Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our strategy is to develop innovative medicines in six focused therapeutic areas that meet important unmet medical needs in addressing serious illness. We have a presence in approximately 100 countries worldwide with a primary focus in: oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience.

Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987. Amgen operates in one business segment: human therapeutics.

Significant Developments

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, 2016, and in early 2018.

Products/Pipeline

Bone health

Prolia ^® (denosumab)

XGEVA ^® (denosumab)

EVENITY ^™ (romosozumab)*

woMen with ostEoporosis) study. We are currently evaluating all EVENITY ^™ data and will be working in close collaboration with the FDA.

Cardiovascular

Repatha ^® (evolocumab)

Neuroscience

Aimovig ^™ (erenumab)*

Oncology/Hematology

Aranesp ^® (darbepoetin alfa)

BLINCYTO ^® (blinatumomab)

KYPROLIS ^® (carfilzomib)

Vectibix ^® (panitumumab)

Nephrology

Sensipar ^® /Mimpara ^® (cinacalcet)

Biosimilars

AMJEVITA ^™ (adalimumab-atto) / AMGEVITA ^™ (biosimilar adalimumab)

ABP 980

MVASI ^™ (bevacizumab-awwb)

Next-generation biomanufacturing

2017 U.S. Tax Reform

Offer to Purchase Common Stock

* FDA provisionally approved trade name

Marketing, Distribution and Selected Marketed Products

The largest concentration of our sales and marketing forces is based in the United States and Europe. Additionally, we continue to expand the commercialization and marketing of our products into other geographic territories, including parts of Latin America, the Middle East and Asia. This expansion is occurring by establishing our own affiliates, by acquiring existing third-party businesses or product rights or by partnering with third parties. Whether we use our own sales and marketing forces or a third-party’s varies across these markets. Such use typically depends on several factors, including the nature of entry into the new market, the size of an opportunity and operational capabilities. Together with our partners, we market our products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies.

In the United States, we sell primarily to pharmaceutical wholesale distributors that are the principal means of distributing our products to healthcare providers. We also market certain products directly to consumers through several direct-to-consumer channels, including print, television and online media, as well as through multi-channel marketing. For further discussion, see

Government Regulation—Regulation of Product Marketing and Promotion. Outside the United States, we sell principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country.

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 ended December 31, 2017, 2016 and 2015. On a combined basis, these wholesalers accounted for 96% , 96% and 97% of our U.S. gross product sales, for each of the years ended December 31, 2017, 2016 and 2015, respectively, and 81% of worldwide gross revenues for each of these years. We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits and, in certain circumstances, by requiring letters of credit or obtaining credit insurance.

For financial information related to our one business segment, see Part IV—Consolidated Statements of Income, Consolidated Balance Sheets, and Note 19, Segment information, to the Consolidated Financial Statements.

Our products are marketed around the world with the United States being our largest market. The following chart shows our product sales by principal product and by geography for the years ended 2017, 2016 and 2015.

Enbrel ^® (etanercept)

We market ENBREL primarily in the United States. It was launched in 1998 and is used primarily in indications for the treatment of adult patients with the following conditions:

Neulasta ^® (pegfilgrastim)

We market Neulasta ^® , a pegylated protein based on the filgrastim molecule, primarily in the United States and Europe. Neulasta ^® was launched in 2002, and is used primarily in the indication to help reduce the chance of infection due to a low white blood cell count, in patients with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count. In 2015, the Neulasta ^® Onpro ^® kit became available in the United States. The Neulasta ^® Onpro ^® kit provides patients the opportunity to administer the recommended dose of Neulasta ^® at home the day after chemotherapy, saving a trip back to the doctor.

Aranesp ^® (darbepoetin alfa)

We market Aranesp ^® primarily in Europe and the United States. 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) (in both patients on dialysis and patients not on dialysis). Aranesp ^® is also indicated for the treatment of anemia due to concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies, and when chemotherapy will be used for at least two months after starting Aranesp ^® .

Aranesp ^® and EPOGEN ^® compete with each other in the United States, primarily in the dialysis setting.

Prolia ^® (denosumab)

We market Prolia ^® primarily in the United States and Europe. Prolia ^® contains the same active ingredient as XGEVA ^® but is approved for different indications, patient populations, doses and frequencies of administration. Prolia ^® was launched in the United States and Europe in 2010. In the United States, it is used primarily in the indication for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In Europe, Prolia ^® is used primarily for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Sensipar ^® /Mimpara ^® (cinacalcet)

We market cinacalcet as Sensipar ^® primarily in the United States and as Mimpara ^® primarily in Europe. It was launched in 2004 and is used primarily in the indication for the treatment of sHPT in adult patients with CKD who are on dialysis.

XGEVA ^® (denosumab)

We market XGEVA ^® primarily in the United States and Europe. XGEVA ^® was launched in the United States in 2010, and is used primarily in the indication for the prevention of SREs (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with bone metastases from solid tumors, including multiple myeloma. 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, and was recently approved for the prevention of SREs in patients with multiple myeloma.

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 to lessen the need for red blood cell transfusions. The majority of our sales are to a large dialysis provider.

Other Marketed Products

We also market a number of other products, including KYPROLIS ^® (carfilzomib), Vectibix ^® (panitumumab), Nplate ^® (romiplostim), NEUPOGEN ^® (filgrastim), Repatha ^® (evolocumab), BLINCYTO ^® (blinatumomab), IMLYGIC ^® (talimogene laherparepvec), Corlanor ^® (ivabradine) and Parsabiv ^™ (etelcalcetide).

• denosumab — France, Italy, Spain and the United Kingdom, expiring in 2025

• cinacalcet — France, Germany, Spain and the United Kingdom, expiring in 2019; and Italy, expiring in 2020

• carfilzomib — France, Germany, Italy and Spain, expiring in 2030

• panitumumab — France, Germany, Italy, Spain and the United Kingdom, expiring in 2022

• romiplostim — France, Germany, Italy, Spain and the United Kingdom, expiring in 2024

• blinatumomab — France, Italy and Spain, expiring in 2029

• talimogene laherparepvec — Italy, expiring in 2026

Competition

We operate in a highly competitive environment. A number of our marketed products are indicated in disease areas where other products or treatments are currently available or are being pursued by our competitors through research and development (R&D) activities. We continue to pursue ways to increase the value of our medicines through innovations during their lifecycles. This can include expanding the disease areas for which our products are indicated and finding new methods to make the delivery of our medicines easier and less costly. Such activities can offer important opportunities for differentiation. For example, in 2015, we launched the Neulasta ^® Onpro ^® kit, which provides patients the opportunity to administer the recommended dose of Neulasta ^® at home the day after chemotherapy, thereby saving a trip back to the doctor. We also developed the AutoTouch ^™ reusable auto-injector to be used with Enbrel Mini ^™ single-dose prefilled cartridges (50 mg/mL), which was approved by the FDA in September 2017. The Enbrel Mini ^™ utilizes a new drug formulation of ENBREL that was associated with substantially significant lower mean injection site pain than the current formulation. We plan to continue pursuing such innovation efforts to strengthen our competitive position. Such position may be based on, among other things, safety, efficacy, reliability, availability, patient convenience/delivery devices, price, reimbursement, access to and timing of market entry and patent position and expiration.

