What changed in this filing

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Item 1. Business

2023-02-09 compared with 2022-02-16 · 268 added, 257 removed, 594 unchanged (47% of the section changed)

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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, 2021.

Business Development

Five Prime Therapeutics acquisition

• On April 16, 2021, Amgen completed its acquisition of Five Prime, a public clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, for approximately $1.6 billion in cash, net of cash acquired.

• In April 2021, the FDA granted Breakthrough Therapy designation for bemarituzumab as first-line treatment for patients with FGFR2b overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with fluoropyrimidine, leucovorin and oxaliplatin based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.

KKC collaboration

• We and KKC entered into an agreement, effective July 30, 2021, to jointly develop and commercialize KKC’s potential first-in-class, phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases.

Teneobio acquisition

• On October 19, 2021, Amgen completed its acquisition of Teneobio, a privately held, clinical-stage biotechnology company developing a new class of biologics called human heavy-chain antibodies, which are single-chain antibodies composed of the human heavy-chain domain, for $900 million as well as future contingent milestone payments potentially worth up to an additional $1.6 billion upon the achievement of certain developmental and regulatory events.

Proposed acquisition of Horizon Therapeutics plc

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

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

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

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

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

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

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

ChemoCentryx, Inc.

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

Products/Pipeline

• In December 2021, we announced that the FDA had approved the expanded indication for Otezla for the treatment of adult patients with plaque psoriasis, who are candidates for phototherapy or systemic therapy, across all severities.

• In December 2021, we and AstraZeneca announced that the FDA had approved TEZSPIRE for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Cardiometabolic

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

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

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

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

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

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

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

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

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

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

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

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

Oncology/Hematology

LUMAKRAS/LUMYKRAS

• In May 2021, we announced that the FDA had approved LUMAKRAS for the treatment of adult patients with KRAS G12C –mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

LUMAKRAS received accelerated approval based on ORR and DoR.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.

• In January 2022, we announced that the EC had granted conditional marketing authorization for LUMYKRAS for the treatment of adults with advanced NSCLC with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

We also announced that LUMAKRAS had been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent NSCLC that has progressed after systemic anticancer therapy.

• In December 2021, we announced that the FDA had approved the expansion of the KYPROLIS prescribing information to include its use in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

New manufacturing facilities

We announced plans to expand our United States–based manufacturing footprint.

• In August 2021, we announced plans to build a drug substance plant in North Carolina that will increase our manufacturing network capacity to reliably supply more medicines for patients.

• In November 2021, we broke ground to build an advanced assembly and packaging plant in Ohio.

The new facility will assemble and package vials and syringes to support the growing demand for our medicines.

We expect that both of these facilities will be built faster and at lower cost than traditional plants.

Once completed, both will also utilize cutting-edge technologies to be more efficient and environmentally friendly than traditional plants.

COVID-19 pandemic

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

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

To date, we have not experienced disruptions to or shortages of our supply of medicines.

We continue to take appropriate steps to minimize risks to our employees.

Employee access to company facilities has been in accordance with applicable government health and safety protocols and guidance issued in response to the COVID-19 pandemic.

The pandemic has shifted how we work as an organization and in the fourth quarter of 2021, we enabled our U.S.

based workforce to return to the workplace for work that benefits from face-to-face interaction, while maintaining appropriate safety measures to ensure staff well-being.

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.

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

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

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

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

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

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

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

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

• In August 2022, we announced positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS.

The safety and immunogenicity profile of ABP 959 was comparable to that of SOLIRIS.

New manufacturing facility

• In March 2022, we broke ground to build a drug substance plant in North Carolina that will increase our manufacturing network capacity.

Marketing, Distribution and Selected Marketed Products

The largest concentration of our sales and marketing forces is based in the United States and Europe.

In recent years, we have expanded the commercialization and marketing of our products into other geographic territories, including China and Japan and other parts of Asia, the Middle East and Latin America.

In recent years, we have expanded the commercialization and marketing of our products into other geographic territories, including Japan, China and other parts of Asia;

Latin America;

and the Middle East.

This expansion has occurred, and is expected to continue to occur, by establishing our own affiliates, by acquiring existing third-party businesses or product rights or by collaborating with third parties.

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Outside the United States, we sell principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country.

In the Asia Pacific region, we also sell our products in partnership with other companies, including BeiGene, Daiichi Sankyo, KKC and Takeda.

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

Our product sales to three large wholesalers, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2022, 2021 and 2020.

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Total $ 24,801 100 % $ 24,297 100 % $ 24,240 100 %

(1) Consists of product sales of our non-principal products, as well as our Gensenta and Bergamo subsidiaries.

We market ENBREL, a tumor necrosis factor blocker, in the United States and Canada.

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We market Prolia in many countries around the world.

Prolia contains the same active ingredient as XGEVA but is approved for different indications, patient populations, doses and frequencies of administration.

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

Prolia was launched in the United States and Europe in 2010.

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In Europe, Prolia is used primarily for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

We market Otezla, a small molecule that inhibits PDE4, in many countries around the world.

Otezla was acquired from BMS in November 2019 after their acquisition of Celgene.

Otezla is an oral therapy approved for the treatment of adult patients with plaque psoriasis across all severities for whom phototherapy or systemic therapy is appropriate, patients with active psoriatic arthritis and patients with oral ulcers associated with Behçet’s disease.

In Europe, Otezla is approved for second-line use in the treatment of psoriatic arthritis and psoriasis and for patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.

We market Otezla, a small molecule that inhibits phosphodiesterase 4 (PDE4), in many countries around the world.

Otezla was acquired from Bristol Myers Squibb Company in November 2019 after their acquisition of Celgene.

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

We market XGEVA in many countries around the world.

XGEVA was launched in 2010 and is used primarily in the indication for prevention of SREs (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with bone metastases from solid tumors and multiple myeloma.

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 (nonmyeloid) who receive anticancer 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 physicians the opportunity to initiate administration of Neulasta on the same day as chemotherapy, with drug delivery of the recommended dose of Neulasta at home the day after chemotherapy, thereby saving the patient a trip back to the doctor.

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

We market Aranesp primarily in the United States and Europe.

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

Aranesp 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 certain patients with nonmyeloid malignancies and when chemotherapy will be used for at least two months after starting Aranesp.

We market Nplate in many countries around the world.

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

We market Repatha, a PCSK9 inhibitor, in many countries around the world.

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

Repatha is also indicated to reduce LDL-C in adults with primary hyperlipidemia, including HeFH;

in pediatric patients aged 10 years and older with HeFH;

and in adults and pediatric patients aged 10 years and older with HoFH.

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

We market KYPROLIS primarily in the United States and Europe.

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It is also approved as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous therapies.

We market Nplate in many countries around the world.

Nplate was launched in 2008 and is indicated to treat thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

We market Neulasta, a pegylated protein based on the filgrastim molecule, primarily in the United States and Europe.

