Amgen (AMGN) 10-K risk factor changes: FY2020 vs FY2019

[added: See] *Our sales depend on coverage and reimbursement from third-party payers, and pricing and reimbursement pressures may affect our profitability.*

These payers are increasingly focused on the effectiveness, benefits and costs of similar treatments, which could result [removed: for our products] in lower reimbursement rates [added: for our products] or narrower populations for whom payers will reimburse.

Continued intense public scrutiny of the price of drugs and other healthcare costs, together with payer dynamics, [removed: may limit] [added: have limited, and are likely to continue to limit,] our ability to set or adjust the price of our products based on their value, which could have a material adverse effect on our business.

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

These include proposals that [removed: would, for example,] [added: would] allow the U.S. government to negotiate [removed: directly on] drug [removed: prices,] [added: price directly,] limit drug [removed: prices] [added: reimbursement] based on prices abroad or permit importation of drugs from Canada.

Proposals [removed: addressing] [added: focused on] drug pricing are likely to continue to be [removed: introduced] [added: proposed] and may be adopted and implemented in some form.

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

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

[removed: Further, following the change of party control of the U.S. House of Representatives in November] [added: Since late] 2018, Congressional focus on drug pricing has increased, placing our industry under greater Congressional scrutiny.

For example, in [removed: January] [added: early] 2019, the chair of the House Oversight and Reform Committee sent letters to twelve different biopharmaceutical manufacturers, including Amgen, seeking documents and detailed information about such companies’ [removed: drug-pricing] [added: drug pricing] practices.

[removed: A] [added: Also, between 2019 and 2020, a] number of other Congressional committees [removed: have also] held hearings and evaluated proposed legislation on drug-pricing and payment policy.

For example, in [removed: July] 2019, the Senate Finance Committee advanced a bill that would, among other things, penalize pharmaceutical manufacturers for raising prices on drugs covered by Medicare Parts B [added: and/or D faster than the rate of inflation, cap out-of-pocket expenses for Medicare Part D beneficiaries,] and [added: require higher/additional manufacturer discounts in Medicare Part D.]

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

Additional legislative or regulatory proposals have been introduced by members of Congress [removed: or] [added: and] the [added: prior] Administration that, if enacted and [removed: implemented,] [added: implemented in whole or in part,] could also affect access to and sales of our products, [removed: including] [added: including,] but not limited [removed: to] [added: to,] proposals to [removed: overhaul provisions of the ACA, to] allow importation of prescription medications from Canada or other countries and to [removed: base] [added: set] Medicare payment rates [removed: on an] [added: using] international [removed: index price.][added: price referencing.]

[removed: Also, our] [added: Our] business has been, and is expected to continue to be, affected by changes in U.S. federal reimbursement policy resulting from [removed: executive actions,] federal regulations and federal demonstration projects.

For example, the [removed: Administration’s drug-pricing blueprint] [added: previous Administration] released [added: a drug pricing blueprint] in [removed: May] 2018 [removed: contains] [added: which introduced] an array of policy ideas intended to increase competition, improve the negotiating power of the federal government, reduce drug prices and lower patient out-of-pocket costs with the potential to significantly affect, whether individually or collectively, our industry.

Such policy ideas [removed: include,] [added: included,] but [removed: are] [added: were] not limited to, moving coverage and reimbursement for Medicare Part B drugs into Medicare Part D and instituting a competitive acquisition program for Part B drugs in which competing third-party vendors take on the financial risk of acquiring drugs and billing Medicare.

[removed: Since the release of the Administration’s drug-pricing blueprint,] [added: Also, over] the [removed: Administration and] [added: past three years,] federal agencies, including the [removed: CMS, have] [added: Centers for Medicare & Medicaid Services (CMS),] announced a number of [removed: demonstration projects,] recommendations, [removed: policies and] [added: policies,] proposals [added: and demonstration projects] to implement various elements of the [added: drug pricing] blueprint.

CMS [removed: has also] issued guidance to allow certain Medicare plans offered by private insurance companies to require that patients receiving Medicare Part B drugs first try a drug preferred by the plan before covering another therapy (Step Therapy) and lowered reimbursement rates for new Medicare Part B drugs.

In [removed: December 2019,] [added: September 2020, in response to] the [removed: Administration] [added: corresponding Executive Order, HHS] released a [removed: proposed] [added: final] rule to allow states (or other [removed: non-federal] [added: nonfederal] government entities) to submit proposals to the FDA allowing for the importation of certain [added: nonbiologic] prescription drugs from Canada.

[removed: Separate from the drug-pricing blueprint,] CMS policy changes and demonstration projects to test new care, delivery and payment models can significantly affect how drugs, including our products, are covered and reimbursed.

In [removed: ESRD,] [added: end-stage renal disease (ESRD),] CMS uses [removed: a] bundled payment [removed: system.][added: rates.]

[removed: Since 2018,] [added: Between 2018 and 2020,] Sensipar® and Parsabiv®, [removed: which] [added: our calcimimetics that] are used in dialysis [removed: clinics and are curently outside of the bundled payment system, have been] [added: clinics, were] eligible for temporary drug add-on payment adjustments (TDAPA) [removed: and will continue] to [removed: be eligible in 2020.][added: the bundled rate.]

Additionally, [removed: in July 2019,] CMS [removed: released a proposed rule creating] [added: created] a new mandatory payment model [added: effective January 1, 2021] focused on encouraging greater use of home dialysis and kidney transplants for ESRD patients [removed: that, if finalized as proposed,] [added: that] could result in changes to treatment of dialysis patients, including reduction of the use of our ESAs.

[removed: In] [added: Further, back in] November 2019, CMS announced additional voluntary payment models for nephrologists and dialysis facility partners that also seek to encourage home dialysis and preemptive transplantation through increased risk [removed: sharing beginning in] [added: sharing, but due to COVID-19, the start date of such programs has been pushed back to April 1,] 2021.

[added: In 2016,] CMS initiated [removed: in 2016] the Oncology Care Model demonstration, which provides participating physician practices with performance-based financial incentives that aim to manage or reduce Medicare costs without negatively affecting the efficacy of [removed: care.][added: care, that has been extended by one year (to 2022) due to COVID-19.]

Additionally, in [removed: November] [added: late] 2019, CMS announced a request for information on the Oncology Care First model, a new voluntary model that builds on the Oncology Care [removed: Model that would be slated to begin in January 2021.][added: Model.]

In this dynamic environment, we are unable to predict which or how many [removed: of these various] federal policy, legislative, regulatory, executive or administrative changes may ultimately [removed: be] [added: be, or effectively estimate the consequences to our business if,] enacted and implemented.

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

A number of states have adopted, and many other states are considering, drug importation programs or other new pricing actions, including proposals designed to require biopharmaceutical manufacturers publicly to report proprietary pricing information, limit price increases or [removed: to] place a maximum price ceiling or cap on biopharmaceutical products.

For example, [removed: in late 2017, California enacted] a [removed: drug-pricing transparency bill that requires] [added: California law, the constitutionality of which is currently being challenged, purports to require] biopharmaceutical manufacturers to notify health insurers and government health plans at least 60 days before scheduled prescription drug price increases that exceed certain thresholds.

Similar laws [added: exist] in Oregon and [removed: Washington were passed in 2019.][added: Washington.]

Additionally, Colorado, Florida, [removed: Maine] [added: Maine, New Hampshire, New Mexico] and [removed: Vermont,] [added: Vermont] have enacted laws, and several other states have proposed laws, to facilitate the importation of drugs from Canada.

With increasing frequency, payers are adopting benefit plan changes that shift a greater [removed: portion] [added: proportion] of drug costs to patients.

Such measures include more limited benefit plan designs, high deductible plans, higher patient [removed: co-pay] [added: copay] or coinsurance obligations and more significant limitations on patients’ use of manufacturer commercial [removed: co-pay payment] [added: copay] assistance [removed: programs (including through co-pay accumulator adjustment or maximization programs).][added: programs.]

Payers have [removed: sought] [added: sought,] and will likely continue to [removed: seek] [added: seek,] price discounts or rebates in connection with the placement of our products on their formularies or those they manage, particularly in treatment areas where the payer has taken the position that multiple branded products are therapeutically comparable.

Payers also control costs by imposing restrictions on access to or usage of our products, such as Step [removed: Therapy] [added: Therapy,] or requiring that patients receive the payer’s prior authorization before covering the product or that patients use a mail-order pharmacy or a limited network of payer fully-owned mail-order or specialty [removed: pharmacies; payers may also choose to exclude certain indications for which our products are approved or even choose to exclude coverage entirely.][added: pharmacies.]

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

[removed: In] [added: For example, in] late 2018 and early 2019, [added: in response to a very high percentage of Medicare patients abandoning their Repatha® prescriptions rather than pay their co-pay payment,] we introduced a set of new National Drug Codes to make Repatha® available at a lower list price to attempt to address affordability for patients, particularly those on Medicare and on December 31, [removed: 2019] [added: 2019,] we discontinued the higher list price option for Repatha®.

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

SUMMARY

*Risks Related to Economic Conditions and Operating a Global Business, Including During the COVID-19 Pandemic*

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

- Our sales and operations are subject to the risks of doing business internationally, including in emerging markets.

*Risks Related to Government Regulations and Third-Party Policies*

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

- Guidelines and recommendations published by various organizations can reduce the use of our products.

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

- Our business may be affected by litigation and government investigations.

*Risks Related to Competition*

- Our intellectual property positions may be challenged, invalidated or circumvented, or we may fail to prevail in current and future intellectual property litigation.

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

*Risks Related to Research and Development*

- We may not be able to develop commercial products despite significant investments in R&D.

- We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications.

- Our current products and products in development cannot be sold without regulatory approval.

- Some of our products are used with drug delivery or companion diagnostic devices that have their own regulatory, manufacturing and other risks.

- 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.

*Risks Related to Operations*

- We perform a substantial majority of our commercial manufacturing activities at our facility in the U.S. territory of Puerto Rico and a substantial majority of our clinical manufacturing activities at our facility in Thousand Oaks, California; significant disruptions or production failures at these facilities could significantly impair our ability to supply our products or continue our clinical trials.

