☒
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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95-3540776
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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One Amgen Center Drive
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91320-1799
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Thousand Oaks
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California
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Trading Symbol (s)
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Name of each exchange on which registered
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Common stock, $0.0001 par value
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AMGN
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The NASDAQ Global Select Market
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1.250% Senior Notes Due 2022
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AMGN22
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New York Stock Exchange
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2.00% Senior Notes Due 2026
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AMGN26
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New York Stock Exchange
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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☒
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☐
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☐
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☐
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☐
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(A)
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Excludes 744,928 shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, at June 30, 2019. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, directly or indirectly, to direct or cause the direction of the management or policies of the registrant, or that such person is controlled by or under common control with the registrant.
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Page No.
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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Item 15.
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Item 16.
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Item 1.
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BUSINESS
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•
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In June 2019, the U.S. Food and Drug Administration (FDA) approved KANJINTITM for all approved indications of the reference product Herceptin® (trastuzumab) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In July 2019, we and Allergan plc (Allergan) launched KANJINTITM in the United States.
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In September 2019, we announced that the phase 3 CANDOR (Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma) study evaluating KYPROLIS® in combination with dexamethasone and DARZALEX® (daratumumab) compared to KYPROLIS® and dexamethasone alone in patients with relapsed multiple myeloma met its primary endpoint of progression-free survival (PFS).
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•
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In January 2020, a supplemental New Drug Application (sNDA) was submitted to the FDA to expand the Prescribing Information to include KYPROLIS® in combination with dexamethasone and DARZALEX® for patients with relapsed or refractory multiple myeloma based on data from the phase 3 CANDOR study.
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•
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In January 2020, our Marketing Authorization Application (MAA) was accepted by the China National Medical Products Administration for the use of KYPROLIS® and dexamethasone for the treatment of relapsed or refractory multiple myeloma.
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In July 2019, we and Allergan launched MVASITM in the United States.
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In January 2020, we entered into a strategic collaboration with BeiGene, Ltd. (BeiGene) to support our oncology pipeline and expand our oncology presence in China. As part of the agreement we acquired a 20.5% stake in BeiGene for $2.8 billion in cash.
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•
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In October 2019, the FDA granted AMG 510 fast track designation for the treatment of patients with previously treated metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation. AMG 510 is a small molecule inhibitor of KRAS G12C.
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In August 2019, we and Allergan announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan® in patients with CD20-positive B-cell non-Hodgkin’s lymphoma. The primary endpoint, an assessment of overall response rate by week 28, was within the prespecified margin for ABP 798 compared to Rituxan®, showing clinical equivalence. Safety and immunogenicity of ABP 798 were comparable to Rituxan®.
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•
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In December 2019, we and Allergan submitted a Biologics License Application (BLA) to the FDA for ABP 798.
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•
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In August 2019, the U.S. District Court for the District of Delaware overturned a unanimous jury verdict upholding the validity of two of our patents related to proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies in our infringement action against Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC and Regeneron Pharmaceuticals, Inc. See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.
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•
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In December 2019, the FDA approved AVSOLATM for all approved indications of the reference product REMICADE® (infliximab).
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In August 2019, the U.S. District Court for the District of New Jersey ruled in Amgen’s favor on validity of the two patents that describe and claim ENBREL and methods for making it. See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.
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•
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In November 2019, we completed our acquisition of the worldwide rights to Otezla®, the only oral, non-biologic treatment for psoriasis and psoriatic arthritis from Celgene Corporation (Celgene). Otezla®, along with certain related assets and liabilities, was acquired for $13.4 billion in cash.
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In April 2019, the FDA approved EVENITY® for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
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In December 2019, the European Commission (EC) granted marketing authorization for EVENITY® for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
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In July 2019, we and Novartis AG (Novartis) discontinued investigating AMG 520/CNP520, a small molecule inhibitor of beta-site amyloid precursor protein-cleaving enzyme-1 (BACE), for the prevention of Alzheimer’s disease.
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Product
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Territory
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General subject matter
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Expiration
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Enbrel® (etanercept)
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U.S.
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Methods of treatment using aqueous formulations
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6/8/2023
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U.S.
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Formulations
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10/19/2037
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U.S.
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Fusion protein and pharmaceutical compositions
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11/22/2028
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U.S.
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DNA encoding fusion protein and methods of making fusion protein
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4/24/2029
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Prolia®/XGEVA® (denosumab)
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U.S.
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RANKL antibodies
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9/17/2021
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U.S.
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Methods of treatment
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6/25/2022
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U.S.
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Nucleic acids encoding RANKL antibodies and methods of producing RANKL antibodies
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11/30/2023
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U.S.
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RANKL antibodies, including sequences
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2/19/2025
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Europe
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RANKL antibodies, including epitope binding
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2/23/2021
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Europe
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RANKL antibodies, including sequences(1)
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6/25/2022
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Aranesp® (darbepoetin alfa)
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U.S.
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Glycosylation analogs of erythropoietin proteins
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5/15/2024
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Sensipar®/Mimpara® (cinacalcet)
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U.S.
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Formulation
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9/22/2026
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Europe
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Calcium receptor-active molecules(1)
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10/23/2015
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Europe
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Formulation
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9/10/2024
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KYPROLIS® (carfilzomib)
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U.S.
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Compositions and compounds
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12/7/2027
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U.S.
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Methods of treatment
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4/14/2025
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U.S.
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Methods of making
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5/8/2033
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Europe
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Compositions, compounds and methods of treatment(1)
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8/8/2025
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Nplate® (romiplostim)
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U.S.
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Thrombopoietic compounds
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1/19/2022
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U.S.
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Formulation
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2/12/2028
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Europe
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Thrombopoietic compounds(1)
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10/22/2019
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Europe
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Formulation
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4/20/2027
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Vectibix® (panitumumab)
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U.S.
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Human monoclonal antibodies to epidermal growth factor receptor
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4/8/2020
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Europe
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Human monoclonal antibodies to epidermal growth factor receptor(1)
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5/5/2018
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Repatha® (evolocumab)
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U.S.
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Antibodies(2)
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10/25/2029
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U.S.
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Methods of treatment
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10/8/2030
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Europe
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Compositions(1)
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8/22/2028
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Europe
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Methods of treatment
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5/10/2032
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Parsabiv® (etelcalcetide)
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U.S.
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Compound and pharmaceutical composition(2)
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7/29/2030
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U.S.
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Formulation
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6/27/2034
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U.S.
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Methods of making
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8/9/2035
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Europe
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Compound and pharmaceutical composition(1)
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7/29/2030
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Europe
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Formulation
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6/27/2034
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BLINCYTO® (blinatumomab)
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U.S.
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Bifunctional polypeptides
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4/23/2023
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U.S.
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Method of administration
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9/28/2027
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Europe
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Bifunctional polypeptides(1)
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11/26/2024
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Europe
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Method of administration
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11/6/2029
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Aimovig® (erenumab-aooe)
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U.S.
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CGRP receptor antibodies(2)
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11/9/2031
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U.S.
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Methods of treatment
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4/22/2036
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Europe
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CGRP receptor antibodies(1)
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12/18/2029
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Europe
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Methods of treatment
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8/10/2035
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IMLYGIC® (talimogene laherparepvec)
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U.S.
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Compositions
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11/23/2025
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U.S.
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Method of treatment
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3/27/2022
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Europe
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Composition and uses(1)
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3/27/2022
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Corlanor® (ivabradine)
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U.S.
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Crystalline forms
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2/22/2026
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EVENITY® (romosozumab-aqqg)
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U.S.
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Antibodies(2)
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4/25/2026
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U.S.
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Methods of treatment(2)
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1/11/2029
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U.S.
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Formulation and methods of using formulation
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5/11/2031
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Europe
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Antibodies
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4/28/2026
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Europe
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Methods of treatment
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4/18/2032
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Europe
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Formulation and methods of using formulation
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5/11/2031
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Otezla® (apremilast)
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U.S.
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Compositions and compounds
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2/16/2028
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U.S.
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Crystalline form
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12/9/2023
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U.S.
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Methods of treatment
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5/29/2034
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Europe
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Compositions, compounds and methods of treatment(1)
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3/20/2023
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(1)
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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. For example, supplementary protection certificates have been issued related to the indicated products for patents in at least the following countries:
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(2)
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A patent with this subject matter may be entitled to patent term extension in the United States.
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Product
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Territory
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Competitor-marketed product
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Competitors
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ENBREL
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U.S. & Canada
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REMICADE®*
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Janssen Biotech, Inc. (Janssen)(1)
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U.S. & Canada
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HUMIRA®
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AbbVie Inc.
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U.S. & Canada
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STELARA®(2)
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Janssen(1)
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Neulasta®(3)
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U.S.
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UDENYCATM
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Coherus BioSciences, Inc.
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U.S.
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Fulphila®
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Mylan Institutional Inc.
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U.S. & Europe
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Filgrastim biosimilars
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Various
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Prolia®
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U.S. & Europe
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Alendronate, raloxifene and zoledronate generics
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Various
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Aranesp®
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U.S.
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PROCRIT®(4)
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Janssen(1)
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U.S.
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MIRCERA®(5)
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Galenica Group (Galenica)/F. Hoffmann-La Roche Ltd. (Roche)
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U.S. & Europe
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Epoetin alfa biosimilars
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Various
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XGEVA®
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U.S. & Europe
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Zoledronate generics
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Various
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Sensipar®(6)/Mimpara®
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U.S. & Europe
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Active vitamin D analogs
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Various
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EPOGEN®(3)
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U.S.
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MIRCERA®
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Galenica/Roche
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U.S.
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RETACRITTM
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Hospira(7)
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KYPROLIS®(9)
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U.S.
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NINLARO®
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Millennium Pharmaceuticals, Inc.(8)
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U.S. & Europe
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REVLIMID®
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Celgene (10)
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U.S.
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POMALYST®
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Celgene (10)
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U.S.
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DARZALEX®
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Janssen(1)
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Repatha®
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U.S. & Europe
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PRALUENT®
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Regeneron
Sanofi
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Otezla®
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U.S. & Europe
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HUMIRA®(2)
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AbbVie Inc.
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U.S. & Europe
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STELARA®(2)
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Janssen(1)
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U.S. & Europe
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Cosentyx®(2)
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Novartis
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U.S. & Europe
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Methotrexate generics(2)
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Various
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(1)
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A subsidiary of Johnson & Johnson (J&J).
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(2)
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Dermatology only.
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(3)
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Other biosimilars under regulatory review in the United States and Europe.
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(4)
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PROCRIT® competes with Aranesp® in supportive cancer care and predialysis settings.
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(5)
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MIRCERA® competes with Aranesp® only in the nephrology segment.
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(6)
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Our U.S. composition-of-matter patent for Sensipar® expired in March 2018. We are engaged in litigation with a number of companies seeking to market generic versions of Sensipar® surrounding our U.S. formulation patent that expires in September 2026. See Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements, for further information. Several of these generic versions of Sensipar® have been approved by the FDA.
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(7)
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A subsidiary of Pfizer Inc.
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(8)
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A subsidiary of Takeda Pharmaceutical Company Limited.
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(9)
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KYPROLIS® is facing increased competition from several recently approved products.
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(10)
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A subsidiary of Bristol-Myers Squibb Company (BMS).
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•
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investing billions of dollars annually in R&D;
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•
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developing more affordable therapeutic choices in the form of high-quality and reliably-supplied biosimilars;
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•
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pricing our medicines to reflect the value they provide;
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•
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partnering with payers to share risk and accountability for health outcomes;
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•
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providing patient support and education programs;
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•
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helping patients in financial need access our medicines; and
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•
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working with policy makers, patients and other stakeholders to establish a sustainable healthcare system with access to affordable care and where patients and their healthcare professionals are the primary decision makers.
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•
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In phase 1, we conduct small clinical trials to investigate the safety and proper dose ranges of our product candidates in a small number of human subjects.
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•
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In phase 2, we conduct clinical trials to investigate side-effect profiles and the efficacy of our product candidates in a large number of patients who have the disease or condition under study.
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•
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In phase 3, we conduct clinical trials to investigate the safety and efficacy of our product candidates in a large number of patients who have the disease or condition under study.
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Molecule
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Disease/condition
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Phase 3 programs
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EVENITY®
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Male osteoporosis
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IMLYGIC®
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Metastatic melanoma
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KYPROLIS®
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Multiple myeloma
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Weekly dosing for relapsed multiple myeloma
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Nplate®
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Chemotherapy-induced thrombocytopenia
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Omecamtiv mecarbil
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Chronic heart failure
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Otezla®
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Behcet’s disease
|
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Genital psoriasis
|
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Mild-to-moderate psoriasis
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Repatha®
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Cardiovascular disease
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Tezepelumab
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Severe asthma
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ABP 798
|
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Rheumatoid arthritis
|
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Non-Hodgkin’s lymphoma
|
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ABP 959
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Paroxysmal nocturnal hemoglobinuria
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Phase 2 programs
|
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Rozibafusp alfa (formerly AMG 570)
|
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Systemic lupus erythematosus
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Tezepelumab
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Atopic dermatitis
|
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Chronic obstructive pulmonary disease
|
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AMG 510
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Solid tumors with KRAS mutations
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AMG 714/PRV-015
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Celiac disease
|
Phase 1 programs
|
|
|
AMG 119
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Small-cell lung cancer
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AMG 160
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Prostate cancer
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AMG 171
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Obesity
|
AMG 176
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|
Hematologic malignancies
|
AMG 199
|
|
Metastatic gastric and gastroesophageal junction cancer
|
AMG 212
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Prostate cancer
|
AMG 330
|
|
Acute myeloid leukemia
|
AMG 397
|
|
Hematologic malignancies
|
AMG 404
|
|
Solid tumors
|
AMG 420
|
|
Multiple myeloma
|
AMG 424
|
|
Multiple myeloma
|
AMG 427
|
|
Acute myeloid leukemia
|
AMG 430
|
|
Cystic fibrosis
|
AMG 506
|
|
Solid tumors
|
AMG 562
|
|
Non-Hodgkin’s lymphoma
|
Efavaleukin alfa (formerly AMG 592)
|
|
Inflammatory diseases
|
AMG 594
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|
Cardiovascular disease
|
AMG 596
|
|
Glioblastoma
|
AMG 673
|
|
Acute myeloid leukemia
|
AMG 701
|
|
Multiple myeloma
|
AMG 757
|
|
Small-cell lung cancer
|
AMG 890
|
|
Cardiovascular disease
|
Phase 3
|
Clinical trials investigate the safety and efficacy of product candidates in a large number of patients who have the disease or condition under study; typically performed with registrational intent.
|
Phase 2
|
Clinical trials investigate side-effect profiles and efficacy of product candidates in a large number of patients who have the disease or condition under study.
|
Phase 1
|
Clinical trials investigate the safety and proper dose ranges of product candidates in a small number of human subjects.
|
Molecule
|
|
Disease/condition
|
|
Program change
|
AVSOLATM
|
|
All approved indications for the reference product REMICADE® (infliximab)
|
|
Approved by the FDA
|
ENBREL
|
|
Rheumatoid arthritis remission
|
|
Study was completed
|
EVENITY®
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|
Postmenopausal osteoporosis
|
|
Approved by the FDA and the EC
|
KYPROLIS®
|
|
Relapsed multiple myeloma
|
|
Initiated phase 3 study
|
Nplate®
|
|
Chemotherapy-induced thrombocytopenia
|
|
Initiated phase 3 study
|
Otezla®
|
|
Behcet’s disease
|
|
Acquired from Celgene
|
|
Genital psoriasis
|
|
Acquired from Celgene
|
|
|
Mild-to-moderate psoriasis
|
|
Acquired from Celgene
|
|
Repatha®
|
|
Cardiovascular disease
|
|
Initiated phase 3 study
|
AMG 520/CNP 520
|
|
Alzheimer’s disease
|
|
Terminated
|
Molecule
|
|
Territory
|
|
General subject matter
|
|
Estimated expiration*
|
Omecamtiv mecarbil
|
|
U.S.
|
|
Compound
|
|
2027
|
|
Europe
|
|
Compound
|
|
2025
|
|
Tezepelumab
|
|
U.S.
|
|
Polypeptides
|
|
2029
|
|
Europe
|
|
Polypeptides
|
|
2028
|
Item 1A.
|
RISK FACTORS
|
•
|
revised or restrictive labeling for our products, or the potential for restrictive labeling that has resulted, and may in the future result, in our decision not to commercialize a product candidate;
|
•
|
requirement of risk management or minimization activities or other regulatory agency compliance actions related to the promotion and sale of our products;
|
•
|
post-marketing commitments, mandated post-marketing requirements or pharmacovigilance programs for our approved products;
|
•
|
product recalls of our approved products;
|
•
|
required changes to the processes used in the manufacture of our products, which could increase our manufacturing costs and affect the availability of contract manufacturers we may utilize to assist in such manufacturing;
|
•
|
revocation of approval for our products from the market completely, or within particular therapeutic areas or patient types;
|
•
|
increased timelines or delays in being approved by the FDA or other regulatory bodies; and/or
|
•
|
treatments or product candidates not being approved by regulatory bodies.
|
•
|
the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive preclinical trial results, for reasons that could include changes in the standard of care of medicine;
|
•
|
the product candidate was not effective or not more effective than currently available therapies in treating a specified condition or illness;
|
•
|
the product candidate was not cost effective in light of existing therapeutics;
|
•
|
the product candidate had harmful side effects in animals or humans;
|
•
|
the necessary regulatory bodies, such as the FDA or EMA, did not approve the product candidate for an intended use;
|
•
|
the product candidate was not economical for us to manufacture and commercialize;
|
•
|
other parties had or may have had proprietary rights relating to our product candidate, such as patent rights, and did not let us sell it on reasonable terms, or at all;
|
•
|
we and certain of our licensees, partners, contracted organizations or independent investigators may have failed to effectively conduct clinical development or clinical manufacturing activities;
|
•
|
the pathway to regulatory approval or reimbursement for product candidates was uncertain or not well-defined;
|
•
|
the biosimilar product candidate failed to demonstrate the requisite biosimilarity to the applicable reference product, or was otherwise determined by a regulatory authority to not meet applicable standards for approval; and
|
•
|
a companion diagnostic device that is required with the use of a product candidate is not approved by the necessary regulatory authority.
|
•
|
regulatory requirements or action by regulatory agencies or others;
|
•
|
adverse financial or other strategic developments at or affecting the supplier, including bankruptcy;
|
•
|
unexpected demand for or shortage of raw materials, medical devices or components;
|
•
|
failure to comply with our quality standards which results in quality and product failures, product contamination and/or recall;
|
•
|
a material shortage, contamination, recall and/or restrictions on the use of certain biologically derived substances or other raw materials;
|
•
|
discovery of previously unknown or undetected imperfections in raw materials, medical devices or components;
|
•
|
cyber-attacks on supplier systems; and
|
•
|
labor disputes or shortages, including from the effects of health emergencies (such as novel viruses or pandemics) and natural disasters.
|
•
|
capacity of manufacturing facilities;
|
•
|
contamination by microorganisms or viruses, or foreign particles from the manufacturing process;
|
•
|
natural or other disasters, including hurricanes, earthquakes, volcanoes or fires;
|
•
|
labor disputes or shortages, including the effects of health emergencies (such as novel viruses or pandemics) or natural disasters;
|
•
|
compliance with regulatory requirements;
|
•
|
changes in forecasts of future demand;
|
•
|
timing and actual number of production runs and production success rates and yields;
|
•
|
updates of manufacturing specifications;
|
•
|
contractual disputes with our suppliers and contract manufacturers;
|
•
|
timing and outcome of product quality testing;
|
•
|
power failures and/or other utility failures;
|
•
|
cyber-attacks on supplier systems;
|
•
|
breakdown, failure, substandard performance or improper installation or operation of equipment (including our information technology systems and network-connected control systems or those of our contract manufacturers or third-party service providers); and/or
|
•
|
delays in the ability of the FDA or foreign regulatory agencies to provide us necessary reviews, inspections and approvals, including as a result of a subsequent extended U.S. federal government shutdown.
|
Item 1B.
|
UNRESOLVED STAFF COMMENTS
|
Item 2.
|
PROPERTIES
|
Item 3.
|
LEGAL PROCEEDINGS
|
Item 4.
|
MINE SAFETY DISCLOSURES
|
Item 5.
|
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
|
12/31/2018
|
|
12/31/2019
|
Amgen (AMGN)
|
$100.00
|
|
$103.97
|
|
$96.12
|
|
$117.57
|
|
$135.31
|
|
$172.68
|
Amex Biotech (BTK)
|
$100.00
|
|
$111.39
|
|
$90.06
|
|
$124.11
|
|
$124.44
|
|
$149.87
|
Amex Pharmaceutical (DRG)
|
$100.00
|
|
$104.18
|
|
$95.49
|
|
$111.37
|
|
$119.66
|
|
$141.66
|
S&P 500 (SPX)
|
$100.00
|
|
$101.37
|
|
$113.49
|
|
$138.33
|
|
$132.29
|
|
$173.93
|
|
|
Total
number of
shares
purchased
|
|
Average
price paid
per share(1)
|
|
Total number
of shares
purchased as
part of
publicly
announced
program
|
|
Maximum dollar
value that may
yet be purchased
under the
program(2)
|
||||||
October 1 - October 31
|
|
2,500,729
|
|
|
$
|
199.94
|
|
|
2,500,729
|
|
|
$
|
3,064,464,667
|
|
November 1 - November 30
|
|
1,349,900
|
|
|
$
|
222.55
|
|
|
1,349,900
|
|
|
$
|
2,764,044,387
|
|
December 1 - December 31
|
|
1,218,800
|
|
|
$
|
237.95
|
|
|
1,218,800
|
|
|
$
|
6,474,033,251
|
|
|
|
5,069,429
|
|
|
$
|
215.10
|
|
|
5,069,429
|
|
|
|
||
January 1 - December 31
|
|
40,244,414
|
|
|
$
|
189.85
|
|
|
40,244,414
|
|
|
|
(1)
|
Average price paid per share includes related expenses.
|
(2)
|
In May 2019 and December 2019, our Board of Directors increased the amount authorized under our stock repurchase program by an additional $5.0 billion and $4.0 billion, respectively.
|
Item 6.
|
SELECTED FINANCIAL DATA
|
|
Years ended December 31,
|
||||||||||||||||||
Consolidated Statements of Income Data:
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
|
(In millions, except per-share data)
|
||||||||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
Product sales
|
$
|
22,204
|
|
|
$
|
22,533
|
|
|
$
|
21,795
|
|
|
$
|
21,892
|
|
|
$
|
20,944
|
|
Other revenues
|
1,158
|
|
|
1,214
|
|
|
1,054
|
|
|
1,099
|
|
|
718
|
|
|||||
Total revenues
|
$
|
23,362
|
|
|
$
|
23,747
|
|
|
$
|
22,849
|
|
|
$
|
22,991
|
|
|
$
|
21,662
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of sales
|
$
|
4,356
|
|
|
$
|
4,101
|
|
|
$
|
4,069
|
|
|
$
|
4,162
|
|
|
$
|
4,227
|
|
Research and development
|
$
|
4,116
|
|
|
$
|
3,737
|
|
|
$
|
3,562
|
|
|
$
|
3,840
|
|
|
$
|
4,070
|
|
Selling, general and administrative
|
$
|
5,150
|
|
|
$
|
5,332
|
|
|
$
|
4,870
|
|
|
$
|
5,062
|
|
|
$
|
4,846
|
|
Net income(1)
|
$
|
7,842
|
|
|
$
|
8,394
|
|
|
$
|
1,979
|
|
|
$
|
7,722
|
|
|
$
|
6,939
|
|
Diluted earnings per share(1)
|
$
|
12.88
|
|
|
$
|
12.62
|
|
|
$
|
2.69
|
|
|
$
|
10.24
|
|
|
$
|
9.06
|
|
Dividends paid per share
|
$
|
5.80
|
|
|
$
|
5.28
|
|
|
$
|
4.60
|
|
|
$
|
4.00
|
|
|
$
|
3.16
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
As of December 31,
|
||||||||||||||||||
Consolidated Balance Sheets Data:
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
|
(In millions)
|
||||||||||||||||||
Total assets
|
$
|
59,707
|
|
|
$
|
66,416
|
|
|
$
|
79,954
|
|
|
$
|
77,626
|
|
|
$
|
71,449
|
|
Total debt(2)
|
$
|
29,903
|
|
|
$
|
33,929
|
|
|
$
|
35,342
|
|
|
$
|
34,596
|
|
|
$
|
31,429
|
|
Total stockholders’ equity(3)
|
$
|
9,673
|
|
|
$
|
12,500
|
|
|
$
|
25,241
|
|
|
$
|
29,875
|
|
|
$
|
28,083
|
|
(1)
|
In 2017, we recorded a net charge of $6.1 billion as a result of the 2017 Tax Act. See Part IV—Note 6, Income taxes, to the Consolidated Financial Statements.
