
Item 3.			QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Information about our market risk is disclosed in Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk, of our Annual Report on Form 10-K for the year ended December 31, ~~2020,~~2021, and is incorporated herein by reference. ~~Except as discussed below, there~~There were no material changes during the six months ended June 30, ~~2021,~~2022, to the information provided in Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk, of our Annual Report on Form 10-K for the year ended December 31, ~~2020.~~

~~Interest rate sensitive financial instruments~~

To achieve a desired mix of fixed and floating interest rate debt, we entered into additional interest rate swap contracts with an aggregate notional amount of $1.5 billion during the three months ended June 30, 2021. As of June 30, 2021, an aggregate notional amount of $7.4 billion of interest rate swap contracts was outstanding. These interest rate swap contracts effectively converted a fixed interest rate coupon to a floating-rate LIBOR-based coupon over the life of the respective notes. A hypothetical 100 basis point increase in interest rates relative to interest rates at June 30, 2021, would have resulted in a reduction in fair value of approximately $390 million on our interest rate swap contracts on that date. The analysis for the interest rate swap contracts does not consider the impact that hypothetical changes in interest rates would have on the related fair value of debt that these interest-rate-sensitive instruments were designed to offset.


Item 4.			CONTROLS AND PROCEDURES

We maintain “disclosure controls and procedures,” as such term is defined under the Securities Exchange Act Rule 13a-15(e) that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports gets recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information gets accumulated and communicated to Amgen’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to facilitate timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, Amgen’s management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, Amgen’s management necessarily was required to apply its judgment in evaluating the cost–benefit relationship of possible controls and procedures. We carried out an evaluation under the supervision and with the participation of our management, including Amgen’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of Amgen’s disclosure controls and procedures. Based on 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 June 30, ~~2021.~~2022.

Management determined that as of June 30, ~~2021,~~2022, no changes in our internal control over financial reporting had occurred during the fiscal quarter then ended that materially affected or are reasonably likely to materially affect our internal control over financial reporting.

4042

PART II — OTHER INFORMATION


Item 1.			LEGAL PROCEEDINGS

See ~~Notes 12 and~~Note 13, Contingencies and commitments, to the condensed consolidated financial statements included in our Quarterly Reports on Form 10-Q for the periods ended March 31, ~~2021~~2022 and June 30, ~~2021, respectively,~~2022, for discussions that are limited to certain recent developments concerning our legal proceedings. Those discussions should be read in conjunction with Part IV—Note 19, Contingencies and commitments, to the consolidated financial statements in ~~Part IV of~~ our Annual Report on Form 10-K for the year ended December 31, ~~2020.~~2021.


Item 1A.			RISK FACTORS

This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. These statements are not guarantees of future performance, and they involve certain risks, uncertainties and assumptions that are difficult to predict. You should carefully consider the risks and uncertainties our business faces. The risks described below are not the only ones we face. Our business is also subject to the risks that affect many other companies, such as employment relations, general economic conditions, geopolitical events and international operations. Further, additional risks not currently known to us or that we currently believe are immaterial may in the future materially and adversely affect our business, operations, liquidity and stock price.

Below we provide in supplemental form the material changes to our risk factors that occurred during the past quarter. Our risk factors disclosed in Part I, Item 1A, of our Annual Report on Form 10-K for the year ended December 31, ~~2020,~~2021, provide additional disclosure for these supplemental risks and are incorporated herein by reference.

~~RISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL BUSINESS, INCLUDING DURING THE COVID-19 PANDEMIC~~

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

The novel coronavirus identified in late 2019, SARS-CoV-2, which causes the disease known as COVID-19, is an ongoing global pandemic that has resulted in public and governmental efforts to contain or slow the spread of the disease, including widespread shelter-in-place orders, social distancing interventions, quarantines, travel restrictions and various forms of operational shutdowns. 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 of our suppliers, customers, third-party payers and our patients. See our Annual Report on Form 10-K for the year ended December 31, 2020, Part I, Item 1A. Risk Factors—The COVID-19 pandemic, and the public and governmental effort to mitigate against the spread of the disease, have had, and are expected to continue to have, an adverse effect, and may have a material adverse effect, on our clinical trials, operations, supply chains, distribution systems, product development, product sales, business and results of operations;~~see also~~ ~~Our current products and products in development cannot be sold without regulatory approval~~;~~and see also~~ ~~We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications~~. Due to the pandemic and these measures and their effects, we have experienced, and expect to continue to experience, unpredictable reductions in demand for certain of our products, exacerbated by COVID-19 surges resulting in repeated shut-downs and/or disruptions in certain geographies.

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 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. These measures and challenges will likely continue to varying degrees for the duration of the pandemic and have significantly reduced patient access to, and administration of, certain of our drugs. For example, Prolia® ~~requires administration by a healthcare provider in doctors’ offices or other healthcare settings that are affected by COVID-19. The U.S. label for Prolia~~® ~~instructs healthcare professionals who discontinue Prolia~~® to transition the patient to an alternative antiresorptive, including oral treatments that do not require administration by a healthcare provider. Further, as a result of COVID-19, oncology patients, in consultation with their doctors, may be selecting therapies that are less immunosuppressive or therapies that do not require administration in a hospital setting, potentially adversely affecting certain of our products. Also, new patients have been, and are expected to continue to be, less likely to be diagnosed and/or to start therapeutics during the pandemic, and these effects, together with the lower treatment rates

during the pandemic, have had, and are expected to continue to have, a cumulative negative effect on the commercial performance of our business. The decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business during the second half of the year. Once the pandemic subsides, we anticipate there could be a backlog of patients seeking appointments with physicians relating to a variety of medical conditions, and as a result, patients seeking treatment with certain of our products may have to navigate lower provider capacity, and this lower provider capacity could have a continued adverse effect on our sales following the opening up of various geographies and/or the end of the pandemic. Further, the effects of the COVID-19 pandemic may result in long-term shifts in preferences among healthcare professionals and patients toward treatments that do not require administration by healthcare professionals or visits to medical facilities.

As the pandemic continues, and if conditions worsen or if the duration of the pandemic extends significantly, we expect to experience additional adverse effects on our development, operational and commercial activities, customer purchases and our collections of accounts receivable. It remains uncertain the degree to which these adverse effects would impact our future operational and commercial activities, customer purchases and our collections as conditions begin to improve. There has been a resurgence in COVID-19 infections in numerous jurisdictions in the first half of 2021, resulting in the reinstatement of stricter restrictions and shutdowns in a number of jurisdictions, including in the U.S., Europe and Asia Pacific regions. It is expected that the pandemic will continue to ebb and flow, with different jurisdictions having higher levels of infections than others over the course of the pandemic. New variants of the SARS-CoV-2 virus have emerged, and have been shown to be present in many geographies, and appear to spread more easily and quickly than other variants. Further, although some studies suggest that antibodies generated with currently authorized vaccines may be effective against these variants, it remains uncertain whether currently available vaccines will retain their efficacy against current and/or future variants of the virus. Jurisdictions may implement, continue or reinstate border closures, impose or reimpose prolonged quarantines and further restrict travel and business activity, which could significantly affect our ability to support our operations and customers and the ability of our employees to get to their workplaces to discover, study, develop and produce our product candidates and products, disrupt the movement of our products through the supply chain, and further prevent or discourage patients from participating in our clinical trials, seeking healthcare services and the administration of certain of our products. Further, in connection with the global outbreak and spread of COVID-19 and in an effort to increase the wider availability of needed medical products, we or our suppliers may elect to, or governments may require us or our suppliers to, allocate manufacturing capacity (for example pursuant to the U.S. Defense Production Act) in a way that adversely affects our regular operations, customer relationships and financial results. In the U.S., on January 21, 2021, President Biden issued an Executive Order instructing federal agencies to use all available legal authorities, including the Defense Production Act, to improve current and future pandemic response and biological threat preparedness. The rapid reallocation of resources for the treatment and prevention of COVID-19 (including the production of COVID-19 vaccinations or related therapies, such as our agreement to contribute to the production of Lilly’s COVID-19 antibody therapies) 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 used in the development, manufacturing, 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 clinical trials has developed that we are actively monitoring and managing. In addition, unpredictable increases in demand for certain of our products could exceed our capacity to meet such demand, which could adversely affect our financial results and customer relationships.

The COVID-19 pandemic and the volatile global economic conditions stemming from it may precipitate or amplify the other risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2020, which could materially adversely affect our business, operations and financial conditions and results. For example, if a natural disaster or other potentially disruptive event occurs concurrently with the COVID-19 pandemic, such disaster or event could deplete our inventory levels and we could experience a disruption to our manufacturing or ability to supply our products. Further, the global pandemic has exacerbated geopolitical tensions, and some countries, such as China, may be especially vulnerable to such dynamics. If relations between the United States and China or other governments deteriorates, our business and investments in China or other such markets may also be adversely affected. See our Annual Report on Form 10-K for the year ended December 31, 2020, Part I, Item 1A. Risk Factors—~~Our sales and operations are subject to the risks of doing business internationally, including in emerging markets.~~

The rapid development and fluidity of the pandemic preclude any prediction as to the ultimate effect of COVID-19 on us. The duration of the measures being taken by the authorities to mitigate against the spread of COVID-19 (including the distribution and/or availability of vaccines), and the extent to which such measures are effective, if at all, remain highly uncertain. The magnitude and degree of COVID-19’s adverse effect on our business (including our product development, product sales, operating results and resulting cash flows) and financial condition will be driven by the severity and duration of the pandemic, the pandemic’s effect on the United States and global economies and the timing, scope and effectiveness of federal, state, local and international governmental responses to the pandemic. If mitigation of the pandemic continues to require further shelter-in-place and shut-down orders and/or restrictions on individual and/or group conduct, any adverse effects of the COVID-19 pandemic will likely grow and could be enduring and our business and financial position could be materially

~~adversely affected.~~

A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our information technology systems, network-connected control systems and/or our data, interrupt the operation of our business and/or affect our reputation.

To achieve our business objectives, we rely on sophisticated information technology systems, including software, mobile applications, cloud services and network-connected control systems, some of which are managed, hosted, provided or serviced by third parties. Internal or external events that compromise the confidentiality, integrity and availability of our systems and data may significantly interrupt the operation of our business, result in significant costs and/or adversely affect our reputation.

Our information technology systems are highly integrated into our business, including our R&D efforts, our clinical and commercial manufacturing processes and our product sales and distribution processes. Further, as the majority of our employees are working remotely, our reliance on our and third-party information technology systems has increased substantially and is expected to continue to increase. The complexity and interconnected nature of our systems makes them potentially vulnerable to breakdown or other service interruptions. Our systems are also subject to frequent cyberattacks. As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity and are becoming increasingly difficult to detect. Such attacks could include the use of harmful and virulent malware, including ransomware or other denials of service, that can be deployed through various means, including the software supply chain, e-mail, malicious websites and/or the use of social engineering. We have also experienced unsuccessful denial of service attacks against our network, and although such attacks did not succeed, there can be no assurance that our efforts to guard against the wide and growing variety of potential attack techniques will be successful in the future. Attacks such as those experienced by governmental entities (including those that approve and/or regulate our products, such as the European Medicines Agency (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 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. For example, in 2017, a pharmaceutical company experienced a cyberattack involving virulent malware that significantly disrupted its operations, including its research and sales operations and the production of some of its medicines and vaccines. As a result of the cyberattack, its orders and sales for certain products in certain markets were negatively affected. In December 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. See our Annual Report on Form 10-K for the year ended December 31, 2020, ~~Part I, Item 1A. Risk Factors—~~The COVID-19 pandemic, and the public and governmental effort to mitigate against the spread of the disease, have had, and are expected to continue to have, an adverse effect, and may have a material adverse effect, on our clinical trials, operations, supply chains, distribution systems, product development, product sales, business and results of operations ~~for a discussion of the cyberattack on the EMA.~~

Our systems also contain and utilize a high volume of sensitive data, including intellectual property, trade secrets, financial information, regulatory information, strategic plans, sales trends and forecasts, litigation materials and/or personal information belonging to us, our staff, our patients, customers and/or other parties. In some cases, we utilize third-party service providers to process, store, manage or transmit such data, which may increase our risk. 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), nation states (including groups associated with or supported by foreign intelligence agencies), organized crime organizations, “hacktivists” or others, create risks that our sensitive data may be exposed to unauthorized persons, our competitors, or the public. For example, a supplier recently experienced a data breach in which an unauthorized third party acquired access to certain information provided to the supplier in the course of its provision of services to us, including business documents and certain personally identifiable patient information (not including social security or other financial or health insurance information). As required, we promptly notified the applicable state attorneys general and the individuals whose personally identifiable information was affected of this data breach at the supplier. Although the supplier data breach did not result in a material adverse effect on our business, there can be no assurance that a similar future cybersecurity incident would not result in a material adverse effect on our business or results of operations.

