Amgen (AMGN) 10-K risk factor changes: FY2022 vs FY2021

- A [removed: breakdown,] [added: breakdown of our information technology systems,] 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.

- Concentration of sales at certain of our wholesaler distributors and [removed: at one free-standing dialysis clinic business and] consolidation of private payers may negatively affect our business.

- Some of our pharmaceutical pipeline and our commercial product sales rely on collaborations with third parties, which may adversely affect the development and [removed: sale] [added: sales] of our products.

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

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 [added: 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 [removed: has] had to delay care for serious illnesses.

These measures and challenges will likely continue to varying degrees [removed: for the duration of the pandemic] and have significantly reduced patient access to, and administration of, certain of our drugs.

[removed: Once the pandemic subsides,] [added: As COVID-19 infection rates ebb and flow,] we anticipate there could be [removed: a backlog] [added: periodic backlogs] 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 lower provider capacity, and this lower provider capacity could have a continued adverse effect on our [removed: sales following the opening up of various geographies and/or the end of the pandemic.][added: sales.]

There was a resurgence in COVID-19 infections in numerous jurisdictions in [removed: 2021,] [added: 2022,] resulting in the reinstatement of stricter restrictions and shutdowns in a number of jurisdictions, including in the United States, Europe and Asia Pacific regions.

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

The rapid reallocation of resources for the treatment and prevention of COVID-19 (including the production of COVID-19 [removed: vaccinations] [added: vaccines] or related therapies, such as our agreement to contribute to the production of COVID-19 antibody 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 or components used in the development, manufacturing, [removed: distribution,] [added: distribution] or administration of our products.

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

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 [added: financial condition and results.]

*A [removed: breakdown,] [added: breakdown of our information technology systems,] 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.*

Further, as the majority of our employees [removed: are working remotely,] [added: work remotely for some portion of their jobs in] our [added: hybrid work environment, our] reliance on our and third-party information technology systems has increased substantially and is expected to continue to increase.

Our systems are also subject to frequent [added: perimeter network reconnaissance and scanning, phishing and other] cyberattacks.

Attacks such as those experienced by governmental entities (including those that approve and/or regulate our products, such as the EMA) and other multi-national companies, including some of our peers, could leave us unable to utilize key business systems or access or protect important [removed: data,] [added: data] and could have a material adverse effect on our ability to operate our business, including developing, gaining regulatory approval for, manufacturing, selling and/or distributing our products.

In [removed: December] [added: late] 2020, SolarWinds Corporation, a leading provider of software for monitoring and managing information technology infrastructure, disclosed that it had suffered a cybersecurity incident whereby attackers had inserted malicious code into legitimate software updates for its products that were installed by myriad private and government customers, enabling the attackers to access a backdoor to such systems.

Intentional or inadvertent data privacy or security breaches (including cyberattacks) resulting from attacks or lapses by employees, service providers (including providers of information technology-specific services), [added: business partners,] 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 [removed: competitors,] [added: competitors] or the public.

For example, [added: in the first half of 2021,] a supplier [removed: 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).

Although [removed: the supplier data] [added: this] breach did not [removed: result in] [added: have] a [removed: material adverse] [added: significant] effect on our business, there can be no assurance that a similar [added: future breach would not result in a material adverse effect on our business or results of operations.]

[added: Although these supplier data breaches have not resulted in material adverse effects 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.

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

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 have [added: acquired] or may acquire face similar risks, and security breaches of their systems 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 data or sensitive personal information.

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

The CCPA was amended in late 2020, to create the California Privacy Rights Act to create [removed: opt-in] [added: 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.

[removed: Since then, Virginia] [added: Virginia, Colorado, Utah] and [removed: Colorado both] [added: Connecticut have all subsequently] passed similar consumer privacy [removed: laws that] [added: laws, which went into effect in Virginia as of January 1, 2023, and] will go into effect in [added: Colorado, Utah and Connecticut later in] 2023.

*Our sales and operations are subject to the risks of doing business internationally, including in emerging [removed: markets.*][added: markets.*]

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

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 [added: in emerging markets.]

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

[removed: These payers] [added: Payers] are increasingly focused on costs, which have resulted, and are expected to continue to result, in lower reimbursement rates for our products or narrower populations for [removed: whom] [added: which] payers will reimburse.

In the United States, particularly over the past few years, a number of legislative and regulatory proposals have been introduced [removed: in an] [added: and/or signed into law that] attempt to lower drug prices.

[removed: Certain] [added: Additional] proposals focused on drug pricing [removed: have been adopted] [added: continue to be debated,] and additional [removed: proposals] [added: executive orders focused on drug pricing and competition] are likely to be adopted and implemented in some form.

*—Changing U.S. federal coverage and reimbursement policies and practices have [removed: affected,] [added: affected] and [removed: may] [added: are likely to] continue to affect access to, pricing [added: of] and sales of our products*

[removed: Also,] [added: For example,] in [removed: response to the July] 2021 [removed: Executive Order,] the FDA sent a letter to the USPTO describing ways to strengthen coordination between the two agencies, [removed: offering] [added: offered] 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 [removed: PTAB] [added: Patent Trial and Appeal Board] on drug patents.

[removed: In this dynamic environment, particularly in light of the pressures on healthcare budgets as a result of the pandemic, we] [added: We] are unable to predict which or how many [removed: federal] policy, [removed: legislative,] regulatory, [removed: executive or] administrative [added: or legislative] changes may ultimately be, or effectively estimate the consequences to our business if, enacted and implemented.

However, to the extent that [removed: these or other federal government initiatives] [added: payer actions] further decrease or modify the coverage or reimbursement available for our products, require that we pay increased rebates or shift other costs to us, limit or affect our decisions regarding the pricing of or otherwise reduce the use of our [removed: U.S.] products, [removed: or limit our ability to offer co-pay payment assistance to commercial patients,] such actions could have a material adverse effect on our business and results of operations.

We also face risks [removed: relating] [added: related] to the reporting of pricing data that affects [removed: the] reimbursement of and discounts provided for our products.

U.S. government price reporting regulations are complex and may require [removed: a] biopharmaceutical [removed: manufacturer] [added: manufacturers] to update certain previously submitted data.

of our suppliers, customers, third-party payers and our patients.

clinical trials has developed that we are actively monitoring and managing.

In 2022 we identified a number of security vulnerabilities introduced into our information systems as a result of flaws that we subsequently identified in software that we purchased and installed, and these flaws required that we apply emergency patches to certain of our systems.

While we did not experience any significant adverse effects as a result of these vulnerabilities, there can be no assurance that we will timely identify and address any future vulnerabilities.

In 2022, Okta, Inc., a provider of software that helps companies manage user authentication, disclosed that several hundred of its corporate customers were vulnerable to a security breach that allowed

attackers to access Okta’s internal network.

System vulnerabilities and/or cybersecurity breaches experienced by our third-party service providers have constituted a substantial share of the information security risks that have affected us.

In the third quarter of 2022, another service provider experienced a similar cybersecurity breach in which an attacker exfiltrated certain data (including non-significant Amgen data) from the service provider’s systems.

Further, the timeliness of our awareness of a cybersecurity incident affects our ability to respond to and work to mitigate the severity of such events.

For example, in 2020 and 2022, two of our vendors experienced cyberattacks and each initially reported to us that neither event involved our data.

However, upon further investigation, they each subsequently informed us that the attackers had accessed limited, non-significant Amgen information.

Although neither of these breaches had a significant adverse effect on our business, in the future we may again not receive timely reporting of cybersecurity events and such events could have a material adverse effect on our business.

For example, in China, the Personal Information Protection Law and the Data Security Law, which regulate data processing activities associated with personal and nonpersonal data, are in effect and build upon the existing Cybersecurity Law.

Further, in 2022 and continuing through early 2023, the Asia Pacific region also experienced a surge of COVID-19 infections.

While one country in the region initially responded to the surge by activating strict containment measures, in late 2022 that country abruptly reversed those measures, resulting in a significant COVID-19 outbreak, causing issues such as lack of capacity at hospitals that could lead to a local health emergencies.

Between 2020 and 2022, we experienced delays in our applications to the Human Genetic Resources Administration of China that sought approval to conduct clinical trials in China.

In response to the ongoing armed conflict in Ukraine, the U.S. government, numerous state governments, the EU and other countries in which we conduct business have imposed a wide range of economic sanctions that restrict commerce and business dealings with Russia, certain regions of Ukraine and certain entities and individuals.

This conflict may also precipitate or amplify the other risks described herein, including risks relating to cybersecurity, global economic conditions, clinical trials and supply chains, which could adversely affect our business, operations and financial condition and results.

Further, pressures on healthcare budgets from the pandemic, the economic downturn and inflation continue and are likely to increase across the markets we serve.

These include legislation promulgated by the IRA that enables the U.S. government to set prices for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater portion of the costs to manufacturers and enables the U.S. government to impose penalties if drug prices are increased at a rate faster than inflation.

Government actions or ballot initiatives at the state level also represent a highly active area of policymaking and experimentation, including pursuit of proposals that limit drug reimbursement under state run Medicaid programs based on reference prices or permitting importation of drugs from Canada.

Such state policies may also eventually be adopted at the federal level.

For example, in August 2022, the IRA was enacted and includes provisions requiring that: (1) beginning in 2026, mandatory price setting be introduced in Medicare for certain drugs paid for under Parts B and D, whereby manufacturers must accept a price established by the government or face penalties on all U.S. sales (starting with 10 drugs in 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that by 2031 approximately 100 drugs could be subject to such set prices); (2) starting in 2024, Medicare Part D be redesigned to cap beneficiary out-of-pocket costs and, beginning January 1, 2025, Federal reinsurance be reduced in the catastrophic phase (resulting in a shift and increase of such costs to Part D plans and manufacturers, including by requiring manufacturer discounts on certain drugs); and (3) beginning October 1, 2022, manufacturers will owe rebates on drugs reimbursed under Medicare Part D if price increases outpace inflation, and beginning January 1, 2023, will owe rebates on drugs reimbursed under Medicare Part B if price increases outpace inflation.

The IRA’s drug pricing controls and Medicare redesign is likely to have a material adverse effect on our sales (particularly for our products that are more substantially reliant on Medicare reimbursement), our business and our results of operations.

However, as the degree of impact from this legislation on our business depends on a number of implementation decisions, the extent of the IRA’s impact on our sales and, in turn, our business remains unclear.

Further, following the passage of the IRA, the environment remains dynamic, and in October 2022, the Administration issued an Executive Order on Lowering Prescription Drug Costs for Americans that calls for the HHS to issue a report within 90 days on Innovation Center models that would lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries.

This Executive Order follows a 2021 Executive Order that included a timeline designed to increase competition in the healthcare sector, including by calling for the FDA to develop prescription drug importation programs and the FTC to apply greater scrutiny of anticompetitive activity.

Responses to this order, including by the HHS, which released a report with drug pricing proposals that seek to promote competition, and by the USPTO, which has taken steps to strengthen coordination with the FDA to address impediments to generic drug and biosimilar competition.

In September 2021, HHS released a plan to address drug pricing that included potential future mandatory models that link payment for prescription drugs and biologics to certain factors, including the overall cost of care.

Additional proposals directed at Medicaid seek to penalize manufacturers for pricing drugs above a certain threshold or limit spending on biopharmaceutical products.

New York has established a Medicaid drug spending cap, and Massachusetts implemented a new review and supplemental rebate negotiation process.

Six states (Colorado, Maine, New Hampshire, Maryland, Oregon and Washington) have enacted laws that establish Prescription Drug Affordability Boards (PDABs) to study drug prices and identify drugs that pose affordability challenges, and in three states (Colorado, Maryland and Washington) include authority for the state PDAB to set upper payment limits on certain drugs in state regulated plans.

Other states may consider implementing similar policies and laws.