|
(2)
|
See Part IV—Note 15, Financing arrangements, to the Consolidated Financial Statements, for discussion of our financing arrangements. In 2016, we issued $7.3 billion of debt and repaid $3.7 billion of debt. In 2015, we issued $3.5 billion of debt and repaid $2.4 billion of debt.
|
(3)
|
Throughout the five years ended December 31, 2019, we had a stock repurchase program authorized by the Board of Directors, through which we repurchased $7.6 billion, $17.9 billion, $3.1 billion, $3.0 billion and $1.9 billion, respectively, of Amgen common stock.
|
Item 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|||||
Product sales:
|
|
|
|
|
|
|||||
U.S.
|
$
|
16,531
|
|
|
(5
|
)%
|
|
$
|
17,429
|
|
Rest of world (ROW)
|
5,673
|
|
|
11
|
%
|
|
5,104
|
|
||
Total product sales
|
22,204
|
|
|
(1
|
)%
|
|
22,533
|
|
||
Other revenues
|
1,158
|
|
|
(5
|
)%
|
|
1,214
|
|
||
Total revenues
|
$
|
23,362
|
|
|
(2
|
)%
|
|
$
|
23,747
|
|
Operating expenses
|
$
|
13,688
|
|
|
2
|
%
|
|
$
|
13,484
|
|
Operating income
|
$
|
9,674
|
|
|
(6
|
)%
|
|
$
|
10,263
|
|
Net income
|
$
|
7,842
|
|
|
(7
|
)%
|
|
$
|
8,394
|
|
Diluted EPS
|
$
|
12.88
|
|
|
2
|
%
|
|
$
|
12.62
|
|
Diluted shares
|
609
|
|
|
(8
|
)%
|
|
665
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
ENBREL
|
$
|
5,226
|
|
|
4
|
%
|
|
$
|
5,014
|
|
|
(8
|
)%
|
|
$
|
5,433
|
|
Neulasta®
|
3,221
|
|
|
(28
|
)%
|
|
4,475
|
|
|
(1
|
)%
|
|
4,534
|
|
|||
Prolia®
|
2,672
|
|
|
17
|
%
|
|
2,291
|
|
|
16
|
%
|
|
1,968
|
|
|||
XGEVA®
|
1,935
|
|
|
8
|
%
|
|
1,786
|
|
|
13
|
%
|
|
1,575
|
|
|||
Aranesp®
|
1,729
|
|
|
(8
|
)%
|
|
1,877
|
|
|
(9
|
)%
|
|
2,053
|
|
|||
KYPROLIS®
|
1,044
|
|
|
8
|
%
|
|
968
|
|
|
16
|
%
|
|
835
|
|
|||
EPOGEN®
|
867
|
|
|
(14
|
)%
|
|
1,010
|
|
|
(8
|
)%
|
|
1,096
|
|
|||
Sensipar®/Mimpara®
|
551
|
|
|
(69
|
)%
|
|
1,774
|
|
|
3
|
%
|
|
1,718
|
|
|||
Other products
|
4,959
|
|
|
49
|
%
|
|
3,338
|
|
|
29
|
%
|
|
2,583
|
|
|||
Total product sales
|
$
|
22,204
|
|
|
(1
|
)%
|
|
$
|
22,533
|
|
|
3
|
%
|
|
$
|
21,795
|
|
Total U.S.
|
$
|
16,531
|
|
|
(5
|
)%
|
|
$
|
17,429
|
|
|
2
|
%
|
|
$
|
17,131
|
|
Total ROW
|
5,673
|
|
|
11
|
%
|
|
5,104
|
|
|
9
|
%
|
|
4,664
|
|
|||
Total product sales
|
$
|
22,204
|
|
|
(1
|
)%
|
|
$
|
22,533
|
|
|
3
|
%
|
|
$
|
21,795
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
ENBREL — U.S.
|
$
|
5,050
|
|
|
5
|
%
|
|
$
|
4,807
|
|
|
(8
|
)%
|
|
$
|
5,206
|
|
ENBREL — Canada
|
176
|
|
|
(15
|
)%
|
|
207
|
|
|
(9
|
)%
|
|
227
|
|
|||
Total ENBREL
|
$
|
5,226
|
|
|
4
|
%
|
|
$
|
5,014
|
|
|
(8
|
)%
|
|
$
|
5,433
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
Neulasta® — U.S.
|
$
|
2,814
|
|
|
(27
|
)%
|
|
$
|
3,866
|
|
|
(2
|
)%
|
|
$
|
3,931
|
|
Neulasta® — ROW
|
407
|
|
|
(33
|
)%
|
|
609
|
|
|
1
|
%
|
|
603
|
|
|||
Total Neulasta®
|
$
|
3,221
|
|
|
(28
|
)%
|
|
$
|
4,475
|
|
|
(1
|
)%
|
|
$
|
4,534
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
Prolia® — U.S.
|
$
|
1,772
|
|
|
18
|
%
|
|
$
|
1,500
|
|
|
18
|
%
|
|
$
|
1,272
|
|
Prolia® — ROW
|
900
|
|
|
14
|
%
|
|
791
|
|
|
14
|
%
|
|
696
|
|
|||
Total Prolia®
|
$
|
2,672
|
|
|
17
|
%
|
|
$
|
2,291
|
|
|
16
|
%
|
|
$
|
1,968
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
XGEVA® — U.S.
|
$
|
1,457
|
|
|
9
|
%
|
|
$
|
1,338
|
|
|
16
|
%
|
|
$
|
1,157
|
|
XGEVA® — ROW
|
478
|
|
|
7
|
%
|
|
448
|
|
|
7
|
%
|
|
418
|
|
|||
Total XGEVA®
|
$
|
1,935
|
|
|
8
|
%
|
|
$
|
1,786
|
|
|
13
|
%
|
|
$
|
1,575
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
Aranesp® — U.S.
|
$
|
758
|
|
|
(20
|
)%
|
|
$
|
942
|
|
|
(15
|
)%
|
|
$
|
1,114
|
|
Aranesp® — ROW
|
971
|
|
|
4
|
%
|
|
935
|
|
|
—
|
%
|
|
939
|
|
|||
Total Aranesp®
|
$
|
1,729
|
|
|
(8
|
)%
|
|
$
|
1,877
|
|
|
(9
|
)%
|
|
$
|
2,053
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
KYPROLIS® — U.S.
|
$
|
654
|
|
|
12
|
%
|
|
$
|
583
|
|
|
4
|
%
|
|
$
|
562
|
|
KYPROLIS® — ROW
|
390
|
|
|
1
|
%
|
|
385
|
|
|
41
|
%
|
|
273
|
|
|||
Total KYPROLIS®
|
$
|
1,044
|
|
|
8
|
%
|
|
$
|
968
|
|
|
16
|
%
|
|
$
|
835
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
EPOGEN® — U.S.
|
$
|
867
|
|
|
(14
|
)%
|
|
$
|
1,010
|
|
|
(8
|
)%
|
|
$
|
1,096
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
Sensipar® — U.S.
|
$
|
252
|
|
|
(82
|
)%
|
|
$
|
1,436
|
|
|
5
|
%
|
|
$
|
1,374
|
|
Sensipar®/Mimpara® — ROW
|
299
|
|
|
(12
|
)%
|
|
338
|
|
|
(2
|
)%
|
|
344
|
|
|||
Total Sensipar®/Mimpara®
|
$
|
551
|
|
|
(69
|
)%
|
|
$
|
1,774
|
|
|
3
|
%
|
|
$
|
1,718
|
|
|
Year ended December 31, 2019
|
|
Change
|
|
Year ended December 31, 2018
|
|
Change
|
|
Year ended December 31, 2017
|
||||||||
Nplate® — U.S.
|
$
|
480
|
|
|
10
|
%
|
|
$
|
438
|
|
|
12
|
%
|
|
$
|
392
|
|
Nplate® — ROW
|
315
|
|
|
13
|
%
|
|
279
|
|
|
12
|
%
|
|
250
|
|
|||
Vectibix® — U.S.
|
316
|
|
|
10
|
%
|
|
288
|
|
|
15
|
%
|
|
251
|
|
|||
Vectibix® — ROW
|
428
|
|
|
6
|
%
|
|
403
|
|
|
3
|
%
|
|
391
|
|
|||
Repatha® — U.S.
|
376
|
|
|
5
|
%
|
|
358
|
|
|
59
|
%
|
|
225
|
|
|||
Repatha® — ROW
|
285
|
|
|
48
|
%
|
|
192
|
|
|
*
|
|
|
94
|
|
|||
Parsabiv® — U.S.
|
550
|
|
|
82
|
%
|
|
302
|
|
|
*
|
|
|
—
|
|
|||
Parsabiv® — ROW
|
80
|
|
|
*
|
|
|
34
|
|
|
*
|
|
|
5
|
|
|||
BLINCYTO® — U.S.
|
176
|
|
|
31
|
%
|
|
134
|
|
|
18
|
%
|
|
114
|
|
|||
BLINCYTO® — ROW
|
136
|
|
|
42
|
%
|
|
96
|
|
|
57
|
%
|
|
61
|
|
|||
Aimovig® — U.S.
|
306
|
|
|
*
|
|
|
119
|
|
|
*
|
|
|
—
|
|
|||
NEUPOGEN® — U.S.
|
178
|
|
|
(20
|
)%
|
|
223
|
|
|
(40
|
)%
|
|
369
|
|
|||
NEUPOGEN® — ROW
|
86
|
|
|
(39
|
)%
|
|
142
|
|
|
(21
|
)%
|
|
180
|
|
|||
KANJINTITM — U.S.
|
118
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
KANJINTITM — ROW
|
108
|
|
|
*
|
|
|
44
|
|
|
*
|
|
|
—
|
|
|||
AMGEVITATM — ROW
|
215
|
|
|
*
|
|
|
11
|
|
|
*
|
|
|
—
|
|
|||
EVENITY® — U.S.
|
42
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
EVENITY® — ROW
|
147
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
Otezla® — U.S.
|
139
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
Otezla® — ROW
|
39
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
MVASITM — U.S.
|
121
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
MVASITM — ROW
|
6
|
|
|
*
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
Other — U.S.
|
105
|
|
|
24
|
%
|
|
85
|
|
|
25
|
%
|
|
68
|
|
|||
Other — ROW
|
207
|
|
|
9
|
%
|
|
190
|
|
|
4
|
%
|
|
183
|
|
|||
Total other product sales
|
$
|
4,959
|
|
|
49
|
%
|
|
$
|
3,338
|
|
|
29
|
%
|
|
$
|
2,583
|
|
Total U.S. — other products
|
$
|
2,907
|
|
|
49
|
%
|
|
$
|
1,947
|
|
|
37
|
%
|
|
$
|
1,419
|
|
Total ROW — other products
|
2,052
|
|
|
48
|
%
|
|
1,391
|
|
|
20
|
%
|
|
1,164
|
|
|||
Total other product sales
|
$
|
4,959
|
|
|
49
|
%
|
|
$
|
3,338
|
|
|
29
|
%
|
|
$
|
2,583
|
|
Category
|
|
Description
|
Research and early pipeline
|
|
R&D expenses incurred in activities substantially in support of early research through the completion of phase 1 clinical trials, including drug discovery, toxicology, pharmacokinetics and drug metabolism, and process development
|
Later-stage clinical programs
|
|
R&D expenses incurred in or related to phase 2 and phase 3 clinical programs intended to result in registration of a new product or a new indication for an existing product primarily in the United States or the EU
|
Marketed products
|
|
R&D expenses incurred in support of the Company’s marketed products that are authorized to be sold primarily in the United States or the EU. Includes clinical trials designed to gather information on product safety (certain of which may be required by regulatory authorities) and their product characteristics after regulatory approval has been obtained, as well as the costs of obtaining regulatory approval of a product in a new market after approval in either the United States or the EU has been obtained
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Research and early pipeline
|
$
|
1,649
|
|
|
$
|
1,201
|
|
|
$
|
972
|
|
Later-stage clinical programs
|
1,062
|
|
|
1,034
|
|
|
879
|
|
|||
Marketed products
|
1,405
|
|
|
1,502
|
|
|
1,711
|
|
|||
Total R&D expense
|
$
|
4,116
|
|
|
$
|
3,737
|
|
|
$
|
3,562
|
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Interest expense, net
|
$
|
1,289
|
|
|
$
|
1,392
|
|
|
$
|
1,304
|
|
Interest and other income, net
|
$
|
753
|
|
|
$
|
674
|
|
|
$
|
928
|
|
Provision for income taxes
|
$
|
1,296
|
|
|
$
|
1,151
|
|
|
$
|
7,618
|
|
Effective tax rate
|
14.2
|
%
|
|
12.1
|
%
|
|
79.4
|
%
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Cash, cash equivalents and marketable securities
|
$
|
8,911
|
|
|
$
|
29,304
|
|
Total assets
|
$
|
59,707
|
|
|
$
|
66,416
|
|
Current portion of long-term debt
|
$
|
2,953
|
|
|
$
|
4,419
|
|
Long-term debt
|
$
|
26,950
|
|
|
$
|
29,510
|
|
Stockholders’ equity
|
$
|
9,673
|
|
|
$
|
12,500
|
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net cash provided by operating activities
|
$
|
9,150
|
|
|
$
|
11,296
|
|
|
$
|
11,177
|
|
Net cash provided by (used in) investing activities
|
$
|
5,709
|
|
|
$
|
14,339
|
|
|
$
|
(4,024
|
)
|
Net cash used in financing activities
|
$
|
(15,767
|
)
|
|
$
|
(22,490
|
)
|
|
$
|
(6,594
|
)
|
|
|
Payments due by period as of December 31, 2019
|
||||||||||||||||||
Contractual obligations
|
|
Total
|
|
Year 1
|
|
Years 2 and 3
|
|
Years 4 and 5
|
|
Years 6
and beyond
|
||||||||||
Long-term debt obligations (1) (2) (3)
|
|
$
|
48,080
|
|
|
$
|
4,086
|
|
|
$
|
9,612
|
|
|
$
|
4,467
|
|
|
$
|
29,915
|
|
Operating lease obligations (4)
|
|
910
|
|
|
159
|
|
|
266
|
|
|
157
|
|
|
328
|
|
|||||
Purchase obligations (5)
|
|
1,938
|
|
|
1,512
|
|
|
255
|
|
|
100
|
|
|
71
|
|
|||||
U.S. repatriation tax (6)
|
|
6,162
|
|
|
587
|
|
|
1,174
|
|
|
2,567
|
|
|
1,834
|
|
|||||
Unrecognized tax benefits (UTBs) (7)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total contractual obligations
|
|
$
|
57,090
|
|
|
$
|
6,344
|
|
|
$
|
11,307
|
|
|
$
|
7,291
|
|
|
$
|
32,148
|
|
(1)
|
Long-term debt obligations include future interest payments on our fixed-rate obligations at the contractual coupon rates. To achieve a desired mix of fixed-rate and floating-rate debt, we enter into interest rate swap contracts that effectively convert a fixed-rate interest coupon for certain of our debt issuances to a floating LIBOR-based coupon over the terms of the related hedge contracts. We used an interest rate forward curve as of December 31, 2019, in computing net amounts to be paid or received under our interest rate swap contracts, which resulted in an aggregate net decrease in future interest payments of $309 million. See Part IV—Note 15, Financing arrangements, to the Consolidated Financial Statements.
|
(2)
|
Long-term debt obligations include future interest payments on our LIBOR-based variable-rate obligations. We used an interest rate forward curve as of December 31, 2019, in computing the LIBOR-based portion of interest payments on these debt obligations. See Part IV—Note 15, Financing arrangements, to the Consolidated Financial Statements.
|
(3)
|
Long-term debt obligations include contractual interest payments and principal repayments of our foreign-denominated debt obligations. In order to hedge our exposure to foreign currency exchange rate risk associated with certain of our euro-, pound-sterling- and Swiss-franc-denominated long-term debt, we entered into cross-currency swap contracts that effectively converted interest payments and principal repayments on this debt from euros, pounds sterling and Swiss francs to U.S. dollars. For purposes of this table, we used the contracted exchange rates in the cross-currency swap contracts to compute the net amounts of future interest payments and principal repayments on this debt. See Part IV—Note 18, Derivative instruments, to the Consolidated Financial Statements.
|
(4)
|
Operating lease obligations includes payments for leases that have not yet commenced, net of lease incentives, and excludes $141 million of future receipts under noncancelable subleases of abandoned facilities.
|
(5)
|
Purchase obligations relate primarily to (i) R&D commitments (including those related to clinical trials) for new and existing products, (ii) capital expenditures and (iii) open purchase orders for the acquisition of goods and services in the ordinary course of business. Our obligation to pay certain of these amounts may be reduced based on certain future events.
|
(6)
|
Under the 2017 Tax Act, we elected to pay in eight annual installments the repatriation tax related primarily to our prior indefinitely invested earnings of our foreign operations. See Part IV—Note 19, Contingencies and commitments—Commitments – U.S. repatriation tax, to the Consolidated Financial Statements.
|
(7)
|
Liabilities for UTBs are not included in the table above because due to their nature there is a high degree of uncertainty regarding the timing of future cash outflows and other events that extinguish these liabilities. See Part IV—Note 6, Income taxes, to the Consolidated Financial Statements.
|
|
Rebates
|
|
Chargebacks
|
|
Other deductions
|
|
Total
|
||||||||
Balance as of December 31, 2016
|
$
|
1,417
|
|
|
$
|
342
|
|
|
$
|
115
|
|
|
$
|
1,874
|
|
Amounts charged against product sales
|
4,909
|
|
|
6,098
|
|
|
992
|
|
|
11,999
|
|
||||
Payments
|
(4,459
|
)
|
|
(6,168
|
)
|
|
(999
|
)
|
|
(11,626
|
)
|
||||
Balance as of December 31, 2017
|
1,867
|
|
|
272
|
|
|
108
|
|
|
2,247
|
|
||||
Amounts charged against product sales
|
6,180
|
|
|
6,926
|
|
|
1,180
|
|
|
14,286
|
|
||||
Payments
|
(5,458
|
)
|
|
(6,744
|
)
|
|
(1,161
|
)
|
|
(13,363
|
)
|
||||
Balance as of December 31, 2018
|
2,589
|
|
|
454
|
|
|
127
|
|
|
3,170
|
|
||||
Amounts charged against product sales
|
6,825
|
|
|
7,090
|
|
|
1,292
|
|
|
15,207
|
|
||||
Payments
|
(6,249
|
)
|
|
(6,985
|
)
|
|
(1,263
|
)
|
|
(14,497
|
)
|
||||
Balance as of December 31, 2019
|
$
|
3,165
|
|
|
$
|
559
|
|
|
$
|
156
|
|
|
$
|
3,880
|
|
•
|
determining the timing and expected costs to complete in-process projects, taking into account the stage of completion at the acquisition date;
|
•
|
projecting the probability and timing of obtaining marketing approval from the FDA and other regulatory agencies for product candidates;
|
•
|
estimating the timing of and future net cash flows from product sales resulting from completed products and in-process projects; and
|
•
|
developing appropriate discount rates to calculate the present values of the cash flows.
|
Item 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Item 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
Item 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
Item 9A.
|
CONTROLS AND PROCEDURES
|
Item 9B.
|
OTHER INFORMATION
|
Item 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
Item 11.
|
EXECUTIVE COMPENSATION
|
Item 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
(1)
|
The Amended and Restated 2009 Equity Incentive Plan employs a fungible share-counting formula for determining the number of shares available for issuance under the plan. In accordance with this formula, each option or stock appreciation right counts as one share, while each restricted stock unit, performance unit or dividend equivalent counts as 1.9 shares. The number under column (a) represents the actual number of shares issuable under our outstanding awards without giving effect to the fungible share-counting formula. The number under column (c) represents the number of shares available for issuance under this plan based on each such available share counting as one share. Commencing with the grants made in April 2012, RSUs and performance units accrue dividend equivalents that are payable in shares only to the extent and when the underlying RSUs vest or underlying performance units have been earned and the related shares are issued to the grantee. The performance units granted under this plan are earned based on the accomplishment of specified performance goals at the end of their respective three-year performance periods; the number of performance units granted represent target performance, and the maximum number of units that could be earned based on our performance is 200% of the performance units granted in 2017, 2018 and 2019.
|
(2)
|
This plan has terminated as to future grants. The number under column (a) with respect to this plan includes 13,439 shares issuable upon the settlement of deferred RSUs (including 2,357 related dividend equivalents).
|
(3)
|
The Amgen Profit Sharing Plan for Employees in Ireland (the Profit Sharing Plan) was approved by the Board of Directors on July 28, 2011. The Profit Sharing Plan permits eligible employees of the Company’s subsidiaries located in Ireland who participate in the Profit Sharing Plan to apply a portion of their qualifying bonus and salary to the purchase the Company’s common stock on the open market at the market price by a third-party trustee as described in the Profit Sharing Plan.
|
Item 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
|
Item 14.
|
PRINCIPAL ACCOUNTING FEES AND SERVICES
|
Item 15.
|
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
|
(a)1.
|
Index to Financial Statements
|
|
Page
number
|
Report of Independent Registered Public Accounting Firm
|
|
|
|
Consolidated Statements of Income for each of the three years in the period ended December 31, 2019
|
|
|
|
Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, 2019
|
|
|
|
Consolidated Balance Sheets as of December 31, 2019 and 2018
|
|
|
|
Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, 2019
|
|
|
|
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2019
|
|
|
|
Notes to Consolidated Financial Statements
|
(a)2.
|
Index to Financial Statement Schedules
|
|
Page
number
|
II. Valuation and Qualifying Accounts
|
(a)3.
|
Exhibits
|
Exhibit No.
|
|
Description
|
2.1
|
|
Asset Purchase Agreement, dated August 25, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.)
|
|
|
|
2.2
|
|
Amendment No. 1 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 8-K on October 17, 2019 and incorporated herein by reference.)
|
|
|
|
2.3*
|
|
|
|
|
|
2.4*
|
|
|
|
|
|
2.5
|
|
Irrevocable Guarantee, dated August 25, 2019, by and between Amgen Inc. and Bristol-Myers Squibb Company. (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.)
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Amgen Inc. (As Restated March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.)