- We rely on third-party suppliers for certain of our raw materials, medical devices and components.

- Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.

*General Risk Factors*

- Global economic conditions may negatively affect us and may magnify certain risks that affect our business.

- Our stock price is volatile

- We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

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

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

The novel coronavirus identified in late 2019, SARS-CoV-2, which causes the disease known as COVID-19, is an ongoing global pandemic that has resulted in public and governmental efforts to contain or slow the spread of the disease, including widespread shelter-in-place orders, social distancing interventions, quarantines, travel restrictions and various forms of operational shutdowns.

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

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

Due to the pandemic and these measures and their effects, we have experienced, and expect to continue to experience, unpredictable reductions in demand for certain of our products, and in some cases, have experienced, and could continue to experience, unpredictable increases in demand for certain of our products.

Our clinical trials have been, and are expected to continue to be, adversely affected by the COVID-19 pandemic.

We have clinical work ongoing at investigational sites across the globe.

A number of clinical trial sites, including those in regions experiencing new or resurgent outbreaks of COVID-19, have restricted site visits and imposed restrictions on the initiation of new clinical trials and/or patient visits to protect both site staff and patients from possible COVID-19 exposure that has stopped or slowed clinical trial activities.

In response to the safety concerns related to COVID-19, we have suspended, and will continue to suspend, enrollment and screening in clinical trials where sites are unable to perform clinical trial work due to COVID-19 or there is uncertainty around the ability of sites to ensure subject safety or data integrity.

Further, the COVID-19 pandemic has adversely affected, and may continue to adversely affect, our ability to enroll or to continue to enroll certain required post-marketing studies, including pediatric studies.

While many of our clinical trial activities have recommenced over the course of 2020, the initial disruption caused by the COVID-19 pandemic to our clinical trials and our clinical trial plans and timelines, and any similar future disruptions (including as a result of the current surge and lockdowns in numerous regions), may have a significant adverse effect on our product development and launches, and, in turn, on future product sales, business and results of operations.

For example, to ensure patient safety we initially paused enrollment of our sotorasib Phase 1 combination cohort with Keytruda® and Phase 3 lung cancer study, and such interruptions in enrollment may ultimately affect the timeline of these or other studies.

Additionally, while we are investing in research, collaborations and operational support to potentially develop and/or produce treatments for COVID-19, such activities may not result in therapeutic candidates, product approvals, successful production and/or significant commercial value being derived from potential COVID-19-related medicines.

For example, beginning in 2019, legislation requiring biopharmaceutical manufacturers to provide greater discounts on products dispensed to patients in the coverage gap between the initial coverage limit of Medicare Part D and the program’s catastrophic-coverage threshold has, and will continue to, reduce our net product sales relating to such patients.

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

We expect continued significant focus on health care and drug-pricing legislation through 2020 leading up to the November U.S. presidential election and beyond.

For example, in late 2018, CMS began evaluating a pilot program that would initially, among other things, include fifty percent of Medicare Part B single source drugs and set payment amounts to more closely align with international drug prices, and in June 2019, Administration officials announced that the Office of Management and Budget was in the process of reviewing a draft proposed rule to implement this model.

Congress is also interested in exploring solutions that may move biopharmaceutical manufacturers from back-end rebate agreements with PBMs to front-end discounts.

Such a rule could subject some of our product to importation.

CMS is expected to release details in 2020 on the rate setting analysis that it will conduct to determine whether and how CMS would adjust ESRD Prospective Payment System base rates to account for calcimimetics after the TDAPA for calcimimetics ends, which is expected in 2021.

In January 2019, California’s governor issued an executive order expanding state Medicaid coverage and directing its agencies and programs to develop a plan to consolidate drug purchases and to negotiate drug prices with biopharmaceutical manufacturers.

Additionally, New York, Massachusetts and Ohio have established Medicaid drug spending caps.

For example, a very high percentage of Medicare patients abandoned their Repatha® prescriptions rather than pay their co-pay payment.

For example, in the United States, in 2018, the top three PBMs oversaw greater than two-thirds of prescription claims as well as government and commercial covered lives.

Also in 2018, two of

the nation’s largest PBMs, Express Scripts and CVS Health, completed their combinations with major insurance companies Cigna and Aetna, respectively.

Additional consolidation would further increase the leverage of such entities.

Our U.S. composition-of-matter patent for Sensipar®, a small molecule product, expired in March 2018.

We are engaged in litigation with a number of companies seeking to market generic cinacalcet products surrounding our U.S. formulation patent that expires in September 2026.

Several of these generic products have been approved by the FDA, and the manufacturer of one of the approved generic products began selling its product in late 2018 before reaching a settlement agreement with us in early January 2019.

Our current litigation also includes disputes with a number of other manufacturers that began selling their approved generic cinacalcet products in the United States in early 2019.

If we do not prevail in these matters, these manufacturers and other companies may be able to launch their approved generic products into the U.S. market.

In addition, even before the resolution of our ongoing litigation, a number of other companies have elected to launch their approved generic products at risk or have sought and obtained a judicial declaration that they are permitted to launch their generic products.

Third parties have challenged and may continue to challenge, invalidate or circumvent our patents and patent applications relating to our products, product candidates and technologies.

For example, we are currently engaged in litigation in the United States regarding MVASITM and KANJINTITM.

While we have attempted, and may

For information related to our patent litigation, see Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.

For example, CVS Caremark indicated in August 2018 that it will begin utilizing third-party cost effectiveness analyses to make formulary and coverage determinations for newly-approved drugs.

| | |

| --- | --- |

to products or product candidates for which clinical trials have been or are being conducted.

result in increased development costs; delays in, or failure to obtain or maintain, regulatory approval; and/or associated delays in a product candidate reaching the market or in the addition of new indications for existing products.

Business—Significant Developments—Collaboration with BeiGene, Ltd., and Item 1.

As previously disclosed, we received a Revenue Agent Report (RAR) from the IRS for the years 2010, 2011 and 2012.

In November 2017, we received a modified RAR that revised the IRS’s calculation but continued to propose substantial adjustments.

If we deem necessary, we will vigorously contest the proposed adjustments through the judicial process.

Although final resolution of this complex matter is not likely within the next 12 months, such resolution could have a material negative effect on our consolidated financial statements.

The Tax Cuts and Jobs Act (the 2017 Tax Act) is complex and further regulations and interpretations are still being issued.

We could face audit challenges to our application of the new law that could have a negative effect on our provision for income taxes.

A change to the U.S. tax system, such as a repeal or modification of the 2017 Tax Act, a change to the tax system in a jurisdiction where we have

We are also operating on backup generators since the early 2020 earthquakes.

Also, during the summer of 2019 political instability in the Puerto Rico government led to civil unrest and the resignation and replacement of the governor.

Certain creditors and labor unions have brought suit claiming the appointment process of the Oversight Board was unconstitutional, and as of October 2019, the U.S. Supreme Court heard oral arguments on these claims.

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

In 2020, we [removed: celebrate] [added: celebrated] our 40th anniversary, continuing our history of focusing on innovative medicines that have the potential to be first-in-class molecules and that have a large-effect size on serious diseases.

Our principal products—those with the most significant annual commercial sales—are ENBREL, [removed: Neulasta®,] Prolia®, [added: Neulasta®, Otezla®,] XGEVA®, Aranesp®, [removed: KYPROLIS®, EPOGEN®] [added: KYPROLIS®] and [removed: our recently acquired product Otezla®.][added: Repatha®.]

We also market a number of other products, including Nplate®, Vectibix®, [removed: Repatha®,] [added: MVASI®,] Parsabiv®, [removed: Sensipar®/Mimpara®,] [added: EPOGEN®, KANJINTI®,] BLINCYTO®, Aimovig®, [removed: NEUPOGEN®, KANJINTITM, AMGEVITATM,] EVENITY®, [removed: MVASITM, IMLYGIC®] [added: AMGEVITATM, Sensipar®/Mimpara®, NEUPOGEN®, IMLYGIC®, Corlanor®] and [removed: Corlanor®.][added: AVSOLA®.]

We focus on six commercial areas: inflammation, oncology/hematology, bone health, [removed: cardiovascular] [added: CV] disease, nephrology and [removed: neuroscience] [added: neuroscience,] and [added: we] conduct discovery research primarily in three therapeutic areas: inflammation, oncology/hematology and [removed: cardiovascular/metabolic] [added: CV/metabolic] diseases.

Product sales [removed: decreased 5%] [added: increased 9% and 10%] in the United States and [removed: grew 11% in the] rest of the [removed: world.][added: world, respectively.]

We also continued to advance our biosimilar program with the [removed: launches] [added: launch] of [removed: KANJINTITM and MVASITM in the United States] [added: AVSOLA®] and the approval of [removed: AVSOLATM for all approved indications of the reference product REMICADE® (infliximab)] [added: RIABNITM] in the United States.

Cash flows from operating activities [removed: were $9.2] [added: totaled $10.5] billion, enabling us to invest in our business while returning capital to shareholders through the payment of cash dividends and stock repurchases.

For [removed: 2019,] [added: 2020,] we increased our quarterly cash dividend by 10% to [removed: $1.45] [added: $1.60] per share of common stock.

In December [removed: 2019,] [added: 2020,] we declared a cash dividend of [removed: $1.60] [added: $1.76] per share of common stock for the first quarter of [removed: 2020,] [added: 2021,] an increase of 10% for this period, to be paid in March [removed: 2020.][added: 2021.]

We also repurchased [removed: 40.2] [added: 15.2] million shares of our common stock throughout [removed: 2019] [added: 2020,] at an aggregate cost of [removed: $7.6] [added: $3.5] billion.

Our long-term success [removed: depends,] [added: depends] to a great [removed: extent,] [added: extent] on our ability to continue to discover, develop and commercialize innovative products and acquire or collaborate on therapies currently in development by other companies.

We devote considerable resources to R&D activities, but successful product development in the biotechnology industry is highly [removed: uncertain and we also are facing increasing regulatory scrutiny of safety and efficacy both before and after products launch.][added: uncertain.]

