Amgen (AMGN) 10-K risk factor changes: FY2025 vs FY2024

- We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, [removed: and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026; such tax liabilities could adversely affect our profitability and results of operations.][added: including OB3.]

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

- Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our [removed: environmental, social and governance] [added: sustainability] objectives.

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

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

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

[removed: However, to] [added: To] the extent [removed: that payer] [added: such] actions [removed: further decrease] [added: reduce] or modify [removed: the] coverage or reimbursement [removed: available] for our products, [removed: require that we pay increased] [added: increase] rebates or [removed: shift] other [removed: costs to us, limit or affect our decisions regarding the] [added: costs, constrain] pricing [removed: of] [added: decisions,] or otherwise [removed: reduce the use of our products, such actions could] [added: limit product use, they would] have [removed: a material] [added: an] adverse effect on our business and results of operations.

See Part [removed: I,] [added: II,] Item [removed: 1.][added: 7.]

For example, the IRA includes provisions requiring [removed: that, beginning in 2026,] mandatory [removed: price setting be introduced] [added: pricing] in Medicare for certain drugs [removed: paid for] under Parts B and [removed: D, whereby manufacturers must accept a price established by the government or face penalties on all U.S. sales] [added: D] (starting with 10 drugs [removed: in] [added: effective January 1,] 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent [added: years such that, by 2031, approximately 100 drugs would be subject to such set prices).]

[removed: In 2024,] CMS [added: has] set [removed: a price for ENBREL under] Medicare Part D [removed: that is significantly lower than currently applicable, beginning on] [added: prices for ENBREL, effective] January 1, 2026, [removed: which we expect will] [added: and Otezla, effective January 2027, in each case at significantly lower prices that are expected to] negatively impact [removed: its] [added: their] profitability in Medicare.

See [removed: Part I,] Item [removed: 2.][added: 1.]

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of [removed: operations—Product sales—ENBREL.][added: operations—*Product sales*.]

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 [removed: setting.][added: setting, we may be required to accept a price set by the government for Medicare using the process that was applied to ENBREL and Otezla.]

Also under the IRA, Medicare Part D was redesigned to cap beneficiary out-of-pocket costs [removed: and, beginning January 1, 2025,] [added: and reduce] Federal reinsurance [removed: will be reduced] in the catastrophic [removed: phase (resulting in a shift and increase of such costs to] [added: phase; increasing cost-sharing obligations for] Part D plans and manufacturers, including by requiring manufacturer [removed: discounts on certain drugs).][added: discounts.]

Further, the IRA inflation penalties [removed: allows] [added: allow] CMS to collect rebates from manufacturers if [added: Medicare] price increases outpace [removed: inflation.][added: inflation, and several of our products have been subject to such IRA inflation rebates.]

The IRA’s Medicare price setting and Medicare redesign [added: have had, and] are likely to [removed: have a material] [added: have, an] 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 Medicare price setting and the timing of market entry of generic or biosimilar competition.

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

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

Existing and proposed state pricing [removed: laws] [added: laws, which may move forward more rapidly than similar efforts at the federal level,] have added complexity to the pricing of [removed: drugs and may already be affecting industry pricing decisions.][added: drugs.]

[removed: A number of states have adopted, and many] other [removed: states are considering, PDABs,] drug [removed: importation programs, reference] pricing [removed: schemes, and other 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 [removed: are also enacting] [added: continue to pursue] laws [added: related to price controls,] referencing the IRA and seeking to regulate and prohibit restrictions on the 340B Program.

Further, inappropriate expanded utilization of the 340B Program from broadened application of the 340B discounts has had, and is [added: expected to continue to have, a negative impact on the Company’s product sales, business and results of operations.]

[removed: expected to continue to have, a negative impact on the Company’s] [added: our] product sales, business and results of operations.

[removed: Louisiana,] [added: Twenty states (Louisiana,] Arkansas, West Virginia, Minnesota, [removed: Kansas,] Mississippi, [removed: Missouri] [added: Missouri, Maryland, North Dakota, South Dakota, Utah, Nebraska, New Mexico, Colorado, Tennessee, Oregon, Vermont, Hawaii, Oklahoma, Rhode Island] and [removed: Maryland] [added: Maine)] have enacted laws with mandates on manufacturers participating in the 340B Program, and, in [removed: 2024,] [added: 2025,] no fewer than [removed: 25] [added: 30] states [removed: considered] [added: have introduced] similar legislation.

These bills vary, but typically include provisions [removed: 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, where] [added: Becerra*,] the U.S. District Court for the District of South Carolina issued an order in November 2023 [removed: that enjoins] [added: enjoining] the Health Resources and Services Administration from enforcing [removed: its] [added: a] more restrictive interpretation [removed: of] [added: against Genesis Health Care as to] who [removed: is considered] [added: qualifies as] a patient under the 340B Program, [removed: to the potential benefit of healthcare systems seeking to expand] [added: which could, if adopted more broadly, affect] the [removed: application] [added: scope] of [added: eligibility for] 340B discounts.

Additionally, [removed: on January 5,] [added: in] 2024, the FDA authorized Florida to move forward with its importation program proposal, though the state has not [added: yet] completed any significant steps towards importation within the [removed: one-year] [added: two-year] authorization window.

Ultimately, [removed: as with U.S. federal government actions,] existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations.

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

[added: See *—Concentration of sales at certain of our wholesaler distributors, and consolidation of private payers, such as insurers, and PBMs has negatively affected, and may continue to negatively affect, our business.*] This high degree of consolidation among insurers, PBMs and other payers, including integrated healthcare delivery systems and/or with specialty or mail-order pharmacies and pharmacy retailers, has increased the negotiating leverage such entities have over us and other biopharmaceutical manufacturers and has resulted in greater price discounts, rebates and service fees realized by those payers from our business.

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

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

Pressures to decrease drug expenditures may intensify as governments take actions to address budgets strained by high inflation and weak economic conditions, including in [removed: Europe] [added: Europe,] where [removed: the effects of the Russia–Ukraine conflict have challenged the economies in that region.][added: sustained fiscal pressures continue to challenge public healthcare systems.]

Value assessments may come from private organizations that publish their findings and offer recommendations relating to the products’ reimbursement by government and [removed: private payers.]

Such health technology assessment organizations have [removed: recommended,] [added: *recommended*,] and may in the future recommend, reimbursement for certain of our products for a narrower indication than was approved by applicable regulatory agencies or may recommend against reimbursement entirely.

[added: See *Our sales depend on] coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our [removed: profitability.][added: profitability*.]

*We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, [removed: and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026; such tax liabilities could adversely affect our profitability and results of operations.*][added: including OB3.]

Significant disputes can and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts, and such tax authorities (including the IRS) are becoming more aggressive in [removed: their] [added: its] audits and are particularly focused on such matters.

[removed: In July] [added: We disagreed with the proposed adjustments and calculations, and in] 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years [removed: 2010–2012 that we received in May and July 2021 which seek to increase our U.S. taxable income for the years] 2010–2012.

[removed: In July 2022, we filed a petition in the U.S. Tax Court to contest a] [added: The] Notice [removed: for the years 2013–2015 that we previously reported receiving in April 2022 that] seeks to increase our U.S. taxable income for the years 2013–2015 and asserts penalties.

Such tax liabilities could adversely affect our profitability and results of operations.

On July 4, 2025, OB3 was enacted and included several changes to Medicare, Medicaid and Affordable Care Act policies, including provisions affecting eligibility, that, when implemented, are expected to adversely affect coverage and reimbursement for our products.

On May 12, 2025, the Administration issued the Most-Favored-Nations (MFN) Prescription Drug Pricing Executive Order (MFN EO) aimed at using price benchmarks from other developed countries to set U.S. pricing targets.

Subsequently, on July 31, 2025 the Administration sent letters to many pharmaceutical manufacturers, including Amgen (the July MFN Letter) as further described below, outlining steps that such manufacturers could take to advance actions consistent with elements of the MFN EO.

In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests.

Further, the Administration has called on Congress to enact legislation that would codify the terms that the Administration arrived at with recipients of the July MFN Letter (the MFN Terms).

The details of such legislative framework are unknown and, if enacted, such legislation could apply to a broader range of products, payers or pricing arrangements for a longer period than those resulting from the MFN Terms.

It remains unclear what further policies, legislation and/or actions the Administration, Congress, or state governments will advance with respect to other drug pricing proposals or other healthcare regulations affecting pharmaceuticals, including the MFN EO, IRA and OB3 implementation, trade policies, or state laws affecting the 340B Program or Medicaid reimbursement that could ultimately be adopted more broadly.

Further, CMS has issued guidance that allows for the re-setting of prices for drugs for which it previously set a price.

On April 15, 2025, the Administration issued an executive order (the April 2025 EO) that, among other directives, directs HHS to work with Congress to align the treatment of small molecule drugs and biologics in the Medicare price setting program under the IRA.

It is currently unclear how such modifications would affect the timeframe in which Medicare price setting becomes applicable for selected drugs or biologics.

Implementation of OB3 also may impact access to and reimbursement of our products.

For example, the Congressional Budget Office has projected that the OB3 will result in significant reductions in federal Medicaid spending over the next decade and an increase in the number of people without health insurance.

These developments would place greater stress on state budgets and hospital finances, and could result in reduced access to medicines, additional pressure to further discount medicines and further growth of 340B Program utilization.

The MFN EO directs HHS to pursue pricing policies that align U.S. drug prices with the prices available in certain comparably developed countries and directs a range of actions to advance that objective, including through regulatory, trade and other policy measures.

In July 2025, the Administration delivered the July MFN Letter to us and a number of other manufacturers that called for drug manufacturers to: 1) extend MFN pricing to Medicaid; 2) guarantee MFN pricing to Medicaid, Medicare and commercial payers on all newly launched drugs; 3) use future increased revenues from outside the U.S. to lower U.S. drug prices; and 4) participate in direct-to-patient models to provide MFN pricing for certain drugs.

Since the issuance of the July MFN Letter, most recipients have announced that they have reached agreement with the Administration to address the matters described in the letter.

In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests.

We also announced the expansion of our direct-to-patient program.

While this development reflects ongoing engagement on pricing policy, the ultimate effects on our pricing, reimbursement, net sales and profitability remain uncertain in light of evolving regulatory and policy expectations.

A number of states have adopted, and many other states are considering, PDABs, drug importation programs, reference pricing schemes and

In 2025, Maryland expanded the scope of its PDAB law to include the commercial market.

The Colorado PDAB deemed three of five drugs “unaffordable,” including ENBREL, and in October 2025 the Colorado PDAB established an Upper Payment Limit (UPL) substantially lower than the wholesale acquisition cost of ENBREL that would be generally applicable to all formulations of ENBREL, effective no earlier than January 1, 2027, and will be reviewed annually.

On July 16, 2025, Washington state’s PDAB selected ENBREL for one of its first affordability reviews.