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated February 15, 2016.) (Filed as an exhibit to Form 8-K on February 17, 2016 and incorporated herein by reference.)
|
|
|
|
4.1
|
|
Form of stock certificate for the common stock, par value $.0001 of the Company. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1997 on May 14, 1997 and incorporated herein by reference.)
|
|
|
|
4.22
|
|
Officer’s Certificate of Amgen Inc., dated as of February 25, 2016, including forms of the Company’s 1.250% Senior Notes due 2022 and 2.000% Senior Notes due 2026. (Filed as an exhibit on Form 8-K on February 26, 2016 and incorporated herein by reference.)
|
|
|
|
4.23
|
|
Form of Permanent Global Certificate for the Company’s 0.410% bonds due 2023. (Filed as an exhibit on Form 8-K on March 8, 2016 and incorporated herein by reference.)
|
|
|
|
4.24
|
|
Terms of the Bonds for the Company’s 0.410% bonds due 2023. (Filed as an exhibit on Form 8-K on March 8, 2016 and incorporated herein by reference.)
|
|
|
|
4.25
|
|
Officer’s Certificate of Amgen Inc., dated as of June 14, 2016, including forms of the Company’s 4.563% Senior Notes due 2048 and 4.663% Senior Notes due 2051. (Filed as an exhibit to Form 8-K on June 14, 2016 and incorporated herein by reference.)
|
|
|
|
4.26
|
|
Officer’s Certificate of Amgen Inc., dated as of August 19, 2016, including forms of the Company’s 1.850% Senior Notes due 2021, 2.250% Senior Notes due 2023 and 2.600% Senior Notes due 2026. (Filed as an exhibit to Form 8-K on August 19, 2016 and incorporated herein by reference.)
|
|
|
|
4.27
|
|
Officer’s Certificate of Amgen Inc., dated as of May 11, 2017 including forms of the Company’s Senior Floating Rate Notes due 2020, 2.200% Senior Notes due 2020 and 2.650% Senior Notes due 2022. (Filed as an exhibit to Form 8-K on May 11, 2017 and incorporated herein by reference.)
|
|
|
|
4.28
|
|
Officer’s Certificate of Amgen Inc., dated as of November 2, 2017, including in the form of the Company’s 3.200% Senior Notes due 2027. (Filed as an exhibit to Form 8-K on November 2, 2017 and incorporated by reference.)
|
|
|
|
4.29*
|
|
|
|
|
|
10.1+
|
|
Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (Filed as Appendix C to the Definitive Proxy Statement on Schedule 14A on April 8, 2013 and incorporated herein by reference.)
|
|
|
|
10.2+
|
|
First Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 4, 2015. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2015 on April 27, 2015 and incorporated herein by reference.)
|
|
|
|
10.3+
|
|
Second Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 2, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2016 on May 2, 2016 and incorporated herein by reference.)
|
|
|
|
10.4+*
|
|
|
|
|
|
10.5+*
|
|
|
|
|
|
10.6+
|
|
Amgen Inc. 2009 Performance Award Program. (As Amended on December 12, 2017.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2017 on February 13, 2018 and incorporated herein by reference.)
|
|
|
|
10.7+*
|
|
|
|
|
|
10.8+*
|
|
|
|
|
|
10.9+
|
|
Form of Grant of Non-Qualified Stock Option Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (Filed as an exhibit to Form 8-K on May 8, 2009 and incorporated herein by reference.)
|
|
|
|
10.10+*
|
|
|
|
|
|
10.11+*
|
|
|
|
|
|
10.12+
|
|
Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.)
|
|
|
|
10.13+
|
|
First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.)
|
|
|
|
10.32
|
|
Settlement Agreement and Release, dated October 11, 2011, by and between Bayer Corporation, Bayer AG, Bayer HealthCare LLC and Bayer Pharma AG and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.)
|
|
|
|
10.33
|
|
Fourth Amendment to Collaboration Agreement, dated October 11, 2011, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.)
|
|
|
|
10.34
|
|
Side Letter Regarding Collaboration Agreement, dated May 29, 2015, by and between Bayer HealthCare LLC and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2015 on August 5, 2015 and incorporated herein by reference.)
|
|
|
|
10.35
|
|
Sourcing and Supply Agreement, dated January 6, 2017, by and between Amgen USA Inc., a wholly owned subsidiary of Amgen Inc., and DaVita Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2017 on April 27, 2017 and incorporated herein by reference.)
|
|
|
|
10.36
|
|
Exclusive License and Collaboration Agreement, dated August 28, 2015, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
10.37
|
|
Amendment No. 1 to the Exclusive License and Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
10.38
|
|
Amendment No. 2 to the Exclusive License and Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
10.39
|
|
Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
10.40
|
|
Amendment No. 1 to the Collaboration Agreement, dated March 20, 2018, by and between Novartis Pharma AG and Amgen Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2018 on April 25, 2018 and incorporated herein by reference.)
|
|
|
|
10.41*
|
|
Collaboration Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene Switzerland GmbH, a wholly-owned subsidiary of BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed).
|
|
|
|
10.42*
|
|
|
|
|
|
10.43
|
|
Share Purchase Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.)
|
|
|
|
10.44
|
|
Amendment No. 1 to Share Purchase Agreement, dated December 6, 2019, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.)
|
|
|
|
21*
|
|
|
|
|
|
23
|
|
Consent of the Independent Registered Public Accounting Firm. The consent is set forth on page 77 of this Annual Report on the 10-K.
|
|
|
|
24
|
|
Power of Attorney. The Power of Attorney is set forth on page 78 of this Annual Report on Form 10-K.
|
|
|
|
31*
|
|
|
|
|
|
32**
|
|
|
|
|
|
101.INS
|
|
Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document.
|
|
|
|
101.SCH*
|
|
Inline XBRL Taxonomy Extension Schema Document.
|
|
|
|
101.CAL*
|
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
101.DEF*
|
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
101.LAB*
|
|
Inline XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
101.PRE*
|
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
104
|
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
Item 16.
|
FORM 10-K SUMMARY
|
|
|
AMGEN INC.
|
||
|
|
(Registrant)
|
||
|
|
|
|
|
Date:
|
February 12, 2020
|
By:
|
|
/S/ PETER H. GRIFFITH
|
|
|
|
|
Peter H. Griffith
|
|
|
|
|
Executive Vice President and Chief Financial Officer
|
|
|
|
|
(Principal Financial and Accounting Officer)
|
•
|
Registration Statement (Form S-3 No. 333-236351) of Amgen Inc.,
|
•
|
Registration Statement (Form S-8 No. 333-159377) pertaining to the Amgen Inc. 2009 Equity Incentive Plan,
|
•
|
Registration Statement (Form S-8 No. 33-39183) pertaining to the Amended and Restated Employee Stock Purchase Plan,
|
•
|
Registration Statements (Form S-8 No. 33-39104, as amended by Form S-8 Nos. 333-144581 and 333-216719) pertaining to the Amended and Restated Amgen Retirement and Savings Plan (formerly known as the Amgen Retirement and Savings Plan),
|
•
|
Registration Statements (Form S-8 Nos. 33-47605, 333-144580 and 333-216715) pertaining to the Retirement and Savings Plan for Amgen Manufacturing, Limited (formerly known as the Retirement and Savings Plan for Amgen Manufacturing, Inc.),
|
•
|
Registration Statements (Form S-8 Nos. 333-81284, 333-177868 and 333-216723) pertaining to the Amgen Nonqualified Deferred Compensation Plan, and
|
•
|
Registration Statement (Form S-8 No. 333-176240) pertaining to the Amgen Profit Sharing Plan for Employees in Ireland;
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/S/ ROBERT A. BRADWAY
|
|
Chairman of the Board, Chief Executive Officer
and President, and Director (Principal Executive Officer) |
|
2/12/2020
|
Robert A. Bradway
|
|
|
|
|
|
|
|
|
|
/S/ PETER H. GRIFFITH
|
|
Executive Vice President and
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
2/12/2020
|
Peter H. Griffith
|
|
|
|
|
|
|
|
|
|
/S/ WANDA M. AUSTIN
|
|
Director
|
|
2/12/2020
|
Wanda M. Austin
|
|
|
|
|
|
|
|
|
|
/S/ BRIAN J. DRUKER
|
|
Director
|
|
2/12/2020
|
Brian J. Druker
|
|
|
|
|
|
|
|
|
|
/S/ ROBERT A. ECKERT
|
|
Director
|
|
2/12/2020
|
Robert A. Eckert
|
|
|
|
|
|
|
|
|
|
/S/ GREG C. GARLAND
|
|
Director
|
|
2/12/2020
|
Greg C. Garland
|
|
|
|
|
|
|
|
|
|
/S/ FRED HASSAN
|
|
Director
|
|
2/12/2020
|
Fred Hassan
|
|
|
|
|
|
|
|
|
|
/S/ REBECCA M. HENDERSON
|
|
Director
|
|
2/12/2020
|
Rebecca M. Henderson
|
|
|
|
|
|
|
|
|
|
/S/ CHARLES M. HOLLEY, JR.
|
|
Director
|
|
2/12/2020
|
Charles M. Holley, Jr.
|
|
|
|
|
|
|
|
|
|
/S/ TYLER JACKS
|
|
Director
|
|
2/12/2020
|
Tyler Jacks
|
|
|
|
|
|
|
|
|
|
/S/ ELLEN J. KULLMAN
|
|
Director
|
|
2/12/2020
|
Ellen J. Kullman
|
|
|
|
|
|
|
|
|
|
/S/ RONALD D. SUGAR
|
|
Director
|
|
2/12/2020
|
Ronald D. Sugar
|
|
|
|
|
|
|
|
|
|
/S/ R. SANDERS WILLIAMS
|
|
Director
|
|
2/12/2020
|
R. Sanders Williams
|
|
|
|
|
|
Sales deductions
|
|
|
Description of the Matter
|
As of December 31, 2019, the Company recorded accrued sales deductions of $3.9 billion. As described in Note 1 to the financial statements under the caption “Product sales and sales deductions,” revenues from product sales are recognized net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions, (collectively sales deductions), which are established at the time of sale.
Auditing the estimation of sales deductions, which are netted against product sales, is complex, requires significant judgment, and the amounts involved are material to the financial statements taken as a whole. Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, and is based on an amount that reflects the consideration to which the Company expects to be entitled, which represents an amount that is net of accruals for estimated sales deductions. The estimated sales deductions are based on current contractual and statutory requirements, market events and trends, internal and external historical data, and forecasted customer buying patterns.
|
How We Addressed the Matter in Our Audit
|
We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the sales deduction processes. This included testing controls over management’s review of significant assumptions and inputs used in the estimate of sales deductions, including actual sales, contractual terms, historical experience, wholesaler inventory levels, demand data and estimated patient population. We also tested management’s controls over the accuracy of forecasting demand activity as well as the completeness and accuracy of all other components included in the final sales deduction estimates.
To test management’s estimated sales deductions, we obtained management’s calculations for the respective estimates and performed the following procedures, among others. We tested management’s estimation process over the determination of sales discount accruals by developing an independent expectation of the estimated accrual rate, including a comparison of rates used in management’s forecast to rates in the underlying contracts, performing a lookback analysis using actual historical data to evaluate the forecasted amounts, assessing subsequent events to determine whether there was any new information that would require adjustment to the initial accruals, evaluating trends in actual sales and discount accrual balances, comparing cash receipts to product sales, confirming terms and conditions for a sample of contracts with the Company’s customers, testing a sample of credits issued and payments made throughout the year, and agreeing rates to underlying contract terms.
|
|
Unrecognized Tax Benefits
|
|
|
Description of the Matter
|
As discussed in Notes 1 and 6 to the consolidated financial statements, the Company operates in various jurisdictions in which differing interpretations of complex tax laws and regulations create uncertainty and necessitate the use of significant judgment in the determination of the Company’s unrecognized tax benefits related to allocation of profits among various jurisdictions (“transfer pricing”), particularly in the U.S. federal tax jurisdiction where the Company has significant assets and operations. In this regard, the Company uses significant judgment in (1) determining whether a tax position’s technical merits are more-likely-than-not to be sustained and (2) measuring the amount of tax benefit that qualifies for recognition. As of December 31, 2019, the Company accrued $3.3 billion of gross unrecognized tax benefits including transfer pricing. Auditing the assessment of the technical merits and measurement of the Company’s unrecognized tax benefits is challenging because they can be complex, highly judgmental, and based on interpretations of tax laws and regulations.
|
How We Addressed the Matter in Our Audit
|
We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company’s process to assess the technical merits of its tax positions, as well as management’s process to measure the unrecognized tax benefits of those tax positions, particularly in regard to transfer pricing. This included testing controls over management’s review of the inputs, calculations, assumptions and methods selected to measure the amount of tax benefits that qualify for recognition.
We involved tax and transfer pricing professionals to assist in assessing the technical merits and measurement of certain of the Company’s unrecognized tax benefits. Depending on the nature of the specific tax position and, as applicable, developments with the relevant tax authorities, our procedures included obtaining and reviewing the Company’s correspondence with such tax authorities and evaluating certain third-party advice to support the Company’s evaluations and recorded positions. We used our knowledge of and experience with how the income tax laws and regulations related to transfer pricing are applied by the relevant tax authorities to evaluate the Company’s accounting for its unrecognized tax benefits. We evaluated developments in the applicable regulatory environments to assess potential effects on the Company’s recorded positions. We analyzed the assumptions and data used by the Company when it determined the amount of tax benefits to recognize, including applicable interest and penalties, and we tested the accuracy of those underlying calculations. We have also evaluated the Company’s income tax disclosures included in Note 6 in relation to these matters.
|
|
2019
|
|
2018
|
|
2017
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales
|
$
|
22,204
|
|
|
$
|
22,533
|
|
|
$
|
21,795
|
|
Other revenues
|
1,158
|
|
|
1,214
|
|
|
1,054
|
|
|||
Total revenues
|
23,362
|
|
|
23,747
|
|
|
22,849
|
|
|||
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of sales
|
4,356
|
|
|
4,101
|
|
|
4,069
|
|
|||
Research and development
|
4,116
|
|
|
3,737
|
|
|
3,562
|
|
|||
Selling, general and administrative
|
5,150
|
|
|
5,332
|
|
|
4,870
|
|
|||
Other
|
66
|
|
|
314
|
|
|
375
|
|
|||
Total operating expenses
|
13,688
|
|
|
13,484
|
|
|
12,876
|
|
|||
|
|
|
|
|
|
||||||
Operating income
|
9,674
|
|
|
10,263
|
|
|
9,973
|
|
|||
|
|
|
|
|
|
||||||
Interest expense, net
|
1,289
|
|
|
1,392
|
|
|
1,304
|
|
|||
Interest and other income, net
|
753
|
|
|
674
|
|
|
928
|
|
|||
|
|
|
|
|
|
||||||
Income before income taxes
|
9,138
|
|
|
9,545
|
|
|
9,597
|
|
|||
|
|
|
|
|
|
||||||
Provision for income taxes
|
1,296
|
|
|
1,151
|
|
|
7,618
|
|
|||
|
|
|
|
|
|
||||||
Net income
|
$
|
7,842
|
|
|
$
|
8,394
|
|
|
$
|
1,979
|
|
|
|
|
|
|
|
||||||
Earnings per share:
|
|
|
|
|
|
||||||
Basic
|
$
|
12.96
|
|
|
$
|
12.70
|
|
|
$
|
2.71
|
|
Diluted
|
$
|
12.88
|
|
|
$
|
12.62
|
|
|
$
|
2.69
|
|
|
|
|
|
|
|
||||||
Shares used in the calculation of earnings per share:
|
|
|
|
|
|
||||||
Basic
|
605
|
|
|
661
|
|
|
731
|
|
|||
Diluted
|
609
|
|
|
665
|
|
|
735
|
|
|
2019
|
|
2018
|
|
2017
|
||||||
Net income
|
$
|
7,842
|
|
|
$
|
8,394
|
|
|
$
|
1,979
|
|
Other comprehensive income (loss), net of reclassification adjustments and taxes:
|
|
|
|
|
|
|
|
|
|||
(Losses) gains on foreign currency translation
|
(48
|
)
|
|
(141
|
)
|
|
81
|
|
|||
(Losses) gains on cash flow hedges
|
(66
|
)
|
|
247
|
|
|
(288
|
)
|
|||
Gains (losses) on available-for-sale securities
|
360
|
|
|
(185
|
)
|
|
(6
|
)
|
|||
Other (losses) gains
|
(5
|
)
|
|
(2
|
)
|
|
5
|
|
|||
Other comprehensive income (loss), net of taxes
|
241
|
|
|
(81
|
)
|
|
(208
|
)
|
|||
Comprehensive income
|
$
|
8,083
|
|
|
$
|
8,313
|
|
|
$
|
1,771
|
|
|
2019
|
|
2018
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
6,037
|
|
|
$
|
6,945
|
|
Marketable securities
|
2,874
|
|
|
22,359
|
|
||
Trade receivables, net
|
4,057
|
|
|
3,580
|
|
||
Inventories
|
3,584
|
|
|
2,940
|
|
||
Other current assets
|
1,888
|
|
|
1,794
|
|
||
Total current assets
|
18,440
|
|
|
37,618
|
|
||
|
|
|
|
||||
Property, plant and equipment, net
|
4,928
|
|
|
4,958
|
|
||
Intangible assets, net
|
19,413
|
|
|
7,443
|
|
||
Goodwill
|
14,703
|
|
|
14,699
|
|
||
Other assets
|
2,223
|
|
|
1,698
|
|
||
Total assets
|
$
|
59,707
|
|
|
$
|
66,416
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,371
|
|
|
$
|
1,207
|
|
Accrued liabilities
|
8,511
|
|
|
7,862
|
|
||
Current portion of long-term debt
|
2,953
|
|
|
4,419
|
|
||
Total current liabilities
|
12,835
|
|
|
13,488
|
|
||
|
|
|
|
||||
Long-term debt
|
26,950
|
|
|
29,510
|
|
||
Long-term deferred tax liabilities
|
606
|
|
|
864
|
|
||
Long-term tax liabilities
|
8,037
|
|
|
8,770
|
|
||
Other noncurrent liabilities
|
1,606
|
|
|
1,284
|
|
||
|
|
|
|
||||
Contingencies and commitments
|
|
|
|
|
|
||
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Common stock and additional paid-in capital; $0.0001 par value per share; 2,750.0 shares authorized; outstanding—591.4 shares in 2019 and 629.6 shares in 2018
|
31,531
|
|
|
31,246
|
|
||
Accumulated deficit
|
(21,330
|
)
|
|
(17,977
|
)
|
||
Accumulated other comprehensive loss
|
(528
|
)
|
|
(769
|
)
|
||
Total stockholders’ equity
|
9,673
|
|
|
12,500
|
|
||
Total liabilities and stockholders’ equity
|
$
|
59,707
|
|
|
$
|
66,416
|
|
|
Number
of shares
of common
stock
|
|
Common
stock and
additional
paid-in capital
|
|
Accumulated
deficit
|
|
Accumulated
other
comprehensive
loss
|
|
Total
|
|||||||||
Balance as of December 31, 2016
|
738.2
|
|
|
$
|
30,784
|
|
|
$
|
(438
|
)
|
|
$
|
(471
|
)
|
|
$
|
29,875
|
|
Net income
|
—
|
|
|
—
|
|
|
1,979
|
|
|
—
|
|
|
1,979
|
|
||||
Other comprehensive loss, net of taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
(208
|
)
|
|
(208
|
)
|
||||
Dividends declared on common stock ($4.77 per share)
|
—
|
|
|
—
|
|
|
(3,487
|
)
|
|
—
|
|
|
(3,487
|
)
|
||||
Issuance of common stock in connection with the Company’s equity award programs
|
2.5
|
|
|
52
|
|
|
—
|
|
|
—
|
|
|
52
|
|
||||
Stock-based compensation expense
|
—
|
|
|
347
|
|
|
—
|
|
|
—
|
|
|
347
|
|
||||
Tax impact related to employee stock-based compensation expense
|
—
|
|
|
(191
|
)
|
|
—
|
|
|
—
|
|
|
(191
|
)
|
||||
Repurchases of common stock
|
(18.5
|
)
|
|
—
|
|
|
(3,126
|
)
|
|
—
|
|
|
(3,126
|
)
|
||||
Balance as of December 31, 2017
|
722.2
|
|
|
30,992
|
|
|
(5,072
|
)
|
|
(679
|
)
|
|
25,241
|
|
||||
Cumulative effect of changes in accounting principles, net of taxes
|
—
|
|
|
—
|
|
|
38
|
|
|
(9
|
)
|
|
29
|
|
||||
Net income
|
—
|
|
|
—
|
|
|
8,394
|
|
|
—
|
|
|
8,394
|
|
||||
Other comprehensive loss, net of taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
(81
|
)
|
|
(81
|
)
|
||||
Dividends declared on common stock ($5.41 per share)
|
—
|
|
|
—
|
|
|
(3,482
|
)
|
|
—
|
|
|
(3,482
|
)
|
||||
Issuance of common stock in connection with the Company’s equity award programs
|
1.9
|
|
|
56
|
|
|
—
|
|
|
—
|
|
|
56
|
|
||||
Stock-based compensation expense
|
—
|
|
|
327
|
|
|
—
|
|
|
—
|
|
|
327
|
|
||||
Tax impact related to employee stock-based compensation expense
|
—
|
|
|
(129
|
)
|
|
—
|
|
|
—
|
|
|
(129
|
)
|
||||
Repurchases of common stock
|
(94.5
|
)
|
|
—
|
|
|
(17,855
|
)
|
|
—
|
|
|
(17,855
|
)
|
||||
Balance as of December 31, 2018
|
629.6
|
|
|
31,246
|
|
|
(17,977
|
)
|
|
(769
|
)
|
|
12,500
|
|
||||
Net income
|
—
|
|
|
—
|
|
|
7,842
|
|
|
—
|
|
|
7,842
|
|
||||
Other comprehensive income, net of taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
241
|
|
|
241
|
|
||||
Dividends declared on common stock ($5.95 per share)
|
—
|
|
|
—
|
|
|
(3,555
|
)
|
|
—
|
|
|
(3,555
|
)
|
||||
Issuance of common stock in connection with the Company’s equity award programs
|
2.0
|
|
|
97
|
|
|
—
|
|
|
—
|
|
|
97
|
|
||||
Stock-based compensation expense
|
—
|
|
|
323
|
|
|
—
|
|
|
—
|
|
|
323
|
|
||||
Tax impact related to employee stock-based compensation expense
|
—
|
|
|
(135
|
)
|
|
—
|
|
|
—
|
|
|
(135
|
)
|
||||
Repurchases of common stock
|
(40.2
|
)
|
|
—
|
|
|
(7,640
|
)
|
|
—
|
|
|
(7,640
|
)
|
||||
Balance as of December 31, 2019
|
591.4
|
|
|
$
|
31,531
|
|
|
$
|
(21,330
|
)
|
|
$
|
(528
|
)
|
|
$
|
9,673
|
|
|
2019
|
|
2018
|
|
2017
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net income
|
$
|
7,842
|
|
|
$
|
8,394
|
|
|
$
|
1,979
|
|
Depreciation, amortization and other
|
2,206
|
|
|
1,946
|
|
|
1,955
|
|
|||
Stock-based compensation expense
|
308
|
|
|
311
|
|
|
329
|
|
|||
Deferred income taxes
|
(289
|
)
|
|
(363
|
)
|
|
(1,330
|
)
|
|||
Other items, net
|
(186
|
)
|
|
386
|
|
|
334
|
|
|||
Changes in operating assets and liabilities, net of acquisitions:
|
|
|
|
|
|
||||||
Trade receivables, net
|
(504
|
)
|
|
(378
|
)
|
|
(58
|
)
|
|||
Inventories
|
(66
|
)
|
|
(3
|
)
|
|
133
|
|
|||
Other assets
|
10
|
|
|
35
|
|
|
(24
|
)
|
|||
Accounts payable
|
164
|
|
|
(143
|
)
|
|
424
|
|
|||
Accrued income taxes, net
|
(585
|
)
|
|
(361
|
)
|
|
523
|
|
|||
Long-term tax liabilities
|
(146
|
)
|
|
258
|
|
|
6,681
|
|
|||
Other liabilities
|
396
|
|
|
1,214
|
|
|
231
|
|
|||
Net cash provided by operating activities
|
9,150
|
|
|
11,296
|
|
|
11,177
|
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
(9,394
|
)
|
|
(18,741
|
)
|
|
(33,607
|
)
|
|||
Proceeds from sales of marketable securities
|
8,842
|
|
|
28,356
|
|
|
24,240
|
|
|||
Proceeds from maturities of marketable securities
|
20,548
|
|
|
5,412
|
|
|
6,174
|
|
|||
Purchases of property, plant and equipment
|
(618
|
)
|
|
(738
|
)
|
|
(664
|
)
|
|||
Cash paid for acquisitions, net of cash acquired
|
(13,617
|
)
|
|
195
|
|
|
(19
|
)
|
|||
Other
|
(52
|
)
|
|
(145
|
)
|
|
(148
|
)
|
|||
Net cash provided by (used in) investing activities
|
5,709
|
|
|
14,339
|
|
|
(4,024
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Net proceeds from issuance of debt
|
—
|
|
|
—
|
|
|
4,476
|
|
|||
Repayment of debt
|
(4,514
|
)
|
|
(1,121
|
)
|
|
(4,405
|
)
|
|||
Repurchases of common stock
|
(7,702
|
)
|
|
(17,794
|
)
|
|
(3,160
|
)
|
|||
Dividends paid
|
(3,509
|
)
|
|
(3,507
|
)
|
|
(3,365
|
)
|
|||
Withholding taxes arising from shares withheld for share-based payments
|
(137
|
)
|
|
(126
|
)
|
|
(191
|
)
|
|||
Other
|
95
|
|
|
58
|
|
|
51
|
|
|||
Net cash used in financing activities
|
(15,767
|
)
|
|
(22,490
|
)
|
|
(6,594
|
)
|
|||
(Decrease) increase in cash and cash equivalents
|
(908
|
)
|
|
3,145
|
|
|
559
|
|
|||
Cash and cash equivalents at beginning of year
|
6,945
|
|
|
3,800
|
|
|
3,241
|
|
|||
Cash and cash equivalents at end of year
|
$
|
6,037
|
|
|
$
|
6,945
|
|
|
$
|
3,800
|
|
|
|
Amounts
|
||
Cash purchase price
|
|
$
|
13,400
|
|
Transaction costs
|
|
40
|
|
|
Accumulated cost (consideration transferred)
|
|
$
|
13,440
|
|
|
|
|
||
Intangible assets:
|
|
|
||
Developed-product-technology rights
|
|
$
|
13,007
|
|
Marketing-related rights
|
|
195
|
|
|
Inventory
|
|
367
|
|
|
Deferred tax liability, net
|
|
(24
|
)
|
|
Deferred credit
|
|
(96
|
)
|
|
Other liabilities, net
|
|
(9
|
)
|
|
Total assets acquired, net
|
|
$
|
13,440
|
|
|
|
Amounts
|
||
Total cash paid to Kirin
|
|
$
|
780
|
|
Fair value of contingent consideration obligation
|
|
45
|
|
|
Loss on settlement of preexisting relationship
|
|
(168
|
)
|
|
Total consideration transferred to acquire K-A
|
|
657
|
|
|
|
|
|
||
Fair value of Amgen’s investment in K-A
|
|
825
|
|
|
Total acquisition date fair value
|
|
$
|
1,482
|
|
|
|
Year ended December 31, 2019
|
||||||||||
|
|
U.S.
