Amgen (AMGN) 10-K risk factor changes: FY2024 vs FY2023

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

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

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

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

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

Such state [removed: policies may] [added: laws could] also eventually be adopted at the federal level.

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

A substantial [removed: portion] [added: proportion] of our U.S. business relies on reimbursement from federal government healthcare programs and commercial insurance plans regulated by federal and state governments.

Our business has [removed: been] [added: been,] and will continue to [removed: be] [added: be,] affected by legislative actions changing U.S. federal reimbursement policy.

For example, [removed: in 2022,] the IRA [removed: was enacted and] includes provisions requiring [removed: that] [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: ten] [added: 10] drugs in 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent [removed: years such that by 2031 approximately 100 drugs could be subject to such set prices).]

[added: The Medicare] price setting process [removed: began on August 29, 2023 when CMS announced] [added: for] the first [removed: ten] [added: 10] drugs [removed: for] [added: subject to] Medicare price [removed: setting,] [added: setting in Part D began in 2023 ,] which includes [removed: ENBREL.][added: ENBREL, our product that currently generates considerable revenues.]

Also under the IRA, [removed: 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 [removed: created a mechanism for] [added: inflation penalties allows] CMS to collect rebates from manufacturers if price increases outpace inflation.

[removed: Rebate] [added: Such 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 [removed: it must bill] [added: to issue such invoices to] manufacturers.

We expect that several of our products will be subject to [removed: these] [added: IRA] inflation [removed: rebates,] [added: penalties,] 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 [removed: drug pricing controls] [added: Medicare price setting] 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 [removed: mandatory] [added: Medicare] price setting and the timing of market entry of generic or biosimilar competition.

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

*—Changing reimbursement and pricing actions in various states have negatively [removed: affected] [added: affected,] and may continue to negatively [removed: affect] [added: affect,] access [removed: to] [added: to,] and have [removed: affected] [added: affected,] and may continue to [removed: affect] [added: affect,] sales of our products*

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

A number of states have adopted, and many other states are considering, [added: PDABs,] drug importation [removed: programs] [added: programs, reference pricing schemes,] and other [added: drug] 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.

States are also enacting laws referencing the IRA and seeking to regulate [added: and prohibit restrictions on] the 340B [removed: 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 [removed: state.][added: state, and such references to IRA price caps have also been included in PDAB legislation.]

[removed: Seven] [added: Eight] states (Colorado, Maine, New Hampshire, [added: New Jersey,] Maryland, Minnesota, Oregon and Washington) have enacted laws that establish PDABs to [added: identify drugs that pose affordability challenges, and four such states include authority for the state PDABs to set upper payment limits on certain drugs for in-state patients, payers and providers.]

[removed: So far in] [added: In] 2024, no fewer than [removed: 11] [added: 17] states [removed: have pending] [added: introduced] PDAB legislation.

[removed: States] [added: The eight states] with enacted PDAB laws are in various phases of implementation, with Colorado’s PDAB being the furthest along.

[removed: Louisiana] [added: Louisiana, Arkansas, West Virginia, Minnesota, Kansas, Mississippi, Missouri] and [removed: Arkansas] [added: Maryland] have enacted laws with mandates on manufacturers participating in [removed: 340B, and thus far] [added: the 340B Program, and,] in 2024, no fewer than [removed: 15] [added: 25] states [removed: have] [added: considered] similar [removed: legislation pending.][added: legislation.]

These bills vary, but [added: typically] 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.

[removed: Becerra*,] [added: Becerra, where] 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 [removed: what] [added: who] is considered a patient under the 340B [removed: program,] [added: 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 [removed: proposal.][added: proposal, though the state has not completed any significant steps towards importation within the one-year authorization window.]

*—U.S. commercial payer actions have [removed: affected] [added: affected,] and may continue to [removed: affect] [added: affect,] access to and sales of our products*

Payers, including healthcare insurers, PBMs, integrated healthcare delivery systems (vertically-integrated organizations built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, [removed: increasingly] [added: are continuing to] seek ways to [added: further] reduce their costs.

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

For example, some payers require physicians to demonstrate or document that the patients for whom Repatha has been prescribed meet their utilization criteria, and these requirements have served to limit [removed: and may continue to limit] patient access to Repatha treatment.

However, affordability of patient out-of-pocket co-pay cost has [removed: limited] [added: limited,] and may continue to [removed: limit] [added: limit,] patient use.

Further, despite these net and list price reductions, some payers have restricted, and may continue to restrict, patient access and may seek further discounts or rebates or take other actions, such as changing formulary coverage for Repatha, that could reduce [removed: our sales of Repatha.][added: its sales.]

For example, in the United States, [removed: as of] the [removed: beginning of 2024,] [added: FTC’s interim report released in 2024 showed that] the top [removed: five] [added: six] integrated health plans and PBMs controlled about [removed: 92%] [added: 94%] of all pharmacy prescriptions.

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

Ultimately, additional discounts, rebates, fees, coverage changes, plan changes, restrictions or exclusions imposed by these commercial payers could have a material adverse [removed: effect on our product sales, business and results of operations.]

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

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

It is unclear what policies the new Administration will advance with respect to IRA implementation and other drug pricing proposals.

Further, state government activity has been dynamic, including certain states enacting new laws limiting drug reimbursement under state run Medicaid programs and prohibiting restrictions on 340B Program use.

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

In 2024, CMS set a price for ENBREL under Medicare Part D that is significantly lower than currently applicable, beginning on January 1, 2026, which we expect will negatively impact its profitability in Medicare.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of operations—Product sales—ENBREL.

In January 2025, CMS announced the next 15 drugs for Medicare price setting that will be applicable beginning on January 1, 2027, which includes Otezla.

Depending on the growth and success of our medicines, other of our medicines may also be subject to selection by CMS in the next, or in a future, cycle of mandatory Medicare price setting.

If other of our medicines are selected by CMS for Medicare price setting, we may be required to accept a price set by the government for Medicare similar to the process that was applied to ENBREL.

For example, in April 2024, CMS finalized policy changes that will give Part D plans more flexibility to substitute biosimilars for innovator products on formularies in 2025.

Additionally, various government agencies have taken actions designed to reduce expenditures on prescription drugs.

For example, HHS released a report with drug pricing proposals that seek to promote competition.

The USPTO has also taken steps to strengthen coordination with the FDA to address perceived impediments to generic drug and biosimilar competition.

The Colorado PDAB deemed three of five drugs “unaffordable,” including ENBREL, and are subject to rulemaking to establish an Upper Payment Limit (UPL) commencing March 2025 and that could be effective as soon as the fourth quarter of 2025.

Further, inappropriate expanded utilization of the 340B Program from broadened application of the 340B discounts has had, and is

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

In March 2024, the U.S. Court of Appeals for the 8th Circuit ruled that Arkansas’ Act 1103, which prohibits drugmakers from restricting the acquisition or delivery of 340B drugs to covered entities and their contract pharmacies, was not preempted by the federal 340B statute.

The decision contributed to an increase in the number of states considering similar legislation.

In July 2024, the U.S. District Court for the Southern District of Mississippi denied motions for a preliminary injunction in two cases challenging a similar law in Mississippi, finding that neither plaintiff had demonstrated a substantial likelihood of success on the merits.

These orders are being appealed at the U.S. Court of Appeals for the 5th Circuit.

In September 2024, the U.S. District Court for the Western District of Louisiana dismissed a lawsuit challenging Louisiana’s 340B contract pharmacy mandate law, and the U.S. District Court for the District of Maryland denied a motion for preliminary injunction challenging a similar law in Maryland.

These lawsuits challenging states on their 340B contract pharmacy laws are subsequent to Genesis Health Care, Inc. v.

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

For example, in September 2024, the FTC brought action against the three largest PBMs alleging anticompetitive and unfair rebating practices.

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 trial began on November 4, 2024 and concluded on January 17, 2025.

With the conclusion of the trial, the parties will file post-trial briefs and make closing arguments in 2025.

The Company expects a decision from the U.S. Tax Court no earlier than 2026.

We believe that the IRS may also seek to continue to audit similar issues related to the allocation of income between the United States and the U.S. territory of Puerto Rico for years beyond 2018.

with managing remote computing assets and security vulnerabilities that are present in many non-corporate and home networks.

For example, in July 2024, businesses worldwide were affected by an information technology outage due to a faulty software update issued by a cybersecurity firm.

Although our systems and operations were temporarily affected by the outage, the impact of this firm’s faulty update on the Company was immaterial to our business operations.

However, there can be no assurance that a future similar incident would not result in a material adverse effect on our business or results of operations.

Malicious actors, including those working under state-sponsored campaigns, have sought employment, often in remote information technology roles, as a means to gain inside access at targeted companies.

In the third quarter of 2024, an individual used fraudulent identification in connection with their hiring by the Company.

While the individual was detected and terminated before any data was extracted or malware installed, there can be no assurance that future attempts by similar actors will be unsuccessful.

In the third quarter of 2022, another service provider experienced a

Additionally, in April 2024, one of our former vendors notified us that its subsidiary that had provided us with certain patient support services until mid-2022, experienced a cybersecurity incident that it discovered in February 2024 and that data containing individually identifiable health information of over 1.7 million Amgen patients (that was retained as required by FDA regulations) was involved in the incident.

Pursuant to the Health Breach Notification Rule requirements, we notified the FTC of this incident.

In February 2024, Change Healthcare, a large U.S. insurance claim and co-pay card processing clearinghouse, experienced a ransomware attack that has caused significant disruptions to healthcare provider and pharmacy operations.