The FDA has met with representatives from Colorado, Florida, Maine and New Mexico to discuss those states’ proposed importation programs, and the FDA may be working towards approving such plans.

Payers, including PBMs, have sought, and continue to seek, price discounts or rebates in connection with the placement of our products on their formularies or those they manage, and to also impose restrictions on access to or usage of our products (such as Step Therapy), require that patients receive the payer’s prior authorization before covering the product, and/or chosen to exclude certain indications for which our products are approved.

This high degree of

For example, on June 7, 2022, the FTC launched an inquiry into the business practices of PBMs, and the results of such inquiry could have an effect on manufacturer interactions with PBMs, resulting in changes to access for certain medicines.

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

For example, in the second quarter of 2022, several Medicare Administrative Contractors issued notice, in contravention of TEZSPIRE’s FDA approved labeling, that TEZSPIRE would be added to their “self-administered drug” exclusion lists.

Although the Medicare Administrative Contractors subsequently removed TEZSPIRE from their exclusion lists, these exclusions, if reintroduced and/or implemented, would result in Medicare beneficiaries with severe asthma losing access to TEZSPIRE coverage under Medicare Part B and potentially also under Medicare Advantage.

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.

financial condition and results.

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.

in emerging markets.

Our applications to the HGRAC seeking approval to conduct clinical trials in China are delayed pending further guidance from HGRAC.

In addition, we have a number of financial instruments referencing the LIBOR.

On July 27, 2017, the U.K. Financial Conduct Authority, which regulates LIBOR, announced that it will no longer require banks to submit rates for the calculation of LIBOR to the LIBOR administrator after 2021, and it is anticipated that LIBOR will be completely phased out and replaced by 2023.

In March 2020 and in January 2021, the FASB issued a new accounting standard to ease the financial burdens of the expected market transition from LIBOR and other interbank offered rates to alternative reference rates.

While it appears likely that SOFR will be the replacement reference rate adopted in the market, the specific mechanisms to replace LIBOR in our existing LIBOR-linked financial instruments have not been finalized.

As such, the replacement of LIBOR could have an adverse effect on the market for, or value of, our LIBOR-linked financial instruments.

See Part IV—Note 1, Summary of significant accounting policies—Recent accounting pronouncements.

We are also subject to the economic and political uncertainties stemming from the United Kingdom’s exit from the EU, commonly referred to as “Brexit,” which occurred on January 31, 2020.

While our manufacturing and packaging activities take place largely outside the United Kingdom, minimizing the need to make costly and significant changes to those operations, we have nevertheless been working to put in place contingency plans to attempt to mitigate the effects of Brexit on us.

These include proposals that would allow the U.S. government to negotiate drug prices directly, limit drug reimbursement in Medicare and/or the commercial market based on reference prices or permit importation of drugs from Canada.

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

covered by Medicare Parts B and/or D faster than the rate of inflation, cap out-of-pocket expenses for Medicare Part D beneficiaries and require higher/additional manufacturer discounts in Medicare Part D.

Additionally, in late 2019, a drug-pricing bill, H.R. 3, passed the House of Representatives, which would, among other things, enable direct price negotiations by the federal government on certain drugs (with the maximum price paid by Medicare capped by prices derived from an international index), include a penalty for failing to reach agreement with the government and require that manufacturers offer these negotiated prices to other payers.

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.

There are other outstanding proposals that, if enacted and implemented in whole or in part, could also affect access to and sales of our products, including, but not limited to, proposals to allow importation of prescription medications from Canada or other countries.

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).

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.

The Infrastructure Investment and Jobs Act also delays implementation until January 1, 2026 of a final rule issued by HHS, that revises regulations under the federal antikickback statute to encourage PBMs to use rebates received from biopharmaceutical manufacturers to reduce patient cost-sharing at the point of sale under Medicare Part D.

This rule is also subject to litigation, has numerous logistical hurdles to overcome before it can be effectively implemented, and it is unclear how PBMs will respond to the implementation of such rule.

Further, a permanent repeal of this rule is also being considered in other legislation.

Our business has been, and is expected to continue to be, affected by changes in U.S. federal reimbursement policy resulting from federal regulations and federal demonstration projects.

Over the past several years, federal agencies, including the CMS, announced a number of recommendations, policies, proposals and demonstration projects addressing drug pricing.

The Administration has also developed and sought to advance a range of policy proposals that could impact U.S. federal reimbursement policy for drugs and biologics, including changes to Medicare Parts B and D.

For example, in 2020, in response to an Executive Order, HHS released a rule to allow states to potentially enable the importation of certain drugs from Canada.

While this rule is in litigation, should such litigation be unsuccessful, it could allow for the importation of Canadian versions of certain of Amgen’s products (including Otezla), that could have a material adverse effect on Amgen’s business.

Also in response to an Executive Order, CMS released an interim final rule to implement the MFN pricing approach aimed at setting the reimbursement rate for 50 Medicare Part B drugs (including our products, such as Prolia, XGEVA, KYPROLIS, Neulasta, Nplate, EPOGEN and Aranesp) equal to the lowest adjusted price in 22 OECD nations for these drugs.

In December 2021, subsequent to challenges, including procedural defects, CMS announced it was withdrawing the MFN rule.

Notwithstanding the withdrawal of the rule, the MFN rule’s approach to drug pricing and other similar approaches remain of interest to policymakers.

In connection with its withdrawal of the MFN rule, CMS noted that it will “… explore all options to incorporate value into payments for Medicare Part B drugs, improve beneficiaries’ access to evidence-based care, and reduce drug spending for consumers and throughout the health care system.” Further, we expect continued significant focus on healthcare and similar drug pricing proposals for the foreseeable future, including proposals under which the government would set drug prices or limit drug reimbursement.

Our principal products are ENBREL, Prolia, Otezla, XGEVA, [removed: Neulasta,] Aranesp, [added: Nplate,] Repatha, [removed: KYPROLIS] [added: KYPROLIS, Neulasta] and [removed: Nplate.][added: EVENITY.]

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

Our strategy includes integrated activities intended to [removed: maintain and] strengthen our competitive position in the industry.

We [removed: focus on] [added: operate in] six commercial areas: inflammation, oncology/hematology, bone health, [removed: CV] [added: cardiovascular (CV)] disease, nephrology and neuroscience.

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

In [removed: 2021,] [added: 2022,] we advanced our innovative pipeline, [removed: launched new products,] [added: grew our international business,] completed [removed: several] [added: a] strategic [removed: transactions] [added: transaction] to augment our [removed: pipeline and research capabilities,] [added: marketed product portfolio, announced our intention to acquire Horizon] and continued providing uninterrupted supplies of our medicines globally through the [removed: second] [added: third] year of the COVID-19 pandemic.

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

[removed: In 2021, we] [added: We] continued to [removed: advance] [added: grow] our [removed: pipeline,] [added: international business,] including achieving key regulatory approvals for [removed: LUMAKRAS] [added: TEZSPIRE in the EU] and [removed: TEZSPIRE.][added: Japan.]

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

Our biosimilars are expected to continue launching in new markets throughout [removed: 2022.][added: 2023, including the U.S. launch of AMJEVITA in January 2023.]

During [removed: 2021,] [added: 2022,] while [removed: meeting] [added: gradually recovering from] the [removed: challenges of a] global pandemic and facing increased competition from biosimilars and generics, total product sales [removed: were relatively flat as] [added: increased 2%, primarily driven by] volume growth [removed: was] [added: for certain brands, partially] offset by [removed: lower] [added: declines in] net selling [removed: prices.][added: prices of certain products and unfavorable changes to foreign currency exchange rates.]

Product sales [removed: decreased 4%] [added: increased 3%] in the United States, [added: primarily] driven by [removed: lower net selling prices,] [added: volume growth,] partially offset by [removed: volume growth,] [added: declines in net selling prices,] and increased [removed: 12%] [added: 1% in] ROW, [added: primarily] driven by volume growth, partially offset by [removed: lower] [added: unfavorable changes to foreign currency exchange rates and declines in] net selling prices.

Total operating expenses [removed: increased 13%, driven by] [added: decreased 9% due to both the acquired] IPR&D [removed: expense] [added: write-off] from the Five Prime acquisition and [removed: the] [added: a licensing-related] upfront payment [removed: associated with the] [added: to] KKC [removed: licensing agreement.][added: in 2021, partially offset by a loss on a nonstrategic divestiture in 2022.]

Cash flows from operating activities totaled [removed: $9.3] [added: $9.7] billion, which supported investment in our business while returning capital to shareholders through the payment of cash dividends and stock repurchases.

For [removed: 2021,] [added: 2022,] we increased our quarterly cash dividend by 10% to [removed: $1.76] [added: $1.94] per share of common stock.

In December [removed: 2021,] [added: 2022,] we declared a cash dividend of [removed: $1.94] [added: $2.13] per share of common stock for the first quarter of [removed: 2022,] [added: 2023,] an increase of 10% for this period, to be paid in March [removed: 2022.][added: 2023.]

We also repurchased [removed: 21.7] [added: 26.1] million shares of our common stock during [removed: 2021] [added: 2022] at an aggregate cost of [removed: $5.0] [added: $6.3] billion.

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

[removed: 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 35%.2] We achieved our [removed: 2020] targets [added: for the 2013–2020 period] while growing revenues, increasing production capacity and expanding to approximately 100 countries over the same [removed: 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%.2, 3][added: 75%.(1)(2) Additionally, in 2022 we issued our first green bonds to finance eligible projects that meet specified criteria to reduce our impact on the environment.]

[removed: 2] [added: (1)] Represents reductions against established baselines, taking into account only verified reduction [removed: projects,] [added: projects] and does not take into account changes associated with contraction or expansion of the Company.

[removed: 3] [added: (2)] Carbon neutrality goal refers to Scope 1 and 2.

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

During 2021, there was [added: a] gradual recovery in both patient visits and [removed: diagnoses] [added: diagnosis rates] that approached [removed: pre-COVID-19 levels early in the fourth quarter.][added: pre-pandemic levels.]

[removed: The] [added: However, the] cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which [removed: we expect to continue] [added: continues] to impact our business.

Since early 2021, [removed: global vaccination] efforts have been under way to control the [added: COVID-19] pandemic.

Challenges to vaccination efforts, new variants and other causes of virus spread may require governments to [removed: issue additional] [added: change] restrictions and/or [removed: order shutdowns] [added: shutdown requirements] in various geographies.

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

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

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

| | | | Year ended December 31, [added: 2022 | | | | | | Change | | | | | | Year ended December 31,] 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

| [added: Total] U.S. | | | $ | [added: 17,743 | | | | | 3 | | % | | | | $ |] 17,286 | | | | | (4) | | % | | | | $ | 17,985 | |

| [added: Total] ROW | | | [added: 7,058 | | | | | | 1 | | % | | | |] 7,011 | | | | | | 12 | | % | | | | 6,255 | | |

| Total product sales | | | [removed: 24,297] [added: $] | [added: 24,801] | | | | | [added: 2 | | % | | | | $ | 24,297 | | | | |] — | | % | | | | [removed: 24,240] [added: $] | [added: 24,240] | |

| Other revenues | | | [removed: 1,682] [added: 1,522] | | | | | | [removed: 42] [added: (10)] | | % | | | | [removed: 1,184] [added: 1,682] | | |

| Total revenues | | | $ | [removed: 25,979] [added: 26,323] | | | | | [removed: 2] [added: 1] | | % | | | | $ | [removed: 25,424] [added: 25,979] | |

| [removed: Operating] [added: Total operating] expenses | | | $ | [added: 16,757 | | | | | (9) | | % | | | | $ |] 18,340 | | | | | 13 | | % | | | | $ | 16,285 | |

| Operating income | | | $ | [removed: 7,639] [added: 9,566] | | | | | [removed: (16)] [added: 25] | | % | | | | $ | [removed: 9,139] [added: 7,639] | |

| Net income | | | $ | [removed: 5,893] [added: 6,552] | | | | | [removed: (19)] [added: 11] | | % | | | | $ | [removed: 7,264] [added: 5,893] | |

| Diluted EPS | | | $ | [removed: 10.28] [added: 12.11] | | | | | [removed: (16)] [added: 18] | | % | | | | $ | [removed: 12.31] [added: 10.28] | |

In 2022, we continued to advance our pipeline, initiating phase 3 clinical trials for a number of programs, including LUMAKRAS/LUMYKRAS for advanced colorectal cancer, olpasiran for CV disease and rocatinlimab for atopic dermatitis.