|
|
ROW
|
|
Total
|
||||||
Enbrel® (etanercept)
|
|
$
|
5,050
|
|
|
$
|
176
|
|
|
$
|
5,226
|
|
Neulasta® (pegfilgrastim)
|
|
2,814
|
|
|
407
|
|
|
3,221
|
|
|||
Prolia® (denosumab)
|
|
1,772
|
|
|
900
|
|
|
2,672
|
|
|||
XGEVA® (denosumab)
|
|
1,457
|
|
|
478
|
|
|
1,935
|
|
|||
Aranesp® (darbepoetin alfa)
|
|
758
|
|
|
971
|
|
|
1,729
|
|
|||
KYPROLIS® (carfilzomib)
|
|
654
|
|
|
390
|
|
|
1,044
|
|
|||
EPOGEN® (epoetin alfa)
|
|
867
|
|
|
—
|
|
|
867
|
|
|||
Sensipar®/Mimpara® (cinacalcet)
|
|
252
|
|
|
299
|
|
|
551
|
|
|||
Other products
|
|
2,907
|
|
|
2,052
|
|
|
4,959
|
|
|||
Total product sales(1)
|
|
16,531
|
|
|
5,673
|
|
|
22,204
|
|
|||
Other revenues
|
|
693
|
|
|
465
|
|
|
1,158
|
|
|||
Total revenues
|
|
$
|
17,224
|
|
|
$
|
6,138
|
|
|
$
|
23,362
|
|
|
|
Year ended December 31, 2018
|
||||||||||
|
|
U.S.
|
|
ROW
|
|
Total
|
||||||
ENBREL
|
|
$
|
4,807
|
|
|
$
|
207
|
|
|
$
|
5,014
|
|
Neulasta®
|
|
3,866
|
|
|
609
|
|
|
4,475
|
|
|||
Prolia®
|
|
1,500
|
|
|
791
|
|
|
2,291
|
|
|||
Aranesp®
|
|
942
|
|
|
935
|
|
|
1,877
|
|
|||
XGEVA®
|
|
1,338
|
|
|
448
|
|
|
1,786
|
|
|||
Sensipar®/Mimpara®
|
|
1,436
|
|
|
338
|
|
|
1,774
|
|
|||
EPOGEN®
|
|
1,010
|
|
|
—
|
|
|
1,010
|
|
|||
KYPROLIS®
|
|
583
|
|
|
385
|
|
|
968
|
|
|||
Other products
|
|
1,947
|
|
|
1,391
|
|
|
3,338
|
|
|||
Total product sales(1)
|
|
17,429
|
|
|
5,104
|
|
|
22,533
|
|
|||
Other revenues
|
|
929
|
|
|
285
|
|
|
1,214
|
|
|||
Total revenues
|
|
$
|
18,358
|
|
|
$
|
5,389
|
|
|
$
|
23,747
|
|
|
|
Year ended December 31, 2017
|
||||||||||
|
|
U.S.
|
|
ROW
|
|
Total
|
||||||
ENBREL
|
|
$
|
5,206
|
|
|
$
|
227
|
|
|
$
|
5,433
|
|
Neulasta®
|
|
3,931
|
|
|
603
|
|
|
4,534
|
|
|||
Aranesp®
|
|
1,114
|
|
|
939
|
|
|
2,053
|
|
|||
Prolia®
|
|
1,272
|
|
|
696
|
|
|
1,968
|
|
|||
Sensipar®/Mimpara®
|
|
1,374
|
|
|
344
|
|
|
1,718
|
|
|||
XGEVA®
|
|
1,157
|
|
|
418
|
|
|
1,575
|
|
|||
EPOGEN®
|
|
1,096
|
|
|
—
|
|
|
1,096
|
|
|||
KYPROLIS®
|
|
562
|
|
|
273
|
|
|
835
|
|
|||
Other products
|
|
1,419
|
|
|
1,164
|
|
|
2,583
|
|
|||
Total product sales(1)
|
|
17,131
|
|
|
4,664
|
|
|
21,795
|
|
|||
Other revenues
|
|
898
|
|
|
156
|
|
|
1,054
|
|
|||
Total revenues
|
|
$
|
18,029
|
|
|
$
|
4,820
|
|
|
$
|
22,849
|
|
(1)
|
Hedging gains and losses, which are included in product sales, were not material for the years ended December 31, 2019, 2018 and 2017.
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
AmerisourceBergen Corporation:
|
|
|
|
|
|
||||||
Gross product sales
|
$
|
12,301
|
|
|
$
|
12,091
|
|
|
$
|
10,742
|
|
% of total gross revenues
|
33
|
%
|
|
33
|
%
|
|
31
|
%
|
|||
McKesson Corporation:
|
|
|
|
|
|
||||||
Gross product sales
|
$
|
11,795
|
|
|
$
|
11,434
|
|
|
10,625
|
|
|
% of total gross revenues
|
31
|
%
|
|
31
|
%
|
|
30
|
%
|
|||
Cardinal Health, Inc.:
|
|
|
|
|
|
||||||
Gross product sales
|
$
|
6,538
|
|
|
$
|
7,475
|
|
|
$
|
7,049
|
|
% of total gross revenues
|
17
|
%
|
|
20
|
%
|
|
20
|
%
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
RSUs
|
$
|
168
|
|
|
$
|
165
|
|
|
$
|
174
|
|
Performance units
|
105
|
|
|
117
|
|
|
133
|
|
|||
Stock options
|
35
|
|
|
29
|
|
|
22
|
|
|||
Total stock-based compensation expense, pretax
|
308
|
|
|
311
|
|
|
329
|
|
|||
Tax benefit from stock-based compensation expense
|
(67
|
)
|
|
(67
|
)
|
|
(118
|
)
|
|||
Total stock-based compensation expense, net of tax
|
$
|
241
|
|
|
$
|
244
|
|
|
$
|
211
|
|
|
Year ended December 31, 2019
|
|||||
|
Units
(in millions)
|
|
Weighted-average
grant date
fair value
|
|||
Balance nonvested as of December 31, 2018
|
3.1
|
|
|
$
|
168.11
|
|
Granted
|
1.2
|
|
|
$
|
182.12
|
|
Vested
|
(1.0
|
)
|
|
$
|
163.21
|
|
Forfeited
|
(0.2
|
)
|
|
$
|
170.52
|
|
Balance nonvested as of December 31, 2019
|
3.1
|
|
|
$
|
174.97
|
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Closing price of our common stock on grant date
|
$
|
177.31
|
|
|
$
|
177.46
|
|
|
$
|
162.60
|
|
Expected volatility (average of implied and historical volatility)
|
23.5
|
%
|
|
24.6
|
%
|
|
22.7
|
%
|
|||
Expected life (in years)
|
5.8
|
|
|
5.8
|
|
|
5.8
|
|
|||
Risk-free interest rate
|
2.4
|
%
|
|
2.8
|
%
|
|
2.1
|
%
|
|||
Expected dividend yield
|
3.1
|
%
|
|
2.9
|
%
|
|
2.8
|
%
|
|||
Fair value of stock options granted
|
$
|
30.47
|
|
|
$
|
34.60
|
|
|
$
|
27.54
|
|
|
Year ended December 31, 2019
|
|||||||||||
|
Options
(in millions)
|
|
Weighted-
average
exercise price
|
|
Weighted-
average
remaining
contractual
life (in years)
|
|
Aggregate
intrinsic
value
(in millions)
|
|||||
Balance unexercised as of December 31, 2018
|
4.4
|
|
|
$
|
143.57
|
|
|
|
|
|
||
Granted
|
1.4
|
|
|
$
|
177.31
|
|
|
|
|
|
||
Exercised
|
(0.7
|
)
|
|
$
|
107.13
|
|
|
|
|
|
||
Expired/forfeited
|
(0.3
|
)
|
|
$
|
171.01
|
|
|
|
|
|
||
Balance unexercised as of December 31, 2019
|
4.8
|
|
|
$
|
157.00
|
|
|
7.2
|
|
$
|
406
|
|
Vested or expected to vest as of December 31, 2019
|
4.6
|
|
|
$
|
156.02
|
|
|
7.1
|
|
$
|
390
|
|
Exercisable as of December 31, 2019
|
1.3
|
|
|
$
|
117.13
|
|
|
4.3
|
|
$
|
162
|
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Closing price of our common stock on grant date
|
$
|
177.31
|
|
|
$
|
177.93
|
|
|
$
|
162.60
|
|
Volatility
|
22.1
|
%
|
|
23.8
|
%
|
|
25.9
|
%
|
|||
Risk-free interest rate
|
2.3
|
%
|
|
2.6
|
%
|
|
1.4
|
%
|
|||
Fair value of units granted
|
$
|
188.40
|
|
|
$
|
189.21
|
|
|
$
|
178.87
|
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Domestic
|
$
|
4,371
|
|
|
$
|
4,856
|
|
|
$
|
4,436
|
|
Foreign
|
4,767
|
|
|
4,689
|
|
|
5,161
|
|
|||
Total income before income taxes
|
$
|
9,138
|
|
|
$
|
9,545
|
|
|
$
|
9,597
|
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Current provision:
|
|
|
|
|
|
||||||
Federal
|
$
|
1,284
|
|
|
$
|
1,270
|
|
|
$
|
8,615
|
|
State
|
39
|
|
|
17
|
|
|
5
|
|
|||
Foreign
|
277
|
|
|
227
|
|
|
275
|
|
|||
Total current provision
|
1,600
|
|
|
1,514
|
|
|
8,895
|
|
|||
Deferred (benefit) provision:
|
|
|
|
|
|
||||||
Federal
|
(276
|
)
|
|
(317
|
)
|
|
(1,120
|
)
|
|||
State
|
(22
|
)
|
|
(7
|
)
|
|
—
|
|
|||
Foreign
|
(6
|
)
|
|
(39
|
)
|
|
(157
|
)
|
|||
Total deferred (benefit) provision
|
(304
|
)
|
|
(363
|
)
|
|
(1,277
|
)
|
|||
Total provision for income taxes
|
$
|
1,296
|
|
|
$
|
1,151
|
|
|
$
|
7,618
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred income tax assets:
|
|
|
|
||||
NOL and credit carryforwards
|
$
|
800
|
|
|
$
|
810
|
|
Accrued expenses
|
457
|
|
|
428
|
|
||
Expenses capitalized for tax
|
170
|
|
|
185
|
|
||
Stock-based compensation
|
91
|
|
|
95
|
|
||
Other
|
269
|
|
|
174
|
|
||
Total deferred income tax assets
|
1,787
|
|
|
1,692
|
|
||
Valuation allowance
|
(517
|
)
|
|
(509
|
)
|
||
Net deferred income tax assets
|
1,270
|
|
|
1,183
|
|
||
|
|
|
|
||||
Deferred income tax liabilities:
|
|
|
|
||||
Acquired intangible assets
|
(1,288
|
)
|
|
(1,509
|
)
|
||
Debt
|
(210
|
)
|
|
(184
|
)
|
||
Other
|
(286
|
)
|
|
(267
|
)
|
||
Total deferred income tax liabilities
|
(1,784
|
)
|
|
(1,960
|
)
|
||
Total deferred income taxes, net
|
$
|
(514
|
)
|
|
$
|
(777
|
)
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Beginning balance
|
$
|
3,061
|
|
|
$
|
2,953
|
|
|
$
|
2,543
|
|
Additions based on tax positions related to the current year
|
215
|
|
|
173
|
|
|
447
|
|
|||
Additions based on tax positions related to prior years
|
22
|
|
|
13
|
|
|
1
|
|
|||
Reductions for tax positions of prior years
|
(11
|
)
|
|
(17
|
)
|
|
(5
|
)
|
|||
Reductions for expiration of statute of limitations
|
—
|
|
|
—
|
|
|
(5
|
)
|
|||
Settlements
|
—
|
|
|
(61
|
)
|
|
(28
|
)
|
|||
Ending balance
|
$
|
3,287
|
|
|
$
|
3,061
|
|
|
$
|
2,953
|
|
|
Years ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Federal statutory tax rate
|
21.0
|
%
|
|
21.0
|
%
|
|
35.0
|
%
|
2017 Tax Act, net repatriation tax
|
—
|
%
|
|
—
|
%
|
|
70.7
|
%
|
Foreign earnings
|
(4.5
|
)%
|
|
(4.3
|
)%
|
|
(15.8
|
)%
|
2017 Tax Act, net deferred tax remeasurement
|
—
|
%
|
|
—
|
%
|
|
(6.9
|
)%
|
Credits, Puerto Rico Excise Tax
|
(2.6
|
)%
|
|
(2.5
|
)%
|
|
(2.2
|
)%
|
2017 Tax Act, net impact on intercompany sales
|
—
|
%
|
|
(1.8
|
)%
|
|
—
|
%
|
Interest on uncertain tax positions
|
1.6
|
%
|
|
1.2
|
%
|
|
0.6
|
%
|
Credits, primarily federal R&D
|
(1.0
|
)%
|
|
(0.8
|
)%
|
|
(0.6
|
)%
|
Share-based payments
|
(0.3
|
)%
|
|
(0.2
|
)%
|
|
(0.7
|
)%
|
Other, net
|
—
|
%
|
|
(0.5
|
)%
|
|
(0.7
|
)%
|
Effective tax rate
|
14.2
|
%
|
|
12.1
|
%
|
|
79.4
|
%
|
|
Years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Income (Numerator):
|
|
|
|
|
|
||||||
Net income for basic and diluted EPS
|
$
|
7,842
|
|
|
$
|
8,394
|
|
|
$
|
1,979
|
|
|
|
|
|
|
|
||||||
Shares (Denominator):
|
|
|
|
|
|
||||||
Weighted-average shares for basic EPS
|
605
|
|
|
661
|
|
|
731
|
|
|||
Effect of dilutive securities
|
4
|
|
|
4
|
|
|
4
|
|
|||
Weighted-average shares for diluted EPS
|
609
|
|
|
665
|
|
|
735
|
|
|||
|
|
|
|
|
|
||||||
Basic EPS
|
$
|
12.96
|
|
|
$
|
12.70
|
|
|
$
|
2.71
|
|
Diluted EPS
|
$
|
12.88
|
|
|
$
|
12.62
|
|
|
$
|
2.69
|
|
Types of securities as of December 31, 2019
|
|
Amortized
cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair
values
|
||||||||
U.S. Treasury notes
|
|
$
|
359
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
360
|
|
U.S. Treasury bills
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S.
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Foreign and other
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Financial
|
|
1,108
|
|
|
13
|
|
|
—
|
|
|
1,121
|
|
||||
Industrial
|
|
824
|
|
|
10
|
|
|
—
|
|
|
834
|
|
||||
Other
|
|
195
|
|
|
3
|
|
|
—
|
|
|
198
|
|
||||
Residential-mortgage-backed securities
|
|
181
|
|
|
1
|
|
|
—
|
|
|
182
|
|
||||
Other mortgage- and asset-backed securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Money market mutual funds
|
|
5,250
|
|
|
—
|
|
|
—
|
|
|
5,250
|
|
||||
Other short-term interest-bearing securities
|
|
289
|
|
|
—
|
|
|
—
|
|
|
289
|
|
||||
Total available-for-sale investments
|
|
$
|
8,206
|
|
|
$
|
28
|
|
|
$
|
—
|
|
|
$
|
8,234
|
|
Types of securities as of December 31, 2018
|
|
Amortized
cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair
values
|
||||||||
U.S. Treasury notes
|
|
$
|
2,710
|
|
|
$
|
—
|
|
|
$
|
(47
|
)
|
|
$
|
2,663
|
|
U.S. Treasury bills
|
|
8,191
|
|
|
—
|
|
|
—
|
|
|
8,191
|
|
||||
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S.
|
|
112
|
|
|
—
|
|
|
(2
|
)
|
|
110
|
|
||||
Foreign and other
|
|
972
|
|
|
1
|
|
|
(41
|
)
|
|
932
|
|
||||
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Financial
|
|
2,778
|
|
|
—
|
|
|
(81
|
)
|
|
2,697
|
|
||||
Industrial
|
|
2,603
|
|
|
—
|
|
|
(99
|
)
|
|
2,504
|
|
||||
Other
|
|
583
|
|
|
—
|
|
|
(21
|
)
|
|
562
|
|
||||
Residential-mortgage-backed securities
|
|
1,458
|
|
|
—
|
|
|
(36
|
)
|
|
1,422
|
|
||||
Other mortgage- and asset-backed securities
|
|
483
|
|
|
—
|
|
|
(14
|
)
|
|
469
|
|
||||
Money market mutual funds
|
|
5,659
|
|
|
—
|
|
|
—
|
|
|
5,659
|
|
||||
Other short-term interest-bearing securities
|
|
3,515
|
|
|
—
|
|
|
—
|
|
|
3,515
|
|
||||
Total available-for-sale investments
|
|
$
|
29,064
|
|
|
$
|
1
|
|
|
$
|
(341
|
)
|
|
$
|
28,724
|
|
|
|
December 31,
|
||||||
Consolidated Balance Sheets locations
|
|
2019
|
|
2018
|
||||
Cash and cash equivalents
|
|
$
|
5,360
|
|
|
$
|
6,365
|
|
Marketable securities
|
|
2,874
|
|
|
22,359
|
|
||
Total available-for-sale investments
|
|
$
|
8,234
|
|
|
$
|
28,724
|
|
|
|
December 31,
|
||||||
Contractual maturities
|
|
2019
|
|
2018
|
||||
Maturing in one year or less
|
|
$
|
5,629
|
|
|
$
|
17,424
|
|
Maturing after one year through three years
|
|
2,304
|
|
|
3,356
|
|
||
Maturing after three years through five years
|
|
119
|
|
|
5,168
|
|
||
Maturing after five years through ten years
|
|
—
|
|
|
885
|
|
||
Mortgage- and asset-backed securities
|
|
182
|
|
|
1,891
|
|
||
Total available-for-sale investments
|
|
$
|
8,234
|
|
|
$
|
28,724
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 12 months
|
|
12 months or more
|
||||||||||||
Types of securities as of December 31, 2018
|
|
Fair values
|
|
Unrealized losses
|
|
Fair values
|
|
Unrealized losses
|
||||||||
U.S. Treasury notes
|
|
$
|
1,219
|
|
|
$
|
(21
|
)
|
|
$
|
1,444
|
|
|
$
|
(26
|
)
|
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S.
|
|
—
|
|
|
—
|
|
|
110
|
|
|
(2
|
)
|
||||
Foreign and other
|
|
631
|
|
|
(31
|
)
|
|
240
|
|
|
(10
|
)
|
||||
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Financial
|
|
1,968
|
|
|
(59
|
)
|
|
718
|
|
|
(22
|
)
|
||||
Industrial
|
|
1,898
|
|
|
(81
|
)
|
|
529
|
|
|
(18
|
)
|
||||
Other
|
|
529
|
|
|
(20
|
)
|
|
28
|
|
|
(1
|
)
|
||||
Residential-mortgage-backed securities
|
|
576
|
|
|
(14
|
)
|
|
840
|
|
|
(22
|
)
|
||||
Other mortgage- and asset-backed securities
|
|
17
|
|
|
—
|
|
|
451
|
|
|
(14
|
)
|
||||
Total
|
|
$
|
6,838
|
|
|
$
|
(226
|
)
|
|
$
|
4,360
|
|
|
$
|
(115
|
)
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
358
|
|
|
$
|
257
|
|
Work in process
|
2,227
|
|
|
1,660
|
|
||
Finished goods
|
999
|
|
|
1,023
|
|
||
Total inventories
|
$
|
3,584
|
|
|
$
|
2,940
|
|
|
|
|
December 31,
|
||||||
|
Useful life (in years)
|
|
2019
|
|
2018
|
||||
Land
|
—
|
|
$
|
263
|
|
|
$
|
265
|
|
Buildings and improvements
|
10-40
|
|
3,757
|
|
|
3,616
|
|
||
Manufacturing equipment
|
8-12
|
|
2,655
|
|
|
2,418
|
|
||
Laboratory equipment
|
8-12
|
|
1,236
|
|
|
1,174
|
|
||
Capitalized software
|
3-5
|
|
1,154
|
|
|
1,124
|
|
||
Other
|
3-15
|
|
3,313
|
|
|
3,204
|
|
||
Construction in progress
|
—
|
|
907
|
|
|
953
|
|
||
Property, plant and equipment, gross
|
|
|
13,285
|
|
|
12,754
|
|
||
Less accumulated depreciation and amortization
|
|
|
(8,357
|
)
|
|
(7,796
|
)
|
||
Property, plant and equipment, net
|
|
|
$
|
4,928
|
|
|
$
|
4,958
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
United States
|
$
|
2,433
|
|
|
$
|
2,373
|
|
Puerto Rico
|
1,402
|
|
|
1,476
|
|
||
ROW
|
1,093
|
|
|
1,109
|
|
||
Total property, plant and equipment, net
|
$
|
4,928
|
|
|
$
|
4,958
|
|
|
Years ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Beginning balance
|
$
|
14,699
|
|
|
$
|
14,761
|
|
Addition from acquisitions
|
26
|
|
|
6
|
|
||
Currency translation adjustments
|
(22
|
)
|
|
(68
|
)
|
||
Ending balance
|
$
|
14,703
|
|
|
$
|
14,699
|
|
|
December 31,
|
||||||||||||||||||||||
|
2019
|
|
2018
|
||||||||||||||||||||
|
Gross
carrying
amounts
|
|
Accumulated
amortization
|
|
Other intangible
assets, net
|
|
Gross
carrying
amounts
|
|
Accumulated
amortization
|
|
Other intangible
assets, net
|
||||||||||||
Finite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Developed-product-technology rights
|
$
|
25,575
|
|
|
$
|
(8,322
|
)
|
|
$
|
17,253
|
|
|
$
|
12,573
|
|
|
$
|
(7,479
|
)
|
|
$
|
5,094
|
|
Licensing rights
|
3,761
|
|
|
(2,398
|
)
|
|
1,363
|
|
|
3,772
|
|
|
(2,032
|
)
|
|
1,740
|
|
||||||
Marketing-related rights
|
1,382
|
|
|
(965
|
)
|
|
417
|
|
|
1,297
|
|
|
(1,019
|
)
|
|
278
|
|
||||||
R&D technology rights
|
1,273
|
|
|
(947
|
)
|
|
326
|
|
|
1,148
|
|
|
(872
|
)
|
|
276
|
|
||||||
Total finite-lived intangible assets
|
31,991
|
|
|
(12,632
|
)
|
|
19,359
|
|
|
18,790
|
|
|
(11,402
|
)
|
|
7,388
|
|
||||||
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
IPR&D
|
54
|
|
|
—
|
|
|
54
|
|
|
55
|
|
|
—
|
|
|
55
|
|
||||||
Total other intangible assets
|
$
|
32,045
|
|
|
$
|
(12,632
|
)
|
|
$
|
19,413
|
|
|
$
|
18,845
|
|
|
$
|
(11,402
|
)
|
|
$
|
7,443
|
|
Consolidated Balance Sheets locations
|
|
December 31, 2019
|
||
Assets:
|
|
|
||
Other assets
|
|
$
|
469
|
|
Liabilities:
|
|
|
||
Accrued liabilities
|
|
$
|
140
|
|
Other noncurrent liabilities
|
|
388
|
|
|
Total lease liabilities
|
|
$
|
528
|
|
Lease costs
|
|
Year ended December 31, 2019
|
||
Operating(1)
|
|
$
|
204
|
|
Sublease income
|
|
(33
|
)
|
|
Total net lease costs
|
|
$
|
171
|
|
(1)
|
Includes short-term leases and variable lease costs, which were not material for the year ended December 31, 2019.
