What changed in this filing

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Item 1. Business

2024-02-14 compared with 2023-02-09 · 309 added, 260 removed, 602 unchanged (49% of the section changed)

(including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a biotechnology company 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.

Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987.

(including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease.

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

Our robust pipeline includes potential first-in-class medicines at all stages of development.

We have a presence in approximately 100 countries worldwide.

Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987.

Amgen operates in one business segment:

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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, 2022.

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.

Acquisition of Horizon Therapeutics plc

In October 2023, we completed our acquisition of Horizon for $116.50 per share in cash, representing a total transaction price of $27.8 billion.

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

The acquisition aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for thyroid eye disease (TED), KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder.

Risk Factors— Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions .

Products/Pipeline

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

In October 2023, we announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 (DLL3) targeting BiTE ® (bispecific T-cell engager) molecule, in patients with advanced stage small cell lung cancer (SCLC) who had failed two or more prior lines of treatment.

With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an objective response rate (ORR;

primary endpoint) of 40%.

For key secondary endpoints, median progression-free survival (mPFS) was 4.9 months, and median overall survival (mOS) was 14.3 months.

There were no new safety signals observed compared to the Phase 1 study.

Additionally in October 2023, the FDA granted tarlatamab Breakthrough Therapy Designation for the treatment of adult patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy.

In December 2023, we announced the FDA accepted and granted Priority Review for the Company’s BLA for tarlatamab, with a PDUFA date of June 12, 2024.

LUMAKRAS/LUMYKRAS

• 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.

In December 2023, we announced that the FDA completed its review of our supplemental New Drug Application seeking full approval of LUMAKRAS, resulting in a Complete Response Letter.

The review was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.

Additionally, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS’s accelerated approval has been fulfilled.

LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.

In October 2023, we announced positive data from the global Phase 3 CodeBreaK 300 trial.

This global Phase 3 study evaluated two doses of LUMAKRAS/LUMYKRAS (960 mg or 240 mg) in combination with Vectibix versus investigator’s choice of therapy (trifluridine and tipiracil, or regorafenib) in patients with chemorefractory G12C-mutated mCRC.

In June 2023, based on data from the previous CodeBreaK 101 study, the FDA granted Breakthrough Therapy Designation to LUMAKRAS in combination with Vectibix for the treatment of patients with metastatic KRAS G12C-mutated CRC, as determined by an FDA approved test, who have received prior chemotherapy.

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 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.

We also commercialize and market our products into other geographic territories, including Japan, China and other parts of Asia, Latin America and the Middle East by using our own affiliates, by acquiring existing third-party businesses or product rights or by collaborating with third parties.

This international footprint allows us to deliver our medicines to more patients globally.

See Business Relationships for our significant alliances.

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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 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.

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

and Kyowa Kirin.

Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc.

(formerly AmerisourceBergen) and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2023, 2022 and 2021.

On a combined basis, these wholesalers accounted for 79%, 82% and 82% of worldwide gross revenues for 2023, 2022 and 2021, respectively.

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Total $ 26,910 100 % $ 24,801 100 % $ 24,297 100 %

(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.

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

(1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales from the acquisition date through December 31, 2023.

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

We market Prolia in many countries around the world.

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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 of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture;

or in 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.

In the United States, it is used primarily in the indication for the treatment of postmenopausal women with osteoporosis at high risk of fracture and for treatment to increase bone mass in men with osteoporosis at high risk of fracture.

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

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

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.

Otezla is an oral therapy approved for the treatment of adults with plaque psoriasis across all severities (in the United States, Japan and Australia) and moderate-to-severe plaque psoriasis (in other global markets, including 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 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.

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.

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

We market Nplate in many countries around the world.

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

We market KYPROLIS primarily in the United States and Europe.

KYPROLIS was launched in 2012 and is indicated in combination with (i) dexamethasone, (ii) lenalidomide plus dexamethasone and (iii) DARZALEX plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

KYPROLIS was launched in 2012 and is indicated in combination with (i) dexamethasone, (ii) lenalidomide plus dexamethasone, (iii) daratumumab plus dexamethasone, (iv) daratumumab plus hyaluronidase-fihj plus dexamethasone, and (v) isatuximab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

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 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.

We market Aranesp primarily in the United States and Europe.

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

We market Vectibix in many countries around the world.

Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, cancer that has spread outside the colon and rectum).

RAS status is determined by an FDA-approved test.

We market BLINCYTO in many countries around the world.