Domestic and global government regulators, our business partners, suppliers with whom we do business, companies that provide us or our partners with business services and companies we may acquire may face similar risks, and security breaches of their systems 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, in 2019, two vendors that perform testing and analytical services that we use in developing and manufacturing our products have experienced cyberattacks, and in April and September of 2020, vendors that provide us with information technology services and clinical data services, respectively, each experienced ransomware attacks. Although there was no breach of our systems,

each of these incidents required us to disconnect our systems from those vendors’ systems. While we were able to reconnect our systems following restoration of these vendor’s capabilities without significantly affecting product availability, a more extended service outage affecting these or other vendors, particularly where such vendor is the single source from which we obtain the services, could have a material adverse effect on our business or results of operations. In addition, we distribute our products in the United States primarily through three pharmaceutical wholesalers, and a security breach that impairs the distribution operations of our wholesalers could significantly impair our ability to deliver our products to healthcare providers and patients.

Although we have experienced system breakdowns, attacks and information security breaches, we do not believe such breakdowns, attacks and breaches have had a material adverse effect on our business or results of operations. We continue to invest in the monitoring, protection and resilience of our critical and/or sensitive data and systems. However, there can be no assurances that our efforts will detect, prevent or fully recover systems or data from all breakdowns, service interruptions, attacks and/or breaches of our systems that could adversely affect our business and operations and/or result in the loss or exposure of critical, proprietary, private, confidential or otherwise sensitive data, which could result in material financial, legal, business or reputational harm to us or negatively affect our stock price. While we maintain cyber-liability insurance, our insurance is not sufficient to cover us against all losses that could potentially result from a service interruption, breach of our systems or loss of our critical or sensitive data.

We are also subject to various laws and regulations globally regarding privacy and data protection, including laws and regulations relating to the collection, storage, handling, use, disclosure, transfer and security of personal data. The legislative and regulatory environment regarding privacy and data protection is continuously evolving and developing and the subject of significant attention globally. For example, we are subject to the European Union’s General Data Protection Regulation, which became effective in May 2018, and the California Consumer Privacy Act of 2018 (CCPA), which became effective in January 2020, both of which provide for substantial penalties for non-compliance. The CCPA was amended in late 2020, to create the California Privacy Rights Act to create opt in requirements for the use of sensitive personal data and the formation of a new dedicated agency for the enforcement of the law, the California Privacy Protection Agency. Since then, Virginia and Colorado both passed similar consumer privacy laws that will go into effect in 2023. Other jurisdictions where we operate continue to propose similar legislation and/or regulations with others expected to pass in 2021. Failure to comply with these current and future laws could result in significant penalties and reputational harm and could have a material adverse effect on our business and results of operations.

~~RISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES~~

Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected and are likely to continue to affect our profitability.

Sales of our products depend on the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans. Governments and private payers continue to pursue initiatives to manage drug utilization and contain costs. These payers are increasingly focused on ~~the effectiveness, benefits~~costs, which have resulted, and ~~costs of similar treatments, which could~~are expected to continue to result, in lower reimbursement rates for our products or narrower populations for whom payers will reimburse. Continued intense public scrutiny of the price of drugs and other healthcare costs, together with payer dynamics, have limited, and are likely to continue to limit, our ability to set or adjust the price of our products based on their value, which ~~could~~can have a material adverse effect on our business. In the United States, particularly over the past few years, a number of legislative and regulatory proposals have been introduced ~~in an~~to attempt to lower drug prices. These include proposals that would ~~allow~~enable the U.S. government to negotiate drug ~~price~~prices directly, limit drug reimbursement in Medicare and/or the commercial market based on reference prices, ~~abroad~~impose penalties if drug prices are increased at a rate faster than inflation or permit importation of drugs from Canada. ~~Proposals~~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 costs. Certain proposals focused on drug pricing have been ~~implemented~~adopted, and additional proposals are likely to ~~continue to be proposed and may~~ be adopted and implemented in some form. ~~See our Annual Report on Form 10-K for the year ended December 31, 2020, Part I, Item 1A. Risk Factors—~~Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability.

—Changing U.S. federal coverage and reimbursement policies and practices have affected and may continue to affect access to, pricing of and sales of our products

A substantial portion of our U.S. business relies on reimbursement from federal government healthcare programs and commercial insurance plans regulated by federal and state governments. See Part I, Item 1. Business—Reimbursement of our Annual Report on Form 10-K for the year ended December 31, ~~2020, Part I, Item 1. Business—Reimbursement.~~2021. Our business has been and will continue to be affected by legislative actions changing U.S. federal reimbursement policy. Congress has ~~been~~ focused on drug pricing reforms and oversight since 2018, and ~~that~~this activity ~~continues today. For example,~~is still ongoing and has intensified.Since 2019, 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. ~~Additionally, in 2019 and 2020, a number of other Congressional committees debated drug pricing reform proposals. For example, in~~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/~~higher or 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,~~and included provisions that, among other things, ~~enable~~enabled 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), ~~includes a penalty for failing~~penalized failures to reach agreement with the government and ~~requires~~required that manufacturers offer these negotiated prices to other payers. ~~We expect~~Provisions from H.R. 3 ~~to again be debated~~have

been incorporated and adapted into other proposed legislation, including the most recent reconciliation bill released by the Senate in July 2022, 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 penalties on all U.S. sales), and Part D redesign including a cap on beneficiary spending and a new manufacturer discount program. This framework remains in discussion with policymakers in Congress inand the coming months. Most recently, Congress passed the American Rescue Plan Act of 2021 to provide additional stimulus money and support for COVID relief. As part of that legislation, a provision that is expected to be implemented in 2024 was included that has the effect of increasing the Medicaid rebate liability for some medicines that increase prices in excess of inflation.Administration. There are other outstanding proposals ~~that have been introduced by the prior Administration~~ 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, federal and various state proposals to allow importation of prescription medications from Canada or other ~~countries~~countries. See —Changing reimbursement and pricing actions in various states have negatively affected and may continue to ~~set Medicare payment rates using international~~negatively affect access to and have affected and may continue to affect sales of our products. 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 to the Administration ideas that address drug pricing. 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 ~~referencing. Further,~~negotiation in ~~mid-2020, the prior Administration announced a number of Executive Orders intended to reduce the cost of biopharmaceuticals for patients, including a most favored nation (MFN) policy for~~ Medicare Parts B and D, ~~under which~~making those negotiated prices available to commercial plans and legislation to speed the ~~Health & Human Services (HHS) was directed~~entry of biosimilar and generic drugs) and examples of potential administrative tools available to ~~take steps~~the HHS (including testing various models and enhanced focus of the FTC and the USPTO to ~~implement payment models that set Medicare purchase prices based on the lowest price available in economically comparable countries for certain Part B~~address impediments to generic drug and ~~Part D medicines. In September 2020,~~biosimilar competition). Also, in response to the ~~corresponding~~July 2021 Executive Order, ~~HHS~~the FDA sent a letter to the USPTO describing ways to strengthen coordination between the two agencies, offering training to help identify prior art and seeking USPTO’s views on practices that extend market exclusivities, whether pharmaceutical patent examiners need additional resources, and the effect of post-grant challenges at the PTAB on drug patents. In its reply to the FDA, on July 6, 2022, the USPTO affirmed its interest in coordinating with the FDA and outlined specific initiatives, including enhancing procedures for obtaining patents and easing the process for challenging issued patents before the PTAB.

Legislation enacted in 2021 also contained drug pricing reforms. For example, the Infrastructure Investment and Jobs Act includes a provision requiring manufacturers to provide refunds, beginning in 2023, to the government for discarded amounts of certain drugs (including certain Amgen products) from single use containers under Medicare Part B, and CMS recently released proposed regulations to implement this requirement. Also, the American Rescue Plan Act of 2021 includes a provision that increases the Medicaid rebate liability, beginning in 2024, by no longer capping Medicaid rebates at 100% of the Average Manufacturer Price for certain medicines that raise prices in excess of inflation. The implementation of a final rule issued by HHS that revises regulations under the federal antikickback statute to ~~allow states (or~~encourage PBMs to use rebates received from biopharmaceutical manufacturers to reduce patient cost-sharing at the point of sale under Medicare Part D has been delayed to January 1, 2027. However, the future of this rule remains uncertain because, among other ~~nonfederal government entities)~~issues, it is subject to ~~submit proposals to the FDA allowing for the importation of certain nonbiologic prescription drugs from Canada. Currently, the rule~~litigation and because a permanent repeal is being challenged by litigation, however, should such litigation be unsuccessful and should the Secretary of HHS authorize state proposals for importation, this rule could allow the importation of Canadian versions of certain of Amgen’s products (including Otezla®~~), that could have a material adverse effect on Amgen’s business. Further,~~considered in November 2020, also in response to the corresponding Executive Order, HHS released an interim final rule to implement the MFN pricing approach. If implemented, the MFN rule would set 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 for such products of the 22 OECD nations. Lawsuits have been filed by certain trade groups challenging the implementation of this MFN rule based on, among~~ other things, procedural defects. Late in 2020, in the case filed by the Biotechnology Innovation Organization (BIO) and others, the U.S. District Court for the Northern District of California issued a preliminary injunction preventing the rule from taking effect nationwide, pending the government’s completion of required administrative procedures. The case was subsequently stayed by the court. On July 29, 2021, the court granted the parties’ request for the stay to remain in place and ordered the parties to file their joint status report by September 27, 2021. Another case, filed by the Pharmaceutical Research and Manufacturers of America and others in the U.S. District Court for the District of Maryland, was also stayed until either a final rule based on the MFN interim rule is published in the Federal Register, or until the court orders a lifting of the stay based on, among other things, the status of the nationwide preliminary injunction issued in the BIO case. Notwithstanding these stays, the MFN rule’s approach to drug pricing and other similar approaches, remain of interest. Further, despite the change in Administration, we expect continued significant focus on healthcare and similar drug pricing proposals for the foreseeable future, including proposals similar to the MFN rule or other proposals that would grant the HHS secretary the authority to negotiate drug prices directly with manufacturers.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 ~~three~~several years, federal agencies, including the ~~Centers for Medicare & Medicaid Services (CMS),~~CMS, announced a number of recommendations, policies, proposals and demonstration projects addressing drug pricing. CMS is the federal agency responsible for administering Medicare and overseeing state Medicaid programs and Health Insurance Marketplaces and has substantial power to implement policy changes or demonstration projects that can quickly and significantly affect how drugs, including our products, are covered and reimbursed. CMS issued guidance to allow certain Medicare plans offered by private insurance companies to require that patients receiving Medicare Part B drugs first try a drug preferred by the plan before covering another therapy (Step Therapy) and lowered reimbursement rates for new Medicare Part B drugs. Further, HHS issued a final rule under Medicare Part D revising the regulations under the federal antikickback statute to encourage Pharmacy Benefit Managers (PBMs) to use rebates received from biopharmaceutical manufacturers to reduce patient cost-sharing at the point of sale. While the implementation date for the rule is January 1, 2023, the rule remains subject to litigation, there are numerous logistical hurdles to overcome before it can be effectively implemented, and it is unclear how PBMs will respond and what the current Administration’s position is on such rule. Further, while the prior Administration finalized a rule (effective January 1, 2022) mandating price and cost-sharing transparency for almost all health plans and insurers in the individual and group commercial markets, it also is unclear how the current Administration views this rule and how plans and PBMs may respond when it goes into effect. Separately, the Administration is seeking information on how best to implement new reporting requirements relating to the cost of pharmacy benefits, including premiums for drug coverage, manufacturer rebates and the most utilized drugs under group health plans. Such reporting requirements begin no later than December 27, 2021. It is unclear how group health plans and health insurers may respond. The Administration has also ~~could develop~~developed and ~~seek~~sought to advance a range of policy proposals that could ~~impact~~affect 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. This rule is in litigation, but 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.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. 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. While the effective date for adding TEZSPIRE to the exclusion list has been deferred until further notice, this exclusion, if implemented, would result in Medicare beneficiaries with severe asthma losing access to TEZSPIRE coverage under Medicare Part B and potentially also under Medicare Advantage.