In 2015, the Neulasta Onpro kit became available in the United States.

Together with our collaboration partners, we market EVENITY in many countries around the world.

EVENITY was launched in the United States and Japan in 2019.

In the United States, it is used in the indication for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

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

Other Marketed Products

We also market a number of other products in various markets worldwide, including MVASI, Vectibix, KANJINTI, EVENITY, EPOGEN, BLINCYTO, AMGEVITA, Aimovig, Parsabiv, NEUPOGEN, LUMAKRAS/LUMYKRAS, Sensipar/Mimpara, AVSOLA, RIABNI and TEZSPIRE.

We also market a number of other products in various markets worldwide, including MVASI, Vectibix, BLINCYTO, EPOGEN, AMGEVITA, Aimovig, Parsabiv, KANJINTI, LUMAKRAS/LUMYKRAS, TEZSPIRE, NEUPOGEN, Sensipar/Mimpara and TAVNEOS.

The following table lists our outstanding material patents for the indicated product by territory, general subject matter and latest expiry date.

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Methods of treatment using aqueous formulations 6/8/2023

Formulations 10/19/2037

Formulations and methods of preparing formulations 10/19/2037

Fusion protein and pharmaceutical compositions 11/22/2028

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Prolia ® /XGEVA ® (denosumab)

Methods of treatment 6/25/2022

Nucleic acids encoding RANKL antibodies and methods of producing RANKL antibodies 11/30/2023

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Glycosylation analogs of erythropoietin proteins 5/15/2024

KYPROLIS ® (carfilzomib)

Compositions and compounds 12/7/2027

Methods of treatment 4/14/2025

Methods of making 5/8/2033

Europe Compositions, compounds and methods of treatment (1)

Nplate ® (romiplostim)

Polynucleotides encoding fusion protein 7/25/2023

Formulation 2/12/2028

Europe Thrombopoietic compounds (1)

Europe Formulation 4/20/2027

Repatha ® (evolocumab)

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Europe Formulation 5/3/2033

Nplate ® (romiplostim)

Formulation 2/12/2028

Europe Thrombopoietic compounds (1)

Europe Formulation 4/20/2027

Vectibix ® (panitumumab)

Europe Human monoclonal antibodies to epidermal growth factor receptor (1)

KYPROLIS ® (carfilzomib)

Compositions and compounds 12/7/2027

Methods of treatment 4/14/2025

Methods of making 5/8/2033

Europe Compositions, compounds and methods of treatment (1)

Product Territory General subject matter Expiration

EVENITY ® (romosozumab-aqqg)

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Europe Method of administration 11/6/2029

Product Territory General subject matter Expiration

Aimovig ® (erenumab-aooe)

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Methods of treatment 4/22/2036

Compositions and pharmaceutical formulations 4/1/2039

Europe CGRP receptor antibodies (1)

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Europe Formulation 6/27/2034

LUMAKRAS ® /LUMYKRAS™(sotorasib)

LUMAKRAS® /LUMYKRAS™ (sotorasib) U.S.

Compounds and pharmaceutical compositions 5/21/2038

Crystalline form, pharmaceutical compositions and methods of treatment 5/20/2040

Methods of treatment 8/11/2040

Europe Compounds, pharmaceutical compositions and methods of treatment 5/21/2038

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Europe Polypeptides 9/9/2028

TAVNEOS ® (avacopan)

Compounds and pharmaceutical compositions (3)

(1) A European patent with this subject matter may also be entitled to supplemental protection in one or more countries in Europe, and the length of any such extension will vary by country.

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

• apremilast — Italy, Spain and the United Kingdom expiring in 2028

• apremilast — France, Germany, Italy, Spain and the United Kingdom expiring in 2028

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

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

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

• romosozumab — France, Italy and Spain, expiring in 2031

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

• erenumab — France, Italy and Spain, expiring in 2033

• romosozumab — France, Italy, Spain and the United Kingdom, expiring in 2031

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

• erenumab — France, Italy, Spain and the United Kingdom, expiring in 2033

• etelcalcetide — France, Germany, Italy, Spain and the United Kingdom, expiring in 2031

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In 2019, Amgen launched MVASI, a biosimilar to Avastin, and KANJINTI, a biosimilar to Herceptin;

and in 2018, Amgen launched AMGEVITA, a biosimilar to Humira in ex-U.S.

and in 2018, Amgen launched AMGEVITA, a biosimilar to HUMIRA in markets outside the United States.

We have also received FDA approval of AMJEVITA, a biosimilar to HUMIRA for the U.S.

market, and plan to launch in the United States in January 2023.

market, which launched in January 2023.

In 2020, we launched AVSOLA, a biosimilar to Remicade;

and in January 2021, we launched RIABNI, a biosimilar to Rituxan.

and in 2021 we launched RIABNI, a biosimilar to Rituxan.

We expect additional biosimilar competition against both our branded and biosimilar products in the future across markets.

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Risk Factors— Our products face substantial competition and our product candidates are also likely to 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 .

Risk Factors— We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future .

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

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& Canada RINVOQ AbbVie

& Europe Alendronate, raloxifene and zoledronate generics Various

Prolia U.S., Europe & Asia Pacific Alendronate, raloxifene and zoledronate generics Various

& Europe HUMIRA †

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& Europe Tremfya Janssen (1)

& Europe Skyrizi (2)

& Europe Skyrizi AbbVie

& Europe Methotrexate generics Various

& Europe Zoledronate generics

UDENYCA Coherus BioSciences, Inc.

Mylan Institutional Inc.

& Europe Filgrastim biosimilars Various

& Europe Epoetin alfa biosimilars

& Europe PRALUENT

& Europe PROMACTA/REVOLADE Novartis

U.S., Europe & Asia Pacific PRALUENT

Regeneron Pharmaceuticals, Inc.

KYPROLIS U.S.

Millennium Pharmaceuticals, Inc.

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& Europe DARZALEX

& Europe PROMACTA/REVOLADE Novartis

& Europe UDENYCA Coherus BioSciences, Inc.

& Europe Fulphila

Mylan Institutional Inc.

& Europe Filgrastim biosimilars Various

Alendronate, raloxifene and zoledronate generics Various

Japan Teribone Asahi Kasei Pharma

† Approved biosimilars available in Europe and Canada.

(1) A subsidiary of J&J.

(2) Dermatology only.

(3) Other biosimilars under regulatory review in the United States and Europe.

(1) A subsidiary of Johnson & Johnson.

(2) PROCRIT competes with Aranesp in supportive cancer care and predialysis settings.

(5) KYPROLIS is facing increased competition from several recently approved products.

(6) A subsidiary of Takeda.

(7) A subsidiary of BMS.

(3) REVLIMID also includes generics.

(4) A subsidiary of Takeda Pharmaceutical Company Limited.

(5) A subsidiary of Bristol Myers Squibb Company.

(6) Other biosimilars under regulatory review in the United States and Europe.