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

Risk Factors for further discussion of certain [removed: of the] factors that could impact our future product sales.

| | [added: | |] Year ended December 31, [added: 2020 | | | | | | Change | | | | | | Year ended December 31,] 2019 | | | | [added: | |] Change | | | [added: | | |] Year ended December 31, 2018 | | |

| Product sales: | | | | | | | | | | | [added: | | | | | | |]

| [added: Total] U.S. | [added: | |] $ | [added: 17,985 | | | | | 9 | | % | | | | $ |] 16,531 | | | [removed: (5] | [removed: )%] | [added: (5)] | [added: | % | | | |] $ | 17,429 | |

| [removed: Rest of world] [added: Rest-of-world] (ROW) | [removed: 5,673] | | [added: 6,255] | | [removed: 11] | [added: | | | 10 | |] % | | [removed: 5,104] | | [added: 5,673] | [added: | |]

| Total product sales | [added: | | $ | 24,240 | | | | | 9 | | % | | | | $ |] 22,204 | | | | [removed: (1] | [removed: )%] [added: (1)] | | [removed: 22,533] [added: %] | | | [added: | $ | 22,533 | |]

| Other revenues | [removed: 1,158] | | [added: 1,184] | | [removed: (5] | [removed: )%] | | [removed: 1,214] | [added: 2] | | [added: % | | | | 1,158 | | |]

| Total revenues | [added: | |] $ | [removed: 23,362] [added: 25,424] | | | [removed: (2] | [removed: )%] | [added: 9] | [added: | % | | | |] $ | [removed: 23,747] [added: 23,362] | |

| Operating expenses | [added: | |] $ | [removed: 13,688] [added: 16,285] | | | [removed: 2] | [added: | 19 | |] % | | [added: | |] $ | [removed: 13,484] [added: 13,688] | |

| Operating income | [added: | |] $ | [removed: 9,674] [added: 9,139] | | | [removed: (6] | [removed: )%] | [added: (6)] | [added: | % | | | |] $ | [removed: 10,263] [added: 9,674] | |

| Net income | [added: | |] $ | [removed: 7,842] [added: 7,264] | | | [removed: (7] | [removed: )%] | [added: (7)] | [added: | % | | | |] $ | [removed: 8,394] [added: 7,842] | |

| Diluted EPS | [added: | |] $ | [removed: 12.88] [added: 12.31] | | | [removed: 2] | [added: | (4) | |] % | | [added: | |] $ | [removed: 12.62] [added: 12.88] | |

| Diluted shares | [removed: 609] | | [added: 590] | | [removed: (8] | [removed: )%] | | [removed: 665] | [added: (3)] | | [added: % | | | | 609 | | |]

In the following discussion of changes in product sales, any reference to unit demand growth or decline refers to changes in the purchases of our products by healthcare providers [removed: such] [added: (such] as physicians or their [removed: clinics,] [added: clinics),] dialysis centers, hospitals and pharmacies.

In addition, any reference to increases or decreases in inventory refers to changes in inventory held [removed: at] [added: by] wholesaler customers and end users [removed: such] [added: (such] as [removed: pharmacies.][added: pharmacies).]

[removed: Total product] [added: The increase in ENBREL] sales [removed: decreased] for [removed: 2019, driven] [added: 2019 was] primarily [added: driven] by [removed: a decline] [added: favorable changes to estimated sales deductions and an increase] in net selling price, [removed: offset] partially [added: offset] by [removed: higher] [added: lower] unit demand.

For [removed: 2020,] [added: 2021,] we expect [added: that] net selling [removed: price to] [added: prices will] continue to decline.

Other revenues [removed: decreased] [added: increased] for [removed: 2019, driven] [added: 2020,] primarily [removed: by lower milestone payments, offset partially] [added: driven] by higher royalties.

[removed: Operating expenses increased] [added: The increase in R&D expense] for [removed: 2019, driven] [added: 2019 was] primarily [added: driven] by higher [removed: spending] [added: spend] in research and early pipeline in support of our oncology programs, [removed: offset] partially [added: offset] by [removed: an impairment charge associated with an IPR&D asset in 2018.][added: lower marketed-product support.]

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

The net impact from changes in foreign currency exchange rates was not material in [removed: 2019, 2018] [added: 2020, 2019] or [removed: 2017.][added: 2018.]

| | [added: | |] Year ended December 31, [removed: 2019] [added: 2020] | | | | [added: | |] Change | | | [added: | | |] Year ended December 31, [removed: 2018] [added: 2019] | | | | [added: | |] Change | | | [added: | | |] Year ended December 31, [removed: 2017] [added: 2018] | | |

| ENBREL | [added: | |] $ | [removed: 5,226] [added: 4,996] | | | [removed: 4] | [added: | (4) | |] % | | [added: | |] $ | [removed: 5,014] [added: 5,226] | | | [removed: (8] | [removed: )%] | [added: 4] | [added: | % | | | |] $ | [removed: 5,433] [added: 5,014] | |

| Neulasta® | [removed: 3,221] | | [added: 2,293] | | [removed: (28] | [removed: )%] | | [removed: 4,475] | [added: (29)] | | [added: %] | [removed: (1] | [removed: )%] | | [removed: 4,534] [added: 3,221] | | | [added: | | | (28) | | % | | | | 4,475 | | |]

| Prolia® | [removed: 2,672] | | [added: 2,763] | | [removed: 17] | [added: | | | 3 | |] % | | [removed: 2,291] | | [added: 2,672] | | [removed: 16] | [added: | | | 17 | |] % | | [removed: 1,968] | | [added: 2,291] | [added: | |]

| XGEVA® | [removed: 1,935] | | [added: 1,899] | | [removed: 8] | [added: | | | (2) | |] % | | [removed: 1,786] | | [added: 1,935] | | [removed: 13] | [added: | | | 8 | |] % | | [removed: 1,575] | | [added: 1,786] | [added: | |]

In 2020, we advanced our innovative pipeline, successfully integrated Otezla®, acquired in November 2019, into our inflammation portfolio, advanced our international expansion and continued to provide uninterrupted supply of our medicines globally through the COVID-19 pandemic.

We accomplished these objectives while maintaining a strategic and disciplined approach to capital allocation, and advancing our environmental, social and governance efforts.

During the year, while meeting the challenges of a global pandemic and facing increased competition from biosimilars and generics, total product sales increased 9%, driven by volume growth primarily from Otezla®, partially offset by lower net selling prices.

Total operating expenses increased 19%, driven by expenses related to Otezla®.

We continued to advance our pipeline, including sotorasib and tezepelumab—two molecules with respect to which we have achieved positive registration enabling data from our clinical trial activities.

Our biosimilars are expected to launch in new markets throughout 2021.

Lastly, we broadened our international reach, particularly in the Asia Pacific region with our investment in and strategic collaboration with BeiGene to expand our oncology presence in China, as well as the establishment of our wholly owned affiliate in Japan.

During the year, we had proceeds from the issuance of debt of $8.9 billion and repayments of debt of $6.5 billion.

In addition, we exchanged some of our higher interest rate debt for newly issued debt with a lower interest rate and a later maturity date.

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

Our compensation, benefits and development programs are designed to encourage performance, promote accountability and adherence to Company values, and in alignment with the interests of the Company’s shareholders.

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

We also believe our global presence is strengthened by having a workforce that reflects the diversity of the patients we serve.

It is with these beliefs in mind that we have continued to strengthen and grow our culture of diversity, inclusion and belonging.

Our internal efforts include, in 2019, establishing a Diversity, Inclusion and Belonging Council.

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

For further information on these and other efforts, see Part I, Item 1.

Business—Human Capital Resources.

We have a long-standing ambition to be environmentally responsible, and we regularly set targets to challenge ourselves to deliver further improvements.

In 2020, we met or exceeded our environmental sustainability targets set out in 2013 that called for reducing fleet carbon output by up to 20%, facility carbon output by 10%, water consumption by 10% and waste disposal by 35%2.

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

To continue on our path to greater environmental sustainability, in January 2021 we announced a new set of long-term environmental targets to achieve by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by 75%.

We also face increasing regulatory scrutiny of safety and efficacy both before and after products launch.

*COVID-19 pandemic*

The COVID-19 pandemic has had a moderate impact to our business in 2020.

Since the onset of the pandemic in early 2020, we have been carefully monitoring its impact on our global operations.

We have taken appropriate steps to minimize the risk to our employees.

A significant number of our employees have been working remotely, with the exception of certain staff that require access to our manufacturing and laboratory research facilities, in accordance with applicable government health and safety protocols and guidance issued in response to the COVID-19 pandemic.

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

Since the beginning of the COVID-19 pandemic, we have seen changes in demand trends for some of our products, including lower demand for certain products as continuing patient access to those products has been affected by COVID-19, particularly in the early phases of the pandemic.

For example, near the end of March, we began to observe a decline in sales of Prolia®, as elderly patients, who are relatively more vulnerable to COVID-19, avoided doctors’ offices.

Demand has since recovered to varying degrees by product as local conditions improved in certain geographies that opened after an initial improvement in COVID-19 infection rates, allowing patients to resume receiving their treatments.

During the second half of the year, our own efforts remain focused on assisting patients with improving their continuity of care to increase product access as compared to what they experienced during the earlier stages of the pandemic.

Recently, higher rates of infection have been observed in certain geographies, including the United States and Europe, which may further restrict demand, similar to early phases of the pandemic.

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

2 Represents reductions against established baselines, taking into account only verified reduction projects, and does not take into account changes associated with contraction or expansion of the company.

The majority of clinical trials that were paused at the onset of the pandemic to ensure subject safety or data integrity have resumed.

Study enrollment was affected negatively the most in the second quarter of the year and by the end of 2020 resumed to around pre-pandemic levels.

However, going forward COVID-19 infection rates and related vaccination activities may impact future study enrollment.

We continuously monitor our ability for study enrollment on an institution by institution basis and reevaluate the status of studies, pausing when uncertainty arises with regard to the trial sites’ ability to ensure safety or data integrity.

In 2019, we advanced our innovative pipeline, launched branded biosimilar programs, built our global geographic reach and expanded our next generation manufacturing capabilities, while returning capital to shareholders.

During the year we delivered strong financial results while facing competition from biosimilars and generics.