4544

CMS policy changes and demonstration projects to test new care, delivery and payment models can also significantly affect how drugs, including our products, are covered and reimbursed. ~~In end-stage renal disease (ESRD), CMS uses bundled payment rates. Between 2018 and 2020, Sensipar~~® ~~and Parsabiv~~®~~, our calcimimetics~~For example, we believe that are used in dialysis clinics, were eligible for temporary drug add-on payment adjustments (TDAPA) to the bundled rate. In November 2020, CMS released its final rule ending the TDAPA for calcimimetics and adjusting ESRD Prospective Payment System bundled rates on January 1, 2021 by $9.93 per dialysis treatment for calcimimetics. As a result, sales of Parsabiv® have been materially adversely affected by this rule change. Additionally, CMS created a new mandatory payment model, effective January 1, 2021, focused on encouraging greater use of home dialysis and kidney transplants for ESRD patients that could result in changes to treatment of dialysis patients, including reduction of the use of our ESAs. Further, in November 2019, CMS announced additional voluntary payment models for nephrologists and dialysis facility partners that also seek to encourage home dialysis and preemptive transplantation through increased risk sharing, but the start date of such programs has been pushed back to January 1, 2022. CMS has also solicited suggestions regarding other potential care models. In 2016, CMS initiated theCMS’s Oncology Care Model demonstration ~~which provides~~(which has, beginning in 2016, provided participating physician practices with performance-based financial incentives that aim to manage or reduce Medicare costs without negatively affecting the efficacy of ~~care, that has been extended by one year (to 2022) due to COVID-19. We believe the Oncology Care Model has~~care) reduced utilization of certain of our oncology products by participating physician ~~practices and expect it to continue to do so in~~practices. While the ~~future. Additionally, in late 2019,~~Oncology Care Model demonstration ended on June 30, 2022, CMS announced a ~~request~~new oncology model (the Enhancing Oncology Model) that will run for ~~information on the Oncology Care First model, a new voluntary model~~five years (from July 2023 through June 2028) that builds on ~~the Oncology Care Model. CMS has indicated a continued interest in exploring demonstrations of~~this prior demonstration program. Further, HHS’s September 2021 comprehensive plan to address drug pricing included potential future mandatory models that link payment for prescription drugs and ~~may propose both new mandatory~~biologics to factors such as: improved patient outcomes, reductions in health disparities, patient affordability and lower overall costs; bundled payment models; total cost of care models; models in which Medicare Part B savings from utilization of biosimilars, generics, or other high-value products are shared between prescribing providers and the ~~future that could adversely affect our business.~~government; additional Medicare Part D cost-sharing support for biosimilars and generics; and potential expansion of the Part D Senior Savings Model to additional classes of drugs. CMS also recently finalized a ~~rule~~national Medicare coverage determination for certain Alzheimer’s disease medications that ~~starting January 1, 2023, unless a manufacturer can ensure~~received accelerated FDA approvals that ~~the~~limits coverage to only patients in qualifying clinical trials, thereby suggesting that accelerated regulatory approval does not necessarily result in full amount of manufacturer patient assistance programs is passed on to the patient, such amount will be treated as a price reduction that will be taken into account when reporting our Best Price and/or Average Manufacturer Price. Given the use by PBMs and insurers of copay accumulator adjustment programs to apply such patient assistance for the benefit of such companies and not to defray costs to patients, it could be difficult to impossible for manufacturers to ensure that the full value of such amounts is being passed on to the patient. This new policy, if implemented, would have significant implications for our ability to offer copay assistance programs.

Medicare coverage. In this dynamic environment, particularly in light of the pressures on healthcare budgets as a result of the pandemic, we are unable to predict which or how many federal policy, legislative, regulatory, executive or administrative changes may ultimately be, or effectively estimate the consequences to our business if, enacted and implemented. However, to the extent that these or other federal government initiatives 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 U.S. products, 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 ~~relating~~related to the reporting of pricing data that affects ~~the~~ reimbursement of and discounts provided for our products. U.S. government price reporting regulations are complex and may require a biopharmaceutical ~~manufacturer~~manufacturers to update certain previously submitted data. If our submitted pricing data are incorrect, we may become subject to substantial fines and penalties or other government enforcement actions, which could have a material adverse effect on our business and results of operations. In addition, as a result of restating previously reported price data, we ~~also~~ may be required to pay additional rebates and provide additional discounts. The prior Administration finalized a rule (the implementation of which has been delayed by the current Administration) mandating price and cost-sharing transparency for almost all health plans and insurers in the individual and group commercial markets. Further, the current Administration finalized transparency provisions required under the Consolidated Appropriations Act of 2021 for health plans and insurer reporting of certain drug pricing information by December 27, 2022, and each June thereafter, resulting in a biennial public report highlighting drug pricing trends and the impact of prescription drug costs on premiums and out-of-pocket costs. It is unclear how group health plans and health insurers may respond.

—Changing reimbursement and pricing actions in various states have negatively affected and may continue to negatively affect access to and have affected and may continue to affect sales of our products

At the state level, government actions or ballot initiatives can also affect how our products are covered and reimbursed and/or create additional pressure on our pricing decisions. A number of states have adopted, and many other states are considering, drug importation programs or other new pricing actions, including proposals designed to require biopharmaceutical manufacturers to publicly report proprietary pricing information, limit price increases or place a maximum price ceiling or cap on biopharmaceutical products. Existing and proposed state pricing laws have added complexity to the pricing of drugs and may already be affecting industry pricing decisions. For example, a California law, the constitutionality of which is currently being challenged, purports to require biopharmaceutical manufacturers to notify health insurers and government health plans at least 60 days before scheduled prescription drug price increases that exceed certain thresholds. Similar laws exist in Oregon and Washington. States are also seeking to change the way they pay for drugs for patients covered by state programs. California adopted a 2020–21 budget that incorporates international pricing into Medicaid supplemental rebate negotiations and allows its Medicaid program to seek federal approval to extend supplemental rebates to non-Medicaid populations. New York has established a Medicaid drug spending cap, and Massachusetts implemented a new review and supplemental rebate negotiation process. Other states may consider implementing similar policies and procedures as they face budget deficits from the effects of the COVID-19 pandemic. Additionally, Colorado, Florida, Maine, New Hampshire, New Mexico and Vermont have enacted laws, and several other states have proposed bills, to implementimportation of drugs from Canada. The FDA recently 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. Other states could adopt similar approaches or could pursue different policy changes in a continuing effort to reduce their costs. Ultimately, as with U.S. federal government actions, existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations.

—U.S. commercial payer actions have affected and may continue to affect access to and sales of our products

Payers, including healthcare insurers, PBMs, integrated healthcare delivery systems (vertically-integrated organizations built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, increasingly seek ways to reduce their costs. With increasing frequency, payers are adopting benefit plan changes that shift a greater proportion of drug costs to patients. Such measures include more limited benefit plan designs, high deductible plans, higher patient copay or coinsurance obligations and more significant limitations on patients’ use of manufacturer commercial copay assistance programs. Further, government regulation of payers may affect these trends. For example, CMS finalized a policy in May 2020 (for plan years starting on or after January 1, 2021, which remains standing policy for 2022) that has caused commercial payers to more widely adopt copay accumulator adjustment programs. Payers 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, particularly in treatment areas in which the payer has taken the position that multiple branded products are therapeutically comparable. Payers also control costs by imposing restrictions on access to or usage of our products, such as Step Therapy, or requiring that patients receive the payer’s prior authorization before covering the product or that patients use a mail-order pharmacy or a limited network of payer fully-owned mail-order or specialty pharmacies. Payers have also chosen to exclude certain indications for which our products are approved or chosen to exclude coverage entirely. For example, some payers require physicians to demonstrate or document that the patients for whom Repatha has been prescribed meet payer utilization management criteria, and these requirements have served to limit and may continue to limit patient access to Repatha treatment. In an effort to reduce barriers to access, we reduced the net price of Repatha by providing greater discounts and rebates to payers, including PBMs that administer Medicare Part D prescription drug plans. However, affordability of patient out-of-pocket co-pay cost has limited and may continue to limit patient use. For example, in late 2018 and early 2019, in response to a very high percentage of Medicare patients abandoning their Repathaprescriptions rather than paying their co-pay, we introduced a set of new National Drug Codes to make Repatha available at a lower list price in an attempt to address affordability for patients, particularly those on Medicare, and on December 31, 2019, we discontinued the higher list price option for Repatha. Despite these net and list price reductions, some payers have restricted and may continue to restrict patient access, and have changed and may continue to change formulary coverage for Repatha, and they may seek further discounts or rebates or take other actions that could reduce our sales of Repatha. These factors have served to limit and may continue to limit patient affordability and use, and negatively affect Repatha sales.

Further, significant consolidation in the health insurance industry has resulted in a few large insurers and PBMs, which places greater pressure on pricing and usage negotiations with biopharmaceutical manufacturers, significantly increasing discount and rebate requirements and limiting patient access and usage. For example, in the United States, as of the beginning of 2021, the top five integrated health plans and PBMs controlled about 85% of all pharmacy prescriptions. The consolidation among insurers, PBMs and other payers, including through integrated healthcare delivery systems and/or with specialty or mail-order pharmacies and pharmacy retailers, has increased the negotiating leverage such entities have over us and other biopharmaceutical manufacturers, and has resulted in greater price discounts, rebates and service fees realized by those payers. In 2019, 2020 and 2021, CVS, Express Scripts and United Health Group, respectively, each created Rebate Management Organizations that further increase their respective leverage to negotiate deeper discounts. Ultimately, additional discounts, rebates, fees, coverage changes, plan changes, restrictions or exclusions imposed by these commercial payers could have a material adverse effect on our product sales, business and results of operations. Policy reforms advanced by Congress or the Administration that refine the role of PBMs in the U.S. marketplace could have downstream implications or consequences for our business and how we interact with these entities. 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 to certain medicines. See our Annual Report on Form 10-K for the year ended December 31, 2021, Part I, Item 1A. Risk Factors—Concentration of sales at certain of our wholesaler distributors and at one free-standing dialysis clinic business and consolidation of private payers may negatively affect our business.

—Government and commercial payer actions outside the United States have affected and will continue to affect access to and sales of our products

Outside the United States, we expect countries will also continue to take actions to reduce their drug expenditures. See Part I, Item 1. Business—Reimbursement of our Annual Report on Form 10-K for the year ended December 31, 2021. IRP has been widely used by many countries outside the United States to control costs based on an external benchmark of a product’s price in other countries. IRP policies can change quickly and frequently and may not reflect differences in the burden of disease, indications, market structures, or affordability differences across countries or regions. Other expenditure control practices, including but not limited to the use of revenue clawbacks, rebates and percentage caps on price increases, are used in various foreign jurisdictions as well. In addition, countries may refuse to reimburse or may restrict the reimbursed population for a product when their national health technology assessments do not consider a medicine to demonstrate sufficient clinical benefit beyond existing therapies or to meet certain cost effectiveness thresholds. For example, despite the EMA’s approval of Repatha for the treatment of patients with established atherosclerotic disease, the reimbursement for Repatha in France prior to

2020 was limited to a narrower patient population (such as those with homozygous familial hypercholesterolemia (HoFH)) following a national health technology assessment, which had limited our efforts in France to expand Repatha access to the broader patient population covered by the approved label. Some countries decide on reimbursement between potentially competing products through national or regional tenders that often result in one product receiving most or all of the sales in that country or region. Failure to obtain coverage and reimbursement for our products, a deterioration in their existing coverage and reimbursement, or a decline in the timeliness or certainty of payment by payers to physicians and other providers has negatively affected, and may further negatively affect, the ability or willingness of healthcare providers to prescribe our products for their patients and otherwise negatively affect the use of our products or the prices we realize for them. Such changes have had, and could in the future have, a material adverse effect on our product sales, business and results of operations.

The adoption and interpretation of new tax legislation or exposure to additional tax liabilities could affect our profitability.

We are subject to income and other taxes in the United States and other jurisdictions in which we do business. As a result, our provision for income taxes is derived from a combination of applicable tax rates in the various places we operate. Significant judgment is required for determining our provision for income tax.