Our external business development activities for 2022 included the acquisition of ChemoCentryx, adding recently launched TAVNEOS to our inflammation portfolio.

In 2022, we received net proceeds from the issuance of debt of $6.9 billion and extinguished $0.3 billion of debt.

In December 2022, in connection with the proposed acquisition of Horizon, we entered into a bridge credit agreement and a term loan credit agreement which provide for borrowings in the aggregate of $28.5 billion.

Rising healthcare costs, uncertain macroeconomic conditions, including higher inflation and rising interest rates, and geopolitical conflicts continue to pose challenges to our business.

Moreover, legislation enacted to reduce healthcare expenditures, including provisions of the IRA, have affected, and are likely to continue to affect, our business.

In 2022, the pandemic continued to impact the healthcare sector and our business, to varying degrees across our markets.

During 2022, with the exception of the Asia Pacific region that was affected by lockdowns during most of the year, we saw greater stability in patient visits and demand patterns even in areas that were facing surges in the virus.

Given the evolution of COVID-19 since its onset, including the proliferation of variants, we cannot predict the impact of future virus surges on our business and will continue to closely monitor the impact of COVID-19 on our business and on the healthcare sector more generally.

However, uncertainty remains as to the efficacy of these activities with respect to the ongoing trajectory of the pandemic.

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

| U.S. | | | $ | 17,743 | | | | | 3 | | % | | | | $ | 17,286 | |

| ROW | | | 7,058 | | | | | | 1 | | % | | | | 7,011 | | |

| Total product sales | | | 24,801 | | | | | | 2 | | % | | | | 24,297 | | |

Total product sales increased in 2022, primarily driven by volume growth for certain brands, including Repatha, Prolia, EVENITY, Nplate, LUMAKRAS/LUMYKRAS, KYPROLIS, Otezla and TEZSPIRE, partially offset by declines in net selling prices of certain products, including Neulasta, Repatha and MVASI, and unfavorable changes to foreign currency exchange rates.

As a result of uncertain macroeconomic conditions, we expect volatility around foreign currency exchange rates to continue.

The impact of unfavorable changes to foreign currency exchange rates will be partially offset by corresponding decreases in our international operating expenses.

As discussed above, our product sales have been affected by reduced demand as a result of the COVID-19 pandemic.

In late 2021 and early 2022, increased infection rates caused by variants of the virus (including Omicron) led to diminished capacity in the healthcare sector and reduced working days for our own sales force, which impacted our business.

As of the second quarter of 2022, we saw the effects of these variants recede in most markets, which allowed us to engage in increased field-facing activities.

Provider and patient activity also increased, leading to improvements in demand for our products to pre-pandemic levels.

Other revenues decreased for 2022, driven by lower revenue from COVID-19 antibody material and licensing-related revenues.

on a nonstrategic divestiture in 2022.

See Part IV—Note 2, Acquisitions and divestitures, and Note 8, Collaborations, to the Consolidated Financial Statements.

| EVENITY | | | 787 | | | | | | 48 | | % | | | | 530 | | | | | | 51 | | % | | | | 350 | | |

| Other products(1) | | | 5,570 | | | | | | 5 | | % | | | | 5,321 | | | | | | (1) | | % | | | | 5,374 | | |

____________

(1) Consists of product sales of our non-principal products, as well as our Gensenta and Bergamo subsidiaries.

The decrease in ENBREL sales for 2022 was primarily driven by unfavorable changes to estimated sales deductions, lower volume and lower net selling price.

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

The increase in global Prolia sales for 2022 was driven by volume growth and higher net selling price, partially offset by unfavorable changes to foreign currency exchange rates.

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

ROW Otezla sales for 2022 were impacted by unfavorable changes to foreign currency exchange rates.

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

Global XGEVA sales were relatively unchanged for 2022 as higher net selling price was offset by lower volume as a result of increased competition and unfavorable changes to foreign currency exchange rates.

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

The increase in global Nplate sales for 2022 was driven by volume growth.

Nplate sales for 2022 included a $207 million order in the fourth quarter from the U.S. government.

| | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | | | | | Change | | | | | | Year ended December 31, 2020 | | |

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.

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

Rising healthcare costs and uncertain economic conditions continue to pose challenges to our business, including increasing pressure by third-party payers, such as governments and private payers, to reduce healthcare expenditures.

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.

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.

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

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.

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 capital-return and other business initiatives that we plan to pursue.

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

Throughout the pandemic, we experienced changes in demand for some of our products.

The pandemic has interrupted many physician–patient interactions, which has led to delays in diagnoses and treatments, with varying degrees of impact across our portfolio.

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.

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

Although changes in foreign currency exchange rates result in increases or decreases in our reported international product sales, the benefit or detriment that such movements have on our international product sales is partially offset by corresponding increases or decreases in our international operating expenses and our related foreign currency hedging activities.

The net impact from changes in foreign currency exchange rates was not material in 2021, 2020 or 2019.

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

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

| Total ROW | | | 7,011 | | | | | | 12 | | % | | | | 6,255 | | | | | | 10 | | % | | | | 5,673 | | |

Otezla was acquired on November 21, 2019, and generated $2.2 billion and $178 million in global sales for the years ended December 31, 2020 and 2019, respectively.

The decrease in global XGEVA sales for 2020 was driven by lower unit demand as a result of the COVID-19 pandemic.

The decrease in global Aranesp sales for 2020 was driven by declines in net selling price and unit demand.

Contracting changes to improve Medicare Part D patient access resulted in the decrease to net selling price.

N/A = not applicable

Cost of sales increased to 24.2% of total revenues for 2020, primarily driven by the amortization of expenses related to our acquisition of Otezla and by higher royalty expenses and profit share, partially offset by lower manufacturing costs.

The increase in R&D expense for 2020 was driven by higher spend for later-stage clinical programs, including LUMAKRAS, biosimilar programs and Otezla, and higher spend for Otezla included in marketed-product support.

These increases were partially offset by recoveries from our collaboration with BeiGene that reduced expenses in later-stage clinical programs and in research and early pipeline, and lower spend in certain oncology programs included in research and early pipeline.

The increase in SG&A expense for 2020 was driven by investments in certain marketed products, primarily Otezla, and preparation for product launches, partially offset by a reduction in conference-related expenses due to the impact of COVID-19.

The decrease in Interest expense, net, for 2020 was primarily due to lower LIBOR rates on debt for which we effectively pay a variable rate of interest, partially offset by net costs associated with the early retirement of debt.

The decrease in our effective tax rate for 2020 compared with 2019 was primarily driven by favorable items, including audit settlements, adjustments to prior-year tax liabilities, lower interest expense on uncertain tax positions and amortization related to the Otezla acquisition, partially offset by changes in valuation allowance.

The Administration proposed and Congress is considering significant changes to existing tax law.

If enacted, this agreement could result in tax increases in both the United States and foreign jurisdictions.

The U.S. territory of Puerto Rico is considering changes to its tax system that may minimize or eliminate this impact, but the outcome of such potential changes is uncertain.

Changes to existing tax law in the United States, the U.S. territory of Puerto Rico, or other jurisdictions, including the potential changes discussed above, could result in tax increases where we do business and could have a material adverse effect on the results of our operations.

We were unable to reach resolution at the administrative appeals level, and we anticipate that we will receive a statutory notice of deficiency for these years as well.

We expect to contest any such notice related to 2013–15 through the judicial process.

In 2019, we repurchased $7.6 billion of common stock and had cash settlements of $7.7 billion.

During 2019, we did not issue any debt or debt securities.

The agreement contains provisions related to the determination of successor rates to address the possible phaseout or unavailability of designated reference rates.

This shelf registration statement expires in February 2023.

In the discussion that follows, we assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, [removed: 2021] [added: 2022] and [removed: 2020.][added: 2021.]

Except as noted below, we 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: 2021] [added: 2022] and [removed: 2020.][added: 2021.]

Our portfolio of available-for-sale investments as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] was composed almost entirely of U.S. Treasury securities and money market mutual funds.

The fair values of our available-for-sale investments were [removed: $7.3] [added: $4.3] billion and [removed: $9.8] [added: $7.3] billion as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively.

Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] would not result in a material effect on income in the respective ensuing year.

As of December 31, [removed: 2020,] [added: 2022,] we had outstanding debt with a carrying value of [removed: $33.0] [added: $38.9] billion and a fair value of [removed: $39.4] [added: $35.0] billion.

A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] would have resulted in an increase of [removed: $4.5] [added: $3.5] billion [added: and $4.5 billion, respectively,] in the aggregate fair value of our outstanding debt on [removed: both of] these dates.

Interest rate swap contracts with aggregate notional amounts of $6.7 billion [removed: and $5.9 billion] were outstanding as of [added: both] December 31, [removed: 2021] [added: 2022] and [removed: 2020, respectively.][added: 2021.]

A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] would have resulted in reductions in fair values of approximately [removed: $330] [added: $210] million and [removed: $230] [added: $330] million, respectively, on our interest rate swap contracts on these dates.

As of [added: both] December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we had outstanding cross-currency swap contracts with aggregate notional [removed: amounts] [added: amount] of $3.4 billion [removed: 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] would have resulted in reductions in the fair values of our cross-currency swap contracts of approximately [removed: $170] [added: $90] million and [removed: $250] [added: $170] million, respectively.

As of December 31, [removed: 2020,] [added: 2022,] we had outstanding euro-, pound-sterling- and Swiss-franc-denominated debt with a principal carrying value and a fair value of [removed: $4.8] [added: $3.0] billion and [removed: $5.4] [added: $2.9] 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, 2021, would have resulted in an increase in fair value of this debt of [removed: approximately] $710 million on this date and a reduction in income in the ensuing year of [removed: approximately] $640 million.

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: 2020,] [added: 2022,] would have resulted in an increase in fair value of this debt of [removed: $1.1 billion] [added: approximately $580 million] on this date and a reduction in income in the ensuing year of [removed: $1.0 billion.][added: approximately $600 million.]

We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros, pounds sterling and Swiss francs, with aggregate notional [removed: amounts] [added: amount] of $3.4 billion [removed: and $4.8 billion] as of [added: both] December 31, [removed: 2021] [added: 2022] and [removed: 2020, respectively.][added: 2021.]

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 approximately [removed: $700] [added: $540] million and [removed: $1.1 billion] [added: $700 million] on these dates, respectively.

As of December 31, [removed: 2020,] [added: 2022,] the fair values of these contracts were a [removed: $28] [added: $288] million asset and a [removed: $237] [added: $76] million liability.

As of December 31, [removed: 2020,] [added: 2022,] we had primarily euro-based open foreign currency forward contracts with notional amounts of [removed: $5.1] [added: $6.0] billion.

With regard to [removed: foreign currency forward] contracts that were open as of December 31, 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, 2021, would have resulted in a reduction in fair value of these contracts of approximately $1.1 billion on this date and in the ensuing year, a reduction in income of [removed: approximately] $390 million.