Total product sales decreased 1% as lower net selling prices were offset partially by volume growth.

Total operating expenses increased 2% as we invested in our innovative R&D pipeline, including our early oncology assets.

We continued to advance our pipeline, including AMG 510, which was granted fast track designation from the FDA for the treatment of patients with previously treated metastatic NSCLC with KRAS G12C mutation.

We launched EVENITY® in the United States and Japan, and it was granted marketing authorization in Europe; and the United States label for KYPROLIS® was expanded.

Lastly, we made a regulatory submission for ABP 798 in the United States.

We have also continued to invest in external opportunities to augment our internal programs and products.

We completed our acquisition of worldwide rights to Otezla®, the only oral, non-biologic treatment for psoriasis and psoriatic arthritis.

We strengthened our international footprint with the announcement of a strategic collaboration with BeiGene to expand our oncology presence in China.

In addition, we expanded our human genetics capabilities, by entering into a collaboration with a regional healthcare system in the United States and joining a consortium to perform whole genome sequencing of approximately 500,000 participants from the United Kingdom.

Our human genetics capabilities allow us to identify new development targets in our chosen areas of therapeutic focus.

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

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

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

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

| Sensipar®/Mimpara® | 551 | | | | (69 | )% | | 1,774 | | | | 3 | % | | 1,718 | | |

| Other products | 4,959 | | | | 49 | % | | 3,338 | | | | 29 | % | | 2,583 | | |

| Total U.S. | $ | 16,531 | | | (5 | )% | | $ | 17,429 | | | 2 | % | | $ | 17,131 | |

For 2020, we expect the trend of lower unit demand to continue.

The decrease in global Neulasta® sales for 2018 was driven primarily by favorable changes in accounting estimates of product returns in 2017, offset partially by favorable changes in inventory.

Neulasta® sales for 2018 included a $55 million order in the fourth quarter from the U.S. government.

Prolia®, which has a six-month dosing interval, has exhibited a historical sales pattern, with the first and third quarters of a year representing lower sales than the second and fourth quarters of a year.

Other biosimilar versions of EPOGEN® may also receive approval in the future.

*EPOGEN®*

| EPOGEN® — U.S. | $ | 867 | | | (14 | )% | | $ | 1,010 | | | (8 | )% | | $ | 1,096 | |

The decreases in EPOGEN® sales for 2019 and 2018 were driven primarily by a decline in net selling price due to our contract with DaVita.

Business—Business Relationships.

In 2020, we expect a lower net selling price compared with 2019 due to our contract with DaVita.

A biosimilar version of EPOGEN® has been approved and launched, and other biosimilar versions may also receive approval in the future.

Therefore, we face increased competition in the United States, which has had and will continue to have a material adverse impact on sales of EPOGEN®.

*Sensipar®/Mimpara®*

| Total Sensipar®/Mimpara® | $ | 551 | | | (69 | )% | | $ | 1,774 | | | 3 | % | | $ | 1,718 | |

The increase in global Sensipar®/Mimpara® sales for 2018 was driven primarily by an increase in net selling price in the United States, offset partially by lower unit demand.

Our U.S. composition-of-matter patent related to Sensipar®, a small molecule, expired in March 2018.

We are involved in litigation with a number of companies seeking to market generic cinacalcet products surrounding our U.S. formulation patent, which expires in September 2026.

During the course of the patent litigation, we have entered into confidential settlement agreements with several of these companies.

The court has entered consent judgments enjoining certain of those companies from infringing certain of our patents, subject to terms of the confidential settlement agreements.

Companies manufacturing generics began selling their generic cinacalcet products in the United States in late 2018 and 2019.

Sensipar® sales have been and, we believe, may continue to be adversely impacted as a result of generic-product sales in the U.S. market.

In the discussion that follows, we have assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, [removed: 2019] [added: 2020] and [removed: 2018.][added: 2019.]

Except as noted below, we have 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: 2019] [added: 2020] and [removed: 2018.][added: 2019.]

Our portfolio of available-for-sale investments as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] was composed of U.S. Treasury [removed: securities, corporate debt securities, residential-mortgage-backed and other mortgage-] [added: securities] and [removed: asset-backed securities,] money market mutual [removed: funds and other short-term interest-bearing securities composed principally of commercial paper,] [added: funds,] and with respect to investments as of December 31, [removed: 2018,] [added: 2019, corporate debt securities and] other [removed: government-related] [added: short-term interest-bearing] securities.

The fair values of our available-for-sale investments were [removed: $8.2] [added: $9.8] billion and [removed: $28.7] [added: $8.2] billion as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, [added: 2020 and] 2019, would not have resulted in a material reduction in the fair [removed: value] [added: values] of these [removed: securities, and with respect to available-for-sale securities as of December 31, 2018, would have resulted in a reduction of approximately $360 million in fair value.][added: securities.]

In addition, a hypothetical 100 basis point decrease in interest rates as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] would not result in a material effect on income in the respective ensuing year.

As of December 31, [removed: 2018,] [added: 2020,] we had outstanding debt with a carrying value of [removed: $33.9] [added: $33.0] billion and a fair value of [removed: $35.0] [added: $39.4] billion.

[added: A hypothetical 100 basis] point decrease in interest rates relative to interest rates as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] would have resulted in increases of [removed: $3.0] [added: $4.5] billion and [removed: $2.6] [added: $3.0] billion, respectively, in the aggregate fair value of our outstanding debt on each of these dates.

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

Interest rate swap contracts with aggregate notional amounts of [removed: $9.6] [added: $5.9] billion and [removed: $11.0] [added: $9.6] billion were outstanding as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] would have resulted in reductions in fair values of approximately [removed: $380] [added: $230] million and [removed: $460] [added: $380] million, respectively, on our interest rate swap contracts on these [removed: dates and would not result in a material effect on the related income in the respective ensuing years.][added: dates.]

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] we had outstanding cross-currency swap contracts with aggregate notional amounts of $4.8 billion [removed: and $5.6 billion, respectively,] that hedge our foreign-currency-denominated debt and related interest payments.

A hypothetical 100 basis point adverse movement in interest rates relative to interest rates as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] would have resulted in reductions in the fair values of our cross-currency swap contracts of approximately [removed: $280] [added: $250] million and [removed: $320] [added: $280] million, respectively.

Increases and decreases in our international product sales from movements in foreign currency exchange rates are [removed: offset] partially [added: offset] by the corresponding increases or decreases in our international operating expenses.

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

As of December 31, [removed: 2018,] [added: 2020,] we had outstanding euro-, pound-sterling- and Swiss-franc-denominated debt with a principal carrying value and a fair value of [removed: $5.3] [added: $4.8] billion and [removed: $5.6] [added: $5.4] billion, respectively.

A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, [removed: 2019,] [added: 2020,] would have resulted in an increase in fair value of this debt of [removed: $1.0] [added: $1.1] billion on this date and a reduction in income in the ensuing year of [removed: $0.9] [added: $1.0] 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, [removed: 2018,] [added: 2019,] would have resulted in an increase in fair value of this debt of [removed: $1.1] [added: $1.0] billion on this date and a reduction in income in the ensuing year of [removed: $1.1 billion.][added: $900 million.]

We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros, pounds sterling and Swiss francs with aggregate notional amounts of $4.8 billion [removed: and $5.6 billion] as of [added: both] December 31, [removed: 2019] [added: 2020] and [removed: 2018, respectively.][added: 2019.]

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 [removed: $1.0] [added: $1.1] billion and [removed: $1.2] [added: $1.0] billion on these dates, respectively.

As of December 31, [removed: 2018,] [added: 2020,] we had primarily euro based open foreign currency forward [removed: and option] contracts with notional amounts of [removed: $4.5 billion and $21 million, respectively.][added: $5.1 billion.]

As of December 31, [removed: 2018,] [added: 2020,] the fair values of these contracts were a [removed: $181] [added: $28] million asset and a [removed: $26] [added: $237] million liability.

With regard to [removed: foreign currency forward and option] contracts that were open as of December 31, 2019, a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2019, would have resulted in a reduction in fair value of these contracts of [removed: approximately] $930 million on this date [removed: and,] [added: and] in the ensuing year, a reduction in income of [removed: approximately] $400 million.

[added: With regard to foreign] currency [added: forward and option contracts that were open as of December 31, 2020, 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: 2018,] [added: 2020,] would have resulted in a reduction in fair value of these contracts of [removed: $810 million] [added: approximately $1.1 billion] on this date [removed: and,] [added: and] in the ensuing year, a reduction in income of [removed: $380] [added: approximately $420] million.

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] we had open short-duration foreign currency forward contracts that mature in less than one [removed: month] [added: month,] with notional amounts of [removed: $1.2] [added: $1.0] billion and [removed: $737 million,] [added: $1.2 billion,] respectively, 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: 2019] [added: 2020] and [removed: 2018.][added: 2019.]

With regard to these foreign currency forward contracts that were open as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] 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: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] 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 are generally in small-capitalization stocks in the biotechnology [removed: industry sector.][added: industry.]

Price risk relative to our equity investment portfolio as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] was not material.

Our financial risk management policy limits derivative transactions by requiring that transactions be made only with institutions with minimum credit ratings of A– or equivalent by S&P, Moody’s or Fitch; and it [removed: requires placing] [added: places] exposure limits on the amount with any individual counterparty.

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

Our outstanding debt was composed almost entirely of debt with fixed interest rates.

| | | | | | |

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

Our outstanding debt was composed primarily of debt with fixed interest rates, with variable-rate debt having carrying values of $300 million and $850 million as of December 31, 2019 and 2018, respectively.

A hypothetical 100 basis

With regard to contracts that were open as of December 31, 2018, a hypothetical 20% adverse movement in foreign

| | |

| --- | --- |

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: 2018.][added: 2019.]

[removed: For a discussion of litigation related to KANJINTITM, see] [added: See] Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.

*KYPROLIS®* [removed: *(carfilzomib)*]

[removed: | • |] In September 2019, [removed: we announced that] the [added: CANDOR] phase 3 [removed: CANDOR (Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma)] study [removed: evaluating] [added: of] KYPROLIS® in combination with dexamethasone and DARZALEX® (daratumumab) [removed: compared to KYPROLIS® and dexamethasone alone in patients with relapsed multiple myeloma] met its primary endpoint of [removed: progression-free survival (PFS). |][added: PFS in patients with relapsed or refractory multiple myeloma.]