One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely examined by tax authorities in those jurisdictions. Significant disputes can ~~arise~~and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts, and such tax authorities (including the IRS) are becoming more aggressive in their audits and are particularly focused on such matters. In 2017, we received aan RAR and a modified RAR from the IRS for the years ~~2010, 2011 and~~ 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. ~~As previously reported, we~~We disagreed with the proposed adjustments and calculations and pursued a resolution with the IRS administrative appeals ~~office. However, we~~office but were unable to reach ~~resolution with the IRS appeals office.~~resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two ~~duplicative~~duplicate Notices for ~~2010, 2011 and~~ the years 2010–2012 that we received in May and July 2021 which seek to increase our U.S. taxable ~~income. We firmly believe that~~income for the ~~IRS’ positions set forth in the Notices are without merit, and we will vigorously contest the Notices through the judicial~~

~~process. See Note 4, Income taxes, to the condensed consolidated financial statements.~~years 2010–2012.

In ~~addition, in~~ 2020, we received an RAR and a modified RAR from the IRS for the years 2013, 2014 and 2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years ~~2010, 2011 and~~ 2010–2012. We ~~disagree~~disagreed with the ~~2013, 2014 and 2015~~ proposed adjustments and calculations and ~~are pursuing~~pursued resolution with the IRS ~~administrative~~ appeals ~~office.~~office but were unable to reach resolution. In July 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that seeks to increase our U.S. taxable income for the years 2013–2015 and asserts penalties.

We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We are contesting the 2010–2012 and 2013–2015 Notices through the judicial process, and we will seek consolidation of the two periods into one case in the U.S. Tax Court.

We are currently also under examination by the IRS for the years 2016, 2017 and ~~2018. We~~2018 with respect to issues similar to those for the 2010 through 2015 period. In addition, we are ~~also currently~~ under examination by a number of ~~other~~ state and foreign tax jurisdictions.

Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse effect on the results of our operations.

See Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations, Income Taxes, and Part I—Note 4, Income taxes, to the condensed consolidated financial statements.

Our provision for income taxes and results of operations in the future could be adversely affected by changes to our operating structure, changes in the mix of income and expenses in countries with differing tax rates, changes in the valuation of deferred tax assets and liabilities and changes in applicable tax laws, regulations or administrative interpretations thereof. The ~~Tax Cuts and Jobs Act (the~~ 2017 Tax ~~Act)~~Act is complex and a large volume of regulations and guidance has been issued and could be subject to different interpretations. We could face audit challenges to our application of the 2017 Tax Act. The Administration proposed and Congress ~~are~~is considering a variety of potentially significant changes to existing tax ~~law, including an increase in the corporate tax rate and the tax rate on foreign earnings.~~law. These changes, or others, could substantially increase ~~U.S. taxation of our operations both in and outside the United States, including~~taxes we pay to the U.S. ~~territory of Puerto Rico.~~government. Further, the OECD recently reached an agreement to align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries. If enacted, either by all OECD participants or unilaterally by individual countries, this agreement could result in tax increases in both the United States and

foreign ~~jurisdictions~~. jurisdictions.

The U.S. Treasury recently released final foreign tax credit regulations that eliminate U.S. creditability of the Puerto Rico Excise Tax beginning 2023, which would increase our U.S. tax liability. However, the U.S. territory of Puerto Rico recently enacted Act 52-2022, which provides for an alternate fixed tax rate on industrial development income that is expected to be creditable under U.S. law. As part of this new law, eligible businesses would be subject to incremental income and withholding taxes in lieu of payment of the Puerto Rico Excise Tax. In order to qualify for the alternative fixed tax rate, we must amend our current tax grant with the Puerto Rico government by December 31, 2022. Once we qualify for this alternative fixed tax rate, which we expect to occur as of January 1, 2023, our tax expense will increase. While we expect these taxes to be partially offset by U.S. foreign tax credits, the U.S. Treasury has not yet issued guidance on whether the alternative fixed tax rate will be creditable under U.S. law.

Changes to existing tax law in the ~~U.S.,~~United States, the U.S. territory of Puerto Rico, or other jurisdictions, ~~that would likely~~including the changes and 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.

Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions.

We seek innovation through significant investment in both internal R&D and external transactions, including collaborations, partnerships, alliances, licenses, joint ventures, mergers and acquisitions (collectively, acquisition activity). Acquisition activities may be subject to regulatory approvals or other requirements that are not within our control. There can be no assurance that such regulatory or other approvals will be obtained or that all closing conditions required in connection with our acquisition activities will be satisfied or waived, which could result in us being unable to complete the planned acquisition activities. In addition, antitrust scrutiny by regulatory agencies and changes to regulatory approval process in the U.S. and foreign jurisdictions may cause approvals to take longer than anticipated to obtain, not be obtained at all, or contain burdensome conditions, which may jeopardize, delay or reduce the anticipated benefits of acquisitions to us and could impede the execution of our business strategy.

Acquisition activities are complex, time consuming and expensive and may result in unanticipated costs, delays or other operational or financial problems related to integrating the acquired company and business with our company, which may divert our management’s attention from other business issues and opportunities and restrict the full realization of the anticipated benefits of such transactions within the expected timeframe or at all. We may pay substantial amounts of cash, incur debt or issue equity securities to pay for acquisition activities, which could adversely affect our liquidity or result in dilution to our stockholders, respectively. Further, failures or difficulties in integrating or retaining new personnel or in integrating the operations of the businesses, products or assets we acquire (including related technology, commercial operations, compliance programs, manufacturing, distribution and general business operations and procedures) may affect our ability to realize the benefits of the transaction and grow our business and may result in us incurring asset impairment or restructuring charges. These and other challenges may arise in connection with our proposed acquisition of ChemoCentryx, in addition to our acquisitions of Otezla, Five Prime, Teneobio and/or our collaborations with BeiGene and Kyowa Kirin Co., Ltd., or with other acquisition activities, which could have a material adverse effect on our business, results of operations and stock price.

4748


Item 2.			UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

During the three months ended June 30, ~~2021,~~2022, we had one outstanding stock repurchase program, under which the repurchase activity was as follows:

Period Total number
of shares
purchased
Average
price paid
per share (1)
Total number
of shares purchased
as part of publicly announced program
Maximum dollar
value that may
yet be purchased
under the program(2)
April 1 - 30 1,912,921 $ 244.13 1,912,921 $ 5,044,280,273
May 1 - 31 2,425,697 $ 248.21 2,425,697 $ 4,442,191,440
June 1 - 30 2,180,367 $ 239.80 2,180,367 $ 3,919,349,391
Total 6,518,985 $ 244.20 6,518,985


Period	Total number of shares purchased (1)	Average price paid per share	Total number of shares purchased as part of publicly announced program	Maximum dollar value that may yet be purchased under the program
April 1 - 30	—	—	—	4,579,263,848
May 1 - 31	—	—	—	4,579,263,848
June 1 - 30	—	—	—	4,579,263,848
Total	—		—

___________

(1)~~Average price paid per share includes related expenses.~~

~~(2)~~ ~~In March 2021, our Board~~As part of ~~Directors increased~~ the ~~amount authorized under our~~ stock repurchase program, the Company entered into ASR agreements with three third-party financial institutions (Dealers) in February 2022. Under the ASR agreements, the Company made payments in an aggregate amount of $6.0 billion to the Dealers and received and retired an initial 23,258,997 shares of common stock. Approximately $0.9 billion of stock was held back by anthe Dealers pending final settlement of the ASR agreement, which will be based on the volume-weighted average stock price of the Company’s common stock during the term of the ASR agreements, less a discount and subject to adjustments pursuant to the terms and conditions of the ASR agreements. At settlement, which is scheduled to occur in the third quarter of 2022, the Dealers may be required to deliver additional ~~$3.4 billion.~~shares of common stock to the Company, or under certain circumstances, the Company may be required to deliver shares of common stock or to make a cash payment, at its election, to the Dealers.


Item 6.			EXHIBITS

Reference is made to the Index to Exhibits included herein.

4850

INDEX TO EXHIBITS


Exhibit No.						Description
2.1						Asset Purchase Agreement, dated August 25, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.)

2.2						Amendment No. 1 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 8-K on October 17, 2019 and incorporated herein by reference.)

2.3						Amendment No. 2 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

2.4						Letter Agreement, dated November 21, 2019, by and between Amgen Inc. and the parties named therein re: Treatment of Certain Product Inventory in connection with Amgen’s acquisition of ~~Otezla~~®.Otezla. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

2.5						Irrevocable Guarantee, dated August 25, 2019, by and between Amgen Inc. and Bristol-Myers Squibb Company. (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.)

2.6						Agreement and Plan of Merger, dated ~~as of March 4,~~July 27, 2021, by and among Amgen Inc., ~~Franklin Acquisition~~Teneobio, Inc., Tuxedo Merger Sub, Inc., and ~~Five Prime Therapeutics, Inc.~~Fortis Advisors LLC. ~~(Filed~~(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 ~~8-K~~10-Q for the quarter ended September 30, 2021 on ~~March 4,~~November 3, 2021 and incorporated herein by reference.)

3.1						Restated Certificate of Incorporation of Amgen Inc. (As Restated March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.)

3.2						Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated February 15, 2016.) (Filed as an exhibit to Form 8-K on February 17, 2016 and incorporated herein by reference.)

4.1						Form of stock certificate for the common stock, par value $.0001 of the Company. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1997 on May 14, 1997 and incorporated herein by reference.)

4.2						Form of Indenture, dated January 1, 1992. (Filed as an exhibit to Form S-3 Registration Statement filed on December 19, 1991 and incorporated herein by reference.)

4.3						Agreement of Resignation, Appointment and Acceptance dated February 15, 2008. (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.)

4.4						First Supplemental Indenture, dated February 26, 1997. (Filed as an exhibit to Form 8-K on March 14, 1997 and incorporated herein by reference.)

4.5						8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.)

4.6						~~Officer~~’s Officer’s Certificate of Amgen Inc., dated April 8, 1997, establishing a series of securities entitled “8 1/8% Debentures due April 1, 2097.” (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.)

4.7						Indenture, dated August 4, 2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.)

4.8						Corporate Commercial Paper - Master Note between and among Amgen Inc., as Issuer, Cede & Co., as Nominee of The Depository Trust Company, and Citibank, N.A., as Paying Agent. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1998 on May 13, 1998 and incorporated herein by reference.)

4.9						Officers’ Certificate of Amgen Inc., dated May 30, 2007, including form of the Company’s 6.375% Senior Notes due 2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference.)

4.10						Officers’ Certificate of Amgen Inc., dated May 23, 2008, including form of the Company’s 6.90% Senior Notes due 2038. (Filed as exhibit to Form 8-K on May 23, 2008 and incorporated herein by reference.)

4.11						Officers’ Certificate of Amgen Inc., dated January 16, 2009, including form of the Company’s 6.40% Senior Notes due 2039. (Filed as exhibit to Form 8-K on January 16, 2009 and incorporated herein by reference.)

4951


Exhibit No.						Description
4.12						Officers’ Certificate of Amgen Inc., dated March 12, 2010, including form of the Company’s 5.75% Senior Notes due 2040. (Filed as exhibit to Form 8-K on March 12, 2010 and incorporated herein by reference.)

4.13						Officers’ Certificate of Amgen Inc., dated September 16, 2010, including form of the Company’s 4.95% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on September 17, 2010 and incorporated herein by reference.)

4.14						Officers’ Certificate of Amgen Inc., dated June 30, 2011, including form of the Company’s 5.65% Senior Notes due 2042. (Filed as an exhibit to Form 8-K on June 30, 2011 and incorporated herein by reference.)

4.15						Officers’ Certificate of Amgen Inc., dated November 10, 2011, including form of the Company’s 5.15% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on November 10, 2011 and incorporated herein by reference.)

4.16						Officers’ Certificate of Amgen Inc., dated December 5, 2011, including form of the Company’s 5.50% Senior Notes due 2026. (Filed as an exhibit to Form 8-K on December 5, 2011 and incorporated herein by reference.)

4.17						Officers’ Certificate of Amgen Inc., dated May 15, 2012, including ~~forms~~form of the Company’s ~~3.625% Senior Notes due 2022 and~~ 5.375% Senior Notes due 2043. (Filed as an exhibit to Form 8-K on May 15, 2012 and incorporated herein by reference.)

4.18						Officers’ Certificate of Amgen Inc., dated September 13, 2012, including form of the Company’s 4.000% Senior Notes due 2029. (Filed as an exhibit to Form 8-K on September 13, 2012 and incorporated herein by reference.)