Certain of the existing patents on our principal products have expired, and we face new and increasing competition, including from biosimilars and generics. We may also compete against biosimilar or generic versions of our competitors’ products. A biosimilar is another version of a biological product for which marketing approval is sought or has been obtained based on a demonstration that it is “highly similar” to the original reference product. See Government Regulation. We expect that the adverse impact from biosimilars will be more like branded biologic competition than that seen when branded small molecules face generics. Although we expect biosimilars to compete on price, we believe many patients, providers and payers will continue to place high value on the reputation, reliability and safety of our products. Zarxio ^® , a biosimilar version of NEUPOGEN ^® from Sandoz, a Novartis company (Sandoz), which launched in the United States in 2015, was the first biosimilar entrant into the U.S. market. Companies have pending applications with the FDA for biosimilar versions of EPOGEN ^® and Neulasta ^® , along with additional biosimilar versions of NEUPOGEN ^® . See also Government Regulation—Regulation in the United States—Approval of Biosimilars. As biosimilar competitors come to market, we will leverage both the experience we have had in the United States versus branded competition, and our experience in competing against epoetin alfa and filgrastim biosimilars in Europe.

The introduction of new products, the development of new processes or technologies by competitors or the emergence of new information about existing products may result in increased competition for our marketed products, even for those protected by patents, or in reductions in the prices we receive from selling our products. In addition, the development of new treatment options or standards of care may reduce the use of our products or may limit the utility and application of ongoing clinical trials for our product candidates. (As used in this document, the term clinical trials may include prospective clinical trials, observational studies, registries and other studies.) See Item 1A. Risk Factors— Our products face substantial competition and Item 1A. Risk Factors— We currently face competition from biosimilars and expect to face increasing competition from biosimilars and generics in the future .

The following table reflects our significant competitors and is not exhaustive.

* Approved biosimilars available.

Reimbursement

Sales of our principal products are dependent on the availability and extent of coverage and reimbursement from third-party payers. In many markets around the world, these payers, including government health systems, private health insurers and other organizations, remain intensely focused on reducing the cost of healthcare. Their efforts have intensified as a result of rising healthcare costs and economic challenges. Drugs, and in particular specialty drugs such as our products, remain heavily scrutinized for cost containment. As a result, payers are being more restrictive regarding the use of biopharmaceutical products, while requiring a higher level of clinical evidence to support the benefit such products bring to patients and the broader healthcare system.

In the United States, biopharmaceutical product pricing remains central to discussions on controlling healthcare costs. The pricing practices of certain companies have increased public media and government scrutiny of the biopharmaceutical industry,

providing greater incentive for governments and private payers to limit or regulate the prices of drug products and services. Policymakers from both major U.S. political parties, including key members of the presidential administration, have indicated their support for pursuing policies to lower drug costs for patients. At the same time, value assessments of new technologies, previously used predominantly outside the United States, are having an impact in the U.S. healthcare environment. Healthcare provider organizations and independent organizations are creating their own value assessments of biopharmaceutical drugs for comparison with manufacturer pricing. Although these organizations do not set drug prices, they seek to influence pricing as well as payer and provider decision making by publicly disclosing their assessments, often making assertions around what they believe to be the appropriate price to charge for a product. In addition, continued consolidation of payers and integration of providers and payers (integrated delivery systems) increase the level of market power held by our customers. These developments put greater pressure on access to, pricing of and sales of our products.

In the United States, healthcare providers are reimbursed for covered services and products they deliver through Medicare, Medicaid and other government healthcare programs, as well as through private payers. Pharmacies are also reimbursed in a similar manner for drug products they dispense. We are required to provide rebates or discounts on our products that are reimbursed through certain government programs, including Medicare and Medicaid, and also provide discounts to qualifying health care providers under the Federal 340B Drug Pricing Program. These rebates and/or discounts levels, as well as entities who are entitled to receive them, have increased over time. For example, the Patient Protection and Affordable Care Act (ACA), enacted in 2010, increased many of the mandatory discounts and rebates required of us. The ACA also imposed a new Branded Prescription Pharmaceutical Manufacturers and Importers fee payable each year by us and other manufacturers. The U.S. presidential administration has identified repealing and replacing the ACA as a priority. In the tax reform bill signed by President Trump in December 2017, Congress removed a key ACA provision by repealing the individual mandate penalty which required each individual to have health insurance or pay a penalty. Future changes to government programs such as the ACA, whether legislative or regulatory, could impact the number of patient lives covered, could raise or lower the cost of quality insurance, could affect Medicaid eligibility and could change levels of patient protections provided unless alternatives are put in place.

Additional efforts by state legislatures and government agencies in the United States could also affect us and our industry. For example, a recently enacted California law requires manufacturers to provide payers advance notice of a price increase over a specified threshold, and a Vermont law requires manufacturers to submit price increase justifications to the state attorney general if certain price increase and state-spending thresholds are met. Examples of other proposals that have been discussed and debated, but not yet enacted, include state ballot initiatives that would place a maximum price ceiling, or cap, on pharmaceutical products purchased by state agencies and state legislative efforts to cap pharmaceutical prices for commercial payers. Other government legislative and regulatory actions that would have a significant impact on Amgen include: changes to how the Medicare program covers and reimburses current and future drugs, including for patients with End-Stage Renal Disease; changes in the Federal payment rate or new rebate requirements for covered drugs and policies for drug payment in Medicare or Medicaid; and changes to coverage and payment for biosimilars, such as policies that would enable easier substitution for, or provide reimbursement advantages over, the corresponding innovative products. Centers for Medicare & Medicaid Services (CMS) has indicated interest in testing new models for drug payment in Medicare Part B and Part D. CMS also continues to test alternative payment models with providers, such as the Oncology Care Model. These models provide financial incentives to providers who participate under which providers take on greater risk for the overall cost and quality of care. In addition, CMS recently finalized changes to Medicare payment to hospitals for Part B drugs acquired through the Federal 340B Drug Pricing Program but provide financial incentive for hospitals to use biosimilar products over the corresponding innovative products. CMS is also proposing changes to Medicare Part D and Medicare Advantage. These and/or other changes have the potential to impact prescribing and patient access to Amgen’s therapies.

In the U.S. private sector, payers continue to institute cost reduction and containment measures that lower drug utilization and/or spending altogether and/or shift a greater portion of the costs to patients. Such measures include more limited benefit plan designs, higher patient co-pays or coinsurance obligations, limitations on patients’ use of commercial manufacturer co-pay payment assistance programs (including through co-pay accumulator adjustment or maximization programs), higher-tier formulary placement that increases the level of patient out-of-pocket costs and/or stricter utilization management criteria before a patient may get access to a drug. In the specialty pharmacy sector, in which the majority of our sales for ENBREL and Repatha ^® occur, the use of such measures by Pharmacy Benefit Managers (PBMs) and insurers has continued to intensify which have limited Amgen product usage and sales. PBMs are third-party organizations tasked with administrating prescription drug programs for large employers, health plans and government programs. Consolidation has resulted in a smaller number of PBMs and insurers overseeing a large portion of total covered lives in the United States. As a result, PBMs and insurers have greater market power and negotiating leverage to exclude drugs from their formularies in favor of competitor drugs or alternative treatments, and/or to mandate stricter utilization criteria. Formulary exclusion effectively encourages patients and providers to seek alternative treatments or pay 100% of the cost of a drug. Our experience with Repatha ^® underscores that utilization management requirements, including the burdensome administrative processes required of physicians to demonstrate and document that patients meet such requirements, continue to be a significant challenge for patients and physicians, limiting access for appropriate usage. Even when access is available, some patients abandon their prescriptions due to economic reasons. In highly competitive treatment markets such as

with ENBREL and Repatha ^® , PBMs are also able to exert negotiating leverage by requiring incremental rebates from manufacturers in order to maintain their formulary position. A drug’s inclusion and favorable positioning on formulary is essential to ensure patients have access.

