Amgen (AMGN) 10-K risk factor changes: FY2023 vs FY2022

*Risks Related to Economic Conditions and Operating a Global [removed: Business, Including During the COVID-19 Pandemic*][added: Business*]

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

- Concentration of sales at certain of our wholesaler [removed: distributors] [added: distributors,] and consolidation of private [removed: payers] [added: payers, such as insurers, and PBMs has negatively affected, and] may [added: continue to] negatively [removed: affect] [added: affect,] our business.

RISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL [removed: BUSINESS, INCLUDING DURING THE COVID-19 PANDEMIC][added: BUSINESS]

[removed: The COVID-19 pandemic and the volatile global economic conditions stemming from it] [added: These conflicts] may [added: also] precipitate or amplify the other risks described [removed: in this “Risk Factors” section,] [added: herein, including risks relating to cybersecurity, global economic conditions, clinical trials and supply chains,] which could [removed: materially] adversely affect our business, operations and financial condition and results.

*A breakdown of our information technology systems, cyberattack or information security breach could [added: significantly] 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 [added: hardware,] software, [added: technology infrastructure, online sites and networks for both internal and external operations,] mobile applications, cloud services and network-connected control systems, some of which are managed, hosted, provided or serviced by third parties.

The complexity and interconnected nature of [added: software, hardware and] our systems [removed: makes] [added: make] them [removed: potentially] vulnerable to breakdown or other service [removed: interruptions.][added: interruptions, and to software errors or defects, misconfiguration and other security vulnerabilities.]

Upgrades or changes to our systems or the software that we use [removed: may] [added: have resulted and we expect, in the future, will] result in the introduction of new cybersecurity vulnerabilities and risks.

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

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

As the cyber-threat landscape evolves, these attacks are growing in frequency, [removed: sophistication] [added: sophistication,] and intensity, and are becoming increasingly difficult to [removed: detect.][added: detect and increasingly sophisticated in using techniques and tools—including artificial intelligence—that circumvent security controls, evade detection and remove forensic evidence.]

Such attacks could include the use of harmful and virulent malware, including ransomware or other denials of service, [removed: that] [added: which] can be deployed through various means, including the software supply chain, e-mail, malicious websites and/or the use of social [removed: engineering.][added: engineering/phishing.]

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

As a result of the cyberattack, its orders and sales for certain products [removed: in certain markets] were negatively affected.

In 2022, Okta, Inc., a provider of software that helps companies manage user authentication, disclosed that several hundred of its corporate customers were vulnerable to a security breach that allowed [added: attackers to access Okta’s internal network.]

Our systems also contain and [removed: utilize] [added: use] a high volume of sensitive data, including intellectual property, trade [removed: secrets,] [added: secrets and other proprietary business information,] financial information, regulatory information, strategic plans, sales trends and forecasts, litigation materials and/or personal [added: identifiable] information belonging to us, our staff, our patients, customers and/or other parties.

In some cases, we utilize third-party service providers to [added: collect,] process, store, manage or transmit such data, which [removed: may increase] [added: have increased] our risk.

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

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

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

[removed: However,] [added: Even though we continue to invest in the monitoring, protection and resilience of our critical and/or sensitive data and systems,] 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, [removed: legal,] [added: legal] business or reputational harm to us or negatively affect our stock price.

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

[removed: Other] [added: Outside the United States, other] jurisdictions where we operate have passed, or continue to propose, similar legislation and/or regulations.

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

Our international business, including in China and emerging market countries, may be especially vulnerable to periods of global and local political, legal, regulatory and financial instability, including issues of geopolitical relations, the imposition of international sanctions in response to certain state actions and/or sovereign debt [removed: issues.][added: issues, and management of health policy in response to pressures such as global pandemics.]

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

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

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

[removed: This] [added: That] Executive Order [removed: follows] [added: followed] a 2021 Executive Order [removed: that included a timeline] designed to increase competition in the healthcare sector, including by calling for the FDA to develop prescription drug importation programs and the FTC to apply greater scrutiny of anticompetitive [removed: activity.][added: activity and responses to which include actions from the HHS (which released a report with drug pricing proposals that seek to promote competition) and from the USPTO (which has taken steps to strengthen coordination with the FDA to address impediments to generic drug and biosimilar competition).]

[added: Other] 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 [removed: September] [added: the fourth quarter of] 2021, HHS released a plan to address drug pricing that included potential future mandatory models that link payment for prescription drugs and biologics to certain factors, including the overall cost of care.

A number of states have adopted, and many other states are considering, drug importation programs [removed: or] [added: and] other pricing actions, including proposals designed to require biopharmaceutical manufacturers to report to the state proprietary pricing information or provide advance notice of certain price increases.

[removed: New York has] [added: For Medicaid patients, states have] established a Medicaid drug spending [removed: cap,] [added: cap (New York)] and [removed: Massachusetts] implemented a new review and supplemental rebate negotiation [removed: process.][added: process (Massachusetts).]

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

For example, in the United States, as of the beginning of [removed: 2023,] [added: 2024,] the top five integrated health plans and PBMs controlled about 92% of all pharmacy prescriptions.

[added: This high degree of] consolidation among [removed: insurers and] [added: insurers,] PBMs and other payers, including [removed: 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 from our business.

Each of CVS, Express Scripts and United Health Group (among the top five integrated health plans and PBMs), [removed: each] have Rebate Management Organizations that further increase their leverage to negotiate deeper discounts.

Policy reforms advanced by Congress or the Administration that refine the role of PBMs in the U.S. marketplace could have downstream implications or [removed: consequences for our business and how we interact with these entities.]

- We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026; such tax liabilities could adversely affect our profitability and results of operations.

The Medicare

price setting process began on August 29, 2023 when CMS announced the first ten drugs for Medicare price setting, which includes ENBREL.

Our wholly owned subsidiary, Immunex Corporation, which holds the rights to the ENBREL BLA, entered into an agreement with the U.S. government to participate in the price setting process and submitted the required data to CMS for ENBREL, including certain price, cost and patent data.

The Medicare price setting process will conclude by August 1, 2024, and by September 1, 2024, CMS will publish prices that will be applicable to these ten drugs in the Medicare program beginning January 1, 2026.

Also under the IRA, starting on January 1, 2024, Medicare Part D was redesigned to cap beneficiary out-of-pocket costs and, beginning January 1, 2025, Federal reinsurance will be reduced in the catastrophic phase (resulting in a shift and increase of such costs to Part D plans and manufacturers, including by requiring manufacturer discounts on certain drugs).

Further, the IRA created a mechanism for CMS to collect rebates from manufacturers if price increases outpace inflation.

Rebate obligations began to accrue October 1, 2022 for Medicare Part D and January 1, 2023 for Medicare Part B, but CMS has not yet issued invoices and has some discretion as to when it must bill manufacturers.

We expect that several of our products will be subject to these inflation rebates, and several of our products have been on lists that are issued and updated on a quarterly basis by CMS under a related program under which Medicare beneficiaries are charged reduced coinsurance if price increases exceed inflation.

The IRA’s drug pricing controls and Medicare redesign are likely to have a material adverse effect on our sales, our business and our results of operations, and such impact is expected to increase through the end of the decade and will depend on factors including the extent of our portfolio’s exposure to Medicare reimbursement, the rate of inflation over time, the number of our products selected for mandatory price setting and the timing of market entry of generic or biosimilar competition.

Further, following the passage of the IRA, the environment remains dynamic and U.S. policymakers continue to demonstrate interest in health care and drug pricing changes.

For example, CMS issued a proposed Medicaid Drug Rebate Program rule that, if finalized, would require manufacturers to aggregate or “stack” all rebates, discounts, or other price concessions made to separate, unrelated entities across the pharmaceutical supply chain on a given unit of product to determine the “Best Price,” a metric that is used to determine Medicaid rebates and 340B statutory rates.

In early 2023, the HHS selected new healthcare payment and delivery models for testing, in response to an October 2022 Executive Order on Lowering Prescription Drug Costs for Americans, including the Accelerating Clinical Evidence Model, which could introduce new payment methods that reduce reimbursement for drugs approved under accelerated approval.

In March 2023, the Administration released its budget plan for fiscal year 2024 that included proposals to expand the number of drugs subject to mandatory Medicare price setting under the IRA, imposing such price setting activity earlier, and extending to commercial health insurance the requirement that drug manufacturers pay rebates if price increases outpace inflation.

While those proposed expansions of the IRA’s drug pricing controls have not been enacted, the proposals demonstrate that this area continues to be a focus of the Administration.

States are also enacting laws referencing the IRA and seeking to regulate the 340B Drug Pricing Program.

For example, following the passage of the IRA, bills have been proposed in multiple states that would apply the drug price caps set by HHS for Medicare to drug prices in an individual state.

Seven states (Colorado, Maine, New Hampshire, Maryland, Minnesota, Oregon and Washington) have enacted laws that establish PDABs to

So far in 2024, no fewer than 11 states have pending PDAB legislation.

States with enacted PDAB laws are in various phases of implementation, with Colorado’s PDAB being the furthest along.

In August 2023, the Colorado PDAB announced the first five drugs to undergo an affordability review, one of which is ENBREL.

If the PDAB process determines that ENBREL is unaffordable, ENBREL could be subject to an upper payment limit as early as Q4 2024.

Louisiana and Arkansas have enacted laws with mandates on manufacturers participating in 340B, and thus far in 2024, no fewer than 15 states have similar legislation pending.

These bills vary, but include provisions on restricting a manufacturer’s ability to direct drugs in 340B channels, recognizing 340B contract pharmacies and a prohibition on requiring the inclusion of 340B claims modifiers.

Further, in *Genesis Health Care, Inc. v.

Becerra*, the U.S. District Court for the District of South Carolina issued an order in November 2023 that enjoins the Health Resources and Services Administration from enforcing its more restrictive interpretation of what is considered a patient under the 340B program, to the potential benefit of healthcare systems seeking to expand the application of 340B discounts.

Additionally, on January 5, 2024, the FDA authorized Florida to move forward with its importation program proposal.

Colorado, Maine, New Hampshire, New Mexico, Texas and Vermont have also enacted state importation laws, and some have submitted plans for approval to the FDA.

While the U.S. District Court for the District of Columbia struck down this policy in September 2023 and further clarified in December 2023 that its ruling had the effect of reinstating the co-pay accumulator adjustment policy from 2020, CMS and HHS have signaled that they do not intend to enforce certain restrictions from the 2020 policy that would reduce the adoption of co-pay accumulator adjustment programs.

consequences for our business and how we interact with these entities.

For example, in June 2022, the FTC launched an inquiry into the business practices of PBMs and subsequently expanded the investigation to the three rebate management organizations owned by the three largest PBMs.

In addition, multiple Congressional Committees are investigating PBM practices and have also proposed legislation that could increase transparency and reporting of these practices and/or impact rebates and service fees.

Further, the EU is currently undergoing a review and possible revision of its pharmaceutical legislation that, while full implementation is not expected before 2027, could lead to proposals that will reduce intellectual property protection for new products (including potentially shortening the duration of regulatory data exclusivity and orphan drug exclusivity protections), as well as change the reimbursement and regulatory landscape.

approved by applicable regulatory agencies or may recommend against reimbursement entirely.

See *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.* The EU has adopted regulations, effective beginning in January 2025, that are intended to increase cooperation among EU member states and harmonize various procedures and standards at the EU level in assessing health technologies and in support of joint clinical assessments of health technologies and medicines.

*We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026; such tax liabilities could adversely affect our profitability and results of operations.*

Effective January 1, 2024, select individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement.