With regard to [added: foreign currency forward] contracts that were open as of December 31, [removed: 2020,] [added: 2022,] 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: 2020,] [added: 2022,] would have resulted in a reduction in fair value of these contracts of [added: approximately] $1.1 billion on this date and in the ensuing year, a reduction in income of [removed: $420] [added: approximately $590] million.

As of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we had open, short-duration, foreign currency forward contracts that mature in one month or less, that had notional amounts of [removed: $0.7] [added: $0.5] billion and [removed: $1.0] [added: $0.7] billion, respectively, 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: 2021] [added: 2022] and [removed: 2020.][added: 2021.]

With regard to these foreign currency forward contracts that were open as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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 [removed: and our investment in BeiGene.]

A 20% decrease in the aggregate value of our equity investment portfolio as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] would result in losses in fair value of approximately [removed: $1.4] [added: $1.1] billion and [removed: $1.2] [added: $1.4] billion, respectively.

In connection with the anticipated issuance of long-term fixed-rate debt, we occasionally enter into forward interest rate contracts, which are designated as cash flow hedges, in order to hedge the variability in cash flows due to changes in the applicable U.S. Treasury rate between the time we enter into these contracts and the time the related debt is issued.

As of December 31, 2022, we had forward interest rate contracts outstanding with an aggregate notional amount of $700 million; there were no outstanding forward interest rate contracts as of December 31, 2021.

A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, 2022 would have resulted in a reduction in fair value of approximately $60 million on our forward interest rate contracts on this date.

and our investment in BeiGene.

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: 2020.][added: 2021.]

*New manufacturing [removed: facilities*][added: facility*]

- In [removed: August 2021,] [added: March 2022,] we [removed: announced plans] [added: broke ground] to build a drug substance plant in North Carolina that will increase our manufacturing network [removed: capacity to reliably supply more medicines for patients.][added: capacity.]

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

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

Our product sales to three large wholesalers, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019.][added: 2020.]

On a combined basis, these wholesalers accounted for 82%, [removed: 83%] [added: 82%] and [removed: 81%] [added: 83%] of worldwide gross revenues for [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019,] [added: 2020,] respectively.

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: 2021, 2020] [added: 2022, 2021] and [removed: 2019.][added: 2020.]

[removed: ][added: ]

| | | | [removed: 2021] [added: 2022] | | | | | | | | | [removed: 2020] [added: 2021] | | | | | | | | | [removed: 2019] [added: 2020] | | | | | |

| U.S. | | | $ | [removed: 17,286] [added: 17,743] | | [removed: 71] [added: 72] | | % | | | | $ | [removed: 17,985] [added: 17,286] | | [removed: 74] [added: 71] | | % | | | | $ | [removed: 16,531] [added: 17,985] | | 74 | | % |

| ROW | | | [removed: 7,011] [added: 7,058] | | | [removed: 29] [added: 28] | | % | | | | [removed: 6,255] [added: 7,011] | | | [removed: 26] [added: 29] | | % | | | | [removed: 5,673] [added: 6,255] | | | 26 | | % |

| Total | | | $ | [removed: 24,297] [added: 24,801] | | 100 | | % | | | | $ | [removed: 24,240] [added: 24,297] | | 100 | | % | | | | $ | [removed: 22,204] [added: 24,240] | | 100 | | % |

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

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

Otezla was acquired from [removed: BMS] [added: Bristol Myers Squibb Company] in November 2019 after their acquisition of Celgene.

Otezla is an oral therapy approved for the treatment of [removed: adult patients] [added: adults] with plaque psoriasis across all severities [added: (United States and Japan) and moderate-to-severe plaque psoriasis (other global markets including Europe),] for [removed: whom phototherapy or systemic therapy is appropriate, patients] [added: adults] with active psoriatic arthritis and [removed: patients] [added: for adults] with oral ulcers associated with Behçet’s disease.

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

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

Repatha is also indicated to reduce [removed: LDL-C] [added: low-density lipoprotein cholesterol (LDL-C)] in adults with primary hyperlipidemia, including [removed: HeFH; in pediatric patients aged 10 years and older with HeFH; and in adults and pediatric patients aged 10 years and older with HoFH.][added: heterozygous familial hypercholesterolemia (HeFH).]

Nplate was launched in 2008 and is indicated to treat thrombocytopenia in patients with chronic [removed: ITP] [added: immune thrombocytopenia (ITP)] who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

We also market a number of other products in various markets worldwide, including MVASI, Vectibix, [removed: KANJINTI, EVENITY, EPOGEN,] BLINCYTO, [added: EPOGEN,] AMGEVITA, Aimovig, Parsabiv, [removed: NEUPOGEN,] [added: KANJINTI,] LUMAKRAS/LUMYKRAS, [removed: Sensipar/Mimpara, AVSOLA, RIABNI] [added: TEZSPIRE, NEUPOGEN, Sensipar/Mimpara] and [removed: TEZSPIRE.][added: TAVNEOS.]

| | | | U.S. | | | | | | Formulations [added: and methods of preparing formulations] | | | | | | 10/19/2037 | | | | | |

| [added: Prolia®/XGEVA® (denosumab)] | | | [added: | | |] U.S. | | | | | | Nucleic acids encoding RANKL antibodies and methods of producing RANKL antibodies | | | | | | 11/30/2023 | | | [removed: | | |]

| [removed: Nplate® (romiplostim)] | | | [removed: | | |] U.S. | | | | | | Formulation | | | | | | 2/12/2028 | | | [added: | | |]

| EVENITY® (romosozumab-aqqg) | | | | | | U.S. | | | | | | [removed: Antibodies(3)] [added: Antibodies] | | | | | | 4/25/2026 | | |

| | | | U.S. | | | | | | Methods of [removed: treatment(3)] [added: treatment] | | | | | | [removed: 1/11/2029] [added: 4/9/2033] | | | | | |

| LUMAKRAS® [removed: /LUMYKRAS™(sotorasib)] [added: /LUMYKRAS™ (sotorasib)] | | | | | | U.S. | | | | | | Compounds and pharmaceutical compositions | | | | | | 5/21/2038 | | |

| [removed: TEZSPIRE™] [added: TEZSPIRE®] (tezepelumab-ekko) | | | | | | U.S. | | | | | | Polypeptides(3) | | | | | | 2/3/2029 | | |

- apremilast — [added: France, Germany,] Italy, Spain and the United Kingdom expiring in 2028

- [removed: panitumumab] [added: romosozumab] — France, [removed: Germany,] Italy, Spain and the United Kingdom, expiring in [removed: 2022][added: 2031]

- [removed: romosozumab] [added: blinatumomab] — France, [added: Germany,] Italy and Spain, expiring in [removed: 2031][added: 2029]

- [removed: blinatumomab] [added: erenumab] — France, [removed: Italy] [added: Italy, Spain] and [removed: Spain,] [added: the United Kingdom,] expiring in [removed: 2029][added: 2033]

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

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

In 2019, Amgen launched MVASI, a biosimilar to Avastin, and KANJINTI, a biosimilar to Herceptin; and in 2018, Amgen launched AMGEVITA, a biosimilar to [removed: Humira] [added: HUMIRA] in [removed: ex-U.S. markets.][added: markets outside the United States.]

We have also received FDA approval of AMJEVITA, a biosimilar to [removed: Humira] [added: HUMIRA] for the U.S. market, [removed: and plan to launch in the United States] [added: which launched] in January 2023.

In 2020, we launched AVSOLA, a biosimilar to Remicade; and in [removed: January 2021,] [added: 2021] we launched RIABNI, a biosimilar to Rituxan.

Risk Factors—*We currently face competition from biosimilars and [added: generics and] expect to face increasing competition from biosimilars and generics in the future*.

| Prolia | | | | | | [removed: U.S. &] [added: U.S.,] Europe [added: & Asia Pacific] | | | | | | Alendronate, raloxifene and zoledronate generics | | | | | | Various | | |

*Acquisitions*

*Proposed acquisition of Horizon Therapeutics plc*

- On December 12, 2022, we announced that we entered into a transaction agreement under which Amgen will acquire all shares of Horizon for $116.50 per share in cash for a transaction equity value of approximately $27.8 billion.

In connection with the proposed acquisition of Horizon, in December 2022 we entered into a bridge credit agreement and a term loan credit agreement with an aggregate principal amount of $28.5 billion.

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

Horizon has 12 marketed medicines and a pipeline with more than 20 development programs.

The closing of this transaction is contingent upon satisfaction of certain regulatory (including FTC review) and other customary closing conditions.

◦On January 30, 2023, the Company and Horizon each received a request for additional information and documentary materials (Second Request) from the FTC in connection with the FTC’s review of the Company’s proposed acquisition of Horizon.

The effect of the Second Request is to extend the waiting period imposed by the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, until 30 days after the Company and Horizon have substantially complied with the Second Request, unless that period is extended voluntarily by the Company and Horizon or terminated sooner by the FTC.

*ChemoCentryx, Inc.*

- On October 20, 2022, we completed our acquisition of ChemoCentryx for $52.00 per share in cash totaling approximately $3.8 billion, net of cash acquired.

*Cardiometabolic*

- In 2022, we presented results from the Repatha FOURIER-OLE studies, two open label extension (OLE) studies (with 6,635 patients) to the Phase 3 FOURIER cardiovascular (CV) outcomes trial.

FOURIER-OLE was designed to assess the long-term safety and tolerability of Repatha in adults with clinically evident atherosclerotic cardiovascular disease (ASCVD).

In these studies, an exploratory analysis demonstrated that earlier initiation of Repatha resulted in a lower risk of cardiovascular outcomes as defined by the composite endpoint of cardiovascular death, myocardial infarction (MI) and stroke, and the incidence of serious adverse events did not increase over time.

- In November 2022, we presented positive end-of-treatment results from the Phase 2 OCEAN(a)-DOSE study evaluating olpasiran in adult patients with lipoprotein(a), or Lp(a), levels over 150 nmol/L and a history of ASCVD.

Olpasiran is a small interfering RNA (siRNA) designed to lower the body’s production of apolipoprotein(a), a key component of Lp(a) that has been associated with an increased risk of CV events.

In the double-blind placebo-controlled treatment period, olpasiran was administered up to 225 mg subcutaneously every 12 weeks to patients with a median baseline Lp(a) of approximately 260 nmol/L.

Patients who received a 75 mg or higher dose every 12 weeks had a 95% or greater reduction in Lp(a) compared to placebo at week 36.

Overall, the rates of adverse events were similar in the olpasiran and placebo arms.

- In September 2022, the EC approved TEZSPIRE in the EU as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

The approval follows the recommendation by the CHMP of the EMA in July 2022.

- In April 2022, we announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate-to-severe plaque psoriasis.

The study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and STELARA.

- In April 2022, we announced long-term efficacy and safety data from the CodeBreaK 100 Phase 1/2 trial in patients with KRAS G12C–mutated advanced non-small cell lung cancer (NSCLC) who received LUMAKRAS/LUMYKRAS.

In 174 heavily pre-treated patients (172 with baseline measurable lesion(s)), LUMAKRAS/LUMYKRAS demonstrated a centrally confirmed objective response rate (ORR) of 40.7%, disease control rate of 83.7% and median duration of response (DOR) of 12.3 months.

The results also showed median progression-free survival (PFS) of 6.3 months and overall survival of 12.5 months, with 32.5% of patients still alive at two years.

No new safety signals for LUMAKRAS/LUMYKRAS were identified with the long-term follow-up.

- In September 2022, we announced results from the global Phase 3 CodeBreaK 200 trial, which showed once-daily oral LUMAKRAS/LUMYKRAS led to significantly superior PFS (primary endpoint) and a significantly higher ORR (a key secondary endpoint) in patients with KRAS G12C–mutated NSCLC, compared with intravenous chemotherapy, docetaxel.

LUMAKRAS/LUMYKRAS significantly improved PFS compared to docetaxel in heavily pre-treated patients.