In many countries outside the United States, government-sponsored healthcare systems are the primary payers for drugs and biologics. With increasing budgetary constraints, payers in many countries are applying a variety of measures to exert downward price pressure. These measures can include mandatory price controls, price referencing, therapeutic reference pricing, increases in mandates or incentives for generic substitution and biosimilar usage, and government-mandated price cuts. In this regard, many countries have Health Technology Assessment (HTA) organizations that use formal economic metrics such as cost-effectiveness to determine prices, coverage and reimbursement of new therapies, and these organizations are expanding in established and emerging markets. We expect that countries will continue to take aggressive actions to seek to reduce expenditures on drugs and biologics. Similarly, fiscal constraints may also impact the extent to which countries are willing to approve new and innovative therapies and/or allow access to new technologies.

The dynamics and developments discussed above serve to create pressure on the pricing and potential usage of our products, and the industry as a whole. We remain focused on delivering breakthrough treatments for unmet medical needs. Amgen is committed to working with the entire healthcare community to ensure continued innovation and to enable patient access to needed medicines. We do this by:

See Item 1A. Risk Factors— Our sales depend on coverage and reimbursement from third-party payers, and pricing and reimbursement pressures may affect our profitability and Item 1A. Risk Factors— Guidelines and recommendations published by various organizations can reduce the use of our products.

Manufacturing, Distribution and Raw Materials

Manufacturing

We believe we are a leader in the manufacturing of biologics and that our manufacturing capabilities represent a competitive advantage. The products we manufacture consist of both biologics and small molecule drugs. The majority of our products are biologics that are produced in living cells and that are inherently complex due to naturally-occurring molecular variations. Highly specialized knowledge and extensive process and product characterization are required to transform laboratory-scale processes into reproducible commercial manufacturing processes. Further, our expertise in manufacturing of biologics positions us well for leadership in the global biosimilars market. For additional information regarding manufacturing facilities, see Item 2. Properties.

Our internal manufacturing network has the commercial production capabilities of bulk manufacturing, formulation, fill, finish and device assembly. These activities are performed within the United States and its territories in our Puerto Rico, Rhode Island and California facilities, as well as internationally in our Ireland, Netherlands and Singapore facilities. In addition, we utilize third-party contract manufacturers to supplement our commercial manufacturing requirements. We utilize these internal facilities and third-party contract manufacturers to develop similar capabilities in multiple geographic areas to mitigate potential supply impacts of the most important risks facing our supply chain.

In September 2017, Hurricane Maria made landfall on the island of Puerto Rico causing some damage to our facility in Juncos. Critical manufacturing areas of our facility were not significantly affected, and we have resumed our full manufacturing operations. Further recovery efforts on the island are ongoing. We have continued to provide an uninterrupted supply of medicines for patients around the world.

We manufacture products to support our clinical trials primarily at our California and Rhode Island facilities. We also utilize third-party contract manufacturers for certain clinical products.

See Item 1A. Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products.

Distribution

We operate distribution centers in Kentucky, California and the Netherlands for worldwide distribution of the majority of our commercial and clinical products. We also use third-party distributors to supplement distribution of our products worldwide.

Other

In addition to the manufacturing and distribution activities noted above, our operations in the United States, the U.S. territory of Puerto Rico and the Netherlands include key manufacturing support functions, including quality control, process development, procurement, production scheduling and warehousing. Certain of those manufacturing and distribution activities are highly regulated by the FDA as well as other international regulatory agencies. See Government Regulation—Regulation in the United States—Regulation of Manufacturing Standards.

Manufacturing Initiatives

We have multiple ongoing initiatives that are designed to extend our manufacturing advantage by optimizing our manufacturing network and/or mitigating risks while continuing to ensure adequate supply of our products. In 2017, our new biologics manufacturing facility in Singapore was licensed by the FDA and EMA for certain commercial scale production. The Singapore facility was completed in approximately half the time typically required for conventional biomanufacturing equivalents. It utilizes a flexible and modular design that can be replicated in future facilities, enabling higher production and accessibility to patients around the world. The Singapore facility is fully reconfigurable, allowing the production of other products for worldwide supply. For example, in October 2017, we completed a second bulk process qualification campaign, which, if approved, would enable a second molecule to be manufactured at that facility. We also completed the construction of a second facility in Singapore and we are currently carrying out a qualification campaign.

See Item 1A. Risk Factors— Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.

Raw Materials and Medical Devices

Certain raw materials, medical devices (including companion diagnostics) and components necessary for the commercial and/or clinical manufacturing of our products are provided by and are the proprietary products of unaffiliated third-party suppliers, certain of which may be our only sources for such materials. We currently attempt to manage the risk associated with such suppliers by inventory management, relationship management and evaluation of alternative sources when feasible. We also monitor the financial condition of certain suppliers and their ability to supply our needs. See Item 1A. Risk Factors— We rely on third-party suppliers for certain of our raw materials, medical devices and components.

We perform various procedures to help authenticate the source of raw materials, including intermediary materials used in the manufacture of our products, which include verification of the country of origin. The procedures are incorporated into the manufacturing processes we and our third-party contract manufacturers perform.

Government Regulation

Regulation by government authorities in the United States and other countries is a significant factor in the production and marketing of our products and our ongoing R&D activities. In order to clinically test, manufacture and market products for therapeutic use, we must satisfy mandatory procedures and safety and effectiveness standards established by various regulatory bodies. Compliance with these standards is complex and failure to comply with any of these standards can result in significant implications. See Item 1A. Risk Factors for a discussion of factors that can adversely impact our development and marketing of commercial products including global regulatory implications.

Regulation in the United States

In the United States, the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act (FDCA) and the regulations promulgated thereunder, as well as other federal and state statutes and regulations govern, among other things, the production, research, development, testing, manufacture, quality control, labeling, storage, record keeping, approval, advertising and promotion, and distribution of our products, as well as the reporting of certain payments and other transfers of value to healthcare professionals and teaching hospitals.

Clinical Development and Product Approval. Drug development in our industry is complex, challenging and risky; and failure rates are high. Product development cycles are typically very long—approximately 10 to 15 years from discovery to market. A potential new medicine must undergo many years of preclinical and clinical testing to establish its safety and efficacy for use in humans at appropriate dosing levels and with an acceptable risk-benefit profile.

After laboratory analysis and preclinical testing in animals, we file an Investigational New Drug Application (IND) with the FDA to begin human testing. Typically, we undertake an FDA-designated three-phase human clinical testing program.