Following the timeline and process established by the state for such affordability review, the manufacturer and the PDAB will undertake a number of required interactions.

However, the Washington state PDAB may not establish a UPL for any prescription drug before January 1, 2027.

With OB3’s reductions to federal Medicaid funding to states, increased pressure is anticipated for providers to find and preserve existing revenue sources at the state level, which may result in increased use of 340B contract pharmacy mandates.

In *Genesis Health Care, Inc. v.

Since this decision, various courts have reached differing conclusions on challenges to state laws regulating aspects of the 340B Program, with some courts declining to enjoin such laws and others granting relief to challengers.

Certain appellate courts have issued decisions both upholding certain state 340B statues and affirming the denial of preliminary injunctive relief to manufacturers, while litigation and appeals concerning the validity, interpretation, and enforcement of these laws remain ongoing.

Further, the April 2025 EO also directs HHS to, within 90 days, streamline and improve the drug importation program to ease the process for states to obtain drug importation approvals.

On May 21, 2025, the FDA issued a press release indicating it was taking steps to enhance state importation programs and would offer individual states and tribes the opportunity to submit draft proposals for pre-review and to meet with the agency to obtain initial feedback prior to formally submitting importation proposals.

While under federal law biologics remain exempt from such state importation activities, our small molecule products could be impacted by these initiatives.

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

In addition, policies under consideration or adopted in the United States that reference or tie drug prices to those paid in foreign jurisdictions, including through most-favored-nation or similar pricing approaches, could increase the significance of pricing decisions in such foreign jurisdictions.

private payers.

The EU has adopted and begun implementing Regulation 2021/2282 on Health Technology Assessment, which establishes a permanent framework for cooperation among EU member states on joint clinical assessments and scientific consultations of health technologies, with key provisions that became applicable in January 2025, and further phased implementation continuing through 2030.

Such tax liabilities could adversely affect our profitability and results of operations.*

The Notices seek to increase our U.S. taxable income for the years 2010–2012.

We disagreed with the proposed adjustments and calculations, and in 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015.

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

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.

Such state laws could also eventually be adopted at the federal level.

We are unable to predict which or how many policy, regulatory, administrative or legislative changes may ultimately be, or effectively estimate the consequences to our business if, enacted and implemented.

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

The Medicare price setting process for the first 10 drugs subject to Medicare price setting in Part D began in 2023 , which includes ENBREL, our product that currently generates considerable revenues.

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.

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.

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 to issue such invoices to manufacturers.

We expect that several of our products will be subject to IRA inflation 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.

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.

Other CMS policy changes and demonstration projects to test new care, delivery and payment models can also significantly affect how drugs, including our products, are covered and reimbursed.

In 2024, no fewer than 17 states introduced PDAB legislation.

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.

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.

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 patient access to Repatha treatment.

In an effort to reduce barriers to access, we reduced the net price of Repatha by providing greater discounts and rebates to payers (including PBMs that administer Medicare Part D prescription drug plans), and in response to a very high percentage of Medicare patients abandoning their Repatha prescriptions rather than paying their co-pay, we introduced a set of new National Drug Codes to make Repatha available at a lower list price.

However, affordability of patient out-of-pocket co-pay cost has limited, and may continue to 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 its sales.

These factors have limited, and may continue to limit, patient affordability and use, negatively affecting Repatha sales.

For example, in the United States, the FTC’s interim report released in 2024 showed that the top six integrated health plans and PBMs controlled about 94% of all pharmacy prescriptions.

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

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

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

In addition, multiple Congressional Committees 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.

The results of such inquiries could have an effect on manufacturer interactions with PBMs, resulting in changes to access for certain medicines.

For example, in 2022, several Medicare Administrative Contractors issued notice that TEZSPIRE would be added to their “self-administered drug” exclusion lists.

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

See Our sales depend on

The EU has adopted regulations, beginning this year, intended to increase cooperation among EU member states and harmonize various procedures and standards at the EU level in assessing health technologies and in support of joint clinical assessments of health technologies and medicines.

We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS administrative appeals office but were unable to reach resolution.

We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution.

We helped launch the biotechnology industry more than [removed: 40] [added: 45] years ago and have grown to be one of the world’s leading independent biotechnology companies.

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

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

In [removed: 2024,] [added: 2025,] we [removed: advanced our innovative pipeline;] generated strong sales growth across our product portfolio and regions; [added: advanced our innovative pipeline;] and [removed: expanded] [added: continued to expand and enhance] our world-class manufacturing network.

We accomplished these objectives while maintaining a strategic and disciplined approach to capital [removed: allocation.][added: allocation, including retiring $6.0 billion of debt.]

For [removed: more] [added: additional] information on our pipeline and clinical development updates, see Part I, Item 1.

Total product sales increased [added: 10%] in [removed: 2024, primarily] [added: 2025,] driven by volume growth of [removed: 23%,] [added: 13%,] partially offset by declines in net selling price of [removed: 2%.][added: 3%.]

Cash flows from operating activities in [removed: 2024] [added: 2025] totaled [removed: $11.5] [added: $10.0] billion, which supported investment in our business, including capital expenditures of [removed: $1.1] [added: $1.9] billion to enhance and expand our manufacturing network, and allowed us to both reduce our debt [removed: outstanding] and return capital to shareholders through the payment of cash dividends.

For [removed: 2024,] [added: 2025,] we [added: retired $6.0 billion of debt and] increased our quarterly cash dividend by 6% to [removed: $2.25] [added: $2.38] per share of common stock.

[removed: $2.38] [added: In December 2025, the Board of Directors declared a cash dividend of $2.52] per share of common stock for the first quarter of [removed: 2025,] [added: 2026,] an increase of 6% over the same period in the prior year, to be paid in March [removed: 2025.][added: 2026.]

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

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

For [removed: further information on] [added: additional discussion of] these and other [removed: efforts,] [added: risks,] see Part I, Item [removed: 1.][added: 1A.]

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

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

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

Business—Marketing, Distribution and Selected Marketed [removed: Products—Competition.][added: Products—*Competition*.]

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

Moreover, provisions of the IRA, as well as the [added: expanded utilization of the] 340B Program, have [added: negatively] affected, and are likely to continue to [added: negatively] affect, our business.

For example, [added: CMS has selected] ENBREL and Otezla [removed: have been selected by CMS] for Medicare price setting beginning in 2026 and 2027, respectively.

Risk [removed: Factors] [added: Factors, of this Annual Report on Form 10-K] for further discussion of certain factors that could impact our future product sales.

| | | | Year ended December 31, [added: 2025 | | | | | | Change | | | | | | Year ended December 31,] 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | |

| [added: Total] U.S. | | | $ | [added: 25,656 | | | | | 10 | | % | | | | $ |] 23,301 | | | | | 21 | | % | | | | $ | 19,272 | |

| [added: Total] ROW | | | [added: 9,492 | | | | | | 9 | | % | | | |] 8,725 | | | | | | 14 | | % | | | | 7,638 | | |

| Total product sales | | | [removed: 32,026] [added: $] | [added: 35,148] | | | | | [added: 10 | | % | | | | $ | 32,026 | | | | |] 19 | | % | | | | [removed: 26,910] [added: $] | [added: 26,910] | |

| Other revenues | | | [removed: 1,398] [added: 1,603] | | | | | | [removed: 9] [added: 15] | | % | | | | [removed: 1,280] [added: 1,398] | | |

| Total revenues | | | $ | [removed: 33,424] [added: 36,751] | | | | | [removed: 19] [added: 10] | | % | | | | $ | [removed: 28,190] [added: 33,424] | |

| [removed: Operating] [added: Total operating] expenses | | | $ | [added: 27,671 | | | | | 6 | | % | | | | $ |] 26,166 | | | | | 29 | | % | | | | $ | 20,293 | |

| Operating income | | | $ | [removed: 7,258] [added: 9,080] | | | | | [removed: (8)] [added: 25] | | % | | | | $ | [removed: 7,897] [added: 7,258] | |

| Net income | | | $ | [removed: 4,090] [added: 7,711] | | | | | [removed: (39)] [added: 89] | | % | | | | $ | [removed: 6,717] [added: 4,090] | |

| Diluted EPS | | | $ | [removed: 7.56] [added: 14.23] | | | | | [removed: (39)] [added: 88] | | % | | | | $ | [removed: 12.49] [added: 7.56] | |

| Diluted shares | | | [removed: 541] [added: 542] | | | | | | [removed: 1] [added: 0] | | % | | | | [removed: 538] [added: 541] | | |

Total product sales increased [removed: 19%] [added: 10%] in [removed: 2024, primarily] [added: 2025,] driven by volume growth of [removed: 23%,] [added: 13%,] partially offset by declines in net selling price of [removed: 2%.][added: 3%.]

For [removed: 2025,] [added: 2026,] we expect volume growth from certain brands to be partially offset by net selling price declines.

Further, the first quarter of a year historically represents the lowest product sales quarter for the year, in part due to plan changes, insurance reverifications and higher co-pay expenses as U.S. patients work through deductibles, [added: including for ENBREL and Otezla, and to a lesser extent for KRYSTEXXA, TEZSPIRE and Repatha,] particularly for products acquired through pharmacy benefit programs.

Uncertain macroeconomic conditions, [added: including uncertainty around tariffs and trade protection measures, ongoing geopolitical conflicts and rising geopolitical tensions,] changes in the healthcare [removed: ecosystem] [added: ecosystem,] and [removed: geopolitical conflicts] [added: potential government policy actions, including MFN pricing or similar drug pricing reforms,] have the potential to introduce variability into product sales.

Furthermore, product sales continue to be impacted by actions from governments and other entities to [removed: curb high inflation,] [added: address macroeconomic challenges,] provisions of the IRA, [removed: inappropriate] expanded utilization of the 340B Program and growth in numbers of Medicaid enrollees and uninsured individuals.

See [removed: Risk Factors in] Part I, Item 1A.

Other revenues increased [added: 15%] for [removed: 2024,] [added: 2025,] primarily driven by higher [removed: corporate partner revenue from licensed products and] royalty income.

[removed: Operating expenses increased] [added: The decrease in SG&A expense] for [removed: 2024,] [added: 2025 was] driven by [removed: higher] [added: lower Horizon acquisition-related expenses and lower] amortization expense from [removed: Horizon] acquisition-related assets, [removed: higher R&D and SG&A expenses, including expenses from the acquired Horizon business, and] [added: partially offset by] higher [removed: profit share] [added: general] and [removed: royalty expense.][added: administrative expenses.]

In 2025, we achieved several significant regulatory, clinical and operational milestones.

We obtained multiple regulatory approvals, including new indications for UPLIZNA and TEZSPIRE; a broadened FDA approval for Repatha; and full FDA approval for IMDELLTRA for the treatment of ES-SCLC.

We also advanced our innovative pipeline, including the initiation of six global Phase 3 clinical studies for MariTide and the reporting of Phase 3 data across several programs.