4.19						Indenture, dated May 22, 2014, between Amgen Inc. and The Bank of New York Mellon Trust Company, N.A., as Trustee. (Filed as an exhibit to Form 8-K on May 22, 2014 and incorporated herein by reference.)

4.20						Officers’ Certificate of Amgen Inc., dated May 22, 2014, including form of the Company’s 3.625% Senior Notes due 2024. (Filed as an exhibit to Form 8-K on May 22, 2014 and incorporated herein by reference.)

4.21						Officer’s Certificate of Amgen Inc., dated May 1, 2015, including forms of the Company’s ~~2.700% Senior Notes due 2022,~~ 3.125% Senior Notes due 2025 and 4.400% Senior Notes due 2045. (Filed as an exhibit on Form 8-K on May 1, 2015 and incorporated herein by reference.)

4.22						Officer’s Certificate of Amgen Inc., dated as of February 25, 2016, including ~~forms~~form of the Company’s ~~1.250% Senior Notes due 2022 and~~ 2.000% Senior Notes due 2026. (Filed as an exhibit on Form 8-K on February 26, 2016 and incorporated herein by reference.)

4.23						Form of Permanent Global Certificate for the Company’s 0.410% bonds due 2023. (Filed as an exhibit on Form 8-K on March 8, 2016 and incorporated herein by reference.)

4.24						Terms of the Bonds for the Company’s 0.410% bonds due 2023. (Filed as an exhibit on Form 8-K on March 8, 2016 and incorporated herein by reference.)

4.25						Officer’s Certificate of Amgen Inc., dated as of June 14, 2016, including forms of the Company’s 4.563% Senior Notes due 2048 and 4.663% Senior Notes due 2051. (Filed as an exhibit to Form 8-K on June 14, 2016 and incorporated herein by reference.)

4.26						Officer’s Certificate of Amgen Inc., dated as of August 19, 2016, including forms of the Company’s 2.250% Senior Notes due 2023 and 2.600% Senior Notes due 2026. (Filed as an exhibit to Form 8-K on August 19, 2016 and incorporated herein by reference.)

4.27						Officer’s Certificate of Amgen Inc., dated as of ~~May 11, 2017 including form of the Company’s 2.650% Senior Notes due 2022.~~ ~~(Filed as an exhibit to Form 8-K on May 11, 2017 and incorporated herein by reference.)~~

~~4.28~~						~~Officer’s Certificate of Amgen Inc., dated as of~~ November 2, 2017, including in the form of the Company’s 3.200% Senior Notes due 2027. (Filed as an exhibit to Form 8-K on November 2, 2017 and incorporated herein by reference.)

~~4.29~~4.28						Officer’s Certificate of Amgen Inc., dated as of February 21, 2020, including forms of the Company’s 1.900% Senior Notes due 2025, 2.200% Senior Notes due 2027, 2.450% Senior Notes due 2030, 3.150% Senior Notes due 2040 and 3.375% Senior Notes due 2050. (Filed as an exhibit to Form 8-K on February 21, 2020 and incorporated herein by reference.)


~~4.30~~4.29						Officer’s Certificate of Amgen Inc., dated as of May 6, 2020, including form of the Company’s 2.300% Senior Notes due 2031. (Filed as an exhibit to Form 8-K on May 6, 2020 and incorporated herein by reference.)


~~4.31~~Exhibit No.						Description
4.30						Officer’s Certificate of Amgen Inc., dated as of August 17, 2020, including forms of the Company’s 2.770% Senior Notes due 2053. (Filed as an exhibit to Form 8-K on August 18, 2020 and incorporated herein by reference.)

~~4.32~~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. (Filed as an exhibit to Form 8-K on August 18, 2020 and incorporated herein by reference.)

4.32						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. (Filed as an exhibit to Form 8-K on August 9, 2021 and incorporated herein by reference.)

4.33						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. (Filed as an exhibit to Form 8-K on February 22, 2022 and incorporated herein by reference.)

10.1+						Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (Filed as Appendix C to the Definitive Proxy Statement on Schedule 14A on April 8, 2013 and incorporated herein by reference.)

10.2+						First Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 4, 2015. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2015 on April 27, 2015 and incorporated herein by reference.)

10.3+						Second Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 2, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2016 on May 2, 2016 and incorporated herein by reference.)

10.4+						Form of Grant of Stock Option Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (As Amended and Restated on December ~~15, 2020.~~2, 2021.) (Filed as an exhibit to Form 10-K for the year ended December 31, ~~2020~~2021 on February ~~9, 2021~~16, 2022 and incorporated herein by reference.)

10.5+						Form of Restricted Stock Unit Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (As Amended and Restated on December ~~15, 2020.~~2, 2021.) (Filed as an exhibit to Form 10-K for the year ended December 31, ~~2020~~2021 on February ~~9, 2021~~16, 2022 and incorporated herein by reference.)

10.6+						Amgen Inc. 2009 Performance Award Program. (As Amended on December 12, 2017.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2017 on February 13, 2018 and incorporated herein by reference.)

10.7+						Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award Program. (As Amended and Restated on December ~~15, 2020.~~2, 2021.) (Filed as an exhibit to Form 10-K for the year ended December 31, ~~2020~~2021 on February ~~9, 2021~~16, 2022 and incorporated herein by reference.)

10.8+						Amgen Inc. 2009 Director Equity Incentive Program. (As Amended and Restated on October 21, 2020.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2020 on February 9, 2021 and incorporated herein by reference.)

10.9+						Form of Grant of Non-Qualified Stock Option Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (Filed as an exhibit to Form 8-K on May 8, 2009 and incorporated herein by reference.)

10.10+						Form of Restricted Stock Unit Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (As Amended on December 11, 2019.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

10.11+						Form of Cash-Settled Restricted Stock Unit Agreement for the Amgen 2009 Director Equity Incentive Program. (As Amended on December 11, 2019.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

10.12+						Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.)

10.13+						First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.)


Exhibit No.						Description

10.14+						Second Amendment to the Amgen Inc. Supplemental Retirement Plan, ~~(As Amended and Restated~~ effective October 23, 2019). (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

10.15+						Third Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2021. (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.)

10.16+						Amended and Restated Amgen Change of Control Severance Plan. (As Amended and Restated effective December 9, 2010 and subsequently amended effective March 2, 2011.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated herein by reference.)



~~10.16+~~10.17+						Amgen Inc. Executive Incentive Plan. (As Amended and Restated effective January 1, ~~2009.~~2022.) (Filed as an exhibit to Form 10-Q for the quarter ended ~~September 30, 2008~~March 31, 2022 on ~~November 7, 2008~~April 28, 2022 and incorporated herein by reference.)

~~10.17+~~						~~First Amendment to the Amgen Inc. Executive Incentive Plan, effective December 13, 2012.~~ ~~(Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.)~~

10.18+						~~Second Amendment to the Amgen Inc. Executive Incentive Plan, effective January 1, 2017.~~ ~~(Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2017 on April 27, 2017 and incorporated herein by reference.)~~

~~10.19+~~						Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.)

~~10.20+~~10.19+						First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.)

~~10.21+~~10.20+						Second Amendment to the Amgen Nonqualified Deferred Compensation Plan, ~~(As Amended and Restated~~ effective January 1, ~~2020).~~2020. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

~~10.22+~~10.21+						~~Agreement between~~Third Amendment to the Amgen ~~Inc. and Murdo Gordon, dated July 25, 2018.~~Nonqualified Deferred Compensation Plan, effective January 1, 2022. ~~(Filed~~(Filed as an exhibit to Form ~~10-Q~~10-K for the ~~quarter~~year ended ~~September 30, 2018~~December 31, 2021 on ~~October 31, 2018~~February 16, 2022 and incorporated herein by reference.)

~~10.23+~~10.22+						Agreement between Amgen Inc. and Peter Griffith, dated October 18, 2019. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2020 on May 1, 2020 and incorporated herein by reference.)

10.23+						Aircraft Time Sharing Agreement, dated December 3, 2021, by and between Amgen Inc. and Robert A. Bradway. (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.)

10.24						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. (Filed as an exhibit to Form 8-K on December 12, 2019 and incorporated herein by reference.)

10.25						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). (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.)

10.26						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). (Filed as an exhibit to Form 10-K for the year ended December 31, 2016 on February 14, 2017 and incorporated herein by reference.)

10.27						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). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2019 on July 31, 2019 and incorporated herein by reference.)

10.28						Collaboration Agreement, dated April 22, 1994, by and between Bayer Corporation (formerly Miles, Inc.) and Onyx Pharmaceuticals, Inc. (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.)

10.29						Amendment to Collaboration Agreement, dated April 24, 1996, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (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.)


Exhibit No.						Description
10.30						Amendment to Collaboration Agreement, dated February 1, 1999, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (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.)

10.31						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. (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.)

10.32

Fourth Amendment to Collaboration Agreement, dated October 11, 2011, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (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.)

10.33

Side Letter Regarding Collaboration Agreement, dated May 29, 2015, by and between Bayer HealthCare LLC and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2015 on August 5, 2015 and incorporated herein by reference.)

10.34

Side Letter Regarding Collaboration Agreement and Stivarga Agreement, dated February 13, 2020, by and between Onyx Pharmaceuticals, Inc. and Bayer HealthCare LLC. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2020 on May 1, 2020 and incorporated herein by reference.)

10.35

Sourcing and Supply Agreement, dated January 6, 2017, by and between Amgen USA Inc., a wholly owned subsidiary of Amgen Inc., and DaVita Inc. (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.)

10.36

Exclusive License and Collaboration Agreement, dated August 28, 2015, by and between Amgen Inc. and Novartis Pharma AG (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 June 30, 2017 on July 26, 2017 and incorporated herein by reference.)

10.37

Amendment No. 1 to the Exclusive License and Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (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 June 30, 2017 on July 26, 2017 and incorporated herein by reference.)

10.38

Amendment No. 2 to the Exclusive License and Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (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 June 30, 2017 on July 26, 2017 and incorporated herein by reference.)

10.39*10.39

~~Amended~~Amendment No. 3 to the Exclusive License and ~~Restated~~ Collaboration Agreement, dated ~~June 2, 2021,~~January 31, 2022, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted because they are both (i) not material and (ii) ~~would be competitively harmful if publicly disclosed)~~is the type of information that the Company treats as private or confidential). (Filed as an exhibit to the Company’s Current Report on Form 8-K on January 31, 2022 and incorporated herein by reference.)

10.40

Collaboration Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene Switzerland GmbH, a wholly-owned subsidiary of BeiGene, Ltd. (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, 2019 on February 12, 2020 and incorporated herein by reference.)

~~10.41~~10.41*

First Amendment to Collaboration Agreement, dated April 20, 2022, by and between Amgen Inc. and BeiGene Switzerland GmbH, and BeiGene, Ltd. (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.)

10.42

Guarantee, dated as of October 31, 2019, made by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.)

~~10.42~~10.43

Share Purchase Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene, Ltd. (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 Schedule 13D on January 8, 2020 and incorporated herein by reference.)

~~10.43~~10.44

Amendment No. 1 to Share Purchase Agreement, dated December 6, 2019, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.)


Exhibit No.						Description

~~10.44~~10.45						Restated Amendment No. 2 to Share Purchase Agreement, dated September 24, 2020, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2020 on October 29, 2020 and incorporated herein by reference.)

~~10.45~~10.46*						Collaboration Agreement dated March 30, 2012 by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, a wholly owned subsidiary of AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted ~~pursuant to a request for confidential treatment). (Filed~~because they are both (i) not material and (ii) is the type of information that the Company treats as ~~an exhibit to Form 10-Q for the quarter ended March 31, 2012 on May 8, 2012 and incorporated herein by reference.~~private or confidential.)

~~10.46~~10.47*						Amendment No. 1 to the Collaboration Agreement, dated October 1, 2014, by and among Amgen Inc., AstraZeneca Collaboration Ventures, LLC and AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted ~~pursuant to a request for confidential treatment). (Filed~~because they are both (i) not material and (ii) is the type of information that the Company treats as ~~an exhibit to Form 10-K for the year ended December 31, 2014 on February 19, 2015 and incorporated herein by reference.~~private or confidential.)


~~10.47~~10.48						Amendment Nos. 2 through 6 to the March 30, 2012 Collaboration Agreement between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, dated May 2 and 27 and October 2, 2016, January 31, 2018, and May 15, 2020, respectively (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, 2020 on July 29, 2020 and incorporated herein by reference.)