Our legal entities in the countries that have enacted the agreement, along with their direct and indirect subsidiaries, are now subject to a 15% minimum tax rate on adjusted financial statement income.

Additional provisions of the OECD agreement may come into effect in future years, and the OECD is expected to continue to release additional guidance that may impact the application and interpretation of the agreement that could further increase our tax liabilities.

The tax rates associated with certain international provisions of the 2017 Tax Act are set to increase beginning in 2026.

- 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, manufacturing, supply chains, distribution systems, product development, 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.

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

Due to the pandemic and these measures and their effects, we have experienced, and expect to continue to experience, unpredictable reductions in demand for certain of our products, exacerbated by COVID-19 surges resulting in repeated shutdowns 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.

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

These measures and challenges will likely continue to varying degrees 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 sales of 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.

As COVID-19 infection rates ebb and flow, we anticipate there could be periodic backlogs of patients seeking appointments with physicians relating to a variety of medical conditions, and as a result, patients seeking treatment with certain of our products may have to navigate lower provider capacity, and this lower provider capacity could have a continued adverse effect on our sales.

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

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, including the delta and omicron variants and its subvariants, and have been shown to be present in many geographies and appear to spread more easily and quickly than other variants.

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

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

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

These measures could significantly affect our ability to support our operations and customers and the ability of our employees to get to their workplaces to discover, study, develop and produce our product candidates and products, disrupt the movement of our products through the supply chain, and further prevent or discourage patients from participating in our clinical trials, seeking healthcare services and the administration of certain of our products.

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

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

The rapid reallocation of resources for the treatment and prevention of COVID-19 (including the production of COVID-19 vaccines or related therapies, such as our agreement to contribute to the production of COVID-19 antibody therapies for Lilly) and/or disruptions and shortages in the global supply chain caused by the pandemic, could also result in increased competition for, or reduced availability of, materials or components used in the development, manufacturing, 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.

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

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.

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.

The rapid development and fluidity of the pandemic precludes any prediction as to the ultimate effect of COVID-19 on us.

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

The magnitude and degree of COVID-19’s adverse effect on our business (including our product development, product sales, operating 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 shutdown 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.

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

We also market a number of other products, including [added: but not limited to Neulasta,] MVASI, [removed: Vectibix, BLINCYTO, EPOGEN, AMGEVITA, Aimovig,] [added: AMJEVITA/AMGEVITA, TEZSPIRE,] Parsabiv, [removed: KANJINTI,] [added: Aimovig,] LUMAKRAS/LUMYKRAS, [removed: TEZSPIRE, NEUPOGEN, Sensipar/Mimpara] [added: EPOGEN, KANJINTI, TAVNEOS, RAVICTI, UPLIZNA] and [removed: TAVNEOS.][added: PROCYSBI.]

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

[removed: During 2022, while gradually recovering from the] [added: The increase in] global [removed: pandemic and facing increased competition from biosimilars and generics, total product] [added: Vectibix] sales [removed: increased 2%, primarily] [added: for 2022 was] driven by [added: higher net selling price and] volume [removed: growth for certain brands,] [added: growth,] partially offset by [removed: declines in net selling prices of certain products and] unfavorable changes to foreign currency exchange rates.

Cash flows from operating activities totaled [removed: $9.7] [added: $8.5] billion, which supported investment in our [removed: business] [added: business, including our Horizon acquisition,] while returning capital to shareholders through the payment of cash [removed: dividends and stock repurchases.][added: dividends.]

For [removed: 2022,] [added: 2023,] we increased our quarterly cash dividend by 10% to [removed: $1.94] [added: $2.13] per share of common stock.

In December [removed: 2022,] [added: 2023,] we declared a cash dividend of [removed: $2.13] [added: $2.25] per share of common stock for the first quarter of [removed: 2023,] [added: 2024,] an increase of [removed: 10%] [added: 6%] for this period, to be paid in March [removed: 2023.][added: 2024.]

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

To continue on our path to greater environmental sustainability, in January 2021 we announced a new set of long-term environmental targets to achieve by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by [removed: 75%.(1)(2)] [added: 75%.(2)(3)] Additionally, in 2022 we issued our first green [removed: bonds] [added: bonds, which were used] to finance eligible projects that [removed: meet] [added: met] specified criteria to reduce our impact on the environment.

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

[removed: Rising healthcare costs, uncertain] [added: Uncertain] macroeconomic conditions, including higher [removed: inflation and] [added: inflation,] rising interest [removed: rates,] [added: rates] and [removed: geopolitical conflicts] [added: instability in the financial system, as well as rising healthcare costs] continue to pose challenges to our business.

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

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

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

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

| | | | Year ended December 31, [added: 2023 | | | | | | Change | | | | | | Year ended December 31,] 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

| [added: Total] U.S. | | | $ | [added: 19,272 | | | | | 9 | | % | | | | $ |] 17,743 | | | | | 3 | | % | | | | $ | 17,286 | |

| [added: Total] ROW | | | [added: 7,638 | | | | | | 8 | | % | | | |] 7,058 | | | | | | 1 | | % | | | | 7,011 | | |

| Total product sales | | | [removed: 24,801] [added: $] | [added: 26,910] | | | | | [added: 9 | | % | | | | $ | 24,801 | | | | |] 2 | | % | | | | [removed: 24,297] [added: $] | [added: 24,297] | |

| Other revenues | | | [removed: 1,522] [added: 1,280] | | | | | | [removed: (10)] [added: (16)] | | % | | | | [removed: 1,682] [added: 1,522] | | |

| Total revenues | | | $ | [removed: 26,323] [added: 28,190] | | | | | [removed: 1] [added: 7] | | % | | | | $ | [removed: 25,979] [added: 26,323] | |

| [removed: Operating] [added: Total operating] expenses | | | $ | [added: 20,293 | | | | | 21 | | % | | | | $ |] 16,757 | | | | | (9) | | % | | | | $ | 18,340 | |

| Operating income | | | $ | [removed: 9,566] [added: 7,897] | | | | | [removed: 25] [added: (17)] | | % | | | | $ | [removed: 7,639] [added: 9,566] | |

| Net income | | | $ | [removed: 6,552] [added: 6,717] | | | | | [removed: 11] [added: 3] | | % | | | | $ | [removed: 5,893] [added: 6,552] | |

| Diluted EPS | | | $ | [removed: 12.11] [added: 12.49] | | | | | [removed: 18] [added: 3] | | % | | | | $ | [removed: 10.28] [added: 12.11] | |

| Diluted shares | | | [removed: 541] [added: 538] | | | | | | [removed: (6)] [added: (1)] | | % | | | | [removed: 573] [added: 541] | | |

Total product sales increased in [removed: 2022,] [added: 2023,] primarily driven by volume growth for certain brands, including Repatha, [removed: Prolia,] [added: TEZSPIRE,] EVENITY, [removed: Nplate, LUMAKRAS/LUMYKRAS, KYPROLIS, Otezla] [added: Prolia] and [removed: TEZSPIRE,] [added: BLINCYTO, and the contribution of $954 million in product sales from the Horizon acquisition during the period from the acquisition date of October 6, 2023 through December 31, 2023,] partially offset by declines in net selling prices of certain products, including Neulasta, [removed: Repatha and MVASI,] [added: MVASI] and [removed: unfavorable changes to foreign currency exchange rates.][added: ENBREL.]

For [removed: 2023,] [added: 2024,] we expect that net selling prices will continue to decline at a portfolio level driven by increased competition.

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

[removed: However,] [added: Our product sales were affected by reduced demand as a result of] the [added: COVID-19 pandemic, and the] cumulative decrease in diagnoses over the course of the pandemic [removed: has] suppressed the volume of new patients starting treatment, which continues to impact [removed: our] [added: the] business.

Given the unpredictable nature of [removed: the pandemic,] [added: future virus surges,] there could be [added: future] intermittent disruptions in physician–patient [removed: interactions, and as a result, we may experience quarter-to-quarter variability.][added: interactions.]

[removed: In addition, other] [added: Uncertain macroeconomic conditions,] changes in the healthcare ecosystem [added: and geopolitical conflicts] have the potential to introduce variability into product [removed: sales trends.][added: sales.]

[removed: Growth] [added: For example, actions by governments and other entities to curb high inflation, provisions of the IRA and growth] in numbers of Medicaid enrollees and uninsured [removed: individuals, along with provisions of the IRA,] [added: individuals] may have a negative impact on product sales.

See Part IV—Note [removed: 2,] [added: 3,] Acquisitions and divestitures, [removed: and Note 8, Collaborations,] to the Consolidated Financial Statements.

| | | | Year ended December 31, [removed: 2022] [added: 2023] | | | | | | Change | | | | | | Year ended December 31, [removed: 2021] [added: 2022] | | | | | | Change | | | | | | Year ended December 31, [removed: 2020] [added: 2021] | | |

| ENBREL | | | [removed: $] [added: 3,697] | [removed: 4,117] | | | | | [removed: (8)] [added: (10)] | | % | | | | [removed: $] [added: 4,117] | [removed: 4,465] | | | | | [removed: (11)] [added: (8)] | | % | | | | [removed: $] [added: 4,465] | [removed: 4,996] | |

| Prolia | | | [removed: 3,628] [added: $] | [added: 4,048] | | | | | 12 | | % | | | | [removed: 3,248] [added: $] | [added: 3,628] | | | | | [removed: 18] [added: 12] | | % | | | | [removed: 2,763] [added: $] | [added: 3,248] | |

| Otezla | | | [removed: 2,288] [added: 2,188] | | | | | | [removed: 2] [added: (4)] | | % | | | | [removed: 2,249] [added: 2,288] | | | | | | 2 | | % | | | | [removed: 2,195] [added: 2,249] | | |

| XGEVA | | | [removed: 2,014] [added: 2,112] | | | | | | [removed: —] [added: 5] | | % | | | | [removed: 2,018] [added: 2,014] | | | | | | [removed: 6] [added: —] | | % | | | | [removed: 1,899] [added: 2,018] | | |

| Aranesp | | | [removed: 1,421] [added: 1,362] | | | | | | (4) | | % | | | | [removed: 1,480] [added: 1,421] | | | | | | [removed: (6)] [added: (4)] | | % | | | | [removed: 1,568] [added: 1,480] | | |

Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease.

We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies.

Our robust pipeline includes potential first-in-class medicines at all stages of development.

In 2023, we completed our acquisition of Horizon, advanced our innovative pipeline and generated strong volume growth across our product portfolio and regions.

Our newly established rare disease therapeutic area is designed to maximize the potential of medicines acquired in connection with our Horizon acquisition, including TEPEZZA for thyroid eye disease, KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder, as well as TAVNEOS, acquired from the ChemoCentryx acquisition in 2022, for severe active ANCA-associated vasculitis.

We are advancing our pipeline of innovative medicines, including initiating and completing enrollment of our Phase 2 study of maridebart cafraglutide for the treatment of obesity; announcing results from our Phase 2 study of tarlatamab in patients with SCLC; and rapidly enrolling patients in Phase 2 and Phase 3 studies for several of our later-stage clinical programs across our therapeutic areas.

For more information on our pipeline, including programs acquired from our Horizon acquisition, see Part I, Item 1.

Business—Research and Development and Selected Product Candidates.

In our effort to attract and retain the best talent, we seek out and support talent across the globe, including in underrepresented populations, consistent with our commitment to equal opportunity.

*Macroeconomic and other challenges*

Further, ongoing geopolitical conflicts continue to create additional uncertainty in global macroeconomic conditions.

Given the unpredictable nature of future virus surges, there could be similar intermittent disruptions in the future in physician–patient interactions.