In addition, we continued to invest in expanding and enhancing our manufacturing capacity, including facilities in Ohio, North Carolina and the U.S. territory of Puerto Rico.

Furthermore, in 2025 we also broke ground on a new state-of-the-art R&D facility in Thousand Oaks, California, to further enhance collaboration and innovation across R&D and process development activities.

For additional information on our manufacturing operations, see Part I, Item 1.

Business—Manufacturing, Distribution and Raw Materials.

We believe our culture supports innovation, collaboration and productivity as we execute on our mission to serve patients.

For additional information, see Part I, Item 1.

*Tariffs and trade protection measures*

Recent and ongoing changes in U.S. trade and tariff policies, including the imposition, modification, suspension and threatened expansion of tariffs on imported goods, as well as retaliatory measures by foreign governments, have increased uncertainty in the overall business and operating environment.

Numerous tariffs and trade protection measures have been proposed, and in a number of cases, implemented by the United States and other countries, including the April 2025 Tariff EO, which imposed a universal 10% tariff on goods imported into the United States, with certain exceptions including pharmaceuticals.

Further, there were previous proposals for sector-specific tariffs on our industry, and in December 2025, in recognition of our capital investments in U.S. manufacturing, we received relief from Section 232 tariffs, pending final determination under such section of the Trade Expansion Act of 1962, for approximately the next three years.

Tariffs and trade protection measures may adversely affect our business and results of operations.

Risk Factors, of this Annual Report on Form 10-K.

Uncertainty around tariffs and trade protection measures in the United States and other countries, including the imposition, modification, suspension and threatened expansion of tariffs on imported goods, along with ongoing geopolitical conflicts and rising geopolitical tensions, continue to create additional uncertainty in global macroeconomic conditions.

In addition to the IRA, other recent and proposed U.S. policy actions focus on drug pricing, including the Most-Favored-Nations Prescription Drug Pricing Executive Order (MFN EO) and the July MFN Letter that was delivered to a number of pharmaceutical companies, including Amgen.

In December 2025, we announced

that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests.

We also announced the expansion of our direct-to-patient program.

While this development reflects ongoing engagement on pricing policy, the ultimate effects on our pricing, reimbursement, net sales and profitability remain uncertain in light of such evolving regulatory and policy expectations.

For additional discussion of these and other risks, see Part I, Item 1A.

Risk Factors, of this Annual Report on Form 10-K.

| | | | Year ended December 31, 2025 | | | | | | Change | | | | | | Year ended December 31, 2024 | | |

| U.S. | | | $ | 25,656 | | | | | 10 | | % | | | | $ | 23,301 | |

| ROW | | | 9,492 | | | | | | 9 | | % | | | | 8,725 | | |

| Total product sales | | | 35,148 | | | | | | 10 | | % | | | | 32,026 | | |

U.S. volume grew 13% and ROW volume grew 14%, driven by volume growth in certain brands, including Repatha, PAVBLU, EVENITY, IMDELLTRA/IMDYLLTRA and TEZSPIRE.

Operating expenses increased 6% for 2025, primarily driven by investments in Later-Stage Clinical Programs and Otezla intangible asset impairment charges in 2025, partially offset by lower amortization expense from acquisition-related assets, including the fair value step-up of inventory acquired from Horizon.

See Part IV—Note 13, Goodwill and other intangible assets, to the Consolidated Financial Statements, for additional information related to the Otezla intangible asset impairment charges.

See Part I, Item 1.

Business—Reimbursement, and Part I, Item 1A.

Risk Factors, of this Annual Report on Form 10-K.

(2) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.

Business—Marketing, Distribution and Selected Marketed Products—*Competition*.

For 2026, we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW.

| | | | Year ended December 31, 2025 | | | | | | Change | | | | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | |

For 2026, we expect product sales for Repatha to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters, as discussed above.

Additionally, for 2026, we expect net selling price to decline by approximately mid-single digits.

| | | | Year ended December 31, 2025 | | | | | | Change | | | | | | Year ended December 31, 2024 | | | | | | Change | | | | | | Year ended December 31, 2023 | | |

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.

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

In our effort to attract and retain the best talent, we seek out and support talent across the globe.

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.

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

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

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

of this Form 10-K.

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

| Total ROW | | | 8,725 | | | | | | 14 | | % | | | | 7,638 | | | | | | 8 | | % | | | | 7,058 | | |

N/A = not applicable

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

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.

The decrease in ENBREL sales for 2023 was driven by lower net selling price, lower inventory and unfavorable changes to estimated sales deductions.

For 2025, we expect lower declines in net selling price.

The decrease in global Otezla sales for 2023 was driven by lower net selling price and inventory, partially offset by volume growth.

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

U.S. Aranesp sales for 2023 decreased due to lower unit demand as a result of independent and medium-sized dialysis organizations transitioning from Aranesp to EPOGEN.

| KRYSTEXXA — ROW | | | — | | | | | | N/A | | | | | | — | | | | | | N/A | | | | | | — | | |

| Total KRYSTEXXA | | | $ | 1,185 | | | | | * | | | | | | $ | 272 | | | | | N/A | | | | | | $ | — | |

| EPOGEN — U.S. | | | 125 | | | | | | (45) | | % | | | | 226 | | | | | | (55) | | % | | | | 506 | | |

| Other — U.S.(2) | | | 916 | | | | | | 34 | | % | | | | 685 | | | | | | 5 | | % | | | | 650 | | |

| Marketed products | | | 1,600 | | | | | | 1,302 | | | | | | 1,196 | | |

The increase in SG&A expense for 2023 was primarily driven by acquisition-related expenses, in addition to commercial and general and administrative expenses related to the Horizon acquisition, partially offset by lower spend for other marketed products.

Other operating expenses for 2022 primarily consisted of a loss on the divestiture of Gensenta.

The change in Other income (expense), net, for 2023 was primarily due to gains recognized in connection with recording our BeiGene investment at fair value and an increase in interest income due to higher average cash balances and higher interest rates as compared to the prior year.

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

Other countries, including the United States and the U.S. territory of Puerto Rico, have not yet enacted the OECD agreement and implementation remains highly uncertain.

The continued enactment of the agreement, either by all OECD participants or unilaterally by individual countries, could result in tax increases or double taxation in the United States or foreign jurisdictions.

A 2022 Puerto Rico tax law change replaced the excise tax with an income tax, beginning in 2023.

As of January 1, 2023, we are no longer subject to a 4% excise tax in the U.S. territory of Puerto Rico on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico.

We qualify for and are subject to the alternative income tax rate on industrial development income of our Puerto Rico affiliate.

In the United States, this income tax qualifies for foreign tax credits under the U.S. Treasury final foreign tax credit regulations.

We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution.

In addition, the Notice asserts penalties of approximately $2.0 billion.

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

During 2022, we repurchased $6.3 billion of common stock, including $6.0 billion under ASR agreements and had cash settlements for stock repurchases of $6.4 billion.

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

During 2022, we issued debt with an aggregate principal amount of $7.0 billion.

In the discussion that follows, we assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, [removed: 2024] [added: 2025] and [removed: 2023.][added: 2024.]

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: 2024] [added: 2025] and [removed: 2023.][added: 2024.]

Our portfolio of available-for-sale investments as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] 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: $11.5] [added: $8.5] billion and [removed: $10.4] [added: $11.5] billion as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] respectively.

Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] 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: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] would not result in a material effect on income in the respective ensuing year.

As of December 31, [removed: 2023,] [added: 2025,] we had outstanding notes with an aggregate carrying value of [removed: $60.6] [added: $52.8] billion and an aggregate fair value of [removed: $59.2] [added: $51.0] billion.

A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] would have resulted in increases of [removed: $4.7] [added: $4.4] billion and [removed: $5.4] [added: $4.7] billion, respectively, in the aggregate fair values of our outstanding debt on these dates.

In addition, the analysis above does not include our term loans, which had [added: a] carrying [removed: values] [added: value] of $1.8 billion [removed: and $4.0 billion] at [added: both] December 31, [removed: 2024] [added: 2025] and [removed: 2023, respectively.][added: 2024.]

Interest rate swap contracts with an aggregate notional amount of $6.7 billion were outstanding as of both December 31, [removed: 2024] [added: 2025] and [removed: 2023.][added: 2024.]

A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] would have resulted in reductions in fair values of approximately [removed: $220] [added: $240] million and [removed: $180] [added: $220] million, respectively, on our interest rate swap contracts on these dates.

As of both December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] we had outstanding cross-currency swap contracts with [added: an] aggregate notional [removed: amounts] [added: amount] of $2.7 billion that hedge our foreign-currency-denominated debt and related interest payments.

A hypothetical 100 basis point adverse movement in interest rates relative to interest rates as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] would [added: not] have [removed: resulted in reductions in] [added: a material effect on] the fair values of our cross-currency swap [removed: contracts of approximately $70 million and $100 million, respectively.][added: contracts.]

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

As of December 31, [removed: 2023,] [added: 2025,] we had outstanding euro- and pound-sterling-denominated debt with both a principal carrying value and a fair value of [removed: $2.3] [added: $2.5] 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, 2024, would have resulted in an increase in fair value of this debt of [removed: approximately] $440 million on this date and a reduction in income in the ensuing year of [removed: approximately] $450 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: 2023,] [added: 2025,] would have resulted in an increase in fair value of this debt of [removed: $460] [added: approximately $490] million on this date and a reduction in income in the ensuing year of [removed: $470] [added: approximately $490] million.

We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros and pounds sterling with [added: an] aggregate notional [removed: amounts] [added: amount] of $2.7 billion as of both December 31, [removed: 2024] [added: 2025] and [removed: 2023.][added: 2024.]

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: $450] [added: $500] million and [removed: $480] [added: $450] million on these dates, respectively.

As of December 31, [removed: 2023,] [added: 2025,] the fair values of these contracts were a [removed: $145] [added: $195] million asset and a [removed: $116] [added: $213] million liability.

As of December 31, [removed: 2023,] [added: 2025,] we had primarily euro-based open foreign currency forward contracts with an aggregate notional amount of [removed: $6.6] [added: $7.8] billion.

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

With regard to [added: foreign currency forward] contracts that were open as of December 31, [removed: 2023,] [added: 2025,] 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: 2023,] [added: 2025,] would have resulted in a reduction in fair value of these contracts of approximately [removed: $1.2] [added: $1.5] billion on this date and in the ensuing year, a reduction in income of [removed: $690] [added: approximately $800] million.

As of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] we had open, short-duration, foreign currency forward contracts that mature in one month or less, that had aggregate notional amounts of [removed: $0.1 billion] [added: $240 million] and [removed: $0.5 billion,] [added: $148 million,] 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: 2024] [added: 2025] and [removed: 2023.][added: 2024.]