Reimbursement

Sales of our principal products are dependent on the availability and extent of coverage and reimbursement from third-party payers.

Sales of our 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 focused on reducing the cost of healthcare;

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In addition to market actions taken by private and government payers in the United States, policy makers in both of the major U.S.

political parties are pursuing policies to lower drug costs.

Potential policies cover a wide range of areas, including allowing the importation of drugs from other countries;

instituting IRP schemes, which would set the prices of certain drugs based on those available in other countries;

implementing policies that in effect would require manufacturers to accept government-set prices for certain drugs, with price ceilings based on a domestic reference-pricing scheme;

redesigning the Medicare Part D benefit so as to establish a cap on patient out-of-pocket costs, paired with new requirements that manufacturers cover a share of the costs of Part D drugs;

stipulating penalties if drug price benchmarks rise faster than inflation;

political parties have supported policies to lower drug costs.

Risk Factors— 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 .

In August 2022, the Inflation Reduction Act (IRA) was enacted and includes provisions requiring that (1) beginning in 2026, mandatory price setting be introduced in Medicare for certain drugs paid for under Parts B and D, whereby manufacturers must accept a price established by the government or face penalties on all U.S.

sales (starting with 10 drugs in 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that by 2031 approximately 100 drugs could be subject to such set prices);

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

and (3) beginning October 1, 2022, manufacturers now owe rebates on drugs reimbursed under Medicare Part D if price increases outpace inflation, and beginning January 1, 2023, now owe rebates on drugs reimbursed under Medicare Part B if price increases outpace inflation.

Although the IRA has passed, the environment remains dynamic, and the Administration and Congress are continuing to consider drug pricing reforms.

Other potential policies cover a wide range of areas, including allowing the importation of drugs from other countries;

increasing transparency in drug pricing;

and using third-party value assessments to determine drug prices.

Examples of such policies include, but are not limited to, the previous Administration’s November 2020 interim final rule, which attempts to institute an MFN IRP model in Medicare Part B and a final rule instituting rebate reform in Medicare Part D.

Both of the resulting rules are being challenged in court and have not yet been implemented.

Further, although CMS withdrew the MFN IRP, policy makers continue to express strong interest in policies to address drug pricing.

The Infrastructure Investment and Jobs Act signed into law on November 15, 2021, delays implementation of the rebate reform rule until 2026 and requires manufacturers of certain Part B–covered drugs packaged in single-use containers to give refunds to the government starting in 2023 for discarded amounts.

Although the direction of drug-pricing-policy reforms remains unclear at this time, Congress is continuing to consider prescription-drug-pricing reforms, including legislative proposals for a number of the concepts discussed above (including a full repeal of the prior Administration’s Part D rebate reform rule).

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

In many countries other than the United States, government-sponsored healthcare systems are the primary payers for drugs and biologics.

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Similarly, fiscal constraints may also affect the extent to which countries are willing to approve new and innovative therapies and/or allow access to new technologies.

The EU is currently undergoing a review and possible revision of its pharmaceutical legislation, scheduled to conclude at the end 2022.

There is a risk that this review will lead to proposals that may reduce intellectual property protection for new products, as well as change the reimbursement and regulatory landscape in ways that are difficult to predict at this point.

The EU is currently undergoing a review and possible revision of its pharmaceutical legislation, now scheduled to end in the first half of 2023, with implementation by 2025 or 2026.

It is likely that this review will lead to proposals that will reduce intellectual property protection for new products, as well as change the reimbursement and regulatory landscape in ways that are difficult to predict at this point.

The dynamics and developments discussed above create pressures on the pricing and potential usage of our products and on the industry.

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We have been innovating our manufacturing facilities designed to extend our manufacturing advantage by optimizing our manufacturing network and/or by mitigating risks while continuing to ensure adequate supply of our products.

For example, our licensed next-generation biomanufacturing plant operating in Singapore, and our recently FDA approved facility in West Greenwich, Rhode Island, incorporate multiple innovative technologies into a single facility.

For example, our licensed next-generation biomanufacturing plants operating in Singapore and West Greenwich, Rhode Island, incorporate multiple innovative technologies into a single facility.

Next-generation biomanufacturing plants require smaller manufacturing footprints and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

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Our internal manufacturing network has commercial production capabilities for bulk manufacturing, formulation, fill, finish, tableting 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.

These activities are performed within the United States and its territory in our Puerto Rico, Rhode Island and California facilities as well as internationally in our Ireland, Netherlands and Singapore facilities.

In addition, we use third-party contract manufacturers to supplement the capacity or capability of our commercial manufacturing network.

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As discussed above, we have been expanding capacity and advancing new innovations with multiple ongoing projects.

Our next-generation biomanufacturing plant at our West Greenwich, Rhode Island, campus, the first of its kind in the United States, received FDA approval in January 2022.

Our next-generation biomanufacturing plant at our West Greenwich, Rhode Island, campus, the first of its kind in the United States, has been approved by the FDA and EMA.

This plant expands our capacity to manufacture certain products for U.S.

and global markets, as we receive regulatory approval in those markets.

We initiated projects in 2019 to expand our clinical and commercial manufacturing capabilities in Thousand Oaks, California, which we have completed.

In August 2021, we initiated a project to build a new multi-product drug substance manufacturing facility in Holly Springs, North Carolina.

The new plant will support both traditional stainless steel-fed batch manufacturing and next-generation single-use technologies, allowing flexibility in the production of multiple products in one plant.

In November 2021, we broke ground for our newest biomanufacturing plant located in New Albany, Ohio.

This final product assembly and packaging plant will support the growing demand for Amgen’s medicines in the United States and will use state-of-the-art technologies.

In March 2022, we broke ground for our new multi-product drug substance manufacturing facility in Holly Springs, North Carolina.

Amgen continues to embed environmental sustainability into the upfront design, development and execution of our new facilities.

The new facilities under construction in North Carolina and Ohio contain many examples of environmental advances, including on-site photovoltaic renewable energy generation at both sites.

We expect our North Carolina facility’s carbon, waste and water footprints to be substantially lower than those at a traditional drug substance manufacturing plant, and we expect lower footprints per unit produced as well at our Ohio facility compared with existing similar facilities.

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

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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 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 either a BLA for biologic products or a New Drug Application for small molecule products.

The results of preclinical and clinical trials are submitted to the FDA in the form of either a Biologics License Application for biologic products or a 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 Affordable Care Act 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 nonclinical-trial 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 with regard to safety, purity and potency.

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As part of the implementation of the abbreviated approval pathway for biosimilars, the FDA released a number of guidance documents, some of which remain in draft form.

Risk Factors— We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future .

Regulation of Product Marketing and Promotion .

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pathway, an applicant seeks and obtains 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” with regard to quality, safety and efficacy to the original reference product authorized in the European Economic Area.

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.

Risk Factors— We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future .

Other countries such as 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.

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Each risk management program is unique and varies depending on the specific factors required.