~~10.48~~10.49						Amendment No. 7 to the Collaboration Agreement, dated December ~~18,~~17, 2020, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (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.)

10.49*10.50						Amendment No. 8 to the Collaboration Agreement, dated November 19, 2021, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (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-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.)

10.51						License and Collaboration Agreement, dated June 1, 2021, by and between Amgen Inc. and Kyowa Kirin Co., Ltd.~~(portions~~ (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.)

10.52						Form of ASR Agreement. (Filed as an exhibit to Form 8-K on February 24, 2022 and incorporated herein by reference.)

31*						Rule 13a-14(a) Certifications.

32**						Section 1350 Certifications.

101.INS						Inline XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document.

101.SCH*						Inline XBRL Taxonomy Extension Schema Document.

101.CAL*						Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*						Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*						Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE*						Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104						Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

____________________________

(* = filed herewith)

(** = furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended)

(+ = management contract or compensatory plan or arrangement)

5456

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.

Amgen Inc.

(Registrant)

Date:

August ~~3, 2021~~4, 2022

By:

/S/ PETER H. GRIFFITH

Peter H. Griffith

Executive Vice President and Chief Financial Officer

(Principal Financial Officer)

5557


Delaware						95-3540776
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

One Amgen Center Drive						91320-1799
Thousand Oaks
California
(Address of principal executive offices)						(Zip Code)


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, $0.0001 par value	AMGN	~~The Nasdaq Stock Market LLC~~
~~1.250% Senior Notes due 2022~~	~~AMGN22~~	The Nasdaq Stock Market LLC
2.00% Senior Notes due 2026	AMGN26	The Nasdaq Stock Market LLC


Term						Description
Aimovig						Aimovig® (erenumab-aooe)
AMGEVITA						AMGEVITA™ (adalimumab)
Aranesp						Aranesp® (darbepoetin alfa)
AVSOLA						AVSOLA® (infliximab-axxq)
BLINCYTO						BLINCYTO® (blinatumomab)
Corlanor						Corlanor® (ivabradine)
ENBREL						Enbrel® (etanercept)
EPOGEN						EPOGEN® (epoetin alfa)
EVENITY						EVENITY® (romosozumab-aqqg)
IMLYGIC						IMLYGIC® (talimogene laherparepvec)
KANJINTI						KANJINTI® (trastuzumab-anns)
KYPROLIS						KYPROLIS® (carfilzomib)
LUMAKRAS/LUMYKRAS						LUMAKRAS® / LUMYKRAS™ (sotorasib)
MVASI						MVASI® (bevacizumab-awwb)
Neulasta						Neulasta® (pegfilgrastim)
NEUPOGEN						NEUPOGEN® (filgrastim)
Nplate						Nplate® (romiplostim)
Olpasiran						Olpasiran (formerly AMG 890)
Onpro						Onpro®
Otezla						Otezla® (apremilast)
Parsabiv						Parsabiv® (etelcalcetide)
Prolia						Prolia® (denosumab)
Repatha						Repatha® (evolocumab)
RIABNI						RIABNI™ (rituximab-arrx)
Sensipar/Mimpara						Sensipar®/Mimpara™ (cinacalcet)
TEZSPIRE						TEZSPIRE® (tezepelumab-ekko)
Vectibix						Vectibix® (panitumumab)
XGEVA						XGEVA® (denosumab)


		Three months ended June 30,				Six months ended June 30,					Three months ended June 30,				Six months ended June 30,
		2021		2020		2021		2020			2022		2021		2022		2021
Revenues:	Revenues:									Revenues:
Product sales	Product sales	$	6,114	$	5,908	$	11,706	$	11,802	Product sales	$	6,281	$	6,114	$	12,012	$	11,706
Other revenues	Other revenues	412		298		721		565		Other revenues	313		412		820		721
Total revenues	Total revenues	6,526		6,206		12,427		12,367		Total revenues	6,594		6,526		12,832		12,427

Operating expenses:	Operating expenses:									Operating expenses:
Cost of sales	Cost of sales	1,637		1,488		3,127		3,001		Cost of sales	1,510		1,637		3,071		3,127
Research and development	Research and development	1,082		964		2,049		1,916		Research and development	1,039		1,082		1,998		2,049
Acquired in-process research and development	Acquired in-process research and development	1,505		0		1,505		0		Acquired in-process research and development	—		1,505		—		1,505
Selling, general and administrative	Selling, general and administrative	1,384		1,295		2,638		2,611		Selling, general and administrative	1,327		1,384		2,555		2,638
Other	Other	90		136		151		161		Other	542		90		532		151
Total operating expenses	Total operating expenses	5,698		3,883		9,470		7,689		Total operating expenses	4,418		5,698		8,156		9,470

Operating income	Operating income	828		2,323		2,957		4,678		Operating income	2,176		828		4,676		2,957

Other income (expense):	Other income (expense):									Other income (expense):
Interest expense, net	Interest expense, net	(281)		(296)		(566)		(642)		Interest expense, net	(328)		(281)		(623)		(566)
Other income, net		11		3		24		14
Other (expense) income, net										Other (expense) income, net	(317)		11		(847)		24

Income before income taxes	Income before income taxes	558		2,030		2,415		4,050		Income before income taxes	1,531		558		3,206		2,415

Provision for income taxes	Provision for income taxes	94		227		305		422		Provision for income taxes	214		94		413		305

Net income	Net income	$	464	$	1,803	$	2,110	$	3,628	Net income	$	1,317	$	464	$	2,793	$	2,110

Earnings per share:	Earnings per share:									Earnings per share:
Basic	Basic	$	0.81	$	3.07	$	3.67	$	6.16	Basic	$	2.46	$	0.81	$	5.16	$	3.67
Diluted	Diluted	$	0.81	$	3.05	$	3.65	$	6.12	Diluted	$	2.45	$	0.81	$	5.13	$	3.65

Shares used in calculation of earnings per share:	Shares used in calculation of earnings per share:									Shares used in calculation of earnings per share:
Basic	Basic	573		588		575		589		Basic	535		573		541		575
Diluted	Diluted	576		592		578		593		Diluted	537		576		544		578


	Three months ended June 30,				Six months ended June 30,
	2021		2020		2021		2020
Net income	$	464	$	1,803	$	2,110	$	3,628
Other comprehensive (loss) income, net of reclassification adjustments and taxes:
Gains (losses) on foreign currency translation	14		(3)		(25)		(55)
(Losses) gains on cash flow hedges	(48)		(116)		142		(177)
Losses on available-for-sale securities	0		(2)		0		(21)
Other	(1)		0		0		(2)
Other comprehensive (loss) income, net of taxes	(35)		(121)		117		(255)
Comprehensive income	$	429	$	1,682	$	2,227	$	3,373


☑			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


		Page No.
	DEFINED TERMS AND PRODUCTS	ii
PART I - FINANCIAL INFORMATION		1
Item 1.	FINANCIAL STATEMENTS	1
	CONDENSED CONSOLIDATED STATEMENTS OF INCOME	1
	CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME	2
	CONDENSED CONSOLIDATED BALANCE SHEETS	3
	CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY	4
	CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS	6
	NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS	7
Item 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	2729
Item 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	4041
Item 4.	CONTROLS AND PROCEDURES	4042
PART II - OTHER INFORMATION		4143
Item 1.	LEGAL PROCEEDINGS	4143
Item 1A.	RISK FACTORS	4143
Item 2.	UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS	4849
Item 6.	EXHIBITS	4850
INDEX TO EXHIBITS		4951
SIGNATURES		5557


		June 30, 2021		December 31, 2020			June 30, 2022		December 31, 2021
		(Unaudited)					(Unaudited)
ASSETS	ASSETS					ASSETS
Current assets:	Current assets:					Current assets:
Cash and cash equivalents	Cash and cash equivalents	$	6,630	$	6,266	Cash and cash equivalents	$	5,203	$	7,989
Marketable securities	Marketable securities	1,452		4,381		Marketable securities	1,980		48
Trade receivables, net	Trade receivables, net	4,479		4,525		Trade receivables, net	5,327		4,895
Inventories	Inventories	4,115		3,893		Inventories	4,554		4,086
Other current assets	Other current assets	2,423		2,079		Other current assets	2,258		2,367
Total current assets	Total current assets	19,099		21,144		Total current assets	19,322		19,385

Property, plant and equipment, net	Property, plant and equipment, net	4,906		4,889		Property, plant and equipment, net	5,158		5,184
Intangible assets, net	Intangible assets, net	15,308		16,587		Intangible assets, net	13,927		15,182
Goodwill	Goodwill	14,676		14,689		Goodwill	14,865		14,890
Other noncurrent assets	Other noncurrent assets	5,784		5,639		Other noncurrent assets	6,022		6,524
Total assets	Total assets	$	59,773	$	62,948	Total assets	$	59,294	$	61,165

LIABILITIES AND STOCKHOLDERS’ EQUITY	LIABILITIES AND STOCKHOLDERS’ EQUITY					LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:	Current liabilities:					Current liabilities:
Accounts payable	Accounts payable	$	1,277	$	1,421	Accounts payable	$	1,256	$	1,366
Accrued liabilities	Accrued liabilities	8,984		10,141		Accrued liabilities	10,545		10,731
Current portion of long-term debt	Current portion of long-term debt	4,324		91		Current portion of long-term debt	817		87
Total current liabilities	Total current liabilities	14,585		11,653		Total current liabilities	12,618		12,184

Long-term debt	Long-term debt	28,458		32,895		Long-term debt	35,705		33,222
Long-term tax liabilities	Long-term tax liabilities	6,428		6,968		Long-term tax liabilities	5,603		6,594
Other noncurrent liabilities	Other noncurrent liabilities	2,055		2,023		Other noncurrent liabilities	2,949		2,465

Contingencies and commitments	Contingencies and commitments	0		0		Contingencies and commitments	0		0

Stockholders’ equity:	Stockholders’ equity:					Stockholders’ equity:
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—569.6 shares in 2021 and 578.3 shares in 2020		31,877		31,802
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—534.9 shares in 2022 and 558.3 shares in 2021						Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—534.9 shares in 2022 and 558.3 shares in 2021	31,343		32,096
Accumulated deficit	Accumulated deficit	(22,762)		(21,408)		Accumulated deficit	(28,252)		(24,600)
Accumulated other comprehensive loss	Accumulated other comprehensive loss	(868)		(985)		Accumulated other comprehensive loss	(672)		(796)
Total stockholders’ equity	Total stockholders’ equity	8,247		9,409		Total stockholders’ equity	2,419		6,700
Total liabilities and stockholders’ equity	Total liabilities and stockholders’ equity	$	59,773	$	62,948	Total liabilities and stockholders’ equity	$	59,294	$	61,165


		Number of shares of common stock	Common stock and additional paid-in capital		Accumulated deficit		Accumulated other comprehensive loss		Total			Number of shares of common stock	Common stock and additional paid-in capital		Accumulated deficit		Accumulated other comprehensive loss		Total
Balance as of December 31, 2020		578.3	$	31,802	$	(21,408)	$	(985)	$	9,409
Balance as of December 31, 2021											Balance as of December 31, 2021	558.3	$	32,096	$	(24,600)	$	(796)	$	6,700

Net income	Net income	—	—		1,646		—		1,646		Net income	—	—		1,476		—		1,476
Other comprehensive income, net of taxes	Other comprehensive income, net of taxes	—	—		—		152		152		Other comprehensive income, net of taxes	—	—		—		33		33
Dividends declared on common stock ($1.76 per share)		—	—		(1,012)		—		(1,012)
Dividends declared on common stock ($1.94 per share)											Dividends declared on common stock ($1.94 per share)	—	—		(1,034)		—		(1,034)
Issuance of common stock in connection with the Company’s equity award programs	Issuance of common stock in connection with the Company’s equity award programs	0.7	6		—		—		6		Issuance of common stock in connection with the Company’s equity award programs	0.5	18		—		—		18
Stock-based compensation expense	Stock-based compensation expense	—	57		—		—		57		Stock-based compensation expense	—	78		—		—		78
Tax impact related to employee stock-based compensation expense	Tax impact related to employee stock-based compensation expense	—	(59)		—		—		(59)		Tax impact related to employee stock-based compensation expense	—	(45)		—		—		(45)
Repurchases of common stock		(3.7)	—		(865)		—		(865)
Balance as of March 31, 2021		575.3	31,806		(21,639)		(833)		9,334
Repurchases of common stock (Note 10)											Repurchases of common stock (Note 10)	(24.6)	(900)		(5,410)		—		(6,310)
Balance as of March 31, 2022											Balance as of March 31, 2022	534.2	31,247		(29,568)		(763)		916