With regard to these foreign currency forward contracts that were open as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] 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: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] 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 [removed: investments] [added: investment] in [removed: BeiGene and Neumora,] [added: BeOne,] as well as other publicly and privately held small-capitalization 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: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] would result in losses in fair value of approximately [removed: $950 million] [added: $1.4 billion] and [removed: $1.0 billion,] [added: $950 million,] respectively.

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

The fair value of our term loan is approximated at its carrying value as this debt instrument bears interest at a floating rate.

In addition, we have an investment policy that limits

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.

We helped launch the biotechnology industry more than [removed: 40] [added: 45] years ago and have grown to be one of the world’s leading independent biotechnology companies.

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: 2023.][added: 2024.]

*Maridebart [removed: cafraglutide*][added: cafraglutide (MariTide™)*]

[removed: *IMDELLTRA*][added: *IMDELLTRA/IMDYLLTRA*]

In [removed: May 2024,] [added: November 2025,] we announced [removed: IMDELLTRA received accelerated approval from] [added: that] the FDA [added: granted full approval] for [added: IMDELLTRA for] the treatment of adult patients with [removed: extensive-stage] [added: extensive stage] small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based [removed: chemotherapy.][added: chemotherapy, converting its prior accelerated approval to full approval based on results from the global Phase 3 DeLLphi-304 study.]

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

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

For further discussion, see Government [removed: Regulation—Regulation] [added: Regulation—*Regulation] in the United [removed: States—Regulation] [added: States*—*Regulation] of Product Marketing and [removed: Promotion.][added: Promotion*.]

Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc. and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years [removed: 2024, 2023] [added: 2025, 2024] and [removed: 2022.][added: 2023.]

On a combined basis, these wholesalers accounted for 77%, [removed: 79%] [added: 77%] and [removed: 82%] [added: 79%] of worldwide gross revenues for [removed: 2024, 2023] [added: 2025, 2024] and [removed: 2022,] [added: 2023,] 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: 2024, 2023] [added: 2025, 2024] and [removed: 2022.][added: 2023.]

[removed: ][added: ]

| | | | [removed: 2024] [added: 2025] | | | | | | | | | [removed: 2023] [added: 2024] | | | | | | | | | [removed: 2022] [added: 2023] | | | | | |

| U.S. | | | $ | [removed: 23,301] [added: 25,656] | | 73 | | % | | | | $ | [removed: 19,272] [added: 23,301] | | [removed: 72] [added: 73] | | % | | | | $ | [removed: 17,743] [added: 19,272] | | 72 | | % |

| ROW | | | [removed: 8,725] [added: 9,492] | | | 27 | | % | | | | [removed: 7,638] [added: 8,725] | | | [removed: 28] [added: 27] | | % | | | | [removed: 7,058] [added: 7,638] | | | 28 | | % |

| Total | | | $ | [removed: 32,026] [added: 35,148] | | 100 | | % | | | | $ | [removed: 26,910] [added: 32,026] | | 100 | | % | | | | $ | [removed: 24,801] [added: 26,910] | | 100 | | % |

Our patents for RANKL antibodies, including sequences, for Prolia [removed: expire] [added: expired] in February 2025 in the United States and [added: in] November 2025 in select countries in Europe.

ENBREL was launched in 1998 and is used primarily in indications for the treatment of adult patients with [removed: moderately to severely] [added: moderately-to-severely] active rheumatoid arthritis, patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and patients with active psoriatic arthritis.

Our patents for RANKL antibodies, including sequences, for XGEVA [removed: expire] [added: expired] in February 2025 in the United States and [added: in] November 2025 in select countries in Europe.

Repatha was launched in 2015 and is indicated to reduce the [removed: risks] [added: risk] of [added: major adverse cardiovascular (CV) events (CV death,] myocardial infarction, [removed: stroke and] [added: stroke, unstable angina requiring hospitalization, or] coronary [removed: revascularization] [added: revascularization)] in adults [removed: with established cardiovascular disease.][added: at increased risk for these events.]

Repatha is also indicated to reduce [removed: low-density lipoprotein cholesterol (LDL-C)] [added: LDL-C] in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

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

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 approved medicine for the treatment of [removed: thyroid eye disease (TED).][added: TED.]

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

Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, [added: which is a] cancer that has spread outside the colon and 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.

TEZSPIRE is currently approved for the treatment of severe [added: uncontrolled] asthma [added: (SUA)] in the United States, Europe, Japan and more than [removed: 50] [added: 70] countries across the globe.

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

| | | | U.S. | | | | | | Methods of treatment | | | | | | [removed: 11/22/2030] [added: 5/10/2032] | | | | | |

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

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

| [added: KYPROLIS® (carfilzomib)] | | | [added: | | |] U.S. | | | | | | Compositions and [removed: compounds] [added: compounds(4)] | | | | | | 12/7/2027 | | | [removed: | | |]

| | | | U.S. | | | | | | Methods of treatment [added: using formulations] | | | | | | [removed: 6/25/2030] [added: 2/22/2038] | | | | | |

| TEZSPIRE® (tezepelumab-ekko) | | | | | | U.S. | | | | | | [removed: Polypeptides(5)] [added: Polypeptides] | | | | | | [removed: 2/3/2029] [added: 2/3/2034] | | |

| TAVNEOS® (avacopan) | | | | | | U.S. | | | | | | Compounds and pharmaceutical [removed: compositions(5)] [added: compositions] | | | | | | [removed: 2/3/2031] [added: 1/6/2034] | | |

| | | | U.S. | | | | | | Amorphous forms and pharmaceutical compositions [added: and uses thereof] | | | | | | [removed: 5/29/2041] [added: 11/27/2039] | | | | | |

| [removed: IMDELLTRA®(tarlatamab-dlle)/IMDYLLTRA®] [added: IMDELLTRA®(tarlatamab-dlle)/IMDYLLTRA™] (tarlatamab) | | | | | | U.S. | | | | | | Bifunctional polypeptides(5) | | | | | | 8/12/2036 | | |

- [removed: denosumab] [added: inebilizumab] — France, Germany, [removed: Italy, Spain] [added: Italy] and [removed: the United Kingdom,] [added: Spain,] expiring in [removed: November 2025][added: 2032]

[removed: (3)Pediatric] [added: (2)Pediatric] exclusivity granted to [removed: 8/16/2028] [added: August 16, 2028] for a patent with this subject matter.

[removed: (4)We] [added: (3)We] have biologic exclusivity in the United States [added: and regulatory exclusivity in Europe] covering teprotumumab-trbw that will expire in [removed: 2032.][added: 2032 and 2035, respectively.]

[removed: Our] [added: For example, our] patents for RANKL antibodies, including sequences, for Prolia and XGEVA [removed: expire] [added: expired] in February 2025 in the United States and [added: in] November 2025 in select countries in Europe, and we expect [added: accelerated] sales erosion driven by [removed: biosimilar competition.][added: increased competition, as multiple biosimilars have launched in the United States and ROW.]

In August 2025, we announced that the FDA broadened the approved use of Repatha to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), removing the previous requirement that a patient have been diagnosed with cardiovascular (CV) disease.

In November 2025, we announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha achieved statistically significant and clinically meaningful reductions in MACEs in high-risk adults without a prior heart attack or stroke, when added to statins or other LDL-C–lowering treatments.

Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and a 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE).

Repatha also reduced the risk of heart attack by 36%.

In a cohort of patients included in a lipid sub-study, the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo arm.

No new safety signals were identified, and tolerability was consistent with the current prescribing information in the United States.

In April 2025, we announced the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

UPLIZNA is the first and only FDA approved treatment for adults living with IgG4-RD.

In December 2025, we announced the FDA approved UPLIZNA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

In June 2025, we announced interim results from the global Phase 3 DeLLphi-304 trial evaluating IMDELLTRA/IMDYLLTRA in patients with small cell lung cancer (SCLC) who had progressed on or after one line of platinum-based chemotherapy.

The study demonstrated that IMDELLTRA/IMDYLLTRA significantly reduced the risk of death by 40% compared to standard-of-care chemotherapy, with a median overall survival of 13.6 months compared to 8.3 months.

Additionally, IMDELLTRA/IMDYLLTRA showed a statistically significant improvement in median progression-free survival of 4.2 months compared to 3.7 months and enhanced patient-reported outcomes related to cancer-associated symptoms, including dyspnea and cough.

The safety profile of IMDELLTRA/IMDYLLTRA was consistent with prior studies.

In October 2025, we announced that the FDA approved TEZSPIRE as an add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.

In June 2025, the European Commission granted marketing authorization approval of TEPEZZA for treatment of adults with moderate-to-severe thyroid eye disease (TED).

In March 2025, we announced the initiation of two global Phase 3 studies to evaluate MariTide, a differentiated antibody-peptide conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR), in chronic weight management: one study in adults living with obesity or overweight without Type 2 diabetes and another study in adults living with obesity or overweight with Type 2 diabetes.

In June 2025, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85th Scientific Sessions and simultaneously published in *The New England Journal of Medicine*.

In November 2025, we announced that, in addition to the two global Phase 3 studies announced in March 2025, four global Phase 3 studies were underway, with studies in adults living with established atherosclerotic cardiovascular disease and obesity or overweight; in adults living with heart failure with preserved or mildly reduced ejection fraction and obesity; in adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight; and in adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.

In January 2026, we announced that Part 2 of the Phase 2 chronic weight management study, an exploratory evaluation of MariTide treatment for an additional 52 weeks in people who lost at least 15% of their body weight in the 52-week Part 1 of the Phase 2 chronic weight management study, is complete.

Key findings included the following: the large majority of participants maintained the weight loss achieved in Part 1 for an additional 52 weeks on a lower monthly dose or quarterly dose of MariTide; the second year of MariTide treatment was very well tolerated, including at quarterly doses, with a very low incidence of nausea and vomiting and no new safety signals observed; and improvements in cardiometabolic parameters were sustained with MariTide at effective maintenance doses for a full second year.

In January 2026 we also announced that a Phase 2 study of MariTide for the treatment of Type 2 diabetes in adults living with and without obesity has completed the 24-week timepoint.

Key findings included the following: robust and clinically meaningful reduction in both hemoglobin A1c (HbA1c) and weight with monthly MariTide at 24 weeks, which is in line with results seen in the Type 2 diabetes population in Part 1 of the Phase 2 chronic weight management study, at 24 weeks; safety and tolerability profile consistent with the GLP-1 class, where the most common side effects were gastrointestinal-related, predominantly mild-to-moderate in nature, and occurred primarily during dose escalation; and favorable improvement in cardiometabolic parameters.

*TAVNEOS*

TAVNEOS was approved by the FDA in October 2021 for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids.

TAVNEOS was developed by ChemoCentryx.

Amgen acquired ChemoCentryx in October 2022, after TAVNEOS had been on the market for a year.

On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market.

The FDA raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial.