In the United States, such a risk management program is known as a REMS;

and we currently have REMSs for Prolia, Nplate and BLINCYTO.

In the United States, such a risk management program is known as a REMS, and we currently have REMSs for Prolia, Nplate and BLINCYTO.

Other Regulation

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The legislative and regulatory environments regarding privacy and data protection are continually evolving and developing because these issues are subjects of increasing amounts of attention in countries globally.

For example, we are subject to the EU’s GDPR, which became effective on May 25, 2018, the California Consumer Privacy Act of 2018, which became effective on January 1, 2020 and China’s Personal Information Protection Law, which became effective on November 1, 2021.

For example, we are subject to the EU’s GDPR, which became effective on May 25, 2018;

the CCPA, which became effective on January 1, 2020;

the California Privacy Rights Act of 2020, which amended the CCPA and became effective on January 1, 2023;

and China’s Personal Information Protection Law, which became effective on November 1, 2021.

Other jurisdictions where we operate have enacted or proposed similar legislation and/or regulations.

For example, the Virginia Consumer Data Protection Act and the Colorado Privacy Act are set to become effective on January 1, 2023, and July 1, 2023, respectively.

For example, Virginia, Colorado, Utah and Connecticut have all subsequently passed similar consumer privacy laws, which went into effect in Virginia as of January 1, 2023, and will go into effect in Colorado, Utah and Connecticut later in 2023.

Failure to comply with these laws could result in significant penalties.

Our business has been and will continue to be subject to various other U.S.

and foreign laws, rules and regulations.

and foreign laws, rules and regulations, including provisions of the IRA.

See Reimbursement section above.

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We have reshaped our portfolio and have increasingly focused our efforts on human genetics when possible to enhance the likelihood of success.

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

However, uncertainty remains as to the length of time required for vaccination of a meaningful portion of the population and as to the efficacy of such vaccinations on the trajectory of the pandemic.

Challenges to vaccination efforts, new variants and other causes of virus spread may require governments to issue additional restrictions and/or order shutdowns in various geographies.

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

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

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

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

With regard to our drug development activities, we are continuously monitoring COVID-19 infection rates, including changes from new variants;

With regard to our clinical trial activities, we are continuously monitoring COVID-19 infection rates, including changes from new variants;

we are working to mitigate effects on future study enrollment in our clinical trials;

and we are evaluating the impact in all countries where clinical trials occur.

and we are evaluating the impact in all relevant countries.

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

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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 8, 2022, unless otherwise indicated.

The following table shows a selection of certain of our product candidates by phase of development in our therapeutic areas of focus as of January 31, 2023, unless otherwise indicated.

Additional product candidate information can be found on our website at www.amgen.com.

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KYPROLIS Weekly dosing for relapsed multiple myeloma

LUMAKRAS/LUMYKRAS Advanced colorectal cancer

Nplate Chemotherapy-induced thrombocytopenia

Olpasiran Cardiovascular disease

Otezla Genital psoriasis;

Palmoplantar pustulosis

Repatha Cardiovascular disease

Rocatinlimab Atopic dermatitis

TEZSPIRE Chronic rhinosinusitis with nasal polyps;

Eosinophilic esophagitis;

Severe asthma

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Ulcerative colitis

LUMAKRAS/LUMYKRAS Advanced colorectal cancer

NSCLC monotherapy

LUMAKRAS/LUMYKRAS NSCLC monotherapy;

Other solid tumors with KRAS G12C mutations

Cardiovascular disease

Ordesekimab Celiac disease

Otezla Palmoplantar pustulosis

Rozibafusp alfa Systemic lupus erythematosus

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Chronic spontaneous urticaria

AMG 451/KHK 4083 Atopic dermatitis

AMG 133 Obesity

Phase 1 programs

Acapatamab Prostate cancer

Pavurutamab Multiple myeloma

Tarlatamab Small-cell lung cancer

Bemarituzumab NSCLC and other tumors

Emirodatamab Acute myeloid leukemia

Latikafusp Solid tumors

Tarlatamab Neuroendocrine prostate cancer

AMG 104 Asthma

AMG 119 Small-cell lung cancer

AMG 133 Obesity

AMG 176 Hematologic malignancies

AMG 193 Solid tumors

AMG 199 Metastatic GEJ cancer

AMG 199 Solid tumors

AMG 330 Acute myeloid leukemia

AMG 340 Prostate cancer

AMG 404 Solid tumors

AMG 427 Acute myeloid leukemia

AMG 506 Solid tumors

AMG 509 Prostate cancer

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AMG 650 Solid tumors

AMG 651 Colorectal cancer

AMG 786 Obesity

AMG 794 Solid tumors

AMG 994 Solid tumors

Phase 3 Clinical trials investigate the short- and long-term safety and efficacy of our product candidates, compared to commonly used treatments, in a large number of patients who have the disease or condition under study.

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As of February 8, 2022, we had 13 phase 3 programs.

As of February 8, 2022, we continued to have 13 phase 3 programs, as regulatory approvals were received for three programs, four programs initiated phase 3 studies and one program was terminated.

As of January 31, 2023, we have 18 phase 3 programs, as five programs initiated phase 3 studies.

These changes are set forth in the following table.

Molecule Investigational indication Program change

LUMAKRAS/LUMYKRAS NSCLC with KRAS G12C mutations Approved by the FDA and conditional marketing approval by the EC

Otezla Mild-to-moderate psoriasis Approved by the FDA

Non-Hodgkin’s lymphoma

Approved by the FDA

AMJEVITA Interchangeability Initiated phase 3 study

Bemarituzumab GEJ adenocarcinoma Initiated phase 3 study

BLINCYTO Ph-negative B-cell precursor Acute lymphoblastic leukemia Initiated phase 3 study

TEZSPIRE Chronic rhinosinusitis with nasal polyps Initiated phase 3 study

Otezla COVID-19 Terminated

LUMAKRAS/LUMYKRAS Advanced colorectal cancer Initiated phase 3 study

Olpasiran Cardiovascular disease Initiated phase 3 study

Otezla Palmoplantar pustulosis Initiated phase 3 study

Rocatinlimab Atopic dermatitis Initiated phase 3 study

TEZSPIRE Eosinophilic esophagitis Initiated phase 3 study

Phase 3 Product Candidate Patent Information

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Europe Polypeptides 2029

Olpasiran U.S.

Compounds 2036

Europe Compounds 2036

Rocatinlimab U.S.

Polypeptides 2027

Europe Polypeptides 2026

* Patent expiration estimates are based on issued patents, which may be challenged, invalidated or circumvented by competitors.

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

AMJEVITA is a biosimilar to HUMIRA, which is a monoclonal antibody that inhibits binding of TNF-alpha to cell surface TNF receptor / TNF-alpha.

AMJEVITA is a biosimilar to HUMIRA, which is a monoclonal antibody that inhibits binding of tumor necrosis factor (TNF) alpha to cell surface TNF receptor / TNF-alpha.

