top-line results from a phase 3 study to assess the efficacy of Otezla® in adults with mild-to-moderate plaque psoriasis.

The study showed that oral Otezla® 30 mg twice daily achieved a statistically significant improvement, compared with placebo, in the primary endpoint of the static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16.

*Enbrel®* *(etanercept)*

- In July 2020, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment by the U.S. District Court for the District of New Jersey upholding the validity of the two patents that describe and claim ENBREL and methods for making it.

*Tezepelumab*

- In November 2020, we and AstraZeneca plc (AstraZeneca) announced positive top-line results from the registrational phase 3 NAVIGATOR trial in adults and adolescents with severe uncontrolled asthma.

The trial met the primary endpoint with tezepelumab added to standard of care (SoC), demonstrating a statistically significant and clinically meaningful reduction compared with placebo plus SoC in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population.

SoC consisted of medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).

We expect to submit results of this study to regulators in 2021.

- In December 2020, we and AstraZeneca announced that the SOURCE trial had not met the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo.

The results of this trial have no impact on our submission plans.

*Cardiovascular*

*Omecamtiv mecarbil*

- In November 2020, based on results of the omecamtiv mecarbil phase 3 trial, we provided notice to Cytokinetics, Incorporated (Cytokinetics) of termination of our collaboration and our intention to transition to them the development and commercialization rights for omecamtiv mecarbil and AMG 594.

*Establishment of wholly owned affiliate in Japan*

- In April 2020, we completed our purchase from Astellas of the remaining shares of Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas established in 2013.

AABP, now a wholly owned Amgen affiliate in Japan and renamed Amgen K.K., has enabled us to build a strong presence in Japan as we continue to advance treatments for serious illnesses.

The purchase did not have a material impact to our consolidated financial statements.

For the fiscal year ended December 31, [removed: 2020][added: 2021]

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was [removed: $138,056,968,288] [added: $137,531,019,585] as of June 30, [removed: 2020.(A)][added: 2021.(A)]

(A)Excludes [removed: 1,045,777] [added: 811,415] shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, at June 30, [removed: 2020.][added: 2021.]

(Number of shares of common stock outstanding as of February [removed: 3, 2021)][added: 11, 2022)]

Specified portions of the registrant’s Proxy Statement with respect to the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be held May [removed: 18, 2021,] [added: 17, 2022,] are incorporated by reference into Part III of this annual report.

| Item 1. | | | [removed: [BUSINESS](#if8d0740b43d148a5ba67e4dd5b38ce46_13)] [added: [BUSINESS](#i2a971cfaef98424f9692041d6ed3a222_13)] | | | [removed: [1](#if8d0740b43d148a5ba67e4dd5b38ce46_13)] [added: [1](#i2a971cfaef98424f9692041d6ed3a222_13)] | | |

| | | | [Significant [removed: Developments](#if8d0740b43d148a5ba67e4dd5b38ce46_16)] [added: Developments](#i2a971cfaef98424f9692041d6ed3a222_16)] | | | [removed: [1](#if8d0740b43d148a5ba67e4dd5b38ce46_16)] [added: [1](#i2a971cfaef98424f9692041d6ed3a222_16)] | | |

| | | | [Marketing, Distribution and Selected Marketed [removed: Products](#if8d0740b43d148a5ba67e4dd5b38ce46_19)] [added: Products](#i2a971cfaef98424f9692041d6ed3a222_19)] | | | [removed: [3](#if8d0740b43d148a5ba67e4dd5b38ce46_19)] [added: [3](#i2a971cfaef98424f9692041d6ed3a222_19)] | | |

| | | | [Manufacturing, Distribution and Raw [removed: Materials](#if8d0740b43d148a5ba67e4dd5b38ce46_25)] [added: Materials](#i2a971cfaef98424f9692041d6ed3a222_25)] | | | [removed: [12](#if8d0740b43d148a5ba67e4dd5b38ce46_25)] [added: [11](#i2a971cfaef98424f9692041d6ed3a222_25)] | | |

| | | | [Government [removed: Regulation](#if8d0740b43d148a5ba67e4dd5b38ce46_28)] [added: Regulation](#i2a971cfaef98424f9692041d6ed3a222_28)] | | | [removed: [13](#if8d0740b43d148a5ba67e4dd5b38ce46_28)] [added: [12](#i2a971cfaef98424f9692041d6ed3a222_28)] | | |

| | | | [Research and Development and Selected Product [removed: Candidates](#if8d0740b43d148a5ba67e4dd5b38ce46_31)] [added: Candidates](#i2a971cfaef98424f9692041d6ed3a222_31)] | | | [removed: [17](#if8d0740b43d148a5ba67e4dd5b38ce46_31)] [added: [16](#i2a971cfaef98424f9692041d6ed3a222_31)] | | |

| | | | [Business [removed: Relationships](#if8d0740b43d148a5ba67e4dd5b38ce46_34)] [added: Relationships](#i2a971cfaef98424f9692041d6ed3a222_34)] | | | [removed: [23](#if8d0740b43d148a5ba67e4dd5b38ce46_34)] [added: [21](#i2a971cfaef98424f9692041d6ed3a222_34)] | | |

| | | | [removed: [Human](#if8d0740b43d148a5ba67e4dd5b38ce46_37) [Capital](#if8d0740b43d148a5ba67e4dd5b38ce46_37) [Resources](#if8d0740b43d148a5ba67e4dd5b38ce46_37)] [added: [Human Capital Resources](#i2a971cfaef98424f9692041d6ed3a222_37)] | | | [removed: [24](#if8d0740b43d148a5ba67e4dd5b38ce46_37)] [added: [22](#i2a971cfaef98424f9692041d6ed3a222_37)] | | |

| | | | [Information about our Executive [removed: Officers](#if8d0740b43d148a5ba67e4dd5b38ce46_40)] [added: Officers](#i2a971cfaef98424f9692041d6ed3a222_40)] | | | [removed: [26](#if8d0740b43d148a5ba67e4dd5b38ce46_40)] [added: [24](#i2a971cfaef98424f9692041d6ed3a222_40)] | | |

| | | | [Geographic Area Financial [removed: Information](#if8d0740b43d148a5ba67e4dd5b38ce46_43)] [added: Information](#i2a971cfaef98424f9692041d6ed3a222_43)] | | | [removed: [27](#if8d0740b43d148a5ba67e4dd5b38ce46_43)] [added: [25](#i2a971cfaef98424f9692041d6ed3a222_43)] | | |

| | | | [Investor [removed: Information](#if8d0740b43d148a5ba67e4dd5b38ce46_46)] [added: Information](#i2a971cfaef98424f9692041d6ed3a222_46)] | | | [removed: [27](#if8d0740b43d148a5ba67e4dd5b38ce46_46)] [added: [26](#i2a971cfaef98424f9692041d6ed3a222_46)] | | |

| Item 1A. | | | [RISK [removed: FACTORS](#if8d0740b43d148a5ba67e4dd5b38ce46_2411)] [added: FACTORS](#i2a971cfaef98424f9692041d6ed3a222_49)] | | | [removed: [27](#if8d0740b43d148a5ba67e4dd5b38ce46_2411)] [added: [26](#i2a971cfaef98424f9692041d6ed3a222_49)] | | |

| Item 1B. | | | [UNRESOLVED STAFF [removed: COMMENTS](#if8d0740b43d148a5ba67e4dd5b38ce46_52)] [added: COMMENTS](#i2a971cfaef98424f9692041d6ed3a222_52)] | | | [removed: [54](#if8d0740b43d148a5ba67e4dd5b38ce46_52)] [added: [50](#i2a971cfaef98424f9692041d6ed3a222_52)] | | |