Hepatotoxicity, which is a known infrequent risk of TAVNEOS treatment for AAV, was also raised in the context of the benefit-risk profile of the medicine.

Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial, and after review of the relevant clinical data and years of real-world evidence, Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile.

On January 28, 2026, following FDA regulatory process, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market.

Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront.

In February 2026, we announced that, based upon data from the FORTITUDE-101 and FORTITUDE-102 Phase 3 studies, the Company does not intend to pursue regulatory approval of bemarituzumab in first-line gastric cancer.

In January 2026, we and Kyowa Kirin agreed to terminate the rocatinlimab collaboration agreement and to transition control of the global development and commercialization program to Kyowa Kirin, subject to receipt of clearance under the

Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In February 2026, we received such regulatory clearance.

In the first quarter of 2026, Kyowa Kirin will assume full responsibility for rocatinlimab worldwide, except that Amgen will continue to manufacture rocatinlimab and perform other transition activities for an agreed upon period of time.

Otezla is also approved in Japan for the treatment of palmoplantar pustulosis (PPP).

We market TEPEZZA for the treatment of TED in multiple countries globally, including the United States, Japan, Brazil, among others.

See Significant Developments for additional information regarding regulatory developments.

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.

*BLINCYTO*

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.

*UPLIZNA*

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.

Rocatinlimab is being developed in collaboration with Kyowa Kirin.

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.

TEZSPIRE is being developed in collaboration with AstraZeneca.

See Patents table below.

*Otezla*

We market TEPEZZA primarily in the United States.

*EVENITY*

Aranesp is also indicated for the treatment of anemia due to concomitant myelosuppressive chemotherapy in certain patients with nonmyeloid malignancies and when chemotherapy will be used for at least two months after starting Aranesp.

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

For the fiscal year ended December 31, [removed: 2024][added: 2025]

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was [removed: $167.6] [added: $150.1] billion as of the last business day of the registrant’s most recently completed second fiscal quarter.(A)

(A)Excludes [removed: 948,404] [added: 879,180] shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, 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: 11, 2025)][added: 10, 2026)]

Specified portions of the registrant’s Proxy Statement with respect to the [removed: 2025] [added: 2026] Annual Meeting of Stockholders to be held on May [removed: 23, 2025,] [added: 19, 2026,] are incorporated by reference into Part III of this annual report.

| | | | [DEFINED TERMS AND [removed: PRODUCTS](#i68e02b122dea42499d61169f19cd8da5_10)] [added: PRODUCTS](#i67b82d5f375d45cfa2a43922ddba0f97_10)] | | | [removed: [ii](#i68e02b122dea42499d61169f19cd8da5_10)] [added: [ii](#i67b82d5f375d45cfa2a43922ddba0f97_10)] | | |

| Item 1. | | | [removed: [BUSINESS](#i68e02b122dea42499d61169f19cd8da5_16)] [added: [BUSINESS](#i67b82d5f375d45cfa2a43922ddba0f97_16)] | | | [removed: [1](#i68e02b122dea42499d61169f19cd8da5_16)] [added: [1](#i67b82d5f375d45cfa2a43922ddba0f97_16)] | | |

| | | | [Significant [removed: Developments](#i68e02b122dea42499d61169f19cd8da5_19)] [added: Developments](#i67b82d5f375d45cfa2a43922ddba0f97_19)] | | | [removed: [1](#i68e02b122dea42499d61169f19cd8da5_19)] [added: [1](#i67b82d5f375d45cfa2a43922ddba0f97_19)] | | |

| | | | [Marketing, Distribution and Selected Marketed [removed: Products](#i68e02b122dea42499d61169f19cd8da5_22)] [added: Products](#i67b82d5f375d45cfa2a43922ddba0f97_22)] | | | [removed: [2](#i68e02b122dea42499d61169f19cd8da5_22)] [added: [3](#i67b82d5f375d45cfa2a43922ddba0f97_22)] | | |

| | | | [Manufacturing, Distribution and Raw [removed: Materials](#i68e02b122dea42499d61169f19cd8da5_28)] [added: Materials](#i67b82d5f375d45cfa2a43922ddba0f97_28)] | | | [removed: [12](#i68e02b122dea42499d61169f19cd8da5_28)] [added: [13](#i67b82d5f375d45cfa2a43922ddba0f97_28)] | | |

| | | | [Government [removed: Regulation](#i68e02b122dea42499d61169f19cd8da5_31)] [added: Regulation](#i67b82d5f375d45cfa2a43922ddba0f97_31)] | | | [removed: [13](#i68e02b122dea42499d61169f19cd8da5_31)] [added: [15](#i67b82d5f375d45cfa2a43922ddba0f97_31)] | | |

| | | | [Research and Development and Selected Product [removed: Candidates](#i68e02b122dea42499d61169f19cd8da5_34)] [added: Candidates](#i67b82d5f375d45cfa2a43922ddba0f97_34)] | | | [removed: [17](#i68e02b122dea42499d61169f19cd8da5_34)] [added: [18](#i67b82d5f375d45cfa2a43922ddba0f97_34)] | | |

| | | | [Business [removed: Relationships](#i68e02b122dea42499d61169f19cd8da5_37)] [added: Relationships](#i67b82d5f375d45cfa2a43922ddba0f97_37)] | | | [removed: [23](#i68e02b122dea42499d61169f19cd8da5_37)] [added: [24](#i67b82d5f375d45cfa2a43922ddba0f97_37)] | | |

| | | | [Human Capital [removed: Resources](#i68e02b122dea42499d61169f19cd8da5_40)] [added: Resources](#i67b82d5f375d45cfa2a43922ddba0f97_40)] | | | [removed: [24](#i68e02b122dea42499d61169f19cd8da5_40)] [added: [25](#i67b82d5f375d45cfa2a43922ddba0f97_40)] | | |

| | | | [Information about our Executive [removed: Officers](#i68e02b122dea42499d61169f19cd8da5_43)] [added: Officers](#i67b82d5f375d45cfa2a43922ddba0f97_43)] | | | [removed: [26](#i68e02b122dea42499d61169f19cd8da5_43)] [added: [27](#i67b82d5f375d45cfa2a43922ddba0f97_43)] | | |

| | | | [Geographic Area Financial [removed: Information](#i68e02b122dea42499d61169f19cd8da5_46)] [added: Information](#i67b82d5f375d45cfa2a43922ddba0f97_46)] | | | [removed: [27](#i68e02b122dea42499d61169f19cd8da5_46)] [added: [28](#i67b82d5f375d45cfa2a43922ddba0f97_46)] | | |

| | | | [Investor [removed: Information](#i68e02b122dea42499d61169f19cd8da5_49)] [added: Information](#i67b82d5f375d45cfa2a43922ddba0f97_49)] | | | [removed: [27](#i68e02b122dea42499d61169f19cd8da5_49)] [added: [28](#i67b82d5f375d45cfa2a43922ddba0f97_49)] | | |

| Item 1A. | | | [RISK [removed: FACTORS](#i68e02b122dea42499d61169f19cd8da5_52)] [added: FACTORS](#i67b82d5f375d45cfa2a43922ddba0f97_52)] | | | [removed: [28](#i68e02b122dea42499d61169f19cd8da5_52)] [added: [29](#i67b82d5f375d45cfa2a43922ddba0f97_52)] | | |

| Item 1B. | | | [UNRESOLVED STAFF [removed: COMMENTS](#i68e02b122dea42499d61169f19cd8da5_55)] [added: COMMENTS](#i67b82d5f375d45cfa2a43922ddba0f97_55)] | | | [removed: [54](#i68e02b122dea42499d61169f19cd8da5_55)] [added: [55](#i67b82d5f375d45cfa2a43922ddba0f97_55)] | | |

| Item 1C. | | | [removed: [CYBERSECURITY](#i68e02b122dea42499d61169f19cd8da5_58)] [added: [CYBERSECURITY](#i67b82d5f375d45cfa2a43922ddba0f97_58)] | | | [removed: [54](#i68e02b122dea42499d61169f19cd8da5_58)] [added: [55](#i67b82d5f375d45cfa2a43922ddba0f97_58)] | | |

| Item 2. | | | [removed: [PROPERTIES](#i68e02b122dea42499d61169f19cd8da5_61)] [added: [PROPERTIES](#i67b82d5f375d45cfa2a43922ddba0f97_61)] | | | [removed: [57](#i68e02b122dea42499d61169f19cd8da5_61)] [added: [57](#i67b82d5f375d45cfa2a43922ddba0f97_61)] | | |

| Item 3. | | | [LEGAL [removed: PROCEEDINGS](#i68e02b122dea42499d61169f19cd8da5_64)] [added: PROCEEDINGS](#i67b82d5f375d45cfa2a43922ddba0f97_64)] | | | [removed: [58](#i68e02b122dea42499d61169f19cd8da5_64)] [added: [57](#i67b82d5f375d45cfa2a43922ddba0f97_64)] | | |

| Item 4. | | | [MINE SAFETY [removed: DISCLOSURES](#i68e02b122dea42499d61169f19cd8da5_67)] [added: DISCLOSURES](#i67b82d5f375d45cfa2a43922ddba0f97_67)] | | | [removed: [58](#i68e02b122dea42499d61169f19cd8da5_67)] [added: [58](#i67b82d5f375d45cfa2a43922ddba0f97_67)] | | |

| Item 5. | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i68e02b122dea42499d61169f19cd8da5_73)] [added: SECURITIES](#i67b82d5f375d45cfa2a43922ddba0f97_73)] | | | [removed: [59](#i68e02b122dea42499d61169f19cd8da5_73)] [added: [59](#i67b82d5f375d45cfa2a43922ddba0f97_73)] | | |

| Item 6. | | | [removed: [RESERVED](#i68e02b122dea42499d61169f19cd8da5_76)] [added: [RESERVED](#i67b82d5f375d45cfa2a43922ddba0f97_76)] | | | [removed: [60](#i68e02b122dea42499d61169f19cd8da5_76)] [added: [60](#i67b82d5f375d45cfa2a43922ddba0f97_76)] | | |

| Item 7. | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i68e02b122dea42499d61169f19cd8da5_79)] [added: OPERATIONS](#i67b82d5f375d45cfa2a43922ddba0f97_79)] | | | [removed: [61](#i68e02b122dea42499d61169f19cd8da5_79)] [added: [61](#i67b82d5f375d45cfa2a43922ddba0f97_79)] | | |

| Item 7A. | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i68e02b122dea42499d61169f19cd8da5_109)] [added: RISK](#i67b82d5f375d45cfa2a43922ddba0f97_109)] | | | [removed: [81](#i68e02b122dea42499d61169f19cd8da5_109)] [added: [81](#i67b82d5f375d45cfa2a43922ddba0f97_109)] | | |