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

| U.S. | | | $ | 19,272 | | | | | 9 | | % | | | | $ | 17,743 | |

| ROW | | | 7,638 | | | | | | 8 | | % | | | | 7,058 | | |

| Total product sales | | | 26,910 | | | | | | 9 | | % | | | | 24,801 | | |

Total product sales increased in 2023, primarily driven by volume growth for certain brands, including Repatha, TEZSPIRE, EVENITY, Prolia and BLINCYTO, and the contribution of $954 million in product sales from the Horizon

acquisition during the period from the acquisition date of October 6, 2023 through December 31, 2023, partially offset by declines in net selling prices of certain products, including Neulasta, MVASI and ENBREL.

Furthermore, our product sales were affected by reduced demand as a result of the COVID-19 pandemic, and the cumulative decrease in diagnoses over the course of the pandemic suppressed the volume of new patients starting treatment, which continues to impact the business.

Other revenues decreased for 2023, primarily due to lower revenue from our COVID-19 manufacturing collaboration.

Operating expenses increased for 2023, due to higher amortization and acquisition-related expenses incurred as a result of the Horizon acquisition, a net impairment charge resulting from the termination of AMG 340, higher profit share and royalty expense, changes in our product mix and higher spend in later-stage clinical programs and marketed products support, partially offset by a loss on the divestiture of Gensenta in 2022.

See Part IV—Note 3, Acquisitions and divestitures; Note 13, Goodwill and other intangible assets; and Note 18, Fair value measurement, to the Consolidated Financial Statements.

| Vectibix | | | 984 | | | | | | 10 | | % | | | | 893 | | | | | | 2 | | % | | | | 873 | | |

| BLINCYTO | | | 861 | | | | | | 48 | | % | | | | 583 | | | | | | 24 | | % | | | | 472 | | |

| TEPEZZA(1) | | | 448 | | | | | | NM | | | | | | — | | | | | | NM | | | | | | — | | |

| KRYSTEXXA(1) | | | 272 | | | | | | NM | | | | | | — | | | | | | NM | | | | | | — | | |

| Other products(2) | | | 5,263 | | | | | | 1 | | % | | | | 5,220 | | | | | | (9) | | % | | | | 5,710 | | |

(1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales from the acquisition date through December 31, 2023.

The increase in global Prolia sales for 2023 was primarily driven by volume growth and higher net selling price.

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

For a discussion of ongoing litigation related to XGEVA, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

The increase in global Nplate sales for 2022 was driven by volume growth, including a U.S. government order of $207 million.

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

| | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | | | | | Change | | | | | | Year ended December 31, 2021 | | |

The decrease in global Aranesp sales for 2023 was driven by unfavorable changes to foreign currency exchange rates and lower net selling price.

Amgen is a biotechnology company committed to unlocking the potential of biology for patients suffering from serious illnesses.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We operate in six commercial areas: inflammation, oncology/hematology, bone health, cardiovascular (CV) disease, nephrology and neuroscience.

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

In 2022, we advanced our innovative pipeline, grew our international business, completed a strategic transaction to augment our marketed product portfolio, announced our intention to acquire Horizon and continued providing uninterrupted supplies of our medicines globally through the third year of the COVID-19 pandemic.

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

We continued to grow our international business, including achieving key regulatory approvals for TEZSPIRE in the EU and Japan.

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

We also continued to advance our biosimilar program, with launches in new markets.

Our biosimilars are expected to continue launching in new markets throughout 2023, including the U.S. launch of AMJEVITA in January 2023.

Product sales increased 3% in the United States, primarily driven by volume growth, partially offset by declines in net selling prices, and increased 1% in ROW, primarily driven by volume growth, partially offset by unfavorable changes to foreign currency exchange rates and declines in net selling prices.

Total operating expenses decreased 9% due to both the acquired IPR&D write-off from the Five Prime acquisition and a licensing-related upfront payment to KKC in 2021, partially offset by a loss on a nonstrategic divestiture in 2022.

We also repurchased 26.1 million shares of our common stock during 2022 at an aggregate cost of $6.3 billion.

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

We are engaging in activities and setting goals to improve our focus on diversity, inclusion and belonging.

*COVID-19 pandemic*

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

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

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

Over the course of the pandemic we have experienced changes in demand for some of our products as fluctuations in the frequency of patient visits to doctors’ offices have impacted the provision of treatments to existing patients and reduced diagnoses in new patients.

During 2021, there was a gradual recovery in both patient visits and diagnosis rates that approached pre-pandemic levels.

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

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

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

Since early 2021, efforts have been under way to control the COVID-19 pandemic.

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

Challenges to vaccination efforts, new variants and other causes of virus spread may require governments to change restrictions and/or shutdown requirements in various geographies.

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

For a discussion of the risks the COVID-19 pandemic could present to our results, see Part I, Item 1A.

Risk Factors of this Form 10-K.

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

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

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

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

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

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

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

Overall, uncertainty remains around the timing and magnitude of our sales during the COVID-19 pandemic.

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

Operating expenses decreased for 2022 due to both the acquired IPR&D write-off related to the bemarituzumab program acquired as part of the Five Prime acquisition and a licensing-related upfront payment to KKC in 2021, partially offset by a loss

In the discussion that follows, we assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022.]

Except as noted below, we also assumed a hypothetical 20% change in foreign currency exchange rates against the U.S. dollar based on its position relative to other currencies as of December 31, [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022.]

Our portfolio of available-for-sale investments as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] was composed almost entirely of U.S. Treasury securities and money market mutual funds.

The fair values of our available-for-sale investments were [removed: $4.3] [added: $10.4] billion and [removed: $7.3] [added: $4.3] billion as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] respectively.

Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] would not have resulted in a material reduction in the fair values of these securities.

In addition, a hypothetical 100 basis point decrease in interest rates as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] would not result in a material effect on income in the respective ensuing year.

As of December 31, [removed: 2021,] [added: 2023,] we had outstanding debt with a carrying value of [removed: $33.3] [added: $64.6] billion and a fair value of [removed: $37.9] [added: $59.2] billion.

A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] would have resulted in an increase of [removed: $3.5] [added: $5.4] billion and [removed: $4.5] [added: $3.5] billion, respectively, in the aggregate fair value of our outstanding debt on these dates.

These interest rate swap contracts effectively converted a fixed-rate interest coupon to a floating-rate [removed: LIBOR-based] [added: SOFR-based] coupon over the life of the respective notes.

Interest rate swap contracts with aggregate notional amounts of $6.7 billion were outstanding as of both December 31, [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022.]

A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] would have resulted in reductions in fair values of approximately [removed: $210] [added: $180] million and [removed: $330] [added: $210] million, respectively, on our interest rate swap contracts on these dates.

A hypothetical 100 basis point [removed: decrease] [added: adverse movement] in interest rates relative to interest rates as of December 31, [removed: 2022] [added: 2023 and 2022,] would have resulted in [removed: a reduction] [added: reductions] in [added: the] fair [removed: value] [added: values] of [removed: approximately $60 million on] our [removed: forward interest rate] [added: cross-currency swap] contracts [removed: on this date.][added: of approximately $100 million and $90 million, respectively.]

As of [removed: both] December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we had outstanding cross-currency swap contracts with aggregate notional [removed: amount] [added: amounts] of [removed: $3.4] [added: $2.7] billion [added: and $3.4 billion, respectively,] that hedge our foreign-currency-denominated debt and related interest payments.

A hypothetical [removed: 100 basis point] [added: 20%] adverse movement in [removed: interest] [added: foreign currency exchange] rates [added: compared with the U.S. dollar] relative to [removed: interest] [added: exchange] rates [removed: as of December 31, 2022 and 2021,] [added: on these dates] would have resulted in reductions in the fair values of [removed: our cross-currency swap] [added: these] contracts of approximately [removed: $90] [added: $480] million and [removed: $170 million,] [added: $540 million on these dates,] respectively.

As of December 31, [removed: 2021,] [added: 2023,] we had outstanding [removed: euro-, pound-sterling-] [added: euro-] and [removed: Swiss-franc-denominated] [added: pound-sterling- denominated] debt with a principal carrying value and a fair value of [removed: $3.2] [added: $2.3] billion and [removed: $3.6] [added: $2.3] billion, respectively.

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2022, would have resulted in an increase in fair value of this debt of [removed: approximately] $580 million on this date and a reduction in income in the ensuing year of [removed: approximately] $600 million.

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, [removed: 2021,] [added: 2023,] would have resulted in an increase in fair value of this debt of [removed: $710] [added: approximately $470] million on this date and a reduction in income in the ensuing year of [removed: $640] [added: approximately $460] million.

We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in [removed: euros,] [added: euros and] pounds sterling [removed: and] [added: (and] Swiss [removed: francs,] [added: francs] with [added: respect to the prior year), with] aggregate notional amount of [added: $2.7 billion and] $3.4 billion as of [removed: both] December 31, [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022, respectively.]

[removed: A] [added: With regard to contracts that were open as of December 31, 2022, a] hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates [removed: on these dates] [added: as of December 31, 2022,] would have resulted in [removed: reductions] [added: a reduction] in [removed: the] fair [removed: values] [added: value] of these contracts of approximately [removed: $540 million and $700 million] [added: $1.1 billion] on [removed: these dates, respectively.][added: this date and in the ensuing year, a reduction in income of $590 million.]

As of December 31, [removed: 2021,] [added: 2023,] the fair values of these contracts were a [removed: $183] [added: $145] million asset and a [removed: $39] [added: $116] million liability.

As of December 31, [removed: 2021,] [added: 2023,] we had primarily euro-based open foreign currency forward contracts with notional amounts of [removed: $5.7] [added: $6.6] billion.

With regard to foreign currency forward contracts that were open as of December 31, [removed: 2022,] [added: 2023,] a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, [removed: 2022,] [added: 2023,] would have resulted in a reduction in fair value of these contracts of approximately [removed: $1.1] [added: $1.2] billion on this date and in the ensuing year, a reduction in income of approximately [removed: $590] [added: $690] million.

With regard to [added: these foreign currency forward] contracts that were open as of December 31, [removed: 2021,] [added: 2023 and 2022,] a hypothetical [removed: 20%] [added: 5%] adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates [removed: as of December 31, 2021,] [added: on these dates] would [added: not] have [removed: resulted in] a [removed: reduction in] [added: material effect on the] fair [removed: value] [added: values] of these contracts [removed: of approximately $1.1 billion on this date and] [added: or related income] in the [added: respective] ensuing [removed: year, a reduction in income of $390 million.][added: years.]

As of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we had open, short-duration, foreign currency forward contracts that mature in one month or less, that had notional amounts of $0.5 billion and [removed: $0.7] [added: $0.5] billion, respectively, and that hedged fluctuations of certain assets and liabilities denominated in foreign currencies but were not designated as hedges for accounting purposes.

These contracts had no material net unrealized gains or losses as of December 31, [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022.]

As of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we were exposed to price risk on equity securities included in our portfolio of investments, which were acquired primarily for the promotion of business and strategic objectives.

These investments include [added: our investments in BeiGene and Neumora, as well as other] publicly and privately held small-capitalization stocks, limited partnerships that invest in early-stage biotechnology [removed: companies][added: companies.]

A 20% decrease in the aggregate value of our equity investment portfolio as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] would result in losses in fair value of approximately [removed: $1.1] [added: $1.0] billion and [removed: $1.4] [added: $1.1] billion, respectively.

[removed: In addition, we have an investment policy that limits] investments to certain types of debt and money market instruments issued by institutions with investment-grade credit ratings and places restriction on maturities and concentrations by asset class and issuer.