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

ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

Subsequent to the closing of our Horizon acquisition, we market TEPEZZA primarily in the United States.

TEPEZZA is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is the first and only FDA approved medicine for the treatment of thyroid eye disease (TED).

TED is a serious, progressive and vision-threatening rare autoimmune condition.

While TED often occurs in people living with hyperthyroidism or Graves’ disease, it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.

This leads to a cascade of negative effects, which may cause long-term, irreversible eye damage.

As TED progresses, it causes serious damage, including proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision), and in some cases can lead to blindness.

Historically, patients have had to live with TED until the inflammation subsides, after which they are often left with permanent and vision-impairing consequences and may require multiple surgeries that do not completely return the patient to their pre-disease state.

Subsequent to the closing of our Horizon acquisition, we market KRYSTEXXA in the United States.

KRYSTEXXA is the first and only FDA-approved medicine for the treatment of chronic refractory gout.

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

Other Marketed Products

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.

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

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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Product Territory General subject matter Expiration

Prolia ® /XGEVA ® (denosumab)

RANKL antibodies, including sequences 2/19/2025

Europe RANKL antibodies, including sequences (1)

Product Territory General subject matter Expiration

Enbrel ® (etanercept)

Methods of treatment using aqueous formulations 6/8/2023

Formulations and methods of preparing formulations 10/19/2037

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DNA encoding fusion protein and methods of making fusion protein 4/24/2029

Prolia ® /XGEVA ® (denosumab)

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

RANKL antibodies, including sequences 2/19/2025

Europe RANKL antibodies, including sequences (1)

Otezla ® (apremilast)

Compositions and compounds 2/16/2028

Crystalline form 12/9/2023

Methods of treatment (2)

Europe Compositions, compounds and methods of treatment (1)

Aranesp ® (darbepoetin alfa)

Glycosylation analogs of erythropoietin proteins 5/15/2024

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

KYPROLIS ® (carfilzomib)

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Europe Compositions, compounds and methods of treatment (1)

Product Territory General subject matter Expiration

Aranesp ® (darbepoetin alfa)

Glycosylation analogs of erythropoietin proteins 5/15/2024

EVENITY ® (romosozumab-aqqg)

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Europe Method of administration 11/6/2029

Aimovig ® (erenumab-aooe)

CGRP receptor antibodies 5/17/2032

TEZSPIRE ® (tezepelumab-ekko)

Polypeptides (2)

Methods of treatment 8/23/2038

Compositions and pharmaceutical formulations 4/1/2039

Europe CGRP receptor antibodies (1)

Europe Methods of treatment 8/10/2035

Europe Polypeptides (1)

TEPEZZA ® (teprotumumab-trbw)

IGF-1R antibodies (3)

Parsabiv ® (etelcalcetide)

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Europe Formulation 6/27/2034

LUMAKRAS® /LUMYKRAS™ (sotorasib) U.S.

Aimovig ® (erenumab-aooe)

CGRP receptor antibodies 5/17/2032

Methods of treatment 4/22/2036

Compositions and pharmaceutical formulations 4/1/2039

Europe CGRP receptor antibodies (1)

Europe Methods of treatment 8/10/2035

LUMAKRAS ® /LUMYKRAS™ (sotorasib)

Compounds and pharmaceutical compositions 5/21/2038

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

TEZSPIRE ® (tezepelumab-ekko)

Polypeptides (3)

KRYSTEXXA ® (pegloticase)

Polypeptides and pharmaceutical compositions

Methods of treatment

Europe Polypeptides 9/9/2028

TAVNEOS ® (avacopan)

Compounds and pharmaceutical compositions (2)

Crystalline and amorphous forms and pharmaceutical compositions 5/29/2041

UPLIZNA ® (inebilizumab-cdon)

CD19 antibodies and pharmaceutical compositions (2)

Europe CD19 antibodies, pharmaceutical compositions and methods of treatment (1)

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

• evolocumab — France, Spain and the United Kingdom, expiring in 2030

• evolocumab — France, expiring in 2030 and Spain and the United Kingdom, expiring in 2031

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

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

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

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

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

10,092,541 was held invalid by the New Jersey District Court.

We disagree with the court’s holding and we are in the process of appealing this judgment.

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

Sandoz Inc., et al.

• tezepelumab — France and Italy, expiring in 2033

• inebilizumab — Italy and Spain, expiring in 2032

(2) A patent with this subject matter may be entitled to patent term extension in the United States.