| Item 8. | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i68e02b122dea42499d61169f19cd8da5_112)] [added: DATA](#i67b82d5f375d45cfa2a43922ddba0f97_112)] | | | [removed: [83](#i68e02b122dea42499d61169f19cd8da5_112)] [added: [83](#i67b82d5f375d45cfa2a43922ddba0f97_112)] | | |

| Item 9. | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i68e02b122dea42499d61169f19cd8da5_115)] [added: DISCLOSURE](#i67b82d5f375d45cfa2a43922ddba0f97_115)] | | | [removed: [83](#i68e02b122dea42499d61169f19cd8da5_115)] [added: [83](#i67b82d5f375d45cfa2a43922ddba0f97_115)] | | |

| Item 9A. | | | [CONTROLS AND [removed: PROCEDURES](#i68e02b122dea42499d61169f19cd8da5_118)] [added: PROCEDURES](#i67b82d5f375d45cfa2a43922ddba0f97_118)] | | | [removed: [83](#i68e02b122dea42499d61169f19cd8da5_118)] [added: [83](#i67b82d5f375d45cfa2a43922ddba0f97_118)] | | |

| Item 9B. | | | [OTHER [removed: INFORMATION](#i68e02b122dea42499d61169f19cd8da5_127)] [added: INFORMATION](#i67b82d5f375d45cfa2a43922ddba0f97_127)] | | | [removed: [85](#i68e02b122dea42499d61169f19cd8da5_127)] [added: [85](#i67b82d5f375d45cfa2a43922ddba0f97_127)] | | |

| Item 9C. | | | [DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT [removed: INSPECTIONS](#i68e02b122dea42499d61169f19cd8da5_130)] [added: INSPECTIONS](#i67b82d5f375d45cfa2a43922ddba0f97_130)] | | | [removed: [85](#i68e02b122dea42499d61169f19cd8da5_130)] [added: [85](#i67b82d5f375d45cfa2a43922ddba0f97_130)] | | |

| [PART [removed: III](#i68e02b122dea42499d61169f19cd8da5_133)] [added: III](#i67b82d5f375d45cfa2a43922ddba0f97_133)] | | | | | | [removed: [85](#i68e02b122dea42499d61169f19cd8da5_133)] [added: [85](#i67b82d5f375d45cfa2a43922ddba0f97_133)] | | |

| Item 10. | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i68e02b122dea42499d61169f19cd8da5_136)] [added: GOVERNANCE](#i67b82d5f375d45cfa2a43922ddba0f97_136)] | | | [removed: [85](#i68e02b122dea42499d61169f19cd8da5_136)] [added: [85](#i67b82d5f375d45cfa2a43922ddba0f97_136)] | | |

| Item 11. | | | [EXECUTIVE [removed: COMPENSATION](#i68e02b122dea42499d61169f19cd8da5_142)] [added: COMPENSATION](#i67b82d5f375d45cfa2a43922ddba0f97_142)] | | | [removed: [85](#i68e02b122dea42499d61169f19cd8da5_142)] [added: [85](#i67b82d5f375d45cfa2a43922ddba0f97_142)] | | |

| Item 12. | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i68e02b122dea42499d61169f19cd8da5_145)] [added: MATTERS](#i67b82d5f375d45cfa2a43922ddba0f97_145)] | | | [removed: [86](#i68e02b122dea42499d61169f19cd8da5_145)] [added: [86](#i67b82d5f375d45cfa2a43922ddba0f97_145)] | | |

| Item 13. | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR [removed: INDEPENDENCE](#i68e02b122dea42499d61169f19cd8da5_154)] [added: INDEPENDENCE](#i67b82d5f375d45cfa2a43922ddba0f97_154)] | | | [removed: [87](#i68e02b122dea42499d61169f19cd8da5_154)] [added: [87](#i67b82d5f375d45cfa2a43922ddba0f97_154)] | | |

| Item 14. | | | [PRINCIPAL ACCOUNTANT FEES AND [removed: SERVICES](#i68e02b122dea42499d61169f19cd8da5_157)] [added: SERVICES](#i67b82d5f375d45cfa2a43922ddba0f97_157)] | | | [removed: [87](#i68e02b122dea42499d61169f19cd8da5_157)] [added: [87](#i67b82d5f375d45cfa2a43922ddba0f97_157)] | | |

| [PART [removed: IV](#i68e02b122dea42499d61169f19cd8da5_160)] [added: IV](#i67b82d5f375d45cfa2a43922ddba0f97_160)] | | | | | | [removed: [88](#i68e02b122dea42499d61169f19cd8da5_160)] [added: [88](#i67b82d5f375d45cfa2a43922ddba0f97_160)] | | |

| Item 15. | | | [EXHIBITS AND FINANCIAL STATEMENT [removed: SCHEDULES](#i68e02b122dea42499d61169f19cd8da5_163)] [added: SCHEDULES](#i67b82d5f375d45cfa2a43922ddba0f97_163)] | | | [removed: [88](#i68e02b122dea42499d61169f19cd8da5_163)] [added: [88](#i67b82d5f375d45cfa2a43922ddba0f97_163)] | | |

539,067,675

| [PART I](#i67b82d5f375d45cfa2a43922ddba0f97_13) | | | | | | [1](#i67b82d5f375d45cfa2a43922ddba0f97_13) | | |

| | | | [Reimbursement](#i67b82d5f375d45cfa2a43922ddba0f97_25) | | | [11](#i67b82d5f375d45cfa2a43922ddba0f97_25) | | |

| [PART II](#i67b82d5f375d45cfa2a43922ddba0f97_70) | | | | | | [59](#i67b82d5f375d45cfa2a43922ddba0f97_70) | | |

| AI | | | artificial intelligence | | | | | | | | | | | | | | |

| EO | | | Executive Order | | | | | | | | | | | | | | |

| GIPR | | | glucose-dependent insulinotropic polypeptide receptor | | | | | | | | | | | | | | |

| GLP-1 | | | glucagon like peptide 1 | | | | | | | | | | | | | | |

| IgG4-RD | | | Immunoglobulin G4-related disease | | | | | | | | | | | | | | |

| July MFN Letter | | | Letter dated July 31, 2025, by the Administration to a number of pharmaceutical manufacturers, including Amgen | | | | | | | | | | | | | | |

| MFN | | | Most-Favored-Nations | | | | | | | | | | | | | | |

| MFN EO | | | Most-Favored-Nations Prescription Drug Pricing Executive Order, dated May 12, 2025 | | | | | | | | | | | | | | |

| NIH | | | National Institutes of Health | | | | | | | | | | | | | | |

| OB3 | | | P.L. 119-21, also The One Big Beautiful Bill Act signed into law on July 4, 2025 | | | | | | | | | | | | | | |

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

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

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

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

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

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

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

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

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

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

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

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

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

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

| | | | | | |

| | | | | | |

537,204,943

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

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

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

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

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

| ESG | | | environmental, social and governance | | | | | | | | | | | | | | |

| FTC | | | Federal Trade Commission | | | | | | | | | | | | | | |

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

| Lilly | | | Eli Lilly and Company | | | | | | | | | | | | | | |

| OIG | | | Office of Inspector General | | | | | | | | | | | | | | |

| PDE4 | | | phosphodiesterase 4 | | | | | | | | | | | | | | |

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

| DUEXIS | | | DUEXIS® (ibuprofen and famotidine) | | |

| Pushtronex | | | Pushtronex® | | |

They are Avastin®, BESPONSA®, Cosentyx®, DARZALEX®, DUPIXENT®, ERBITUX®, EYLEA®, FASENRA®, Herceptin®, HUMIRA®, HYRIMOZ®, KEYTRUDA®, LEQVIO®, Nucala®, POMALYST®/IMNOVID®, PRALUENT®, PROCRIT®, PROMACTA®/REVOLADE™, Remicade®, REVLIMID®, RINVOQ®, Rituxan®/MabThera®, Skyrizi®, SOLIRIS®, SOTYKTU®, STELARA®, Taltz®, Teribone™, Tremfya®, VELCADE®, Xeljanz® and XOLAIR®.

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 CDT, Worldwide Compliance and Business Ethics, Regulatory Affairs, Operations, R&D, Global Commercial Operations, Corporate Audit, [added: Finance,] Law and Business Development functions).

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

Our CISO is overseen by our CIO, who has [removed: 27] [added: 28] years of experience in information systems (including over [removed: 14] [added: 15] 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.

on our business strategy, results of operations or financial condition.

In 2025, we substantially transitioned or decommissioned the technology systems from the legacy Horizon environment to the Amgen environment.

The remaining systems are being monitored by the Amgen cybersecurity team in accordance with the governance processes detailed above.

*Information Systems Acquired from Horizon Therapeutics plc*

On October 6, 2023, we completed our acquisition of Horizon.

Certain Horizon legacy information systems are maintained separately from Amgen’s preexisting information system infrastructure.

We are continuing to operationally integrate and transition the legacy Horizon systems into our own, with the integrated systems becoming subject to Amgen’s cybersecurity risk management structure and strategy.

While we 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 Operations, Incident Response and Cyber Threat Intelligence teams and reported in accordance with the governance processes detailed above.

See Item 1A.

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* and Item 1A.

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

As of December 31, [removed: 2024,] [added: 2025,] we owned or leased approximately 160 properties.

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

| ROW Location: | | | Manufacturing | | | Administrative | | | R&D | | | Sales [removed: &] [added: and] marketing | | | Warehouse | | | Distribution center | | |

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

(1) Corporate headquarters.

Additionally, in 2025 we broke ground on our second drug substance manufacturing facility in Holly Springs, North Carolina; announced expansions of our manufacturing network in Ohio and the U.S. territory of Puerto Rico; and broke ground on a new, state-of-the-art science and innovation center at our corporate headquarters in Thousand Oaks, California.

| Brazil | | | | | | x | | | | | | x | | | | | | | | |

| United Kingdom | | | | | | x | | | x | | | x | | | | | | | | |

(1) Corporate headquarters

Additionally, in 2024 we received FDA licensure of our manufacturing facility in New Albany, Ohio; opened a new technology and innovation site in India; and continued to progress on the construction of our first drug substance manufacturing facility in Holly Springs, North Carolina.

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

As of February [removed: 11, 2025,] [added: 10, 2026,] there were approximately [removed: 4,047] [added: 3,824] holders of record of our common stock.

The following graph shows the value of an investment of $100 on December 31, [removed: 2019,] [added: 2020,] in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index.

[removed: ][added: ]

| | | | [removed: 12/31/2019] [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] | | | | | | [removed: 12/31/2024] [added: 12/31/2025] | | |

During the year ended December 31, [removed: 2024,] [added: 2025,] we had one outstanding stock repurchase program, under which repurchase activity was as follows:

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

| December 1–December 31 | | | | | | [removed: 718,799] [added: —] | | | | | | $ | [removed: 278.26] [added: —] | | | | | [removed: 718,799] [added: —] | | | | | | $ | 6,779,253,902 | |

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

(1) During the year ended December 31, [removed: 2024,] [added: 2025,] the Company purchased [removed: an additional 1,225] [added: 1,700] shares at an average price paid of [removed: $323.34] [added: $284.67] per share from staff members to satisfy federal law compliance obligations.