While Change Healthcare does not directly provide us with services, disruptions to co-pay card support, insurance billing and Medicaid rebate processing led to lost sales and required us to take action to help patients access their medications and to provide extended payment terms to certain customers.

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

The Medicare

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.

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.

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

In 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.

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.

identify drugs that pose affordability challenges, and four such states include authority for the state PDAB to set upper payment limits on certain drugs for in-state patients, payers and providers.

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.

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

For example, CMS finalized a policy for plan years starting on or after January 1, 2021 that has caused commercial payers to more widely adopt co-pay accumulator adjustment programs.

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.

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

As a result, we entered into a corporate integrity agreement with the OIG that requires us to maintain a corporate compliance program and to undertake a set of defined corporate integrity obligations through April 2024.

Similar consumer privacy laws went into effect in Virginia, Colorado, Utah, Connecticut and Florida in 2023.

Consumer privacy laws were also passed in eleven other states, with the earliest effective dates later this year, and proposed in three additional states.

For example, we are in a dispute with Roche regarding a license agreement that we acquired through our acquisition of Horizon for patents and know-how for TEPEZZA.

cease using the technology or product in dispute.

Impact to our Neulasta sales has accelerated as additional competitors have launched.

substantial percentage of total covered lives in the United States.

However, product candidates based on

sufficiency of the data or studies underlying a product’s approved label.

We are also dependent on those

business, they have resulted in disruptions to our third-party suppliers on the island.

We may experience similar or

Business—Manufacturing, Distribution and Raw Materials—Manufacturing; see also *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*.

coordinated activity, and we may be required to incur additional costs or allocate additional resources towards monitoring, reporting and implementing our ESG programs.

Economic conditions may also adversely affect the ability of our distributors, customers and suppliers to

obtain the liquidity required to buy inventory or raw materials and to perform their obligations under agreements with us, which could disrupt our operations.

Amgen operates in one [removed: business] [added: operating] segment: human therapeutics.

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

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

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

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

Our strategy [removed: includes] [added: is the] integrated [removed: activities intended] [added: set of actions we take] to [removed: strengthen] [added: improve] our competitive position in the industry.

In [removed: 2023,] [added: 2024,] we [removed: completed our acquisition of Horizon,] advanced our innovative [removed: pipeline and] [added: pipeline;] generated strong [removed: volume] [added: sales] growth across our product portfolio and [removed: regions.][added: regions; and expanded our world-class manufacturing network.]

For more information on our [removed: pipeline, including programs acquired from our Horizon acquisition,] [added: pipeline and clinical development updates,] see Part I, Item 1.

Business—Research and Development and Selected Product [removed: Candidates.][added: Candidates, and Part I, Item 1.]

Cash flows from operating activities [added: in 2024] totaled [removed: $8.5] [added: $11.5] billion, which supported investment in our business, including [added: capital expenditures of $1.1 billion to enhance and expand] our [removed: Horizon acquisition, while returning] [added: manufacturing network, and allowed us to both reduce our debt outstanding and return] capital to shareholders through the payment of cash dividends.

For [removed: 2023,] [added: 2024,] we increased our quarterly cash dividend by [removed: 10%] [added: 6%] to [removed: $2.13] [added: $2.25] per share of common stock.

In December [removed: 2023, we] [added: 2024, the Board of Directors] declared a cash dividend of [removed: $2.25] [added: $2.38] per share of common stock for the first quarter of [removed: 2024,] [added: 2025,] an increase of 6% [removed: for this period,] [added: over the same period in the prior year,] to be paid in March [removed: 2024.][added: 2025.]

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

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

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

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

Uncertain macroeconomic conditions, including [removed: higher] [added: the risk of] inflation, [removed: rising] [added: tariffs or trade protection measures, higher] interest rates and instability in the financial system, as well as rising healthcare [removed: costs] [added: costs,] continue to pose challenges to our business.

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

Moreover, [removed: legislation enacted to reduce healthcare expenditures, including] provisions of the IRA, [added: as well as the 340B Program,] have affected, and are likely to continue to affect, our business.

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

| | | | Year ended December 31, [added: 2024 | | | | | | Change | | | | | | Year ended December 31,] 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

| [added: Total] U.S. | | | $ | [added: 23,301 | | | | | 21 | | % | | | | $ |] 19,272 | | | | | 9 | | % | | | | $ | 17,743 | |

| [added: Total] ROW | | | [added: 8,725 | | | | | | 14 | | % | | | |] 7,638 | | | | | | 8 | | % | | | | 7,058 | | |

| Total product sales | | | [removed: 26,910] [added: $] | [added: 32,026] | | | | | [added: 19 | | % | | | | $ | 26,910 | | | | |] 9 | | % | | | | [removed: 24,801] [added: $] | [added: 24,801] | |

| Other revenues | | | [removed: 1,280] [added: 1,398] | | | | | | [removed: (16)] [added: 9] | | % | | | | [removed: 1,522] [added: 1,280] | | |

| Total revenues | | | $ | [removed: 28,190] [added: 33,424] | | | | | [removed: 7] [added: 19] | | % | | | | $ | [removed: 26,323] [added: 28,190] | |

| [removed: Operating] [added: Total operating] expenses | | | $ | [added: 26,166 | | | | | 29 | | % | | | | $ |] 20,293 | | | | | 21 | | % | | | | $ | 16,757 | |

| Operating income | | | $ | [removed: 7,897] [added: 7,258] | | | | | [removed: (17)] [added: (8)] | | % | | | | $ | [removed: 9,566] [added: 7,897] | |

| Net income | | | $ | [removed: 6,717] [added: 4,090] | | | | | [removed: 3] [added: (39)] | | % | | | | $ | [removed: 6,552] [added: 6,717] | |

| Diluted EPS | | | $ | [removed: 12.49] [added: 7.56] | | | | | [removed: 3] [added: (39)] | | % | | | | $ | [removed: 12.11] [added: 12.49] | |

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

[removed: Total product] [added: Product] sales [removed: increased] [added: from acquired Horizon products contributed $4.2 billion] in [added: 2024 compared to $954 million in] 2023, [removed: primarily driven by] [added: with] volume growth [removed: for certain] [added: of 11% from our other] brands, including Repatha, TEZSPIRE, EVENITY, [removed: Prolia and BLINCYTO,] [added: BLINCYTO] and [removed: the contribution of $954 million in product sales from the Horizon][added: Prolia.]

[removed: For example, actions] [added: Furthermore, product sales continue to be impacted] by [added: actions from] governments and other entities to curb high inflation, provisions of the [removed: IRA] [added: IRA, inappropriate expanded utilization of the 340B Program] and growth in numbers of Medicaid enrollees and uninsured [removed: individuals may have a negative impact on product sales.][added: individuals.]

See Part IV—Note [removed: 3,] [added: 4,] Acquisitions and [removed: divestitures; Note 13, Goodwill and other intangible assets; and Note 18, Fair value measurement,] [added: divestitures,] to the Consolidated Financial Statements.

| | | | Year ended December 31, [removed: 2023] [added: 2024] | | | | | | Change | | | | | | Year ended December 31, [removed: 2022] [added: 2023] | | | | | | Change | | | | | | Year ended December 31, [removed: 2021] [added: 2022] | | |

| Prolia | | | $ | [removed: 4,048] [added: 4,374] | | | | | [removed: 12] [added: 8] | | % | | | | $ | [removed: 3,628] [added: 4,048] | | | | | 12 | | % | | | | $ | [removed: 3,248] [added: 3,628] | |

| ENBREL | | | [removed: 3,697] [added: 3,316] | | | | | | (10) | | % | | | | [removed: 4,117] [added: 3,697] | | | | | | [removed: (8)] [added: (10)] | | % | | | | [removed: 4,465] [added: 4,117] | | |

| Otezla | | | [removed: 2,188] [added: 2,126] | | | | | | [removed: (4)] [added: (3)] | | % | | | | [removed: 2,288] [added: 2,188] | | | | | | [removed: 2] [added: (4)] | | % | | | | [removed: 2,249] [added: 2,288] | | |

| XGEVA | | | [removed: 2,112] [added: 2,225] | | | | | | 5 | | % | | | | [removed: 2,014] [added: 2,112] | | | | | | [removed: —] [added: 5] | | % | | | | [removed: 2,018] [added: 2,014] | | |

We received regulatory approvals for BLINCYTO in CD19-positive Philadelphia chromosome-negative B-ALL and IMDELLTRA in extensive-stage small cell lung cancer (ES-SCLC) and reported five Phase 3 data readouts, including for BLINCYTO, UPLIZNA, rocatinlimab and TEZSPIRE, as well as MariTide Phase 2 top-line results.

Business—Significant Developments.

Total product sales increased in 2024, primarily driven by volume growth of 23%, partially offset by declines in net selling price of 2%.

Product sales from acquired Horizon products contributed $4.2 billion in 2024 compared to $954 million in 2023, with volume growth from our other brands of 11%.

In December 2024, the Board of Directors declared a cash dividend of

Further, we believe that an inclusive culture helps attract and retain a strong and engaged workforce informed by the varied backgrounds and experiences represented, which fosters innovation, collaboration and productivity as we execute on our mission to serve patients.

For example, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expire in February 2025 in the United States and in November 2025 in select countries in Europe.