| Item 2. | | | [removed: [PROPERTIES](#if8d0740b43d148a5ba67e4dd5b38ce46_55)] [added: [PROPERTIES](#i2a971cfaef98424f9692041d6ed3a222_55)] | | | [removed: [55](#if8d0740b43d148a5ba67e4dd5b38ce46_55)] [added: [51](#i2a971cfaef98424f9692041d6ed3a222_55)] | | |

| Item 3. | | | [LEGAL [removed: PROCEEDINGS](#if8d0740b43d148a5ba67e4dd5b38ce46_58)] [added: PROCEEDINGS](#i2a971cfaef98424f9692041d6ed3a222_58)] | | | [removed: [55](#if8d0740b43d148a5ba67e4dd5b38ce46_58)] [added: [51](#i2a971cfaef98424f9692041d6ed3a222_58)] | | |

| Item 4. | | | [MINE SAFETY [removed: DISCLOSURES](#if8d0740b43d148a5ba67e4dd5b38ce46_61)] [added: DISCLOSURES](#i2a971cfaef98424f9692041d6ed3a222_61)] | | | [removed: [55](#if8d0740b43d148a5ba67e4dd5b38ce46_61)] [added: [51](#i2a971cfaef98424f9692041d6ed3a222_61)] | | |

| Item 5. | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#if8d0740b43d148a5ba67e4dd5b38ce46_67)] [added: SECURITIES](#i2a971cfaef98424f9692041d6ed3a222_67)] | | | [removed: [56](#if8d0740b43d148a5ba67e4dd5b38ce46_67)] [added: [52](#i2a971cfaef98424f9692041d6ed3a222_67)] | | |

| Item 7. | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#if8d0740b43d148a5ba67e4dd5b38ce46_73)] [added: OPERATIONS](#i2a971cfaef98424f9692041d6ed3a222_73)] | | | [removed: [59](#if8d0740b43d148a5ba67e4dd5b38ce46_73)] [added: [54](#i2a971cfaef98424f9692041d6ed3a222_73)] | | |

| Item 7A. | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#if8d0740b43d148a5ba67e4dd5b38ce46_109)] [added: RISK](#i2a971cfaef98424f9692041d6ed3a222_109)] | | | [removed: [78](#if8d0740b43d148a5ba67e4dd5b38ce46_109)] [added: [73](#i2a971cfaef98424f9692041d6ed3a222_109)] | | |

| Item 8. | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#if8d0740b43d148a5ba67e4dd5b38ce46_112)] [added: DATA](#i2a971cfaef98424f9692041d6ed3a222_112)] | | | [removed: [80](#if8d0740b43d148a5ba67e4dd5b38ce46_112)] [added: [75](#i2a971cfaef98424f9692041d6ed3a222_112)] | | |

| Item 9. | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#if8d0740b43d148a5ba67e4dd5b38ce46_115)] [added: DISCLOSURE](#i2a971cfaef98424f9692041d6ed3a222_115)] | | | [removed: [80](#if8d0740b43d148a5ba67e4dd5b38ce46_115)] [added: [75](#i2a971cfaef98424f9692041d6ed3a222_115)] | | |

| Item 9A. | | | [CONTROLS AND [removed: PROCEDURES](#if8d0740b43d148a5ba67e4dd5b38ce46_118)] [added: PROCEDURES](#i2a971cfaef98424f9692041d6ed3a222_118)] | | | [removed: [81](#if8d0740b43d148a5ba67e4dd5b38ce46_118)] [added: [76](#i2a971cfaef98424f9692041d6ed3a222_118)] | | |

| Item 9B. | | | [OTHER [removed: INFORMATION](#if8d0740b43d148a5ba67e4dd5b38ce46_127)] [added: INFORMATION](#i2a971cfaef98424f9692041d6ed3a222_127)] | | | [removed: [83](#if8d0740b43d148a5ba67e4dd5b38ce46_127)] [added: [78](#i2a971cfaef98424f9692041d6ed3a222_127)] | | |

| [PART [removed: III](#if8d0740b43d148a5ba67e4dd5b38ce46_130)] [added: III](#i2a971cfaef98424f9692041d6ed3a222_130)] | | | | | | [removed: [83](#if8d0740b43d148a5ba67e4dd5b38ce46_130)] [added: [78](#i2a971cfaef98424f9692041d6ed3a222_130)] | | |

| Item 10. | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#if8d0740b43d148a5ba67e4dd5b38ce46_133)] [added: GOVERNANCE](#i2a971cfaef98424f9692041d6ed3a222_133)] | | | [removed: [83](#if8d0740b43d148a5ba67e4dd5b38ce46_133)] [added: [78](#i2a971cfaef98424f9692041d6ed3a222_133)] | | |

| Item 11. | | | [EXECUTIVE [removed: COMPENSATION](#if8d0740b43d148a5ba67e4dd5b38ce46_139)] [added: COMPENSATION](#i2a971cfaef98424f9692041d6ed3a222_139)] | | | [removed: [83](#if8d0740b43d148a5ba67e4dd5b38ce46_139)] [added: [78](#i2a971cfaef98424f9692041d6ed3a222_139)] | | |

| Item 12. | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#if8d0740b43d148a5ba67e4dd5b38ce46_142)] [added: MATTERS](#i2a971cfaef98424f9692041d6ed3a222_142)] | | | [removed: [84](#if8d0740b43d148a5ba67e4dd5b38ce46_142)] [added: [79](#i2a971cfaef98424f9692041d6ed3a222_142)] | | |

| Item 13. | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR [removed: INDEPENDENCE](#if8d0740b43d148a5ba67e4dd5b38ce46_151)] [added: INDEPENDENCE](#i2a971cfaef98424f9692041d6ed3a222_151)] | | | [removed: [85](#if8d0740b43d148a5ba67e4dd5b38ce46_151)] [added: [80](#i2a971cfaef98424f9692041d6ed3a222_151)] | | |

| Item 14. | | | [PRINCIPAL [removed: ACCOUNTING FEES] [added: ACCOUNT](#i2a971cfaef98424f9692041d6ed3a222_154)[ANT](#i2a971cfaef98424f9692041d6ed3a222_154) [FEES] AND [removed: SERVICES](#if8d0740b43d148a5ba67e4dd5b38ce46_154)] [added: SERVICES](#i2a971cfaef98424f9692041d6ed3a222_154)] | | | [removed: [85](#if8d0740b43d148a5ba67e4dd5b38ce46_154)] [added: [80](#i2a971cfaef98424f9692041d6ed3a222_154)] | | |

| [PART [removed: IV](#if8d0740b43d148a5ba67e4dd5b38ce46_157)] [added: IV](#i2a971cfaef98424f9692041d6ed3a222_157)] | | | | | | [removed: [86](#if8d0740b43d148a5ba67e4dd5b38ce46_157)] [added: [81](#i2a971cfaef98424f9692041d6ed3a222_157)] | | |

| Item 15. | | | [removed: [EXHIBITS, FINANCIAL] [added: [EXHIBITS](#i2a971cfaef98424f9692041d6ed3a222_160) [AND](#i2a971cfaef98424f9692041d6ed3a222_160) [FINANCIAL] STATEMENT [removed: SCHEDULES](#if8d0740b43d148a5ba67e4dd5b38ce46_160)] [added: SCHEDULES](#i2a971cfaef98424f9692041d6ed3a222_160)] | | | [removed: [86](#if8d0740b43d148a5ba67e4dd5b38ce46_160)] [added: [81](#i2a971cfaef98424f9692041d6ed3a222_160)] | | |

| Item 16. | | | [FORM 10-K [removed: SUMMARY](#if8d0740b43d148a5ba67e4dd5b38ce46_163)] [added: SUMMARY](#i2a971cfaef98424f9692041d6ed3a222_163)] | | | [removed: [92](#if8d0740b43d148a5ba67e4dd5b38ce46_163)] [added: [87](#i2a971cfaef98424f9692041d6ed3a222_163)] | | |

| [removed: [SIGNATURES](#if8d0740b43d148a5ba67e4dd5b38ce46_166)] [added: [SIGNATURES](#i2a971cfaef98424f9692041d6ed3a222_166)] | | | | | | [removed: [93](#if8d0740b43d148a5ba67e4dd5b38ce46_166)] [added: [88](#i2a971cfaef98424f9692041d6ed3a222_166)] | | |