|
Maturity dates
|
|
Amounts
|
||
2020
|
|
$
|
157
|
|
2021
|
|
150
|
|
|
2022
|
|
110
|
|
|
2023
|
|
88
|
|
|
2024
|
|
30
|
|
|
Thereafter
|
|
32
|
|
|
Total lease payments(1)
|
|
567
|
|
|
Less imputed interest
|
|
(39
|
)
|
|
Present value of lease liabilities
|
|
$
|
528
|
|
(1)
|
Includes future rental commitments for abandoned leases of $178 million. We expect to receive total future rental income of $141 million related to noncancelable subleases for abandoned facilities.
|
|
|
Year ended December 31, 2019
|
||
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
||
Operating cash flows for operating leases
|
|
$
|
148
|
|
ROU assets obtained in exchange for lease obligations:
|
|
|
||
Operating leases
|
|
$
|
163
|
|
|
Amounts
|
||
2019
|
$
|
164
|
|
2020
|
126
|
|
|
2021
|
113
|
|
|
2022
|
64
|
|
|
2023
|
56
|
|
|
Thereafter
|
46
|
|
|
Total minimum operating lease commitments
|
$
|
569
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Prepaid expenses
|
$
|
939
|
|
|
$
|
907
|
|
Corporate partner receivables
|
485
|
|
|
444
|
|
||
Interest receivables
|
110
|
|
|
177
|
|
||
Other
|
354
|
|
|
266
|
|
||
Total other current assets
|
$
|
1,888
|
|
|
$
|
1,794
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Sales deductions
|
$
|
3,880
|
|
|
$
|
3,170
|
|
Employee compensation and benefits
|
981
|
|
|
1,001
|
|
||
Dividends payable
|
946
|
|
|
914
|
|
||
Sales returns reserve
|
564
|
|
|
535
|
|
||
Other
|
2,140
|
|
|
2,242
|
|
||
Total accrued liabilities
|
$
|
8,511
|
|
|
$
|
7,862
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
5.70% notes due 2019 (5.70% 2019 Notes)
|
$
|
—
|
|
|
$
|
1,000
|
|
1.90% notes due 2019 (1.90% 2019 Notes)
|
—
|
|
|
700
|
|
||
Floating Rate Notes due 2019
|
—
|
|
|
550
|
|
||
2.20% notes due 2019 (2.20% 2019 Notes)
|
—
|
|
|
1,400
|
|
||
2.125% €675 million notes due 2019 (2.125% 2019 euro Notes)
|
—
|
|
|
774
|
|
||
4.50% notes due 2020 (4.50% 2020 Notes)
|
300
|
|
|
300
|
|
||
2.125% notes due 2020 (2.125% 2020 Notes)
|
750
|
|
|
750
|
|
||
Floating Rate Notes due 2020
|
300
|
|
|
300
|
|
||
2.20% notes due 2020 (2.20% 2020 Notes)
|
700
|
|
|
700
|
|
||
3.45% notes due 2020 (3.45% 2020 Notes)
|
900
|
|
|
900
|
|
||
4.10% notes due 2021 (4.10% 2021 Notes)
|
1,000
|
|
|
1,000
|
|
||
1.85% notes due 2021 (1.85% 2021 Notes)
|
750
|
|
|
750
|
|
||
3.875% notes due 2021 (3.875% 2021 Notes)
|
1,750
|
|
|
1,750
|
|
||
1.25% €1,250 million notes due 2022 (1.25% 2022 euro Notes)
|
1,402
|
|
|
1,433
|
|
||
2.70% notes due 2022 (2.70% 2022 Notes)
|
500
|
|
|
500
|
|
||
2.65% notes due 2022 (2.65% 2022 Notes)
|
1,500
|
|
|
1,500
|
|
||
3.625% notes due 2022 (3.625% 2022 Notes)
|
750
|
|
|
750
|
|
||
0.41% CHF700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)
|
725
|
|
|
713
|
|
||
2.25% notes due 2023 (2.25% 2023 Notes)
|
750
|
|
|
750
|
|
||
3.625% notes due 2024 (3.625% 2024 Notes)
|
1,400
|
|
|
1,400
|
|
||
3.125% notes due 2025 (3.125% 2025 Notes)
|
1,000
|
|
|
1,000
|
|
||
2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)
|
841
|
|
|
860
|
|
||
2.60% notes due 2026 (2.60% 2026 Notes)
|
1,250
|
|
|
1,250
|
|
||
5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)
|
630
|
|
|
606
|
|
||
3.20% notes due 2027 (3.20% 2027 Notes)
|
1,000
|
|
|
1,000
|
|
||
4.00% £700 million notes due 2029 (4.00% 2029 pound sterling Notes)
|
928
|
|
|
893
|
|
||
6.375% notes due 2037 (6.375% 2037 Notes)
|
552
|
|
|
552
|
|
||
6.90% notes due 2038 (6.90% 2038 Notes)
|
291
|
|
|
291
|
|
||
6.40% notes due 2039 (6.40% 2039 Notes)
|
466
|
|
|
466
|
|
||
5.75% notes due 2040 (5.75% 2040 Notes)
|
412
|
|
|
412
|
|
||
4.95% notes due 2041 (4.95% 2041 Notes)
|
600
|
|
|
600
|
|
||
5.15% notes due 2041 (5.15% 2041 Notes)
|
974
|
|
|
974
|
|
||
5.65% notes due 2042 (5.65% 2042 Notes)
|
487
|
|
|
487
|
|
||
5.375% notes due 2043 (5.375% 2043 Notes)
|
261
|
|
|
261
|
|
||
4.40% notes due 2045 (4.40% 2045 Notes)
|
2,250
|
|
|
2,250
|
|
||
4.563% notes due 2048 (4.563% 2048 Notes)
|
1,415
|
|
|
1,415
|
|
||
4.663% notes due 2051 (4.663% 2051 Notes)
|
3,541
|
|
|
3,541
|
|
||
Other notes due 2097
|
100
|
|
|
100
|
|
||
Unamortized bond discounts, premiums and issuance costs, net
|
(868
|
)
|
|
(896
|
)
|
||
Fair value adjustments
|
296
|
|
|
(53
|
)
|
||
Total carrying value of debt
|
29,903
|
|
|
33,929
|
|
||
Less current portion
|
(2,953
|
)
|
|
(4,419
|
)
|
||
Total long-term debt
|
$
|
26,950
|
|
|
$
|
29,510
|
|
•
|
In 2019, we repaid $4.5 billion of debt, including the $1.4 billion aggregate principal amount of the 2.20% 2019 Notes, the $1.0 billion aggregate principal amount of the 5.70% 2019 Notes, the €675 million aggregate principal amount ($864 million upon settlement of the related cross-currency swap) of the 2.125% 2019 euro Notes, the $700 million aggregate principal amount of the 1.90% 2019 Notes and the $550 million Floating Rate Notes due 2019.
|
•
|
In 2018, we repaid $1.1 billion of debt, including the $500 million aggregate principal amount of the 6.15% 2018 Notes and the €550 million aggregate principal amount of the 4.375% 2018 Notes revalued at $621 million upon maturity.
|
•
|
In 2017, we repaid $4.4 billion of debt, including the $605 million short-term floating-rate loan, the $1.25 billion aggregate principal amount of the 2.125% 2017 Notes, the $600 million aggregate principal amount of the Floating Rate Notes due 2017, the $850 million aggregate principal amount of the 1.25% 2017 Notes and the $1.1 billion aggregate principal amount of the 5.85% 2017 Notes.
|
|
|
|
|
December 31,
|
||||||
|
|
|
|
2019
|
|
2018
|
||||
Notes
|
|
Effective interest rates
|
|
Notional amounts
|
||||||
2.20% 2019 Notes
|
|
LIBOR + 0.6%
|
|
$
|
—
|
|
|
$
|
1,400
|
|
3.45% 2020 Notes
|
|
LIBOR + 1.1%
|
|
900
|
|
|
900
|
|
||
4.10% 2021 Notes
|
|
LIBOR + 1.7%
|
|
1,000
|
|
|
1,000
|
|
||
3.875% 2021 Notes
|
|
LIBOR + 2.0%
|
|
1,750
|
|
|
1,750
|
|
||
3.625% 2022 Notes
|
|
LIBOR + 1.6%
|
|
750
|
|
|
750
|
|
||
3.625% 2024 Notes
|
|
LIBOR + 1.4%
|
|
1,400
|
|
|
1,400
|
|
||
3.125% 2025 Notes
|
|
LIBOR + 0.9%
|
|
1,000
|
|
|
1,000
|
|
||
2.60% 2026 Notes
|
|
LIBOR + 0.3%
|
|
1,250
|
|
|
1,250
|
|
||
4.663% 2051 Notes
|
|
LIBOR + 0.0%
|
|
1,500
|
|
|
1,500
|
|
||
Total notional amounts
|
|
|
|
$
|
9,550
|
|
|
$
|
10,950
|
|
Maturity dates
|
|
Amounts
|
||
2020
|
|
$
|
2,950
|
|
2021
|
|
3,500
|
|
|
2022
|
|
4,152
|
|
|
2023
|
|
1,474
|
|
|
2024
|
|
1,400
|
|
|
Thereafter
|
|
16,999
|
|
|
Total
|
|
$
|
30,475
|
|
|
Years ended December 31,
|
|||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|||||||||||||||
|
Shares*
|
|
Dollars
|
|
Shares*
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|||||||||
First quarter
|
15.9
|
|
|
$
|
3,031
|
|
|
56.4
|
|
|
$
|
10,787
|
|
|
3.4
|
|
|
$
|
555
|
|
Second quarter
|
13.1
|
|
|
2,349
|
|
|
18.2
|
|
|
3,190
|
|
|
6.2
|
|
|
1,006
|
|
|||
Third quarter
|
6.2
|
|
|
1,170
|
|
|
8.7
|
|
|
1,713
|
|
|
4.4
|
|
|
769
|
|
|||
Fourth quarter
|
5.1
|
|
|
1,090
|
|
|
11.1
|
|
|
2,165
|
|
|
4.5
|
|
|
796
|
|
|||
Total stock repurchases
|
40.2
|
|
|
$
|
7,640
|
|
|
94.5
|
|
|
$
|
17,855
|
|
|
18.5
|
|
|
$
|
3,126
|
|
|
Foreign
currency
translation
|
|
Cash flow
hedges
|
|
Available-for-sale
securities
|
|
Other
|
|
AOCI
|
||||||||||
Balance as of December 31, 2016
|
$
|
(610
|
)
|
|
$
|
282
|
|
|
$
|
(138
|
)
|
|
$
|
(5
|
)
|
|
$
|
(471
|
)
|
Foreign currency translation adjustments
|
77
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
77
|
|
|||||
Unrealized gains (losses)
|
—
|
|
|
192
|
|
|
(46
|
)
|
|
—
|
|
|
146
|
|
|||||
Reclassification adjustments to income
|
—
|
|
|
(638
|
)
|
|
41
|
|
|
—
|
|
|
(597
|
)
|
|||||
Other gains
|
—
|
|
|
—
|
|
|
—
|
|
|
5
|
|
|
5
|
|
|||||
Income taxes
|
4
|
|
|
158
|
|
|
(1
|
)
|
|
—
|
|
|
161
|
|
|||||
Balance as of December 31, 2017
|
(529
|
)
|
|
(6
|
)
|
|
(144
|
)
|
|
—
|
|
|
(679
|
)
|
|||||
Cumulative effect of change in accounting principle, net of tax
|
—
|
|
|
—
|
|
|
(9
|
)
|
|
—
|
|
|
(9
|
)
|
|||||
Foreign currency translation adjustments
|
(141
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(141
|
)
|
|||||
Unrealized gains (losses)
|
—
|
|
|
61
|
|
|
(556
|
)
|
|
—
|
|
|
(495
|
)
|
|||||
Reclassification adjustments to income
|
—
|
|
|
262
|
|
|
365
|
|
|
—
|
|
|
627
|
|
|||||
Other losses
|
—
|
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|
(2
|
)
|
|||||
Income taxes
|
—
|
|
|
(76
|
)
|
|
6
|
|
|
—
|
|
|
(70
|
)
|
|||||
Balance as of December 31, 2018
|
(670
|
)
|
|
241
|
|
|
(338
|
)
|
|
(2
|
)
|
|
(769
|
)
|
|||||
Foreign currency translation adjustments
|
(48
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(48
|
)
|
|||||
Unrealized gains
|
—
|
|
|
127
|
|
|
424
|
|
|
—
|
|
|
551
|
|
|||||
Reclassification adjustments to income
|
—
|
|
|
(211
|
)
|
|
(56
|
)
|
|
—
|
|
|
(267
|
)
|
|||||
Other losses
|
—
|
|
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
(5
|
)
|
|||||
Income taxes
|
—
|
|
|
18
|
|
|
(8
|
)
|
|
—
|
|
|
10
|
|
|||||
Balance as of December 31, 2019
|
$
|
(718
|
)
|
|
$
|
175
|
|
|
$
|
22
|
|
|
$
|
(7
|
)
|
|
$
|
(528
|
)
|
|
|
Years ended December 31,
|
|
|
||||||||||
Components of AOCI
|
|
2019
|
|
2018
|
|
2017
|
|
Consolidated Statements of Income locations
|
||||||
Cash flow hedges:
|
|
|
|
|
|
|
|
|
||||||
Foreign currency contract gains (losses)
|
|
$
|
101
|
|
|
$
|
(21
|
)
|
|
$
|
65
|
|
|
Product sales
|
Cross-currency swap contract gains (losses)
|
|
110
|
|
|
(241
|
)
|
|
574
|
|
|
Interest and other income, net
|
|||
Forward interest rate contract losses
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
Interest expense, net
|
|||
|
|
211
|
|
|
(262
|
)
|
|
638
|
|
|
Income before income taxes
|
|||
|
|
(46
|
)
|
|
55
|
|
|
(226
|
)
|
|
Provision for income taxes
|
|||
|
|
$
|
165
|
|
|
$
|
(207
|
)
|
|
$
|
412
|
|
|
Net income
|
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
||||||
Net realized gains (losses)
|
|
$
|
56
|
|
|
$
|
(365
|
)
|
|
$
|
(41
|
)
|
|
Interest and other income, net
|
|
|
(14
|
)
|
|
3
|
|
|
(8
|
)
|
|
Provision for income taxes
|
|||
|
|
$
|
42
|
|
|
$
|
(362
|
)
|
|
$
|
(49
|
)
|
|
Net income
|
Level 1
|
—
|
Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access
|
Level 2
|
—
|
Valuations for which all significant inputs are observable either directly or indirectly—other than Level 1 inputs
|
Level 3
|
—
|
Valuations based on inputs that are unobservable and significant to the overall fair value measurement
|
Fair value measurement as of December 31, 2019, using:
|
|
Quoted prices in
active markets for
identical assets
(Level 1)
|
|
Significant other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury notes
|
|
$
|
360
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
360
|
|
U.S. Treasury bills
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S.
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Foreign and other
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Financial
|
|
—
|
|
|
1,121
|
|
|
—
|
|
|
1,121
|
|
||||
Industrial
|
|
—
|
|
|
834
|
|
|
—
|
|
|
834
|
|
||||
Other
|
|
—
|
|
|
198
|
|
|
—
|
|
|
198
|
|
||||
Residential-mortgage-backed securities
|
|
—
|
|
|
182
|
|
|
—
|
|
|
182
|
|
||||
Other mortgage- and asset-backed securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Money market mutual funds
|
|
5,250
|
|
|
—
|
|
|
—
|
|
|
5,250
|
|
||||
Other short-term interest-bearing securities
|
|
—
|
|
|
289
|
|
|
—
|
|
|
289
|
|
||||
Equity securities
|
|
303
|
|
|
—
|
|
|
—
|
|
|
303
|
|
||||
Derivatives:
|
|
|
|
|
|
|
|
|
||||||||
Foreign currency contracts
|
|
—
|
|
|
224
|
|
|
—
|
|
|
224
|
|
||||
Cross-currency swap contracts
|
|
—
|
|
|
66
|
|
|
—
|
|
|
66
|
|
||||
Interest rate swap contracts
|
|
—
|
|
|
259
|
|
|
—
|
|
|
259
|
|
||||
Total assets
|
|
$
|
5,913
|
|
|
$
|
3,173
|
|
|
$
|
—
|
|
|
$
|
9,086
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Derivatives:
|
|
|
|
|
|
|
|
|
||||||||
Foreign currency contracts
|
|
$
|
—
|
|
|
$
|
31
|
|
|
$
|
—
|
|
|
$
|
31
|
|
Cross-currency swap contracts
|
|
—
|
|
|
315
|
|
|
—
|
|
|
315
|
|
||||
Interest rate swap contracts
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Contingent consideration obligations
|
|
—
|
|
|
—
|
|
|
61
|
|
|
61
|
|
||||
Total liabilities
|
|
$
|
—
|
|
|
$
|
346
|
|
|
$
|
61
|
|
|
$
|
407
|
|
Fair value measurement as of December 31, 2018, using:
|
|
Quoted prices in
active markets for
identical assets
(Level 1)
|
|
Significant other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury notes
|
|
$
|
2,663
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,663
|
|
U.S. Treasury bills
|
|
8,191
|
|
|
—
|
|
|
—
|
|
|
8,191
|
|
||||
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S.
|
|
—
|
|
|
110
|
|
|
—
|
|
|
110
|
|
||||
Foreign and other
|
|
—
|
|
|
932
|
|
|
—
|
|
|
932
|
|
||||
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Financial
|
|
—
|
|
|
2,697
|
|
|
—
|
|
|
2,697
|
|
||||
Industrial
|
|
—
|
|
|
2,504
|
|
|
—
|
|
|
2,504
|
|
||||
Other
|
|
—
|
|
|
562
|
|
|
—
|
|
|
562
|
|
||||
Residential-mortgage-backed securities
|
|
—
|
|
|
1,422
|
|
|
—
|
|
|
1,422
|
|
||||
Other mortgage- and asset-backed securities
|
|
—
|
|
|
469
|
|
|
—
|
|
|
469
|
|
||||
Money market mutual funds
|
|
5,659
|
|
|
—
|
|
|
—
|
|
|
5,659
|
|
||||
Other short-term interest-bearing securities
|
|
—
|
|
|
3,515
|
|
|
—
|
|
|
3,515
|
|
||||
Equity securities
|
|
176
|
|
|
—
|
|
|
—
|
|
|
176
|
|
||||
Derivatives:
|
|
|
|
|
|
|
|
|
||||||||
Foreign currency contracts
|
|
—
|
|
|
182
|
|
|
—
|
|
|
182
|
|
||||
Cross-currency swap contracts
|
|
—
|
|
|
170
|
|
|
—
|
|
|
170
|
|
||||
Interest rate swap contracts
|
|
—
|
|
|
56
|
|
|
—
|
|
|
56
|
|
||||
Total assets
|
|
$
|
16,689
|
|
|
$
|
12,619
|
|
|
$
|
—
|
|
|
$
|
29,308
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Derivatives:
|
|
|
|
|
|
|
|
|
||||||||
Foreign currency contracts
|
|
$
|
—
|
|
|
$
|
26
|
|
|
$
|
—
|
|
|
$
|
26
|
|
Cross-currency swap contracts
|
|
—
|
|
|
401
|
|
|
—
|
|
|
401
|
|
||||
Interest rate swap contracts
|
|
—
|
|
|
149
|
|
|
—
|
|
|
149
|
|
||||
Contingent consideration obligations
|
|
—
|
|
|
—
|
|
|
72
|
|
|
72
|
|
||||
Total liabilities
|
|
$
|
—
|
|
|
$
|
576
|
|
|
$
|
72
|
|
|
$
|
648
|
|
|
|
Foreign currency
|
|
U.S. dollars
|
||||||||||
Hedged notes
|
|
Notional amounts
|
|
Interest rates
|
|
Notional amounts
|
|
Interest rates
|
||||||
1.25% 2022 euro Notes
|
|
€
|
1,250
|
|
|
1.3
|
%
|
|
$
|
1,388
|
|
|
3.2
|
%
|
0.41% 2023 Swiss franc Bonds
|
|
CHF
|
700
|
|
|
0.4
|
%
|
|
$
|
704
|
|
|
3.4
|
%
|
2.00% 2026 euro Notes
|
|
€
|
750
|
|
|
2.0
|
%
|
|
$
|
833
|
|
|
3.9
|
%
|
5.50% 2026 pound sterling Notes
|
|
£
|
475
|
|
|
5.5
|
%
|
|
$
|
747
|
|
|
6.0
|
%
|
4.00% 2029 pound sterling Notes
|
|
£
|
700
|
|
|
4.0
|
%
|
|
$
|
1,111
|
|
|
4.5
|
%
|
|
|
|
|
Years ended December 31,
|
||||||||||
Derivatives in cash flow hedging relationships
|
|
|
|
2019
|
|
2018
|
|
2017
|
||||||
Foreign currency contracts
|
|
|
|
$
|
148
|
|
|
$
|
348
|
|
|
$
|
(402
|
)
|
Cross-currency swap contracts
|
|
|
|
(21
|
)
|
|
(287
|
)
|
|
581
|
|
|||
Forward interest rate contracts
|
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|||
Total unrealized gains
|
|
|
|
$
|
127
|
|
|
$
|
61
|
|
|
$
|
192
|
|
|
|
Carrying amounts of
hedged liabilities(1)
|
|
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities(2)
|
||||||||||||
|
|
December 31,
|
|
December 31,
|
||||||||||||
Consolidated Balance Sheets locations
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Current portion of long-term debt
|
|
$
|
903
|
|
|
$
|
2,396
|
|
|
$
|
4
|
|
|
$
|
(3
|
)
|
Long-term debt
|
|
$
|
8,814
|
|
|
$
|
9,361
|
|
|
$
|
292
|
|
|
$
|
(50
|
)
|
(1)
|
Current portion of long-term debt includes $1.0 billion of carrying value with discontinued hedging relationships as of December 31, 2018. Long-term debt includes $136 million and $137 million of carrying value with discontinued hedging relationships as of December 31, 2019 and 2018, respectively.