(3) We have biologic exclusivity in the United States covering teprotumumab-trbw that will expire in 2032.

We operate in a highly competitive environment.

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This competition could impact the pricing and market share of our products.

We continue to pursue ways of increasing the value of our medicines through innovations during their life cycles, which 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.

We continue to pursue ways of increasing the value of our medicines through innovations, which can include expanding the disease areas for which our products are indicated and finding new methods to make the delivery or manufacture of our medicines easier and less costly.

Such activities can offer important opportunities for differentiation.

For example, we market the Neulasta Onpro kit, which provides physicians the opportunity to initiate administration of the recommended dose of Neulasta on the same day as chemotherapy, with drug delivery at home the day after chemotherapy, thereby saving the patient a trip back to the doctor.

We plan to continue pursuing innovation efforts to strengthen our competitive position.

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We have experienced adverse effects from biosimilar competition on our originator product sales.

Companies have launched biosimilar versions of EPOGEN, NEUPOGEN and Neulasta and have approved biosimilars for ENBREL.

Once multiple biosimilar versions of one of our originator products have launched, competition has intensified rapidly, resulting in greater net price declines for both reference and biosimilar products and a greater effect on product sales.

Companies have launched versions of EPOGEN, NEUPOGEN, Neulasta and ENBREL (Canada only) with U.S.

ENBREL biosimilars approved but not launched.

Once multiple biosimilar versions of one of our originator products have launched, competition has intensified rapidly, resulting in greater net price declines for both the reference and the biosimilar products and a greater effect on product sales.

See also Government Regulation—Regulation in the United States—Approval of Biosimilars.

Although competitor biosimilars compete on price, we believe many patients, providers and payers will continue to place high value on the reputation, supply reliability and safety of our products.

As additional biosimilar competitors come to market, we will continue to leverage our global experience to distinguish against both branded and biosimilar competition.

We also have our own biosimilar products both in the United States and outside of U.S.

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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, which launched in January 2023.

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

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

In 2023, we launched AMJEVITA, a biosimilar to HUMIRA, in the United States, and BEKEMV, a biosimilar to SOLIRIS, in the EU.

Additionally, in 2023, Amgen received FDA approval for Wezlana, a biosimilar to STELARA, which we expect to launch in the United States in 2025.

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

Although most of our products are biologics, some are small molecule products.

Although biosimilars compete on price, we believe many patients, providers and payers will continue to place high value on the reputation, supply reliability and safety of our products.

As additional biosimilar competitors come to market, we will continue to leverage our global experience to distinguish against both branded and biosimilar competitors.

Although most of our products are biologics, some are small molecule products, including Otezla, KYPROLIS and LUMAKRAS/LUMYKRAS.

Because the FDA approval process permits generic manufacturers to rely on the safety and efficacy data of the innovator product rather than having to conduct their own costly and time-consuming clinical trials, generic manufacturers can often develop and market their competing versions of our small molecule products at much lower prices.

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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.

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

Product Territory Competitor-marketed product Competitors

& Canada HUMIRA

U.S., Europe & Asia Pacific Bisphosphonates, including generics

Xeljanz Pfizer Inc.

& Canada RINVOQ AbbVie

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

Etanercept biosimilars

& Europe HUMIRA †

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& Europe Skyrizi AbbVie

& Europe Methotrexate generics Various

& Europe SOTYKTU Bristol Myers Squibb (BMS)

& Europe Topical products Various

& Europe Zoledronate generics

& Europe Epoetin alfa biosimilars

& Europe PROMACTA/REVOLADE Novartis

U.S., Europe & Asia Pacific PRALUENT

Regeneron Pharmaceuticals, Inc.

& Europe PROMACTA/REVOLADE Novartis

KYPROLIS U.S.

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& Europe DARZALEX

& Europe UDENYCA Coherus BioSciences, Inc.

& Europe Fulphila

Mylan Institutional Inc.

& Europe Filgrastim biosimilars Various

Alendronate, raloxifene and zoledronate generics Various

& Europe Epoetin alfa biosimilars

Bisphosphonates, including generics Various

Japan Teribone Asahi Kasei Pharma

† Approved biosimilars available in Europe and Canada.

Hoffmann-La Roche Ltd (Roche)

Merck & Co., Inc.

& Europe ERBITUX

Chemotherapy regime Various

† Approved biosimilars available.

(1) Other biosimilars under regulatory review in the United States, Europe and Asia Pacific.