In addition, we have an investment policy that limits

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

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

With regard to these foreign currency forward contracts that were open as of December 31, 2022 and 2021, a hypothetical 5% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would not have a material effect on the fair values of these contracts or related income in the respective ensuing years.

and our investment in BeiGene.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that [removed: improve health outcomes and] dramatically improve people’s [removed: lives.][added: lives, while also reducing the social and economic burden of disease.]

Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, [removed: 2021.][added: 2022.]

[removed: *Proposed acquisition] [added: *Acquisition] of Horizon Therapeutics plc*

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

[removed: In recent years, we have expanded the commercialization] [added: We also commercialize] and [removed: marketing of] [added: market] our products into other geographic territories, including Japan, China and other parts of [removed: Asia;] [added: Asia,] Latin [removed: America;] [added: America] and the Middle [removed: East.][added: East by using our own affiliates, by acquiring existing third-party businesses or product rights or by collaborating with third parties.]

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

Our product sales to three large wholesalers, McKesson Corporation, [removed: AmerisourceBergen Corporation] [added: Cencora, Inc. (formerly AmerisourceBergen)] and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020.][added: 2021.]

On a combined basis, these wholesalers accounted for [removed: 82%,] [added: 79%,] 82% and [removed: 83%] [added: 82%] of worldwide gross revenues for [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020,] [added: 2021,] respectively.

The following chart shows our product sales by principal product, and the table below (dollar amounts in millions) shows product sales by geography for the years [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020.][added: 2021.]

[removed: ][added: ]

| | | | [removed: 2022] [added: 2023] | | | | | | | | | [removed: 2021] [added: 2022] | | | | | | | | | [removed: 2020] [added: 2021] | | | | | |

| U.S. | | | $ | [removed: 17,743] [added: 19,272] | | 72 | | % | | | | $ | [removed: 17,286] [added: 17,743] | | [removed: 71] [added: 72] | | % | | | | $ | [removed: 17,985] [added: 17,286] | | [removed: 74] [added: 71] | | % |

| ROW | | | [removed: 7,058] [added: 7,638] | | | 28 | | % | | | | [removed: 7,011] [added: 7,058] | | | [removed: 29] [added: 28] | | % | | | | [removed: 6,255] [added: 7,011] | | | [removed: 26] [added: 29] | | % |

| Total | | | $ | [removed: 24,801] [added: 26,910] | | 100 | | % | | | | $ | [removed: 24,297] [added: 24,801] | | 100 | | % | | | | $ | [removed: 24,240] [added: 24,297] | | 100 | | % |

[removed: (1)] [added: (2)] Consists of product sales of our non-principal products, as well as [added: sales prior to the divestiture of] our [added: Bergamo and] Gensenta [added: subsidiaries in the second quarter of 2023] and [removed: Bergamo subsidiaries.][added: fourth quarter of 2022, respectively.]

In the United States, it is used [removed: primarily] in the indication for the treatment of [added: osteoporosis in] postmenopausal women [removed: with osteoporosis] at high risk [removed: of] [added: for] fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or [removed: in] patients who have failed or are intolerant to other available osteoporosis therapy.

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

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

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

KYPROLIS was launched in 2012 and is indicated in combination with (i) dexamethasone, (ii) lenalidomide plus [removed: dexamethasone and] [added: dexamethasone,] (iii) [removed: DARZALEX] [added: daratumumab] plus [added: dexamethasone, (iv) daratumumab plus hyaluronidase-fihj plus dexamethasone, and (v) isatuximab plus] dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

In the United States, it is used [added: primarily] in the indication for the treatment of [removed: osteoporosis in] postmenopausal women [added: with osteoporosis] at high risk [added: of fracture and] for [added: treatment to increase bone mass in men with osteoporosis at high risk of] fracture.

We also market a number of other products in various markets worldwide, including [added: but not limited to Neulasta,] MVASI, [removed: Vectibix, BLINCYTO, EPOGEN, AMGEVITA, Aimovig,] [added: AMJEVITA/AMGEVITA, TEZSPIRE,] Parsabiv, [removed: KANJINTI,] [added: Aimovig,] LUMAKRAS/LUMYKRAS, [removed: TEZSPIRE, NEUPOGEN, Sensipar/Mimpara] [added: EPOGEN, KANJINTI, TAVNEOS, RAVICTI, UPLIZNA] and [removed: TAVNEOS.][added: PROCYSBI.]

| Enbrel® (etanercept) | | | | | | U.S. | | | | | | [removed: Methods] [added: Formulations and methods] of [removed: treatment using aqueous] [added: preparing] formulations | | | | | | [removed: 6/8/2023] [added: 10/19/2037] | | |

| [added: Prolia®/XGEVA® (denosumab)] | | | [added: | | |] U.S. | | | | | | RANKL antibodies, including sequences | | | | | | 2/19/2025 | | | [removed: | | |]

| | | | U.S. | | | | | | Methods of [removed: treatment(2)] [added: treatment] | | | | | | [removed: 5/29/2034] [added: 11/22/2030] | | | | | |

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

| Repatha® (evolocumab) | | | | | | U.S. | | | | | | [removed: Antibodies(3)] [added: Antibodies(2)] | | | | | | [removed: 10/25/2029] [added: 8/22/2028] | | |

| | | | U.S. | | | | | | Methods of treatment | | | | | | [removed: 10/8/2030] [added: 6/25/2030] | | | | | |

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

| | | | U.S. | | | | | | Methods of treatment | | | | | | [removed: 8/11/2040] [added: 9/15/2040] | | | | | |

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

| | | | Europe | | | | | | [removed: Polypeptides] [added: Polypeptides(1)] | | | | | | 9/9/2028 | | | | | |

| TAVNEOS® (avacopan) | | | | | | U.S. | | | | | | Compounds and pharmaceutical [removed: compositions(3)] [added: compositions(2)] | | | | | | 2/3/2031 | | |

- evolocumab — France, [added: expiring in 2030 and] Spain and the United Kingdom, expiring in [removed: 2030][added: 2031]

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

See Part IV—Note [removed: 19,] [added: 20,] Contingencies and commitments, to the Consolidated Financial [removed: Statements, Amgen Inc. v.][added: Statements.]

[removed: (3)A] [added: (2)A] patent with this subject matter may be entitled to patent term extension in the United States.

We continue to pursue ways of increasing the value of our medicines through [removed: innovations during their life cycles,] [added: innovations,] which can include expanding the disease areas for which our products are indicated and finding new methods to make the delivery [added: or manufacture] of our medicines easier and less costly.

Companies have launched [removed: biosimilar] versions of EPOGEN, [removed: NEUPOGEN and] [added: NEUPOGEN,] Neulasta and [removed: have approved] [added: ENBREL (Canada only) with U.S. ENBREL] biosimilars [removed: for ENBREL.][added: approved but not launched.]

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

Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases.

We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies.

Our robust pipeline includes potential first-in-class medicines at all stages of development.

In October 2023, we completed our acquisition of Horizon for $116.50 per share in cash, representing a total transaction price of $27.8 billion.

The acquisition aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for thyroid eye disease (TED), KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder.

Risk Factors—*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*.

In October 2023, we announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 (DLL3) targeting BiTE® (bispecific T-cell engager) molecule, in patients with advanced stage small cell lung cancer (SCLC) who had failed two or more prior lines of treatment.

With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an objective response rate (ORR; primary endpoint) of 40%.

For key secondary endpoints, median progression-free survival (mPFS) was 4.9 months, and median overall survival (mOS) was 14.3 months.

There were no new safety signals observed compared to the Phase 1 study.

Additionally in October 2023, the FDA granted tarlatamab Breakthrough Therapy Designation for the treatment of adult patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy.

In December 2023, we announced the FDA accepted and granted Priority Review for the Company’s BLA for tarlatamab, with a PDUFA date of June 12, 2024.

In December 2023, we announced that the FDA completed its review of our supplemental New Drug Application seeking full approval of LUMAKRAS, resulting in a Complete Response Letter.

The review was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.

Additionally, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS’s accelerated approval has been fulfilled.

LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.

In October 2023, we announced positive data from the global Phase 3 CodeBreaK 300 trial.

This global Phase 3 study evaluated two doses of LUMAKRAS/LUMYKRAS (960 mg or 240 mg) in combination with Vectibix versus investigator’s choice of therapy (trifluridine and tipiracil, or regorafenib) in patients with chemorefractory G12C-mutated mCRC.

In June 2023, based on data from the previous CodeBreaK 101 study, the FDA granted Breakthrough Therapy Designation to LUMAKRAS in combination with Vectibix for the treatment of patients with metastatic KRAS G12C-mutated CRC, as determined by an FDA approved test, who have received prior chemotherapy.

This international footprint allows us to deliver our medicines to more patients globally.

(1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales from the acquisition date through December 31, 2023.

*Vectibix*

We market Vectibix in many countries around the world.

Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, cancer that has spread outside the colon and rectum).

RAS status is determined by an FDA-approved test.

We market BLINCYTO in many countries around the world.

BLINCYTO was launched in 2014 and has proven efficacy in a wide range of patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL), including those who are MRD(–) or MRD(+) in frontline consolidation, and those with relapsed or refractory (R/R) disease.

ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

*TEPEZZA*

Subsequent to the closing of our Horizon acquisition, we market TEPEZZA primarily in the United States.

TEPEZZA is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is the first and only FDA approved medicine for the treatment of thyroid eye disease (TED).

TED is a serious, progressive and vision-threatening rare autoimmune condition.

While TED often occurs in people living with hyperthyroidism or Graves’ disease, it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.

This leads to a cascade of negative effects, which may cause long-term, irreversible eye damage.

As TED progresses, it causes serious damage, including proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision), and in some cases can lead to blindness.

Historically, patients have had to live with TED until the inflammation subsides, after which they are often left with permanent and vision-impairing consequences and may require multiple surgeries that do not completely return the patient to their pre-disease state.

*KRYSTEXXA*

Subsequent to the closing of our Horizon acquisition, we market KRYSTEXXA in the United States.

KRYSTEXXA is the first and only FDA-approved medicine for the treatment of chronic refractory gout.

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

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

A biotechnology pioneer, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

*Acquisitions*

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

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

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

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

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

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

*ChemoCentryx, Inc.*

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

*Cardiometabolic*

*Repatha*

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

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

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

*Olpasiran*

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

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

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

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

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

*Inflammation*

*TEZSPIRE*

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

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

*ABP 654*

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

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

*Oncology/Hematology*

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

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

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

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

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

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

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

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

*ABP 959*

Certain of the legal proceedings in which we are involved are discussed in Part IV—Note [removed: 19,] [added: 20,] Contingencies and commitments, to the Consolidated Financial Statements and are hereby incorporated by reference.

For the fiscal year ended December 31, [removed: 2022][added: 2023]

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was [removed: $129,940,091,621] [added: $118,556,278,405] as of June 30, [removed: 2022.(A)][added: 2023.(A)]

(A)Excludes [removed: 818,128] [added: 901,685] shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, at June 30, [removed: 2022.][added: 2023.]