|
(2)
|
Current portion of long-term debt includes $3 million of hedging adjustments on discontinued hedging relationships as of December 31, 2018. Long-term debt includes $36 million and $37 million of hedging adjustments on discontinued hedging relationships as of December 31, 2019 and 2018, respectively.
|
|
|
Year ended December 31, 2019
|
||||||||||
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
||||||
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income
|
|
$
|
22,204
|
|
|
$
|
753
|
|
|
$
|
(1,289
|
)
|
The effects of cash flow and fair value hedging:
|
|
|
|
|
|
|
||||||
Gains on cash flow hedging relationships reclassified out of AOCI:
|
|
|
|
|
|
|
||||||
Foreign currency contracts
|
|
$
|
101
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cross-currency swap contracts
|
|
$
|
—
|
|
|
$
|
110
|
|
|
$
|
—
|
|
(Losses) gains on fair value hedging relationships—interest rate swap agreements:
|
|
|
|
|
|
|
||||||
Hedged items(1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(349
|
)
|
Derivatives designated as hedging instruments
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
352
|
|
|
|
Year ended December 31, 2018
|
||||||||||
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
||||||
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income
|
|
$
|
22,533
|
|
|
$
|
674
|
|
|
$
|
(1,392
|
)
|
The effects of cash flow and fair value hedging:
|
|
|
|
|
|
|
||||||
Losses on cash flow hedging relationships reclassified out of AOCI:
|
|
|
|
|
|
|
||||||
Foreign currency contracts
|
|
$
|
(21
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Cross-currency swap contracts
|
|
$
|
—
|
|
|
$
|
(241
|
)
|
|
$
|
—
|
|
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
|
|
|
|
|
|
|
||||||
Hedged items(1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
65
|
|
Derivatives designated as hedging instruments
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(42
|
)
|
|
|
Year ended December 31, 2017
|
||||||||||
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
||||||
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income
|
|
$
|
21,795
|
|
|
$
|
928
|
|
|
$
|
(1,304
|
)
|
The effects of cash flow and fair value hedging:
|
|
|
|
|
|
|
||||||
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
|
|
|
|
|
|
|
||||||
Foreign currency contracts
|
|
$
|
65
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cross-currency swap contracts
|
|
$
|
—
|
|
|
$
|
574
|
|
|
$
|
—
|
|
Forward interest rate contracts
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(1
|
)
|
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
|
|
|
|
|
|
|
||||||
Hedged items(1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
127
|
|
Derivatives designated as hedging instruments
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(85
|
)
|
(1)
|
(Losses) gains on hedged items do not completely offset gains (losses) on the related designated hedging instruments due to amortization of the cumulative amounts of fair value hedging adjustments included in the carrying amount of the hedged debt for discontinued hedging relationships.
|
|
|
Derivative assets
|
|
Derivative liabilities
|
||||||||
December 31, 2019
|
|
Consolidated Balance Sheets locations
|
|
Fair values
|
|
Consolidated Balance Sheets locations
|
|
Fair values
|
||||
Derivatives designated as hedging instruments:
|
|
|
|
|
|
|
|
|
||||
Foreign currency contracts
|
|
Other current assets/ Other assets
|
|
$
|
223
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
$
|
31
|
|
Cross-currency swap contracts
|
|
Other current assets/ Other assets
|
|
66
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
315
|
|
||
Interest rate swap contracts
|
|
Other current assets/ Other assets
|
|
259
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
—
|
|
||
Total derivatives designated as hedging instruments
|
|
|
|
548
|
|
|
|
|
346
|
|
||
Derivatives not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
||||
Foreign currency contracts
|
|
Other current assets
|
|
1
|
|
|
Accrued liabilities
|
|
—
|
|
||
Total derivatives not designated as hedging instruments
|
|
|
|
1
|
|
|
|
|
—
|
|
||
Total derivatives
|
|
|
|
$
|
549
|
|
|
|
|
$
|
346
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Derivative assets
|
|
Derivative liabilities
|
||||||||
December 31, 2018
|
|
Consolidated Balance Sheets locations
|
|
Fair values
|
|
Consolidated Balance Sheets locations
|
|
Fair values
|
||||
Derivatives designated as hedging instruments:
|
|
|
|
|
|
|
|
|
||||
Foreign currency contracts
|
|
Other current assets/ Other assets
|
|
$
|
181
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
$
|
26
|
|
Cross-currency swap contracts
|
|
Other current assets/ Other assets
|
|
170
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
401
|
|
||
Interest rate swap contracts
|
|
Other current assets/ Other assets
|
|
56
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
149
|
|
||
Total derivatives designated as hedging instruments
|
|
|
|
407
|
|
|
|
|
576
|
|
||
Derivatives not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
||||
Foreign currency contracts
|
|
Other current assets
|
|
1
|
|
|
Accrued liabilities
|
|
—
|
|
||
Total derivatives not designated as hedging instruments
|
|
|
|
1
|
|
|
|
|
—
|
|
||
Total derivatives
|
|
|
|
$
|
408
|
|
|
|
|
$
|
576
|
|
|
Amounts
|
||
2020
|
$
|
587
|
|
2021
|
587
|
|
|
2022
|
587
|
|
|
2023
|
1,100
|
|
|
2024
|
1,467
|
|
|
Thereafter
|
1,834
|
|
|
Total remaining U.S. repatriation tax commitments
|
$
|
6,162
|
|
|
2019 Quarters ended
|
||||||||||||||
|
December 31
|
|
September 30
|
|
June 30
|
|
March 31
|
||||||||
Product sales
|
$
|
5,881
|
|
|
$
|
5,463
|
|
|
$
|
5,574
|
|
|
$
|
5,286
|
|
Gross profit from product sales
|
$
|
4,628
|
|
|
$
|
4,427
|
|
|
$
|
4,562
|
|
|
$
|
4,231
|
|
Net income
|
$
|
1,703
|
|
|
$
|
1,968
|
|
|
$
|
2,179
|
|
|
$
|
1,992
|
|
Earnings per share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
2.87
|
|
|
$
|
3.29
|
|
|
$
|
3.59
|
|
|
$
|
3.20
|
|
Diluted
|
$
|
2.85
|
|
|
$
|
3.27
|
|
|
$
|
3.57
|
|
|
$
|
3.18
|
|
|
2018 Quarters ended
|
||||||||||||||
|
December 31
|
|
September 30
|
|
June 30
|
|
March 31
|
||||||||
Product sales
|
$
|
6,001
|
|
|
$
|
5,510
|
|
|
$
|
5,679
|
|
|
$
|
5,343
|
|
Gross profit from product sales
|
$
|
4,905
|
|
|
$
|
4,473
|
|
|
$
|
4,655
|
|
|
$
|
4,399
|
|
Net income
|
$
|
1,928
|
|
|
$
|
1,859
|
|
|
$
|
2,296
|
|
|
$
|
2,311
|
|
Earnings per share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
3.04
|
|
|
$
|
2.88
|
|
|
$
|
3.50
|
|
|
$
|
3.27
|
|
Diluted
|
$
|
3.01
|
|
|
$
|
2.86
|
|
|
$
|
3.48
|
|
|
$
|
3.25
|
|
Allowance for doubtful accounts
|
|
Balance
at beginning
of period
|
|
Additions
charged to
costs and
expenses
|
|
Other
additions
|
|
Deductions
|
|
Balance
at end
of period
|
||||||||||
Year ended December 31, 2019
|
|
$
|
48
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
22
|
|
|
$
|
26
|
|
Year ended December 31, 2018
|
|
$
|
51
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
4
|
|
|
$
|
48
|
|
Year ended December 31, 2017
|
|
$
|
51
|
|
|
$
|
4
|
|
|
$
|
—
|
|
|
$
|
4
|
|
|
$
|
51
|
|
By:
|
/s/ Mark J. Alles
|
|
Name: Mark J. Alles
Title: Chairman and Chief Executive Officer
|
By:
|
/s/ Jonathan Graham
|
|
Name: Jonathan Graham
Title: Senior Vice President, General Counsel and
Secretary
|
(a)
|
To the extent it is incorrectly assumed by the Asset Selling Entity that no Indirect Taxes are chargeable on the transfer of Product Inventory, the Parties will cooperate in retroactively correcting measures. To the extent required by applicable Law or the immediately preceding sentence, the Asset Selling Entity shall issue (or shall cause to be issued) a correcting invoice with respect to the transfer of the Product Inventory in accordance with applicable Law, and shall reasonably cooperate with
|
(b)
|
To the extent it is incorrectly assumed by the Asset Selling Entity that Indirect Taxes are chargeable on the transfer of Product Inventory, the Parties will cooperate to implement retroactively correcting measures. To the extent required by applicable Law or the immediately preceding sentence, the Asset Selling Entity shall issue (or shall cause to be issued) a correcting invoice with respect to the transfer of the Product Inventory in accordance with applicable Law, and shall reasonably cooperate with the Purchaser or its relevant Affiliate to provide information and documentation necessary for Purchaser or its relevant Affiliate to comply with its Indirect Tax obligations under applicable Law. The Asset Selling Entity shall (and shall cause its Affiliates to) (i) use commercially reasonable efforts to reclaim (through credit, offset, refund or otherwise) any Indirect Taxes incurred in connection with this Agreement and the transactions contemplated hereby, it being understood by the Parties that if the Asset Selling Entity is not able to fully reclaim any such Indirect Taxes, Purchaser or its relevant affiliate shall promptly pay over to Seller or its relevant Affiliate fifty percent (50%) of the unreclaimable portion of such Indirect Tax suffered by the Asset Selling Entity, consistent with Section 7 of this Letter Agreement and Section 7.6(b)(i) of the APA.
|
|
|
|
|
CELGENE AB
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE AB
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE APS.
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Member of the Board of Directors
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Member of the Board of Directors
|
|
|
|
|
CELGENE AS
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Director
|
|
|
|
|
CELGENE BV
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Director
|
|
|
|
|
CELGENE CHEMICALS SARL
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
Very truly yours,
|
|
|
CELGENE CORPORATION
|
|
|
|
|
|
By:
|
/s/ Matthew Roden
|
|
|
Name: Matthew Roden
|
|
|
Title: President
|
|
|
|
|
CELGENE DOO
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Director
|
|
|
|
|
CELGENE DISTRIBUTION BV
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Director
|
|
|
|
|
CELGENE EUROPE BV
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Director
|
|
|
|
|
CELGENE GMBH
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
|
|
|
CELGENE GMBH
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE INC
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Manager
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Manager
|
|
|
|
|
CELGENE INTERNATIONAL HOLDINGS
CORPORATION, PODRUŽINICA V
SLOVENIJI
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
CELGENE INTERNATIONAL HOLDINGS
CORPORATION
|
|
|
|
|
|
By:
|
/s/ Katherine Kelly
|
|
|
Name: Katherine Kelly
|
|
|
Title: Secretary
|
|
|
|
|
CELGENE INTERNATIONAL II SARL
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
CELGENE INTERNATIONAL INC.
|
|
|
|
|
|
By:
|
/s/ Katherine Kelly
|
|
|
Name: Katherine Kelly
|
|
|
Title: Secretary
|
|
|
|
|
CELGENE INTERNATIONAL SARL
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
|
|
|
CELGENE K.K
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE KORLÁTOLT FELELÖSSÉGÜ
TÁRSASÁG
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
|
|
|
CELGENE LIMITED
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Director
|
|
|
|
|
CELGENE LIMITED
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE LOGISTICS SARL
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
|
|
|
CELGENE MANAGEMENT SARL
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE R&D SARL
|
|
|
|
|
|
By:
|
/s/ Tuomo Patsi
|
|
|
Name: Tuomo Patsi
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
|
|
|
CELGENE RECEPTOS SARL
|
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE SLU
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE S.R.O.
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Managing Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Managing Director
|
|
|
|
|
CELGENE SRO
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Executive Director
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Executive Director
|
|
|
|
|
CELGENE SAS
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
|
|
|
CELGENE SPRL
|
|
|
|
|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Manager
|
|
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|
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By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Manager
|
|
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|
|
CELGENE S.R.L
|
|
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|
|
By:
|
/s/ Nakisa Serry
|
|
|
Name: Nakisa Serry
|
|
|
Title: Authorized Signatory
|
|
|
|
|
By:
|
/s/ David Pignolet
|
|
|
Name: David Pignolet
|
|
|
Title: Authorized Signatory
|
|
SIGNAL PHARMACEUTICALS, LLC
|
|
|
|
|
|
By:
|
/s/ Katherine Kelly
|
|
|
Name: Katherine Kelly
|
|
|
Title: Manager and Authorized Person
|
|
|
|
|
AMGEN (EUROPE) GMBH
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Justin G. Claeys
|
|
||
|
|
Name: Justin G. Claeys
|
|
||
|
|
Title: Director
|
|
||
|
|
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|
|
AMGEN (NEW ZEALAND) LIMITED
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Penny Chan Wan
|
|
||
|
|
Name: Penny Chan Wan
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN AB
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Justin G. Claeys
|
|
||
|
|
Name: Justin G. Claeys
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN ASTELLAS BIOPHARMA K.K.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Steve Kenji Sugino
|
|
||
|
|
Name: Steve Kenji Sugino
|
|
||
|
|
Title: Representative Director
|
|
||
|
|
|
|
|
AMGEN AUSTRALIA PTY LIMITED
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Penny Chan Wan
|
|
||
|
|
Name: Penny Chan Wan
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN B.V.
|
|
|
|
|
|
|
|
By:
|
/s/ Marika Murto
|
|
|
|
Name: Marika Murto
|
|
|
|
Title: Director
|
|
|
AMGEN BIO-FARMACĖUTICA LDA
|
|
|
|
|
|
|
|
By:
|
/s/ Tiago Gueds Amieiro
|
|
|
|
Name: Tiago Gueds Amieiro
|
|
|
|
Title: Director
|
|
|
AMGEN CANADA INC.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Jonathan P. Graham
|
|
||
|
|
Name: Jonathan P. Graham
|
|
||
|
|
Title: EVP, General Counsel & Secretary
|
|
||
|
|
|
|
|
AMGEN D.O.O.
|
||||
|
|
|
|||
|
By:
|
/s/ Irena Hampel Hrsak
|
|||
|
|
Name: Irena Hampel Hrsak
|
|||
|
|
Title: Director
|
|||
|
AMGEN D.O.O.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Sanja Cerovac Vodičar
|
|
||
|
|
Name: Sanja Cerovac Vodičar
|
|
||
|
|
Title: Director
|
|
|
AMGEN EUROPE B.V.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Justin G. Claeys
|
|
||
|
|
Name: Justin G. Claeys
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN AB, FILIAL I FINLAND
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Niilo Färkkila
|
|
||
|
|
Name: Niilo Färkkila
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN GMBH
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Lauri Lindgren
|
|
||
|
|
Name: Lauri Lindgren
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
||
|
AMGEN GMBH
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Christoph Eder
|
|
||
|
|
Name: Christoph Eder
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN GMBH
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Andreas Bierl
|
|
||
|
|
Name: Andreas Bierl
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
||
|
AMGEN GMBH
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Roman Stampfli
|
|
||
|
|
Name: Roman Stampfli
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
Very truly yours,
|
|
|
CELGENE CORPORATION
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
|
AMGEN INC.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Jonathan P. Graham
|
|
||
|
|
Name: Jonathan P. Graham
|
|
||
|
|
Title: EVP, General Counsel & Secretary
|
|
||
|
|
|
|
|
AMGEN IRELAND LIMITED
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Caitriona Duggan
|
|
||
|
|
Name: Caitriona Duggan
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN LIMITED
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Christopher Walker
|
|
||
|
|
Name: Christopher Walker
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN MEXICO SA de CV
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Giles Marrache
|
|
||
|
|
Name: Giles Marrache
|
|
||
|
|
Title: Chairman
|
|
||
|
|
|
|
|
AMGEN NV
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Catherine Boutremans
|
|
||
|
|
Name: Catherine Boutremans
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
||
|
AMGEN NV
|
|
|||
|
|
|
|
||
|
By:
|
|
|
||
|
|
Name: Justin G. Claeys
|
|
||
|
|
Title: Director
|
|
|
AMGEN NV
|
|
|||
|
|
|
|
||
|
By:
|
|
|
||
|
|
Name: Catherine Boutremans
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
||
|
AMGEN NV
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Justin G. Claeys
|
|
||
|
|
Name: Justin G. Claeys
|
|
||
|
|
Title: Director
|
|
|
AMGEN S.A.U.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Fina Llados
|
|
||
|
|
Name: Fina Llados
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN S.R.L.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Soren Giese
|
|
||
|
|
Name: Soren Giese
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN S.R.O.
|
|
|||
|
|
|
|
||
|
By:
|
/s/ Tomas Brezina
|
|
||
|
|
Name: Tomas Brezina
|
|
||
|
|
Title: Director
|
|
||
|
|
|
|
|
AMGEN SLOVAKIA S.R.O.
|
|
|
|
|
|
|
|
By:
|
/s/ Sorin Popescu
|
|
|
|
Name: Sorin Popescu
|
|
|
|
Title: Director
|
|
|
AMGEN SWITZERLAND AG
|
|
|
|
|
|
|
|
By:
|
/s/ Giles Marrache
|
|
|
|
Name: Giles Marrache
|
|
|
|
Title: Director
|
|
|
AMGEN SWITZERLAND AG
|
|
|
|
|
|
|
|
By:
|
|
|
|
|
Name: Henrik Asmussen
|
|
|
|
Title: Director
|
|
|
AMGEN SWITZERLAND AG
|
|
|
|
|
|
|
|
By:
|
|
|
|
|
Name: Giles Marrache
|
|
|
|
Title: Director
|
|
|
AMGEN SWITZERLAND AG
|
|
|
|
|
|
|
|
By:
|
/s/ Henrik Asmussen
|
|
|
|
Name: Henrik Asmussen
|
|
|
|
Title: Director
|
|
|
AMGEN ZDRAVILA, TRŽENJE ZDRAVIL D.O.O.
|
|
|
|
|
|
|
|
By:
|
/s/ Sanja Cerovac Vodicar
|
|
|
|
Name: Sanja Cerovac Vodicar
|
|
|
|
Title: Country Director
|
|
|
AMGEN SAS
|
|
|
|
|
|
|
|
By:
|
/s/ Corrine Blachier-Poisson
|
|
|
|
Name: Corrine Blachier-Poisson
|
|
|
|
Title: Director
|
|
•
|
prior to such time, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
|
•
|
upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
|
•
|
at or subsequent to such time, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.
|
•
|
any merger or consolidation involving the corporation and the interested stockholder;
|
•
|
any sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;
|
•
|
any transaction which results in the issuance or transfer by the corporation or by any direct or indirect majority-owned subsidiary of the corporation of any stock of the corporation or of such subsidiary to the interested stockholder, subject to limited exceptions;
|
•
|
any transaction involving the corporation or any direct or indirect majority-owned subsidiary of the corporation which has the effect, directly or indirectly, of increasing the proportionate share of the stock of any class or series, or securities convertible into the stock of any class or series, of the corporation or of any such subsidiary which is owned by the interested stockholder; or
|
•
|
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation or any direct or indirect majority-owned subsidiary of the corporation.
|
|
The 2022 Notes:
|
||
|
•
|
|
We issued €1,250,000,000 in aggregate principal amount of 1.250% Senior Notes, maturing February 25, 2022 and bearing interest at a rate of 1.250% per annum, payable annually on February 25 of each year. As of February 11, 2020, €1,250,000,000 aggregate principal amount of the 2022 Notes was outstanding.
|
|
|
|
|
|
The 2026 Notes:
|
||
|
•
|
|
We issued €750,000,000 in aggregate principal amount of 2.000% Senior Notes, maturing February 25, 2026 and bearing interest at a rate of 2.000% per annum, payable annually on February 25 of each year. As of February 11, 2020, €750,000,000 aggregate principal amount of the 2026 Notes was outstanding.
|
|
(1)
|
the fair market value of the assets subject to such transaction; and
|
|
(2)
|
the present value (discounted at a rate per annum equal to the average interest borne by all outstanding debt securities issued under the Indenture (which may include debt securities in addition to the Notes) determined on a weighted average basis and compounded semi-annually) of the obligations of the lessee for rental payments during the term of the related lease.
|
|
(1)
|
our Indebtedness incurred after the first issue date of the Notes and secured by Liens not permitted by the first sentence under “—Limitation on Liens” below; and
|
|
(2)
|
our and our Subsidiaries’ Attributable Liens in respect of sale and lease-back transactions entered into after the first issue date of the Notes pursuant to the second paragraph of “—Limitation on Sale and Lease-Back Transactions” below.
|
|
(1)
|
any foreign, federal, state, county or municipal government, or political subdivision thereof;
|
|
(2)
|
any governmental or quasi-governmental agency, authority, board, bureau, commission, department, instrumentality or public body;
|
|
(3)
|
any court or administrative tribunal; and
|
|
(4)
|
with respect to any Person, any arbitration tribunal or other nongovernmental authority to whose jurisdiction that Person has consented.
|
|
(1)
|
interest rate swap agreements (whether from fixed to floating or from floating to fixed), interest rate cap agreements and interest rate collar agreements;
|
|
(2)
|
other agreements or arrangements designed to manage interest rates or interest rate risk; and
|
|
(3)
|
other agreements or arrangements designed to protect such Person against fluctuations in currency exchange rates or commodity prices.