The proportion of patients with PFS at one year was 25% for LUMAKRAS/LUMYKRAS versus 10% for docetaxel.

LUMAKRAS/LUMYKRAS demonstrated a significantly higher ORR than docetaxel with double the response rates in the LUMAKRAS/LUMYKRAS arm (28% versus 13%, respectively).

- In August 2022, we announced positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS.

The safety and immunogenicity profile of ABP 959 was comparable to that of SOLIRIS.

____________

(1) Consists of product sales of our non-principal products, as well as our Gensenta and Bergamo subsidiaries.

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

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

In the United States, it is used in the indication for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

*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.

*Otezla*

- 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.

- 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.

*•*In May 2021, we announced that the FDA had approved LUMAKRAS for the treatment of adult patients with KRAS *G12C*–mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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.

*KYPROLIS*

*•*In December 2021, we announced that the FDA had approved the expansion of the KYPROLIS prescribing information to include its use in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

*Operations*

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

*•*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.

*COVID-19 pandemic*

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

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.

For further discussion, see Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, Selected Financial Information and Results of Operations.

For a discussion of the risks presented by the COVID-19 pandemic to our results, see Risk Factors in Item 1A.

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

| Prolia®/XGEVA® (denosumab) | | | | | | U.S. | | | | | | Methods of treatment | | | | | | 6/25/2022 | | |

| Vectibix® (panitumumab) | | | | | | Europe | | | | | | Human monoclonal antibodies to epidermal growth factor receptor(1) | | | | | | 5/5/2018 | | |

- erenumab — France, Italy and Spain, expiring in 2033

See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.

(1)A subsidiary of J&J.

For the fiscal year ended December 31, [removed: 2021][added: 2022]

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was [removed: $137,531,019,585] [added: $129,940,091,621] as of June 30, [removed: 2021.(A)][added: 2022.(A)]

(A)Excludes [removed: 811,415] [added: 818,128] 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: 2021.][added: 2022.]

(Number of shares of common stock outstanding as of February [removed: 11, 2022)][added: 6, 2023)]

Specified portions of the registrant’s Proxy Statement with respect to the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be held May [removed: 17, 2022,] [added: 19, 2023,] are incorporated by reference into Part III of this annual report.

| | | | [removed: [Defined Terms and Products](#i2a971cfaef98424f9692041d6ed3a222_2138)] [added: [DEFINED TERMS AND PRODUCTS](#if8055099d1994bb494875d41c341f00d_10)] | | | [removed: [ii](#i2a971cfaef98424f9692041d6ed3a222_2138)] [added: [ii](#if8055099d1994bb494875d41c341f00d_10)] | | |

| Item 1. | | | [removed: [BUSINESS](#i2a971cfaef98424f9692041d6ed3a222_13)] [added: [BUSINESS](#if8055099d1994bb494875d41c341f00d_16)] | | | [removed: [1](#i2a971cfaef98424f9692041d6ed3a222_13)] [added: [1](#if8055099d1994bb494875d41c341f00d_16)] | | |

| | | | [Significant [removed: Developments](#i2a971cfaef98424f9692041d6ed3a222_16)] [added: Developments](#if8055099d1994bb494875d41c341f00d_19)] | | | [removed: [1](#i2a971cfaef98424f9692041d6ed3a222_16)] [added: [1](#if8055099d1994bb494875d41c341f00d_19)] | | |

| | | | [Marketing, Distribution and Selected Marketed [removed: Products](#i2a971cfaef98424f9692041d6ed3a222_19)] [added: Products](#if8055099d1994bb494875d41c341f00d_22)] | | | [removed: [3](#i2a971cfaef98424f9692041d6ed3a222_19)] [added: [3](#if8055099d1994bb494875d41c341f00d_22)] | | |

| | | | [Manufacturing, Distribution and Raw [removed: Materials](#i2a971cfaef98424f9692041d6ed3a222_25)] [added: Materials](#if8055099d1994bb494875d41c341f00d_28)] | | | [removed: [11](#i2a971cfaef98424f9692041d6ed3a222_25)] [added: [11](#if8055099d1994bb494875d41c341f00d_28)] | | |

| | | | [Government [removed: Regulation](#i2a971cfaef98424f9692041d6ed3a222_28)] [added: Regulation](#if8055099d1994bb494875d41c341f00d_31)] | | | [removed: [12](#i2a971cfaef98424f9692041d6ed3a222_28)] [added: [13](#if8055099d1994bb494875d41c341f00d_31)] | | |

| | | | [Research and Development and Selected Product [removed: Candidates](#i2a971cfaef98424f9692041d6ed3a222_31)] [added: Candidates](#if8055099d1994bb494875d41c341f00d_34)] | | | [removed: [16](#i2a971cfaef98424f9692041d6ed3a222_31)] [added: [16](#if8055099d1994bb494875d41c341f00d_34)] | | |

| | | | [Business [removed: Relationships](#i2a971cfaef98424f9692041d6ed3a222_34)] [added: Relationships](#if8055099d1994bb494875d41c341f00d_37)] | | | [removed: [21](#i2a971cfaef98424f9692041d6ed3a222_34)] [added: [22](#if8055099d1994bb494875d41c341f00d_37)] | | |

| | | | [Human Capital [removed: Resources](#i2a971cfaef98424f9692041d6ed3a222_37)] [added: Resources](#if8055099d1994bb494875d41c341f00d_40)] | | | [removed: [22](#i2a971cfaef98424f9692041d6ed3a222_37)] [added: [23](#if8055099d1994bb494875d41c341f00d_40)] | | |

| | | | [Information about our Executive [removed: Officers](#i2a971cfaef98424f9692041d6ed3a222_40)] [added: Officers](#if8055099d1994bb494875d41c341f00d_43)] | | | [removed: [24](#i2a971cfaef98424f9692041d6ed3a222_40)] [added: [26](#if8055099d1994bb494875d41c341f00d_43)] | | |

| | | | [Geographic Area Financial [removed: Information](#i2a971cfaef98424f9692041d6ed3a222_43)] [added: Information](#if8055099d1994bb494875d41c341f00d_46)] | | | [removed: [25](#i2a971cfaef98424f9692041d6ed3a222_43)] [added: [27](#if8055099d1994bb494875d41c341f00d_46)] | | |

| | | | [Investor [removed: Information](#i2a971cfaef98424f9692041d6ed3a222_46)] [added: Information](#if8055099d1994bb494875d41c341f00d_49)] | | | [removed: [26](#i2a971cfaef98424f9692041d6ed3a222_46)] [added: [27](#if8055099d1994bb494875d41c341f00d_49)] | | |

| Item 1A. | | | [RISK [removed: FACTORS](#i2a971cfaef98424f9692041d6ed3a222_49)] [added: FACTORS](#if8055099d1994bb494875d41c341f00d_52)] | | | [removed: [26](#i2a971cfaef98424f9692041d6ed3a222_49)] [added: [27](#if8055099d1994bb494875d41c341f00d_52)] | | |

| Item 1B. | | | [UNRESOLVED STAFF [removed: COMMENTS](#i2a971cfaef98424f9692041d6ed3a222_52)] [added: COMMENTS](#if8055099d1994bb494875d41c341f00d_55)] | | | [removed: [50](#i2a971cfaef98424f9692041d6ed3a222_52)] [added: [51](#if8055099d1994bb494875d41c341f00d_55)] | | |

| Item 2. | | | [removed: [PROPERTIES](#i2a971cfaef98424f9692041d6ed3a222_55)] [added: [PROPERTIES](#if8055099d1994bb494875d41c341f00d_58)] | | | [removed: [51](#i2a971cfaef98424f9692041d6ed3a222_55)] [added: [52](#if8055099d1994bb494875d41c341f00d_58)] | | |

| Item 3. | | | [LEGAL [removed: PROCEEDINGS](#i2a971cfaef98424f9692041d6ed3a222_58)] [added: PROCEEDINGS](#if8055099d1994bb494875d41c341f00d_61)] | | | [removed: [51](#i2a971cfaef98424f9692041d6ed3a222_58)] [added: [52](#if8055099d1994bb494875d41c341f00d_61)] | | |

| Item 4. | | | [MINE SAFETY [removed: DISCLOSURES](#i2a971cfaef98424f9692041d6ed3a222_61)] [added: DISCLOSURES](#if8055099d1994bb494875d41c341f00d_64)] | | | [removed: [51](#i2a971cfaef98424f9692041d6ed3a222_61)] [added: [52](#if8055099d1994bb494875d41c341f00d_64)] | | |

| Item 5. | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i2a971cfaef98424f9692041d6ed3a222_67)] [added: SECURITIES](#if8055099d1994bb494875d41c341f00d_70)] | | | [removed: [52](#i2a971cfaef98424f9692041d6ed3a222_67)] [added: [53](#if8055099d1994bb494875d41c341f00d_70)] | | |

| Item 6. | | | [removed: [RESERVED](#i2a971cfaef98424f9692041d6ed3a222_70)] [added: [RESERVED](#if8055099d1994bb494875d41c341f00d_73)] | | | [removed: [53](#i2a971cfaef98424f9692041d6ed3a222_70)] [added: [54](#if8055099d1994bb494875d41c341f00d_73)] | | |

| Item 7. | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i2a971cfaef98424f9692041d6ed3a222_73)] [added: OPERATIONS](#if8055099d1994bb494875d41c341f00d_76)] | | | [removed: [54](#i2a971cfaef98424f9692041d6ed3a222_73)] [added: [55](#if8055099d1994bb494875d41c341f00d_76)] | | |

| Item 7A. | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i2a971cfaef98424f9692041d6ed3a222_109)] [added: RISK](#if8055099d1994bb494875d41c341f00d_106)] | | | [removed: [73](#i2a971cfaef98424f9692041d6ed3a222_109)] [added: [75](#if8055099d1994bb494875d41c341f00d_106)] | | |

| Item 8. | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i2a971cfaef98424f9692041d6ed3a222_112)] [added: DATA](#if8055099d1994bb494875d41c341f00d_109)] | | | [removed: [75](#i2a971cfaef98424f9692041d6ed3a222_112)] [added: [77](#if8055099d1994bb494875d41c341f00d_109)] | | |

| Item 9. | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i2a971cfaef98424f9692041d6ed3a222_115)] [added: DISCLOSURE](#if8055099d1994bb494875d41c341f00d_112)] | | | [removed: [75](#i2a971cfaef98424f9692041d6ed3a222_115)] [added: [77](#if8055099d1994bb494875d41c341f00d_112)] | | |

| Item 9A. | | | [CONTROLS AND [removed: PROCEDURES](#i2a971cfaef98424f9692041d6ed3a222_118)] [added: PROCEDURES](#if8055099d1994bb494875d41c341f00d_115)] | | | [removed: [76](#i2a971cfaef98424f9692041d6ed3a222_118)] [added: [78](#if8055099d1994bb494875d41c341f00d_115)] | | |

| Item 9B. | | | [OTHER [removed: INFORMATION](#i2a971cfaef98424f9692041d6ed3a222_127)] [added: INFORMATION](#if8055099d1994bb494875d41c341f00d_124)] | | | [removed: [78](#i2a971cfaef98424f9692041d6ed3a222_127)] [added: [80](#if8055099d1994bb494875d41c341f00d_124)] | | |

| Item 10. | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i2a971cfaef98424f9692041d6ed3a222_133)] [added: GOVERNANCE](#if8055099d1994bb494875d41c341f00d_130)] | | | [removed: [78](#i2a971cfaef98424f9692041d6ed3a222_133)] [added: [80](#if8055099d1994bb494875d41c341f00d_130)] | | |

| Item 11. | | | [EXECUTIVE [removed: COMPENSATION](#i2a971cfaef98424f9692041d6ed3a222_139)] [added: COMPENSATION](#if8055099d1994bb494875d41c341f00d_136)] | | | [removed: [78](#i2a971cfaef98424f9692041d6ed3a222_139)] [added: [80](#if8055099d1994bb494875d41c341f00d_136)] | | |