Bemarituzumab

Bemarituzumab is a monoclonal antibody that inhibits FGFR2b.

It is being investigated for the treatment of advanced GEJ adenocarcinoma.

In April 2021, Amgen announced that the FDA had granted Breakthrough Therapy designation for bemarituzumab.

Bemarituzumab is a monoclonal antibody that inhibits fibroblast growth factor receptor 2b (FGFR2b).

It is being investigated for the treatment of advanced gastroesophageal junction (GEJ) adenocarcinoma.

BLINCYTO is an anti-CD19 x anti-CD3 BiTE ® molecule.

It is being investigated in newly diagnosed adults age 40 and older with Ph negative B-Cell precursor ALL.

It is being investigated in newly diagnosed adults aged 40 and older with Ph negative B-Cell precursor acute lymphoblastic leukemia (ALL).

Efavaleukin alfa

Efavaleukin alfa is an IL-2 mutein Fc fusion protein.

Efavaleukin alfa is an interleukin (IL)-2 mutein Fc fusion protein.

It is being investigated for the treatment of systemic lupus erythematosus and ulcerative colitis.

EVENITY is a monoclonal antibody that inhibits the action of sclerostin.

It is being evaluated as a treatment for male osteoporo sis.

It is being evaluated as a treatment for male osteoporosis.

EVENITY is being developed in collaboration with UCB.

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It is being investigated for weekly dosing in combinations with lenalidomide and dexamethasone for relapsed multiple myeloma.

In December 2021, we announced that the FDA had approved the expansion of the KYPROLIS prescribing information to include its use in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

LUMAKRAS/LUMYKRAS

LUMAKRAS is a KRAS G12C small molecule inhibitor.

LUMAKRAS/LUMYKRAS is a KRAS G12C small molecule inhibitor.

It is being investigated as treatment for a variety of solid tumors, including NSCLC, colorectal cancer and other solid tumor cancers.

In May 2021, we announced that the FDA had approved LUMAKRAS for the treatment of adult patients with KRAS G12C– mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

In November 2021, we announced that the EMA’s CHMP had adopted a positive opinion and recommended conditional marketing authorization of LUMYKRAS, known as LUMAKRAS in the United States, for the treatment of adults with advanced NSCLC with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

In January 2022, we announced that the EC had granted conditional marketing authorization for LUMYKRAS for the treatment of adults with advanced NSCLC with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

Nplate is a TPO-RA.

It is being investigated for the treatment of CIT.

Olpasiran is an siRNA that lowers lipoprotein(a), also known as Lp(a).

It is being investigated in phase 2 for the treatment of atherosclerotic CV disease.

In February 2022, we announced the presentation of efficacy and safety data from the CodeBreaK 100 Phase 1/2 trial in patients with KRAS G12C–mutated advanced pancreatic cancer who received LUMAKRAS/LUMYKRAS.

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

In August 2022, we announced that the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS/LUMYKRAS met its primary endpoint of PFS, demonstrating statistical significance and superiority over standard-of-care chemotherapy, intravenous docetaxel.

The first randomized clinical trial for a KRAS G12C inhibitor assessed the efficacy and safety of LUMAKRAS/LUMYKRAS in 345 previously treated patients with KRAS G12C–mutated NSCLC who had received at minimum, prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.

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

We also announced updated data from its Phase 1b CodeBreaK 101 study, one of the most comprehensive global clinical development programs in patients with KRAS G12C–mutated colorectal cancer.

These data show that combining LUMAKRAS/LUMYKRAS with Vectibix, Amgen's monoclonal anti-epidermal growth factor receptor (anti-EGFR) antibody, demonstrated encouraging efficacy and safety.

Nplate is a thrombopoietin receptor agonist (TPO-RA).

It is being investigated for the treatment of chemotherapy-induced thrombocytopenia (CIT).

Olpasiran is an siRNA that lowers Lp(a).

It is being investigated in phase 3 for the treatment of ASCVD.

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

The study was designed to assess safety, tolerability and optimal dose of olpasiran in adults with established ASCVD to reduce Lp(a).

Ordesekimab is a monoclonal antibody that inhibits the action of IL-15.

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It is being investigated in phase 3 studies for the treatment of patients with moderate-to-severe genital psoriasis.

It is being investigated in a phase 2 study for treatment of palmoplantar pustulosis.

In February 2021, we announced the submission of an sNDA to the FDA for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.

In May 2021, we announced that the FDA had accepted for review our sNDA for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.

The FDA had set a PDUFA action date of December 19, 2021.

In December 2021, we announced that the FDA had approved the expanded indication for Otezla for the treatment of adult patients with plaque psoriasis, who are candidates for phototherapy or systemic therapy, across all severities.

It is also being investigated in a phase 2 study for treatment of palmoplantar pustulosis.

In September 2022, we announced results from two significant Phase 3 clinical studies of oral Otezla, demonstrating efficacy in pediatric patients with moderate-to-severe plaque psoriasis and in adults with moderate-to-severe genital psoriasis.

Repatha is a human monoclonal antibody that inhibits PCSK9.

It is being investigated as a treatment for atherosclerotic CV disease in high-risk patients with high LDL-C without prior heart attack or stroke.

It is being investigated as a treatment for ASCVD in high-risk patients with high LDL-C without prior heart attack or stroke.

In 2022, we presented results from the Repatha OLE studies to the Phase 3 FOURIER CV outcomes trial.

The studies were designed to assess the long-term safety and tolerability of Repatha in adults with clinically evident ASCVD.

Rocatinlimab is a monoclonal antibody that inhibits OX-40.

It is being investigated for the treatment of moderate-to-severe atopic dermatitis.

Rocatinlimab is being developed in collaboration with KKC.

Rozibafusp alfa

Rozibafusp alfa is a novel antibody-peptide conjugate that simultaneously blocks the BAFF and ICOSL activity.

Rozibafusp alfa is a novel antibody-peptide conjugate that simultaneously blocks the B-cell activating factor (BAFF) and inducible costimulatory ligand (ICOSL) activity.

It is being investigated as a treatment for systemic lupus erythematosus.

Tarlatamab is an HLE anti- DLL3 x anti-CD3 BiTE ® molecule.

Tarlatamab is a half-life extended (HLE) anti- DLL3 x anti-CD3 BiTE ® molecule.

It is being investigated for the treatment of small cell lung cancer.

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TEZSPIRE is being developed jointly in collaboration with AstraZeneca.

In May 2021, we announced that our partner AstraZeneca had submitted a BLA to the FDA for tezepelumab, a potential first-in-class medicine in severe asthma.

In July 2021, we announced that the FDA had accepted a BLA and granted Priority Review of TEZSPIRE for the treatment of asthma.

In December 2021, we announced that the FDA had approved Amgen and AstraZeneca's TEZSPIRE for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

In January 2022, we announced that TEZSPIRE is available for shipment to wholesalers in the United States.