|
|
(1)
|
Liens securing Indebtedness under Credit Facilities;
|
|
(2)
|
Liens on accounts receivable, merchandise inventory, equipment, and patents, trademarks, trade names and other intangibles, securing our Indebtedness;
|
|
(3)
|
Liens on any of our assets, any of our Subsidiaries’ assets, or the assets of any joint venture to which we or any of our Subsidiaries is a party, created solely to secure obligations incurred to finance the refurbishment, improvement or construction of such asset, which obligations are incurred no later than 24 months after completion of such refurbishment, improvement or construction, and all renewals, extensions, refinancings, replacements or refundings of such obligations;
|
|
(4)
|
(a) Liens given to secure the payment of the purchase price incurred in connection with the acquisition (including acquisition through merger or consolidation) of Property (including shares of stock), including Capital Lease transactions in connection with any such acquisition, and (b) Liens existing on Property at the time of acquisition thereof or at the time of acquisition by us or one of our Subsidiaries of any Person then owning such Property whether or not such existing Liens were given to secure the payment of the purchase price of the Property to which they attach; provided that, with respect to clause (a), the Liens shall be given within 24 months after such acquisition and shall attach solely to the Property acquired or purchased and any improvements then or thereafter placed thereon;
|
|
(5)
|
Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods;
|
|
(6)
|
Liens upon specific items of inventory or other goods and proceeds of any Person securing such Person’s obligations in respect of bankers’ acceptances issued or created for the account of such Person to facilitate the purchase, shipment or storage of such inventory or other goods;
|
|
(7)
|
Liens securing reimbursement obligations with respect to letters of credit that encumber documents and other Property relating to such letters of credit and the products and proceeds thereof;
|
|
(8)
|
Liens on key-man life insurance policies granted to secure our Indebtedness against the cash surrender value thereof;
|
|
(9)
|
Liens encumbering customary initial deposits and margin deposits and other Liens in the ordinary course of business, in each case securing Hedging Obligations and forward contract, option, futures contracts, futures options or similar agreements or arrangements designed to protect us or any of our Subsidiaries from fluctuations in interest rates, currencies or the price of commodities;
|
|
(10)
|
Liens arising out of conditional sale, title retention, consignment or similar arrangements for the sale of goods entered into by us or any of our Subsidiaries in the ordinary course of business;
|
|
(11)
|
pre-existing Liens on assets acquired by us or any of our Subsidiaries after the first issue date of the Notes;
|
|
(12)
|
Liens in our favor or the favor of any of our Subsidiaries;
|
|
(13)
|
inchoate Liens incident to construction or maintenance of real property, or Liens incident to construction or maintenance of real property, now or hereafter filed of record for sums not yet delinquent or being contested in good faith, if reserves or other appropriate provisions, if any, as shall be required by GAAP shall have been made therefor;
|
|
(14)
|
statutory Liens arising in the ordinary course of business with respect to obligations which are not delinquent or are being contested in good faith, if reserves or other appropriate provisions, if any, as shall be required by GAAP shall have been made therefor;
|
|
(15)
|
Liens consisting of pledges or deposits to secure obligations under workers’ compensation laws or similar legislation, including Liens of judgments thereunder which are not currently dischargeable;
|
|
(16)
|
Liens consisting of pledges or deposits of Property to secure performance in connection with operating leases made in the ordinary course of business to which we or any of our Subsidiaries is a party as lessee, provided the aggregate value of all such pledges and deposits in connection with any such lease does not at any time exceed 16 2⁄3% of the annual fixed rentals payable under such lease;
|
|
(17)
|
Liens consisting of deposits of Property to secure our statutory obligations or statutory obligations of any of our Subsidiaries in the ordinary course of its business;
|
|
(18)
|
Liens consisting of deposits of Property to secure (or in lieu of) surety, appeal or customs bonds in proceedings to which we or any of our Subsidiaries is a party in the ordinary course of its business, but not in excess of $75,000,000;
|
|
(19)
|
purchase money Liens or purchase money security interests upon or in any Property acquired or held by us or any of our Subsidiaries in the ordinary course of business to secure the purchase price of such Property or to secure indebtedness incurred solely for the purpose of financing the acquisition of such Property;
|
|
(20)
|
Liens on an asset created in connection with the acquisition, construction or development of additions, extensions or improvements to such asset which shall be financed by obligations described in Sections 142, 144(a) or 144(c) of the Code, or by obligations entitled to substantially similar tax benefits under other legislation or regulations in effect from time to time; and
|
|
(21)
|
Liens on Property subject to escrow or similar arrangements established in connection with litigation settlements.
|
|
•
|
|
equal in right of payments to all of our other existing and future senior unsecured indebtedness;
|
|
•
|
|
senior in right of payment to all of our existing and future subordinated indebtedness; and
|
|
•
|
|
effectively subordinated in right of payment to all of our subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to our secured obligations, to the extent of the assets securing such obligations.
|
|
•
|
|
for a period of 15 days prior to any date fixed for the redemption of the Notes;
|
|
•
|
|
for a period of 15 days immediately prior to the date fixed for selection of Notes to be redeemed in part;
|
|
•
|
|
for a period of 15 days prior to the record date with respect to any interest payment date; or
|
|
•
|
|
which the holder has tendered (and not withdrawn) for repurchase in connection with a change of control offer.
|
|
•
|
|
the redemption date;
|
|
•
|
|
the redemption price;
|
|
•
|
|
the name and address of the paying agent;
|
|
•
|
|
if any Notes are being redeemed in part, the portion of the principal amount of such notes to be redeemed and that, after the redemption date and upon surrender of such Notes, a new note or notes in principal amount equal to the unredeemed portion of the original note shall be issued in the name of the holder of the Notes thereof upon cancellation of the original note;
|
|
•
|
|
that the notes called for redemption must be surrendered to the paying agent to collect the redemption price;
|
|
•
|
|
that interest on the Notes called for redemption ceases to accrue on and after the redemption date unless we default in the deposit of the redemption price; and
|
|
•
|
|
the CUSIP and/or ISIN number of the Notes.
|
|
•
|
|
accept for payment all notes or portions of notes properly tendered pursuant to the change of control offer;
|
|
•
|
|
by 10:00 a.m., London time, deposit with the principal paying agent an amount equal to the change of control payment in respect of all notes or portions of notes properly tendered; and
|
|
•
|
|
deliver or cause to be delivered to the Trustee the notes properly accepted together with an officer’s certificate stating the aggregate principal amount of notes or portions of notes being repurchased.
|
|
•
|
|
default in the payment of any interest on the notes of that series when it becomes due and payable, and continuance of such default for a period of 30 days (unless the entire amount of the payment is deposited by us with the Trustee or with the principal paying agent prior to the expiration of the 30-day period);
|
|
•
|
|
default in the payment of principal of the notes of that series at their maturity;
|
|
•
|
|
default in the performance or breach of any other covenant or warranty by us in the Indenture (other than defaults pursuant to the previous two bullet points above or pursuant to a covenant or warranty that has been included in the Indenture solely for the benefit of a series of debt securities other than that series of notes), which default continues uncured for a period of 90 days after we receive written notice from the Trustee or we and the Trustee receive written notice from the holders of not less than a majority in principal amount of the outstanding Notes of the affected series as provided in the Indenture; or
|
|
•
|
|
certain voluntary or involuntary events of bankruptcy, insolvency or reorganization of our company.
|
|
•
|
|
that holder has previously given to the Trustee written notice of a continuing event of default with respect to the Notes of that series; and
|
|
•
|
|
the holders of at least a majority in principal amount of the outstanding Notes of that series have made written request, and offered reasonable indemnity or security, to the Trustee to institute the proceeding as Trustee, and the Trustee has not received from the holders of a majority in principal amount of the outstanding Notes of that series a direction inconsistent with that request and has failed to institute the proceeding within 60 days.
|
|
•
|
|
to cure any ambiguity, defect or inconsistency;
|
|
•
|
|
to comply with the covenant described below under the heading “—Consolidation, Merger and Sale of Assets;”
|
|
•
|
|
to provide for uncertificated notes in addition to or in place of certificated notes;
|
|
•
|
|
to add guarantees with respect to Notes of any series or secure notes of any series;
|
|
•
|
|
to surrender any of our rights or powers under the Indenture;
|
|
•
|
|
to add covenants or events of default for the benefit of the holders of Notes of any series;
|
|
•
|
|
to comply with the applicable procedures of the applicable depositary;
|
|
•
|
|
to make any change that would not adversely affect the rights of any holder of Notes in any material respect;
|
|
•
|
|
to provide for the issuance of and establish the form and terms and conditions of additional Notes of any series as permitted by the Indenture;
|
|
•
|
|
to effect the appointment of a successor trustee with respect to the Notes and to add to or change any of the provisions of the Indenture to provide for or facilitate administration by more than one trustee; or
|
|
•
|
|
to comply with requirements of the U.S. Securities and Exchange Commission in order to effect or maintain the qualification of the Indenture under the U.S. Trust Indenture Act of 1939.
|
|
•
|
|
reduce the amount of Notes whose holders must consent to an amendment, supplement or waiver;
|
|
•
|
|
reduce the rate of or extend the time for payment of interest (including any additional amounts) on the Notes;
|
|
•
|
|
reduce the principal of or premium on or change the fixed maturity of the Notes;
|
|
•
|
|
waive a default in the payment of the principal of, premium or interest on the notes (except a rescission of acceleration of the notes by the holders of at least a majority in aggregate principal amount of the then outstanding Notes of that series and a waiver of the payment default that resulted from such acceleration);
|
|
•
|
|
make the principal of or interest on the Notes payable in currency other than that stated in the Notes;
|
|
•
|
|
make any change to certain provisions of the Indenture relating to, among other things, the right of holders of the Notes to receive payment of the principal of, premium and interest on the Notes and to institute suit for the enforcement of any such payment and to waivers or amendments; or
|
|
•
|
|
waive a redemption payment with respect to the Notes.
|
|
•
|
|
we are the surviving corporation or the successor person (if other than Amgen) is organized and validly existing under the laws of any U.S. domestic jurisdiction and expressly assumes, pursuant to a supplemental Indenture, our obligations on the notes and under the Indenture; and
|
|
•
|
|
immediately after giving effect to the transaction, no default or event of default shall have occurred and be continuing under the Indenture.
|
|
•
|
|
we may omit to comply with the covenant described under the heading “—Consolidation, Merger and Sale of Assets” and certain other covenants set forth in the Indenture, as well as any additional covenants set forth in the applicable prospectus supplement; and
|
|
•
|
|
any omission to comply with those covenants will not constitute a default or an event of default with respect to the Notes, which we refer to as a “covenant defeasance.”
|
|
•
|
|
depositing with the Trustee money, U.S. government obligations and/or foreign government obligations that, through the payment of interest and principal in accordance with their terms, will provide money in an amount sufficient in the opinion of a nationally recognized firm of independent public accountants or investment bank to pay and discharge each installment of principal of, premium and interest on the notes on the stated maturity of those payments in accordance with the terms of the Indenture and the Notes; and
|
|
•
|
|
delivering to the Trustee an opinion of counsel to the effect that the holders of the Notes will not recognize income, gain or loss for U.S. federal income tax purposes as a result of the deposit and related covenant defeasance and will be subject to U.S. federal income tax on the same amounts and in the same manner and at the same times as would have been the case if the deposit and related covenant defeasance had not occurred.
|
a.
|
the terms and conditions of this Option, including Appendix A, are deemed modified to the extent necessary or advisable to comply with applicable foreign laws or facilitate the administration to the Plan;
|
b.
|
if applicable, the effectiveness of this Option is conditioned upon its compliance with any applicable foreign laws, regulations, rules or local
|
c.
|
the Company may take any other action before or after the date of this Option that it deems advisable to obtain approval or comply with any necessary local governmental regulatory exemptions or approvals.
|
(2)
|
The Plan and your participation in the Plan are offered by Amgen Inc. on a wholly discretionary basis.
|
(4)
|
Amgen Inc. and its Affiliates are not responsible for any decrease in the value of the Option granted and/or Shares issued under the Plan.
|
(1)
|
Su participación en el Plan de ninguna manera constituye un derecho adquirido.
|
(2)
|
El Plan y su participación en el mismo son ofrecidos por Amgen Inc. de forma completamente discrecional.
|
(4)
|
Amgen Inc. y sus Afiliados no son responsables de ninguna disminución en el valor de la opción otorgada y/o de las Acciones Comunes emitidas mediante el Plan.
|
Plan:
|
Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, as amended and/or restated from time to time
|
Grant Price:
|
$________
|
Expiration Date:
|
The [______ (__th)] anniversary of the Grant Date
|
Vesting Schedule:
|
Means the schedule of vesting set forth under Vesting Details
|
Vesting Details:
|
Means the presentation (tabular or otherwise) of the Vesting Date and the quantity of Shares vesting.
|
a.
|
General. Subject to the terms and conditions of this Agreement, on each Vesting Date, the Number of Units indicated on the Vesting Schedule shall vest, provided that you have remained continuously and actively employed with the Company or an Affiliate (as defined in the Plan) through each applicable Vesting Date, unless (i) [your employment has terminated due to your Voluntary Termination (as defined in paragraph (d) of this Section I below) ]*, [(ii)] you experience a Qualified Termination (as defined below), or (iii)[(ii)] as otherwise determined by the Company in the exercise of its discretion as provided in paragraph (f) of this Section I. The Units represent an unfunded, unsecured promise by the Company to deliver Shares. Only whole Shares shall be issued upon vesting of the Units, and the Company shall be under no obligation to issue any fractional Shares to you. If your employment with the Company or an Affiliate is terminated for any reason or for no reason, including if your active employment is terminated by the Company or an Affiliate without Cause (as defined below), or in the event of any other termination of your active employment caused directly or indirectly by the Company or an Affiliate, except as otherwise provided in paragraphs (b), (c), [(d), ]*(1) (e) or (f) of this Section I below, your unvested Units shall automatically expire and terminate on the date of termination of your active employment. Notwithstanding anything herein to the contrary, the Vesting Schedule may be accelerated (by notice in writing) by the Company in its sole discretion at any time that the Units remain outstanding and unvested (in whole or in part). In addition, if not prohibited by local law, vesting may be suspended by the Company in its sole discretion during a leave of absence as provided from time to time according to Company policies and practices.
|
b.
|
Permanent and Total Disability. Notwithstanding the provisions in paragraph (a) above, if your employment with the Company or an Affiliate terminates due to your Permanent and Total Disability (as defined below), then the vesting of Units granted under this Agreement shall be accelerated, subject to your execution of a general release and waiver in a form provided by the Company (for the purpose of resolving any potential or actual disputes arising from your employment and the termination of your employment with the Company), to vest as of the day immediately preceding such termination of your employment with respect to all Units granted hereunder, except that if the Units were granted in the calendar year in which such termination occurs, the Units shall be accelerated to vest with respect to a number of Units equal to the number of Units subject to this Agreement multiplied by a fraction, the numerator of which is the number of complete months you remained continuously and actively employed during such calendar year, and the denominator of which is twelve (12), and any Units that remain unvested shall automatically expire and terminate on the date of the termination of your active employment due to your Permanent and Total Disability without consideration therefor.
|
c.
|
Death. Notwithstanding the provisions in paragraph (a) above, if your employment with the Company or an Affiliate terminates due to your death, then the vesting of Units granted under this Agreement shall be accelerated to vest as of the day immediately preceding your death with respect to all Units granted hereunder, except that if the Units were granted in the calendar year in which your death occurs the Units shall be accelerated to vest with respect to a number of Units equal to the number of Units subject to this Agreement multiplied by a fraction, the numerator of which is the number of complete months you remained continuously and actively employed during such calendar year, and the denominator of which is twelve (12), and any Units that remain unvested shall automatically expire and terminate on the date of the termination of your active employment due to your death without consideration therefor.
|
d.
|
[Retirement. Notwithstanding the provisions in paragraph (a) above, if you terminate your employment with the Company or an Affiliate due to your voluntary termination (and such voluntary termination is not the result of Permanent and Total Disability (as defined below)) after you are at least sixty-five (65) years of age, or after you are at least fifty-five (55) years of age and have been an employee of the Company and/or an Affiliate for at least ten (10) years in the aggregate as determined by the Company in its sole discretion according to Company policies and practices as in effect from time to time (“Voluntary Termination”), then the Units will vest pursuant to the Vesting Schedule without regard to the termination of employment prior to the Vesting Date, subject to your execution of a general release and waiver in a form provided by the Company (for the purpose of resolving any potential or actual disputes arising from your employment
|
e.
|
Qualified Termination after a Change of Control. Notwithstanding the provisions in paragraph (a) above, in the event of a Qualified Termination (as defined below), then, to the extent permitted by applicable law, the vesting of Units granted under this Agreement shall be accelerated to vest as of the day immediately prior to the Qualified Termination.
|
f.
|
Continued Vesting. Notwithstanding the provisions in paragraph (a) above, the Company may in its sole discretion at any time during the term of this Agreement, in writing, otherwise provide that the Units will vest pursuant to the Vesting Schedule without regard to the termination of employment prior to the Vesting Date, subject to any terms and conditions that the Company may determine.
|
(a)
|
if you are an employee who participates in the Change of Control Plan (as defined below), your termination of employment within two (2) years following a Change of Control (i) by the Company other than for Cause, Disability (as defined below), or as a result of your death or (ii) by you for Good Reason (as defined in the Change of Control Plan); or
|
(b)
|
if you are an employee who does not participate in the Change of Control Plan or the Change of Control Plan is no longer in effect, your termination of employment within two (2) years following a Change of Control by the Company other than for Cause, Disability (as defined below), or as a result of your death;
|
a.
|
the terms and conditions of this Agreement, including Appendix A, are deemed modified to the extent necessary or advisable to comply with applicable foreign laws or facilitate the administration of the Plan;
|
b.
|
if applicable, the effectiveness of your award of Units is conditioned upon its compliance with any applicable foreign laws, regulations, rules or local governmental regulatory exemption and subject to receipt of any required foreign regulatory approvals;
|
c.
|
to the extent necessary to comply with applicable foreign laws, the payment of any earned Units shall be made in cash or Common Stock, at the Company’s election; and
|
d.
|
the Company may take any other action, before or after an award of Units is made, that it deems advisable to obtain approval or comply with any necessary local governmental regulatory exemptions or approvals.
|
(2)
|
The Plan and your participation in the Plan are offered by Amgen Inc. on a wholly discretionary basis.
|
(4)
|
Amgen Inc. and its Affiliates are not responsible for any decrease in the value of the Units granted and/or Shares issued under the Plan.
|
(1)
|
Su participación en el Plan de ninguna manera constituye un derecho adquirido.
|
(2)
|
El Plan y su participación en el mismo son ofrecidos por Amgen Inc. de forma completamente discrecional.
|
(4)
|
Amgen Inc. y sus Afiliados no son responsables de ninguna disminución en el valor de Unidades o de las Acciones Comunes emitidas mediante el Plan.
|
Plan:
|
Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, as amended and/or restated from time to time
|
Grant Price:
|
$________
|
Vesting Schedule:
|
Means the schedule of vesting set forth under Vesting Details
|
Vesting Details:
|
Means the presentation (tabular or otherwise) of the Vesting Date and the quantity of Shares vesting
|
(a)
|
General. Subject to Section XIII and except as set forth in the Program, any Performance Units earned pursuant to Section III above shall be settled by the Company delivering to you a number of Shares equal to the number of Shares covered by the earned Performance Units or in a lump sum in cash with a value equal to the Fair Market Value of the number of Shares subject to the earned Performance Units as of the last day of the Performance Period (without interest thereon), or in a combination of Shares and cash, as determined by the Administrator at any time prior to settlement and in its discretion, as soon as practicable, and in any event within 90 days, after the last day of the Performance Period, in each case, subject to the terms of the Program (including Section 4.2 thereof). Shares issued in respect of a Performance Unit shall be deemed to be issued in consideration of past services actually rendered by you to the Company or an Affiliate or for its benefit for which you have not
|
(b)
|
Retirement. In the event that your employment with the Company or an Affiliate is terminated prior to the last business day of the Performance Period by reason of your Voluntary Retirement and you are Retirement-Eligible on the date of such termination, the full or prorated amount of your Award, if any, applicable to the Performance Period shall be paid in accordance with the provisions of Article VI of the Program. For purposes of the foregoing, the amount of your Award (rounded down to the nearest whole number) shall be determined based on the Company’s performance as compared to the Performance Goals for the Performance Period and (i) if the Award was granted with respect to a Performance Period commencing in a calendar year prior to the calendar year in which your Voluntary Retirement occurs, the full amount of the Award is payable, and (ii) if the Award was granted with respect to the Performance Period commencing in the calendar year in which your Voluntary Retirement occurs, the Award otherwise payable is multiplied by a fraction (rounded to two decimal places), the numerator of which is the number of complete months of employment during such calendar year, and the denominator of which is twelve (12). Notwithstanding the foregoing, you shall not be entitled to such full or prorated amount of your Award pursuant to this paragraph (b) unless either you sign a general release and waiver in a form provided by the Company (for the purpose of resolving any potential or actual disputes arising from your employment and the termination of your employment with the Company) and deliver it to the Company no later than the date specified by the Company, or the Company waives such release requirement in writing; provided, however, that in no event shall payment of such full or prorated amount of your Award be made later than the specified payment date as set forth in Section 6.1 of the Program. This paragraph (b) shall supersede Section 7.1(a) of the Program.
|
(c)
|
Death and Disability. In the event that your employment with the Company or an Affiliate is terminated prior to the last business day of the Performance Period by reason of your death or Permanent and Total Disability, the full or prorated amount of your Award, if any, applicable to such Performance Period shall be paid in accordance with the provisions of Article VI of the Program. For purposes of the foregoing, the amount of your Award (rounded down to the nearest whole number) shall be determined based on the Company’s performance as compared to the Performance Goals for the Performance Period and (i) if the Award was granted with respect to a Performance Period commencing in a calendar year prior to the calendar year in which such termination occurs, the full amount of the Award is payable, and (ii) if the Award was granted with respect to the Performance Period commencing in the calendar year in which such termination occurs, the Award otherwise payable is multiplied by a fraction (rounded to two decimal places), the numerator of which is the number of complete months of employment during such calendar year, and the denominator of which is twelve (12). Notwithstanding the foregoing, if your employment is terminated due to your Permanent and Total Disability, you shall not be entitled to such full or prorated amount of your Award pursuant to this paragraph (c) unless either you sign a general release and waiver in a form provided by the Company (for the purpose of resolving any potential or actual disputes arising from your employment and the termination of your employment
|
(d)
|
Other. In the event that your employment with the Company or an Affiliate is terminated prior to the last business day of the Performance Period for any reason other than as specified in paragraphs (b) and (c) above, all of your rights to an Award for the Performance Period shall be forfeited, unless, prior to the payment date described in Article VI of the Program, the Company, in its sole discretion, makes a written determination to otherwise pay the full or prorated amount of your Award, if any, applicable to the Performance Period, which full or prorated amount shall be paid in accordance with the provisions of Article VI of the Program. For purposes of the foregoing, if the payment of your Award is prorated, the amount of your Award (rounded down to the nearest whole number) shall be determined based on the Company’s performance as compared to the Performance Goals for the Performance Period and (i) if the Award was granted with respect to a Performance Period commencing in a calendar year prior to the calendar year in which such termination occurs, the full amount of the Award is payable, and (ii) if the Award was granted with respect to the Performance Period commencing in the calendar year in which such termination occurs, the Award otherwise payable is multiplied by a fraction (rounded to two decimal places), the numerator of which is the number of complete months of employment during such calendar year, and the denominator of which is twelve (12). Notwithstanding the foregoing, you shall not be entitled to such full or prorated amount of your Award pursuant to this paragraph (d) unless either you sign a general release and waiver in a form provided by the Company (for the purpose of resolving any potential or actual disputes arising from your employment and the termination of your employment with the Company) and deliver it to the Company no later than the date specified by the Company, or the Company waives such release requirement in writing; provided, however, that in no event shall payment of such full or prorated amount of your Award be made later than the specified payment date as set forth in Section 6.1 of the Program. This paragraph (d) shall supersede Section 7.1(c) of the Program.
|
(2)
|
The Plan and your participation in the Plan and the Program are offered by Amgen Inc. on a wholly discretionary basis.
|
(4)
|
Amgen Inc. and its Affiliates are not responsible for any decrease in the value of any Shares issued with respect to the Award.
|
(1)
|
Su participación en el Plan y en el Programa de ninguna manera constituye un derecho adquirido.
|
(2)
|
Su participación en Plan y en el Programa son ofrecidos por Amgen Inc. de forma completamente discrecional.
|
(4)
|
Amgen Inc. y sus Afiliados no son responsables de ninguna disminución en el valor de las Acciones Comunes emitidas mediante el Plan.
|
Plan:
|
Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, as amended and/or restated from time to time
|
Program
|
Amgen Inc. 2009 Performance Award Program, as amended and/or restated from time to time
|
Performance Period:
|
The Performance Period beginning on and ending on .
|
Resolutions:
|
The Resolutions of the Compensation and Management Development Committee of the Board of Directors of Amgen Inc. establishing the performance goals and Performance Period applicable to this Award.
|
Vesting Schedule:
|
Means the schedule of vesting set forth under Vesting Details
|
Vesting Details:
|
Means the presentation (tabular or otherwise) of the Vesting Date and the quantity of Shares vesting.
|
1.
|
Section 2.27 is amended by adding the following at the end thereof:
|
By:
|
/s/ Lori A. Johnston
|
|
Name: Lori A. Johnston
Title: Executive Vice President, Human Resources
|
1.
|
Section 3.1(d) is deleted in its entirety.
|
2.
|
Section 8.5 is amended by deleting the fourth sentence thereof and replacing it with the following:
|
By:
|
/s/ Lori A. Johnston
|
|
Name: Lori A. Johnston
Title: Executive Vice President, Human Resources |
|
AMGEN INC.
BEIGENE SWITZERLAND GMBH
and
BEIGENE, LTD.