Net income	Net income	—	—		464		—		464		Net income	—	—		1,317		—		1,317
Other comprehensive loss, net of taxes		—	—		—		(35)		(35)

Other comprehensive income, net of taxes											Other comprehensive income, net of taxes	—	—		—		91		91
Issuance of common stock in connection with the Company’s equity award programs	Issuance of common stock in connection with the Company’s equity award programs	0.8	47		—		—		47		Issuance of common stock in connection with the Company’s equity award programs	0.7	45		—		—		45
Stock-based compensation expense	Stock-based compensation expense	—	100		—		—		100		Stock-based compensation expense	—	120		—		—		120
Tax impact related to employee stock-based compensation expense	Tax impact related to employee stock-based compensation expense	—	(76)		—		—		(76)		Tax impact related to employee stock-based compensation expense	—	(69)		—		—		(69)
Repurchases of common stock		(6.5)	—		(1,592)		—		(1,592)

Other	Other	—	—		5		—		5		Other	—	—		(1)		—		(1)
Balance as of June 30, 2021		569.6	$	31,877	$	(22,762)	$	(868)	$	8,247
Balance as of June 30, 2022											Balance as of June 30, 2022	534.9	$	31,343	$	(28,252)	$	(672)	$	2,419


	Amounts
Cash purchase price	$	993
Contingent consideration	299
Total consideration	$	1,292

Cash and cash equivalents	$	100
In-process research and development	991
Finite-lived intangible asset – research and development technology rights	115
Finite-lived intangible assets – licensing rights	41
Goodwill	273
Other assets, net	16
Deferred tax liability	(244)
Total assets acquired, net	$	1,292


	Three months ended June 30,
	2021						2020
	U.S.		ROW		Total		U.S.		ROW		Total
Enbrel® (etanercept)	$	1,113	$	31	$	1,144	$	1,213	$	33	$	1,246
Prolia® (denosumab)	538		276		814		441		218		659
Otezla® (apremilast)	423		111		534		464		97		561
Neulasta® (pegfilgrastim)	434		52		486		520		73		593
XGEVA® (denosumab)	355		133		488		318		117		435
Aranesp® (darbepoetin alfa)	135		232		367		156		231		387
Repatha® (evolocumab)	143		143		286		115		85		200
KYPROLIS® (carfilzomib)	190		90		280		167		86		253
Other products	1,043		672		1,715		1,034		540		1,574
Total product sales(1)	$	4,374	$	1,740	6,114		$	4,428	$	1,480	5,908
Other revenues					412						298
Total revenues					$	6,526					$	6,206

	Six months ended June 30,
	2021						2020
	U.S.		ROW		Total		U.S.		ROW		Total
ENBREL	$	2,007	$	61	$	2,068	$	2,330	$	69	$	2,399
Prolia®	1,039		533		1,572		863		450		1,313
Otezla®	789		221		1,010		841		199		1,040
Neulasta®	855		113		968		1,054		148		1,202
XGEVA®	689		267		956		673		243		916
Aranesp®	260		462		722		331		478		809
Repatha®	282		290		572		239		190		429
KYPROLIS®	349		182		531		354		179		533
Other products	2,007		1,300		3,307		2,022		1,139		3,161
Total product sales(1)	$	8,277	$	3,429	11,706		$	8,707	$	3,095	11,802
Other revenues					721						565
Total revenues					$	12,427					$	12,367


Types of securities as of June 30, 2021		Amortized cost		Gross unrealized gains		Gross unrealized losses		Fair values
Types of securities as of June 30, 2022										Types of securities as of June 30, 2022	Amortized cost		Gross unrealized gains		Gross unrealized losses		Fair values
U.S. Treasury notes	U.S. Treasury notes	$	51	$	1	$	0	$	52	U.S. Treasury notes	$	—	$	—	$	—	$	—
U.S. Treasury bills	U.S. Treasury bills	1,400		0		0		1,400		U.S. Treasury bills	1,980		—		—		1,980

Money market mutual funds	Money market mutual funds	5,707		0		0		5,707		Money market mutual funds	4,433		—		—		4,433
Other short-term interest-bearing securities	Other short-term interest-bearing securities	0		0		0		0		Other short-term interest-bearing securities	—		—		—		—

Total interest-bearing securities	Total interest-bearing securities	$	7,158	$	1	$	0	$	7,159	Total interest-bearing securities	$	6,413	$	—	$	—	$	6,413


Types of securities as of December 31, 2020	Amortized cost		Gross unrealized gains		Gross unrealized losses		Fair values
U.S. Treasury notes	$	129	$	1	$	0	$	130
U.S. Treasury bills	4,948		0		0		4,948









Money market mutual funds	4,765		0		0		4,765
Other short-term interest-bearing securities	2		0		0		2
Total interest-bearing securities	$	9,844	$	1	$	0	$	9,845


Condensed Consolidated Balance Sheets locations	June 30, 2021		December 31, 2020
Cash and cash equivalents	$	5,707	$	5,464
Marketable securities	1,452		4,381
Total interest-bearing securities	$	7,159	$	9,845


	Six months ended June 30, ~~2021~~2022
Beginning balance	$	~~14,689~~14,890
Adjustments to goodwill resulting from acquisitions and divestitures, net(1)	7
Currency translation adjustment	~~(13)~~(32)
Ending balance	$	~~14,676~~14,865


		June 30, 2021		December 31, 2020			June 30, 2022		December 31, 2021
1.25% €1,250 million notes due 2022 (1.25% 2022 euro Notes)		$	1,482	$	1,527
2.70% notes due 2022 (2.70% 2022 Notes)		500		500
2.65% notes due 2022 (2.65% 2022 Notes)		1,500		1,500
3.625% notes due 2022 (3.625% 2022 Notes)		750		750
0.41% CHF700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)	0.41% CHF700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)	757		791		0.41% CHF700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)	$	733	$	767
2.25% notes due 2023 (2.25% 2023 Notes)	2.25% notes due 2023 (2.25% 2023 Notes)	750		750		2.25% notes due 2023 (2.25% 2023 Notes)	750		750
3.625% notes due 2024 (3.625% 2024 Notes)	3.625% notes due 2024 (3.625% 2024 Notes)	1,400		1,400		3.625% notes due 2024 (3.625% 2024 Notes)	1,400		1,400
1.90% notes due 2025 (1.90% 2025 Notes)	1.90% notes due 2025 (1.90% 2025 Notes)	500		500		1.90% notes due 2025 (1.90% 2025 Notes)	500		500
3.125% notes due 2025 (3.125% 2025 Notes)	3.125% notes due 2025 (3.125% 2025 Notes)	1,000		1,000		3.125% notes due 2025 (3.125% 2025 Notes)	1,000		1,000
2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)	2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)	889		916		2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)	786		853
2.60% notes due 2026 (2.60% 2026 Notes)	2.60% notes due 2026 (2.60% 2026 Notes)	1,250		1,250		2.60% notes due 2026 (2.60% 2026 Notes)	1,250		1,250
5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)	5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)	657		649		5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)	579		643
2.20% notes due 2027 (2.20% 2027 Notes)	2.20% notes due 2027 (2.20% 2027 Notes)	1,750		1,750		2.20% notes due 2027 (2.20% 2027 Notes)	1,750		1,750
3.20% notes due 2027 (3.20% 2027 Notes)	3.20% notes due 2027 (3.20% 2027 Notes)	1,000		1,000		3.20% notes due 2027 (3.20% 2027 Notes)	1,000		1,000
1.65% notes due 2028 (1.65% 2028 Notes)						1.65% notes due 2028 (1.65% 2028 Notes)	1,250		1,250
3.00% notes due 2029 (3.00% 2029 Notes)						3.00% notes due 2029 (3.00% 2029 Notes)	750		—
4.00% £700 million notes due 2029 (4.00% 2029 pound sterling Notes)	4.00% £700 million notes due 2029 (4.00% 2029 pound sterling Notes)	968		957		4.00% £700 million notes due 2029 (4.00% 2029 pound sterling Notes)	853		947
2.45% notes due 2030 (2.45% 2030 Notes)	2.45% notes due 2030 (2.45% 2030 Notes)	1,250		1,250		2.45% notes due 2030 (2.45% 2030 Notes)	1,250		1,250
2.30% notes due 2031 (2.30% 2031 Notes)	2.30% notes due 2031 (2.30% 2031 Notes)	1,250		1,250		2.30% notes due 2031 (2.30% 2031 Notes)	1,250		1,250
2.00% notes due 2032 (2.00% 2032 Notes)						2.00% notes due 2032 (2.00% 2032 Notes)	1,250		1,250
3.35% notes due 2032 (3.35% 2032 Notes)						3.35% notes due 2032 (3.35% 2032 Notes)	1,000		—
6.375% notes due 2037 (6.375% 2037 Notes)	6.375% notes due 2037 (6.375% 2037 Notes)	478		478		6.375% notes due 2037 (6.375% 2037 Notes)	478		478
6.90% notes due 2038 (6.90% 2038 Notes)	6.90% notes due 2038 (6.90% 2038 Notes)	254		254		6.90% notes due 2038 (6.90% 2038 Notes)	254		254
6.40% notes due 2039 (6.40% 2039 Notes)	6.40% notes due 2039 (6.40% 2039 Notes)	333		333		6.40% notes due 2039 (6.40% 2039 Notes)	333		333
3.15% notes due 2040 (3.15% 2040 Notes)	3.15% notes due 2040 (3.15% 2040 Notes)	2,000		2,000		3.15% notes due 2040 (3.15% 2040 Notes)	2,000		2,000
5.75% notes due 2040 (5.75% 2040 Notes)	5.75% notes due 2040 (5.75% 2040 Notes)	373		373		5.75% notes due 2040 (5.75% 2040 Notes)	373		373
2.80% notes due 2041 (2.80% 2041 Notes)						2.80% notes due 2041 (2.80% 2041 Notes)	1,150		1,150
4.95% notes due 2041 (4.95% 2041 Notes)	4.95% notes due 2041 (4.95% 2041 Notes)	600		600		4.95% notes due 2041 (4.95% 2041 Notes)	600		600
5.15% notes due 2041 (5.15% 2041 Notes)	5.15% notes due 2041 (5.15% 2041 Notes)	729		729		5.15% notes due 2041 (5.15% 2041 Notes)	729		729
5.65% notes due 2042 (5.65% 2042 Notes)	5.65% notes due 2042 (5.65% 2042 Notes)	415		415		5.65% notes due 2042 (5.65% 2042 Notes)	415		415
5.375% notes due 2043 (5.375% 2043 Notes)	5.375% notes due 2043 (5.375% 2043 Notes)	185		185		5.375% notes due 2043 (5.375% 2043 Notes)	185		185
4.40% notes due 2045 (4.40% 2045 Notes)	4.40% notes due 2045 (4.40% 2045 Notes)	2,250		2,250		4.40% notes due 2045 (4.40% 2045 Notes)	2,250		2,250
4.563% notes due 2048 (4.563% 2048 Notes)	4.563% notes due 2048 (4.563% 2048 Notes)	1,415		1,415		4.563% notes due 2048 (4.563% 2048 Notes)	1,415		1,415
3.375% notes due 2050 (3.375% 2050 Notes)	3.375% notes due 2050 (3.375% 2050 Notes)	2,250		2,250		3.375% notes due 2050 (3.375% 2050 Notes)	2,250		2,250
4.663% notes due 2051 (4.663% 2051 Notes)	4.663% notes due 2051 (4.663% 2051 Notes)	3,541		3,541		4.663% notes due 2051 (4.663% 2051 Notes)	3,541		3,541
3.00% notes due 2052 (3.00% 2052 Notes)						3.00% notes due 2052 (3.00% 2052 Notes)	1,350		1,350
4.20% notes due 2052 (4.20% 2052 Notes)						4.20% notes due 2052 (4.20% 2052 Notes)	1,000		—
2.77% notes due 2053 (2.77% 2053 Notes)	2.77% notes due 2053 (2.77% 2053 Notes)	940		940		2.77% notes due 2053 (2.77% 2053 Notes)	940		940


Contractual maturities	June 30, 2021		December 31, 2020
Maturing in one year or less	$	7,159	$	9,795
Maturing after one year through three years	0		50