(Number of shares of common stock outstanding as of February [removed: 6, 2023)][added: 9, 2024)]

Specified portions of the registrant’s Proxy Statement with respect to the [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be held [added: on] May [removed: 19, 2023,] [added: 31, 2024,] are incorporated by reference into Part III of this annual report.

| | | | [DEFINED TERMS AND [removed: PRODUCTS](#if8055099d1994bb494875d41c341f00d_10)] [added: PRODUCTS](#i4bee8fea21084f779a0b7cdc42786b07_10)] | | | [removed: [ii](#if8055099d1994bb494875d41c341f00d_10)] [added: [ii](#i4bee8fea21084f779a0b7cdc42786b07_10)] | | |

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| | | | [Significant [removed: Developments](#if8055099d1994bb494875d41c341f00d_19)] [added: Developments](#i4bee8fea21084f779a0b7cdc42786b07_19)] | | | [removed: [1](#if8055099d1994bb494875d41c341f00d_19)] [added: [1](#i4bee8fea21084f779a0b7cdc42786b07_19)] | | |

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| | | | [Business [removed: Relationships](#if8055099d1994bb494875d41c341f00d_37)] [added: Relationships](#i4bee8fea21084f779a0b7cdc42786b07_37)] | | | [removed: [22](#if8055099d1994bb494875d41c341f00d_37)] [added: [22](#i4bee8fea21084f779a0b7cdc42786b07_37)] | | |

| | | | [Human Capital [removed: Resources](#if8055099d1994bb494875d41c341f00d_40)] [added: Resources](#i4bee8fea21084f779a0b7cdc42786b07_40)] | | | [removed: [23](#if8055099d1994bb494875d41c341f00d_40)] [added: [24](#i4bee8fea21084f779a0b7cdc42786b07_40)] | | |

| | | | [Information about our Executive [removed: Officers](#if8055099d1994bb494875d41c341f00d_43)] [added: Officers](#i4bee8fea21084f779a0b7cdc42786b07_43)] | | | [removed: [26](#if8055099d1994bb494875d41c341f00d_43)] [added: [27](#i4bee8fea21084f779a0b7cdc42786b07_43)] | | |

| | | | [Geographic Area Financial [removed: Information](#if8055099d1994bb494875d41c341f00d_46)] [added: Information](#i4bee8fea21084f779a0b7cdc42786b07_46)] | | | [removed: [27](#if8055099d1994bb494875d41c341f00d_46)] [added: [28](#i4bee8fea21084f779a0b7cdc42786b07_46)] | | |

| | | | [Investor [removed: Information](#if8055099d1994bb494875d41c341f00d_49)] [added: Information](#i4bee8fea21084f779a0b7cdc42786b07_49)] | | | [removed: [27](#if8055099d1994bb494875d41c341f00d_49)] [added: [28](#i4bee8fea21084f779a0b7cdc42786b07_49)] | | |

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| Item 3. | | | [LEGAL [removed: PROCEEDINGS](#if8055099d1994bb494875d41c341f00d_61)] [added: PROCEEDINGS](#i4bee8fea21084f779a0b7cdc42786b07_64)] | | | [removed: [52](#if8055099d1994bb494875d41c341f00d_61)] [added: [57](#i4bee8fea21084f779a0b7cdc42786b07_64)] | | |

| Item 4. | | | [MINE SAFETY [removed: DISCLOSURES](#if8055099d1994bb494875d41c341f00d_64)] [added: DISCLOSURES](#i4bee8fea21084f779a0b7cdc42786b07_67)] | | | [removed: [52](#if8055099d1994bb494875d41c341f00d_64)] [added: [57](#i4bee8fea21084f779a0b7cdc42786b07_67)] | | |

| Item 5. | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#if8055099d1994bb494875d41c341f00d_70)] [added: SECURITIES](#i4bee8fea21084f779a0b7cdc42786b07_73)] | | | [removed: [53](#if8055099d1994bb494875d41c341f00d_70)] [added: [58](#i4bee8fea21084f779a0b7cdc42786b07_73)] | | |

| Item 6. | | | [removed: [RESERVED](#if8055099d1994bb494875d41c341f00d_73)] [added: [RESERVED](#i4bee8fea21084f779a0b7cdc42786b07_76)] | | | [removed: [54](#if8055099d1994bb494875d41c341f00d_73)] [added: [59](#i4bee8fea21084f779a0b7cdc42786b07_76)] | | |

| Item 7. | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#if8055099d1994bb494875d41c341f00d_76)] [added: OPERATIONS](#i4bee8fea21084f779a0b7cdc42786b07_79)] | | | [removed: [55](#if8055099d1994bb494875d41c341f00d_76)] [added: [60](#i4bee8fea21084f779a0b7cdc42786b07_79)] | | |

| Item 7A. | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#if8055099d1994bb494875d41c341f00d_106)] [added: RISK](#i4bee8fea21084f779a0b7cdc42786b07_109)] | | | [removed: [75](#if8055099d1994bb494875d41c341f00d_106)] [added: [80](#i4bee8fea21084f779a0b7cdc42786b07_109)] | | |

| Item 8. | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#if8055099d1994bb494875d41c341f00d_109)] [added: DATA](#i4bee8fea21084f779a0b7cdc42786b07_112)] | | | [removed: [77](#if8055099d1994bb494875d41c341f00d_109)] [added: [82](#i4bee8fea21084f779a0b7cdc42786b07_112)] | | |

| Item 9. | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#if8055099d1994bb494875d41c341f00d_112)] [added: DISCLOSURE](#i4bee8fea21084f779a0b7cdc42786b07_115)] | | | [removed: [77](#if8055099d1994bb494875d41c341f00d_112)] [added: [82](#i4bee8fea21084f779a0b7cdc42786b07_115)] | | |

| Item 9A. | | | [CONTROLS AND [removed: PROCEDURES](#if8055099d1994bb494875d41c341f00d_115)] [added: PROCEDURES](#i4bee8fea21084f779a0b7cdc42786b07_118)] | | | [removed: [78](#if8055099d1994bb494875d41c341f00d_115)] [added: [83](#i4bee8fea21084f779a0b7cdc42786b07_118)] | | |

| Item 9B. | | | [OTHER [removed: INFORMATION](#if8055099d1994bb494875d41c341f00d_124)] [added: INFORMATION](#i4bee8fea21084f779a0b7cdc42786b07_127)] | | | [removed: [80](#if8055099d1994bb494875d41c341f00d_124)] [added: [85](#i4bee8fea21084f779a0b7cdc42786b07_127)] | | |

| Item 10. | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#if8055099d1994bb494875d41c341f00d_130)] [added: GOVERNANCE](#i4bee8fea21084f779a0b7cdc42786b07_133)] | | | [removed: [80](#if8055099d1994bb494875d41c341f00d_130)] [added: [85](#i4bee8fea21084f779a0b7cdc42786b07_133)] | | |

| Item 11. | | | [EXECUTIVE [removed: COMPENSATION](#if8055099d1994bb494875d41c341f00d_136)] [added: COMPENSATION](#i4bee8fea21084f779a0b7cdc42786b07_139)] | | | [removed: [80](#if8055099d1994bb494875d41c341f00d_136)] [added: [85](#i4bee8fea21084f779a0b7cdc42786b07_139)] | | |

| Item 12. | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#if8055099d1994bb494875d41c341f00d_139)] [added: MATTERS](#i4bee8fea21084f779a0b7cdc42786b07_142)] | | | [removed: [81](#if8055099d1994bb494875d41c341f00d_139)] [added: [86](#i4bee8fea21084f779a0b7cdc42786b07_142)] | | |

| Item 13. | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR [removed: INDEPENDENCE](#if8055099d1994bb494875d41c341f00d_148)] [added: INDEPENDENCE](#i4bee8fea21084f779a0b7cdc42786b07_151)] | | | [removed: [82](#if8055099d1994bb494875d41c341f00d_148)] [added: [86](#i4bee8fea21084f779a0b7cdc42786b07_151)] | | |

| Item 14. | | | [PRINCIPAL ACCOUNTANT FEES AND [removed: SERVICES](#if8055099d1994bb494875d41c341f00d_151)] [added: SERVICES](#i4bee8fea21084f779a0b7cdc42786b07_154)] | | | [removed: [82](#if8055099d1994bb494875d41c341f00d_151)] [added: [86](#i4bee8fea21084f779a0b7cdc42786b07_154)] | | |

| Item 15. | | | [EXHIBITS AND FINANCIAL STATEMENT [removed: SCHEDULES](#if8055099d1994bb494875d41c341f00d_157)] [added: SCHEDULES](#i4bee8fea21084f779a0b7cdc42786b07_160)] | | | [removed: [83](#if8055099d1994bb494875d41c341f00d_157)] [added: [87](#i4bee8fea21084f779a0b7cdc42786b07_160)] | | |

| Item 16. | | | [FORM 10-K [removed: SUMMARY](#if8055099d1994bb494875d41c341f00d_160)] [added: SUMMARY](#i4bee8fea21084f779a0b7cdc42786b07_163)] | | | [removed: [89](#if8055099d1994bb494875d41c341f00d_160)] [added: [93](#i4bee8fea21084f779a0b7cdc42786b07_163)] | | |

| [removed: KKC] [added: Kyowa Kirin] | | | Kyowa Kirin Co., Ltd. | | | | | | | | | | | | | | |

| [removed: AMGEVITA] [added: AMJEVITA/AMGEVITA] | | | [removed: AMGEVITA™] [added: AMJEVITA® (adalimumab-atto)/AMGEVITA™] (adalimumab) | | |

| LUMAKRAS/LUMYKRAS | | | [removed: LUMAKRAS® / LUMYKRAS™] [added: LUMAKRAS®/LUMYKRAS™] (sotorasib) | | |

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

535,918,901

| [PART I](#i4bee8fea21084f779a0b7cdc42786b07_13) | | | | | | [1](#i4bee8fea21084f779a0b7cdc42786b07_13) | | |

| | | | [Reimbursement](#i4bee8fea21084f779a0b7cdc42786b07_25) | | | [10](#i4bee8fea21084f779a0b7cdc42786b07_25) | | |

| Item 1C. | | | [CYBERSECURITY](#i4bee8fea21084f779a0b7cdc42786b07_58) | | | [54](#i4bee8fea21084f779a0b7cdc42786b07_58) | | |

| [PART II](#i4bee8fea21084f779a0b7cdc42786b07_70) | | | | | | [58](#i4bee8fea21084f779a0b7cdc42786b07_70) | | |

| Item 9C. | | | [DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS](#i4bee8fea21084f779a0b7cdc42786b07_1099511629882) | | | [85](#i4bee8fea21084f779a0b7cdc42786b07_1099511629882) | | |

| [PART III](#i4bee8fea21084f779a0b7cdc42786b07_130) | | | | | | [85](#i4bee8fea21084f779a0b7cdc42786b07_130) | | |

| [PART IV](#i4bee8fea21084f779a0b7cdc42786b07_157) | | | | | | [87](#i4bee8fea21084f779a0b7cdc42786b07_157) | | |

| [SIGNATURES](#i4bee8fea21084f779a0b7cdc42786b07_166) | | | | | | [94](#i4bee8fea21084f779a0b7cdc42786b07_166) | | |