(2) A subsidiary of Johnson & Johnson.

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

(3) REVLIMID also includes generics.

(3) A subsidiary of Takeda Pharmaceutical Company Limited.

(4) REVLIMID also includes generics.

(5) A subsidiary of Bristol Myers Squibb Company.

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

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

TEPEZZA and KRYSTEXXA currently do not face any direct competitors in the United States or Europe.

TEPEZZA faces competition from other therapies, such as corticosteroids, which have been used on an off-label basis to alleviate some of the symptoms of TED.

TEPEZZA and KRYSTEXXA may face competition from competitor medicines currently in clinical trials.

See TEPEZZA and KRYSTEXXA sections above and Government Regulation—Regulation of Orphan Medicines .

Reimbursement

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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;

and their efforts have intensified as a result of rising healthcare costs, economic pressures and broader challenges generated by the COVID-19 pandemic.

and their efforts have intensified, in part, as a result of uncertain macroeconomic conditions, rising healthcare costs and pressures on healthcare budgets.

Drugs remain heavily scrutinized for cost containment.

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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, but are not limited to, 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), stricter utilization management criteria before a patient may get access to a drug, higher-tier formulary placement that increases the level of patient out-of-pocket costs and formulary exclusion, which effectively encourages patients and providers to seek alternative treatments or pay 100% of the cost of a drug.

Such measures include, but are not limited to, 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), stricter utilization management criteria (such as prior authorization and step therapy) before a patient may get access to a drug, higher-tier formulary placement that increases the level of patient out-of-pocket costs and formulary exclusion, which effectively encourages patients and providers to seek alternative treatments or pay 100% of the cost of a drug.

The use of such measures by PBMs and insurers has continued to intensify and has thereby limited Amgen product usage and sales.

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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.

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

The IRA includes provisions requiring that beginning on January 1, 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.

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

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

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

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.

using third-party value assessments to determine drug prices;

and changes to government rebate programs.

For example, on January 5, 2024, the FDA authorized Florida to move forward with its importation program proposal, which excludes biologics.

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.

CMS also issued a proposed Medicaid Drug Rebate Program rule that, if finalized, would require manufacturers to aggregate or “stack” all rebates, discounts or other price concessions made to separate, unrelated entities across the pharmaceutical supply chain on a given unit of product to determine the “Best Price,” a

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

Further, at the state level, seven states (Colorado, Maine, New Hampshire, Maryland, Minnesota, Oregon and Washington) have enacted laws that establish PDABs to identify drugs that pose affordability challenges, and in four states (Colorado, Maryland, Minnesota and Washington) include authority for the state PDAB to set upper payment limits on certain drugs for in-state patients, payers, and providers.

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, 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 EU is currently undergoing a review and possible revision of its pharmaceutical legislation.

Various proposals are now being considered with a possible first reading in the EU Parliament in the first quarter of 2024, with full implementation not expected until 2027 or possibly later.

The new legislation, if implemented, will likely have a significant impact on the landscape for access and pricing decisions within Member States.

There are both positive and negative aspects to the current proposals being debated within the EU Commission and Parliament, including various proposals which could alter the intellectual property protection regime in Europe.

Nevertheless, the legislation, if implemented, is unlikely to significantly impact the difficult financial situation facing many Member States and is, therefore, not likely to improve the overall business climate for biopharmaceutical firms operating in the EU.

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

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 November 2021, we broke ground for our newest biomanufacturing plant located in New Albany, Ohio, which received FDA licensure for commercial production in January 2024.

This final product assembly and packaging plant will support the growing demand for Amgen’s medicines 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.

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.

Subsequent to the Horizon acquisition, we are evaluating Horizon’s supply chains and pursuing activities to further improve resiliency and efficiency.

Risk factors— Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions.

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.

The new facility under construction in North Carolina and our recently FDA approved facility in 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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To better ensure supply, Amgen has a risk mitigation strategy that uses a combination of methods, including multiple sources or backup inventory of critical raw materials.

In response to the COVID-19 pandemic and as part of our ongoing business continuity efforts, we continue to closely monitor our inventory levels and have taken additional measures to mitigate against raw material supply interruption.

As part of our ongoing business continuity efforts, we continue to closely monitor our inventory levels and have taken additional measures to mitigate against raw material supply interruption.

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

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• In phase 3, we conduct clinical trials to 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.

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 Biologics License Application for biologic products or a New Drug Application for small molecule products.

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.