For the years ended December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] we paid quarterly dividends.

| Amgen (AMGN) | | | $100.00 | | | | | | $100.87 | | | | | | $121.54 | | | | | | $137.97 | | | | | | $128.71 | | | | | | $166.88 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $96.48 | | | | | | $92.61 | | | | | | $95.27 | | | | | | $101.21 | | | | | | $126.28 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $123.37 | | | | | | $132.94 | | | | | | $143.21 | | | | | | $150.48 | | | | | | $186.40 | | |

| Standard & Poor’s 500 (SPX) | | | $100.00 | | | | | | $128.68 | | | | | | $105.29 | | | | | | $133.03 | | | | | | $165.98 | | | | | | $195.62 | | |

| October 1–October 31 | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 6,779,253,902 | |

| November 1–November 30 | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 6,779,253,902 | |

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

| 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 | | |

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

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

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

We maintain “disclosure controls and procedures,” as [removed: such term is] defined [added: in Rule 13a-15(e)] under the Securities Exchange Act [removed: Rule 13a-15(e),] [added: of 1934,] that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and [removed: forms and that such information is accumulated and communicated to Amgen’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.][added: forms.]

Based upon their evaluation and subject to the foregoing, [removed: the] [added: our] Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, [removed: 2024.][added: 2025.]

Management determined that as of December 31, [removed: 2024,] [added: 2025,] 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 of the Company is responsible for establishing and maintaining adequate internal control over financial reporting, as [removed: such term is] defined in Rule 13a-15(f) under the Securities Exchange Act of 1934.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2024.][added: 2025.]

Based on our assessment, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] 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: 2024.][added: 2025.]

We have audited Amgen Inc.’s internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] 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: 2024,] [added: 2025,] 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: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] 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: 2024,] [added: 2025,] and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 and our report dated February [removed: 14, 2025] [added: 13, 2026] expressed an unqualified opinion thereon.

These controls and procedures are also designed to ensure that such information is accumulated and communicated to Amgen’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

February 13, 2026

February 14, 2025

During the three months ended December 31, [removed: 2024,] [added: 2025,] 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: 2025] [added: 2026] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2024] [added: 2025] (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: 2026] [added: 2027] Annual Meeting in our Proxy Statement.

A copy of our Insider Trading Policy and our securities transactions pre-clearance practices and procedures are [removed: filed with] [added: incorporated by reference to] this Annual Report on Form 10-K as Exhibits 19.1 and 19.2, respectively.

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

Information about compensation committee matters is incorporated by reference from the sections entitled CORPORATE GOVERNANCE—Compensation and Management Development Committee and [removed: CORPORATE GOVERNANCE—Compensation Committee Report] [added: COMPENSATION COMMITTEE REPORT] in our Proxy Statement.

The following table sets forth certain information as of December 31, [removed: 2024,] [added: 2025,] concerning the shares of our common stock that may be issued under any form of award granted under our equity compensation plans in effect as of December 31, [removed: 2024,] [added: 2025,] including upon the exercise of options, upon the vesting of awards of RSUs or when performance units are earned and related dividend equivalents have been granted.

| Amended and Restated 2009 Equity Incentive Plan(1) | | | | | | [removed: 10,714,775] [added: 11,098,368] | | | | | | $ | [removed: 225.84] [added: 234.45] | | | | | [removed: 59,435,223] [added: 35,004,385] | | |

| Amended and Restated Employee Stock Purchase Plan | | | | | | | | | | | | | | | | | | [removed: 3,946,553] [added: 3,813,679] | | |

| Amgen Profit Sharing Plan for Employees in Ireland(3) | | | | | | | | | | | | | | | | | | [removed: 175,345] [added: 150,740] | | |

| Horizon stock plans(4) | | | | | | [removed: 467,296] [added: 132,521] | | | | | | | | | | | | | | |

The performance units granted under this plan are earned based on the accomplishment of specified performance goals at the end of their respective three-year performance periods; the number of performance units granted represent target performance, and the maximum number of units that could be earned based on our performance is 200% of the performance units granted in [removed: 2022, 2023] [added: 2023, 2024] and [removed: 2024.][added: 2025.]

As of December 31, [removed: 2024,] [added: 2025,] the number of outstanding awards under column (a) includes (i) [removed: 5,909,018] [added: 6,064,625] shares issuable upon the exercise of outstanding options with a weighted-average exercise price of [removed: $225.84;] [added: $234.45;] (ii) [removed: 3,289,089] [added: 3,797,669] shares issuable upon the vesting of outstanding RSUs, including [removed: 198,925] [added: 221,796] related dividend equivalents; and (iii) [removed: 1,516,669] [added: 1,236,074] shares subject to outstanding [removed: 2022, 2023 and] [added: 2023,] 2024 [added: and 2025] performance units, including [removed: 91,901] [added: 74,616] related dividend equivalents.

The number of available shares under column (c) represents the number of shares that remain available for future issuance under this plan as of December 31, [removed: 2024,] [added: 2025,] employing the fungible share formula and presumes the issuance of target shares under the performance units granted in [removed: 2022, 2023 and] [added: 2023,] 2024 and [added: 2025 and] related dividend equivalents.

Maximum performance under these goals could result in 200% of target shares being awarded for performance units granted in [removed: 2022, 2023] [added: 2023, 2024] and [removed: 2024.][added: 2025.]

| Total approved plans | | | | | | 11,098,468 | | | | | | $ | 234.45 | | | | | 38,818,064 | | |

| Total unapproved plans | | | | | | 132,521 | | | | | | — | | | | | | 150,740 | | |

| Total all plans | | | | | | 11,230,989 | | | | | | $ | 234.45 | | | | | 38,968,804 | | |

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

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

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

| Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) | | | [removed: [F-](#i68e02b122dea42499d61169f19cd8da5_178)[1](#i68e02b122dea42499d61169f19cd8da5_178)] [added: [F-](#i67b82d5f375d45cfa2a43922ddba0f97_178)[1](#i67b82d5f375d45cfa2a43922ddba0f97_178)] | | |

| Consolidated Statements of Income for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] | | | [removed: [F-4](#i68e02b122dea42499d61169f19cd8da5_181)] [added: [F-4](#i67b82d5f375d45cfa2a43922ddba0f97_181)] | | |

| Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] | | | [removed: [F-5](#i68e02b122dea42499d61169f19cd8da5_184)] [added: [F-5](#i67b82d5f375d45cfa2a43922ddba0f97_184)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2024] [added: 2025] and [removed: 2023] [added: 2024] | | | [removed: [F-6](#i68e02b122dea42499d61169f19cd8da5_187)] [added: [F-6](#i67b82d5f375d45cfa2a43922ddba0f97_187)] | | |

| Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] | | | [removed: [F-7](#i68e02b122dea42499d61169f19cd8da5_190)] [added: [F-7](#i67b82d5f375d45cfa2a43922ddba0f97_190)] | | |

| Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] | | | [removed: [F-8](#i68e02b122dea42499d61169f19cd8da5_193)] [added: [F-8](#i67b82d5f375d45cfa2a43922ddba0f97_193)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [F-9](#i68e02b122dea42499d61169f19cd8da5_196)] [added: [F-9](#i67b82d5f375d45cfa2a43922ddba0f97_196)] | | |

| Schedule II. Valuation and Qualifying Accounts | | | [removed: [F-58](#i68e02b122dea42499d61169f19cd8da5_262)] [added: [F-61](#i67b82d5f375d45cfa2a43922ddba0f97_262)] | | |

| [removed: 2.1] [added: 10.23] | | | | | | [removed: [Agreement] [added: [License] and [removed: Plan of Merger,] [added: Collaboration Agreement,] dated [removed: July 27,] [added: June 1,] 2021, by and [removed: among] [added: between] Amgen [removed: Inc., Teneobio, Inc., Tuxedo Merger Sub, Inc.,] [added: Inc.] and [removed: Fortis Advisors LLC.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000045/amgn-ex27_202193021xq3.htm)] [added: Kyowa Kirin Co., Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000034/amgn-ex1049_2021630xq2.htm)[2](https://www.sec.gov/Archives/edgar/data/318154/000031815421000034/amgn-ex1049_2021630xq2.htm)] (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or [removed: confidential)] [added: confidential).] (Filed as an exhibit to Form 10-Q for the quarter ended [removed: September] [added: June] 30, 2021 on [removed: November 3,] [added: August 4,] 2021 and incorporated herein by reference.) | | |

| 4.32* | | | | | | [Description of Amgen Inc.’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit432-descriptionofse.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit432-descriptionofam.htm)] | | |

| 10.2*+ | | | | | | [Form of Grant of Stock Option Agreement for the Amgen Inc. Second Amended and Restated 2009 Equity Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit102formofgrantofsto.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit102-formofgrantofst.htm)] (As Amended and Restated on December [removed: 9, 2024.)] [added: 8, 2025.)] | | |

| 10.3*+ | | | | | | [Form of Restricted Stock Unit Agreement for the Amgen Inc. Second Amended and Restated 2009 Equity Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit103formofrestricted.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit103-formofrestricte.htm).] (As Amended and Restated on December [removed: 9, 2024.)] [added: 8, 2025.)] | | |

| 10.5*+ | | | | | | [Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award [removed: Program.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit105formofperformanc.htm)] [added: Program.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit105-formofperforman.htm)] (As Amended and Restated on December [removed: 9, 2024.)] [added: 8, 2025.)] | | |

| [removed: 10.23] [added: 10.22.6] | | | | | | [removed: [License and] [added: [Amendment No. 9 to the] Collaboration Agreement, dated [removed: June 1, 2021,] [added: May 20, 2025,] by and between Amgen Inc. and [removed: Kyowa Kirin Co., Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815421000034/amgn-ex1049_2021630xq2.htm)] [added: AstraZeneca Collaboration Ventures, LLC](https://www.sec.gov/Archives/edgar/data/318154/000031815425000056/ex10226-amendmentno9tothea.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).] [added: confidential.)] (Filed as an exhibit to Form 10-Q for the quarter ended June 30, [removed: 2021] [added: 2025] on August [removed: 4, 2021] [added: 5, 2025] and incorporated herein by reference.) | | |

| [removed: 19.1*] [added: 19.1] | | | | | | [Amgen Inc. Insider Trading Policy.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit191amgenincinsidert.htm) [added: (Filed as an exhibit to Form 10-K for the year ended December 31, 2024 on February 14, 2025 and incorporated herein by reference.)] | | |

| [removed: 19.2*] [added: 19.2] | | | | | | [Amgen Inc. Securities Transactions Blackout and Pre-Clearance Practices and Procedures.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit192amgenincpre-clea.htm) [added: (Filed as an exhibit to Form 10-K for the year ended December 31, 2024 on February 14, 2025 and incorporated herein by reference.)] | | |