For example, ENBREL and Otezla have been selected by CMS for Medicare price setting beginning in 2026 and 2027, respectively.

| | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | |

| U.S. | | | $ | 23,301 | | | | | 21 | | % | | | | $ | 19,272 | |

| ROW | | | 8,725 | | | | | | 14 | | % | | | | 7,638 | | |

| Total product sales | | | 32,026 | | | | | | 19 | | % | | | | 26,910 | | |

Total product sales increased 19% in 2024, primarily driven by volume growth of 23%, partially offset by declines in net selling price of 2%.

U.S. volume grew 26% and ROW volume grew 17%.

For 2025, we expect volume growth from certain brands to be partially offset by net selling price declines.

Other revenues increased for 2024, primarily driven by higher corporate partner revenue from licensed products and royalty income.

Operating expenses increased for 2024, driven by higher amortization expense from Horizon acquisition-related assets, higher R&D and SG&A expenses, including expenses from the acquired Horizon business, and higher profit share and royalty expense.

| TEZSPIRE | | | 972 | | | | | | 71 | | % | | | | 567 | | | | | | * | | | | | | 170 | | |

| Other products(2) | | | 5,630 | | | | | | 20 | | % | | | | 4,696 | | | | | | (7) | | % | | | | 5,050 | | |

N/A = not applicable

(2) Consists of product sales of our non-principal products.

Business—Reimbursement, Part I, Item 1A.

As disclosed in Part I, Item 1.

Business—Marketing, Distribution and Selected Marketed Products—Patents, our patents for RANKL antibodies, including sequences, for Prolia expire in February 2025 in the United States and in November 2025 in select countries in Europe.

For 2025, we expect sales erosion driven by biosimilar competition.

| | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

In addition, going forward, we expect relatively flat volumes with continued declines in net selling price, including the impact from the IRA Medicare Part D price set by CMS beginning in 2026.

| | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

As disclosed in Part I, Item 1.

Business—Marketing, Distribution and Selected Marketed Products—Patents, our patents for RANKL antibodies, including sequences, for XGEVA expire in February 2025 in the United States and in November 2025 in select countries in Europe.

For 2025, we expect sales erosion driven by biosimilar competition.

| | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

| | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

In January 2025, Otezla was selected by CMS for Medicare price setting that will be applicable beginning on January 1, 2027.

*TEPEZZA*

Total TEPEZZA sales by geographic region were as follows (dollar amounts in millions):

| | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | | | | | Change | | | | | | Year ended December 31, 2022 | | |

| TEPEZZA — U.S. | | | $ | 1,835 | | | | | * | | | | | | $ | 441 | | | | | N/A | | | | | | $ | — | |

| TEPEZZA — ROW | | | 16 | | | | | | * | | | | | | 7 | | | | | | N/A | | | | | | — | | |

| Total TEPEZZA | | | $ | 1,851 | | | | | * | | | | | | $ | 448 | | | | | N/A | | | | | | $ | — | |

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.

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.

Further, we believe that a diverse and inclusive culture fosters innovation, which supports our ability to serve patients.

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

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.

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

With regard to our clinical trial activities, we are continuously monitoring the possible impacts from health-related events, including changes from new 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.

We remain focused on supporting our active clinical sites in their providing care for patients and in our providing investigational drug supply.

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.

For 2024, we expect that net selling prices will continue to decline at a portfolio level driven by increased competition.

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

While not designed to completely address foreign currency changes, our hedging activities also seek to offset, in part, such effects on our net income by hedging our net foreign currency exposure, primarily with respect to product sales denominated in euros.

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.

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

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.

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

| Total U.S. | | | $ | 19,272 | | | | | 9 | | % | | | | $ | 17,743 | | | | | 3 | | % | | | | $ | 17,286 | |

| Total ROW | | | 7,638 | | | | | | 8 | | % | | | | 7,058 | | | | | | 1 | | % | | | | 7,011 | | |

NM = not meaningful

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

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

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

Volume benefited from contracting changes to support and improve Medicare Part D and commercial patient access and the inclusion of Repatha on China’s National Reimbursement Drug List as of January 1, 2022, both of which resulted in decreases to the net selling price in 2022.

We expect Aranesp to continue to face competition from EPOGEN and its biosimilars, which will impact volume and net selling price in the future.

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

| KANJINTI — U.S. | | | 109 | | | | | | (58) | | % | | | | 257 | | | | | | (46) | | % | | | | 479 | | |

| KANJINTI — ROW | | | 50 | | | | | | (15) | | % | | | | 59 | | | | | | (37) | | % | | | | 93 | | |

| Other — U.S.(3) | | | 576 | | | | | | 47 | | % | | | | 393 | | | | | | 27 | | % | | | | 309 | | |

| Other — ROW(3) | | | 160 | | | | | | (35) | | % | | | | 246 | | | | | | (13) | | % | | | | 282 | | |

(1) TAVNEOS was acquired from our ChemoCentryx acquisition on October 20, 2022.

| Acquired in-process research and development | | | $ | — | | | | | NM | | | | | | $ | — | | | | | (100) | | % | | | | $ | 1,505 | |

| % of product sales | | | — | | % | | | | | | | | | | — | | % | | | | | | | | | | 6.2 | | % |

| % of total revenues | | | — | | % | | | | | | | | | | — | | % | | | | | | | | | | 5.8 | | % |

Cost of sales decreased to 24.3% of total revenues for 2022, driven by lower COVID-19 antibody shipments and manufacturing costs, partially offset by changes in our product mix.

The decrease in R&D expense for 2022 was driven by higher business development activity in 2021 included in later-stage clinical programs and research and early pipeline and lower marketed products support, partially offset by higher later-stage clinical programs support and research and early pipeline spend.

*Acquired in-process research and development*

The Acquired IPR&D expense in 2021 was related to the bemarituzumab program, which was acquired as part of the Five Prime acquisition in 2021.

See Part IV—Note 3, Acquisitions and divestitures, to the Consolidated Financial Statements.

In the discussion that follows, we assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, [removed: 2023] [added: 2024] and [removed: 2022.][added: 2023.]

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: 2023] [added: 2024] and [removed: 2022.][added: 2023.]

Our portfolio of available-for-sale investments as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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: $10.4] [added: $11.5] billion and [removed: $4.3] [added: $10.4] billion as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] respectively.

Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] would not result in a material effect on income in the respective ensuing year.

As of December 31, 2023, we had outstanding [removed: debt] [added: notes] with [removed: a] [added: an aggregate] carrying value of [removed: $64.6] [added: $60.6] billion and [removed: a] [added: an aggregate] fair value of $59.2 billion.

As of December 31, [removed: 2022,] [added: 2024,] we had outstanding [removed: debt] [added: notes] with [removed: a] [added: an aggregate] carrying value of [removed: $38.9] [added: $58.3] billion and [removed: a] [added: an aggregate] fair value of [removed: $35.0] [added: $54.9] billion.

Our outstanding [removed: debt was] [added: notes were] composed of debt with fixed interest rates.

A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] would have resulted in [removed: an increase] [added: increases] of [removed: $5.4] [added: $4.7] billion and [removed: $3.5] [added: $5.4] billion, respectively, in the aggregate fair [removed: value] [added: values] of our outstanding debt on these dates.

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

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

Interest rate swap contracts with [added: an] aggregate notional [removed: amounts] [added: amount] of $6.7 billion were outstanding as of both December 31, [removed: 2023] [added: 2024] and [removed: 2022.][added: 2023.]

A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] would have resulted in reductions in fair values of approximately [removed: $180] [added: $220] million and [removed: $210] [added: $180] million, respectively, on our interest rate swap contracts on these dates.

As of [added: both] December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] we had outstanding cross-currency swap contracts with aggregate notional amounts of $2.7 billion [removed: and $3.4 billion, respectively,] that hedge our foreign-currency-denominated debt and related interest payments.

These contracts effectively convert interest payments and principal repayment of this debt to U.S. dollars from [removed: euros,] [added: euros and] pounds sterling and [removed: Swiss francs and] are designated for accounting purposes as cash flow hedges.

A hypothetical 100 basis point adverse movement in interest rates relative to interest rates as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] would have resulted in reductions in the fair values of our cross-currency swap contracts of approximately [removed: $100] [added: $70] million and [removed: $90] [added: $100] million, respectively.

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

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

As of December 31, [removed: 2022,] [added: 2024,] we had outstanding [removed: euro-, pound-sterling-] [added: euro-] and [removed: Swiss-franc-denominated] [added: pound-sterling-denominated] debt with [added: both] a principal carrying value and a fair value of [removed: $3.0 billion and $2.9 billion, respectively.][added: $2.2 billion.]

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2023, would have resulted in an increase in fair value of this debt of [removed: approximately $470] [added: $460] million on this date and a reduction in income in the ensuing year of [removed: approximately $460] [added: $470] 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: 2022,] [added: 2024,] would have resulted in an increase in fair value of this debt of [removed: $580] [added: approximately $440] million on this date and a reduction in income in the ensuing year of [removed: $600] [added: approximately $450] million.

We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros and pounds sterling [removed: (and Swiss francs] with [removed: respect to the prior year), with] aggregate notional [removed: amount] [added: amounts] of $2.7 billion [removed: and $3.4 billion] as of [added: both] December 31, [removed: 2023] [added: 2024] and [removed: 2022, respectively.][added: 2023.]

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would have resulted in reductions in the fair values of these contracts of approximately [removed: $480] [added: $450] million and [removed: $540] [added: $480] million on these dates, respectively.

As of December 31, [removed: 2022,] [added: 2024,] the fair values of these contracts were a [removed: $288] [added: $420] million asset and [removed: a $76] [added: an $8] million liability.