We are not permitted to market or promote a new product until the FDA has approved our marketing application.

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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 the FDA’s advertising and labeling laws and regulations.

The FDA may take enforcement action against a company for violations of the FDA’s 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.

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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 of Orphan Medicines.

Orphan drugs are defined by the FDA as products intended to treat a rare disease or condition that affects less than 200,000 persons in the United States.

A company must request orphan drug designation prior to filing and, if granted for being the first medicine to treat such a rare disease, means the FDA will not approve another sponsor’s marketing application for the same drug for the same indication for seven years.

Orphan drug exclusivity will not bar approval of another medicine for the same indication if it is shown to be clinically superior.

In the United States, a number of our products, including products such as TEPEZZA and UPLIZNA acquired in connection with the Horizon acquisition, have orphan drug exclusivity under this framework.

Regulation outside the United States

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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).

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 Marketing Authorisation Application to the EMA, which conducts an evaluation of the dossier, drawing upon its scientific resources across Europe.

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 requirements for quality, safety and efficacy, the EMA’s CHMP adopts a positive opinion, which is transmitted to the EC for final decision on granting of the marketing authorization.

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

In the EU, Regulation (EC) No 141/2000, as implemented by Regulation (EC) No.

847/2000, provides that a medicine can be designated as an orphan medicinal product by the EC if its sponsor can establish that:

(i) the product is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions;

(ii) either (a) such conditions affect not more than 5 in 10,000 persons in the EU when the application is made, or (b) the product without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in developing the medicinal product;

and (iii) there exists no satisfactory authorized method of diagnosis, prevention, or treatment of the condition that has been authorized in the EU, or even if such method exists, the product will be of significant benefit to those affected by that condition.

An application for the designation of a medicinal product as an orphan medicinal product may be submitted at any stage of development of the medicinal product but before the filing of an MAA.

A marketing authorization for an orphan medicinal product may only include indications designated as orphan.

For non-orphan indications treated with the same active pharmaceutical ingredient, a separate marketing authorization has to be sought.

Approved orphan drugs in the EU receive 10 years of market exclusivity for the approved indication in all EU member states.

We currently have orphan medicinal product designation for BLINCYTO in the EU and intend to seek medicinal product designation for a number of our products 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.

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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 regulators, including the FDA, have authority to mandate labeling changes to products at any point in a product’s life cycle based on new safety information or as part of an evolving label change to a particular class of products.

Health regulators, including the FDA, have authority to mandate labeling changes to products at any point based on new safety information or as part of an evolving label change to a particular class of products.

Health regulators, including the FDA, also have authority both before and after approval to require that a company implement a risk management program for a product to ensure that the benefits of the drug outweigh the risks.

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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, 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.

Other jurisdictions where we operate have enacted or proposed similar legislation and/or regulations, such as consumer privacy laws that went into effect in Virginia, Colorado, Utah, Connecticut and Florida in 2023.

Consumer privacy laws were also passed in 11 other states, with the earliest effective dates later this year, and proposed in three additional states.

In April 2023, a new type of state privacy law focused on protection of consumer health data emerged in Washington with the enactment of the My Health My Data Act, with similar legislation passed subsequently in Nevada.

Both these new consumer health privacy laws become effective March 31, 2024.

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

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

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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, 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 clinical trial 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 the possible impacts from health-related events, including changes from new COVID-19 variants;

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

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For the years ended December 31, 2023, 2022 and 2021, our R&D expenses were $4.8 billion, $4.4 billion and $4.8 billion, respectively.

We have major R&D centers in Thousand Oaks and San Francisco, California;

We have major R&D centers in Thousand Oaks and San Francisco, California, and Deerfield, Illinois;

and the United Kingdom, as well as smaller research centers and development facilities globally.

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BLINCYTO Ph-negative B-cell precursor acute lymphoblastic leukemia

Sjögren’s Syndrome

EVENITY Male osteoporosis

KYPROLIS Weekly dosing for relapsed multiple myeloma

LUMAKRAS/LUMYKRAS Advanced colorectal cancer;

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Olpasiran Cardiovascular disease

Otezla Genital psoriasis;

Palmoplantar pustulosis

Otezla Palmoplantar pustulosis

Repatha Cardiovascular disease

Rocatinlimab Atopic dermatitis

Small cell lung cancer

Active TED in Japan;

Chronic/Low CAS TED in Japan

TEZSPIRE Chronic rhinosinusitis with nasal polyps;