AMG 451/KHK4083

AMG 451/KHK4083 is a monoclonal antibody that inhibits OX-40.

It is being investigated for the treatment of moderate-to-severe atopic dermatitis.

AMG 451/KHK4083 is being developed in collaboration with KKC.

ABP 654, a biosimilar candidate to STELARA (ustekinumab), is a monoclonal antibody that inhibits IL-12 and IL-23.

In February 2022, we announced results from a pooled post hoc analysis of the pivotal NAVIGATOR Phase 3 and PATHWAY Phase 2b trials that showed TEZSPIRE demonstrated reductions in the annualized asthma exacerbation rate (AAER) across biomarker subgroups of patients with severe asthma.

A Phase 3 study of TEZSPIRE in patients with eosinophilic esophagitis has started.

AMG 133 is a gastric inhibitory polypeptide receptor (GIPR) antagonist and glucagon-like peptide 1 (GLP-1) receptor agonist.

It is being investigated for the treatment of obesity.

ABP 654, a biosimilar candidate to STELARA, is a monoclonal antibody that inhibits IL-12 and IL-23.

It is being investigated in a phase 3 study for biosimilarity to STELARA.

The reference-product primary conditions are psoriasis, psoriatic arthritis and Crohn’s disease.

ABP 938, a biosimilar candidate to EYLEA, is a VEGFR Fc fusion protein.

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

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

ABP 938, a biosimilar candidate to EYLEA, is a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein.

It is being investigated in a phase 3 study for biosimilarity to EYLEA.

The reference-product primary conditions are wet AMD, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

The reference-product primary conditions are wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

ABP 959, a biosimilar candidate to SOLIRIS, is a monoclonal antibody that specifically binds to the complement protein C5.

It is being investigated in a phase 3 study for biosimilarity to SOLIRIS.

The reference-product primary conditions are PNH and aHUS.

The reference-product primary conditions are PNH and atypical hemolytic uremic syndrome (aHUS).

In August 2022, we announced positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS, compared with SOLIRIS in adult patients with PNH.

Business Relationships

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In addition, we 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 nonrefundable, upfront license fees, development and commercial-performance milestone payments, cost sharing, royalty payments and/or profit sharing.

These arrangements generally provide for nonrefundable upfront license fees, development and commercial-performance milestone payments, cost sharing, royalties 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.

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BeiGene, Ltd.

On January 2, 2020, we acquired a 20.5% stake in BeiGene for approximately $2.8 billion in cash as part of a collaboration to expand our oncology presence in China.

Under the collaboration, BeiGene began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in early 2022 in China, and Amgen shares profits and losses equally during the initial product-specific commercialization periods;

In January 2020, we acquired an equity stake in BeiGene for approximately $2.8 billion in cash as part of a collaboration to expand our oncology presence in China.

For additional information regarding our equity investment in BeiGene, see Part IV—Note 9, Investments, to the Consolidated Financial Statements.

Under the collaboration, BeiGene began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in 2022 in China, and Amgen shares profits and losses equally during the initial product-specific commercialization periods;

thereafter, product rights may revert to Amgen, and Amgen will pay royalties to BeiGene on sales in China of such products for a specified period.

Amgen manufactures and supplies the collaboration products to BeiGene.

In addition, we jointly develop a portion of our oncology portfolio with BeiGene, which shares in global R&D costs by providing cash and development services of up to $1.25 billion.

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For product sales outside China, Amgen will also pay royalties to BeiGene.

We are in a collaboration with Novartis to jointly develop and commercialize Aimovig.

On January 31, 2022, concurrent with the settlement of the previously disclosed litigation between Amgen and Novartis we modified the terms of the collaboration.

See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.

Arrangement through December 31, 2021

In the United States, Amgen and Novartis jointly developed and collaborated on the commercialization of Aimovig.

Amgen, as the principal, recognized product sales of Aimovig in the United States, shared U.S.

commercialization costs with Novartis and paid Novartis a significant royalty on net sales in the United States.

Novartis held global co-development rights and exclusive commercial rights outside the United States and Japan for Aimovig (the ex-U.S.

Novartis Rights).

Novartis paid Amgen double-digit royalties on net sales of the product in the ex-U.S.

Novartis Rights territories and funded a portion of global R&D expenses.

In addition, Novartis was required to make a payment to Amgen of up to $100 million if certain commercial and expenditure thresholds were achieved with respect to Aimovig in the United States.

Arrangement after January 1, 2022

Pursuant to the amendment effective January 1, 2022, Novartis retains the ex-U.S.

Novartis Rights and will continue to pay double-digit royalties on net sales in the ex-U.S.

Novartis Rights territories.

In the United States, Novartis will no longer collaborate with Amgen, share Aimovig commercialization costs or pay milestones and Amgen will no longer pay royalties to Novartis on sales of Aimovig.

Amgen and Novartis will continue to share development expenses worldwide .

Amgen manufactures and supplies Aimovig worldwide.

In January 2017, we entered into a six-year supply agreement with 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 ESAs used in providing dialysis services in the United States and Puerto Rico.

Such percentages vary during the term of the agreement, but in each year are at least 90%.

The agreement expires in December 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.

AstraZeneca plc

We are in a collaboration with AstraZeneca for the development and commercialization of TEZSPIRE.

Under our collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen.

AstraZeneca leads global development, and both Amgen and AstraZeneca jointly commercialize TEZSPIRE in North America.

In North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada.

AstraZeneca leads commercialization for TEZSPIRE outside North America.

Amgen manufactures and supplies TEZSPIRE worldwide.

We are in a collaboration with UCB for the development and commercialization of EVENITY.

Under our collaboration, UCB has rights to lead commercialization for EVENITY in most countries in Europe and China (excluding Hong Kong).

Amgen, as the principal, leads commercialization for EVENITY and recognizes product sales in all other territories, including the United States.

Global development costs and commercialization profits and losses related to the collaboration are shared equally.

Amgen manufactures and supplies EVENITY worldwide.

For financial information about our significant collaborative arrangements, see Part IV—Note 8, Collaborations, to the Consolidated Financial Statements.

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The unique demands of our industry, together with the challenges of running an enterprise focused on the discovery, development, manufacture and commercialization of innovative medicines, requires a highly engaged and committed workforce.

As of December 31, 2021, Amgen had approximately 24,200 staff members in over 50 countries, and we have had relatively low global turnover rates.

As of December 31, 2022, Amgen had approximately 25,200 staff members in over 50 countries, and we have had relatively low global turnover rates compared to available industry information.

We also supplement our workforce with independent contractors, contingent workers and temporary workers, as needed.

Outside of the United States, some of our employees are represented by unions or works councils.

We consider our staff relations to be good, supported by regular assessments of staff engagement surveys on a wide range of topics (including engagement in the COVID-19 environment, diversity, inclusion and belonging, and maintaining a culture of compliance).