[removed: For a discussion of litigation related to MVASITM, see Part IV—Note] [added: See Note] 19, Contingencies and commitments, to the Consolidated Financial Statements.

[removed: *Collaboration with BeiGene,] [added: *BeiGene,] Ltd.*

[removed: | • | In] [added: On] January [added: 2,] 2020, we [removed: entered into] [added: acquired] a [removed: strategic collaboration with] [added: 20.5% stake in] BeiGene, Ltd. (BeiGene) [added: for approximately $2.8 billion in cash as part of a collaboration] to [removed: support our oncology pipeline and] expand our oncology presence in China. [removed: As part of the agreement we acquired a 20.5% stake in BeiGene for $2.8 billion in cash. |]

[removed: *AMG 510*][added: *Sotorasib (formerly AMG 510)*]

[removed: *ABP 798 (biosimilar rituximab)*][added: *RIABNITM* *(rituximab-arrx) (formerly ABP 798)*]

[removed: *Enbrel®* *(etanercept)*][added: *ENBREL*]

[removed: | • |] [added: -] In [removed: August 2019,] [added: July 2020,] the U.S. [added: Court of Appeals for the Federal Circuit affirmed the judgment by the U.S.] District Court for the District of New Jersey [removed: ruled in Amgen’s favor on] [added: upholding the] validity of the two patents that describe and claim ENBREL and methods for making it. [removed: See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements. |]

[removed: *Acquisition of Otezla®*] [added: *Otezla®*] *(apremilast)*

[removed: *EVENITY®* *(romosozumab-aqqg)*][added: | EVENITY® (romosozumab-aqqg) | | | | | | U.S. | | | | | | Antibodies(2) | | | | | | 4/25/2026 | | |]

In addition, we continue to expand the commercialization and marketing of our products into other geographic territories, including parts of [removed: Latin America,] [added: Asia,] the Middle [removed: East] [added: East, Canada] and [removed: Asia.][added: Latin America.]

This expansion is occurring by establishing our own affiliates, by acquiring existing third-party businesses or product rights or by [removed: partnering] [added: collaborating] with third parties.

Together with our [removed: partners,] [added: collaborators,] we market our products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies.

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

Our product sales to three large wholesalers, AmerisourceBergen Corporation, McKesson Corporation and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017.][added: 2018.]

On a combined basis, these wholesalers accounted for [removed: 81%, 84% and] [added: 83%,] 81% [added: and 84%] of worldwide gross revenues for [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017,] [added: 2018,] respectively.

The following chart shows our product sales by principal [removed: product] [added: product,] and [added: the table below (dollar amounts in millions) shows product sales] by geography for the years [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017.][added: 2018.]

[removed: ][added: ]

We market Prolia® primarily in the United [removed: States] [added: States, Europe] and [removed: Europe.][added: the Asia Pacific region.]

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

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

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

We market [removed: cinacalcet as Sensipar®] [added: Otezla®, a small molecule that inhibits phosphodiesterase 4 (PDE4),] primarily in the United States and [removed: as Mimpara® primarily in] Europe.

We also market a number of other products in various markets worldwide, including Nplate® (romiplostim), Vectibix® (panitumumab), [removed: Repatha® (evolocumab),] [added: MVASI® (bevacizumab-awwb),] Parsabiv® (etelcalcetide), [added: EPOGEN® (epoetin alfa), KANJINTI® (trastuzumab-anns),] BLINCYTO® (blinatumomab), Aimovig® (erenumab-aooe), [removed: NEUPOGEN® (filgrastim), Otezla® (apremilast), AMGEVITATM (adalimumab), KANJINTITM (trastuzumab),] EVENITY® (romosozumab-aqqg), [added: AMGEVITATM (adalimumab), Sensipar®/Mimpara® (cinacalcet), NEUPOGEN® (filgrastim),] IMLYGIC® (talimogene laherparepvec), [removed: MVASITM (bevacizumab-awwb) and] Corlanor® [removed: (ivabradine).][added: (ivabradine) and AVSOLA® (infliximab-axxq).]

Otezla® is [removed: used primarily] [added: an oral therapy approved] for the treatment of [added: adult] patients with moderate-to-severe plaque psoriasis for whom phototherapy or systemic therapy is [removed: appropriate.][added: appropriate, patients with active psoriatic arthritis and patients with oral ulcers associated with Behçet’s disease.]

| Product | | [added: | | | |] Territory | | [added: | | | |] General subject matter | | [added: | | | |] Expiration | [added: | |]

| Enbrel® (etanercept) | | [added: | | | |] U.S. | | [added: | | | |] Methods of treatment using aqueous formulations | | [added: | | | |] 6/8/2023 | [added: | |]

| | [added: | |] U.S. | | [added: | | | |] Formulations | | [added: | | | |] 10/19/2037 | | [added: | | | |]

| | [added: | |] U.S. | | [added: | | | |] Fusion protein and pharmaceutical compositions | | [added: | | | |] 11/22/2028 | | [added: | | | |]

| | [added: | |] U.S. | | [added: | | | |] DNA encoding fusion protein and methods of making fusion protein | | [added: | | | |] 4/24/2029 | | [added: | | | |]

| Prolia®/XGEVA® (denosumab) | | [added: | | | |] U.S. | | [added: | | | |] RANKL antibodies | | [added: | | | |] 9/17/2021 | [added: | |]

| | [added: | |] U.S. | | [added: | | | |] Methods of treatment | | [added: | | | |] 6/25/2022 | | [added: | | | |]

| | [added: | |] U.S. | | [added: | | | |] Nucleic acids encoding RANKL antibodies and methods of producing RANKL antibodies | | [added: | | | |] 11/30/2023 | | [added: | | | |]

| | [added: | |] U.S. | | [added: | | | |] RANKL antibodies, including sequences | | [added: | | | |] 2/19/2025 | | [added: | | | |]

| | [added: | |] Europe | | [added: | | | |] RANKL antibodies, including epitope binding | | [added: | | | |] 2/23/2021 | | [added: | | | |]

| | [added: | |] Europe | | [added: | | | |] RANKL antibodies, including sequences(1) | | [added: | | | |] 6/25/2022 | | [added: | | | |]

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

*COVID-19 pandemic*

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

Since the first quarter of 2020 and continuing into 2021, we have seen some impact of the pandemic to our operations.

We continue to monitor and respond as the pandemic evolves to ensure the continued development, manufacture and distribution of our medicines.

For further discussion, see Item 7.

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

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

Also see the remainder of Item 1.

Business for discussion of pandemic-related impacts to our overall business.

- In August 2020, we announced that the U.S. Food and Drug Administration (FDA) had approved the expansion of the KYPROLIS® U.S. prescribing information to include its use in combination with DARZALEX® (daratumumab) plus dexamethasone in two dosing regimens—once weekly and twice weekly—for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.

- In September 2020, we announced updated phase 1 data evaluating sotorasib in 129 patients across multiple advanced solid tumors with Kirsten rat sarcoma viral oncogene homolog (*KRAS) G12C* mutation, which were published in the New England Journal of Medicine.

Data from 59 patients with advanced non-small cell lung cancer (NSCLC) were also featured in an oral presentation at a September 2020 medical conference.

In the patients with advanced NSCLC who were treated with the 960 mg daily dose, the confirmed objective response rate (ORR) was 35.3%.

Across all dose levels, the confirmed ORR was 32.2%, with median duration of response of 10.9 months and median progression-free survival (PFS) of 6.3 months; 10 of 19 responders were still in response as of the data cutoff.

- In October 2020, we announced top-line phase 2 results in 126 patients with *KRAS G12C*\-mutant advanced NSCLC.

Sotorasib demonstrated an ORR (primary endpoint) consistent with previously reported phase 1 data in patients taking the 960 mg daily dose.

Other measures of efficacy, including duration of response, were promising, and more than half of the responders were still on treatment and continuing to respond as of the data cutoff date.

The results of this phase 2 study are potentially registrational, and a phase 3 confirmatory study comparing sotorasib to docetaxel is currently recruiting patients with *KRAS G12C*\-mutant advanced NSCLC.

- In December 2020, we announced that the FDA had granted Breakthrough Therapy designation for our investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic NSCLC with *KRAS G12C* mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.

Following this announcement, we submitted a New Drug Application (NDA) to the FDA.

The sotorasib NDA is being reviewed by the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.

Later in December, we also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).

- In January 2021, we announced results from the phase 2 cohort of the clinical study evaluating sotorasib in 126 patients with *KRAS G12C*\-mutant advanced NSCLC.

Sotorasib demonstrated a confirmed ORR and disease control rate of 37.1% and 80.6%, respectively, a median duration of response of 10 months and median progression-free survival of 6.8 months.

In addition, sotorasib was granted Breakthrough Therapy designation by the Center for Drug Evaluation of the National Medical Products Administration in China.

*•*In December 2020, we announced that the FDA had approved RIABNITM, a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.

RIABNITM launched in the United States in January 2021.

- In May 2020, we announced positive top-line results from a phase 3 study to assess the efficacy of Otezla® in adults with mild-to-moderate plaque psoriasis.

The study showed that oral Otezla® 30 mg twice daily achieved a statistically significant improvement, compared with placebo, in the primary endpoint of the static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16.

- In November 2020, we and AstraZeneca plc (AstraZeneca) announced positive top-line results from the registrational phase 3 NAVIGATOR trial in adults and adolescents with severe uncontrolled asthma.

The trial met the primary endpoint with tezepelumab added to standard of care (SoC), demonstrating a statistically significant and clinically meaningful reduction compared with placebo plus SoC in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population.

SoC consisted of medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).

We expect to submit results of this study to regulators in 2021.

- In December 2020, we and AstraZeneca announced that the SOURCE trial had not met the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo.

The results of this trial have no impact on our submission plans.