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Severe asthma

ABP 654 Investigational biosimilar to STELARA (ustekinumab)

IgG4-related disease;

Myasthenia gravis

Investigational biosimilar to STELARA (ustekinumab)

Investigational biosimilar to OPDIVO (nivolumab)

ABP 938 Investigational biosimilar to EYLEA (aflibercept)

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Phase 2 programs

Efavaleukin alfa Systemic lupus erythematosus;

Bemarituzumab

Dermatomyositis or anti-synthetase inflammatory myositis;

discoid lupus erythematosus

Efavaleukin alfa

Ulcerative colitis

LUMAKRAS/LUMYKRAS NSCLC monotherapy;

Other solid tumors with KRAS G12C mutations

Ordesekimab Celiac disease

Rozibafusp alfa Systemic lupus erythematosus

Tarlatamab Small cell lung cancer

Fipaxalparant

Diffuse cutaneous systemic sclerosis;

idiopathic pulmonary fibrosis

LUMAKRAS/LUMYKRAS Other solid tumors with KRAS G12C mutations

Maridebart cafraglutide

Celiac disease

TEZSPIRE Chronic obstructive pulmonary disease;

Chronic spontaneous urticaria

AMG 133 Obesity

Phase 1 programs

Acapatamab Prostate cancer

Bemarituzumab NSCLC and other tumors

Emirodatamab Acute myeloid leukemia

Latikafusp Solid tumors

Bemarituzumab NSCLC

Tarlatamab Neuroendocrine prostate cancer

Subcutaneous administration for TED

Prostate cancer

AMG 104 Asthma

AMG 119 Small-cell lung cancer

AMG 176 Hematologic malignancies

AMG 193 Solid tumors

AMG 199 Solid tumors

AMG 340 Prostate cancer

Autoimmune disease

AMG 355 Solid tumors

AMG 509 Prostate cancer

Nonalcoholic steatohepatitis

AMG 651 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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Phase 3 Product Candidate Program Changes

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

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

As of January 31, 2023, we had 18 phase 3 programs.

As of January 31, 2024, we have 24 phase 3 programs, as five phase 3 programs were acquired from Horizon, three programs initiated phase 3 studies, one program was approved by the FDA and one program concluded.

These changes are set forth in the following table.

Molecule Investigational indication Program change

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

Sjögren’s Syndrome Horizon acquired program

KYPROLIS Weekly dosing for relapsed multiple myeloma Concluded—program did not meet its primary endpoint

LUMAKRAS/LUMYKRAS NSCLC in combination with chemotherapy

Initiated phase 3 study

Genital psoriasis

Approved by the FDA

Small cell lung cancer

Initiated phase 3 study

Active TED (OPTIC-J);

Chronic/Low CAS TED in Japan

Horizon acquired programs

IgG4-related disease;

Myasthenia gravis

Horizon acquired programs

Biosimilar to OPDIVO

Initiated phase 3 study

Phase 3 Product Candidate Patent Information

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Europe Polypeptides 2029

Europe Polypeptides

Olpasiran U.S.

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Europe Polypeptides 2026

Polypeptides 2036

Europe Polypeptides 2036

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

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Additional patents may be filed or issued and may provide additional exclusivity for the product candidate or its use.

In addition to patent exclusivity, the product candidates may be protected by regulatory exclusivities upon approval in some countries.

For example, new chemical entities would receive a five year exclusivity period and new molecular entities would receive a 12 year exclusivity period in the United States, whereas new chemical and molecular entities would receive a 10 year exclusivity period in Europe.

Phases 3 and 2 Program Descriptions

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

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

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.

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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.

It is being investigated for the treatment of advanced gastroesophageal junction (GEJ) adenocarcinoma and advanced solid tumors other than advanced squamous NSCLC.

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

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

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

Daxdilimab is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells.

It is being investigated for the treatment of both dermatomyositis and anti-synthetase inflammatory myositis and discoid lupus erythematosus.

Dazodalibep is a fusion protein binding CD40L on T cells, blocking their interaction with CD40-expressing B cells.

It is being investigated for the treatment of Sjögren’s syndrome.

Efavaleukin alfa

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.

It is being investigated for the treatment of ulcerative colitis.

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

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EVENITY is being developed in collaboration with UCB.

KYPROLIS is a small molecule proteasome inhibitor.

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

Fipaxalparant

Fipaxalparant is a molecule that blocks lysophosphatidic acid receptor 1 (LPAR1).