Dated October 31, 2019
|
COLLABORATION AGREEMENT
|
ARTICLE I. DEFINITIONS
|
2
|
ARTICLE II. SCOPE AND GOVERNANCE
|
25
|
Section 2.1
|
Purpose of the Collaboration 25
|
Section 2.2
|
Committees and Teams 25
|
Section 2.3
|
Joint Steering Committee 27
|
Section 2.4
|
Joint Alliance Committee 28
|
Section 2.5
|
Designated Officers 30
|
Section 2.6
|
Reporting 31
|
Section 2.7
|
No Authority to Amend or Modify 31
|
Section 2.8
|
Alliance Managers 31
|
Section 2.9
|
Non-Collaboration Territory Activities 31
|
ARTICLE III. DEVELOPMENT AND REGULATORY
|
32
|
Section 3.1
|
Development Matters 32
|
Section 3.2
|
Regulatory Matters 33
|
Section 3.3
|
Sharing of Data and Know-How 36
|
Section 3.4
|
Cooperation with Audit and Inspection 36
|
ARTICLE IV. MANUFACTURING
|
36
|
Section 4.1
|
Manufacturing Lead 36
|
Section 4.2
|
Manufacturing and Supply 37
|
Section 4.3
|
Supply and Quality Agreements 37
|
Section 4.4
|
Distribution 37
|
Section 4.5
|
Brand Security and Anti-Counterfeiting 37
|
ARTICLE V. COMMERCIALIZATION
|
38
|
Section 5.1
|
Commercialization of In-Line Products and Pipeline Products 38
|
Section 5.2
|
Commercial Lead 41
|
Section 5.3
|
Allocation of Commercial Responsibility 41
|
Section 5.4
|
Training 41
|
Section 5.5
|
Information Concerning Products 42
|
Section 5.6
|
Promotional Materials 42
|
Section 5.7
|
Commercial Reporting, Records, Costs and Audits 43
|
ARTICLE VI. PERFORMANCE STANDARDS
|
44
|
Section 6.1
|
Collaborative Activities 44
|
Section 6.2
|
Diligence Standards 44
|
Section 6.3
|
Fair Value Pricing 44
|
Section 6.4
|
Proper Conduct Practices Standards 44
|
Section 6.5
|
Violation of Laws 45
|
Section 6.6
|
Use of Affiliates and Third Party Contractors 45
|
Section 6.7
|
Management of Personnel 47
|
Section 6.8
|
Obligation to Notify 47
|
ARTICLE VII. FINANCIAL CONSIDERATION
|
47
|
Section 7.1
|
Global Development Cost Sharing 47
|
Section 7.2
|
Profit Sharing 48
|
Section 7.3
|
Example 50
|
Section 7.4
|
Calculation of Net Revenues 50
|
Section 7.5
|
Excluded Losses 51
|
Section 7.6
|
Manufacturing Costs Calculation and True-Up 51
|
Section 7.7
|
Final Balancing Payments 51
|
Section 7.8
|
Commercialization Budget Deadlocks 52
|
Section 7.9
|
Overruns 52
|
Section 7.10
|
Royalties 52
|
Section 7.11
|
Payments 54
|
ARTICLE VIII. PAYMENTS
|
54
|
Section 8.1
|
Appropriate Measure of Value 54
|
Section 8.2
|
No Other Compensation 55
|
Section 8.3
|
Currency 55
|
Section 8.4
|
Audits 56
|
Section 8.5
|
Blocked Currency 57
|
Section 8.6
|
Taxes 58
|
Section 8.7
|
Late Payment 60
|
Section 8.8
|
Change in Accounting Periods 60
|
ARTICLE IX. DISTRACTING PRODUCTS
|
61
|
Section 9.2
|
Pre-Clinical Development Activities 62
|
Section 9.3
|
Distracting Transactions; Notice 62
|
Section 9.4
|
Reasonable Restrictions 63
|
ARTICLE X. INTELLECTUAL PROPERTY
|
63
|
Section 10.1
|
Program Intellectual Property Ownership 63
|
Section 10.2
|
Copyright Ownership 64
|
Section 10.3
|
Product Trademarks 64
|
Section 10.4
|
Joint Ownership 65
|
Section 10.5
|
License Grant by Amgen 65
|
Section 10.6
|
License Grant by BeiGene 65
|
Section 10.7
|
Prosecution and Maintenance of Patents 65
|
Section 10.8
|
Defense and Settlement of Third Party Claims of Infringement and Other Proceedings 66
|
Section 10.9
|
Enforcement 66
|
Section 10.10
|
Patent Term Extensions 67
|
Section 10.11
|
Trademarks 67
|
Section 10.12
|
Personnel Obligations 69
|
Section 10.13
|
No Prejudicial Action. 70
|
ARTICLE XI. CONFIDENTIALITY, PUBLICATIONS AND PRESS RELEASES
|
70
|
Section 11.1
|
Confidentiality; Exceptions 70
|
Section 11.2
|
Authorized Disclosure 70
|
Section 11.3
|
Confidential Treatment of Terms and Conditions 71
|
Section 11.4
|
Press Releases 71
|
Section 11.5
|
Confidential Information Exchanged Prior to the Effective Date 72
|
Section 11.6
|
Publications and Program Information 72
|
Section 11.7
|
Attorney-Client Privilege 72
|
ARTICLE XII. REPRESENTATIONS, WARRANTIES AND COVENANTS
|
73
|
Section 12.1
|
Mutual Representations and Warranties 73
|
Section 12.2
|
Amgen Representations and Warranties 74
|
Section 12.3
|
BeiGene Representations and Warranties Regarding Blocking IP 74
|
Section 12.4
|
Mutual Covenants 75
|
Section 12.5
|
Privacy and Data Protection 76
|
Section 12.6
|
Information Security 76
|
Section 12.7
|
Disclaimer of Warranties 77
|
Section 12.8
|
Limitation of Liability 77
|
ARTICLE XIII. INDEMNIFICATION AND INSURANCE
|
78
|
Section 13.1
|
Indemnity by BeiGene 78
|
Section 13.2
|
Indemnity by Amgen 78
|
Section 13.3
|
Claim for Indemnification 79
|
Section 13.4
|
Defense of Third Party Claims 79
|
Section 13.5
|
Insurance 81
|
Section 13.6
|
Guarantee 81
|
ARTICLE XIV. TERM AND TERMINATION; REVERSION OF PRODUCTS; CAPABILITY BUILD
|
81
|
Section 14.1
|
Term 81
|
Section 14.2
|
Mutual Termination Rights for the Agreement 82
|
Section 14.3
|
Failure to Obtain Waiver 83
|
Section 14.4
|
Mutual Termination Rights for a Product 83
|
Section 14.5
|
Mutual Termination Rights for Commercial Viability in the Collaboration Territory 84
|
Section 14.6
|
Termination Rights for Suspension of a Pipeline Product 84
|
Section 14.7
|
General Effects of Product Reversion, Expiration or Termination 86
|
Section 14.8
|
Product Reinstatement. 87
|
Section 14.9
|
Additional Surviving Provisions 87
|
Section 14.10
|
Transition Obligations. 88
|
Section 14.11
|
Ordinary Course of Business 89
|
Section 14.12
|
Capability Build Services 89
|
ARTICLE XV. MISCELLANEOUS
|
89
|
Section 15.1
|
Assignment; Change of Control 89
|
Section 15.2
|
Compliance with Laws 91
|
Section 15.3
|
Change in Applicable Law 91
|
Section 15.4
|
Governing Law; Dispute Resolution 93
|
Section 15.5
|
Construction 94
|
Section 15.6
|
Counterparts 94
|
Section 15.7
|
Entire Agreement 94
|
Section 15.8
|
Force Majeure 94
|
Section 15.9
|
Further Assurances 95
|
Section 15.10
|
Headings 95
|
Section 15.11
|
No Set-Off 95
|
Section 15.12
|
Notices 95
|
Section 15.13
|
Relationship of the Parties 96
|
Section 15.14
|
Severability 96
|
Section 15.15
|
Third Party Beneficiaries 96
|
Section 15.16
|
Waivers and Modifications 96
|
Total Pipeline Product Regulatory Approvals
|
Number of Pipeline Products BeiGene has Option to Retain
|
Total Pipeline Product Regulatory Approvals
|
Number of Pipeline Products BeiGene has Option to Retain
|
1
|
0
|
11
|
3
|
2
|
0
|
12
|
3
|
3
|
1
|
13
|
4
|
4
|
1
|
14
|
4
|
5
|
1
|
15
|
4
|
6
|
1
|
16
|
5
|
7
|
2
|
17
|
5
|
8
|
2
|
18
|
5
|
9
|
2
|
19
|
6
|
10
|
3
|
|
|
Aggregate Annual Net Revenues of Pipeline Products (excluding AMG 510)
|
Royalty Rate
|
For that portion of aggregate annual Net Revenues of Pipeline Products in the ROW less than or equal to [*] U.S. Dollars (US$[*])
|
[*]%
|
For that portion of aggregate annual Net Revenues of Pipeline Products in the ROW greater than [*] U.S. Dollars (US$[*]) and less than or equal to [*] U.S. Dollars (US$[*])
|
[*]%
|
For that portion of aggregate annual Net Revenues of Pipeline Products in the ROW greater than [*] U.S. Dollars (US$[*]) and less than or equal to [*] U.S. Dollars (US$[*])
|
[*]%
|
For that portion of aggregate annual Net Revenues of Pipeline Products in the ROW greater than [*] Dollars (US$[*])
|
[*]%
|
Period Following Return of Product Rights to Amgen
|
Royalty Rate
|
|
In-Line Product
|
Pipeline Product
|
|
[*] following return of product rights for such Product
|
[*]%
|
[*]%
|
[*] following return of product rights for such Product
|
[*]%
|
[*]%
|
[*] following return of product rights for such Product
|
[*]%
|
[*]%
|
[*] following return of product rights for such Product
|
[*]%
|
[*]%
|
[*] following return of product rights for such Product
|
[*]%
|
[*]%
|
If to Amgen:
|
Amgen Inc.
One Amgen Center Drive Thousand Oaks, California 91320-1799 United States Attention: Corporate Secretary Telephone: [*] Facsimile: [*] |
If to BeiGene:
|
BeiGene Switzerland GmbH
c/o VISCHER AG Aeschenvorstadt 4, 4051 Basel, Switzerland Attention: Managing Director |
With a copy to:
|
BeiGene USA, Inc.
55 Cambridge Parkway, Suite 700W Cambridge, MA 02142, U.S.A. Attention: General Counsel Facsimile: [*] |
If to BeiGene Parent:
|
BeiGene, Ltd.
c/o Mourant Governance Services (Cayman) Limited 94 Solaris Avenue, P.O. Box 1348 Grand Cayman KY1-1108, Cayman Attention: Corporate Secretary |
BEIGENE SWITZERLAND GMBH
|
|
AMGEN INC.
|
||
By:
|
/s/ Guillaume Vignon
|
|
By:
|
/s/ Robert A. Bradway
|
Name:
|
Guillaume Vignon
|
|
Name:
|
Robert A. Bradway
|
Title:
|
Managing Director
|
|
Title:
|
Chairman of the Board, President
& CEO
|
BEIGENE, LTD. (solely with respect to Section 13.6)
|
|
By:
|
/s/ Scott A. Samuels
|
Name:
|
Scott A. Samuels
|
Title:
|
Senior Vice President, General Counsel
|
1.
|
Guarantee of Parent Co.
|
(a)
|
In order to induce Amgen to enter into the Collaboration Agreement, Parent Co. hereby unconditionally and irrevocably guarantees in favor of Amgen, its successors, endorsees and assigns, the due and punctual performance of all obligations of Swiss Co. under the terms of the Collaboration Agreement, and the prompt payment of all amounts payable, from time to time, by Swiss Co. to Amgen under the terms of the Collaboration Agreement, in each case, for the avoidance of doubt, after compliance with any applicable grace periods or notice requirements with respect thereto as provided in the Collaboration Agreement (all of the foregoing being the “Obligations”). In case of the failure of Swiss Co. to punctually perform any such Obligations or pay any such Obligations, Parent Co. hereby agrees to jointly and severally perform, or cause to be performed, or to pay, or cause to be paid, any such amounts, in full, when and as the same shall become due or payable in accordance with the terms of the Collaboration Agreement, and further agrees that Amgen may at any time and from time to time, at its sole discretion, and so long as the Obligations remain unperformed or unpaid, take any and all actions available hereunder to collect Parent Co.’s liabilities hereunder or under Applicable Law.
|
(b)
|
Parent Co. hereby agrees that its obligations under this Guarantee constitute a guarantee of payment and performance and not of collection and are not in any way conditional or contingent upon any attempt to collect from or enforce against Swiss Co. all or any portion of the Obligations or upon any other condition or contingency. Parent Co. covenants that this Guarantee will not be discharged except by final, complete and irrevocable payment and performance of the Obligations contained in the Collaboration Agreement (including any Obligations with respect to this Guarantee). Parent Co. hereby irrevocably waives all rights of subrogation that it may at any time otherwise have as a result of this Guarantee (whether contractual, under Section 509 of Title 11 of the United States Code entitled “Bankruptcy,” as now or hereafter in effect, or any
|
(c)
|
The obligations of Parent Co. under this Guarantee shall not be subject to any counterclaim, setoff, deduction or defense based on any claim Parent Co. may have against Swiss Co. or any other person or entity, except in accordance with the terms of the Collaboration Agreement, and shall remain in full force and effect without regard to, and shall not be released, suspended, abated, deferred, reduced, limited, discharged, terminated or otherwise impaired or adversely affected by any circumstance or occurrence whatsoever, other than full satisfaction of the Obligations, including, without limitation: (i) the validity or enforceability of the Collaboration Agreement, (ii) any delay in enforcing any payment or other obligation under the Collaboration Agreement against Swiss Co., (iii) any waiver, consent, extension, indulgence, or other action or inaction under or in respect of the Collaboration Agreement, (iv) any extension or renewal of, or other change in the time, manner or place of payment or performance, of or in any other term of, any of the Obligations (including any increase in the amount of the Obligations payable under the Collaboration Agreement), (v) failure or omission or delay on the part of Amgen to comply with any term or provision of the Collaboration Agreement, (vi) any assignment or other transfer of any rights or obligations under the Collaboration Agreement (whether by operation of law or otherwise), (vii) the adequacy of any other means Amgen may have of obtaining payment or fulfillment of the Obligations, (viii) any insolvency, bankruptcy, reorganization or other similar proceeding affecting Swiss Co. or any other person now or hereafter liable to Amgen with respect to any of the Obligations, (ix) any change in the existence, structure or ownership of Swiss Co. or any person now or hereafter liable with respect to the Obligations or otherwise interested in the transactions contemplated by the Collaboration Agreement, or (x) the addition, substitution or release of any person now or hereafter liable with respect to the Obligations or the receipt by Amgen of partial satisfaction of the Obligations from Parent Co.. Without limiting the foregoing or Section 2(h) below, Parent Co. acknowledges and agrees that (i) its liability hereunder shall be unconditional and irrevocable irrespective of any Change of Control, Insolvency Event, other restructuring or reorganization or like event of Parent Co. and (ii) in the case of any such Change of Control, Insolvency Event, other restructuring or reorganization or like event, (A) this Guarantee shall automatically be binding upon and enforceable against any successor in interest to Parent Co. (whether direct or indirect, by purchase, merger, sale or disposition of stock or assets, consolidation, restructuring or otherwise) to the same extent as if such successor in interest were Parent Co. and (B) such successor in interest shall assume and agree, in writing, to perform in the same manner and to the same extent any obligations of Parent Co. as part of any such Change of Control.
|
(d)
|
All payments by Parent Co. hereunder shall be in the same lawful currency as the Obligations in immediately available funds, and, except for any set-off, counterclaim, tax, deduction or withholding that Swiss Co. would be entitled to under the Collaboration Agreement, such payments shall be without set-off or counterclaim and free and clear of any tax, deduction or withholding of any kind.
|
(e)
|
For any right of action with respect to an Obligation which shall accrue to Amgen under the Collaboration Agreement, Amgen may, at its option, proceed against Parent Co. to enforce this Guarantee without having to commence any action, join in any action, obtain any judgment, or exhaust any or all of Amgen’s rights, against Swiss Co. or any other person. The Obligations
|
(f)
|
Parent Co. hereby waives all defenses which may be available by virtue of any valuation, stay, moratorium or other similar Applicable Law now or hereafter in effect, any right to require the marshalling of assets of Swiss Co. or any other person liable with respect to any of the Obligations and all suretyship defenses generally.
|
(g)
|
Amgen shall not be obligated to file any claim relating to the Obligations in the event that Amgen becomes subject to a bankruptcy reorganization or similar proceeding, and the failure of Amgen to so file shall not affect Parent Co.’s obligations hereunder. In the event that any payment to Amgen in respect of the Obligations is rescinded or must otherwise be returned for any reason whatsoever, Parent Co. shall remain liable hereunder with respect the Obligations as if any applicable payment had not been made, but only to the extent such Obligations remain outstanding.
|
(h)
|
Parent Co. acknowledges that it will receive substantial direct and indirect benefits from the transactions contemplated by the Collaboration Agreement and that the waivers, agreements, covenants, obligations and other terms of this Guarantee are knowingly made and agreed to in contemplation of such benefits. Parent Co. hereby covenants and agrees that it (i) shall not, and it shall cause its controlled Affiliates not to, assert, directly or indirectly, in any proceeding that this Guarantee is illegal, invalid or unenforceable in accordance with its terms and (ii) except to the extent the Obligations are terminated pursuant to the Collaboration Agreement, (A) shall
|
(i)
|
If Parent Co. fails to pay when due the Obligations, and, in order to obtain such payment, Amgen commences a suit which results in a judgment against Parent Co. for such payment, Parent Co. shall pay Amgen its reasonable costs and expenses (including attorneys’ fees) in connection with such suit.
|
2.
|
Miscellaneous.
|
(a)
|
Any provision of this Guarantee may be amended or waived if, but only if, such amendment or waiver is in writing and is signed, in the case of an amendment, by each party to this Guarantee, or in the case of a waiver, by the party to this Guarantee against whom the waiver is to be effective. No failure or delay by any party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by law.
|
(b)
|
This Guarantee shall remain in full force and effect until the satisfaction and payment in full of all Obligations.
|
(c)
|
Parent Co. represents, warrants and covenants (upon which Amgen relies in acceptance of this Agreement and in executing and agreeing to perform Amgen’s obligations under the Collaboration Agreement) that (i) it is a company duly formed, validly existing and in good standing under the laws of the jurisdiction of its formation, (ii) it has full power and authority to execute and deliver this Guarantee and to perform its obligations hereunder, (iii) it has duly executed and delivered this Guarantee, (iv) this Guarantee constitutes the legal, valid and binding obligation of such party enforceable against such party in accordance with its terms subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors’ rights and to general equity principles, (v) its execution and delivery of this Guarantee and the performance by it of its obligations under this Guarantee have been duly authorized by all requisite corporate or other action on its part and it has the financial capacity to pay all of the Obligations, (vi) its execution and delivery of, and its performance and compliance with the terms and provisions of, this Guarantee does not conflict with, result in a material breach or violation of, or constitute a default under the terms, conditions or provisions of (A) its amended and restated memorandum and articles of association or other applicable organizational agreements or governing instruments, (B) any statute, rule or regulation applicable to, or any judgment, order, injunction, decree, regulation or ruling of any court or other Governmental Authority to which it is subject or by which any of its assets are bound, or (C) any material agreement or contract to which it is a party or to which it or any of its property or assets are subject, and (vii) no authorization, consent, order, approval or license from, filing with, or other act by any Governmental Authority or other person or entity is or will be necessary to permit the valid execution and delivery by it of this Guarantee or the performance by it of the obligations to be performed by it under this Guarantee,
|
(d)
|
Section 15.4 of the Collaboration Agreement is hereby incorporated by reference, mutatis mutandis.
|
(f)
|
All notices, consents, waivers, requests and other communications hereunder shall be in writing and shall be delivered in person, sent by overnight courier (e.g., Federal Express) or posted by registered or certified mail, return receipt requested, with postage prepaid, to following addresses of the parties:
|
(g)
|
Nothing in this Section 2(g) shall preclude any party to the Collaboration Agreement or any other agreement contemplated thereby from making any permitted claim under the Collaboration Agreement or such other agreement, or seeking recourse against any successor in interest to Parent Co. Subject to the foregoing sentence and the last sentence of Section 1(c) above (but notwithstanding anything else to the contrary in this Guarantee), this Guarantee may only be enforced against, and any claims or causes of action that may be based on, arise out of or relate to this Guarantee, the transactions contemplated by this Guarantee, or the negotiation, execution or performance of this Guarantee, may only be made against, the parties to this Guarantee or their successors in interest, and no former, current or future Affiliates, directors, officers, shareholders, partners, members, attorneys, accountants, agents, representatives or employees of any party to this Guarantee, or any heirs, successors or permitted assigns of any of the foregoing shall have any liability for any obligations or liabilities of such party or for any claim (whether in tort, contract or otherwise) based upon, arising out of, or relating to, this Guarantee or the transactions contemplated by this Guarantee or in respect of any representations and warranties made or alleged to be made in connection herewith.
|
(h)
|
If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the parties as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction. Nothing in this Guarantee shall be interpreted so as to require a party to violate any applicable law.
|
|
|
|
|
|
|
SUBSIDIARY
|
|
STATE OF OTHER JURISDICTION OF
|
(Name under which subsidiary does business)
|
|
INCORPORATION OR ORGANIZATION
|
|
|
|
Amgen Canada Inc.
|
|
Ontario
|
Amgen (Europe) GmbH
|
|
Switzerland
|
Amgen Fremont Inc.
|
|
Delaware
|
Amgen Global Finance B.V.
|
|
Netherlands
|
Amgen GmbH Germany
|
|
Germany
|
Amgen Holding No. 1 Limited
|
|
Bermuda
|
Amgen K-A, Inc.
|
|
Delaware
|
Amgen Manufacturing, Limited
|
|
Bermuda
|
Amgen Rockville, Inc.
|
|
Delaware
|
Amgen S.A.S.
|
|
France
|
Amgen SF, LLC
|
|
Delaware
|
Amgen Technology (Ireland) Unlimited Company
|
|
Ireland
|
Amgen Technology, Limited
|
|
Bermuda
|
Amgen USA Inc.
|
|
Delaware
|
Amgen Worldwide Holdings B.V.
|
|
Netherlands
|
ATL Holdings Limited
|
|
Bermuda
|
ATL Holdings II Limited
|
|
Bermuda
|
BioVex, Inc.
|
|
Delaware
|
Immunex Corporation
|
|
Washington
|
Immunex Rhode Island Corporation
|
|
Delaware
|
Onyx Pharmaceuticals, Inc.
|
|
Delaware
|
Onyx Therapeutics, Inc.
|
|
Delaware
|
|
|
|
1.
|
I have reviewed this Annual Report on Form 10-K of Amgen Inc.;
|
2.
|
Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this annual report based on such evaluation; and
|
(d)
|
Disclosed in this annual report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 12, 2020
|
/s/ ROBERT A. BRADWAY
|
|
Robert A. Bradway
|
|
Chairman of the Board,
|
|
Chief Executive Officer and President
|
1.
|
I have reviewed this Annual Report on Form 10-K of Amgen Inc.;
|
2.
|
Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this annual report based on such evaluation; and
|
(d)
|
Disclosed in this annual report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 12, 2020
|
/s/ PETER H. GRIFFITH
|
|
Peter H. Griffith
|
|
Executive Vice President and Chief Financial Officer
|
(i)
|
the accompanying Annual Report on Form 10-K of the Company for the period ended December 31, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
(ii)
|
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: February 12, 2020
|
/s/ ROBERT A. BRADWAY
|
|
Robert A. Bradway
|
|
Chairman of the Board,
|
|
Chief Executive Officer and President
|
(i)
|
the accompanying Annual Report on Form 10-K of the Company for the period ended December 31, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
(ii)
|
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: February 12, 2020
|
/s/ PETER H. GRIFFITH
|
|
Peter H. Griffith
|
|
Executive Vice President and Chief Financial Officer
|