We consider our staff relations to be good, supported by regular assessments of staff engagement surveys on a wide range of topics (including flexible work environments, diversity, inclusion and belonging, and maintaining a culture of compliance).

We discuss the results of these surveys with our workforce and our Board of Directors.

Reflecting our staff members’ desire to retain flexibility to work virtually as COVID-19 related restrictions eased and sites became more accessible, we implemented a flexible workspace initiative that enables many employees to work together with their manager to determine the location that best enables their work at hand, supporting virtual work as well as coming on site.

Compensation, Benefits and Development

Our approach to employee compensation and benefits is designed to deliver cash, equity and benefit programs that are competitive with those offered by leading companies in the biotechnology and pharmaceutical industries to attract, motivate and retain talent with a focus on encouraging performance, promoting accountability and adherence to Company values and alignment with the interests of the Company’s shareholders.

Our approach to employee compensation and benefits is designed to deliver cash, equity and benefit programs that are competitive with those offered by leading companies in the biotechnology and pharmaceutical industries, and to attract, motivate and retain talent with a focus on encouraging performance, promoting accountability and adherence to Company values and alignment with the interests of the Company’s shareholders.

Our base pay program aims to compensate staff members relative to the value of the contributions of their role, which takes into account the skills, knowledge and abilities required to perform each position, as well as the experience brought to the job.

We also provide annual incentive programs to reward our staff in alignment with achievement of Company-wide goals that are established annually and designed to drive aspects of our strategic priorities that support and advance our strategy across our Company.

The majority of our staff members are also eligible for the grant of equity awards under our long-term incentive program that are designed to align the experience of these staff with that of our shareholders.

The majority of our staff members are also eligible for the grant of equity awards under our long-term incentive program that are designed to align the interests of our staff members with those of our shareholders.

For senior level staff, a significant proportion of equity award value is based on company performance.

All staff also participate in a regular performance measurement process through which staff receive performance and development feedback, and pay is aligned to performance.

To support the development of our staff, we provide a variety of programs, including leadership development programs, virtual instructor-led courses and self-paced learning options.

The Amgen Values and leadership behaviors are an integral part of the performance assessments of our staff members, and these evaluations serve as an important information tool and basis for compensation decisions.

To support the development of our staff, we provide a variety of programs, including leadership development programs, classroom-based and virtual instructor-led courses, and self-paced learning options as well as mentoring, networking and coaching opportunities.

Our benefit programs are also generally broad-based, promote health and overall well-being and emphasize saving for retirement.

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Our Compensation and Management Development Committee provides oversight of our compensation plans, policies and programs.

Safety and Wellness and Our Response to COVID-19

Creating a safe and healthy workplace for our staff is a priority at Amgen.

Safety and Wellness and Our Response to the Evolving COVID-19 Pandemic

Creating a safe and healthy workplace for our staff is an important priority at Amgen.

Our goal is to have a world class safety record through safety leadership, risk management practices and integrating safety throughout our business processes.

To foster our safety culture, we implement a comprehensive safety program, driving to understand and mitigate the root cause of safety incidents and manage and control variability.

To foster our safety culture, we implement a comprehensive safety program and reinforce desired safety behaviors, driving to understand and mitigate the root cause of safety incidents and manage and control variability.

We use leading indicators to assess the effectiveness of our safety programs and make course corrections as needed.

Additionally, we perform formal executive management review of functional safety performance for Operations, Global Commercial Operations and R&D on a quarterly basis with a focus on identifying early signals and taking action to drive continuous improvement.

In response to the COVID-19 pandemic and as part of our commitment to work to ensure the safety and well-being of our employees, for 2020 and much of 2021, we have activated our applicable business continuity plans, including having those of our employees who were able to work from home to do so, and for employees returning to the workplace and the field, we took additional safety measures, including implementing occupancy limits, restricting business travel, providing and requiring the use of personal protective equipment, temperature screening and COVID-19 testing to access our workplaces.

Staff member access to our facilities has been in accordance with applicable government health and safety protocols and guidance issued in response to the COVID-19 pandemic, and in 2021 we required staff members in the United States and Puerto Rico to be fully vaccinated against COVID-19.

1 In the fourth quarter of 2021, we enabled our U.S.

based workforce to return to the workplace for work that benefits from face-to-face interactions, while maintaining appropriate safety measures to ensure staff well-being.

This approach intentionally combines the benefits of remote and in-person working at Amgen for the future as COVID-19 restrictions ease around the globe.

In 2022, in response to the evolving requirements of the COVID-19 pandemic, to continue to maintain staff safety while enabling greater flexibility for Amgen sites and enhance efficiencies, we began shifting to a decentralized model for COVID-19 decision-making, empowering our local teams to adjust COVID-19 safety guidance for their individual sites or regions (such as the use of masks and other personal protective equipment, occupancy limits, and temperature check and testing, based on local regulations and risk assessments of local epidemiology criteria).

We will continue to learn and adapt this approach as needed for the future.

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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 chaired by our Chief Executive Officer.

In 2020, we implemented a global unconscious-bias training program, and we launched an ongoing learning journey with tools and resources that guides staff on the role they play in creating diversity, inclusion and belonging throughout the organization.

Each of Amgen’s ERGs is sponsored by an executive leader who reports to the CEO.

We are leveraging our ERGs to represent and support the diversity of Amgen staff, while also providing opportunities to Amgen’s business and the community.

1 The vaccination requirement did not apply to staff who were unable to receive a COVID-19 vaccine because of qualifying religious or medical reasons.

Employee Resource Groups

Our Diversity, Inclusion and Belonging Council is led by our executive leadership and is responsible for overseeing our strategy to further a diverse and inclusive workplace.

We offer a variety of diversity, inclusion and belonging training and learning programs and have continued to launch enhanced tools and resources that guide staff on the role they play in creating diversity, inclusion and belonging throughout the organization.

Further, we continue to incorporate diversity, inclusion and belonging considerations into our business operations, including clinical trial design, procurement and site selection.

Each of Amgen’s Employee Resource Groups is sponsored by senior executive leadership.

Our Employee Resource Groups promote leadership, development and belonging for members while also working to impact our business by leading business initiatives and providing diverse perspectives and experience.

In 2022, Amgen launched its newest global Employee Resource Group called Recognition of Indigenous Peoples, Values and Environmental Resources, or RIVER, to share and continue the traditions, values and culture of Indigenous people.

Global Employee Resource Groups

Amgen Asian Association (AAA) Amgen Black Employee Network (ABEN)

Ability Bettered through Leadership and Education (ABLE), a resource group for those with disabilities,

visible and invisible, including those conditions also experienced by the patients that Amgen serves.