It is being investigated for the treatment of diffuse cutaneous systemic sclerosis and idiopathic pulmonary fibrosis.

LUMAKRAS/LUMYKRAS

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

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.

In October 2023, we announced positive data from the global Phase 3 CodeBreaK 300 trial.

Maridebart cafraglutide

Maridebart cafraglutide 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.

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

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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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Otezla is a small molecule that inhibits PDE4.

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

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.

It is being investigated in phase 3 studies for the treatment of palmoplantar pustulosis.

Repatha is a human monoclonal antibody that inhibits PCSK9.

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 B-cell activating factor (BAFF) and inducible costimulatory ligand (ICOSL) activity.

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

Rocatinlimab is being developed in collaboration with Kyowa Kirin.

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.

In October 2023, we announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational DLL3 targeting BiTE ® molecule, in patients with advanced stage SCLC who had failed two or more prior lines of treatment.

With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an ORR (primary endpoint) of 40%.

For key secondary endpoints, mPFS was 4.9 months, and mOS was 14.3 months.

There were no new safety signals observed compared to the Phase 1 study.

In December 2023, we announced the FDA accepted and granted Priority Review for the Company’s BLA for tarlatamab, with a PDUFA date of June 12, 2024.

TEPEZZA is a monoclonal antibody against IGF-1R.

It is being investigated in phase 3 studies for patients with moderate-to-severe active TED and chronic/low clinical activity score (CAS) TED.

It is also being investigated for subcutaneous administration.

TEZSPIRE is a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin.

It is being evaluated in phase 3 studies as a treatment for severe asthma and chronic rhinosinusitis with nasal polyps.

It is being evaluated in phase 3 studies as a treatment for severe asthma, chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis.

It is also being investigated in phase 2 studies as a treatment for chronic obstructive pulmonary disease and chronic spontaneous urticaria.

TEZSPIRE is being developed jointly in collaboration with AstraZeneca.

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.

UPLIZNA is a humanized, affinity-optimized, afucosylated IgG1 kappa (IgG1κ) monoclonal antibody that binds to the B cell-specific surface antigen CD19.

It is being investigated for the treatment of flare in patients with IgG4-related disease and myasthenia gravis.

Wezlana, 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.

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 206, a biosimilar candidate to OPDIVO, is a monoclonal antibody that binds to the receptor protein called programmed death protein 1 (PD-1).

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

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

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.

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

Business Relationships

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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).

Under our collaboration, UCB has rights to lead commercialization for EVENITY in most countries in Europe.

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

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We strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.

The way we approach our business is guided by our Amgen Values:

The way we approach our business is guided by the Amgen Values:

Be Science-Based

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Collaborate, Communicate and Be Accountable

Our staff are also guided by the Company’s Code of Conduct, which is designed to help every person who does business on our behalf worldwide (including all staff, management, consultants, contract workers and temporary workers) to understand what is expected of them.

Our industry exists in a complex regulatory and reimbursement environment.

Our staff are also guided by, and receive annual training on, the Company’s Code of Conduct, which is designed to help every person who does business on our behalf worldwide (including all staff, management, consultants, contract workers and temporary workers) to understand what is expected of them.

Our industry is subject to a co mplex regulatory and reimbursement environment.

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.

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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 flexible work environments, 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, career development, 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.

Reflecting our staff members’ desire to retain a flexible approach to work, we offer 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 working in person.

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, 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 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 the Amgen Values and alignment with the interests of the Company’s stockholders.

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 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.

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.

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

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

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

The Amgen Values and Leadership Attributes (Inspire, Accelerate, Integrate and Adapt) 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.

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

All regular U.S.

staff members are eligible to participate in the same core health and welfare and retirement savings plans.

employee benefits include medical plans, dental plans, adoption assistance, paid parental leave programs, access to childcare, employee assistance programs, employee stock purchase plan, flexible spending accounts, life, long-term care and business travel accident insurance, short and long-term disability benefits, wellness benefits and work-life resources and referrals.

Comparable programs and benefits are available globally, with the same health and well-being intent, consistent with statutory requirements.

employee benefits include adoption assistance, paid parental leave programs, access to childcare, employee assistance programs, employee stock purchase plan, flexible spending accounts, life, long-term care and business travel accident insurance, short and long-term disability benefits, wellness benefits and work-life resources and referrals.

Comparable programs and benefits are available globally, with the same health and well-being intent, and consistent with local statutory requirements.