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

As of December 31, [removed: 2022,] [added: 2024,] we had primarily euro-based open foreign currency forward contracts with [added: an aggregate] notional [removed: amounts] [added: amount] of [removed: $6.0] [added: $7.2] billion.

With regard to [removed: foreign currency forward] contracts that were open as of December 31, 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, 2023, would have resulted in a reduction in fair value of these contracts of approximately $1.2 billion on this date and in the ensuing year, a reduction in income of [removed: approximately] $690 million.

With regard to [added: foreign currency forward] contracts that were open as of December 31, [removed: 2022,] [added: 2024,] 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: 2024,] would have resulted in a reduction in fair value of these contracts of approximately [removed: $1.1] [added: $1.3] billion on this date and in the ensuing year, a reduction in income of [removed: $590] [added: approximately $700] million.

As of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] we had open, short-duration, foreign currency forward contracts that mature in one month or less, that had [added: aggregate] notional amounts of [removed: $0.5] [added: $0.1] billion and $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: 2023] [added: 2024] and [removed: 2022.][added: 2023.]

With regard to these foreign currency forward contracts that were open as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] a hypothetical 5% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would not have a material effect on the fair values of these contracts or related income in the respective ensuing years.

As of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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 our investments in BeiGene and Neumora, as well as other publicly and privately held small-capitalization [removed: stocks,] [added: stocks and] limited partnerships that invest in early-stage biotechnology companies.

A 20% decrease in the aggregate value of our equity investment portfolio as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] would result in losses in fair value of approximately [removed: $1.0 billion] [added: $950 million] and [removed: $1.1] [added: $1.0] billion, respectively.

[added: 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, the analysis above does not include our term loans, which had carrying values of $1.8 billion and $4.0 billion at December 31, 2024 and 2023, respectively.

The fair values of our term loans approximate their carrying values as these debt instruments bear interest at floating rates.

offset by corresponding increases or decreases in our foreign-currency-denominated liabilities.

In addition, we have an investment policy that limits

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

Amgen operates in one [removed: business] [added: operating] segment: human therapeutics.

Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, [removed: 2022.][added: 2023.]

[removed: Additionally in October 2023,] [added: In May 2024, we announced IMDELLTRA received accelerated approval from] the FDA [removed: granted tarlatamab Breakthrough Therapy Designation] for the treatment of adult patients with extensive-stage [removed: SCLC] [added: small cell lung cancer (ES-SCLC)] with disease progression on or after platinum-based chemotherapy.

[removed: *LUMAKRAS/LUMYKRAS*][added: | LUMAKRAS/LUMYKRAS | | | | | | Other tumors | | |]

In the United States, substantially all of our sales are to pharmaceutical wholesale distributors, which [removed: are] [added: is] the principal means of distributing our products to healthcare providers.

We [removed: also] market certain products through direct-to-consumer channels, including print, television and online media.

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

Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc. [removed: (formerly AmerisourceBergen)] and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021.][added: 2022.]

On a combined basis, these wholesalers accounted for [removed: 79%, 82%] [added: 77%, 79%] and 82% of worldwide gross revenues for [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021,] [added: 2022,] 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: 2023, 2022] [added: 2024, 2023] and [removed: 2021.][added: 2022.]

[removed: ][added: ]

| | | | [removed: 2023] [added: 2024] | | | | | | | | | [removed: 2022] [added: 2023] | | | | | | | | | [removed: 2021] [added: 2022] | | | | | |

| U.S. | | | $ | [removed: 19,272] [added: 23,301] | | [removed: 72] [added: 73] | | % | | | | $ | [removed: 17,743] [added: 19,272] | | 72 | | % | | | | $ | [removed: 17,286] [added: 17,743] | | [removed: 71] [added: 72] | | % |

| ROW | | | [removed: 7,638] [added: 8,725] | | | [removed: 28] [added: 27] | | % | | | | [removed: 7,058] [added: 7,638] | | | 28 | | % | | | | [removed: 7,011] [added: 7,058] | | | [removed: 29] [added: 28] | | % |

| Total | | | $ | [removed: 26,910] [added: 32,026] | | 100 | | % | | | | $ | [removed: 24,801] [added: 26,910] | | 100 | | % | | | | $ | [removed: 24,297] [added: 24,801] | | 100 | | % |

(1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales [removed: from] [added: in] the [added: periods after the] acquisition [removed: date through December 31, 2023.][added: date.]

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

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

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

Otezla is an oral therapy approved for the treatment of adults with plaque psoriasis across all severities (in the United States, Japan and Australia) and moderate-to-severe plaque psoriasis (in other global markets, including [removed: Europe),] [added: Europe);] for adults with active psoriatic [removed: arthritis and] [added: arthritis;] for adults with oral ulcers associated with Behçet’s [removed: disease.][added: disease; and for pediatric patients six years of age and older and weighing at least 20 kilograms with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.]

Repatha was launched in 2015 and is indicated to reduce the risks of myocardial infarction, stroke and coronary revascularization in adults with established [removed: CV] [added: cardiovascular] disease.

In Japan, EVENITY is used primarily in the indication for the treatment of osteoporosis in [added: men and] postmenopausal women [removed: and men] at high risk of fracture.

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 [removed: rectum).][added: rectum) and in the United States, in combination with LUMAKRAS, for the treatment of adult patients with KRAS G12C-mutated mCRC, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.]

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

[removed: ALL] [added: Acute lymphoblastic leukemia (ALL)] is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

[removed: Subsequent to the closing of our Horizon acquisition, we] [added: 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 [removed: FDA] approved medicine for the treatment of thyroid eye disease (TED).

[removed: Subsequent to the closing of our Horizon acquisition, we] [added: We] market KRYSTEXXA in the United States.

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

| [removed: Enbrel® (etanercept)] | | | [removed: | | |] U.S. | | | | | | Formulations and methods of preparing formulations | | | | | | 10/19/2037 | | | [added: | | |]

| [added: Enbrel® (etanercept)] | | | [added: | | |] U.S. | | | | | | Fusion protein and pharmaceutical compositions | | | | | | 11/22/2028 | | | [removed: | | |]

| Otezla® [removed: (apremilast)] [added: (apremilast)(2)] | | | | | | U.S. | | | | | | Compositions and [removed: compounds] [added: compounds(3)] | | | | | | 2/16/2028 | | |

| | | | Europe | | | | | | [removed: Compositions, compounds] [added: Compounds, pharmaceutical compositions,] and methods of treatment(1) | | | | | | [removed: 3/20/2023] [added: 12/21/2029] | | | | | |

| Repatha® (evolocumab) | | | | | | U.S. | | | | | | [removed: Antibodies(2)] [added: Antibodies] | | | | | | [removed: 8/22/2028] [added: 8/27/2029] | | |

| [removed: KYPROLIS® (carfilzomib)] | | | [removed: | | |] U.S. | | | | | | Compositions and compounds | | | | | | 12/7/2027 | | | [added: | | |]

| [added: KYPROLIS® (carfilzomib)] | | | [added: | | |] U.S. | | | | | | Methods of treatment | | | | | | 4/14/2025 | | | [removed: | | |]

| | | | Europe | | | | | | Method of [removed: administration] [added: treatment] | | | | | | 11/6/2029 | | | | | |

| TEZSPIRE® (tezepelumab-ekko) | | | | | | U.S. | | | | | | [removed: Polypeptides(2)] [added: Polypeptides(5)] | | | | | | 2/3/2029 | | |

| TEPEZZA® (teprotumumab-trbw) | | | | | | U.S. | | | | | | IGF-1R [removed: antibodies(3)] [added: antibodies(4)] | | | | | | 3/3/2029 | | |

In November 2024, we announced positive data at 52 weeks in part 1 of a double-blind, dose-ranging Phase 2 study with MariTide, a differentiated peptide-antibody conjugate subcutaneously administered monthly or less frequently.

In people living with obesity or overweight without type 2 diabetes, MariTide demonstrated up to approximately 20% average weight loss at week 52 without a weight loss plateau.

The study also showed people living with obesity or overweight and type 2 diabetes achieved up to approximately 17% average weight loss without a weight loss plateau and lowered their average hemoglobin A1C (HbA1c) by up to 2.2 percentage points at week 52.

MariTide also demonstrated robust and clinically meaningful improvements in cardiometabolic parameters, including blood pressure, triglycerides and high-sensitivity C-reactive protein (hs-CRP) across doses.

The most common adverse events (AEs) in part 1 of the Phase 2 study were gastrointestinal (GI) related, including nausea, vomiting and constipation.

The incidence of nausea and vomiting was substantially reduced with dose escalation.

The discontinuation rate in the dose escalation arms due to any AE was approximately 11% and less than 8% for GI-related AEs.

*IMDELLTRA*

In June 2024, we announced BLINCYTO received approval from the FDA in frontline consolidation for patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).

In December 2024, we announced new data from a Phase 3 trial demonstrating that adding BLINCYTO to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-ALL of average or higher risk of relapse.

The study met its primary endpoint of DFS.

Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy.

The hazard ratio (HR) was 0.39 \[95% confidence interval (CI) 0.24-0.64\], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO.

At three years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone.

Safety results are consistent with the known safety profile of BLINCYTO.

In September 2024, we announced TEPEZZA was approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan.

In June 2024, we announced positive top-line results from our Phase 3 registrational trial evaluating UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD).

The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period.

All key secondary endpoints were also met, which were annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission.

No new safety signals were identified.

The FDA has accepted our submission under priority review, with a Prescription Drug User Fee Action (PDUFA) date of April 3, 2025.