- In November 2020, based on results of the omecamtiv mecarbil phase 3 trial, we provided notice to Cytokinetics, Incorporated (Cytokinetics) of termination of our collaboration and our intention to transition to them the development and commercialization rights for omecamtiv mecarbil and AMG 594.

*Establishment of wholly owned affiliate in Japan*

- In April 2020, we completed our purchase from Astellas of the remaining shares of Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas established in 2013.

AABP, now a wholly owned Amgen affiliate in Japan and renamed Amgen K.K., has enabled us to build a strong presence in Japan as we continue to advance treatments for serious illnesses.

The purchase did not have a material impact to our consolidated financial statements.

*KANJINTITM *(trastuzumab-anns)*

| | |

| --- | --- |

| • | In June 2019, the U.S. Food and Drug Administration (FDA) approved KANJINTITM for all approved indications of the reference product Herceptin® (trastuzumab) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In July 2019, we and Allergan plc (Allergan) launched KANJINTITM in the United States. |

| • | In January 2020, a supplemental New Drug Application (sNDA) was submitted to the FDA to expand the Prescribing Information to include KYPROLIS® in combination with dexamethasone and DARZALEX® for patients with relapsed or refractory multiple myeloma based on data from the phase 3 CANDOR study. |

| • | In January 2020, our Marketing Authorization Application (MAA) was accepted by the China National Medical Products Administration for the use of KYPROLIS® and dexamethasone for the treatment of relapsed or refractory multiple myeloma. |

*MVASITM *(bevacizumab-awwb)*

| • | In July 2019, we and Allergan launched MVASITM in the United States. |

* Registered in the United States.

| • | In October 2019, the FDA granted AMG 510 fast track designation for the treatment of patients with previously treated metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation. AMG 510 is a small molecule inhibitor of KRAS G12C. |

| • | In August 2019, we and Allergan announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan® in patients with CD20-positive B-cell non-Hodgkin’s lymphoma. The primary endpoint, an assessment of overall response rate by week 28, was within the prespecified margin for ABP 798 compared to Rituxan®, showing clinical equivalence. Safety and immunogenicity of ABP 798 were comparable to Rituxan®. |

| • | In December 2019, we and Allergan submitted a Biologics License Application (BLA) to the FDA for ABP 798. |

| • | In August 2019, the U.S. District Court for the District of Delaware overturned a unanimous jury verdict upholding the validity of two of our patents related to proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies in our infringement action against Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC and Regeneron Pharmaceuticals, Inc. See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements. |

*AVSOLATM* *(infliximab-axxq/formerly ABP 710)*

| • | In December 2019, the FDA approved AVSOLATM for all approved indications of the reference product REMICADE® (infliximab). |

| • | In November 2019, we completed our acquisition of the worldwide rights to Otezla®, the only oral, non-biologic treatment for psoriasis and psoriatic arthritis from Celgene Corporation (Celgene). Otezla®, along with certain related assets and liabilities, was acquired for $13.4 billion in cash. |

*Bone health*

| • | In April 2019, the FDA approved EVENITY® for the treatment of osteoporosis in postmenopausal women at high risk for fracture. |

| • | In December 2019, the European Commission (EC) granted marketing authorization for EVENITY*®* for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. |

*Neuroscience*

*AMG 520/CNP520*

| • | In July 2019, we and Novartis AG (Novartis) discontinued investigating AMG 520/CNP520, a small molecule inhibitor of beta-site amyloid precursor protein-cleaving enzyme-1 (BACE), for the prevention of Alzheimer’s disease. |

XGEVA® was launched in Europe in 2011 and is used primarily in the indication for the prevention of SREs in patients with bone metastases from solid tumors.

It was approved in January 2018 in the United States and in April 2018 in Europe for the prevention of SREs in patients with multiple myeloma.

In September 2019, the CANDOR phase 3 study of KYPROLIS® in combination with dexamethasone and DARZALEX® met its primary endpoint of PFS in patients with relapsed or refractory multiple myeloma.

FDA approval of KYPROLIS® in combination with dexamethasone and DARZALEX® is expected in 2020.

*EPOGEN®* *(epoetin alfa)*

We market EPOGEN® in the United States for dialysis patients.

EPOGEN® was launched in 1989, and we market it for the indication to treat anemia caused by CKD in patients on dialysis in order to lessen the need for red blood cell transfusions.

The majority of our sales are to a large dialysis provider.

*Sensipar®/Mimpara®* *(cinacalcet)*

It was launched in 2004 and is used primarily in the indication for the treatment of secondary hyperparathyroidism in adult patients with CKD who are on dialysis.

In November 2019, we began to market Otezla® upon the closing of our acquisition.

| | | | | | | |

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

| Sensipar®/Mimpara® (cinacalcet) | | U.S. | | Formulation | | 9/22/2026 |

| | Europe | | Calcium receptor-active molecules(1) | | 10/23/2015 | |

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

| Corlanor® (ivabradine) | | U.S. | | Crystalline forms | | 2/22/2026 |

| EVENITY® (romosozumab-aqqg) | | U.S. | | Antibodies(2) | | 4/25/2026 |

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

| | | | | | |

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

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| --- | --- |

[removed: Form 10-K][added: Form 10-K]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

For the fiscal year [removed: ended December] [added: ended December] 31, [removed: 2019][added: 2020]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

Commission file [removed: number 001-37702][added: number 001-37702]

| Delaware | | [added: | | | |] 95-3540776 | [added: | |]

| (State or other jurisdiction of incorporation or organization) | | [added: | | | |] (I.R.S. Employer Identification No.) | [added: | |]

| One Amgen Center Drive | | [added: | | | |] 91320-1799 | [added: | |]

| Thousand Oaks | | | [added: | | | | | |]

| California | | | [added: | | | | | |]

| (Address of principal executive offices) | | [added: | | | |] (Zip Code) | [added: | |]

[removed: (805) 447-1000][added: (805) 447-1000]

| Title of each class | [added: | |] Trading Symbol (s) | [added: | |] Name of each exchange on which registered | [added: | |]

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

| 1.250% Senior Notes Due 2022 | [added: | |] AMGN22 | [removed: New York] [added: | | The Nasdaq] Stock [removed: Exchange] [added: Market LLC] | [added: | |]

| 2.00% Senior Notes Due 2026 | [added: | |] AMGN26 | [removed: New York] [added: | | The Nasdaq] Stock [removed: Exchange] [added: Market LLC] | [added: | |]

| Large accelerated filer | [added: | |] Accelerated filer | [added: | |] Non-accelerated filer | [added: | |] Smaller reporting company | [added: | |] Emerging growth company | [added: | |]

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was [removed: $110,809,019,075] [added: $138,056,968,288] as of June 30, [removed: 2019.(A)][added: 2020.(A)]

[removed: | (A) | Excludes 744,928 shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, at June 30, 2019.] Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, directly or indirectly, to direct or cause the direction of the management or policies of the registrant, or that such person is controlled by or under common control with the registrant. [removed: |]

(Number of shares of common stock outstanding as of February [removed: 6, 2020)][added: 3, 2021)]

Specified portions of the registrant’s Proxy Statement with respect to the [removed: 2020] [added: 2021] Annual Meeting of Stockholders to be held May [removed: 19, 2020,] [added: 18, 2021,] are incorporated by reference into Part III of this annual report.

| | | [added: | | | |] Page No. | [added: | |]

| Item 1. | [removed: [BUSINESS](#s25AB16260E1C522C8E60D52C0A3BCC05)] | [removed: [1](#s25AB16260E1C522C8E60D52C0A3BCC05)] | [added: [BUSINESS](#if8d0740b43d148a5ba67e4dd5b38ce46_13) | | | [1](#if8d0740b43d148a5ba67e4dd5b38ce46_13) | | |]

| | [added: | |] [Significant [removed: Developments](#sAE2B50DB872C5E9F915082ABC816DAD9)] [added: Developments](#if8d0740b43d148a5ba67e4dd5b38ce46_16)] | [removed: [1](#sAE2B50DB872C5E9F915082ABC816DAD9)] | [added: | [1](#if8d0740b43d148a5ba67e4dd5b38ce46_16) | | |]

| | [added: | |] [Marketing, Distribution and Selected Marketed [removed: Products](#s9FB3CA38305D5558826268A9C2F83D07)] [added: Products](#if8d0740b43d148a5ba67e4dd5b38ce46_19)] | [removed: [3](#s9FB3CA38305D5558826268A9C2F83D07)] | [added: | [3](#if8d0740b43d148a5ba67e4dd5b38ce46_19) | | |]

| | [added: | |] [Manufacturing, Distribution and Raw [removed: Materials](#s1CD9C8BE9BB451BF9B6A129E21CBE2B4)] [added: Materials](#if8d0740b43d148a5ba67e4dd5b38ce46_25)] | [removed: [11](#s1CD9C8BE9BB451BF9B6A129E21CBE2B4)] | [added: | [12](#if8d0740b43d148a5ba67e4dd5b38ce46_25) | | |]

| | [added: | |] [Government [removed: Regulation](#s4A568FC51C7F5F6890A53175F7572C8D)] [added: Regulation](#if8d0740b43d148a5ba67e4dd5b38ce46_28)] | [removed: [12](#s4A568FC51C7F5F6890A53175F7572C8D)] | [added: | [13](#if8d0740b43d148a5ba67e4dd5b38ce46_28) | | |]

| | [added: | |] [Research and Development and Selected Product [removed: Candidates](#sC80DF5D862865BE19FB5E6E398F2B798)] [added: Candidates](#if8d0740b43d148a5ba67e4dd5b38ce46_31)] | [removed: [15](#sC80DF5D862865BE19FB5E6E398F2B798)] | [added: | [17](#if8d0740b43d148a5ba67e4dd5b38ce46_31) | | |]

| | [added: | |] [Business [removed: Relationships](#s05FCB1CB4ADC539A9A77C87AF8B96CBD)] [added: Relationships](#if8d0740b43d148a5ba67e4dd5b38ce46_34)] | [removed: [20](#s05FCB1CB4ADC539A9A77C87AF8B96CBD)] | [added: | [23](#if8d0740b43d148a5ba67e4dd5b38ce46_34) | | |]