The FDA monitors the progress of each trial conducted under an IND and may, at its discretion, reevaluate, alter, suspend or terminate the testing based on the data accumulated to that point and the FDA’s risk benefit assessment with regard to the patients enrolled in the trial. The results of preclinical and clinical trials are submitted to the FDA in the form of a BLA for biologic products or an New Drug Application for small molecule products. We are not permitted to market or promote a new product until the FDA has approved our marketing application.

Approval of Biosimilars . The ACA authorized the FDA to approve biosimilars via a separate, abbreviated pathway. The pathway allows sponsors of a biosimilar to seek and obtain regulatory approval based in part on the non-clinical and clinical trial data of an originator product to which the biosimilar has been demonstrated to be “highly similar” and to have no clinically meaningful differences in terms of safety, purity and potency. The relevance of demonstrating “similarity” is that in many cases, biosimilars can be brought to market without conducting the full suite of clinical trials typically required of originators, as risk-benefit has previously been established. In order to preserve incentives for future innovation, the law establishes a period of exclusivity for originators’ products, which in general prohibits biosimilars from gaining FDA approval based in part on reliance on or reference to the originator’s data in their application to the FDA for 12 years after FDA approval of the originator product. The law does not change the duration of patents granted on biologic products. The FDA has released a number of guidance documents as part of the implementation of the abbreviated approval pathway for biosimilars, some of which remain in draft form. As of the end of 2017, seven biosimilar applications have been approved by the FDA, including our products AMJEVITA ^™ and MVASI ^™ , as well as competitors to our products ENBREL and NEUPOGEN ^® . A number of manufacturers have announced the filing of marketing applications to the FDA under the biosimilar pathway, some of which are for biosimilars of our products.

Regulation of Product Marketing and Promotion . The FDA regulates the marketing and promotion of products. Our product promotion for approved product indications must comply with the statutory standards of the FDCA and the FDA’s implementing regulations and standards. The FDA’s review of marketing and promotional activities encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-directed advertising and promotion, sales representative communications to healthcare professionals, promotional programming and promotional activities involving electronic media. The FDA may also review industry-sponsored scientific and educational activities that make representations regarding product safety or efficacy in a promotional context. The FDA may take enforcement action against a company for promoting unapproved uses of a product or for other violations of its advertising and labeling laws and regulations. Enforcement action may include product seizures, injunctions, civil or criminal penalties or regulatory letters, which may require corrective advertising or other corrective communications to healthcare professionals. Failure to comply with the FDA’s regulations also can result in adverse publicity or increased scrutiny of company activities by the U.S. Congress or other legislators. Additionally, as described below, such failure may lead to additional liability under U.S. health care fraud and abuse laws.

Regulation of Manufacturing Standards . The FDA regulates and inspects equipment, facilities, laboratories and processes used in the manufacturing and testing of products prior to providing approval to market products. If after receiving approval from the FDA, we make a material change in manufacturing equipment, location or process, additional regulatory review may be required. We also must adhere to current Good Manufacturing Practice regulations and product-specific regulations enforced by the FDA through its facilities inspection program. The FDA conducts regular, periodic visits to re-inspect our equipment, facilities, laboratories and processes following an initial approval.

Regulation of Combination Products . Combination products are defined by the FDA to include products composed of two or more regulated components (e.g., a biologic and/or drug and a device). Biologics/Drugs and devices each have their own regulatory requirements, and combination products may have additional requirements. A number of our marketed products meet this definition and are regulated under this framework, and we expect that a number of our pipeline product candidates will be evaluated for regulatory approval under this framework as well.

Regulation Outside the United States

In the European Union (EU) countries as well as Switzerland, Canada, Australia and Japan, regulatory requirements and approval processes are similar in principle to those in the United States.

In the EU, there are currently two potential tracks for seeking marketing approval for a product which is not authorized in any Member State; a decentralized procedure and a centralized procedure. In the decentralized procedure, identical applications for marketing authorization are submitted simultaneously to the national regulatory agencies. Regulatory review is led by one Member State (the Reference Member State) and its assessment—based on safety, quality and efficacy—is reviewed and approved (assuming there are no concerns that the product poses a serious risk to public health) by the other Member States from which the applicant is seeking approval (the Concerned Member States). The decentralized procedure leads to a series of single national approvals in all relevant countries. In the centralized procedure, which is required of all products derived from biotechnology, a company submits a single MAA to the EMA, which conducts an evaluation of the dossier, drawing upon its scientific resources across Europe. If the drug product is proven to fulfill the requirements for quality, safety and efficacy, the EMA’s CHMP adopts a positive opinion, which is transmitted to the EC for final decision on grant of the marketing authorization. While the EC generally follows the CHMP’s opinion, it is not bound to do so. Subsequent commercialization is enabled by country-by-country reimbursement approval.

In the EU, biosimilars are approved under a specialized pathway of the centralized procedure. As with the U.S. pathway, applicants seek and obtain regulatory approval for a biosimilar once the data exclusivity period for the original reference product has expired relying in part on the data submitted for the originator product together with data evidencing that the biosimilar is “highly similar” in terms of quality, safety and efficacy to the original reference product authorized in the European Economic Area.

As a result of the vote by the United Kingdom (UK) to leave the EU in March 2019, the EMA announced on November 20, 2017 that it will relocate its headquarters from London to Amsterdam by March 30, 2019. In addition to uncertainty regarding the supervision and regulation of our products in the UK, it is unclear what impact the EMA move will have on the EU marketing approval process.

Other countries such as Russia, Turkey and those in Latin America and the Middle East have review processes and data requirements similar to those of the EU, and in some cases can rely on prior marketing approval from U.S. or EU regulatory authorities. The regulatory process in these countries may include manufacturing/testing facility inspections, testing of drug product upon importation and other domestic requirements.

In Asia Pacific, a number of countries such as China, Japan, South Korea and Taiwan may require local clinical trial data for bridging purposes as part of the drug registration process in addition to global clinical trials, which can add to overall drug development and registration timelines. In most of the Asian markets, registration timelines depend on marketing approval in the United States or the EU. In some markets in Asia, such as China, Thailand and Indonesia, the regulatory timelines can be less predictable. The regulatory process may also include manufacturing/testing facility inspections, testing of drug product upon importation and other domestic requirements. Countries such as Australia and Japan have more mature systems that would allow for submissions in more competitive timeframes. Regarding biosimilars, several of these countries have pathways to register biosimilars (e.g., South Korea, India, Australia, Singapore and Taiwan) and biosimilar products are already present on the markets (e.g., Australia and South Korea).

In some countries, such as Japan and those in the EU, medical devices may be subject to regulatory regimes whereby the manufacturer must establish that its medical device conforms to essential requirements set out in the law for the particular device category. For example, in the EU, with limited exceptions, medical devices placed on the market must bear the Conformité Européenne marking to indicate their conformity with legal requirements.