| 21* | | | | | | [Subsidiaries of the [removed: Company.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/amgn-ex21_2024.htm)] [added: Company.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/amgn-ex21_2025x10xk.htm)] | | |

| 23 | | | | | | Consent of the Independent Registered Public Accounting Firm. The consent is set forth on page 96 of this Annual Report on [removed: the] [added: Form] 10-K. | | |

| 31* | | | | | | [Rule 13a-14(a) [removed: Certifications.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/amgn-ex31_20241231x10xk.htm)] [added: Certifications.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/amgn-ex31_20251231x10xk.htm)] | | |

| 32 | | | | | | [Section 1350 [removed: Certifications.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/amgn-ex32_20241231x10xk.htm)] [added: Certifications.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/amgn-ex32_20251231x10xk.htm)] | | |

| [removed: 97*] [added: 97] | | | | | | [Policy Relating to Recovery of Erroneously Awarded Compensation.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000010/exhibit97-policyonrecovery.htm) [added: (Filed as an exhibit to Form 10-K for the year ended December 31, 2024 on February 14, 2025 and incorporated herein by reference.)] | | |

| 10.19.3 | | | | | | [Letter Agreement, dated May 9, 2025, by and between Amgen Inc. and BeiGene Switzerland GmbH, a wholly owned subsidiary of BeiGene, Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815425000056/ex10193-letteragreementbet.htm)[1](https://www.sec.gov/Archives/edgar/data/318154/000031815425000056/ex10193-letteragreementbet.htm) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2025 on August 5, 2025 and incorporated herein by reference.) | | |

| 10.19.4 | | | | | | [Letter Agreement, dated August 11, 2025, by and between Amgen Inc. and BeOne Medicines I GmbH and BeOne Medicines Ltd](https://www.sec.gov/Archives/edgar/data/318154/000031815425000072/exhibit10194-letteragreeme.htm). (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2025 on November 5, 2025 and incorporated herein by reference.) | | |

| 10.19.5* | | | | | | [Letter Agreement, dated October 1, 2025, by and between Amgen Inc. and BeOne Medicines I GmbH and BeOne Medicines Ltd](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit10195-letteragreeme.htm). (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) | | |

| 10.19.6* | | | | | | [Third Amendment to Collaboration Agreement, dated October 31, 2025, by and among Amgen Inc., BeOne Medicines I GmbH, and BeOne Medicines Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit10196-thirdamendmen.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) | | |

| 10.19.7* | | | | | | [Fourth Amendment to Collaboration Agreement, dated November 11, 2025, by and among Amgen Inc., BeOne Medicines I GmbH, and BeOne Medicines Ltd.](https://www.sec.gov/Archives/edgar/data/318154/000031815426000010/exhibit10197-fourthamendme.htm) (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) | | |

| | | | | | | | | |

| | | | | | | | | |

1 In May 2025, BeiGene, Ltd. changed its name to BeOne Medicines Ltd., and BeiGene Switzerland GmbH changed its name

to BeOne Medicines I GmbH.

2 See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin.

| 2.2 | | | | | | [Agreement and Plan of Merger, dated as of August 3, 2022, among ChemoCentryx, Inc., Amgen Inc. and 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 4, 2022 and incorporated herein by reference.) | | |

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

| 2.4 | | | | | | [Appendix 3 to the Rule 2.7 Announcement, dated as of December 12, 2022 (Conditions Appendix).](https://www.sec.gov/Archives/edgar/data/318154/000119312522302256/d346985dex22.htm) (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | | |

| Date: | | | February [removed: 14, 2025] [added: 13, 2026] | | | By: | | | | | | /s/ PETER H. GRIFFITH | | |

of our reports dated February [removed: 14, 2025,] [added: 13, 2026,] with respect to the consolidated financial statements of Amgen Inc. and the effectiveness of internal control over financial reporting of Amgen Inc. included in this Annual Report (Form 10-K) of Amgen Inc. for the year ended December 31, [removed: 2024.][added: 2025.]

| /S/ ROBERT A. BRADWAY | | | | | | Chairman of the Board, Chief Executive Officer and President, and Director (Principal Executive Officer) | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ PETER H. GRIFFITH | | | | | | Executive Vice President and Chief Financial Officer (Principal Financial Officer) | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ MATTHEW C. BUSCH | | | | | | Vice President, Finance and Chief Accounting Officer (Principal Accounting Officer) | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ WANDA M. AUSTIN | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ MICHAEL V. DRAKE | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ BRIAN J. DRUKER | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ ROBERT A. ECKERT | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ GREG C. GARLAND | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ CHARLES M. HOLLEY, JR. | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ S. OMAR ISHRAK | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ TYLER JACKS | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ MARY E. KLOTMAN | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ ELLEN J. KULLMAN | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

| /S/ AMY E. MILES | | | | | | Director | | | | | | [removed: 2/14/2025] [added: 2/13/2026] | | |

We have audited the accompanying consolidated balance sheets of Amgen Inc. (the Company) as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] 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: 2024,] [added: 2025,] and the related notes and [removed: the] financial statement schedule listed in the Index at Item 15(a)2 (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 14, 2025] [added: 13, 2026] expressed an unqualified opinion thereon.

| *Description of the Matter* | | | | | | As of December 31, [removed: 2024,] [added: 2025,] the Company recorded accrued sales deductions of [removed: $8.4] [added: $10.6] billion. As described in Note 1 to the financial statements under the caption “Product sales and sales deductions,” revenues from product sales are recognized net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively sales deductions), which are established at the time of sale. Auditing the estimation of sales deductions, specifically estimated chargebacks, commercial rebates, and Medicaid rebates related to U.S. product sales, which are netted against product sales, is complex, requires significant judgment, and the amounts involved are material to the financial statements taken as a whole. Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, and is based on an amount that reflects the consideration to which the Company expects to be entitled, which represents an amount that is net of accruals for estimated sales deductions. The estimated sales deductions are based on current contractual and statutory requirements, market events and trends, internal and external historical data, and forecasted customer buying patterns. | | |

| *Description of the Matter* | | | | | | As discussed in Notes 1 and 7 to the consolidated financial statements, the Company operates in various jurisdictions in which differing interpretations of complex tax laws and regulations create uncertainty and necessitate the use of significant judgment in the determination of the Company’s unrecognized tax benefits, particularly in the U.S. federal tax jurisdiction where the Company has significant assets and operations. In this regard, the Company uses significant judgment in (1) determining whether a tax position’s technical merits are more-likely-than-not to be sustained and (2) measuring the amount of tax benefit that qualifies for recognition. As of December 31, [removed: 2024,] [added: 2025,] the Company accrued [removed: $4.2] [added: $4.4] billion of gross unrecognized tax benefits. Auditing the assessment of the technical merits and measurement of the Company’s unrecognized tax benefits is challenging due to the high degree of estimation and management [removed: judgement,] [added: judgment,] given the ultimate resolution is dependent on uncontrollable factors such as the resolution of audit disputes with the IRS and results of the U.S. Tax Court case. | | |

| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company’s process to assess the technical merits of its tax positions, as well as management’s process to measure the unrecognized tax benefits of those tax positions, particularly in regard to matters in dispute with the IRS. This included testing controls over management’s review of the inputs, calculations, assumptions and methods selected to measure the amount of tax benefits that qualify for recognition. We involved tax controversy and transfer pricing [removed: specialists] [added: subject matter professionals] to assist in assessing the technical merits and measurement of certain of the Company’s unrecognized tax benefits. Depending on the nature of the specific tax position and, as applicable, developments with the relevant tax authorities, our procedures included obtaining and reviewing the Company’s correspondence with such tax authorities and evaluating certain third-party advice to support the Company’s evaluations and recorded positions. We evaluated the status of the ongoing U.S. Tax Court case and developments in the applicable regulatory environments to assess potential effects on the Company’s recorded positions. We assessed management’s consideration of current tax controversy, litigation and tax litigation trends. We analyzed the assumptions and data used by the Company when it determined the amount of tax benefits to recognize, including applicable interest and penalties, and we tested the accuracy of those underlying calculations. We have also evaluated the Company’s income tax disclosures included in Note 7 in relation to these matters. | | |

| [removed: | | | | | |] /s/ Ernst & Young LLP | | |

Years ended December 31, [removed: 2024, 2023] [added: 2025, 2024] and [removed: 2022][added: 2023]

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

| Product sales | | | $ | [removed: 32,026] [added: 35,148] | | | | | $ | [removed: 26,910] [added: 32,026] | | | | | $ | [removed: 24,801] [added: 26,910] | |

| Other revenues | | | [removed: 1,398] [added: 1,603] | | | | | | [removed: 1,280] [added: 1,398] | | | | | | [removed: 1,522] [added: 1,280] | | |

| Total revenues | | | [removed: 33,424] [added: 36,751] | | | | | | [removed: 28,190] [added: 33,424] | | | | | | [removed: 26,323] [added: 28,190] | | |

| Cost of sales | | | [removed: 12,858] [added: 12,037] | | | | | | [removed: 8,451] [added: 12,858] | | | | | | [removed: 6,406] [added: 8,451] | | |

| Research and development | | | [removed: 5,964] [added: 7,272] | | | | | | [removed: 4,784] [added: 5,964] | | | | | | [removed: 4,434] [added: 4,784] | | |

| Selling, general and administrative | | | [removed: 7,096] [added: 7,050] | | | | | | [removed: 6,179] [added: 7,096] | | | | | | [removed: 5,414] [added: 6,179] | | |

| Other | | | [removed: 248] [added: 1,312] | | | | | | [removed: 879] [added: 248] | | | | | | [removed: 503] [added: 879] | | |

| Total operating expenses | | | [removed: 26,166] [added: 27,671] | | | | | | [removed: 20,293] [added: 26,166] | | | | | | [removed: 16,757] [added: 20,293] | | |

| Operating income | | | [removed: 7,258] [added: 9,080] | | | | | | [removed: 7,897] [added: 7,258] | | | | | | [removed: 9,566] [added: 7,897] | | |

| Interest expense, net | | | [removed: (3,155)] [added: (2,755)] | | | | | | [removed: (2,875)] [added: (3,155)] | | | | | | [removed: (1,406)] [added: (2,875)] | | |

| Other [removed: income (expense),] [added: income,] net | | | [removed: 506] [added: 2,651] | | | | | | [removed: 2,833] [added: 506] | | | | | | [removed: (814)] [added: 2,833] | | |

| Income before income taxes | | | [removed: 4,609] [added: 8,976] | | | | | | [removed: 7,855] [added: 4,609] | | | | | | [removed: 7,346] [added: 7,855] | | |

| Provision for income taxes | | | [removed: 519] [added: 1,265] | | | | | | [removed: 1,138] [added: 519] | | | | | | [removed: 794] [added: 1,138] | | |