557,029,370

| | | | [Defined Terms and Products](#i2a971cfaef98424f9692041d6ed3a222_2138) | | | [ii](#i2a971cfaef98424f9692041d6ed3a222_2138) | | |

| [PART I](#i2a971cfaef98424f9692041d6ed3a222_10) | | | | | | [1](#i2a971cfaef98424f9692041d6ed3a222_10) | | |

| | | | [Reimbursement](#i2a971cfaef98424f9692041d6ed3a222_22) | | | [9](#i2a971cfaef98424f9692041d6ed3a222_22) | | |

| [PART II](#i2a971cfaef98424f9692041d6ed3a222_64) | | | | | | [52](#i2a971cfaef98424f9692041d6ed3a222_64) | | |

| Item 6. | | | [RESERVED](#i2a971cfaef98424f9692041d6ed3a222_70) | | | [53](#i2a971cfaef98424f9692041d6ed3a222_70) | | |

Defined Terms and Products

*Defined terms*

We use several terms in this Form 10-K—including but not limited to those that are finance, regulation and disease-state related—as well as names of other companies, which are given below.

| | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Term | | | Description | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | |

| 2017 Tax Act | | | Tax Cuts and Jobs Act of 2017 | | | | | | | | | | | | | | |

| AbbVie | | | AbbVie Inc. | | | | | | | | | | | | | | |

| ACA | | | Affordable Care Act | | | | | | | | | | | | | | |

| aHUS | | | atypical hemolytic uremic syndrome | | | | | | | | | | | | | | |

| ALL | | | acute lymphoblastic leukemia | | | | | | | | | | | | | | |

| AMD | | | age-related macular degeneration | | | | | | | | | | | | | | |

| Amended 2009 Plan | | | Amended and Restated 2009 Equity Incentive Plan | | | | | | | | | | | | | | |

| ANDA | | | Abbreviated New Drug Application | | | | | | | | | | | | | | |

| AOCI | | | accumulated other comprehensive income (loss) | | | | | | | | | | | | | | |

| AstraZeneca | | | AstraZeneca plc | | | | | | | | | | | | | | |

| BAFF | | | B-cell activating factor | | | | | | | | | | | | | | |

| BeiGene | | | BeiGene, Ltd. | | | | | | | | | | | | | | |

| BiTE® | | | bispecific T-cell engager | | | | | | | | | | | | | | |

| BLA | | | Biologics License Application | | | | | | | | | | | | | | |

| BMS | | | Bristol Myers Squibb Company | | | | | | | | | | | | | | |

| BPCIA | | | Biologics Price Competition and Innovation Act of 2009 | | | | | | | | | | | | | | |

| Celgene | | | Celgene Corporation | | | | | | | | | | | | | | |

| CGRP | | | calcitonin gene-related peptide | | | | | | | | | | | | | | |

| chemotherapy | | | anticancer medicines | | | | | | | | | | | | | | |

| CHMP | | | Committee for Medicinal Products for Human Use | | | | | | | | | | | | | | |

| CIT | | | chemotherapy-induced thrombocytopenia | | | | | | | | | | | | | | |

| CKD | | | chronic kidney disease | | | | | | | | | | | | | | |

| CMS | | | Centers for Medicare & Medicaid Services | | | | | | | | | | | | | | |

| COSO | | | Committee of Sponsoring Organizations of the Treadway Commission | | | | | | | | | | | | | | |

| COVID-19 | | | coronavirus disease 2019 | | | | | | | | | | | | | | |

| CV | | | cardiovascular | | | | | | | | | | | | | | |

| DaVita | | | DaVita Inc. | | | | | | | | | | | | | | |

| 1.250% Senior Notes Due 2022 | | | AMGN22 | | | The Nasdaq Stock Market LLC | | |

577,566,383

| [PART I](#if8d0740b43d148a5ba67e4dd5b38ce46_10) | | | | | | [1](#if8d0740b43d148a5ba67e4dd5b38ce46_10) | | |

| | | | [Reimbursement](#if8d0740b43d148a5ba67e4dd5b38ce46_22) | | | [10](#if8d0740b43d148a5ba67e4dd5b38ce46_22) | | |

| [PART II](#if8d0740b43d148a5ba67e4dd5b38ce46_64) | | | | | | [56](#if8d0740b43d148a5ba67e4dd5b38ce46_64) | | |

| Item 6. | | | [SELECTED FINANCIAL DATA](#if8d0740b43d148a5ba67e4dd5b38ce46_70) | | | [58](#if8d0740b43d148a5ba67e4dd5b38ce46_70) | | |

As of December 31, [removed: 2020,] [added: 2021,] we owned or leased approximately [removed: 180] [added: 160] properties.

| [removed: Ex-U.S.] [added: ROW] Location: | | | Manufacturing | | | Administrative | | | R&D | | | Sales & marketing | | | Warehouse | | | Distribution center | | |

| Japan | | | | | | P | | | [removed: P] | | | P | | | | | | | | |

| Denmark | | | | | | P | | | P | | | P | | | | | | | | |

| Woburn, MA | | | P | | | | | | | | | | | | P | | | | | |

As of February [removed: 3, 2021,] [added: 11, 2022,] there were approximately [removed: 5,336] [added: 5,069] holders of record of our common stock.

The following graph shows the value of an investment of $100 on December 31, [removed: 2015,] [added: 2016,] in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 [removed: Index (S&P 500).][added: Index.]

[removed: ][added: ]

| | | | [removed: 12/31/2015] [added: 12/31/2016] | | | | | | [removed: 12/31/2016] [added: 12/31/2017] | | | | | | [removed: 12/31/2017] [added: 12/31/2018] | | | | | | [removed: 12/31/2018] [added: 12/31/2019] | | | | | | [removed: 12/31/2019] [added: 12/31/2020] | | | | | | [removed: 12/31/2020] [added: 12/31/2021] | | |

The material in [removed: this] [added: the above] performance graph is not soliciting material, is not deemed filed with the SEC and is not incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, whether made on, before or after the date of this filing and irrespective of any general incorporation language in such filing.

During the three months and year ended December 31, [removed: 2020,] [added: 2021,] we had one outstanding stock repurchase program, under which the repurchasing activity was as follows:

(2)In [added: October 2021 and] December [removed: 2019,] [added: 2021,] our Board of Directors increased the amount authorized under the stock repurchase program by an additional [removed: $4.0 billion.][added: $4.5 billion and an additional $5.0 billion, respectively.]