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

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

| CDT | | | Cybersecurity & Digital Trust | | | | | | | | | | | | | | |

| CIO | | | Chief Information Officer | | | | | | | | | | | | | | |

| CISO | | | Chief Information Security Officer | | | | | | | | | | | | | | |

| CRC | | | colorectal cancer | | | | | | | | | | | | | | |

| CRCC | | | Corporate Responsibility and Compliance Committee | | | | | | | | | | | | | | |

| DTI | | | Digital, Technology & Innovation | | | | | | | | | | | | | | |

| IGF-1R | | | insulin-like growth factor-1 receptor | | | | | | | | | | | | | | |

| MAA | | | Marketing Authorisation Application | | | | | | | | | | | | | | |

| mCRC | | | metastatic colorectal cancer | | | | | | | | | | | | | | |

| mOS | | | median overall survival | | | | | | | | | | | | | | |

| mPFS | | | median progression-free survival | | | | | | | | | | | | | | |

| PDAB | | | Prescription Drug Affordability Board | | | | | | | | | | | | | | |

| PDUFA | | | Prescription Drug User Fee Action | | | | | | | | | | | | | | |

| PSUs | | | performance share units | | | | | | | | | | | | | | |

| RAS | | | Rat sarcoma viral oncogene | | | | | | | | | | | | | | |

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

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

| SCLC | | | small cell lung cancer | | | | | | | | | | | | | | |

| TED | | | thyroid eye disease | | | | | | | | | | | | | | |

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

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

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

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

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

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

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

| ACTIMMUNE | | | ACTIMMUNE® (interferon gamma-1b)(1) | | |

533,976,238

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

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

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

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

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

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

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

| K-A | | | Kirin-Amgen, Inc. | | | | | | | | | | | | | | |

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

| PNH | | | paroxysmal nocturnal hemoglobinuria | | | | | | | | | | | | | | |

| Profit Sharing Plan | | | Amgen Profit Sharing Plan for Employees in Ireland | | | | | | | | | | | | | | |

| Acapatamab | | | Acapatamab (formerly AMG 160) | | |

| AMJEVITA | | | AMJEVITA™ (adalimumab-atto) | | |

| Efavaleukin alfa | | | Efavaleukin alfa (formerly AMG 592) | | |

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

| Olpasiran | | | Olpasiran (formerly AMG 890) | | |

| Ordesekimab | | | Ordesekimab (formerly AMG 714) | | |

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

| Rozibafusp alfa | | | Rozibafusp alfa (formerly AMG 570) | | |

| Tarlatamab | | | Tarlatamab (formerly AMG 757) | | |

*Risk Management and Strategy*

Amgen has a multi-layered and iterative approach towards assessing, identifying, managing and mitigating risks from cybersecurity threats.

The Company’s Digital, Technology & Innovation (DTI) function is designed to support our productivity, innovation and outreach globally through the quality delivery of information systems, solutions and services for our business and operations.

The DTI function has a Cybersecurity & Digital Trust (CDT) team that assesses and reduces cybersecurity exposure, including by providing employees with training and resources to identify potential cybersecurity threats and implementing information technology security practices.

The CDT team also monitors for cybersecurity threat activity and seeks to mitigate the impact from cybersecurity incidents by deploying information security engineers, system architects, analysts and cybersecurity specialists to provide monitoring, reporting and management of cybersecurity incidents.

To evaluate the progress of its activities, our DTI function uses various industry and regulatory frameworks as guides to assess the state of the Company’s cybersecurity program maturity and controls, including our organizational, people, physical and technological controls.

The CDT team also conducts reviews and evaluations of our cybersecurity resilience program with Amgen’s Cybersecurity & Digital Trust Governance Council (which includes leaders from information security, compliance, regulatory affairs, manufacturing, audit, law and business development functions).

Our cybersecurity risk management program is considered by and integrated into our Company-wide Enterprise Risk Management program, and shares common methodologies, reporting channels and governance processes that apply across the Enterprise Risk Management program to that of other enterprise level risks (such as product development, safety and surveillance, financial and intellectual property risks).

Regular evaluations are conducted of the greatest risks to our business and their underlying risk drivers as well as the associated mitigation activities, maturity and controls.

This program is overseen by our Executive Vice President and Chief Financial Officer and guided by the Enterprise Risk Council, a cross-functional group of the Company’s business leaders representing key business functions that is chaired by our Chief Audit Executive.

The results of the enterprise risk evaluations and the status and operation of the Enterprise Risk Management program are presented to our Board of Directors, which oversees the Company’s enterprise-level risks.

Further, our corporate audit function is responsible for assessing risk and testing whether, and the extent to which, our information security policies and practices are being implemented effectively within our business and by third party providers.

Findings from such reports and related corrective action plans are shared with our CDT team, Company leadership, and the Audit Committee and Corporate Responsibility and Compliance Committee (CRCC) of our Board of Directors.

In addition to leveraging the Company’s own information technology resources, our Incident Response and Cyber Threat Intelligence teams engage, as needed, third-party cybersecurity risk assessors and consultants to assist in recognizing threats, identifying security vulnerabilities, and evaluating the impact of cybersecurity attacks and incidents when they occur.

On a biennial basis, our DTI organization also engages external third-party experts to assess the Company’s cybersecurity control maturity across the organization and develops plans to address such experts’ recommendations.

Our CDT function has processes to oversee and identify the risks of cybersecurity threats associated with third-party service providers and monitors and works to mitigate the impact of cybersecurity incidents encountered by our third-party service providers.

Upon becoming aware of cybersecurity incidents encountered by our third-party service providers, the CDT function’s Incident Response and Cyber Threat Intelligence teams are deployed to evaluate and mitigate the impact of such incidents on our business.

Despite our layered controls and cybersecurity efforts, the Company and its third-party vendors have experienced cyberattacks and information security vulnerabilities, and while such incidents have not had a material adverse effect on the Company, there can be no assurance that future cybersecurity attacks or incidents would not result in a material adverse effect on our business strategy, results of operations or financial condition.

For examples of such matters and a discussion of the risks that we face, see Item 1A.

Risk Factors—*A breakdown of our information technology systems, cyberattack or information security breach could significantly 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.* However, we have not identified risk from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our operations, business strategy, results of operations or financial condition.

*Governance*

Our Board of Directors oversees an enterprise-wide approach to risk management, including risks related to information systems and cybersecurity, and each Board committee has primary risk oversight responsibilities aligned with its areas of focus.

At each regular meeting of the Board, the Board receives and considers reports from each of its committees, and such reports provide additional detail on significant risk management issues as appropriate, including cybersecurity.

The CRCC is the committee that has primary oversight responsibility for the Company’s information systems and management of cybersecurity and receives reports from our Senior Vice President and Chief Information Officer (CIO) and Chief Information Security Officer (CISO) that includes reviews of our information systems strategy, technology investments, cybersecurity risks and incidents, and third-party risk management, as well as an annual evaluation of the Company’s cybersecurity status.

The Board’s Audit Committee has oversight responsibility of our internal controls, assurances and financial risks.

The Audit Committee is provided with copies of materials presented to our CRCC by our CIO and CISO and receives reports from our CIO regarding topics including integration or implementation of new financial systems and key controls and governance designed to address cybersecurity risks associated with the use of such new financial systems.

Our management team, including our CIO and CISO, supervises efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which may include briefings from internal information security personnel; threat intelligence and other information obtained from governmental, public or private sources, including external consultants engaged by us; and alerts and reports produced by security tools deployed in the information systems environment.

Our CISO, who heads our CDT team and is accountable for the Company’s cybersecurity risk management program, joined the Company’s information systems organization in 2016, is a Certified Information Systems Security Professional and is certified in risk and information systems control.

Previously, our CISO served in both leadership and operational positions as a cybersecurity professional in the U.S. government and was a cybersecurity consultant, providing a wide range of cybersecurity services to various U.S. government agencies and departments.

Our DTI organization is led by, and our CISO is overseen by, our CIO, who has held roles of increasing responsibility within our information systems organization since 2001 and has developed his knowledge and skills in the cybersecurity area over the course of his career in information systems.

Our inaugural Executive Vice President and Chief Technology Officer (CTO), effective as of the end of 2023, oversees our CIO.

Prior to the establishment of the CTO role, our CIO was overseen by our Executive Vice President and Chief Financial Officer.

As leaders of the DTI organization and CDT function, respectively, the Company’s CIO and CISO are informed about and monitor significant cybersecurity threats and incidents through the Company’s internal cybersecurity reporting structure.

Our CDT team is responsible for monitoring and detecting cybersecurity threats and incidents.

Our CDT team, overseen by our CISO, is also responsible for the mitigation and remediation of cybersecurity incidents.

When members of the CDT team detect a cybersecurity threat or incident or are made aware of a cybersecurity incident encountered by a third-party service provider, the discovery is communicated to the Incident Response team, which includes our CISO and other senior members of the CDT function.

The Incident Response team evaluates the severity of the cybersecurity threat or incident and shares its findings with our CISO.

Our CISO and/or his senior team leaders, in addition to our CIO and CTO, also provide regular reports to executives leading our finance, compliance, law and human resources functions on potentially significant cybersecurity incidents and the progress made towards mitigation and remediation of those incidents.

These leaders oversee reporting to our CRCC and Audit Committee, and reporting of such cybersecurity incidents are included in the course of regular meetings of such committees.

Additionally, in appropriate circumstances, reporting of potentially significant cybersecurity incidents are made directly to the leaders of our CRCC and Audit Committee or directly to the Board of Directors outside of their regular meeting schedule.

| Tampa, FL | | | | | | P | | | | | | [added: P] | | | | | | | | |

| Brazil | | | [removed: P] | | | P | | | | | | P | | | P | | | [removed: P] | | |

As of December 31, 2023, we owned or leased approximately 160 properties, including properties acquired from Horizon in Deerfield, Illinois and Ireland.

| Deerfield, IL | | | | | | P | | | P | | | P | | | | | | | | |

____________

| France | | | | | | P | | | | | | P | | | | | | | | |

Additionally, in January 2024 our U.S. manufacturing facility in New Albany, Ohio received licensure from the FDA for commercial production, and our facility in Holly Springs, North Carolina is currently under construction.

As of December 31, 2022, we owned or leased approximately 150 properties.

As of February [removed: 6, 2023,] [added: 9, 2024,] there were approximately [removed: 4,838] [added: 4,614] holders of record of our common stock.

The following graph shows the value of an investment of $100 on December 31, [removed: 2017,] [added: 2018,] in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index.

[removed: ][added: ]

| | | | [removed: 12/31/2017] [added: 12/31/2018] | | | | | | [removed: 12/31/2018] [added: 12/31/2019] | | | | | | [removed: 12/31/2019] [added: 12/31/2020] | | | | | | [removed: 12/31/2020] [added: 12/31/2021] | | | | | | [removed: 12/31/2021] [added: 12/31/2022] | | | | | | [removed: 12/31/2022] [added: 12/31/2023] | | |

During the [removed: three months and] year ended December 31, [removed: 2022,] [added: 2023,] we had one outstanding stock repurchase program, under which [removed: the repurchasing activity was as follows:][added: we had no repurchase activity.]

| | | | | | | Total number of shares purchased | | | | | | Average price paid per [removed: share(1)] [added: share] | | | | | | Total number of shares purchased as part of publicly announced program | | | | | | Maximum dollar value that may yet be purchased under [removed: the program(2)] [added: the program] | | |

| January 1 - December [removed: 31(3)] [added: 31] | | | | | | [removed: 26,147,900] [added: —] | | | | | | [removed: $] | [removed: 241.32] | | | | | [removed: 26,147,900] [added: —] | | | | | | | | |

For the years ended December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we paid quarterly dividends.

Additional information required by this item is incorporated herein by reference to Part IV—Note [removed: 16,] [added: 17,] Stockholders’ equity, to the Consolidated Financial Statements.

| Amgen (AMGN) | | | $100.00 | | | | | | $127.62 | | | | | | $125.07 | | | | | | $126.16 | | | | | | $152.01 | | | | | | $172.55 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $120.43 | | | | | | $136.78 | | | | | | $131.96 | | | | | | $126.68 | | | | | | $130.31 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $118.39 | | | | | | $128.73 | | | | | | $158.82 | | | | | | $171.14 | | | | | | $184.35 | | |

| Standard & Poor’s 500 (SPX) | | | $100.00 | | | | | | $131.48 | | | | | | $155.65 | | | | | | $200.29 | | | | | | $163.90 | | | | | | $207.07 | | |

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

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

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

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

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

(2)In October 2022, our Board of Directors increased the amount authorized under the stock repurchase program by an additional $2.4 billion.