In September 2024, we announced top-line results of the Phase 3 MINT trial of UPLIZNA.

MINT is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis (gMG).

The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared with placebo at week 26 of the combined patient population.

UPLIZNA demonstrated a statistically significant and clinically meaningful change from baseline compared to placebo for four out of five key secondary endpoints.

Overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of UPLIZNA.

In September 2024, we announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor and one of eight studies in the rocatinlimab Phase 3 clinical trial program for atopic dermatitis.

HORIZON, a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate-to-severe atopic dermatitis, met its co-primary endpoints and reached statistically significant difference from placebo for all key secondary endpoints.

Overall safety findings in the study were comparable to those seen in the Phase 2b study.

In November 2024, we announced positive top-line results from the Phase 3 WAYPOINT trial, a double-blind, multi-center, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of TEZSPIRE in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).

The trial demonstrated patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo with safety and tolerability profiles consistent with the known profile of the medicine.

(2) Consists of product sales of our non-principal products.

Our patents for RANKL antibodies, including sequences, for Prolia expire in February 2025 in the United States and November 2025 in select countries in Europe.

See Patents table below.

Prolia and XGEVA contain the same active ingredient but are approved for different indications, patient populations, dose and frequency of administration.

Our patents for RANKL antibodies, including sequences, for XGEVA expire in February 2025 in the United States and November 2025 in select countries in Europe.

See Patents table below.

TEPEZZA was acquired through our Horizon acquisition in October 2023.

KRYSTEXXA was acquired through our Horizon acquisition in October 2023.

*TEZSPIRE*

*Acquisition of Horizon Therapeutics plc*

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.

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

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*.

*Tarlatamab*

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.

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.

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

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.

Chronic refractory gout occurs in patients who have failed to normalize serum uric acid (sUA) and whose signs and symptoms are inadequately controlled with conventional therapies, such as xanthine oxidase inhibitors (XOIs), at the maximum medically appropriate dose, or for whom these drugs are contraindicated.

| | | | Europe | | | | | | Thrombopoietic compounds(1) | | | | | | 10/22/2019 | | | | | |

| Aranesp® (darbepoetin alfa) | | | | | | U.S. | | | | | | Glycosylation analogs of erythropoietin proteins | | | | | | 5/15/2024 | | |

| | | | U.S. | | | | | | Method of administration | | | | | | 9/28/2027 | | | | | |

- inebilizumab — Italy and Spain, expiring in 2032

See Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.

| KYPROLIS | | | | | | U.S. | | | | | | VELCADE | | | | | | Millennium Pharmaceuticals, Inc.(3) | | |

| | | | U.S. & Europe | | | | | | DARZALEX | | | | | | Janssen(2) | | | | | |

Furthermore, during the past few years, many PBMs and insurers have consolidated, resulting in a smaller number of PBMs and insurers overseeing a large portion of total covered lives in the United States.

Although the IRA was enacted in August 2022, the environment remains dynamic, and the Administration and Congress continues to consider drug pricing legislation.

In August 2023, ENBREL, a product in which the rights to the BLA are held by our wholly owned subsidiary Immunex Corporation, was selected for the first round of 10 drugs subject to price setting that will be applicable beginning January 1, 2026.

Further, beginning October 1, 2022, manufacturers owe rebates on drugs reimbursed under Medicare Part D if price increases outpace inflation, and beginning January 1, 2023, owe rebates on drugs reimbursed under Medicare Part B if price increases outpace inflation.

The Infrastructure Investment and Jobs Act, signed into law on November 15, 2021, requires manufacturers of certain Part B–covered drugs packaged in single-use containers to give refunds to the government starting in 2023 for discarded amounts.

metric that is used to determine Medicaid rebates and 340B statutory rates.

In this regard, many countries have health technology assessment organizations that use formal economic metrics such as cost-effectiveness to determine prices, coverage and reimbursement of new therapies; and these organizations are expanding in both established and emerging markets.

For the fiscal year ended December 31, [removed: 2023][added: 2024]

| Common stock, $0.0001 par value | | | AMGN | | | The Nasdaq [removed: Stock Market LLC] [added: Global Select Market] | | |

| 2.00% Senior Notes due 2026 | | | AMGN26 | | | The Nasdaq [removed: Stock Market LLC] [added: Global Select Market] | | |

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was [removed: $118,556,278,405] [added: $167.6 billion] as of [removed: June 30, 2023.(A)][added: the last business day of the registrant’s most recently completed second fiscal quarter.(A)]

(A)Excludes [removed: 901,685] [added: 948,404] shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, [removed: at June 30, 2023.][added: as of the last business day of the registrant’s most recently completed second fiscal quarter.]

(Number of shares of common stock outstanding as of February [removed: 9, 2024)][added: 11, 2025)]

Specified portions of the registrant’s Proxy Statement with respect to the [removed: 2024] [added: 2025] Annual Meeting of Stockholders to be held on May [removed: 31, 2024,] [added: 23, 2025,] are incorporated by reference into Part III of this annual report.

| | | | [DEFINED TERMS AND [removed: PRODUCTS](#i4bee8fea21084f779a0b7cdc42786b07_10)] [added: PRODUCTS](#i68e02b122dea42499d61169f19cd8da5_10)] | | | [removed: [ii](#i4bee8fea21084f779a0b7cdc42786b07_10)] [added: [ii](#i68e02b122dea42499d61169f19cd8da5_10)] | | |

| Item 1. | | | [removed: [BUSINESS](#i4bee8fea21084f779a0b7cdc42786b07_16)] [added: [BUSINESS](#i68e02b122dea42499d61169f19cd8da5_16)] | | | [removed: [1](#i4bee8fea21084f779a0b7cdc42786b07_16)] [added: [1](#i68e02b122dea42499d61169f19cd8da5_16)] | | |

| | | | [Significant [removed: Developments](#i4bee8fea21084f779a0b7cdc42786b07_19)] [added: Developments](#i68e02b122dea42499d61169f19cd8da5_19)] | | | [removed: [1](#i4bee8fea21084f779a0b7cdc42786b07_19)] [added: [1](#i68e02b122dea42499d61169f19cd8da5_19)] | | |

| | | | [Marketing, Distribution and Selected Marketed [removed: Products](#i4bee8fea21084f779a0b7cdc42786b07_22)] [added: Products](#i68e02b122dea42499d61169f19cd8da5_22)] | | | [removed: [2](#i4bee8fea21084f779a0b7cdc42786b07_22)] [added: [2](#i68e02b122dea42499d61169f19cd8da5_22)] | | |

| | | | [Manufacturing, Distribution and Raw [removed: Materials](#i4bee8fea21084f779a0b7cdc42786b07_28)] [added: Materials](#i68e02b122dea42499d61169f19cd8da5_28)] | | | [removed: [11](#i4bee8fea21084f779a0b7cdc42786b07_28)] [added: [12](#i68e02b122dea42499d61169f19cd8da5_28)] | | |

| | | | [Government [removed: Regulation](#i4bee8fea21084f779a0b7cdc42786b07_31)] [added: Regulation](#i68e02b122dea42499d61169f19cd8da5_31)] | | | [removed: [13](#i4bee8fea21084f779a0b7cdc42786b07_31)] [added: [13](#i68e02b122dea42499d61169f19cd8da5_31)] | | |

| | | | [Research and Development and Selected Product [removed: Candidates](#i4bee8fea21084f779a0b7cdc42786b07_34)] [added: Candidates](#i68e02b122dea42499d61169f19cd8da5_34)] | | | [removed: [17](#i4bee8fea21084f779a0b7cdc42786b07_34)] [added: [17](#i68e02b122dea42499d61169f19cd8da5_34)] | | |

| | | | [Business [removed: Relationships](#i4bee8fea21084f779a0b7cdc42786b07_37)] [added: Relationships](#i68e02b122dea42499d61169f19cd8da5_37)] | | | [removed: [22](#i4bee8fea21084f779a0b7cdc42786b07_37)] [added: [23](#i68e02b122dea42499d61169f19cd8da5_37)] | | |

| | | | [Human Capital [removed: Resources](#i4bee8fea21084f779a0b7cdc42786b07_40)] [added: Resources](#i68e02b122dea42499d61169f19cd8da5_40)] | | | [removed: [24](#i4bee8fea21084f779a0b7cdc42786b07_40)] [added: [24](#i68e02b122dea42499d61169f19cd8da5_40)] | | |

| | | | [Information about our Executive [removed: Officers](#i4bee8fea21084f779a0b7cdc42786b07_43)] [added: Officers](#i68e02b122dea42499d61169f19cd8da5_43)] | | | [removed: [27](#i4bee8fea21084f779a0b7cdc42786b07_43)] [added: [26](#i68e02b122dea42499d61169f19cd8da5_43)] | | |

| | | | [Geographic Area Financial [removed: Information](#i4bee8fea21084f779a0b7cdc42786b07_46)] [added: Information](#i68e02b122dea42499d61169f19cd8da5_46)] | | | [removed: [28](#i4bee8fea21084f779a0b7cdc42786b07_46)] [added: [27](#i68e02b122dea42499d61169f19cd8da5_46)] | | |

| | | | [Investor [removed: Information](#i4bee8fea21084f779a0b7cdc42786b07_49)] [added: Information](#i68e02b122dea42499d61169f19cd8da5_49)] | | | [removed: [28](#i4bee8fea21084f779a0b7cdc42786b07_49)] [added: [27](#i68e02b122dea42499d61169f19cd8da5_49)] | | |