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

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

Safety and Wellness

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

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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 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.

Our Corporate Responsibility and Compliance Committee provides general oversight of our safety programs and initiatives, while our Board of Directors, as a whole, has overseen our specific responses to the COVID-19 pandemic.

Diversity, Inclusion and Belonging

Our CRCC provides general oversight of our safety programs and initiatives.

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

Further, we also believe our global presence is strengthened by having a workforce that reflects the diversity of the patients we serve (1) .

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

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.

We offer a variety of diversity, inclusion and belonging programs and have continued to launch enhanced resources that guide staff on the role they play in creating an inclusive culture.

Further, we continue to incorporate diversity, inclusion and belonging considerations into our business operations, including clinical trial design and procurement, to broaden access to patients and suppliers to the benefit of our business.

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.

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

(1) Amgen is an equal opportunity employer and does not make employment decisions based on race, gender, ethnicity, or any other protected characteristic.

Global Employee Resource Groups

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

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

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

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

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.

Building on the successful execution of our 2022 ESG goal under our annual incentive plan, our enhanced ESG goal for 2023 was designed to advance our progress on key ESG initiatives, including by driving measurable achievement of our Representation in Clinical Research (RISE) objectives that seek to improve the diversity and representation of racial and ethnic minority populations in our clinical trial research to help us develop medicines that are studied in participants who better reflect the populations affected by serious illness, and further expanding the number of leaders accountable for establishing, documenting and executing on diversity, inclusion and belonging action plans.

As of December 31, 2023, women comprised approximately 53% of our global workforce, and ethnic minorities accounted for approximately 50% 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 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, 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.

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

In 2023, we launched our Apprenticeship Program as part of our multidimensional inclusive hiring and talent development strategy, with the first phase of the program beginning with our Manufacturing and DTI functions.

Our Apprenticeship Program is a skills-based approach that proactively seeks to hire candidates from nontraditional sources and backgrounds, and is designed to invest in our future workforce through attracting, hiring and upskilling non-four-year degreed talent in the United States.

Through the Apprenticeship Program, we will provide individuals with classroom-based and on-the-job training as well as mentorship opportunities needed to develop proficiency in targeted business areas and roles.

We believe that our Apprenticeship Program and other skills-based approaches to hiring will provide us with access to a larger pool of highly motivated and productive talent while also providing underrepresented groups greater access to innovation economy careers.

Our 2022 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).

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.

Our Compensation and Management Development Committee oversees 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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Bradway was a director of Norfolk Southern Corporation, a transportation company.

Bradner, age 51, became Executive Vice President, Research and Development, and Chief Scientific Officer, in December 2023.

Prior to joining the Company, from 2022 to 2023, Dr.

Bradner was a clinician at the Dana-Farber Cancer Institute.

From 2016 to 2022, Dr.

Bradner served as President of the Novartis Institutes for BioMedical Research, where he was a member of the Executive Committee of Novartis AG.

Bradner previously served on the faculty at Harvard Medical School.

Murdo Gordon, age 57, became Executive Vice President, Global Commercial Operations, in 2018.

Prior to joining the Company, Mr.

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

Gordon was Chief Commercial Officer at 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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Prior to Lazard, Ms.

Khosla had various roles at Credit Suisse Group AG, Sanofi Aventis, Aventis Capital, J.P.

Khosla held various roles in investment banking (mergers and acquisitions) and corporate venture capital at Credit Suisse Group AG, Sanofi Aventis, Aventis Capital, J.P.

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

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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.

Reese joined the Company in 2005 and has held leadership roles in development, medical sciences and discovery research.

Reese was Senior Vice President, Translational Sciences and Oncology, from 2017 to 2018 and Senior Vice President, Translational Sciences, from 2015 to 2017.

Reese, age 61, became the Company’s inaugural Executive Vice President and Chief Technology Officer, in December 2023, responsible for accelerating the use of technology and artificial intelligence across the organization.

From 2018 to December 2023, Dr.

Reese served as Executive Vice President, Research and Development.

Reese joined the Company in 2005 and has held leadership roles in development, translational and medical sciences, and discovery research, including as Senior Vice President, Translational Sciences and Oncology, from 2017 to 2018.

Prior to joining Amgen, Dr.

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 the University of California, Los Angeles and the University of California, San Francisco.

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

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

Esteban Santos, age 56, became Executive Vice President, Operations, in 2016.

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Prior to joining the Company, Mr.

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

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

Prior to J&J, Mr.

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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