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

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 [removed: necessarily was] [added: is] required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based upon their evaluation and subject to the foregoing, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, [removed: 2022.][added: 2023.]

Management determined that as of December 31, [removed: 2022,] [added: 2023,] there were no changes in our internal control over financial reporting that occurred during the fiscal quarter then ended that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]

Based on our assessment, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on the COSO criteria.

The effectiveness of the Company’s internal control over financial reporting has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their attestation report appearing below, which expresses an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]

We have audited Amgen Inc.’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Amgen Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 and our report dated February [removed: 9, 2023] [added: 14, 2024] expressed an unqualified opinion thereon.

Management has excluded Horizon, which was acquired by us on October 6, 2023, from its assessment of internal control over financial reporting as of December 31, 2023.

Total assets and revenues of Horizon excluded from our assessment of internal control over financial reporting were approximately 7% of total assets and 3% of total revenues as of and for the year ended December 31, 2023, respectively.

As indicated in the accompanying Management’s Report on Internal Control over Financial Reporting, management’s assessment of and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of Horizon Therapeutics plc, which is included in the 2023 consolidated financial statements of the Company and constituted 7% of total assets as of December 31, 2023 and 3% of revenues for the year then ended.

Our audit of internal control over financial reporting of the Company also did not include an evaluation of the internal control over financial reporting of Horizon Therapeutics plc.

February 14, 2024

February 9, 2023

*Rule 10b5-1 trading arrangements*

During the three months ended December 31, 2023, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.

Not applicable.

PART III

Not applicable.

PART III

| | | | | | |

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

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

Information about the procedures by which stockholders may recommend nominees for the Board of Directors is incorporated by reference from APPENDIX A—AMGEN INC. BOARD OF DIRECTORS GUIDELINES FOR DIRECTOR QUALIFICATIONS AND EVALUATIONS and OTHER MATTERS—Stockholder Proposals for the [removed: 2024] [added: 2025] Annual Meeting in our Proxy Statement.

Information about securities authorized for issuance under existing equity compensation plans is incorporated by reference from the section entitled SECURITIES AUTHORIZED FOR ISSUANCE UNDER EXISTING EQUITY COMPENSATION PLANS in our Proxy Statement.

The following table sets forth certain information as of December 31, 2022, concerning the shares of our common stock that may be issued under any form of award granted under our equity compensation plans in effect as of December 31, 2022 (including upon the exercise of options, upon the vesting of awards of RSUs or when performance units are earned and related dividend equivalents have been granted).

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

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

| | | | | | | (a) | | | | | | (b) | | | | | | (c) | | |

| Plan category | | | | | | Number of securities to be issued upon exercise of outstanding options and rights | | | | | | Weighted-average exercise price of outstanding options and rights | | | | | | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | | |

| Equity compensation plans approved by Amgen security holders: | | | | | | | | | | | | | | | | | | | | |

| Amended and Restated 2009 Equity Incentive Plan(1) | | | | | | 10,235,620 | | | | | | $ | 207.29 | | | | | 15,255,297 | | |

| Amended and Restated 1991 Equity Incentive Plan(2) | | | | | | 2,191 | | | | | | | | | | | | | | |

| Amended and Restated Employee Stock Purchase Plan | | | | | | | | | | | | | | | | | | 4,180,287 | | |

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

| Equity compensation plan not approved by Amgen security holders: | | | | | | | | | | | | | | | | | | | | |

| Amgen Profit Sharing Plan for Employees in Ireland(3) | | | | | | | | | | | | | | | | | | 222,310 | | |

| Total unapproved plans | | | | | | — | | | | | | — | | | | | | 222,310 | | |

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

(1)The Amended 2009 Plan employs a fungible share-counting formula for determining the number of shares available for issuance under the plan.

In accordance with this formula, each option or stock appreciation right counts as one share, while each RSU, performance unit or dividend equivalent counts as 1.9 shares.

The number under column (a) represents the actual number of shares issuable under our outstanding awards without giving effect to the fungible share-counting formula.

The number under column (c) represents the number of shares available for issuance under this plan based on each such available share counting as one share.

Commencing with the grants made in April 2012, RSUs and performance units accrue dividend equivalents that are payable in shares only to the extent and when the underlying RSUs vest or underlying performance units have been earned and the related shares are issued to the grantee.

The performance units granted under this plan are earned based on the accomplishment of specified performance goals at the end of their respective three-year performance periods; the number of performance units granted represent target performance, and the maximum number of units that could be earned based on our performance is 200% of the performance units granted in 2020, 2021 and 2022.

As of December 31, 2022, the number of outstanding awards under column (a) includes (i) 5,322,407 shares issuable upon the exercise of outstanding options with a weighted-average exercise price of $207.29; (ii) 3,173,806 shares issuable upon the vesting of outstanding RSUs (including 307,825 related dividend equivalents); and (iii) 1,739,407 shares subject to outstanding 2020, 2021 and 2022 performance units (including 84,603 related dividend equivalents).

The weighted-average exercise price shown in column (b) is for the outstanding options only.

The number of available shares under column (c) represents the number of shares that remain available for future issuance under this plan as of December 31, 2022, employing the fungible share formula and presumes the issuance of target shares under the performance units granted in 2020, 2021 and 2022 and related dividend equivalents.

The numbers under columns (a) and (c) do not give effect to the additional shares that could be issuable in the event above target performance on the performance goals under these outstanding performance units is achieved.

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

(2)This plan has terminated as to future grants.

The number under column (a) with respect to this plan includes 2,191 shares issuable upon the settlement of deferred RSUs (including 519 related dividend equivalents).

(3)The Profit Sharing Plan was approved by the Board of Directors on July 28, 2011.

The Profit Sharing Plan permits eligible employees of the Company’s subsidiaries located in Ireland who participate in the Profit Sharing Plan to apply a portion of their qualifying bonus and salary to the purchase of the Company’s common stock on the open market at the market price by a third-party trustee as described in the Profit Sharing Plan.

| Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_172)[1](#if8055099d1994bb494875d41c341f00d_172)] [added: [F-](#i4bee8fea21084f779a0b7cdc42786b07_175)[1](#i4bee8fea21084f779a0b7cdc42786b07_175)] | | |

| Consolidated Statements of Income for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_175)[4](#if8055099d1994bb494875d41c341f00d_175)] [added: [F-5](#i4bee8fea21084f779a0b7cdc42786b07_178)] | | |

| Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_178)[5](#if8055099d1994bb494875d41c341f00d_178)] [added: [F-6](#i4bee8fea21084f779a0b7cdc42786b07_181)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_181)[6](#if8055099d1994bb494875d41c341f00d_181)] [added: [F-7](#i4bee8fea21084f779a0b7cdc42786b07_184)] | | |

| Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_184)[7](#if8055099d1994bb494875d41c341f00d_184)] [added: [F-8](#i4bee8fea21084f779a0b7cdc42786b07_187)] | | |

| Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_187)[8](#if8055099d1994bb494875d41c341f00d_187)] [added: [F-9](#i4bee8fea21084f779a0b7cdc42786b07_190)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [F-](#if8055099d1994bb494875d41c341f00d_190)[9](#if8055099d1994bb494875d41c341f00d_190)] [added: [F-10](#i4bee8fea21084f779a0b7cdc42786b07_193)] | | |

| Schedule II. Valuation and Qualifying Accounts | | | [removed: [F-55](#if8055099d1994bb494875d41c341f00d_253)] [added: [F-57](#i4bee8fea21084f779a0b7cdc42786b07_259)] | | |

| 2.2 | | | | | | [Letter Agreement, dated November 21, 2019, by and between Amgen Inc. and the parties named therein re: Treatment of Certain Product Inventory in connection with Amgen’s acquisition of [removed: Otezla](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a24letteragreementv3.htm)] [added: Otezla.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a24letteragreementv3.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| 4.10 | | | | | | [Officers’ Certificate of Amgen Inc., dated May 23, 2008, including form of the Company’s 6.90% Senior Notes due [removed: 2038.](http://www.sec.gov/Archives/edgar/data/318154/000119312508121768/dex42.htm)] [added: 2038.](https://www.sec.gov/Archives/edgar/data/318154/000119312508121768/dex42.htm)] (Filed as exhibit to Form 8-K on May 23, 2008 and incorporated herein by reference.) | | |

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

| 4.23 | | | | | | [removed: [Form of Permanent Global] [added: [Officer’s] Certificate [removed: for] [added: of Amgen Inc., dated as of June 14, 2016, including forms of] the Company’s [removed: 0.410% bonds] [added: 4.563% Senior Notes] due [removed: 2023.](http://www.sec.gov/Archives/edgar/data/318154/000119312516495970/d156859dex41.htm)] [added: 2048 and 4.663% Senior Notes due 2051.](http://www.sec.gov/Archives/edgar/data/318154/000119312516621372/d203675dex42.htm)] (Filed as an exhibit [removed: on] [added: to] Form 8-K on [removed: March 8,] [added: June 14,] 2016 and incorporated herein by reference.) | | |

| 4.24 | | | | | | [removed: [Terms] [added: [Officer’s Certificate] of [removed: the Bonds for] [added: Amgen Inc., dated as of August 19, 2016, including forms of] the [removed: Company’s 0.410% bonds] [added: Company’s](https://www.sec.gov/Archives/edgar/data/318154/000119312516686451/d187158dex43.htm) [2.600% Senior Notes] due [removed: 2023.](http://www.sec.gov/Archives/edgar/data/318154/000119312516495970/d156859dex42.htm)] [added: 2026.](https://www.sec.gov/Archives/edgar/data/318154/000119312516686451/d187158dex43.htm)] (Filed as an exhibit [removed: on] [added: to] Form 8-K on [removed: March 8,] [added: August 19,] 2016 and incorporated herein by reference.) | | |

| 4.25 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: June 14, 2016,] [added: November 2, 2017,] including [removed: forms] [added: in the form] of the Company’s [removed: 4.563% Senior Notes due 2048 and 4.663%] [added: 3.200%] Senior Notes due [removed: 2051.](http://www.sec.gov/Archives/edgar/data/318154/000119312516621372/d203675dex42.htm)] [added: 2027.](http://www.sec.gov/Archives/edgar/data/318154/000119312517331065/d472956dex42.htm)] (Filed as an exhibit to Form 8-K on [removed: June 14, 2016] [added: November 2, 2017] and incorporated herein by reference.) | | |

| [removed: 4.26] [added: 4.28] | | | | | | [Officer’s Certificate of Amgen Inc., dated as of August [removed: 19, 2016,] [added: 17, 2020,] including forms of the Company’s [removed: 2.250% Senior Notes due 2023 and 2.600%] [added: 2.770%] Senior Notes due [removed: 2026.](http://www.sec.gov/Archives/edgar/data/318154/000119312516686451/d187158dex43.htm)] [added: 2053.](https://www.sec.gov/Archives/edgar/data/318154/000119312520222579/d60848dex42.htm)] (Filed as an exhibit to Form 8-K on August [removed: 19, 2016] [added: 18, 2020] and incorporated herein by reference.) | | |

| 4.27 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: November 2, 2017,] [added: May 6, 2020,] including [removed: in the] form of the Company’s [removed: 3.200%] [added: 2.300%] Senior Notes due [removed: 2027.](http://www.sec.gov/Archives/edgar/data/318154/000119312517331065/d472956dex42.htm)] [added: 2031.](https://www.sec.gov/Archives/edgar/data/318154/000119312520134934/d925911dex43.htm)] (Filed as an exhibit to Form 8-K on [removed: November 2, 2017] [added: May 6, 2020] and incorporated herein by reference.) | | |