Post-approval Phase

After approval, we continue to monitor adverse events and product complaints reported following the use of our products through routine post-marketing surveillance and studies when applicable. We report such events to the appropriate regulatory agencies, as required per local regulations for individual cases and aggregate reports. We proactively monitor (according to good pharmacovigilance practices) and ensure implementation of signal detection, assessment and the communication of adverse events that may be associated with the use of our products. We also proactively monitor product complaints through our quality systems, which includes assessing our drug delivery devices for device complaints, adverse events and malfunctions. We may also be required by regulatory agencies to conduct further clinical trials on our marketed products as a condition of their approval or to provide additional information on safety and efficacy. Health authorities, including the FDA, have authority to mandate labeling changes to products at any point in a product’s lifecycle based on new safety information or as part of an evolving label change to a particular class of products.

Health authorities, including the FDA, also have the authority, before or after approval, to require companies to implement a risk management program for a product to ensure that the benefits of the drug outweigh the risks. Each risk management program is unique and varies depending on the specific factors required. In the United States, a risk management program is known as a risk evaluation and mitigation strategy (REMS) and we currently have REMS for Prolia ^® , Nplate ^® and BLINCYTO ^® .

Other Regulation

We are also subject to various laws pertaining to healthcare “fraud and abuse,” including anti-kickback laws and false claims laws. Anti-kickback laws make it illegal to solicit, offer, receive or pay any remuneration in exchange for or to induce the referral of business, including the purchase or prescription of a particular drug that is reimbursed by a state or federal program. False claims laws prohibit knowingly and willingly presenting, or causing to be presented for payment to third-party payers (including Medicare and Medicaid), any claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed or claims for medically unnecessary items or services. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as by the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid). Liability under the false claims laws may also arise when a violation of certain laws or regulations related to the underlying products (e.g., violations regarding improper promotional activity or unlawful payments) contributes to the submission of a false claim.

In 2012, Amgen announced it had finalized a settlement agreement with the U.S. government and various other parties regarding allegations that Amgen’s promotional, contracting, sales and marketing activities and arrangements caused the submission of various false claims under the Federal Civil False Claims Act and various State False Claims Acts. In connection with entering into the settlement agreement, Amgen also entered into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services that requires Amgen to maintain its corporate compliance program and to undertake a set of defined corporate integrity obligations for a period of five years. Although the corporate integrity agreement term ended in December 2017, certain of the corporate integrity agreement’s reporting obligations to OIG continue into 2018. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or court decisions addressing some of our practices, it is possible that in the future our practices might be further challenged under anti-kickback or similar laws.

Additionally, the U.S. Foreign Corrupt Practices Act (FCPA) prohibits U.S. corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad. The scope of the FCPA arguably includes interactions with certain healthcare professionals in many countries. Other countries have enacted similar anti-corruption laws and/or regulations.

Our business has been and will continue to be subject to various other U.S. and foreign laws, rules and/or regulations.

Research and Development and Selected Product Candidates

We focus our R&D on novel human therapeutics for the treatment of serious illness primarily in the areas of oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience. We capitalize on our strength in human genetics, novel biology and protein engineering. We leverage our biologic expertise and take a modality-independent approach to R&D. We use cutting-edge science and technology to study subtle biological mechanisms in search of therapies that will improve the lives of those who suffer from diseases. Our discovery research programs may therefore yield targets that lead to the development of human therapeutics delivered as large molecules, small molecules, other combination modalities or new modalities. Leveraging two decades of research at deCODE, a global leader in analyzing the human genome, we are reshaping our portfolio and increasingly focusing efforts on targets validated in humans. Human genetic validation is used whenever possible in order to enhance the likelihood of success. For the years ended December 31, 2017 , 2016 and 2015 , our R&D expenses were $3.6 billion, $3.8 billion and $4.1 billion , respectively.

We have major R&D centers in Thousand Oaks and San Francisco, California, Cambridge, Massachusetts, Iceland and in the United Kingdom, as well as smaller research centers and development facilities globally. See Item 2. Properties.

Our clinical trial activities are conducted by both our internal staff and third-party contract clinical trial service providers. To increase the number of patients available for enrollment in our clinical trials, we have opened clinical sites and will continue opening clinical sites and enrolling patients in a number of geographic locations. See Government Regulation—Regulation in the Unites States—Clinical Development and Product Approval for a discussion of government regulation over clinical development. Also see Item 1A. Risk Factors— We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications.

Some of our competitors are actively engaged in R&D in areas in which we have products or in which we are developing product candidates or new indications for existing products. For example, we compete with other clinical trials for eligible patients, which may limit the number of available patients who meet the criteria for certain clinical trials. The competitive marketplace for our product candidates is significantly dependent on the timing of entry into the market. Early entry may have important advantages

in gaining product acceptance, thereby contributing to a product’s eventual success and profitability. Accordingly, we expect that in some cases, the relative speed with which we can develop products, complete clinical testing, receive regulatory approval and supply commercial quantities of a product to the market will be important to our competitive position.

In addition to product candidates and marketed products generated from our internal R&D efforts, we acquire companies, acquire and license certain product and R&D technology rights and establish R&D arrangements with third parties to enhance our strategic position within our industry by strengthening and diversifying our R&D capabilities, product pipeline and marketed product base. In pursuing these R&D arrangements and licensing or acquisition activities, we face competition from other pharmaceutical and biotechnology companies that also seek to license or acquire technologies, product candidates or marketed products from those entities performing the R&D.

The following table shows a selection of certain of our product candidates by phase of development in our therapeutic areas of focus as of February 12, 2018, unless otherwise indicated. Additional product candidate information can be found on our website at www.amgen.com. (The website address is not intended to function as a hyperlink, and the information contained on our website is not intended to be a part of this filing.) The information in this section does not include other, non-registrational clinical trials that we may conduct for purposes other than for submission to regulatory agencies for their approval of a new product indication. We may conduct non-registrational clinical trials for various reasons including to evaluate real-world outcomes or to collect additional safety information with the use of our products. In addition, the table does not include the biosimilar products we are developing, which are discussed later in this section.

Molecule		Disease/condition
Phase 3 Programs
Aimovig ™		Migraine prevention
Aranesp ®		Myelodysplastic syndromes
BLINCYTO ®		ALL
ENBREL		Psoriatic arthritis; Rheumatoid arthritis remission
EVENITY ™		Postmenopausal osteoporosis; Male osteoporosis
IMLYGIC ®		Metastatic melanoma
KYPROLIS ®		Multiple myeloma
Omecamtiv mecarbil		Chronic heart failure
Prolia ®		Glucocorticoid-induced osteoporosis
Tezepelumab		Asthma
AMG 520 / CNP520		Alzheimer’s disease
Phase 2 Programs
BLINCYTO ®		Diffuse Large B-Cell Lymphoma (DLBCL)
Tezepelumab		Atopic dermatitis
AMG 301		Migraine prevention
AMG 557		Primary Sj ö gren’s syndrome
AMG 714		Celiac disease
Phase 1 Programs
IMLYGIC ®		Various cancer types
KYPROLIS ®		Small-cell lung cancer
Oprozomib		Multiple myeloma
AMG 176		Various cancer types
AMG 224		Multiple myeloma
AMG 330		Acute myeloid leukemia
AMG 420		Multiple myeloma
AMG 570		Systemic lupus erythematosus
AMG 592		Inflammatory diseases
AMG 596		Glioblastoma
AMG 598		Obesity
AMG 673		Acute myeloid leukemia
AMG 701		Multiple myeloma
AMG 757		Small-cell lung cancer
AMG 820		Various cancer types
AMG 966		Inflammatory bowel diseases (Crohn’s and ulcerative colitis)
AMG 986		Heart failure

Phase 3 Product Candidate Program Changes

As of February 13, 2017, we had 15 phase 3 programs. As of February 12, 2018, we had 13 phase 3 programs, as three programs were approved, two programs advanced into phase 3 and one program concluded. These changes are set forth in the following table.