| Item 12. | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i2a971cfaef98424f9692041d6ed3a222_142)] [added: MATTERS](#if8055099d1994bb494875d41c341f00d_139)] | | | [removed: [79](#i2a971cfaef98424f9692041d6ed3a222_142)] [added: [81](#if8055099d1994bb494875d41c341f00d_139)] | | |

| Item 13. | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR [removed: INDEPENDENCE](#i2a971cfaef98424f9692041d6ed3a222_151)] [added: INDEPENDENCE](#if8055099d1994bb494875d41c341f00d_148)] | | | [removed: [80](#i2a971cfaef98424f9692041d6ed3a222_151)] [added: [82](#if8055099d1994bb494875d41c341f00d_148)] | | |

| Item 14. | | | [PRINCIPAL [removed: ACCOUNT](#i2a971cfaef98424f9692041d6ed3a222_154)[ANT](#i2a971cfaef98424f9692041d6ed3a222_154) [FEES] [added: ACCOUNTANT FEES] AND [removed: SERVICES](#i2a971cfaef98424f9692041d6ed3a222_154)] [added: SERVICES](#if8055099d1994bb494875d41c341f00d_151)] | | | [removed: [80](#i2a971cfaef98424f9692041d6ed3a222_154)] [added: [82](#if8055099d1994bb494875d41c341f00d_151)] | | |

| Item 15. | | | [removed: [EXHIBITS](#i2a971cfaef98424f9692041d6ed3a222_160) [AND](#i2a971cfaef98424f9692041d6ed3a222_160) [FINANCIAL] [added: [EXHIBITS AND FINANCIAL] STATEMENT [removed: SCHEDULES](#i2a971cfaef98424f9692041d6ed3a222_160)] [added: SCHEDULES](#if8055099d1994bb494875d41c341f00d_157)] | | | [removed: [81](#i2a971cfaef98424f9692041d6ed3a222_160)] [added: [83](#if8055099d1994bb494875d41c341f00d_157)] | | |

| Item 16. | | | [FORM 10-K [removed: SUMMARY](#i2a971cfaef98424f9692041d6ed3a222_163)] [added: SUMMARY](#if8055099d1994bb494875d41c341f00d_160)] | | | [removed: [87](#i2a971cfaef98424f9692041d6ed3a222_163)] [added: [89](#if8055099d1994bb494875d41c341f00d_160)] | | |

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

| Term | | | Description | | | [removed: | | | | | | | | | | | |]

| OECD | | | [removed: Organization] [added: Organisation] for Economic Co-operation and Development | | | | | | | | | | | | | | |

533,976,238

| [PART I](#if8055099d1994bb494875d41c341f00d_13) | | | | | | [1](#if8055099d1994bb494875d41c341f00d_13) | | |

| | | | [Reimbursement](#if8055099d1994bb494875d41c341f00d_25) | | | [9](#if8055099d1994bb494875d41c341f00d_25) | | |

| [PART II](#if8055099d1994bb494875d41c341f00d_67) | | | | | | [53](#if8055099d1994bb494875d41c341f00d_67) | | |

| [PART III](#if8055099d1994bb494875d41c341f00d_127) | | | | | | [80](#if8055099d1994bb494875d41c341f00d_127) | | |

| [PART IV](#if8055099d1994bb494875d41c341f00d_154) | | | | | | [83](#if8055099d1994bb494875d41c341f00d_154) | | |

| [SIGNATURES](#if8055099d1994bb494875d41c341f00d_163) | | | | | | [90](#if8055099d1994bb494875d41c341f00d_163) | | |

| ASCVD | | | atherosclerotic cardiovascular disease | | | | | | | | | | | | | | |

| ASR | | | Accelerated Share Repurchase | | | | | | | | | | | | | | |

| Bergamo | | | Laboratorio Quimico Farmaceutico Bergamo Ltda | | | | | | | | | | | | | | |

| CCPA | | | California Consumer Privacy Act of 2018 | | | | | | | | | | | | | | |

| ChemoCentryx | | | ChemoCentryx, Inc. | | | | | | | | | | | | | | |

| Eczacıbaşı | | | EIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş. | | | | | | | | | | | | | | |

| Gensenta | | | Gensenta İlaç Sanayi ve Ticaret A.Ş. | | | | | | | | | | | | | | |

| Horizon | | | Horizon Therapeutics plc | | | | | | | | | | | | | | |

| IRA | | | Inflation Reduction Act | | | | | | | | | | | | | | |

| KRAS | | | Kirsten rat sarcoma viral oncogene | | | | | | | | | | | | | | |

| Lp(a) | | | lipoprotein(a) | | | | | | | | | | | | | | |

| OLE | | | open label extension | | | | | | | | | | | | | | |

| | | | | | |

| Corlanor | | | Corlanor® (ivabradine) | | |

| Emirodatamab | | | Emirodatamab (formerly AMG 427) | | |

| Rocatinlimab | | | Rocatinlimab (formerly AMG 451) | | |

| TAVNEOS | | | TAVNEOS® (avacopan) | | |

| | | | | | |

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

| | | | | | | | | |

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

557,029,370

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

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

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

| [PART III](#i2a971cfaef98424f9692041d6ed3a222_130) | | | | | | [78](#i2a971cfaef98424f9692041d6ed3a222_130) | | |

| [PART IV](#i2a971cfaef98424f9692041d6ed3a222_157) | | | | | | [81](#i2a971cfaef98424f9692041d6ed3a222_157) | | |

| [SIGNATURES](#i2a971cfaef98424f9692041d6ed3a222_166) | | | | | | [88](#i2a971cfaef98424f9692041d6ed3a222_166) | | |

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

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

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

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

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

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

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

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

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

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

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

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

| DoR | | | duration of response | | | | | | | | | | | | | | |

| ERG | | | employee resource group | | | | | | | | | | | | | | |

| ESA | | | erythropoiesis-stimulating agent | | | | | | | | | | | | | | |

| ESRD | | | end-stage renal disease | | | | | | | | | | | | | | |

| FGFR2b | | | fibroblast growth factor receptor 2b | | | | | | | | | | | | | | |

| FOMBPR | | | Financial Oversight and Management Board for Puerto Rico | | | | | | | | | | | | | | |

| HeFH | | | heterozygous familial hypercholesterolemia | | | | | | | | | | | | | | |

| HER2 | | | human epidermal growth factor receptor 2 | | | | | | | | | | | | | | |

| HGRAC | | | Human Genetic Resources Administration of China | | | | | | | | | | | | | | |

| HLE | | | half-life extended | | | | | | | | | | | | | | |

| HoFH | | | homozygous familial hypercholesterolemia | | | | | | | | | | | | | | |

| ICOSL | | | inducible costimulatory ligand | | | | | | | | | | | | | | |

| IRP | | | international reference pricing | | | | | | | | | | | | | | |

| ITP | | | immune thrombocytopenia | | | | | | | | | | | | | | |

| J&J | | | Johnson & Johnson | | | | | | | | | | | | | | |

| Kirin | | | Kirin Holdings Company, Limited | | | | | | | | | | | | | | |

| mCRPC | | | metastatic castrate-resistant prostate cancer | | | | | | | | | | | | | | |

| MFN | | | most favored nation | | | | | | | | | | | | | | |

| Nuevolution | | | Nuevolution AB | | | | | | | | | | | | | | |

As of December 31, [removed: 2021,] [added: 2022,] we owned or leased approximately [removed: 160] [added: 150] properties.

| Ireland | | | P | | | P | | | | | | P | | | P | | | [added: P] | | |

| Turkey | | | P | | | P | | | | | | P | | | P | | | P | | |

As of February [removed: 11, 2022,] [added: 6, 2023,] there were approximately [removed: 5,069] [added: 4,838] holders of record of our common stock.

The following graph shows the value of an investment of $100 on December 31, [removed: 2016,] [added: 2017,] in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index.

[removed: ][added: ]

| | | | [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] | | | | | | [removed: 12/31/2021] [added: 12/31/2022] | | |

During the three months and year ended December 31, [removed: 2021,] [added: 2022,] we had one outstanding stock repurchase program, under which the repurchasing activity was as follows:

(2)In October [removed: 2021 and December 2021,] [added: 2022,] our Board of Directors increased the amount authorized under the stock repurchase program by an additional [removed: $4.5 billion and an additional $5.0 billion, respectively.][added: $2.4 billion.]

For the years ended December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we paid quarterly dividends.

Information about securities authorized for issuance under existing equity compensation plans is incorporated by reference from [added: Part III,] Item 12—Securities Authorized for Issuance Under Existing Equity Compensation Plans.

| Amgen (AMGN) | | | $100.00 | | | | | | $115.08 | | | | | | $146.87 | | | | | | $143.93 | | | | | | $145.19 | | | | | | $174.94 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $100.26 | | | | | | $120.75 | | | | | | $137.14 | | | | | | $132.31 | | | | | | $127.01 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $107.45 | | | | | | $127.20 | | | | | | $138.31 | | | | | | $170.64 | | | | | | $183.88 | | |

| Standard & Poor’s 500 (SPX) | | | $100.00 | | | | | | $95.63 | | | | | | $125.73 | | | | | | $148.86 | | | | | | $191.54 | | | | | | $156.74 | | |

| October 1 - October 31 | | | | | | — | | | | | | | | | | | | — | | | | | | $ | 6,979,263,848 | |

| November 1 - November 30 | | | | | | — | | | | | | | | | | | | — | | | | | | $ | 6,979,263,848 | |

| December 1 - December 31 | | | | | | — | | | | | | | | | | | | — | | | | | | $ | 6,979,263,848 | |

| | | | | | | — | | | | | | | | | | | | — | | | | | | | | |

| January 1 - December 31(3) | | | | | | 26,147,900 | | | | | | $ | 241.32 | | | | | 26,147,900 | | | | | | | | |

(3)Includes the impact of ASR agreements entered into with third-party financial institutions under which a total of 24,784,400 shares of common stock were delivered at an average price of approximately $242.09 per share.

| 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 | | | | | | | | |

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: 2021.][added: 2022.]

Management determined that as of December 31, [removed: 2021,] [added: 2022,] 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: 2021.][added: 2022.]

Based on our assessment, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] 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: 2021.][added: 2022.]

We have audited Amgen Inc.’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 and our report dated February [removed: 16, 2022] [added: 9, 2023] expressed an unqualified opinion thereon.

February 9, 2023

February 16, 2022

Information about our Directors is incorporated by reference from the section entitled ITEM 1—ELECTION OF DIRECTORS in our Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2021] [added: 2022] (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: 2023] [added: 2024] Annual Meeting in our Proxy Statement.

Information about our executive officers is contained in the discussion entitled Part [removed: I—Item] [added: I, Item] 1.

Information about director and executive compensation is incorporated by reference from the [removed: section] [added: sections] entitled [added: COMPENSATION DISCUSSION AND ANALYSIS,] EXECUTIVE COMPENSATION [added: TABLES, DIRECTOR COMPENSATION and CORPORATE GOVERNANCE—Pay Ratio] in our Proxy Statement.