| [removed: 4.28] [added: 4.26] | | | | | | [Officer’s Certificate of Amgen Inc., dated as of February 21, 2020, including forms of the Company’s 1.900% Senior Notes due 2025, 2.200% Senior Notes due 2027, 2.450% Senior Notes due 2030, 3.150% Senior Notes due 2040 and 3.375% Senior Notes due 2050.](https://www.sec.gov/Archives/edgar/data/318154/000119312520044757/d894000dex42.htm) (Filed as an exhibit to Form 8-K on February 21, 2020 and incorporated herein by reference.) | | |

| 4.29 | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: May 6, 2020,] [added: August 9, 2021,] including [removed: form] [added: forms] of the Company’s [removed: 2.300%] [added: 1.650%] Senior Notes due [removed: 2031.](https://www.sec.gov/Archives/edgar/data/318154/000119312520134934/d925911dex43.htm)] [added: 2028, 2.000% Senior Notes due 2032, 2.800% Senior Notes due 2041 and 3.000% Senior Notes due 2052.](https://www.sec.gov/Archives/edgar/data/318154/000119312521240434/d213858dex42.htm)] (Filed as an exhibit to Form 8-K on [removed: May 6, 2020] [added: August 9, 2021] and incorporated herein by reference.) | | |

| [removed: 4.30] [added: 4.31] | | | | | | [Officer’s Certificate of Amgen Inc., dated as of August [removed: 17, 2020,] [added: 18, 2022,] including forms of the Company’s [removed: 2.770%] [added: 4.050%] Senior Notes due [removed: 2053.](https://www.sec.gov/Archives/edgar/data/318154/000119312520222579/d60848dex42.htm)] [added: 2029, 4.200% Senior Notes due 2033 and 4.875% Senior Notes due 2053.](https://www.sec.gov/Archives/edgar/data/318154/000119312522224115/d280175dex42.htm)] (Filed as an exhibit to Form 8-K on August 18, [removed: 2020] [added: 2022] and incorporated herein by reference.) | | |

| [removed: 4.31] [added: 4.30] | | | | | | [Officer’s Certificate of Amgen Inc., dated as of [removed: August 9, 2021,] [added: February 22, 2022,] including forms of the Company’s [removed: 1.650%] [added: 3.000%] Senior Notes due [removed: 2028, 2.000%] [added: 2029, 3.350%] Senior Notes due 2032, [removed: 2.800%] [added: 4.200%] Senior Notes due [removed: 2041] [added: 2052] and [removed: 3.000%] [added: 4.400%] Senior Notes due [removed: 2052.](https://www.sec.gov/Archives/edgar/data/318154/000119312521240434/d213858dex42.htm)] [added: 2062.](https://www.sec.gov/Archives/edgar/data/318154/000119312522048514/d302710dex42.htm)] (Filed as an exhibit to Form 8-K on [removed: August 9, 2021] [added: February 22, 2022] and incorporated herein by reference.) | | |

| 4.32 | | | | | | [Officer’s Certificate of [removed: Amgen Inc.,] [added: the Company,] dated as of [removed: February 22, 2022,] [added: March 2, 2023,] including forms of the Company’s [removed: 3.000%] [added: 5.250%] Senior Notes due [removed: 2029, 3.350%] [added: 2025, 5.507%] Senior Notes due [removed: 2032, 4.200%] [added: 2026, 5.150%] Senior Notes due [removed: 2052] [added: 2028, 5.250% Senior Notes due 2030, 5.250% Senior Notes due 2033, 5.600% Senior Notes due 2043, 5.650% Senior Notes due 2053] and [removed: 4.400%] [added: 5.750%] Senior Notes due [removed: 2062.](https://www.sec.gov/Archives/edgar/data/318154/000119312522048514/d302710dex42.htm)] [added: 2063.](https://www.sec.gov/Archives/edgar/data/318154/000119312523058235/d448346dex42.htm)] (Filed as an exhibit to Form 8-K on [removed: February 22, 2022] [added: March 2, 2023] and incorporated herein by reference.) | | |

| [removed: 4.34*] [added: 4.33*] | | | | | | [Description of Amgen Inc.’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit434-descriptionofse.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit433-descriptionofse.htm)] | | |

| [removed: 10.2+] [added: 10.1.1+] | | | | | | [First Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 4, 2015.](http://www.sec.gov/Archives/edgar/data/318154/000031815415000010/amgn-ex102_2015331xq1.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2015 on April 27, 2015 and incorporated herein by reference.) | | |

| [removed: 10.3+] [added: 10.1.2+] | | | | | | [Second Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 2, [removed: 2016](http://www.sec.gov/Archives/edgar/data/318154/000031815416000035/amgn-ex103_2016331xq1.htm).] [added: 2016.](https://www.sec.gov/Archives/edgar/data/318154/000031815416000035/amgn-ex103_2016331xq1.htm)] (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2016 on May 2, 2016 and incorporated herein by reference.) | | |

| [removed: 10.4+*] [added: 10.2+*] | | | | | | [Form of Grant of Stock Option Agreement for the Amgen [removed: Inc.] [added: Inc](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit102-formofgrantofst.htm).] Amended and Restated 2009 Equity Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit104-formofgrantofst.htm)] [added: Plan.] (As Amended and Restated on December [removed: 12, 2022.)] [added: 11, 2023.)] | | |

| [removed: 10.5+*] [added: 10.3+*] | | | | | | [Form of Restricted Stock Unit [removed: Agreement] [added: Agreement](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit103-formofrestricte.htm)] for the Amgen Inc. Amended and Restated 2009 Equity Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit105-formofrestricte.htm)] [added: Plan.] (As Amended and Restated on December [removed: 12, 2022.)] [added: 11, 2023.)] | | |

| [removed: 10.6+] [added: 10.4+] | | | | | | [Amgen Inc. 2009 Performance Award Program. (As Amended on December 12, 2017.)](http://www.sec.gov/Archives/edgar/data/318154/000031815418000004/exhibit106performanceaward.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2017 on February 13, 2018 and incorporated herein by reference.) | | |

| [removed: 10.7+*] [added: 10.5+*] | | | | | | [Form of Performance Unit [removed: Agreement] [added: Agreement](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit105-formofperforman.htm)] for the Amgen Inc. 2009 Performance Award [removed: Program.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit107-formofperforman.htm)] [added: Program.] (As Amended and Reinstated on December [removed: 12, 2022.)] [added: 11, 2023.)] | | |

| [removed: 10.8+] [added: 10.7+] | | | | | | [removed: [Amgen] [added: [Form of Restricted Stock Unit Agreement for the Amgen] Inc. 2009 Director Equity Incentive Program. (As Amended [removed: and Restated] on [removed: October 21, 2020.)](https://www.sec.gov/Archives/edgar/data/318154/000031815421000010/amgn-ex108_20201231xq4.htm)] [added: December 11, 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, [removed: 2020] [added: 2019] on February [removed: 9, 2021] [added: 12, 2020] and incorporated herein by reference.) | | |

| [removed: 10.9+] [added: 10.8+] | | | | | | [Form of [added: Cash-Settled] Restricted Stock Unit Agreement for the Amgen [removed: Inc.] 2009 Director Equity Incentive Program. (As Amended on December 11, [removed: 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm) [](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1010-amgenxdirectorrs.htm)(Filed] [added: 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1011-amgenxdirectorca.htm) (Filed] as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| [removed: 10.10+] [added: 10.9.2+] | | | | | | [removed: [Form of Cash-Settled Restricted Stock Unit Agreement for] [added: [Second Amendment to] the Amgen [removed: 2009 Director Equity Incentive Program. (As Amended on December 11, 2019.)](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1011-amgenxdirectorca.htm)] [added: Inc. Supplemental Retirement Plan, effective October 23, 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1014-secondamendmento.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| [removed: 10.11+] [added: 10.9+] | | | | | | [Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, 2013.)](https://www.sec.gov/Archives/edgar/data/318154/000031815414000004/amgn-ex109_20131231x10k.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | | |

| [removed: 10.11.1+] [added: 10.9.1+] | | | | | | [First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 14, 2016.](http://www.sec.gov/Archives/edgar/data/318154/000031815416000053/amgn-ex1012_2016930xq3.htm) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.) | | |

| [removed: 10.11.2+] [added: 10.12.2+] | | | | | | [Second Amendment to the Amgen [removed: Inc. Supplemental Retirement] [added: Nonqualified Deferred Compensation] Plan, effective [removed: October 23, 2019.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1014-secondamendmento.htm)] [added: January 1, 2020.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a1021-secondamendmentt.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | | |

| [removed: 10.11.3+] [added: 10.9.3+] | | | | | | [Third Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2021.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000010/amgn-ex1015_20211231xq4.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.) | | |

| [removed: 10.11.4+*] [added: 10.9.4+] | | | | | | [Fourth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2022.](https://www.sec.gov/Archives/edgar/data/318154/000031815423000017/exhibit10114-fourthamendme.htm) [added: (Filed as an exhibit to Form 10-K for the year ended December 31, 2022 on February 9, 2023 and incorporated herein by reference.)] | | |

| [removed: 10.12+] [added: 10.10+] | | | | | | [Amended and Restated Amgen Change of Control Severance Plan. (As Amended and Restated effective December 9, 2010 and subsequently amended effective March 2, 2011.)](http://www.sec.gov/Archives/edgar/data/318154/000095012311048073/v58996exv10w9.htm) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated herein by reference.) | | |

| [removed: 10.13+] [added: 10.11+] | | | | | | [Amgen Inc. Executive Incentive Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815422000021/amgn-ex1017_2022331xq1.htm) (As Amended and Restated effective January 1, 2022.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2022 on April 28, 2022 and incorporated herein by reference.) | | |

| [removed: 10.14+] [added: 10.12+] | | | | | | [Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective October 16, 2013.)](http://www.sec.gov/Archives/edgar/data/318154/000031815414000004/amgn-ex1015_20131231x10k.htm) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | | |

| [removed: 10.14.1+] [added: 10.12.1+] | | | | | | [First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective October 14, 2016.](http://www.sec.gov/Archives/edgar/data/318154/000031815416000053/amgn-ex1017_2016930xq3.htm) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.) | | |

| 10.6+* | | | | | | [Amgen Inc. 2009 Director Equity Incentive Program. (As Amended and Restated on October 24, 2023.)](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit106-2009directorequ.htm) | | |

| 10.9.5+* | | | | | | [Fifth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective January 1, 2024.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit1095-fifthamendment.htm) | | |

| 10.12.4+* | | | | | | [Fourth Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective January 1, 2024.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit10124-fourthamendme.htm) | | |

| 10.14+* | | | | | | [Agreement between Amgen Inc. and James Bradner, dated December 13, 2023.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit1014-agreementbetwe.htm) | | |

| 10.17.1* | | | | | | [Amendment No. 2 to Collaboration and License Agreement, effective November 14, 2016, between Amgen Inc. and Celltech R&D Limited](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit10171-amendmentno2t.htm)[.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit10171-amendmentno2t.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) | | |

| 10.22.5* | | | | | | [Letter Agreement Regarding the Collaboration Agreement, dated as of December 1, 2023, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit10225-letteragreeme.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) | | |

| 97* | | | | | | [Policy Relating to Recovery of Erroneously Awarded Compensation.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit97-policyonrecovery.htm) | | |

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

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

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

| Date: | | | February [removed: 9, 2023] [added: 14, 2024] | | | By: | | | | | | /s/ PETER H. GRIFFITH | | |