Phase 3 Product Candidate Patent Information

The following table describes our outstanding composition of matter patents that have been issued thus far for our product candidates in phase 3 development that have yet to be approved for any indication. Patents for products already approved for one or more indications but currently undergoing phase 3 clinical trials for additional indications are previously described. See Marketing, Distribution and Selected Marketed Products—Patents.

* Patent expiration estimates are based on issued patents, which may be challenged, invalidated, or circumvented by competitors. The patent expiration estimates do not include any term adjustments, extensions or supplemental protection certificates that may be obtained in the future and extend these dates. Corresponding patent applications are pending in other jurisdictions. Additional patents may be filed or issued and may provide additional exclusivity for the product candidate or its use.

Phase 3 and 2 Program Descriptions

The following text provides additional information about selected product candidates that have advanced into human clinical trials.

Aimovig ^™  

Aimovig ^™ is a human monoclonal antibody that inhibits the receptor for calcitonin gene-related peptide. It is being evaluated for the prevention of migraine. Aimovig ^™ is being developed jointly with Novartis.

In July 2017, we announced that the FDA accepted for review the BLA for Aimovig ^™ for the prevention of migraine in patients experiencing four or more migraine days per month. The FDA has set a PDUFA target action date of May 17, 2018.

In January 2018, a phase 3b study met its primary endpoint and all secondary endpoints in patients with episodic migraine who had experienced two to four previous preventive treatment failures due to lack of efficacy or intolerable side effects.

Aranesp ^®  

Aranesp ^® is a recombinant human protein agonist of the erythropoietin receptor. I t is being investigated as a treatment for low risk myelodysplastic syndromes.

In October 2017, we announced that a phase 3 post-marketing requirement study to evaluate the safety and efficacy of Aranesp ^® in anemic patients with advanced non-small cell lung cancer receiving multi-cycle chemotherapy successfully met its primary endpoint of non-inferiority in overall survival compared to placebo, with no new safety findings.

BLINCYTO ^®  

BLINCYTO ^® is an anti-CD19 x anti-CD3 (BiTE ^® ) bispecific antibody construct.

A phase 2/3 study in patients with relapsed or refractory DLBCL is ongoing. In December 2017, we announced that the FDA accepted for priority review the sBLA for the treatment of minimal residual disease in patients with ALL. The PDUFA target action date is March 29, 2018.

In July 2017, we announced that the FDA approved the sBLA for BLINCYTO ^® to include overall survival data from the phase 3 TOWER study. The approval converts BLINCYTO ^® ’s accelerated approval to a full approval. The approval expands the indication of BLINCYTO ^® for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.

In February 2018, we announced that the CHMP of the EMA adopted a positive opinion recommending a label variation for BLINCYTO ^® to include overall survival data from the phase 3 TOWER study supporting the conversion of the conditional marketing authorization to a full marketing authorization in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.

ENBREL

ENBREL is a fusion protein that inhibits tumor necrosis factor.

Phase 3 studies to evaluate ENBREL as a monotherapy for psoriatic arthritis treatment and as a monotherapy in maintaining remission in rheumatoid arthritis are ongoing.

EVENITY ^™  

EVENITY ^™ is a humanized monoclonal antibody that inhibits the action of sclerostin. It is being evaluated as a treatment for osteoporosis. EVENITY ^™ is being developed in collaboration with UCB.

In May 2017, we and UCB announced that the phase 3 ARCH study in postmenopausal women with osteoporosis met both primary endpoints and the key secondary endpoint. An imbalance in positively adjudicated cardiovascular serious adverse events was observed in the study as a new safety signal.

In July 2017, we and UCB announced that the FDA issued a Complete Response Letter for the BLA for EVENITY ^™ as a treatment for postmenopausal women with osteoporosis. The resubmission will include data from the phase 3 ARCH study and select data from the phase 3 BRIDGE study evaluating EVENITY ^™ in men with osteoporosis, in addition to the phase 3 FRAME study. We are currently evaluating all EVENITY ^™ data and will be working in close collaboration with the FDA.

In January 2018, we and UCB announced that the EMA accepted the MAA for EVENITY ^™ for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.

IMLYGIC ^®  

IMLYGIC ^® is an oncolytic immunotherapy derived from herpes simplex virus type 1.

A phase 1b/3 study to evaluate IMLYGIC ^® in combination with Merck & Company, Inc.’s (Merck’s) anti-PD-1 therapy, KEYTRUDA ^® (pembrolizumab), in patients with mid- to late-stage metastatic melanoma is ongoing.

KYPROLIS ^®  

KYPROLIS ^® is a proteasome inhibitor.

In July 2017, we announced positive results from the final analysis of the phase 3 ASPIRE study. The study met the key secondary endpoint of overall survival, demonstrating that KYPROLIS ^® , lenalidomide and dexamethasone reduced the risk of death by 21% over lenalidomide and dexamethasone alone. In December 2017, we submitted a sNDA to the FDA and a variation to the marketing authorization to the EMA to include the overall survival data from the ASPIRE study in the product label.

In October 2017, we announced top-line results of the phase 3 ARROW study, which showed KYPROLIS ^® administered once-weekly at the 70 mg/m ² dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than KYPROLIS ^® administered twice-weekly at the 27 mg/m ² dose with dexamethasone. The overall safety profile of the once-weekly KYPROLIS ^® regimen was comparable to that of the twice-weekly regimen.

In January 2018, we announced that the CHMP of the EMA has adopted a positive opinion recommending a label variation for KYPROLIS ^® to include updated overall survival data from the phase 3 head-to-head ENDEAVOR study in patients with relapsed or refractory multiple myeloma. The ENDEAVOR study demonstrated that KYPROLIS ^® and dexamethasone reduced the risk of death by 21 percent, and increased overall survival by 7.6 months versus VELCADE ^® and dexamethasone.  

A phase 3 study comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma is ongoing.

Omecamtiv mecarbil

Omecamtiv mecarbil is a small-molecule activator of cardiac myosin. It is being evaluated for the treatment of chronic heart failure. Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics, Inc. and in collaboration with Servier for certain territories.

A phase 3 cardiovascular outcomes study for the treatment of chronic heart failure is ongoing.

Prolia ^®  

Prolia ^® is a human monoclonal antibody that inhibits RANKL. It is being investigated for the treatment of glucocorticoid-induced osteoporosis.

In October 2017, we announced that the FDA accepted for review the sBLA for the treatment of patients with glucocorticoid-induced osteoporosis. The FDA has set a PDUFA target action date of May 28, 2018.

Tezepelumab (formerly AMG 157)

Tezepelumab is a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin. It is being evaluated as a treatment for asthma in an ongoing phase 3 study, as well as atopic dermatitis. Tezepelumab is being jointly developed in collaboration with AstraZeneca plc (AstraZeneca).