Total available-for-sale investments	$	7,159	$	9,845


	June 30, 2021						December 31, 2020
	Gross carrying amounts		Accumulated amortization		Other intangible assets, net		Gross carrying amounts		Accumulated amortization		Other intangible assets, net
Finite-lived intangible assets:
Developed-product-technology rights	$	25,584	$	(11,673)	$	13,911	$	25,591	$	(10,564)	$	15,027
Licensing rights	3,766		(2,886)		880		3,743		(2,791)		952
Marketing-related rights	1,363		(1,079)		284		1,367		(1,041)		326
Research and development technology rights	1,308		(1,105)		203		1,317		(1,065)		252
Total finite-lived intangible assets	32,021		(16,743)		15,278		32,018		(15,461)		16,557
Indefinite-lived intangible assets:
In-process research and development	30		—		30		30		—		30
Total other intangible assets	$	32,051	$	(16,743)	$	15,308	$	32,048	$	(15,461)	$	16,587


	Foreign currency translation		Cash flow hedges		Available-for-sale securities		Other		AOCI
Balance as of December 31, 2020	$	(709)	$	(263)	$	1	$	(14)	$	(985)

Foreign currency translation adjustments	(39)		—		—		—		(39)
Unrealized gains	—		108		0		0		108
Reclassification adjustments to income	—		133		0		—		133
Other	—		—		—		1		1
Income taxes	0		(51)		0		—		(51)
Balance as of March 31, 2021	(748)		(73)		1		(13)		(833)

Foreign currency translation adjustments	14		—		—		—		14
Unrealized losses	—		(31)		0		0		(31)
Reclassification adjustments to income	—		(28)		0		—		(28)
Other	—		—		—		(1)		(1)
Income taxes	0		11		0		—		11
Balance as of June 30, 2021	$	(734)	$	(121)	$	1	$	(14)	$	(868)


	Three months ended June 30,
Components of AOCI	2021		2020		Condensed Consolidated Statements of Income locations
Cash flow hedges:
Foreign currency contract (losses) gains	$	(18)	$	68	Product sales
Cross-currency swap contract gains	46		51		Other income, net

	28		119		Income before income taxes
	(6)		(26)		Provision for income taxes
	$	22	$	93	Net income
Available-for-sale securities:
Net realized gains	$	0	$	0	Other income, net
	0		0		Provision for income taxes
	$	0	$	0	Net income

	Six months ended June 30,
Components of AOCI	2021		2020		Condensed Consolidated Statements of Income locations
Cash flow hedges:
Foreign currency contract (losses) gains	$	(19)	$	117	Product sales
Cross-currency swap contract losses	(86)		(82)		Other income, net

	(105)		35		Income before income taxes
	22		(8)		Provision for income taxes
	$	(83)	$	27	Net income
Available-for-sale securities:
Net realized gains	$	0	$	33	Other income, net
	0		(7)		Provision for income taxes
	$	0	$	26	Net income


Level 1	—	Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access
Level 2	—	Valuations for which all significant inputs are observable either directly or indirectly—other than Level 1 inputs
Level 3	—	Valuations based on inputs that are unobservable and significant to the overall fair value measurement


		Quoted prices in active markets for identical assets (Level 1)				Significant other observable inputs (Level 2)			Significant unobservable inputs (Level 3)							Quoted prices in active markets for identical assets (Level 1)				Significant other observable inputs (Level 2)			Significant unobservable inputs (Level 3)

Fair value measurement as of June 30, 2021, using:								Total
Fair value measurement as of June 30, 2022, using:													Fair value measurement as of June 30, 2022, using:						Quoted prices in active markets for identical assets (Level 1)			Significant other observable inputs (Level 2)			Significant unobservable inputs (Level 3)			Total
Assets:	Assets:																						Assets:
Available-for-sale securities:	Available-for-sale securities:												Available-for-sale securities:
U.S. Treasury notes	U.S. Treasury notes			$	52				$	0	$	0		$	52			U.S. Treasury notes					$	—				$	—	$	—	$	—
U.S. Treasury bills	U.S. Treasury bills	1,400				0			0		1,400		U.S. Treasury bills			1,980					—			—			1,980

Money market mutual funds	Money market mutual funds	5,707				0			0		5,707		Money market mutual funds			4,433				—			—			4,433
Other short-term interest-bearing securities	Other short-term interest-bearing securities	0				0			0		0		Other short-term interest-bearing securities			—				—			—			—
Equity securities	Equity securities	403				0			0		403		Equity securities			361				—			131			492
Derivatives:	Derivatives:												Derivatives:
Foreign currency contracts	Foreign currency contracts	0				62			0		62		Foreign currency contracts			—				413			—			413
Cross-currency swap contracts	Cross-currency swap contracts	0				182			0		182		Cross-currency swap contracts			—				29			—			29
Interest rate swap contracts	Interest rate swap contracts	0				45			0		45		Interest rate swap contracts			—				—			—			—

Total assets	Total assets	$	7,562			$	289		$	0	$	7,851	Total assets			$	6,774			$	442		$	131		$	7,347

Liabilities:	Liabilities:												Liabilities:
Derivatives:	Derivatives:												Derivatives:
Foreign currency contracts	Foreign currency contracts	$	0			$	119		$	0	$	119	Foreign currency contracts			$	—			$	30		$	—		$	30
Cross-currency swap contracts	Cross-currency swap contracts	0				305			0		305		Cross-currency swap contracts			—				503			—			503
Interest rate swap contracts	Interest rate swap contracts	0				90			0		90		Interest rate swap contracts			—				591			—			591
Contingent consideration obligations	Contingent consideration obligations	0				0			48		48		Contingent consideration obligations			—				—			310			310
Total liabilities	Total liabilities	$	0			$	514		$	48	$	562	Total liabilities			$	—			$	1,124		$	310		$	1,434


	Foreign currency				U.S. dollars
Hedged notes	Notional amounts		Interest rates		Notional amounts		Interest rates

1.25% 2022 euro Notes	€	1,250	1.3	%	$	1,388	3.2	%
0.41% 2023 Swiss franc Bonds	CHF	700	0.4	%	$	704	3.4	%
2.00% 2026 euro Notes	€	750	2.0	%	$	833	3.9	%
5.50% 2026 pound sterling Notes	£	475	5.5	%	$	747	6.0	%
4.00% 2029 pound sterling Notes	£	700	4.0	%	$	1,111	4.5	%


	Three months ended June 30,				Six months ended June 30,
Derivatives in cash flow hedging relationships	2021		2020		2021		2020
Foreign currency contracts	$	(46)	$	(101)	$	137	$	138
Cross-currency swap contracts	15		71		(60)		(330)

Total unrealized (losses) gains	$	(31)	$	(30)	$	77	$	(192)


		Carrying amounts of hedged liabilities(1)				Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities(2)					Carrying amounts of hedged liabilities(1)				Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities(2)
Condensed Consolidated Balance Sheets locations	Condensed Consolidated Balance Sheets locations	June 30, 2021		December 31, 2020		June 30, 2021		December 31, 2020		Condensed Consolidated Balance Sheets locations	June 30, 2022		December 31, 2021		June 30, 2022		December 31, 2021
Current portion of long-term debt	Current portion of long-term debt	$	844	$	89	$	94	$	89	Current portion of long-term debt	$	82	$	85	$	82	$	85
Long-term debt	Long-term debt	$	6,857	$	6,258	$	330	$	477	Long-term debt	$	6,241	$	6,729	$	(292)	$	199


		Three months ended June 30, 2021						Six months ended June 30, 2021							Three months ended June 30, 2022						Six months ended June 30, 2022
		Product sales		Other income, net		Interest expense, net		Product sales		Other income, net		Interest expense, net			Product sales		Other (expense) income, net		Interest expense, net		Product sales		Other (expense) income, net		Interest expense, net
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income	Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income	$	6,114	$	11	$	(281)	$	11,706	$	24	$	(566)	Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income	$	6,281	$	(317)	$	(328)	$	12,012	$	(847)	$	(623)
The effects of cash flow and fair value hedging:	The effects of cash flow and fair value hedging:													The effects of cash flow and fair value hedging:
(Losses) gains on cash flow hedging relationships reclassified out of AOCI:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:														Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
Foreign currency contracts	Foreign currency contracts	$	(18)	$	—	$	—	$	(19)	$	—	$	—	Foreign currency contracts	$	53	$	—	$	—	$	80	$	—	$	—
Cross-currency swap contracts	Cross-currency swap contracts	$	—	$	46	$	—	$	—	$	(86)	$	—	Cross-currency swap contracts	$	—	$	(185)	$	—	$	—	$	(263)	$	—

(Losses) gains on fair value hedging relationships—interest rate swap agreements:
Gains (losses) on fair value hedging relationships—interest rate swap agreements:														Gains (losses) on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)	Hedged items(1)	$	—	$	—	$	(34)	$	—	$	—	$	141	Hedged items(1)	$	—	$	—	$	157	$	—	$	—	$	494
Derivatives designated as hedging instruments	Derivatives designated as hedging instruments	$	—	$	—	$	55	$	—	$	—	$	(97)	Derivatives designated as hedging instruments	$	—	$	—	$	(135)	$	—	$	—	$	(450)


		Three months ended June 30, 2020						Six months ended June 30, 2020							Three months ended June 30, 2021						Six months ended June 30, 2021
		Product sales		Other income, net		Interest expense, net		Product sales		Other income, net		Interest expense, net			Product sales		Other (expense) income, net		Interest expense, net		Product sales		Other (expense) income, net		Interest expense, net
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income	Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income	$	5,908	$	3	$	(296)	$	11,802	$	14	$	(642)	Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income	$	6,114	$	11	$	(281)	$	11,706	$	24	$	(566)
The effects of cash flow and fair value hedging:	The effects of cash flow and fair value hedging:													The effects of cash flow and fair value hedging:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
(Losses) gains on cash flow hedging relationships reclassified out of AOCI:														(Losses) gains on cash flow hedging relationships reclassified out of AOCI:
Foreign currency contracts	Foreign currency contracts	$	68	$	—	$	—	$	117	$	—	$	—	Foreign currency contracts	$	(18)	$	—	$	—	$	(19)	$	—	$	—
Cross-currency swap contracts	Cross-currency swap contracts	$	—	$	51	$	—	$	—	$	(82)	$	—	Cross-currency swap contracts	$	—	$	46	$	—	$	—	$	(86)	$	—

(Losses) gains on fair value hedging relationships—interest rate swap agreements:	(Losses) gains on fair value hedging relationships—interest rate swap agreements:													(Losses) gains on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)	Hedged items(1)	$	—	$	—	$	(30)	$	—	$	—	$	180	Hedged items(1)	$	—	$	—	$	(34)	$	—	$	—	$	141
Derivatives designated as hedging instruments	Derivatives designated as hedging instruments	$	—	$	—	$	53	$	—	$	—	$	(137)	Derivatives designated as hedging instruments	$	—	$	—	$	55	$	—	$	—	$	(97)


	Derivative assets			Derivative liabilities
December 31, 2020	Condensed Consolidated Balance Sheets locations	Fair values		Condensed Consolidated Balance Sheets locations	Fair values
Derivatives designated as hedging instruments:
Foreign currency contracts	Other current assets/ Other assets	$	28	Accrued liabilities/ Other noncurrent liabilities	$	237
Cross-currency swap contracts	Other current assets/ Other assets	255		Accrued liabilities/ Other noncurrent liabilities	318

Interest rate swap contracts	Other current assets/ Other assets	66		Accrued liabilities/ Other noncurrent liabilities	15
Total derivatives designated as hedging instruments		$	349		$	570


	June 30, 2021		December 31, 2020
Cash, cash equivalents and marketable securities	$	8,082	$	10,647
Total assets	$	59,773	$	62,948
Current portion of long-term debt	$	4,324	$	91
Long-term debt	$	28,458	$	32,895
Stockholders’ equity	$	8,247	$	9,409


Period	Total number of shares purchased	Average price paid per share (1)		Total number of shares purchased as part of publicly announced program	Maximum dollar value that may yet be purchased under the program(2)
April 1 - 30	1,912,921	$	244.13	1,912,921	$	5,044,280,273
May 1 - 31	2,425,697	$	248.21	2,425,697	$	4,442,191,440
June 1 - 30	2,180,367	$	239.80	2,180,367	$	3,919,349,391
Total	6,518,985	$	244.20	6,518,985