For the years ended December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] we paid quarterly dividends.

| Amgen (AMGN) | | | $100.00 | | | | | | $122.32 | | | | | | $140.76 | | | | | | $179.65 | | | | | | $176.05 | | | | | | $177.59 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $137.81 | | | | | | $138.18 | | | | | | $166.41 | | | | | | $189.00 | | | | | | $182.34 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $116.63 | | | | | | $125.31 | | | | | | $148.36 | | | | | | $161.31 | | | | | | $199.02 | | |

| Standard & Poor’s 500 (SPX) | | | $100.00 | | | | | | $121.89 | | | | | | $116.56 | | | | | | $153.26 | | | | | | $181.44 | | | | | | $233.47 | | |

| October 1 - October 31 | | | | | | 1,874,976 | | | | | | $ | 208.06 | | | | | 1,874,976 | | | | | | $ | 6,960,277,756 | |

| November 1 - November 30 | | | | | | 2,484,905 | | | | | | $ | 208.35 | | | | | 2,484,905 | | | | | | $ | 6,442,554,907 | |

| December 1 - December 31 | | | | | | 2,559,300 | | | | | | $ | 216.14 | | | | | 2,559,300 | | | | | | $ | 10,889,377,513 | |

| | | | | | | 6,919,181 | | | | | | $ | 211.15 | | | | | 6,919,181 | | | | | | | | |

| January 1 - December 31 | | | | | | 21,730,283 | | | | | | $ | 229.50 | | | | | 21,730,283 | | | | | | | | |

| Amgen (AMGN) | | | $100.00 | | | | | | $92.45 | | | | | | $113.08 | | | | | | $130.14 | | | | | | $166.09 | | | | | | $162.76 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $80.85 | | | | | | $111.42 | | | | | | $111.72 | | | | | | $134.54 | | | | | | $152.81 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $91.66 | | | | | | $106.90 | | | | | | $114.86 | | | | | | $135.96 | | | | | | $147.86 | | |

| S&P 500 (SPX) | | | $100.00 | | | | | | $111.95 | | | | | | $136.46 | | | | | | $130.50 | | | | | | $171.57 | | | | | | $203.12 | | |

| October 1 - October 31 | | | | | | 1,774,922 | | | | | | $ | 235.06 | | | | | 1,774,922 | | | | | | $ | 3,781,230,811 | |

| November 1 - November 30 | | | | | | 1,660,605 | | | | | | $ | 229.16 | | | | | 1,660,605 | | | | | | $ | 3,400,688,112 | |

| December 1 - December 31 | | | | | | 1,868,786 | | | | | | $ | 226.94 | | | | | 1,868,786 | | | | | | $ | 2,976,579,948 | |

| | | | | | | 5,304,313 | | | | | | $ | 230.35 | | | | | 5,304,313 | | | | | | | | |

| January 1 - December 31 | | | | | | 15,190,194 | | | | | | $ | 230.24 | | | | | 15,190,194 | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | Years ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Consolidated Statements of Income Data: | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |

| | | | (In millions, except per-share data) | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Revenues: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Product sales | | | $ | 24,240 | | | | | $ | 22,204 | | | | | $ | 22,533 | | | | | $ | 21,795 | | | | | $ | 21,892 | |

| Other revenues | | | 1,184 | | | | | | 1,158 | | | | | | 1,214 | | | | | | 1,054 | | | | | | 1,099 | | |

| Total revenues | | | $ | 25,424 | | | | | $ | 23,362 | | | | | $ | 23,747 | | | | | $ | 22,849 | | | | | $ | 22,991 | |

| Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Cost of sales | | | $ | 6,159 | | | | | $ | 4,356 | | | | | $ | 4,101 | | | | | $ | 4,069 | | | | | $ | 4,162 | |

| Research and development | | | $ | 4,207 | | | | | $ | 4,116 | | | | | $ | 3,737 | | | | | $ | 3,562 | | | | | $ | 3,840 | |

| Selling, general and administrative | | | $ | 5,730 | | | | | $ | 5,150 | | | | | $ | 5,332 | | | | | $ | 4,870 | | | | | $ | 5,062 | |

| Net income(1) | | | $ | 7,264 | | | | | $ | 7,842 | | | | | $ | 8,394 | | | | | $ | 1,979 | | | | | $ | 7,722 | |

| Diluted earnings per share(1) | | | $ | 12.31 | | | | | $ | 12.88 | | | | | $ | 12.62 | | | | | $ | 2.69 | | | | | $ | 10.24 | |

| Dividends paid per share | | | $ | 6.40 | | | | | $ | 5.80 | | | | | $ | 5.28 | | | | | $ | 4.60 | | | | | $ | 4.00 | |

| | | | As of December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Consolidated Balance Sheets Data: | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |

| | | | (In millions) | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Total assets | | | $ | 62,948 | | | | | $ | 59,707 | | | | | $ | 66,416 | | | | | $ | 79,954 | | | | | $ | 77,626 | |

| Total debt(2) | | | $ | 32,986 | | | | | $ | 29,903 | | | | | $ | 33,929 | | | | | $ | 35,342 | | | | | $ | 34,596 | |

| Total stockholders’ equity(3) | | | $ | 9,409 | | | | | $ | 9,673 | | | | | $ | 12,500 | | | | | $ | 25,241 | | | | | $ | 29,875 | |

(1) In 2017, we recorded a net charge of $6.1 billion as a result of the 2017 Tax Act.

(2) See Part IV—Note 15, Financing arrangements, to the Consolidated Financial Statements, for discussion of our financing arrangements in 2020, 2019 and 2018.

In 2017, we issued $4.5 billion of debt and repaid $4.4 billion of debt.

In 2016, we issued $7.3 billion of debt and repaid $3.7 billion of debt.

(3) Throughout the five years ended December 31, 2020, we had a stock repurchase program authorized by the Board of Directors, through which we repurchased $3.5 billion, $7.6 billion, $17.9 billion, $3.1 billion and $3.0 billion, respectively, of Amgen common stock.

In addition to the above notes, see Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations, Part IV—Consolidated Financial Statements and accompanying notes as well as previously filed Annual Reports on Form 10-K for further information regarding our consolidated results of operations and financial position for periods reported therein and for known factors that will affect the comparability of future results.

Also see Part IV—Note 16, Stockholders’ equity, to the Consolidated Financial Statements, for information regarding cash dividends declared per share of common stock for each of the four quarters of 2020, 2019 and 2018.

In addition, our Board of Directors declared dividends per share of $1.15 and $1.00, which were paid in each of the four quarters of 2017 and 2016, respectively.

Based upon their evaluation and subject to the foregoing, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, [removed: 2020.][added: 2021.]

Management determined that as of December 31, [removed: 2020,] [added: 2021,] there were no changes in our internal control over financial reporting that occurred during the fiscal quarter then ended that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2020.][added: 2021.]

In making this assessment, management used the criteria set forth by the [removed: Committee of Sponsoring Organizations of the Treadway Commission (COSO)] [added: COSO] in Internal [removed: Control-Integrated] [added: Control—Integrated] Framework (2013 framework).

Based on our assessment, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on the COSO criteria.

The effectiveness of the Company’s internal control over financial reporting has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their attestation report appearing below, which expresses an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2020.][added: 2021.]

We have audited Amgen Inc.’s internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Amgen Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 and our report dated February [removed: 8, 2021] [added: 16, 2022] expressed an unqualified opinion thereon.