The following table sets forth certain information as of December 31, [removed: 2021,] [added: 2022,] 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: 2021] [added: 2022] (including upon the exercise of options, upon the vesting of awards of RSUs or when performance units are earned and related dividend equivalents have been granted).

| Amended and Restated [removed: 2009] [added: 1991] Equity Incentive [removed: Plan(1)] [added: Plan(2)] | | | | | | [removed: 10,217,143] [added: 2,191] | | | | | | [removed: $] | [removed: 197.27] | | | | | [removed: 18,987,053] | | |

| Amended and Restated [removed: 1991] [added: 2009] Equity Incentive [removed: Plan(2)] [added: Plan(1)] | | | | | | [removed: 3,550] [added: 10,235,620] | | | | | | [removed: —] [added: $] | [added: 207.29] | | | | | [removed: —] [added: 15,255,297] | | |

| Amended and Restated Employee Stock Purchase Plan | | | | | | [removed: —] | | | | | | [removed: —] | | | | | | [removed: 4,280,585] [added: 4,180,287] | | |

| Amgen Profit Sharing Plan for Employees in Ireland(3) | | | | | | [removed: —] | | | | | | [removed: —] | | | | | | [removed: 242,172] [added: 222,310] | | |

| Total unapproved plans | | | | | | — | | | | | | — | | | | | | [removed: 242,172] [added: 222,310] | | |

(1)The Amended [removed: and Restated] 2009 [removed: Equity Incentive] Plan employs a fungible share-counting formula for determining the number of shares available for issuance under the plan.

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: 2019, 2020] [added: 2020, 2021] and [removed: 2021.][added: 2022.]

As of December 31, [removed: 2021,] [added: 2022,] the number of outstanding awards under column (a) includes (i) [removed: 5,138,659] [added: 5,322,407] shares issuable upon the exercise of outstanding options with a weighted-average exercise price of [removed: $197.27;] [added: $207.29;] (ii) [removed: 3,362,823] [added: 3,173,806] shares issuable upon the vesting of outstanding RSUs (including [removed: 292,972] [added: 307,825] related dividend equivalents); and (iii) [removed: 1,715,660] [added: 1,739,407] shares subject to outstanding [removed: 2019, 2020 and] [added: 2020,] 2021 [added: and 2022] performance units (including [removed: 88,269] [added: 84,603] 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: 2021,] [added: 2022,] employing the fungible share formula and presumes the issuance of target shares under the performance units granted in [removed: 2019, 2020 and] [added: 2020,] 2021 and [added: 2022 and] related dividend equivalents.

Maximum performance under these goals could result in 200% of target shares being awarded for performance units granted in [removed: 2019, 2020] [added: 2020, 2021] and [removed: 2021.][added: 2022.]

The number under column (a) with respect to this plan includes [removed: 3,550] [added: 2,191] shares issuable upon the settlement of deferred RSUs (including [removed: 774] [added: 519] related dividend equivalents).

| Total approved plans | | | | | | 10,237,811 | | | | | | 207.29 | | | | | | 19,435,584 | | |

| Total all plans | | | | | | 10,237,811 | | | | | | $ | 207.29 | | | | | 19,657,894 | | |

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

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

| Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_175)[1](#i2a971cfaef98424f9692041d6ed3a222_175)] [added: [F-](#if8055099d1994bb494875d41c341f00d_172)[1](#if8055099d1994bb494875d41c341f00d_172)] | | |

| Consolidated Statements of [added: Comprehensive] Income for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_178)[4](#i2a971cfaef98424f9692041d6ed3a222_178)] [added: [F-](#if8055099d1994bb494875d41c341f00d_178)[5](#if8055099d1994bb494875d41c341f00d_178)] | | |

| Consolidated Statements of [removed: Comprehensive] Income for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_181)[5](#i2a971cfaef98424f9692041d6ed3a222_181)] [added: [F-](#if8055099d1994bb494875d41c341f00d_175)[4](#if8055099d1994bb494875d41c341f00d_175)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_184)[6](#i2a971cfaef98424f9692041d6ed3a222_184)] [added: [F-](#if8055099d1994bb494875d41c341f00d_181)[6](#if8055099d1994bb494875d41c341f00d_181)] | | |

| Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_187)[7](#i2a971cfaef98424f9692041d6ed3a222_187)] [added: [F-](#if8055099d1994bb494875d41c341f00d_184)[7](#if8055099d1994bb494875d41c341f00d_184)] | | |

| Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_190)[8](#i2a971cfaef98424f9692041d6ed3a222_190)] [added: [F-](#if8055099d1994bb494875d41c341f00d_187)[8](#if8055099d1994bb494875d41c341f00d_187)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_193)[9](#i2a971cfaef98424f9692041d6ed3a222_193)] [added: [F-](#if8055099d1994bb494875d41c341f00d_190)[9](#if8055099d1994bb494875d41c341f00d_190)] | | |

| Schedule II. Valuation and Qualifying Accounts | | | [removed: [F-](#i2a971cfaef98424f9692041d6ed3a222_262)[55](#i2a971cfaef98424f9692041d6ed3a222_262)] [added: [F-55](#if8055099d1994bb494875d41c341f00d_253)] | | |

| [removed: 2.2] [added: 2.1.1] | | | | | | [Amendment No. 1 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation.](http://www.sec.gov/Archives/edgar/data/318154/000119312519270139/d655928dex101.htm) (Filed as an exhibit to Form 8-K on October 17, 2019 and incorporated herein by reference.) | | |

| [removed: 2.3] [added: 2.1.2] | | | | | | [Amendment No. 2 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a23amendmentno2toapa.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: 2.4] [added: 2.2] | | | | | | [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 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.) | | |

| [removed: 2.5] [added: 2.3] | | | | | | [Irrevocable Guarantee, dated August 25, 2019, by and between Amgen Inc. and Bristol-Myers Squibb Company.](http://www.sec.gov/Archives/edgar/data/318154/000119312519228830/d787825dex22.htm) (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.) | | |

| [removed: 2.6] [added: 2.4] | | | | | | [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.) | | |

| 4.22 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of February 25, 2016, including form of the [removed: Company’s 2.000%] [added: Company’s](http://www.sec.gov/Archives/edgar/data/318154/000119312516476783/d129782dex42.htm) [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.) | | |

| [removed: 4.32*] [added: 4.34*] | | | | | | [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/318154/000031815422000010/amgn-ex432_202131xq4.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit434-descriptionofse.htm)] | | |

| 10.4+* | | | | | | [Form of Grant of Stock Option Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive [removed: Plan.] [added: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit104-formofgrantofst.htm)] (As [removed: 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)] [added: Amended and Restated on December 12, 2022.)] | | |

| 10.5+* | | | | | | [Form of Restricted Stock Unit Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive [removed: Plan.] [added: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit105-formofrestricte.htm)] (As [removed: 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)] [added: Amended and Restated on December 12, 2022.)] | | |

| 10.7+* | | | | | | [Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award [removed: Program.] [added: Program.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit107-formofperforman.htm)] (As [removed: 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)] [added: Amended and Reinstated on December 12, 2022.)] | | |

| 10.9+ | | | | | | [Form of [removed: Grant of Non-Qualified] [added: Restricted] Stock [removed: Option] [added: Unit] Agreement for the Amgen Inc. 2009 Director Equity Incentive [removed: Program.](http://www.sec.gov/Archives/edgar/data/318154/000119312509105621/dex107.htm) (Filed] [added: Program. (As Amended on December 11, 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm) [](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm)(Filed] as an exhibit to Form [removed: 8-K] [added: 10-K for the year ended December 31, 2019] on [removed: May 8, 2009] [added: February 12, 2020] and incorporated herein by reference.) | | |

| 10.10+ | | | | | | [Form of [added: Cash-Settled] Restricted Stock Unit Agreement for the Amgen [removed: Inc.] 2009 Director Equity Incentive Program. (As Amended on December 11, [removed: 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm) [](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm)(Filed] [added: 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1011-amgenxdirectorca.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: 10.11+] [added: 10.11.2+] | | | | | | [removed: [Form of Cash-Settled Restricted Stock Unit Agreement for] [added: [Second Amendment to] the Amgen [removed: 2009 Director Equity Incentive Program. (As Amended on December 11, 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1011-amgenxdirectorca.htm)] [added: Inc. Supplemental Retirement Plan, effective October 23, 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: 10.12+] [added: 10.11+] | | | | | | [Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, [removed: 2013.)](http://www.sec.gov/Archives/edgar/data/318154/000031815414000004/amgn-ex109_20131231x10k.htm)] [added: 2013.)](https://www.sec.gov/Archives/edgar/data/318154/000031815414000004/amgn-ex109_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: 10.13+] [added: 10.11.1+] | | | | | | [First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 14, 2016.](http://www.sec.gov/Archives/edgar/data/318154/000031815416000053/amgn-ex1012_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: 10.14+] [added: 10.14.2+] | | | | | | [Second Amendment to the Amgen [removed: Inc. Supplemental Retirement] [added: Nonqualified Deferred Compensation] Plan, effective [removed: October 23, 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1014-secondamendmento.htm)] [added: January 1, 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: 10.15+*] [added: 10.11.3+] | | | | | | [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) [added: (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.)] | | |

| [removed: 10.16+] [added: 10.12+] | | | | | | [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: 10.17+] [added: 10.13+] | | | | | | [Amgen Inc. Executive Incentive [removed: Plan.] [added: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000021/amgn-ex1017_2022331xq1.htm)] (As Amended and Restated effective January 1, [removed: 2009.)](http://www.sec.gov/Archives/edgar/data/318154/000119312508228861/dex1019.htm)] [added: 2022.)] (Filed as an exhibit to Form 10-Q for the quarter ended [removed: September 30, 2008] [added: March 31, 2022] on [removed: November 7, 2008] [added: April 28, 2022] and incorporated herein by reference.) | | |

| [removed: 10.18+] [added: 10.14.1+] | | | | | | [First Amendment to the Amgen [removed: Inc. Executive Incentive] [added: Nonqualified Deferred Compensation] Plan, effective [removed: December 13, 2012.](http://www.sec.gov/Archives/edgar/data/318154/000144530513000364/amgn-ex1017_2012123110k.htm)] [added: October 14, 2016.](http://www.sec.gov/Archives/edgar/data/318154/000031815416000053/amgn-ex1017_2016930xq3.htm)] (Filed as an exhibit to Form [removed: 10-K] [added: 10-Q] for the [removed: year] [added: quarter] ended [removed: December 31, 2012] [added: September 30, 2016] on [removed: February 27, 2013] [added: October 28, 2016] and incorporated herein by reference.) | | |

| [removed: 10.19+] [added: 10.14.3+] | | | | | | [removed: [Second] [added: [Third] Amendment to the Amgen [removed: Inc. Executive Incentive] [added: Nonqualified Deferred Compensation] Plan, effective January 1, [removed: 2017.](http://www.sec.gov/Archives/edgar/data/318154/000031815417000009/amgn-ex1016_2017033110q.htm)] [added: 2022.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex1023_20211231xq4.htm)] (Filed as an exhibit to Form [removed: 10-Q] [added: 10-K] for the [removed: quarter] [added: year] ended [removed: March] [added: December] 31, [removed: 2017] [added: 2021] on [removed: April 27, 2017] [added: February 16, 2022] and incorporated herein by reference.) | | |

| [removed: 10.20+] [added: 10.14+] | | | | | | [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: 10.21+] [added: 10.23.2] | | | | | | [removed: [First] [added: [Restated] Amendment [added: No. 2] to [removed: the] [added: Share Purchase Agreement, dated September 24, 2020, by and among BeiGene, Ltd. and] Amgen [removed: Nonqualified Deferred Compensation Plan, effective October 14, 2016.](http://www.sec.gov/Archives/edgar/data/318154/000031815416000053/amgn-ex1017_2016930xq3.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000060/a1046restatedamendment.htm)] (Filed as an exhibit to Form 10-Q for the quarter ended September 30, [removed: 2016] [added: 2020] on October [removed: 28, 2016] [added: 29, 2020] and incorporated herein by reference.) | | |