AMG 301

AMG 301 is a human monoclonal antibody that inhibits the pituitary adenylate cyclase-activating polypeptide type 1 (PAC1) receptor. It is being investigated for migraine prevention. AMG 301 is being jointly developed in collaboration with Novartis.

AMG 520 / CNP520

AMG 520 / CNP520 is a small molecule inhibitor of beta-site amyloid precursor protein-cleaving enzyme-1 (BACE). It is being evaluated for the prevention of Alzheimer’s disease, with phase 3 studies ongoing. AMG 520 / CNP520 is being jointly developed in collaboration with Novartis.

* Developed in collaboration with Allergan

Business Relationships

From time to time, we enter into business relationships, including joint ventures and collaborative arrangements, for the R&D, manufacture and/or commercialization of products and/or product candidates. In addition, we also acquire product and R&D technology rights and establish R&D collaborations with third parties to enhance our strategic position within our industry by strengthening and diversifying our R&D capabilities, product pipeline and marketed product base. These arrangements generally provide for non-refundable, upfront license fees, development and commercial-performance milestone payments, cost sharing, royalty payments and/or profit sharing. The activities under these collaboration agreements are performed with no guarantee of either technological or commercial success, and each is unique in nature.

Trade secret protection for our unpatented confidential and proprietary information is important to us. To protect our trade secrets, we generally require counterparties to execute confidentiality agreements upon the commencement of the business relationship with us. However, others could either develop independently the same or similar information or unlawfully obtain access to our information.

Kirin-Amgen, Inc.

On October 30, 2017, we announced that we agreed to acquire the remaining 50% ownership interest of Kirin-Amgen, Inc. (K-A) from Kirin Holdings Company, Limited (Kirin). We completed the share acquisition during the first quarter of 2018, making K-A a wholly owned subsidiary of Amgen. Prior to the closing of the share acquisition, K-A was a 50-50 joint venture with Kirin. K-A develops and then licenses all product rights which have been transferred from Amgen and Kirin. See Part IV—Note 21, Subsequent event, to the Consolidated Financial Statements.

K-A has given us exclusive licenses to manufacture and market: (i) granulocyte colony-stimulating factor (G-CSF) and pegfilgrastim in the United States, Europe, Canada, Australia, New Zealand, all Central American, South American, Middle Eastern and African countries and certain countries in Asia; (ii) darbepoetin alfa and romiplostim in the United States, Europe, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, Africa and the Middle East; and (iii) recombinant human erythropoietin in the United States. We currently market pegfilgrastim, G-CSF, darbepoetin alfa, recombinant human erythropoietin and romiplostim under the brand names Neulasta ^® , NEUPOGEN ^® /GRANULOKINE ^® , Aranesp ^® , EPOGEN ^® and Nplate ^® , respectively. Under these agreements, Amgen pays K-A royalties based on product sales. In addition, Amgen also receives payments from K-A for milestones earned and for conducting certain R&D activities on its behalf.

K-A has also given Kirin exclusive licenses to manufacture and market: (i) G-CSF and pegfilgrastim in Japan, Taiwan and South Korea; (ii) darbepoetin alfa, romiplostim and brodalumab in Japan, China, Taiwan, South Korea and in certain other countries and/or regions in Asia; and (iii) recombinant human erythropoietin in Japan. K-A also gave Kirin and Amgen co-exclusive licenses to manufacture and market G-CSF, pegfilgrastim and recombinant human erythropoietin in China, which Amgen subsequently assigned to Kirin, and as a result, Kirin now exclusively manufactures and markets G-CSF and recombinant human erythropoietin in China. Kirin markets G-CSF, pegfilgrastim, darbepoetin alfa, romiplostim, recombinant human erythropoietin and brodalumab under the brand names GRAN ^® /Grasin ^® , Peglasta ^® /Neulasta ^® /G-Lasta ^® , NESP ^® /Aranesp ^® , ROMIPLATE ^® , ESPO ^® and LUMICEF ^® , respectively. Under these agreements, Kirin pays K-A royalties based on product sales. In addition, Kirin also receives payments from K-A for conducting certain R&D activities on its behalf.

K-A has also given J&J exclusive licenses to manufacture and market recombinant human erythropoietin for all geographic areas of the world outside the United States, China and Japan. Under this agreement, J&J pays royalties to K-A based on product sales. See Part IV—Note 8, Related party transactions, to the Consolidated Financial Statements.

Novartis

In April 2017, we expanded our existing migraine collaboration with Novartis. In the United States, Amgen and Novartis will jointly develop and collaborate on the commercialization of Aimovig ^™ . Amgen, as the principal, will recognize product sales of Aimovig ^™ in the United States, will share U.S. commercialization costs with Novartis and will pay Novartis a significant royalty on net sales in the United States. Novartis holds global co-development rights and exclusive commercial rights outside the United States and Japan for Aimovig ^™ and other specified migraine programs. Novartis will pay Amgen double-digit royalties on net sales of the products in the Novartis exclusive territories. Novartis will fund a portion of global R&D expenses. Novartis will also make payments to Amgen that could collectively amount to approximately $400 million if certain regulatory events occur and commercial thresholds are achieved with respect to Aimovig ^™ in the United States. Amgen will manufacture and supply Aimovig ^™ worldwide.

Pfizer Inc.

The co-promotion term of our ENBREL collaboration agreement with Pfizer Inc. (Pfizer) in the United States and Canada expired on October 31, 2013. Under this agreement, we paid Pfizer a profit share until October 31, 2013, and residual royalties from November 1, 2013 to October 31, 2016, which were significantly less than the profit share payments. In 2015 and 2016, the residual royalty payments ranged from 11% to 10% of annual net ENBREL sales in the United States and Canada. Effective November 1, 2016, there are no further royalty payments.

UCB

We are in a collaboration with UCB for the development and commercialization of EVENITY ^™ . In 2016, we amended the commercialization rights and responsibilities of the parties. Under the amended agreement, we have the rights to commercialize EVENITY ^™ for all indications in the United States, Japan and Hong Kong. UCB has the rights for Europe, China and Brazil. The rest of the countries have been allocated to Amgen. Generally, development costs and future worldwide commercialization profits and losses related to the collaboration after accounting for expenses are shared equally.

Bayer HealthCare Pharmaceuticals Inc.

We are in a collaboration with Bayer HealthCare Pharmaceuticals Inc. (Bayer) to jointly develop and commercialize Nexavar ^® (sorafenib). In 2015, we amended the terms of our collaboration agreement with Bayer, which terminated the co-promotion agreement in the United States, and transferred all U.S. operational responsibilities to Bayer, including commercial and medical affairs activities. Prior to the termination of the co-promotion agreement, we co-promoted Nexavar ^® with Bayer and shared equally in the profits in the United States. In lieu of this profit share, Bayer now pays us a royalty on U.S. sales of Nexavar ^® at a percentage rate in the high 30s. Outside of the United States, excluding Japan, Bayer manages all commercialization activities and incurs all of the sales and marketing expenditures and mutually agreed R&D expenses, and we reimburse Bayer for half of those expenditures. In all countries outside of the United States, except Japan, we receive 50% of net profits on sales of Nexavar ^® after deducting certain Bayer-related costs. The rights to develop and market Nexavar ^® in Japan are reserved to Bayer.