February 16, 2022

February 8, 2021

Information about our Directors is incorporated by reference from the section entitled ITEM 1—ELECTION OF DIRECTORS in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2020] [added: 2021] (the Proxy Statement).

Information about the procedures by which stockholders may recommend nominees for the Board of Directors is incorporated by reference from APPENDIX A—AMGEN INC. BOARD OF DIRECTORS GUIDELINES FOR DIRECTOR QUALIFICATIONS AND EVALUATIONS and OTHER MATTERS—Stockholder Proposals for the [removed: 2022] [added: 2023] Annual Meeting in our Proxy Statement.

[removed: (This] [added: (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.) We intend to satisfy the disclosure requirements under Item 5.05 of Form 8-K regarding an amendment to or a waiver from a provision of this code of ethics, if any, by posting such information on our website as set forth above.

The following table sets forth certain information as of December 31, [removed: 2020,] [added: 2021,] concerning the shares of our common stock that may be issued under any form of award granted under our equity compensation plans in effect as of December 31, [removed: 2020] [added: 2021] (including upon the exercise of options, upon the vesting of awards of [removed: restricted stock units (RSUs)] [added: RSUs] or when performance units are earned and related dividend equivalents have been granted).

| [removed: Equity] [added: Equity] compensation plans approved by Amgen security [removed: holders:] [added: holders:] | | | | | | | | | | | | | | | | | | | | |

| Amended and Restated [removed: 2009] [added: 1991] Equity Incentive [removed: Plan(1)] [added: Plan(2)] | | | | | | [removed: 9,890,702] [added: 3,550] | | | | | | [removed: $] [added: —] | [removed: 179.92] | | | | | [removed: 23,108,576] [added: —] | | |

| Amended and Restated [removed: 1991] [added: 2009] Equity Incentive [removed: Plan(2)] [added: Plan(1)] | | | | | | [removed: 5,913] [added: 10,217,143] | | | | | | [removed: —] [added: $] | [added: 197.27] | | | | | [removed: —] [added: 18,987,053] | | |

| Amended and Restated Employee Stock Purchase Plan | | | | | | — | | | | | | — | | | | | | [removed: 4,393,614] [added: 4,280,585] | | |

| [removed: Equity] [added: Equity] compensation plan not approved by Amgen security [removed: holders:] [added: holders:] | | | | | | | | | | | | | | | | | | | | |

| Amgen Profit Sharing Plan for Employees in Ireland(3) | | | | | | — | | | | | | — | | | | | | [removed: 60,059] [added: 242,172] | | |

| [removed: Total] [added: Total] unapproved [removed: plans] [added: plans] | | | | | | — | | | | | | — | | | | | | [removed: 60,059] [added: 242,172] | | |

The performance units granted under this plan are earned based on the accomplishment of specified performance goals at the end of their respective three-year performance periods; the number of performance units granted represent target performance, and the maximum number of units that could be earned based on our performance is 200% of the performance units granted in [removed: 2018, 2019] [added: 2019, 2020] and [removed: 2020.][added: 2021.]

As of December 31, [removed: 2020,] [added: 2021,] the number of outstanding awards under column (a) includes (i) [removed: 4,721,305] [added: 5,138,659] shares issuable upon the exercise of outstanding options with a weighted-average exercise price of [removed: $179.92;] [added: $197.27;] (ii) [removed: 3,256,390] [added: 3,362,823] shares issuable upon the vesting of outstanding RSUs (including [removed: 199,676] [added: 292,972] related dividend equivalents); and (iii) [removed: 1,913,007] [added: 1,715,660] shares subject to outstanding [removed: 2018, 2019 and] [added: 2019,] 2020 [added: and 2021] performance units (including [removed: 93,738] [added: 88,269] related dividend equivalents).

The number of available shares under column (c) represents the number of shares that remain available for future issuance under this plan as of December 31, [removed: 2020,] [added: 2021,] employing the fungible share formula and presumes the issuance of target shares under the performance units granted in [removed: 2018, 2019 and] [added: 2019,] 2020 and [added: 2021 and] related dividend equivalents.

Maximum performance under these goals could result in 200% of target shares being awarded for performance units granted in [removed: 2018, 2019] [added: 2019, 2020] and [removed: 2020.][added: 2021.]

The number under column (a) with respect to this plan includes [removed: 5,913] [added: 3,550] shares issuable upon the settlement of deferred RSUs (including [removed: 1,160] [added: 774] related dividend equivalents).

(3)The [removed: Amgen] Profit Sharing Plan [removed: for Employees in Ireland (the Profit Sharing Plan)] was approved by the Board of Directors on July 28, 2011.

| Total approved plans | | | | | | 10,220,693 | | | | | | 197.27 | | | | | | 23,267,638 | | |

| Total all plans | | | | | | 10,220,693 | | | | | | $ | 197.27 | | | | | 23,509,810 | | |

| Total approved plans | | | | | | 9,896,615 | | | | | | 179.92 | | | | | | 27,502,190 | | |

| Total all plans | | | | | | 9,896,615 | | | | | | $ | 179.92 | | | | | 27,562,249 | | |

| Report of Independent Registered Public Accounting Firm [added: (PCAOB ID: 42)] | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_175)[1](#if8d0740b43d148a5ba67e4dd5b38ce46_175)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_175)[1](#i2a971cfaef98424f9692041d6ed3a222_175)] | | |

| Consolidated Statements of Income for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_178)[4](#if8d0740b43d148a5ba67e4dd5b38ce46_178)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_178)[4](#i2a971cfaef98424f9692041d6ed3a222_178)] | | |

| Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_181)[5](#if8d0740b43d148a5ba67e4dd5b38ce46_181)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_181)[5](#i2a971cfaef98424f9692041d6ed3a222_181)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_184)[6](#if8d0740b43d148a5ba67e4dd5b38ce46_184)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_184)[6](#i2a971cfaef98424f9692041d6ed3a222_184)] | | |

| Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_190)[7](#if8d0740b43d148a5ba67e4dd5b38ce46_190)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_187)[7](#i2a971cfaef98424f9692041d6ed3a222_187)] | | |

| Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_196)[8](#if8d0740b43d148a5ba67e4dd5b38ce46_196)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_190)[8](#i2a971cfaef98424f9692041d6ed3a222_190)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_199)[9](#if8d0740b43d148a5ba67e4dd5b38ce46_199)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_193)[9](#i2a971cfaef98424f9692041d6ed3a222_193)] | | |

| [added: Schedule] II. Valuation and Qualifying Accounts | | | [removed: [F-](#if8d0740b43d148a5ba67e4dd5b38ce46_286)[60](#if8d0740b43d148a5ba67e4dd5b38ce46_286)] [added: [F-](#i2a971cfaef98424f9692041d6ed3a222_262)[55](#i2a971cfaef98424f9692041d6ed3a222_262)] | | |

| 2.4 | | | | | | [Letter Agreement, dated November 21, 2019, by and between Amgen Inc. and the parties named therein re: Treatment of Certain Product Inventory in connection with Amgen’s acquisition of [removed: Otezla®](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a24letteragreementv3.htm)] [added: Otezla](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a24letteragreementv3.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| 4.12 | | | | | | [Officers’ Certificate of Amgen Inc., dated March 12, 2010, including [removed: form](http://www.sec.gov/Archives/edgar/data/318154/000119312510055545/dex42.htm) [of] [added: form of] the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312510055545/dex42.htm) [5.75%] [added: Company’s 5.75%] Senior Notes due 2040.](http://www.sec.gov/Archives/edgar/data/318154/000119312510055545/dex42.htm) (Filed as exhibit to Form 8-K on March 12, 2010 and incorporated herein by reference.) | | |