| [removed: 10.22+] [added: 10.22] | | | | | | [removed: [Second Amendment to the] [added: [Guarantee, dated as of October 31, 2019, made by and among BeiGene, Ltd. and] Amgen [removed: Nonqualified Deferred Compensation Plan, effective January 1, 2020.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1021-secondamendmentt.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1042guaranteeagreement.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: 10.24+] [added: 10.15+] | | | | | | [removed: [Agreement] [added: [Aircraft Time Sharing Agreement, dated December 3, 2021, by and] between Amgen Inc. and [removed: Peter Griffith, dated October 18, 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000031/petergriffith-signedof.htm)] [added: Robert A. Bradway.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex1025_20211231xq4.htm)] (Filed as an exhibit to Form [removed: 10-Q] [added: 10-K] for the [removed: quarter] [added: year] ended [removed: March] [added: December] 31, [removed: 2020] [added: 2021] on [removed: May 1, 2020] [added: February 16, 2022] and incorporated herein by reference.) | | |

| [removed: 10.26] [added: 10.16] | | | | | | [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: 10.27] [added: 10.19] | | | | | | [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: 10.28] [added: 10.19.1] | | | | | | [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.) | | |

| [removed: 10.29] [added: 10.20] | | | | | | [Letter Agreement, dated June 25, 2019, by and between Amgen Inc. and UCB Celltech (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed).](http://www.sec.gov/Archives/edgar/data/318154/000031815419000037/amgn-ex282019630xq2.htm) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2019 on July 31, 2019 and incorporated herein by reference.) | | |

| [removed: 10.38] [added: 10.25] | | | | | | [removed: [Exclusive License] [added: [License] and Collaboration Agreement, dated [removed: August 28, 2015,] [added: June 1, 2021,] by and between Amgen Inc. and [removed: Novartis Pharma AG](http://www.sec.gov/Archives/edgar/data/318154/000031815417000021/amgn-ex1041amgenxnovartism.htm)] [added: Kyowa Kirin Co., Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000034/amgn-ex1049_2021630xq2.htm)] (portions of the exhibit have been omitted [removed: pursuant to a request for confidential treatment).] [added: because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed).] (Filed as an exhibit to Form 10-Q for the quarter ended June 30, [removed: 2017] [added: 2021] on [removed: July 26, 2017] [added: August 4, 2021] and incorporated herein by reference.) | | |

| [removed: 10.39] [added: 10.21.1] | | | | | | [removed: [Amendment No. 1] [added: [First Amendment] to [removed: the Exclusive License and] Collaboration Agreement, dated April [removed: 21, 2017,] [added: 20, 2022,] by and between Amgen Inc. and [removed: Novartis Pharma AG](http://www.sec.gov/Archives/edgar/data/318154/000031815417000021/amgn-ex1042amend1tolicense.htm)] [added: BeiGene Switzerland GmbH, and BeiGene, Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000041/exhibit1041-firstamendment.htm)] (portions of the exhibit have been omitted [removed: pursuant to a request for confidential treatment).] [added: 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 June 30, [removed: 2017] [added: 2022] on [removed: July 26, 2017] [added: August 5, 2022] and incorporated herein by reference.) | | |

| [removed: 10.40] [added: 10.24.3] | | | | | | [Amendment No. [removed: 2] [added: 7] to the [removed: Exclusive License and] Collaboration Agreement, dated [removed: April 21, 2017,] [added: December 17, 2020,] by and between Amgen Inc. and [removed: Novartis Pharma AG](http://www.sec.gov/Archives/edgar/data/318154/000031815417000021/amgn-ex1043amend2tonovarti.htm)] [added: AstraZeneca Collaboration Ventures, LLC](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex1050_20201231xq4.htm)] (portions of the exhibit have been omitted [removed: pursuant to a request for confidential treatment).] [added: because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.)] (Filed as an exhibit to Form [removed: 10-Q] [added: 10-K] for the [removed: quarter] [added: year] ended [removed: June 30, 2017] [added: December 31, 2020] on [removed: July 26, 2017] [added: February 9, 2021] and incorporated herein by reference.) | | |

| 2.6 | | | | | | [Transaction Agreement, dated as of December 11, 2022, by and among Amgen Inc., Pillartree Limited and Horizon Therapeutics plc.](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex21.htm) (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | | |

| 2.7 | | | | | | [Appendix 3 to the Rule 2.7 Announcement, dated as of December 12, 2022 (Conditions Appendix).](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex22.htm) (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | | |

| 4.31 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of August 9, 2021, including forms of the Company’s 1.650% Senior Notes due 2028, 2.000% Senior Notes due 2032, 2.800% Senior Notes due 2041 and 3.000% Senior Notes due 2052.](https://www.sec.gov/Archives/edgar/data/318154/000119312521240434/d213858dex42.htm) (Filed as an exhibit to Form 8-K on August 9, 2021 and incorporated herein by reference.) | | |

| 4.32 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of February 22, 2022, including forms of the Company’s 3.000% Senior Notes due 2029, 3.350% Senior Notes due 2032, 4.200% Senior Notes due 2052 and 4.400% Senior Notes due 2062.](https://www.sec.gov/Archives/edgar/data/318154/000119312522048514/d302710dex42.htm) (Filed as an exhibit to Form 8-K on February 22, 2022 and incorporated herein by reference.) | | |

| 4.33 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of August 18, 2022, including forms of the Company’s 4.050% Senior Notes due 2029, 4.200% Senior Notes due 2033 and 4.875% Senior Notes due 2053.](https://www.sec.gov/Archives/edgar/data/318154/000119312522224115/d280175dex42.htm) (Filed as an exhibit to Form 8-K on August 18, 2022 and incorporated herein by reference.) | | |

| 10.11.4+* | | | | | | [Fourth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2022.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit10114-fourthamendme.htm) | | |

| 10.16.1* | | | | | | [Amendment No. 1 to the Second Amended and Restated Credit Agreement, dated as of December 29, 2022, between Amgen Inc. and Citibank, N.A., as the Administrative Agent and an Issuing Bank.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit10161-amendmentno1t.htm) | | |

| 10.17 | | | | | | [Bridge Credit Agreement, dated as of December 12, 2022, by and among Amgen Inc., Citibank, N.A., as administrative agent, Bank of America, N.A., as syndication agent, Citibank, N.A. and Bank of America, N.A., as lead arrangers and book runners, and the other banks party thereto.](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex101.htm) (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | | |

| 10.18 | | | | | | [Term Loan Credit Agreement, dated as of December 22, 2022, by and among Amgen Inc., Citibank, N.A., as administrative agent, Bank of America, N.A., as syndication agent, Citibank, N.A., Bank of America, N.A., Goldman Sachs Bank USA and Mizuho Bank, Ltd., as lead arrangers and book runners, Goldman Sachs Bank USA and Mizuho Bank, Ltd. as documentation agents, and the other banks party thereto.](https://www.sec.gov/Archives/edgar/data/318154/000119312522311112/d429654dex101.htm) (Filed as an exhibit to Form 8-K on December 22, 2022 and incorporated herein by reference.) | | |

| | | | | | | | | |

| 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 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.) | | |

| 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) | | |

| 10.30 | | | | | | [Collaboration Agreement, dated April 22, 1994, by and between Bayer Corporation (formerly Miles, Inc.) and Onyx Pharmaceuticals, Inc.](http://www.sec.gov/Archives/edgar/data/1012140/000095012311047784/f58570exv10w1wi.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 by Onyx Pharmaceuticals, Inc. on May 10, 2011 and incorporated herein by reference.) | | |

| 10.31 | | | | | | [Amendment to Collaboration Agreement, dated April 24, 1996, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc.](http://www.sec.gov/Archives/edgar/data/1012140/000095014906000261/f20295exv10w1xiy.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2006 by Onyx Pharmaceuticals, Inc. on May 10, 2006 and incorporated herein by reference.) | | |

| 10.32 | | | | | | [Amendment to Collaboration Agreement, dated February 1, 1999, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc.](http://www.sec.gov/Archives/edgar/data/1012140/000095014906000261/f20295exv10w12.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2006 by Onyx Pharmaceuticals, Inc. on May 10, 2006 and incorporated herein by reference.) | | |

| 10.33 | | | | | | [Settlement Agreement and Release, dated October 11, 2011, by and between Bayer Corporation, Bayer AG, Bayer HealthCare LLC and Bayer Pharma AG and Onyx Pharmaceuticals, Inc.](http://www.sec.gov/Archives/edgar/data/1012140/000119312512081975/d265452dex101v.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.) | | |

| 10.34 | | | | | | [Fourth Amendment to Collaboration Agreement, dated October 11, 2011, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc.](http://www.sec.gov/Archives/edgar/data/1012140/000119312512081975/d265452dex101iv.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.) | | |

| 10.35 | | | | | | [Side Letter Regarding Collaboration Agreement, dated May 29, 2015, by and between Bayer HealthCare LLC and Onyx Pharmaceuticals, Inc.](http://www.sec.gov/Archives/edgar/data/318154/000031815415000022/amgn-ex1043_2015630xq2.htm) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2015 on August 5, 2015 and incorporated herein by reference.) | | |

| 10.36 | | | | | | [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.) | | |

| 10.37 | | | | | | [Sourcing and Supply Agreement, dated January 6, 2017, by and between Amgen USA Inc., a wholly owned subsidiary of Amgen Inc., and DaVita Inc](http://www.sec.gov/Archives/edgar/data/318154/000031815417000009/amgn-exhibit1040_2017033110q.htm). (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2017 on April 27, 2017 and incorporated herein by reference.) | | |

| 10.45 | | | | | | [Amendment No. 1 to Share Purchase Agreement, dated December 6, 2019, by and among BeiGene, Ltd. and Amgen Inc.](http://www.sec.gov/Archives/edgar/data/318154/000119312520003926/d848812dex992.htm) (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.) | | |

| 10.50 | | | | | | [Amendment No. 7 to the Collaboration Agreement, dated December 17, 2020, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex1050_20201231xq4.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2020 on February 9, 2021 and incorporated herein by reference.) | | |

| 10.51* | | | | | | [Amendment No. 8 to the Collaboration Agreement, dated November 19, 2021, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-1051_20211231xq4.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.) | | |

| 10.52 | | | | | | [License and Collaboration Agreement, dated June 1, 2021, by and between Amgen Inc. and Kyowa Kirin Co., Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000034/amgn-ex1049_2021630xq2.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2021 on August 4, 2021 and incorporated herein by reference.) | | |

| Date: | | | February [removed: 16, 2022] [added: 9, 2023] | | | By: | | | | | | [removed: /S/] [added: /s/] PETER H. GRIFFITH | | |

of our reports dated February [removed: 16, 2022,] [added: 9, 2023,] 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: 2021.][added: 2022.]

| /S/ ROBERT A. BRADWAY | | | | | | Chairman of the Board, Chief Executive Officer and President, and Director (Principal Executive Officer) | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ PETER H. GRIFFITH | | | | | | Executive Vice President and Chief Financial Officer (Principal Financial Officer) | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ LINDA H. LOUIE | | | | | | Vice President, Finance and Chief Accounting Officer (Principal Accounting Officer) | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ WANDA M. AUSTIN | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ BRIAN J. DRUKER | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ ROBERT A. ECKERT | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ GREG C. GARLAND | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ CHARLES M. HOLLEY, JR. | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ S. OMAR ISHRAK | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ TYLER JACKS | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ ELLEN J. KULLMAN | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ AMY E. MILES | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ RONALD D. SUGAR | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

| /S/ R. SANDERS WILLIAMS | | | | | | Director | | | | | | [removed: 2/16/2022] [added: 2/9/2023] | | |

We have audited the accompanying consolidated balance sheets of Amgen Inc. (the Company) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] 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 Company’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 16, 2022] [added: 9, 2023] expressed an unqualified opinion thereon.

| *Description of the Matter* | | | | | | As of December 31, [removed: 2021,] [added: 2022,] the Company recorded accrued sales deductions of [removed: $5.2] [added: $6.0] 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. | | |