| Item 1A. | | | [RISK [removed: FACTORS](#i4bee8fea21084f779a0b7cdc42786b07_2071)] [added: FACTORS](#i68e02b122dea42499d61169f19cd8da5_52)] | | | [removed: [29](#i4bee8fea21084f779a0b7cdc42786b07_2071)] [added: [28](#i68e02b122dea42499d61169f19cd8da5_52)] | | |

| Item 1B. | | | [UNRESOLVED STAFF [removed: COMMENTS](#i4bee8fea21084f779a0b7cdc42786b07_55)] [added: COMMENTS](#i68e02b122dea42499d61169f19cd8da5_55)] | | | [removed: [54](#i4bee8fea21084f779a0b7cdc42786b07_55)] [added: [54](#i68e02b122dea42499d61169f19cd8da5_55)] | | |

| Item 1C. | | | [removed: [CYBERSECURITY](#i4bee8fea21084f779a0b7cdc42786b07_58)] [added: [CYBERSECURITY](#i68e02b122dea42499d61169f19cd8da5_58)] | | | [removed: [54](#i4bee8fea21084f779a0b7cdc42786b07_58)] [added: [54](#i68e02b122dea42499d61169f19cd8da5_58)] | | |

| Item 2. | | | [removed: [PROPERTIES](#i4bee8fea21084f779a0b7cdc42786b07_61)] [added: [PROPERTIES](#i68e02b122dea42499d61169f19cd8da5_61)] | | | [removed: [56](#i4bee8fea21084f779a0b7cdc42786b07_61)] [added: [57](#i68e02b122dea42499d61169f19cd8da5_61)] | | |

| Item 3. | | | [LEGAL [removed: PROCEEDINGS](#i4bee8fea21084f779a0b7cdc42786b07_64)] [added: PROCEEDINGS](#i68e02b122dea42499d61169f19cd8da5_64)] | | | [removed: [57](#i4bee8fea21084f779a0b7cdc42786b07_64)] [added: [58](#i68e02b122dea42499d61169f19cd8da5_64)] | | |

| Item 4. | | | [MINE SAFETY [removed: DISCLOSURES](#i4bee8fea21084f779a0b7cdc42786b07_67)] [added: DISCLOSURES](#i68e02b122dea42499d61169f19cd8da5_67)] | | | [removed: [57](#i4bee8fea21084f779a0b7cdc42786b07_67)] [added: [58](#i68e02b122dea42499d61169f19cd8da5_67)] | | |

| Item 5. | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i4bee8fea21084f779a0b7cdc42786b07_73)] [added: SECURITIES](#i68e02b122dea42499d61169f19cd8da5_73)] | | | [removed: [58](#i4bee8fea21084f779a0b7cdc42786b07_73)] [added: [59](#i68e02b122dea42499d61169f19cd8da5_73)] | | |

| Item 6. | | | [removed: [RESERVED](#i4bee8fea21084f779a0b7cdc42786b07_76)] [added: [RESERVED](#i68e02b122dea42499d61169f19cd8da5_76)] | | | [removed: [59](#i4bee8fea21084f779a0b7cdc42786b07_76)] [added: [60](#i68e02b122dea42499d61169f19cd8da5_76)] | | |

| Item 7. | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i4bee8fea21084f779a0b7cdc42786b07_79)] [added: OPERATIONS](#i68e02b122dea42499d61169f19cd8da5_79)] | | | [removed: [60](#i4bee8fea21084f779a0b7cdc42786b07_79)] [added: [61](#i68e02b122dea42499d61169f19cd8da5_79)] | | |

| Item 7A. | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i4bee8fea21084f779a0b7cdc42786b07_109)] [added: RISK](#i68e02b122dea42499d61169f19cd8da5_109)] | | | [removed: [80](#i4bee8fea21084f779a0b7cdc42786b07_109)] [added: [81](#i68e02b122dea42499d61169f19cd8da5_109)] | | |

| Item 8. | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i4bee8fea21084f779a0b7cdc42786b07_112)] [added: DATA](#i68e02b122dea42499d61169f19cd8da5_112)] | | | [removed: [82](#i4bee8fea21084f779a0b7cdc42786b07_112)] [added: [83](#i68e02b122dea42499d61169f19cd8da5_112)] | | |

| Item 9. | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i4bee8fea21084f779a0b7cdc42786b07_115)] [added: DISCLOSURE](#i68e02b122dea42499d61169f19cd8da5_115)] | | | [removed: [82](#i4bee8fea21084f779a0b7cdc42786b07_115)] [added: [83](#i68e02b122dea42499d61169f19cd8da5_115)] | | |

| Item 9A. | | | [CONTROLS AND [removed: PROCEDURES](#i4bee8fea21084f779a0b7cdc42786b07_118)] [added: PROCEDURES](#i68e02b122dea42499d61169f19cd8da5_118)] | | | [removed: [83](#i4bee8fea21084f779a0b7cdc42786b07_118)] [added: [83](#i68e02b122dea42499d61169f19cd8da5_118)] | | |

| Item 9B. | | | [OTHER [removed: INFORMATION](#i4bee8fea21084f779a0b7cdc42786b07_127)] [added: INFORMATION](#i68e02b122dea42499d61169f19cd8da5_127)] | | | [removed: [85](#i4bee8fea21084f779a0b7cdc42786b07_127)] [added: [85](#i68e02b122dea42499d61169f19cd8da5_127)] | | |

| Item 9C. | | | [DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT [removed: INSPECTIONS](#i4bee8fea21084f779a0b7cdc42786b07_1099511629882)] [added: INSPECTIONS](#i68e02b122dea42499d61169f19cd8da5_130)] | | | [removed: [85](#i4bee8fea21084f779a0b7cdc42786b07_1099511629882)] [added: [85](#i68e02b122dea42499d61169f19cd8da5_130)] | | |

| Item 10. | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i4bee8fea21084f779a0b7cdc42786b07_133)] [added: GOVERNANCE](#i68e02b122dea42499d61169f19cd8da5_136)] | | | [removed: [85](#i4bee8fea21084f779a0b7cdc42786b07_133)] [added: [85](#i68e02b122dea42499d61169f19cd8da5_136)] | | |

| Item 11. | | | [EXECUTIVE [removed: COMPENSATION](#i4bee8fea21084f779a0b7cdc42786b07_139)] [added: COMPENSATION](#i68e02b122dea42499d61169f19cd8da5_142)] | | | [removed: [85](#i4bee8fea21084f779a0b7cdc42786b07_139)] [added: [85](#i68e02b122dea42499d61169f19cd8da5_142)] | | |

| Item 12. | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i4bee8fea21084f779a0b7cdc42786b07_142)] [added: MATTERS](#i68e02b122dea42499d61169f19cd8da5_145)] | | | [removed: [86](#i4bee8fea21084f779a0b7cdc42786b07_142)] [added: [86](#i68e02b122dea42499d61169f19cd8da5_145)] | | |

| Item 13. | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR [removed: INDEPENDENCE](#i4bee8fea21084f779a0b7cdc42786b07_151)] [added: INDEPENDENCE](#i68e02b122dea42499d61169f19cd8da5_154)] | | | [removed: [86](#i4bee8fea21084f779a0b7cdc42786b07_151)] [added: [87](#i68e02b122dea42499d61169f19cd8da5_154)] | | |

| Item 14. | | | [PRINCIPAL ACCOUNTANT FEES AND [removed: SERVICES](#i4bee8fea21084f779a0b7cdc42786b07_154)] [added: SERVICES](#i68e02b122dea42499d61169f19cd8da5_157)] | | | [removed: [86](#i4bee8fea21084f779a0b7cdc42786b07_154)] [added: [87](#i68e02b122dea42499d61169f19cd8da5_157)] | | |

| Item 15. | | | [EXHIBITS AND FINANCIAL STATEMENT [removed: SCHEDULES](#i4bee8fea21084f779a0b7cdc42786b07_160)] [added: SCHEDULES](#i68e02b122dea42499d61169f19cd8da5_163)] | | | [removed: [87](#i4bee8fea21084f779a0b7cdc42786b07_160)] [added: [88](#i68e02b122dea42499d61169f19cd8da5_163)] | | |