DaVita Inc.

In January 2017, we entered into a six-year supply agreement with DaVita Inc. (DaVita), which superseded the previously existing seven-year supply agreement that commenced in 2012. Pursuant to the 2017 agreement, we supply EPOGEN ^® and Aranesp ^® in amounts necessary to meet specified annual percentages of DaVita’s and its affiliates’ requirements for erythropoiesis-stimulating agents (ESAs) used in providing dialysis services in the United States and Puerto Rico. Such percentage varies during the term of the agreement, but in each year is at least 90%. The agreement expires in 2022. The agreement may be terminated by either party before expiration of its term in the event of certain breaches of the agreement by the other party.

Human Resources

As of December 31, 2017 , Amgen had approximately 20,800 staff members. We consider our staff relations to be good.

Executive Officers of the Registrant

The executive officers of the Company as of February 7, 2018, are set forth below.

Mr. Robert A. Bradway, age 55, has served as a director of the Company since October 2011 and Chairman of the Board of Directors since 2013. Mr. Bradway has been the Company’s President since 2010 and Chief Executive Officer since 2012. From 2010 to 2012, Mr. Bradway served as the Company’s President and Chief Operating Officer. Mr. Bradway joined the Company in 2006 as Vice President, Operations Strategy and served as Executive Vice President and Chief Financial Officer from 2007 to 2010. Prior to joining the Company, he was a Managing Director at Morgan Stanley in London where, beginning in 2001, he had responsibility for the firm’s banking department and corporate finance activities in Europe. Mr. Bradway has been a director of The Boeing Company, an aerospace company and manufacturer of commercial airplanes, defense, space and securities systems, since 2016. He has served on the board of trustees of the University of Southern California since 2014, and on the advisory board of the Leonard D. Schaeffer Center for Health Policy and Economics at that university since 2012. From 2011 to May 2017, Mr. Bradway was a director of Norfolk Southern Corporation, a transportation company.

Mr. Jonathan P. Graham, age 57, became Senior Vice President, General Counsel and Secretary in 2015. From 2006 to 2015, Mr. Graham was Senior Vice President and General Counsel at Danaher Corporation. From 2004 to 2006, Mr. Graham was Vice President, Litigation and Legal Policy at General Electric Company (GE). Prior to GE, Mr. Graham was a partner at Williams & Connolly LLP.

Dr. Sean E. Harper, age 55, became Executive Vice President, Research and Development in 2012. Dr. Harper joined the Company in 2002, and has held leadership roles in early development, medical sciences and global regulatory and safety. Dr. Harper served as Senior Vice President, Global Development and Corporate Chief Medical Officer from 2007 to 2012. Prior to joining the Company, Dr. Harper worked for five years at Merck Research Laboratories.

Mr. Anthony C. Hooper, age 63, became Executive Vice President, Global Commercial Operations in 2011. From 2010 to 2011, Mr. Hooper was Senior Vice President, Commercial Operations and President, U.S., Japan and Intercontinental of Bristol-Myers Squibb Company (BMS). From 2009 to 2010, Mr. Hooper was President, Americas of BMS. From 2004 to 2009, Mr. Hooper was President, U.S. Pharmaceuticals, Worldwide Pharmaceuticals Group, a division of BMS. Prior to this, Mr. Hooper held various senior leadership positions at BMS. Prior to joining BMS, Mr. Hooper was Assistant Vice President of Global Marketing for Wyeth Laboratories.

Ms. Lori A. Johnston, age 53, became Senior Vice President in 2016. From 2012 to 2016, Ms. Johnston was Executive Vice President and Chief Administrative Officer of Celanese Corporation. From 2006 to 2012, Ms. Johnston served in a series of progressive leadership roles at Amgen, with her last position being Vice President, Human Resources. Prior to joining the Company, Ms. Johnston held human resources and other positions at Dell Inc.

Mr. David W. Meline, age 60, became Executive Vice President and Chief Financial Officer in 2014. From 2011 to 2014, Mr. Meline served as Senior Vice President and Chief Financial Officer at 3M Company (3M). From 2008 to 2011, Mr. Meline served as Vice President, Corporate Controller and Chief Accounting Officer of 3M. Prior to 2008, Mr. Meline served in a variety of senior leadership roles for General Motors Company for over 20 years, with his last position being Vice President and Chief Financial Officer, North America. Mr. Meline has been a director of ABB Ltd., a global industrial technology company based in Switzerland, since 2016, serving as a member of the Finance, Audit and Compliance Committee. Mr. Meline was a director of TRW Automotive Holdings, Corp., a supplier of automotive systems, modules and components, from 2014 until its acquisition by ZF Friedrichshafen AG in 2015.

Ms. Cynthia M. Patton, age 56, became Senior Vice President and Chief Compliance Officer in 2012. Ms. Patton joined the Company in 2005. From 2005 to 2010, Ms. Patton was Associate General Counsel. From 2010 to 2012, Ms. Patton was Vice President, Law. Previously, Ms. Patton served as Senior Vice President, General Counsel and Secretary of SCAN Health Plan from 1999 to 2005.

Mr. David A. Piacquad, age 61, became Senior Vice President, Business Development in 2014. Mr. Piacquad joined the Company in 2010 and, until 2014, served as Vice President, Strategy and Corporate Development. From 2014 to 2014, Mr. Piacquad served as Vice President, Business Development. Prior to joining the Company, from 2009 to 2010, Mr. Piacquad was Principal of David A. Piacquad Consulting LLC. From 2006 to 2009, Mr. Piacquad served as Senior Vice President, Business Development and Licensing for Schering-Plough Corporation. Prior to Schering-Plough, Mr. Piacquad served in a series of leadership roles in finance and business development at J&J, with his last position being Vice President, Ventures and Business Development.

Mr. Esteban Santos, age 50, became Executive Vice President, Operations in 2016. Mr. Santos joined the Company in 2007 as Executive Director, Manufacturing Technologies. From 2008 to 2013, Mr. Santos held a number of Vice President roles at the Company in engineering, manufacturing, site operations and drug product. From 2013 to 2016, Mr. Santos was Senior Vice President, Manufacturing. Prior to joining the Company, Mr. Santos served as Site General Manager for J&J’s Cordis operation in Puerto Rico. Prior to J&J, Mr. Santos held several management positions in GE’s industrial and transportation businesses.

Geographic Area Financial Information

For financial information concerning the geographic areas in which we operate, see Part IV—Note 19, Segment information—Geographic information, to the Consolidated Financial Statements.

Investor Information

Financial and other information about us is available on our website at www.amgen.com. We make available on our website, free of charge, copies of our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the U.S. Securities and Exchange Commission (SEC). In addition, we have previously filed registration statements and other documents with the SEC. Any document we file may be inspected, without charge, at the SEC’s public reference room at 100 F Street NE, Washington, DC 20549, or at the SEC’s website at www.sec.gov. (These website addresses are not intended to function as hyperlinks, and the information contained in our website and in the SEC’s website is not intended to be a part of this filing.) Information related to the operation of the SEC’s public reference room may be obtained by calling the SEC at 800-SEC-0330.