| | [removed: [Human Resources](#s6BC2384B424256D592FA3451A21F6423)] | [removed: [21](#s6BC2384B424256D592FA3451A21F6423)] | [added: [Human](#if8d0740b43d148a5ba67e4dd5b38ce46_37) [Capital](#if8d0740b43d148a5ba67e4dd5b38ce46_37) [Resources](#if8d0740b43d148a5ba67e4dd5b38ce46_37) | | | [24](#if8d0740b43d148a5ba67e4dd5b38ce46_37) | | |]

| | [added: | |] [Information about our Executive [removed: Officers](#sA35BBB70E7395885905A5DD82E7D93ED)] [added: Officers](#if8d0740b43d148a5ba67e4dd5b38ce46_40)] | [removed: [21](#sA35BBB70E7395885905A5DD82E7D93ED)] | [added: | [26](#if8d0740b43d148a5ba67e4dd5b38ce46_40) | | |]

| | [added: | |] [Geographic Area Financial [removed: Information](#s1F678532AC5A53B8AF273B850D3A451B)] [added: Information](#if8d0740b43d148a5ba67e4dd5b38ce46_43)] | [removed: [22](#s1F678532AC5A53B8AF273B850D3A451B)] | [added: | [27](#if8d0740b43d148a5ba67e4dd5b38ce46_43) | | |]

| | [added: | |] [Investor [removed: Information](#s7F671A2951175B5B94CCA43DAA81368E)] [added: Information](#if8d0740b43d148a5ba67e4dd5b38ce46_46)] | [removed: [22](#s7F671A2951175B5B94CCA43DAA81368E)] | [added: | [27](#if8d0740b43d148a5ba67e4dd5b38ce46_46) | | |]

| Item 1A. | [added: | |] [RISK [removed: FACTORS](#sD1589E495E2B535BABD97D9493ADD593)] [added: FACTORS](#if8d0740b43d148a5ba67e4dd5b38ce46_2411)] | [removed: [22](#sD1589E495E2B535BABD97D9493ADD593)] | [added: | [27](#if8d0740b43d148a5ba67e4dd5b38ce46_2411) | | |]

| Item 1B. | [added: | |] [UNRESOLVED STAFF [removed: COMMENTS](#sE5B5F678D84A5BD6A015A0DC8962B0DB)] [added: COMMENTS](#if8d0740b43d148a5ba67e4dd5b38ce46_52)] | [removed: [40](#sE5B5F678D84A5BD6A015A0DC8962B0DB)] | [added: | [54](#if8d0740b43d148a5ba67e4dd5b38ce46_52) | | |]

| Item 2. | [removed: [PROPERTIES](#s29B786DBF6B55A148E6DB3BFFB408238)] | [removed: [41](#s29B786DBF6B55A148E6DB3BFFB408238)] | [added: [PROPERTIES](#if8d0740b43d148a5ba67e4dd5b38ce46_55) | | | [55](#if8d0740b43d148a5ba67e4dd5b38ce46_55) | | |]

| Item 3. | [added: | |] [LEGAL [removed: PROCEEDINGS](#s447E676735105106B07A54B061EF5791)] [added: PROCEEDINGS](#if8d0740b43d148a5ba67e4dd5b38ce46_58)] | [removed: [41](#s447E676735105106B07A54B061EF5791)] | [added: | [55](#if8d0740b43d148a5ba67e4dd5b38ce46_58) | | |]

| Item 4. | [added: | |] [MINE SAFETY [removed: DISCLOSURES](#s5EE0488AF2E45E65AFF0D6AC7C549F46)] [added: DISCLOSURES](#if8d0740b43d148a5ba67e4dd5b38ce46_61)] | [removed: [41](#s5EE0488AF2E45E65AFF0D6AC7C549F46)] | [added: | [55](#if8d0740b43d148a5ba67e4dd5b38ce46_61) | | |]

| Item 5. | [added: | |] [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#s6C2F9F236DCA5AC588D7A05C4F7CB489)] [added: SECURITIES](#if8d0740b43d148a5ba67e4dd5b38ce46_67)] | [removed: [42](#s6C2F9F236DCA5AC588D7A05C4F7CB489)] | [added: | [56](#if8d0740b43d148a5ba67e4dd5b38ce46_67) | | |]

| Item 6. | [added: | |] [SELECTED FINANCIAL [removed: DATA](#s807CC16E08775B1E95D0FC81A69BCEF3)] [added: DATA](#if8d0740b43d148a5ba67e4dd5b38ce46_70)] | [removed: [44](#s807CC16E08775B1E95D0FC81A69BCEF3)] | [added: | [58](#if8d0740b43d148a5ba67e4dd5b38ce46_70) | | |]

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| ☒ | | | ☐ | | | ☐ | | | ☐ | | | ☐ | | |

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

(A)Excludes 1,045,777 shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, at June 30, 2020.

577,566,383

| | | | | | | | | |

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

| [PART I](#if8d0740b43d148a5ba67e4dd5b38ce46_10) | | | | | | [1](#if8d0740b43d148a5ba67e4dd5b38ce46_10) | | |

| | | | [Reimbursement](#if8d0740b43d148a5ba67e4dd5b38ce46_22) | | | [10](#if8d0740b43d148a5ba67e4dd5b38ce46_22) | | |

| [PART II](#if8d0740b43d148a5ba67e4dd5b38ce46_64) | | | | | | [56](#if8d0740b43d148a5ba67e4dd5b38ce46_64) | | |

| [PART III](#if8d0740b43d148a5ba67e4dd5b38ce46_130) | | | | | | [83](#if8d0740b43d148a5ba67e4dd5b38ce46_130) | | |

| [PART IV](#if8d0740b43d148a5ba67e4dd5b38ce46_157) | | | | | | [86](#if8d0740b43d148a5ba67e4dd5b38ce46_157) | | |

| [SIGNATURES](#if8d0740b43d148a5ba67e4dd5b38ce46_166) | | | | | | [93](#if8d0740b43d148a5ba67e4dd5b38ce46_166) | | |

| | | | | | |

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

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| --- | --- |

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

| | | | | |

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

| ☒ | ☐ | ☐ | ☐ | ☐ |

589,806,819

| [PART I](#s2B7FA64979DA5DFCA7AC7A85BB200D48) | | [1](#sBCC298E95FF157CDB67F4880E7EF69C2) |

| | [Reimbursement](#s72E136555C8158899342FB8D9E2EB01E) | [10](#s72E136555C8158899342FB8D9E2EB01E) |

| [PART II](#s458AC28661DE5B51A2CBBD813109EC06) | | [42](#sD3B8741D0CF05C269990D1F98AD05DB7) |

| [PART III](#sFD1955216BF65A83923708C012C4197F) | | [67](#sAB80FE86D3A55A13B61FAAD8D8CE5E87) |

| [PART IV](#s0FC1470624F354C4B9654E6F7113163F) | | [70](#s24C1BFD2212752B2AC0B269471A88C0E) |

| [SIGNATURES](#s924CD68A43665ECC89C287435477A3C0) | | [76](#s924CD68A43665ECC89C287435477A3C0) |

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As of December 31, [removed: 2019,] [added: 2020,] we owned or leased approximately [removed: 190] [added: 180] properties.

Excluded from the information above are (i) undeveloped land and leased properties that have been abandoned and (ii) certain buildings [removed: that] we still own but [added: that] are no longer used in our business.

We believe [removed: that] our facilities are suitable for their intended uses and, in conjunction with our third-party [removed: contracting] [added: contract] manufacturing agreements, provide adequate capacity and are sufficient to meet our expected needs.

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| U.S. Location: | | | Manufacturing | | | Administrative | | | R&D | | | Sales & marketing | | | Warehouse | | | Distribution center | | |

| Thousand Oaks, CA* | | | P | | | P | | | P | | | P | | | P | | | P | | |

| San Francisco, CA | | | | | | | | | P | | | | | | | | | | | |

| Louisville, KY | | | | | | | | | | | | | | | P | | | P | | |

| Cambridge, MA | | | | | | | | | P | | | | | | | | | | | |

| Woburn, MA | | | P | | | | | | | | | | | | P | | | | | |

| Juncos, Puerto Rico | | | P | | | P | | | | | | | | | P | | | P | | |

| West Greenwich, RI | | | P | | | P | | | | | | | | | P | | | | | |

| Tampa, FL | | | | | | P | | | | | | | | | | | | | | |

| Other U.S. cities | | | | | | P | | | | | | P | | | | | | | | |

* Corporate headquarters

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| Ex-U.S. Location: | | | Manufacturing | | | Administrative | | | R&D | | | Sales & marketing | | | Warehouse | | | Distribution center | | |

| Brazil | | | P | | | P | | | | | | P | | | P | | | P | | |

| Canada | | | | | | P | | | P | | | P | | | | | | | | |

| China | | | | | | P | | | | | | P | | | | | | | | |

| Germany | | | | | | P | | | P | | | P | | | | | | | | |

| Iceland | | | | | | P | | | P | | | | | | | | | | | |

| Ireland | | | P | | | P | | | | | | P | | | P | | | | | |

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

| Netherlands | | | P | | | P | | | | | | P | | | P | | | P | | |

| Singapore | | | P | | | P | | | | | | P | | | P | | | | | |

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

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

| United Kingdom | | | | | | P | | | P | | | P | | | | | | | | |

| Other countries | | | | | | P | | | P | | | P | | | P | | | | | |

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As of February [removed: 6, 2020,] [added: 3, 2021,] there were approximately [removed: 5,493] [added: 5,336] holders of record of our common stock.

The following graph shows the value of an investment of $100 on December 31, [removed: 2014,] [added: 2015,] in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index (S&P 500).

[removed: ][added: ]

| | [removed: 12/31/2014] | | 12/31/2015 | | [added: | | | |] 12/31/2016 | | [added: | | | |] 12/31/2017 | | [added: | | | |] 12/31/2018 | | [added: | | | |] 12/31/2019 | [added: | | | | | 12/31/2020 | | |]

During the three months and year ended December 31, [removed: 2019,] [added: 2020,] we had one outstanding stock repurchase program, under which the repurchasing activity was as follows:

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

[removed: | (1) | Average] [added: (1)Average] price paid per share includes related expenses. [removed: |]

[removed: | (2) | In May 2019 and] [added: (2)In] December 2019, our Board of Directors increased the amount authorized under [removed: our] [added: the] stock repurchase program by an additional [removed: $5.0 billion and] $4.0 [removed: billion, respectively. |][added: billion.]