| 4.13 | | | | | | [Officers’ Certificate of Amgen Inc., dated September 16, 2010, including [removed: form](http://www.sec.gov/Archives/edgar/data/318154/000119312510211595/dex42.htm) [of] [added: form of] the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312510211595/dex42.htm) [4.95%] [added: Company’s 4.95%] Senior Notes due 2041.](http://www.sec.gov/Archives/edgar/data/318154/000119312510211595/dex42.htm) (Filed as an exhibit to Form 8-K on September 17, 2010 and incorporated herein by reference.) | | |

| 4.14 | | | | | | [Officers’ Certificate of Amgen Inc., dated June 30, 2011, including [removed: form](http://www.sec.gov/Archives/edgar/data/318154/000119312511178620/dex42.htm) [of] [added: form of] the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312511178620/dex42.htm) [5.65%] [added: Company’s 5.65%] Senior Notes due 2042.](http://www.sec.gov/Archives/edgar/data/318154/000119312511178620/dex42.htm) (Filed as an exhibit to Form 8-K on June 30, 2011 and incorporated herein by reference.) | | |

| 4.15 | | | | | | [Officers’ Certificate of Amgen Inc., dated November 10, 2011, including [removed: form](http://www.sec.gov/Archives/edgar/data/318154/000119312511306300/d254287dex42.htm) [of] [added: form of] the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312511306300/d254287dex42.htm) [5.15%] [added: Company’s 5.15%] Senior Notes due 2041.](http://www.sec.gov/Archives/edgar/data/318154/000119312511306300/d254287dex42.htm) (Filed as an exhibit to Form 8-K on November 10, 2011 and incorporated herein by reference.) | | |

| 4.17 | | | | | | [Officers’ Certificate of Amgen Inc., dated May 15, 2012, including [removed: forms] [added: form] of the Company’s [removed: 3.625% Senior Notes due 2022 and] 5.375% Senior Notes due 2043.](http://www.sec.gov/Archives/edgar/data/318154/000119312512234621/d352967dex42.htm) (Filed as an exhibit to Form 8-K on May 15, 2012 and incorporated herein by reference.) | | |

| 4.21 | | | | | | [Officer’s Certificate of Amgen Inc., dated May 1, 2015, including forms of the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312515165541/d919213dex42.htm) [2.700% Senior Notes due 2022,] [added: Company’s] 3.125% Senior Notes due 2025 and 4.400% Senior Notes due 2045.](http://www.sec.gov/Archives/edgar/data/318154/000119312515165541/d919213dex42.htm) (Filed as an exhibit on Form 8-K on May 1, 2015 and incorporated herein by reference.) | | |

| 4.22 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of February 25, 2016, including [removed: forms] [added: form] of the Company’s [removed: 1.250% Senior Notes due 2022 and] 2.000% Senior Notes due 2026.](http://www.sec.gov/Archives/edgar/data/318154/000119312516476783/d129782dex42.htm) (Filed as an exhibit on Form 8-K on February 26, 2016 and incorporated herein by reference.) | | |

| 4.26 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of August 19, 2016, including forms of the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312516686451/d187158dex43.htm) [2.250%] [added: Company’s 2.250%] Senior Notes due 2023 and 2.600% Senior Notes due 2026.](http://www.sec.gov/Archives/edgar/data/318154/000119312516686451/d187158dex43.htm) (Filed as an exhibit to Form 8-K on August 19, 2016 and incorporated herein by reference.) | | |

| 4.27 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: May 11, 2017] [added: November 2, 2017,] including [removed: form](http://www.sec.gov/Archives/edgar/data/318154/000119312517167330/d389370dex42.htm) [of] [added: in] the [removed: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312517167330/d389370dex42.htm) [2.650%] [added: form of the Company’s 3.200%] Senior Notes due [removed: 2022.](http://www.sec.gov/Archives/edgar/data/318154/000119312517167330/d389370dex42.htm)] [added: 2027.](http://www.sec.gov/Archives/edgar/data/318154/000119312517331065/d472956dex42.htm)] (Filed as an exhibit to Form 8-K on [removed: May 11,] [added: November 2,] 2017 and incorporated herein by reference.) | | |

| [removed: 4.28] [added: 4.29] | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: November 2, 2017,] [added: May 6, 2020,] including [removed: in the] form of the Company’s [removed: 3.200%] [added: 2.300%] Senior Notes due [removed: 2027.](http://www.sec.gov/Archives/edgar/data/318154/000119312517331065/d472956dex42.htm)] [added: 2031.](https://www.sec.gov/Archives/edgar/data/318154/000119312520134934/d925911dex43.htm)] (Filed as an exhibit to Form 8-K on [removed: November 2, 2017] [added: May 6, 2020] and incorporated [added: herein] by reference.) | | |

| [removed: 4.29] [added: 4.28] | | | | | | [Officer’s Certificate of Amgen Inc., dated as of February 21, 2020, including forms of the Company’s 1.900% Senior Notes due 2025, 2.200% Senior Notes due 2027, 2.450% Senior Notes due 2030, 3.150% Senior Notes due 2040 and 3.375% Senior Notes due 2050.](https://www.sec.gov/Archives/edgar/data/318154/000119312520044757/d894000dex42.htm) (Filed as an exhibit to Form 8-K on February 21, 2020 and incorporated herein by reference.) | | |

| 4.30 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: May 6,] [added: August 17,] 2020, including [removed: form] [added: forms] of the Company’s [removed: 2.300%] [added: 2.770%] Senior Notes due [removed: 2031.](https://www.sec.gov/Archives/edgar/data/318154/000119312520134934/d925911dex43.htm)] [added: 2053.](https://www.sec.gov/Archives/edgar/data/318154/000119312520222579/d60848dex42.htm)] (Filed as an exhibit to Form 8-K on [removed: May 6,] [added: August 18,] 2020 and incorporated herein by reference.) | | |

| [removed: 4.32] [added: 4.31] | | | | | | [Registration Rights Agreement, dated as of August 17, 2020, by and among Amgen Inc., BofA Securities, Inc. and J.P. Morgan Securities LLC, as lead dealer managers, and BNP Paribas Securities Corp., Deutsche Bank Securities Inc., RBC Capital Markets, LLC, Blaylock Van, LLC and Siebert Williams Shank & Co., LLC, as co-dealer [removed: managers](https://www.sec.gov/Archives/edgar/data/318154/000119312520222579/d60848dex43.htm)] [added: managers.](https://www.sec.gov/Archives/edgar/data/318154/000119312520222579/d60848dex43.htm)] (Filed as an exhibit to Form 8-K on August 18, 2020 and incorporated herein by reference.) | | |

| [removed: 4.33*] [added: 4.32*] | | | | | | [Description of Amgen Inc.’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex433_20201231xq4.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex432_202131xq4.htm)] | | |

| 10.4+* | | | | | | [Form of Grant of Stock Option Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (As [removed: Amended on December 1](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex104_20201231xq4.htm)[5](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex104_20201231xq4.htm)[, 20](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex104_20201231xq4.htm)[20](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex104_20201231xq4.htm)[.)](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex104_20201231xq4.htm)] [added: Amended](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex104_20211231xq4.htm) [and Restated](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex104_20211231xq4.htm) [on December](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex104_20211231xq4.htm) [2, 2021.)](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex104_20211231xq4.htm)] | | |