Amgen Early Career Professionals (AECP) Amgen Indian Subcontinent Network (AISN)

Ability Bettered through Leadership and Education (ABLE), a resource group for those with disabilities, visible and invisible, including those conditions also experienced by the patients that Amgen serves

Amgen Early Career Professionals (AECP) Amgen International Network (AIN)

Amgen Latin Employee Network (ALEN) Amgen LGBTQ and Allies Network (PRIDE)

Amgen Veterans Employees Network (AVEN) Women Empowered to be Exceptional (WE2)

Women in Information Systems Enrichment (WISE) Amgen International Network (AIN)

For 2021, to tangibly deepen and drive our diversity, inclusion and belonging activities enterprise-wide and actively communicate our culture of belonging to all staff, we established an annual diversity, inclusion and belonging goal for leaders at executive director and above levels to establish, document and execute diversity, inclusion and belonging action plans, with a target goal of 75% participation, which we achieved and exceeded in 2021.

Amgen South Asian Network (ASAN) Amgen Veterans Employees Network (AVEN)

Recognition of Indigenous Peoples, Values and Environmental Resources (RIVER)

Women Empowered to be Exceptional (WE2) Women in STEM Enrichment (WISE)

Building on the successful adoption of our 2021 ESG goal under our annual incentive plan, we are driving leadership ownership and accountability for diversity, inclusion and belonging deeper in the organization with an enhanced ESG goal for 2022 designed to advance our progress on key ESG initiatives, including by expanding the number of leaders accountable for establishing, documenting and executing on diversity, inclusion and belonging action plans.

As of December 31, 2022, women comprised over 52% of our global workforce, and ethnic minorities accounted for approximately 52% of our U.S.

and Puerto Rico-based workforce.

In areas of underrepresentation, we develop plans with a goal of bringing our representation in line with availability.

We engage in outreach efforts to attract, retain and advance more women and minorities in our workforce.

For example, we have worked to enhance our diverse candidate recruiting pool by developing relationships with organizations that can serve as a source of diverse candidates, such as the National Black MBA Association and National Sales Network, as well as historically black colleges and universities.

For example, we have worked to enhance our diverse candidate recruiting pool by developing relationships with organizations that can serve as a source of diverse candidates, such as the National Black MBA Association and Society of Women in Engineering, as well as historically black colleges and universities.

In 2021, a fellowship program between Amgen and Howard University was established to expand the talent pool and diversify ranks in research and development.

Additionally, at the end of 2020, we became a founding member of OneTen, a coalition of the world’s largest, best-known companies, that aims to hire one million Black Americans (with a specific focus on those without four-year college degrees) into good-paying, family-sustaining jobs over the next ten years.

As a member of OneTen, Amgen is taking a leadership role in the greater Los Angeles region, where the company is headquartered, to help expand the coalition organizations that share our desire to offer opportunities to diverse talent.

Other examples of actions that we are taking in this area include investment and participation in the Healthcare Businesswomen’s Association (a global organization focused on development and business networking for women in healthcare) and the UCLA Anderson School of Management leadership programs for women and underrepresented talent.

Additionally, we are a founding member of OneTen, a coalition of the world’s largest, best-known companies, that aims to hire one million Black Americans (with a specific focus on those without four-year college degrees) into good-paying, family-sustaining jobs over the next ten years.

Amgen is taking a leadership role in the greater Los Angeles region, where the company is headquartered, to help expand the coalition of OneTen organizations that share our desire to offer opportunities to diverse talent, and we developed an in-house apprenticeship program in support of our OneTen commitment.

Other examples of actions that we are taking in this area include increased investment and participation in the Healthcare Businesswomen’s Association (a global organization focused on development and business networking for women in healthcare) and the UCLA Anderson School of Management leadership advancement programs for women and underrepresented talent.

Our 2021 Consolidated EEO-1 Report can be viewed on our website at www.amgen.com (the website address is not intended to function as a hyperlink, and the information contained in our website is not intended to be a part of this filing).

In 2021, our Corporate Responsibility and Compliance Committee provided oversight of our policies, programs and initiatives focusing on workforce diversity and inclusion.

In 2022, oversight of diversity, inclusion and belonging shifted to the Compensation and Management Development Committee, which also provides oversight of our human capital management.

For 2022, our Compensation and Management Development Committee oversaw our labor and employment policies, programs and initiatives, including those relating to diversity, inclusion and belonging.

Information about Our Executive Officers

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Prior to joining the Company, Mr.

Gordon was Chief Commercial Officer at BMS, a pharmaceutical company, from 2016 to 2018.

Gordon was Chief Commercial Officer at Bristol Myers Squibb Company (BMS), a pharmaceutical company, from 2016 to 2018.

Gordon served as Head of Worldwide Markets at BMS from 2015 to 2016.

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Grygiel held several management positions at Mylan Pharmaceuticals, Inc.

Johnston, age 57, became Executive Vice President, Human Resources, in 2019.

From 2016 to 2019, Ms.

Johnston served as the Company’s Senior Vice President, Human Resources.

From 2012 to 2016, Ms.

Johnston was Executive Vice President and Chief Administrative Officer of Celanese Corporation (Celanese).

Prior to Celanese, Ms.

Johnston served in a series of progressive leadership roles at Amgen from 2001 to 2012, 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.

Rachna Khosla, age 50, became Senior Vice President, Business Development, in 2021.

1 unchanged sentence

From 2018 to 2021, Ms.

Khosla was Executive Director, Business Development, and from 2018 to 2021, was Vice President, Business Development.

Khosla was Vice President, Business Development, and from 2016 to 2018, was Executive Director, Business Development.

Prior to joining the Company, Ms.

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Morgan Chase & Co., and Salomon Brothers, Inc.

Derek Miller, age 50, became Senior Vice President, Human Resources, in 2022.

Miller joined the Company in 2003 and has held human resources leadership roles supporting each of the Company’s major business functions.

From 2020 to 2022, Mr.

Miller was Vice President, Global Total Rewards, and from 2018 to 2020, was Vice President, Human Resources.

From 2015 to 2018, Mr.

Miller was an Executive Director, Human Resources.

Prior to 2015, Mr.

Miller served as a Senior Manager in the Human Resources organization, before his promotion to Director, Human Resources, and then to Strategy Director.

Reese, age 60, became Executive Vice President, R&D, in 2018.

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Reese was director of Clinical Research at the Breast Cancer International Research Group from 2001 to 2003 and a cofounder, president and chief medical officer of Translational Oncology Research International, a not-for-profit academic clinical research organization, from 2003 to 2005.

Reese previously served on the faculty at UCLA and the University of California, San Francisco.

Reese previously served on the faculty at the University of California, Los Angeles and the University of California, San Francisco.

Esteban Santos, age 55, became Executive Vice President, Operations, in 2016.

1 unchanged sentence

From 2013 to 2016, 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.

From 2008 to 2013, Mr.

Santos held a number of Vice President roles at the Company in engineering, manufacturing, site operations and drug product.

Prior to joining the Company, Mr.

Santos served as Site General Manager of J&J’s Cordis operation in Puerto Rico.

Santos served as Site General Manager of Johnson & Johnson’s (J&J) Cordis operation in Puerto Rico.

Prior to J&J, Mr.

10 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business