For the years ended December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] we paid quarterly dividends.

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| Amgen (AMGN) | | | $100.00 | | | | | | $92.45 | | | | | | $113.08 | | | | | | $130.14 | | | | | | $166.09 | | | | | | $162.76 | | |

| Amex Biotech (BTK) | | | $100.00 | | | | | | $80.85 | | | | | | $111.42 | | | | | | $111.72 | | | | | | $134.54 | | | | | | $152.81 | | |

| Amex Pharmaceutical (DRG) | | | $100.00 | | | | | | $91.66 | | | | | | $106.90 | | | | | | $114.86 | | | | | | $135.96 | | | | | | $147.86 | | |

| S&P 500 (SPX) | | | $100.00 | | | | | | $111.95 | | | | | | $136.46 | | | | | | $130.50 | | | | | | $171.57 | | | | | | $203.12 | | |

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| October 1 - October 31 | | | | | | 1,774,922 | | | | | | $ | 235.06 | | | | | 1,774,922 | | | | | | $ | 3,781,230,811 | |

| November 1 - November 30 | | | | | | 1,660,605 | | | | | | $ | 229.16 | | | | | 1,660,605 | | | | | | $ | 3,400,688,112 | |

| December 1 - December 31 | | | | | | 1,868,786 | | | | | | $ | 226.94 | | | | | 1,868,786 | | | | | | $ | 2,976,579,948 | |

| | | | | | | 5,304,313 | | | | | | $ | 230.35 | | | | | 5,304,313 | | | | | | | | |

| January 1 - December 31 | | | | | | 15,190,194 | | | | | | $ | 230.24 | | | | | 15,190,194 | | | | | | | | |

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| Amgen (AMGN) | $100.00 | | $103.97 | | $96.12 | | $117.57 | | $135.31 | | $172.68 |

| Amex Biotech (BTK) | $100.00 | | $111.39 | | $90.06 | | $124.11 | | $124.44 | | $149.87 |

| Amex Pharmaceutical (DRG) | $100.00 | | $104.18 | | $95.49 | | $111.37 | | $119.66 | | $141.66 |

| S&P 500 (SPX) | $100.00 | | $101.37 | | $113.49 | | $138.33 | | $132.29 | | $173.93 |

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| October 1 - October 31 | | 2,500,729 | | | $ | 199.94 | | | 2,500,729 | | | $ | 3,064,464,667 | |

| November 1 - November 30 | | 1,349,900 | | | $ | 222.55 | | | 1,349,900 | | | $ | 2,764,044,387 | |

| December 1 - December 31 | | 1,218,800 | | | $ | 237.95 | | | 1,218,800 | | | $ | 6,474,033,251 | |

| | | 5,069,429 | | | $ | 215.10 | | | 5,069,429 | | | | | |

| January 1 - December 31 | | 40,244,414 | | | $ | 189.85 | | | 40,244,414 | | | | | |

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| | [added: | |] Years ended December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Consolidated Statements of Income Data: | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| | [added: | |] (In millions, except per-share data) | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Revenues: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Product sales | [added: | |] $ | [removed: 22,204] [added: 24,240] | | | [added: | |] $ | [removed: 22,533] [added: 22,204] | | | [added: | |] $ | [removed: 21,795] [added: 22,533] | | | [added: | |] $ | [removed: 21,892] [added: 21,795] | | | [added: | |] $ | [removed: 20,944] [added: 21,892] | |

| Other revenues | [added: | | 1,184 | | | | | |] 1,158 | | | | [added: | |] 1,214 | | | | [removed: 1,054] | | [added: 1,054] | | [removed: 1,099] | | | | [removed: 718] [added: 1,099] | | |

| Total revenues | [added: | |] $ | [removed: 23,362] [added: 25,424] | | | [added: | |] $ | [removed: 23,747] [added: 23,362] | | | [added: | |] $ | [removed: 22,849] [added: 23,747] | | | [added: | |] $ | [removed: 22,991] [added: 22,849] | | | [added: | |] $ | [removed: 21,662] [added: 22,991] | |

| Operating expenses: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Cost of sales | [added: | |] $ | [removed: 4,356] [added: 6,159] | | | [added: | |] $ | [removed: 4,101] [added: 4,356] | | | [added: | |] $ | [removed: 4,069] [added: 4,101] | | | [added: | |] $ | [removed: 4,162] [added: 4,069] | | | [added: | |] $ | [removed: 4,227] [added: 4,162] | |

| Research and development | [added: | |] $ | [removed: 4,116] [added: 4,207] | | | [added: | |] $ | [removed: 3,737] [added: 4,116] | | | [added: | |] $ | [removed: 3,562] [added: 3,737] | | | [added: | |] $ | [removed: 3,840] [added: 3,562] | | | [added: | |] $ | [removed: 4,070] [added: 3,840] | |

| Selling, general and administrative | [added: | |] $ | [removed: 5,150] [added: 5,730] | | | [added: | |] $ | [removed: 5,332] [added: 5,150] | | | [added: | |] $ | [removed: 4,870] [added: 5,332] | | | [added: | |] $ | [removed: 5,062] [added: 4,870] | | | [added: | |] $ | [removed: 4,846] [added: 5,062] | |

| Net income(1) | [added: | |] $ | [removed: 7,842] [added: 7,264] | | | [added: | |] $ | [removed: 8,394] [added: 7,842] | | | [added: | |] $ | [removed: 1,979] [added: 8,394] | | | [added: | |] $ | [removed: 7,722] [added: 1,979] | | | [added: | |] $ | [removed: 6,939] [added: 7,722] | |

| Diluted earnings per share(1) | [added: | |] $ | [removed: 12.88] [added: 12.31] | | | [added: | |] $ | [removed: 12.62] [added: 12.88] | | | [added: | |] $ | [removed: 2.69] [added: 12.62] | | | [added: | |] $ | [removed: 10.24] [added: 2.69] | | | [added: | |] $ | [removed: 9.06] [added: 10.24] | |

| Dividends paid per share | [added: | |] $ | [removed: 5.80] [added: 6.40] | | | [added: | |] $ | [removed: 5.28] [added: 5.80] | | | [added: | |] $ | [removed: 4.60] [added: 5.28] | | | [added: | |] $ | [removed: 4.00] [added: 4.60] | | | [added: | |] $ | [removed: 3.16] [added: 4.00] | |

| | [added: | |] As of December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Consolidated Balance Sheets Data: | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| | [added: | |] (In millions) | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Total assets | [added: | |] $ | [removed: 59,707] [added: 62,948] | | | [added: | |] $ | [removed: 66,416] [added: 59,707] | | | [added: | |] $ | [removed: 79,954] [added: 66,416] | | | [added: | |] $ | [removed: 77,626] [added: 79,954] | | | [added: | |] $ | [removed: 71,449] [added: 77,626] | |

| Total debt(2) | [added: | |] $ | [removed: 29,903] [added: 32,986] | | | [added: | |] $ | [removed: 33,929] [added: 29,903] | | | [added: | |] $ | [removed: 35,342] [added: 33,929] | | | [added: | |] $ | [removed: 34,596] [added: 35,342] | | | [added: | |] $ | [removed: 31,429] [added: 34,596] | |

| Total stockholders’ equity(3) | [added: | |] $ | [removed: 9,673] [added: 9,409] | | | [added: | |] $ | [removed: 12,500] [added: 9,673] | | | [added: | |] $ | [removed: 25,241] [added: 12,500] | | | [added: | |] $ | [removed: 29,875] [added: 25,241] | | | [added: | |] $ | [removed: 28,083] [added: 29,875] | |

In addition to the [removed: following] [added: above] notes, see Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations, Part IV—Consolidated Financial Statements and accompanying notes [removed: and] [added: as well as] previously filed Annual Reports on Form 10-K for further information regarding our consolidated results of operations and financial position for periods reported therein and for known factors that will affect the comparability of future results.

Also see Part IV—Note 16, Stockholders’ equity, to the Consolidated Financial Statements, for information regarding cash dividends declared per share of common stock for each of the four quarters of [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017.][added: 2018.]

In addition, our Board of Directors declared dividends per share of [removed: $1.00] [added: $1.15] and [removed: $0.79 that] [added: $1.00, which] were paid in each of the four quarters of [removed: 2016] [added: 2017] and [removed: 2015,] [added: 2016,] respectively.

[removed: |] (1) [removed: |] In 2017, we recorded a net charge of $6.1 billion as a result of the 2017 Tax Act. [removed: See Part IV—Note 6, Income taxes, to the Consolidated Financial Statements. |]

[removed: |] (2) [removed: |] See Part IV—Note 15, Financing arrangements, to the Consolidated Financial Statements, for discussion of our financing [removed: arrangements. In 2016, we issued $7.3 billion of debt and repaid $3.7 billion of debt. In 2015, we issued $3.5 billion of debt] [added: arrangements in 2020, 2019] and [removed: repaid $2.4 billion of debt. |][added: 2018.]

[removed: |] (3) [removed: |] Throughout the five years ended December 31, [removed: 2019,] [added: 2020,] we had a stock repurchase program authorized by the Board of Directors, through which we repurchased [added: $3.5 billion,] $7.6 billion, $17.9 billion, $3.1 [removed: billion, $3.0] billion and [removed: $1.9] [added: $3.0] billion, respectively, of Amgen common stock. [removed: |]

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In 2017, we issued $4.5 billion of debt and repaid $4.4 billion of debt.

In 2016, we issued $7.3 billion of debt and repaid $3.7 billion of debt.

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We maintain “disclosure controls and procedures,” as such term is defined under the Securities Exchange Act Rule 13a-15(e), that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and [removed: forms,] [added: 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.

In designing and evaluating the disclosure controls and procedures, Amgen’s management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control [removed: objectives] [added: objectives,] and in reaching a reasonable level of [removed: assurance] [added: assurance,] Amgen’s management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.