537,204,943

| [PART I](#i68e02b122dea42499d61169f19cd8da5_13) | | | | | | [1](#i68e02b122dea42499d61169f19cd8da5_13) | | |

| | | | [Reimbursement](#i68e02b122dea42499d61169f19cd8da5_25) | | | [10](#i68e02b122dea42499d61169f19cd8da5_25) | | |

| [PART II](#i68e02b122dea42499d61169f19cd8da5_70) | | | | | | [59](#i68e02b122dea42499d61169f19cd8da5_70) | | |

| [PART III](#i68e02b122dea42499d61169f19cd8da5_133) | | | | | | [85](#i68e02b122dea42499d61169f19cd8da5_133) | | |

| [PART IV](#i68e02b122dea42499d61169f19cd8da5_160) | | | | | | [88](#i68e02b122dea42499d61169f19cd8da5_160) | | |

| [SIGNATURES](#i68e02b122dea42499d61169f19cd8da5_169) | | | | | | [95](#i68e02b122dea42499d61169f19cd8da5_169) | | |

| 340B Program | | | Federal 340B Drug Pricing Program | | | | | | | | | | | | | | |

| ASU | | | Accounting Standards Update | | | | | | | | | | | | | | |

| ATMOS | | | Amgen Technology and Medical Organizations | | | | | | | | | | | | | | |

| EPO | | | European Patent Office | | | | | | | | | | | | | | |

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

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

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

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

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

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

| Regeneron | | | Regeneron Pharmaceuticals, Inc. | | | | | | | | | | | | | | |

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

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

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

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

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

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

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

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

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

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

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

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

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

| ConfiPen | | | ConfiPen™ | | |

| IMDELLTRA/IMDYLLTRA | | | IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA® (tarlatamab) | | |

| PAVBLU | | | PAVBLU™ (aflibercept-ayyh, formerly ABP 938) | | |

535,918,901

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

| Five Prime | | | Five Prime Therapeutics, Inc. | | | | | | | | | | | | | | |

| GEJ | | | gastroesophageal junction | | | | | | | | | | | | | | |

| IL | | | interleukin | | | | | | | | | | | | | | |

| Janssen | | | Janssen Biotech, Inc. | | | | | | | | | | | | | | |

| LIBOR | | | London Interbank Offered Rate | | | | | | | | | | | | | | |

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

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

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

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

| Novartis | | | Novartis Pharma AG | | | | | | | | | | | | | | |

| ORR | | | objective response rate | | | | | | | | | | | | | | |

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

| PFS | | | progression-free survival | | | | | | | | | | | | | | |

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

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

| siRNA | | | small interfering RNA | | | | | | | | | | | | | | |

| Xaluritamig | | | Xaluritamig (formerly AMG 509) | | |

____________

(1) Products were acquired from our Horizon acquisition on October 6, 2023.

vi

The [removed: Company’s Digital,] [added: Amgen] Technology & [removed: Innovation (DTI)] [added: Medical Organizations (ATMOS)] 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 [removed: DTI] [added: ATMOS] 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.

To evaluate the progress of its activities, our [removed: DTI] [added: ATMOS] 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 [removed: information security, compliance, regulatory affairs, manufacturing, audit, law] [added: CDT, Worldwide Compliance] and [removed: business development] [added: Business Ethics, Regulatory Affairs, Operations, R&D, Global Commercial Operations, Corporate Audit, Law and Business Development] functions).

Our cybersecurity risk management program is considered by and integrated into our Company-wide Enterprise Risk Management [removed: program,] [added: 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).

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 [removed: chaired] [added: co-chaired] by our Chief Audit Executive.

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 [removed: vulnerabilities,] [added: vulnerabilities] and evaluating the impact of cybersecurity attacks and incidents when they occur.

On a biennial basis, our [removed: DTI organization] [added: ATMOS] 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 management team, including our CIO and CISO, supervises efforts to prevent, detect, [removed: mitigate,] [added: 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 [removed: inaugural] Executive Vice President and Chief Technology Officer [removed: (CTO), effective as of the end of 2023,] [added: (CTO) leads our ATMOS function and] oversees our CIO.

As leaders of the [removed: DTI organization] [added: Technology] and CDT [removed: function,] [added: functions within ATMOS,] 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.

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

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

Further, in support of our internal controls, our CISO also reviews cybersecurity matters and trends with our [removed: accounting] [added: Accounting] and [removed: law] [added: Law] functions [added: at least] on a quarterly basis.

[removed: Horizon’s] [added: Certain Horizon] legacy information systems are [removed: currently] maintained separately from Amgen’s preexisting information system infrastructure.

[removed: After we] [added: We] are [removed: able to fully evaluate Horizon’s legacy information systems, protocols and practices, we plan] [added: continuing] to operationally integrate [added: and transition] the legacy Horizon systems into our own, [removed: and these] [added: with the] integrated systems [removed: will then be] [added: becoming] subject to Amgen’s cybersecurity risk management structure and strategy.

While we [removed: integrate] [added: are integrating] these systems, our CISO and CDT function are engaging in cybersecurity risk management activities, and any cybersecurity incidents detected on the legacy Horizon information systems are assessed, mitigated and remediated by our CDT function’s [added: Operations,] Incident Response and Cyber Threat Intelligence teams and reported in accordance with the governance processes detailed above.

[removed: *security] [added: 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.*

In connection with our adoption of artificial intelligence (AI) tools in our business, including AI tools customized for our business and a variety of Amgen-built tools for use across applications, the Company established an AI Governance Council composed of cross-functional leadership that oversees the safe adoption of third-party AI services, including by establishing guardrails to reduce risks and allocating resources to provide staff training on the proper use of AI and responsible AI practices.

The AI Governance Council is co-sponsored by our Chief Compliance Officer and Senior Vice President, Artificial Intelligence & Data.

Our CISO is overseen by our CIO, who has 27 years of experience in information systems (including over 14 years at the Company and more than 6 years as a senior technology executive outside of Amgen), and holds a Computer Information Systems B.S. and an Information Technology Management MBA.

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.

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

Risk Factors—*A breakdown of our information technology systems, cyberattack or information*

| Thousand Oaks, [removed: CA*] [added: CA(1)] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | |

| San Francisco, CA | | | | | | | | | [removed: P] [added: x] | | | | | | | | | | | |

| Deerfield, IL | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | |

| Louisville, KY | | | | | | | | | | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | |

| Cambridge, MA | | | | | | | | | [removed: P] [added: x] | | | | | | | | | | | |

| Juncos, Puerto Rico | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | |

| West Greenwich, RI | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | | [removed: P] [added: x] | | | | | |

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

| Other U.S. [removed: cities] [added: cities(2)] | | | | | | [removed: P] [added: x] | | | [added: x] | | | [removed: P] [added: x] | | | | | | | | |

[removed: *] [added: (1)] Corporate headquarters

| Brazil | | | | | | [removed: P] [added: x] | | | | | | [removed: P] [added: x] | | | [removed: P] | | | | | |

| Canada | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | |

| China | | | | | | [removed: P] [added: x] | | | | | | [removed: P] [added: x] | | | | | | | | |

| Denmark | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | |

| Germany | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | |

| Iceland | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | | | | |

| Ireland | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | |

| Netherlands | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | |

| Singapore | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | |

| United Kingdom | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | | | | |

| Other [removed: countries] [added: countries(2)] | | | | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | [removed: P] [added: x] | | | | | |

Additionally, in [removed: January] 2024 [added: we received FDA licensure of] our [removed: U.S.] manufacturing facility in New Albany, [removed: Ohio received licensure from the FDA for commercial production,] [added: Ohio; opened a new technology] and [added: innovation site in India; and continued to progress on the construction of] our [added: first drug substance manufacturing] facility in Holly Springs, North [removed: Carolina is currently under construction.][added: Carolina.]

As of December 31, 2024, we owned or leased approximately 160 properties.

| New Albany, OH | | | x | | | x | | | | | | | | | x | | | | | |

| India | | | | | | x | | | | | | | | | | | | | | |

(2) Includes smaller properties in other U.S. and ROW locations, primarily for administrative and sales & marketing

Furthermore, in January 2025, we broke ground on our second drug substance manufacturing facility in Holly Springs, North Carolina.

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

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

| Japan | | | | | | P | | | | | | P | | | | | | | | |

| Switzerland | | | | | | P | | | | | | P | | | | | | | | |

As of February [removed: 9, 2024,] [added: 11, 2025,] there were approximately [removed: 4,614] [added: 4,047] holders of record of our common stock.

The following graph shows the value of an investment of $100 on December 31, [removed: 2018,] [added: 2019,] in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index.

[removed: ][added: ]

| | | | [removed: 12/31/2018] [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] | | | | | | [removed: 12/31/2023] [added: 12/31/2024] | | |

During the year ended December 31, [removed: 2023,] [added: 2024,] we had one outstanding stock repurchase program, under which [removed: we had no] repurchase [removed: activity.][added: activity was as follows:]

| October [removed: 1 - October] [added: 1–October] 31 | | | | | | — | | | | | | | | | | | | — | | | | | | $ | 6,979,263,848 | |

| November [removed: 1 - November] [added: 1–November] 30 | | | | | | — | | | | | | | | | | | | — | | | | | | $ | 6,979,263,848 | |

| January [removed: 1 - December 31] [added: 1–December 31(1)] | | | | | | [removed: —] [added: 718,799] | | | | | | [added: $] | [added: 278.26] | | | | | [removed: —] [added: 718,799] | | | | | | | | |

For the years ended December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] we paid quarterly dividends.

| Amgen (AMGN) | | | $100.00 | | | | | | $98.00 | | | | | | $98.86 | | | | | | $119.11 | | | | | | $135.21 | | | | | | $126.14 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $113.57 | | | | | | $109.57 | | | | | | $105.18 | | | | | | $108.20 | | | | | | $114.95 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $108.73 | | | | | | $134.15 | | | | | | $144.55 | | | | | | $155.72 | | | | | | $163.62 | | |

| Standard & Poor’s 500 (SPX) | | | $100.00 | | | | | | $118.39 | | | | | | $152.34 | | | | | | $124.66 | | | | | | $157.49 | | | | | | $196.50 | | |

| December 1–December 31 | | | | | | 718,799 | | | | | | $ | 278.26 | | | | | 718,799 | | | | | | $ | 6,779,253,902 | |

| | | | | | | 718,799 | | | | | | | | | | | | 718,799 | | | | | | | | |

____________

(1) During the year ended December 31, 2024, the Company purchased an additional 1,225 shares at an average price paid of $323.34 per share from staff members to satisfy federal law compliance obligations.

These shares were not repurchased under our stock repurchase program.

| 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 | | |

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

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

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: 2023.][added: 2024.]

Management determined that as of December 31, [removed: 2023,] [added: 2024,] 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: 2023.][added: 2024.]