| 10.5+* | | | | | | [Form of Restricted Stock Unit Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (As [removed: Amended on December](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex105_20201231xq4.htm) [15,](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex105_20201231xq4.htm) [](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex105_20201231xq4.htm)[2020.)](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex105_20201231xq4.htm)] [added: Amended](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex105_20211231xq4.htm) [and Restated](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex105_20211231xq4.htm) [on December](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex105_20211231xq4.htm) [2, 2021.)](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex105_20211231xq4.htm)] | | |

| 10.7+* | | | | | | [Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award Program. (As [removed: Amended on December 1](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex107_20201231xq4.htm)[5](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex107_20201231xq4.htm)[, 20](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex107_20201231xq4.htm)[20](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex107_20201231xq4.htm)[.)](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex107_20201231xq4.htm)] [added: Amended](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex107_20211231xq4.htm) [and Reinstated](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex107_20211231xq4.htm) [on December](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex107_20211231xq4.htm) [2, 2021.)](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex107_20211231xq4.htm)] | | |

| [removed: 10.8+*] [added: 10.8+] | | | | | | [Amgen Inc. 2009 Director Equity Incentive Program. (As [removed: Amended](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm) [and Restated](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm) [on](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm) [Octo](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm)[ber](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm) [2](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm)[1, 20](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm)[20](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm)[.)](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm)] [added: Amended and Restated on October 21, 2020.)](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2020 on February 9, 2021 and incorporated herein by reference.)] | | |

| 10.14+ | | | | | | [Second Amendment to the Amgen Inc. Supplemental Retirement [removed: Plan (As Amended and Restated] [added: Plan,] effective October 23, [removed: 2019).](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1014-secondamendmento.htm)] [added: 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1014-secondamendmento.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| [removed: 10.15+] [added: 10.16+] | | | | | | [Amended and Restated Amgen Change of Control Severance Plan. (As Amended and Restated effective December 9, 2010 and subsequently amended effective March 2, 2011.)](http://www.sec.gov/Archives/edgar/data/318154/000095012311048073/v58996exv10w9.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated herein by reference.) | | |

| [removed: 10.16+] [added: 10.17+] | | | | | | [Amgen Inc. Executive Incentive Plan. (As Amended and Restated effective January 1, 2009.)](http://www.sec.gov/Archives/edgar/data/318154/000119312508228861/dex1019.htm) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2008 on November 7, 2008 and incorporated herein by reference.) | | |

| [removed: 10.17+] [added: 10.18+] | | | | | | [First Amendment to the Amgen Inc. Executive Incentive Plan, effective December 13, 2012.](http://www.sec.gov/Archives/edgar/data/318154/000144530513000364/amgn-ex1017_2012123110k.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.) | | |

| [removed: 10.18+] [added: 10.19+] | | | | | | [Second Amendment to the Amgen Inc. Executive Incentive Plan, effective January 1, 2017.](http://www.sec.gov/Archives/edgar/data/318154/000031815417000009/amgn-ex1016_2017033110q.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2017 on April 27, 2017 and incorporated herein by reference.) | | |

| [removed: 10.19+] [added: 10.20+] | | | | | | [Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective October 16, 2013.)](http://www.sec.gov/Archives/edgar/data/318154/000031815414000004/amgn-ex1015_20131231x10k.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | | |

| [removed: 10.20+] [added: 10.21+] | | | | | | [First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective October 14, 2016.](http://www.sec.gov/Archives/edgar/data/318154/000031815416000053/amgn-ex1017_2016930xq3.htm) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.) | | |

| [removed: 10.21+] [added: 10.22+] | | | | | | [Second Amendment to the Amgen Nonqualified Deferred Compensation [removed: Plan (As Amended and Restated] [added: Plan,] effective January 1, [removed: 2020).](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1021-secondamendmentt.htm)] [added: 2020.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1021-secondamendmentt.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| [removed: 10.22+] [added: 10.24+] | | | | | | [Agreement between Amgen Inc. and [removed: Murdo Gordon,] [added: Peter Griffith,] dated [removed: July 25, 2018.](http://www.sec.gov/Archives/edgar/data/318154/000031815418000022/exhibit1023agmtamgenincand.htm)] [added: October 18, 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000031/petergriffith-signedof.htm)] (Filed as an exhibit to Form 10-Q for the quarter ended [removed: September 30, 2018 on October] [added: March] 31, [removed: 2018] [added: 2020 on May 1, 2020] and incorporated herein by reference.) | | |

| [removed: 10.23+] [added: 10.36] | | | | | | [removed: [Agreement] [added: [Side Letter Regarding Collaboration Agreement and Stivarga Agreement, dated February 13, 2020, by and] between [removed: Amgen] [added: Onyx Pharmaceuticals,] Inc. and [removed: Peter Griffith, dated October 18, 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000031/petergriffith-signedof.htm)] [added: Bayer HealthCare LLC.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000031/sideletterregardingcol.htm)] (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2020 on May 1, 2020 and incorporated herein by reference.) | | |

| [removed: 10.24] [added: 10.26] | | | | | | [Second Amended and Restated Credit Agreement, dated December 12, 2019, among Amgen Inc., the Banks therein named, Citibank, N.A., as administrative agent, and JPMorgan Chase Bank, N.A., as syndication agent.](http://www.sec.gov/Archives/edgar/data/318154/000119312519312129/d834361dex101.htm) (Filed as an exhibit to Form 8-K on December 12, 2019 and incorporated herein by reference.) | | |

| [removed: 10.25] [added: 10.27] | | | | | | [Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited dated May 10, 2002 (portions of the exhibit have been omitted pursuant to a request for confidential treatment) and Amendment No. 1, effective June 9, 2003, to Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted pursuant to a request for confidential treatment).](http://www.sec.gov/Archives/edgar/data/318154/000119312513312834/d573775dex1054.htm) (Filed as an exhibit to Form 10-K/A for the year ended December 31, 2012 on July 31, 2013 and incorporated herein by reference.) | | |

| [removed: 10.26] [added: 10.28] | | | | | | [Amendment No. 2 to Collaboration and License Agreement, effective November 14, 2016, between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted pursuant to a request for confidential treatment).](http://www.sec.gov/Archives/edgar/data/318154/000031815417000004/amgn-ex1032_20161231x10k.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2016 on February 14, 2017 and incorporated herein by reference.) | | |

| 2.6 | | | | | | [Agreement and Plan of Merger, dated July 27, 2021, by and among Amgen Inc., Teneobio, Inc., Tuxedo Merger Sub, Inc., and Fortis Advisors LLC.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000045/amgn-ex27_202193021xq3.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential)(Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2021 on November 3, 2021 and incorporated herein by reference.) | | |

| Exhibit No. | | | | | | Description | | |

| Exhibit No. | | | | | | Description | | |

| Exhibit No. | | | | | | Description | | |

| 10.15+* | | | | | | [Third Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2021.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex1015_20211231xq4.htm) | | |

| Exhibit No. | | | | | | Description | | |

| 10.23+* | | | | | | [Third Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective January 1, 2022.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex1023_20211231xq4.htm) | | |

| 10.25+* | | | | | | [Aircraft Time Sharing Agreement, dated December 3, 2021, by and between Amgen Inc. and Robert A. Bradway.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex1025_20211231xq4.htm) | | |

| Exhibit No. | | | | | | Description | | |

| Exhibit No. | | | | | | Description | | |

| | | | | | | | | |

| | | | | | | | | |

| 4.31 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of August 17, 2020, including forms of the Company’s 2.770% Senior Notes due 2053.](https://www.sec.gov/Archives/edgar/data/318154/000119312520222579/d60848dex42.htm) (Filed as an exhibit to Form 8-K on August 18, 2020 and incorporated herein by reference.) | | |

| 10.34 | | | | | | [Side Letter Regarding Collaboration Agreement and Stivarga Agreement, dated February 13, 2020, by and between Onyx Pharmaceuticals, Inc. and Bayer HealthCare LLC.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000031/sideletterregardingcol.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2020 on May 1, 2020 and incorporated herein by reference.) | | |

| Date: | | | February [removed: 8, 2021] [added: 16, 2022] | | | By: | | | | | | /S/ PETER H. GRIFFITH | | |

- Registration Statements (Form S-8 Nos. 333-81284, [removed: 333-177868] [added: 333-177868, 333-216723] and [removed: 333-216723)] [added: 333-260723)] pertaining to the Amgen Nonqualified Deferred Compensation Plan, and

- Registration Statement (Form S-8 [removed: No. 333-176240)] [added: Nos. 333-176240 and 333-260724)] pertaining to the Amgen Profit Sharing Plan for Employees in Ireland;

of our reports dated February [removed: 8, 2021,] [added: 16, 2022,] with respect to the consolidated financial statements of Amgen Inc. and the effectiveness of internal control over financial reporting of Amgen Inc. included in this Annual Report (Form 10-K) of Amgen Inc. for the year ended December 31, [removed: 2020.][added: 2021.]

| /S/ ROBERT A. BRADWAY | | | | | | Chairman of the Board, Chief Executive Officer and President, and Director (Principal Executive Officer) | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ PETER H. GRIFFITH | | | | | | Executive Vice President and Chief Financial Officer (Principal Financial Officer) | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ LINDA H. LOUIE | | | | | | Vice President, Finance and Chief Accounting Officer (Principal Accounting Officer) | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ WANDA M. AUSTIN | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ BRIAN J. DRUKER | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ ROBERT A. ECKERT | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ GREG C. GARLAND | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ CHARLES M. HOLLEY, JR. | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ TYLER JACKS | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ ELLEN J. KULLMAN | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ AMY E. MILES | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ RONALD D. SUGAR | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

| /S/ R. SANDERS WILLIAMS | | | | | | Director | | | | | | [removed: 2/8/2021] [added: 2/16/2022] | | |

We have audited the accompanying consolidated balance sheets of Amgen Inc. (the Company) as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the [removed: Company's] [added: Company’s] internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in Internal [removed: Control-Integrated] [added: Control—Integrated] Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 8, 2021] [added: 16, 2022] expressed an unqualified opinion thereon.

| *Description of the Matter* | | | | | | As of December 31, [removed: 2020,] [added: 2021,] the Company recorded accrued sales deductions of [removed: $4.8] [added: $5.2] billion. As described in Note 1 to the financial statements under the caption “Product sales and sales deductions,” revenues from product sales are recognized net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively sales deductions), which are established at the time of sale. Auditing the estimation of sales deductions, which are netted against product sales, is complex, requires significant judgment, and the amounts involved are material to the financial statements taken as a whole. Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, and is based on an amount that reflects the consideration to which the Company expects to be entitled, which represents an amount that is net of accruals for estimated sales deductions. The estimated sales deductions are based on current contractual and statutory requirements, market events and trends, internal and external historical data, and forecasted customer buying patterns. | | |

| *Description of the Matter* | | | | | | As discussed in Notes 1 and 6 to the consolidated financial statements, the Company operates in various jurisdictions in which differing interpretations of complex tax laws and regulations create uncertainty and necessitate the use of significant judgment in the determination of the Company’s unrecognized tax benefits related to allocation of profits among various jurisdictions (“transfer pricing”), particularly in the U.S. federal tax jurisdiction where the Company has significant assets and operations. In this regard, the Company uses significant judgment in (1) determining whether a tax position’s technical merits are more-likely-than-not to be sustained and (2) measuring the amount of tax benefit that qualifies for recognition. As of December 31, [removed: 2020,] [added: 2021,] the Company accrued [removed: $3.4] [added: $3.5] billion of gross unrecognized tax benefits including [added: those related to] transfer pricing. Auditing the assessment of the technical merits and measurement of the Company’s unrecognized tax benefits is challenging [removed: because they] [added: and] can be complex, highly judgmental, and based on interpretations of tax laws and regulations and application of those interpretations to the Company’s facts and circumstances. | | |

| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company’s process to assess the technical merits of its tax positions, as well as management’s process to measure the unrecognized tax benefits of those tax positions, particularly in regard to transfer pricing. This included testing controls over management’s review of the inputs, calculations, assumptions and methods selected to measure the amount of tax benefits that qualify for recognition. We involved tax and transfer pricing [removed: professionals] [added: specialists] to assist in assessing the technical merits and measurement of certain of the Company’s unrecognized tax benefits. Depending on the nature of the specific tax position and, as applicable, developments with the relevant tax authorities, our procedures included obtaining and reviewing the Company’s correspondence with such tax authorities and evaluating certain third-party advice to support the Company’s evaluations and recorded positions. We used our knowledge of and experience with how the income tax laws and regulations related to transfer pricing are applied by the relevant tax authorities to evaluate the Company’s accounting for its unrecognized tax benefits. We evaluated developments in the applicable regulatory environments to assess potential effects on the Company’s recorded positions. We analyzed the assumptions and data used by the Company when it determined the amount of tax benefits to recognize, including applicable interest and penalties, and we tested the accuracy of those underlying calculations. We have also evaluated the Company’s income tax disclosures included in Note 6 in relation to these matters. | | |

Years ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018][added: 2019]

| | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Product sales | | | $ | [removed: 24,240] [added: 24,297] | | | | | $ | [removed: 22,204] [added: 24,240] | | | | | $ | [removed: 22,533] [added: 22,204] | |

| Other revenues | | | [removed: 1,184] [added: 1,682] | | | | | | [removed: 1,158] [added: 1,184] | | | | | | [removed: 1,214] [added: 1,158] | | |

| Total revenues | | | [removed: 25,424] [added: 25,979] | | | | | | [removed: 23,362] [added: 25,424] | | | | | | [removed: 23,747] [added: 23,362] | | |

| Cost of sales | | | [removed: 6,159] [added: 6,454] | | | | | | [removed: 4,356] [added: 6,159] | | | | | | [removed: 4,101] [added: 4,356] | | |

| Research and development | | | [removed: 4,207] [added: 4,819] | | | | | | [removed: 4,116] [added: 4,207] | | | | | | [removed: 3,737] [added: 4,116] | | |

| Selling, general and administrative | | | [removed: 5,730] [added: 5,368] | | | | | | [removed: 5,150] [added: 5,730] | | | | | | [removed: 5,332] [added: 5,150] | | |

| Other | | | [removed: 189] [added: 194] | | | | | | [removed: 66] [added: 189] | | | | | | [removed: 314] [added: 66] | | |

| Total operating expenses | | | [removed: 16,285] [added: 18,340] | | | | | | [removed: 13,688] [added: 16,285] | | | | | | [removed: 13,484] [added: 13,688] | | |

| Operating income | | | [removed: 9,139] [added: 7,639] | | | | | | [removed: 9,674] [added: 9,139] | | | | | | [removed: 10,263] [added: 9,674] | | |