Based on our assessment, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] 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: 2023.][added: 2024.]

We have audited Amgen Inc.’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] 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: 2023,] [added: 2024,] 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: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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: 2023,] [added: 2024,] and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 and our report dated February 14, [removed: 2024] [added: 2025] expressed an unqualified opinion thereon.

February 14, 2025

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

During the three months ended December 31, [removed: 2023,] [added: 2024,] 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.

Information about our Directors is incorporated by reference from the section entitled ITEM 1—ELECTION OF DIRECTORS in our Proxy Statement for the [removed: 2024] [added: 2025] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2023] [added: 2024] (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: 2025] [added: 2026] Annual Meeting in our Proxy Statement.

Information about our insider trading policies and procedures is incorporated by reference from the section entitled COMPENSATION DISCUSSION AND ANALYSIS—COMPENSATION POLICIES AND PRACTICES—INSIDER TRADING POLICIES AND PROCEDURES in our Proxy Statement.

A copy of our Insider Trading Policy and our securities transactions pre-clearance practices and procedures are filed with this Annual Report on Form 10-K as Exhibits 19.1 and 19.2, respectively.

The following table sets forth certain information as of December 31, 2024, 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, 2024, 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) | | | | | | 10,714,775 | | | | | | $ | 225.84 | | | | | 59,435,223 | | |

| Amended and Restated 1991 Equity Incentive Plan(2) | | | | | | 100 | | | | | | | | | | | | | | |

| Amended and Restated Employee Stock Purchase Plan | | | | | | | | | | | | | | | | | | 3,946,553 | | |

| Total approved plans | | | | | | 10,714,875 | | | | | | $ | 225.84 | | | | | 63,381,776 | | |

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

| Amgen Profit Sharing Plan for Employees in Ireland(3) | | | | | | | | | | | | | | | | | | 175,345 | | |

| Horizon stock plans(4) | | | | | | 467,296 | | | | | | | | | | | | | | |

| Total unapproved plans | | | | | | 467,296 | | | | | | — | | | | | | 175,345 | | |

| Total all plans | | | | | | 11,182,171 | | | | | | $ | 225.84 | | | | | 63,557,121 | | |

(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 2022, 2023 and 2024.

As of December 31, 2024, the number of outstanding awards under column (a) includes (i) 5,909,018 shares issuable upon the exercise of outstanding options with a weighted-average exercise price of $225.84; (ii) 3,289,089 shares issuable upon the vesting of outstanding RSUs, including 198,925 related dividend equivalents; and (iii) 1,516,669 shares subject to outstanding 2022, 2023 and 2024 performance units, including 91,901 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, 2024, employing the fungible share formula and presumes the issuance of target shares under the performance units granted in 2022, 2023 and 2024 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 that 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 2022, 2023 and 2024.

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

The number under column (a) with respect to this plan includes 100 shares issuable upon the settlement of deferred RSUs.

(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.

(4)The Horizon Therapeutics Public Limited Company Amended and Restated 2014 Equity Incentive Plan, the Horizon Therapeutics Public Limited Company Amended and Restated 2020 Equity Incentive Plan and 2020 Restricted Stock Unit Award Sub-Plan and the Horizon Therapeutics Public Limited Company Amended and Restated 2018 Equity Incentive Plan and 2018 Restricted Stock Unit Award Sub-Plan (collectively, the “Horizon stock plans”) were acquired on October 6, 2023, pursuant to our acquisition of Horizon.

In connection with the closing of the Horizon acquisition and pursuant to its terms, outstanding RSUs issued under the Horizon stock plans were converted into Amgen RSUs, and these plans terminated as to future grants on October 6, 2023.

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.

| Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) | | | [removed: [F-](#i4bee8fea21084f779a0b7cdc42786b07_175)[1](#i4bee8fea21084f779a0b7cdc42786b07_175)] [added: [F-](#i68e02b122dea42499d61169f19cd8da5_178)[1](#i68e02b122dea42499d61169f19cd8da5_178)] | | |

| Consolidated Statements of Income for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] | | | [removed: [F-5](#i4bee8fea21084f779a0b7cdc42786b07_178)] [added: [F-4](#i68e02b122dea42499d61169f19cd8da5_181)] | | |

| Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] | | | [removed: [F-6](#i4bee8fea21084f779a0b7cdc42786b07_181)] [added: [F-5](#i68e02b122dea42499d61169f19cd8da5_184)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] | | | [removed: [F-7](#i4bee8fea21084f779a0b7cdc42786b07_184)] [added: [F-6](#i68e02b122dea42499d61169f19cd8da5_187)] | | |

| Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] | | | [removed: [F-8](#i4bee8fea21084f779a0b7cdc42786b07_187)] [added: [F-7](#i68e02b122dea42499d61169f19cd8da5_190)] | | |

| Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] | | | [removed: [F-9](#i4bee8fea21084f779a0b7cdc42786b07_190)] [added: [F-8](#i68e02b122dea42499d61169f19cd8da5_193)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [F-10](#i4bee8fea21084f779a0b7cdc42786b07_193)] [added: [F-9](#i68e02b122dea42499d61169f19cd8da5_196)] | | |

| Schedule II. Valuation and Qualifying Accounts | | | [removed: [F-57](#i4bee8fea21084f779a0b7cdc42786b07_259)] [added: [F-58](#i68e02b122dea42499d61169f19cd8da5_262)] | | |

| [removed: 2.1] [added: 2.2] | | | | | | [removed: [Asset Purchase Agreement,] [added: [Agreement and Plan of Merger,] dated [added: as of] August [removed: 25, 2019, by and between] [added: 3, 2022, among ChemoCentryx, Inc.,] Amgen Inc. and [removed: Celgene Corporation.](http://www.sec.gov/Archives/edgar/data/318154/000119312519228830/d787825dex21.htm)] [added: Carnation Merger Sub, Inc.](https://www.sec.gov/Archives/edgar/data/318154/000119312522211860/d346334dex21.htm)] (Filed as an exhibit to Form 8-K on August [removed: 26, 2019] [added: 4, 2022] and incorporated herein by reference.) | | |

| [removed: 2.1.1] [added: 10.21.1] | | | | | | [Amendment No. 1 to [removed: the Asset] [added: Share] Purchase Agreement, dated [removed: October 17,] [added: December 6,] 2019, by and [removed: between Amgen Inc.] [added: among BeiGene, Ltd.] and [removed: Celgene Corporation.](http://www.sec.gov/Archives/edgar/data/318154/000119312519270139/d655928dex101.htm)] [added: Amgen Inc.](https://www.sec.gov/Archives/edgar/data/318154/000119312520003926/d848812dex992.htm)] (Filed as an exhibit to [removed: Form 8-K] [added: Schedule 13D] on [removed: October 17, 2019] [added: January 8, 2020] and incorporated herein by reference.) | | |

| [removed: 2.1.2] [added: 10.14+] | | | | | | [removed: [Amendment No. 2 to the Asset Purchase Agreement, dated October 17, 2019, by and] [added: [Agreement] between Amgen Inc. and [removed: Celgene Corporation.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a23amendmentno2toapa.htm)] [added: James Bradner, dated December 13, 2023.](https://www.sec.gov/Archives/edgar/data/318154/000031815424000011/exhibit1014-agreementbetwe.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, [removed: 2019] [added: 2023] on February [removed: 12, 2020] [added: 14, 2024] and incorporated herein by reference.) | | |

| [removed: 2.2] [added: 4.3] | | | | | | [removed: [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] [added: [Agreement] of [removed: Otezla.](https://www.sec.gov/Archives/edgar/data/318154/000031815420000017/a24letteragreementv3.htm)] [added: Resignation, Appointment and Acceptance dated February 15, 2008.](https://www.sec.gov/Archives/edgar/data/318154/000119312508040431/dex43.htm)] (Filed as an exhibit to Form 10-K for the year ended December 31, [removed: 2019] [added: 2007] on February [removed: 12, 2020] [added: 28, 2008] and incorporated herein by reference.) | | |

| [removed: 2.4] [added: 2.1] | | | | | | [Agreement and Plan of Merger, dated July 27, 2021, by and among Amgen Inc., Teneobio, Inc., Tuxedo Merger Sub, Inc., and Fortis Advisors LLC.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000045/amgn-ex27_202193021xq3.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or [removed: confidential)(Filed] [added: confidential) (Filed] as an exhibit to Form 10-Q for the quarter ended September 30, 2021 on November 3, 2021 and incorporated herein by reference.) | | |

| [removed: 2.5] [added: 2.3] | | | | | | [removed: [Agreement and Plan of Merger,] [added: [Transaction Agreement,] dated as of [removed: August 3,] [added: December 11,] 2022, [added: by and] among [removed: ChemoCentryx, Inc.,] Amgen [removed: Inc.] [added: Inc., Pillartree Limited] and [removed: Carnation Merger Sub, Inc.](https://www.sec.gov/Archives/edgar/data/318154/000119312522211860/d346334dex21.htm)] [added: Horizon Therapeutics plc.](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex21.htm)] (Filed as an exhibit to Form 8-K on [removed: August 4,] [added: December 12,] 2022 and incorporated herein by reference.) | | |

| [removed: 2.6] [added: 2.4] | | | | | | [removed: [Transaction Agreement,] [added: [Appendix 3 to the Rule 2.7 Announcement,] dated as of December [removed: 11, 2022, by and among Amgen Inc., Pillartree Limited and Horizon Therapeutics plc.](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex21.htm)] [added: 12, 2022 (Conditions Appendix).](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex22.htm)] (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | | |