1、ROBERT A.BRADWAY,CHAIRMAN AND CHIEF EXECUTIVE OFFICER42ND ANNUAL J.P.MORGAN HEALTHCARE CONFERENCEJanuary 8,20242Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.T

2、his presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen.All statements,other than statements of historical fact,are statements that couldbe deemed forward-looking statements,including any statements on the outcome,benefits and synergies of

3、 collaborations,or potential collaborations,with any other company(including BeiGene,Ltd.or Kyowa Kirin Co.,Ltd.),the performance of Otezla(apremilast)(including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion),our acquisitions of Teneobio,Inc.,ChemoCentryx,Inc.,or Horizon T

4、herapeutics plc(including the prospective performance and outlook of Horizons business,performance and opportunities,any potential strategic benefits,synergies oropportunities expected as a result of such acquisition,and any projected impacts from the Horizon acquisition on our acquisition-related e

5、xpenses going forward),as well as estimates of revenues,operating margins,capital expenditures,cash,other financial metrics,expected legal,arbitration,political,regulatory or clinical results or practices,customer and prescriber patterns or practices,reimbursement activities and outcomes,effects of

6、pandemics or other widespread health problems on our business,outcomes,progress,and other such estimates and results.Forward-lookingstatements involve significant risks and uncertainties,including those discussed below and more fully described in the Securities and Exchange Commission reports filed

7、by Amgen,including our mostrecent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K.Unless otherwise noted,Amgen is providing this information as of the date of thispresentation and does not undertake any obligation to update any forward-look

8、ing statements contained in this document as a result of new information,future events or otherwise.No forward-looking statement can be guaranteed and actual results may differ materially from those we project.Our results may be affected by our ability to successfully market both new and existingpro

9、ducts domestically and internationally,clinical and regulatory developments involving current and future products,sales growth of recently launched products,competition from other productsincluding biosimilars,difficulties or delays in manufacturing our products and global economic conditions.In add

10、ition,sales of our products are affected by pricing pressure,political and public scrutinyand reimbursement policies imposed by third-party payers,including governments,private insurance plans and managed care providers and may be affected by regulatory,clinical and guidelinedevelopments and domesti

11、c and international trends toward managed care and healthcare cost containment.Furthermore,our research,testing,pricing,marketing and other operations are subject toextensive regulation by domestic and foreign government regulatory authorities.We or others could identify safety,side effects or manuf

12、acturing problems with our products,including our devices,afterthey are on the market.Our business may be impacted by government investigations,litigation and product liability claims.In addition,our business may be impacted by the adoption of new taxlegislation or exposure to additional tax liabili

13、ties.If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S.government,we could become subject tosignificant sanctions.Further,while we routinely obtain patents for our products and technology,the protection offered by our patents and patent applica

14、tions may be challenged,invalidated orcircumvented by our competitors,or we may fail to prevail in present and future intellectual property litigation.We perform a substantial amount of our commercial manufacturing activities at a few keyfacilities,including in Puerto Rico,and also depend on third p

15、arties for a portion of our manufacturing activities,and limits on supply may constrain sales of certain of our current products and productcandidate development.An outbreak of disease or similar public health threat,such as COVID-19,and the public and governmental effort to mitigate against the spr

16、ead of such disease,could have asignificant adverse effect on the supply of materials for our manufacturing activities,the distribution of our products,the commercialization of our product candidates,and our clinical trial operations,and any such events may have a material adverse effect on our prod

17、uct development,product sales,business and results of operations.We rely on collaborations with third parties for the developmentof some of our product candidates and for the commercialization and sales of some of our commercial products.In addition,we compete with other companies with respect to ma

18、ny of our marketedproducts as well as for the discovery and development of new products.Discovery or identification of new product candidates or development of new indications for existing products cannot beguaranteed and movement from concept to product is uncertain;consequently,there can be no gua

19、rantee that any particular product candidate or development of a new indication for an existingproduct will be successful and become a commercial product.Further,some raw materials,medical devices and component parts for our products are supplied by sole third-party suppliers.Certain ofour distribut

20、ors,customers and payers have substantial purchasing leverage in their dealings with us.The discovery of significant problems with a product similar to one of our products that implicate anentire class of products could have a material adverse effect on sales of the affected products and on our busi

21、ness and results of operations.Our efforts to collaborate with or acquire other companies,products or technology,and to integrate the operations of companies or to support the products or technology we have acquired,may not be successful.There can be no guarantee that we will beable to realize any o

22、f the strategic benefits,synergies or opportunities arising from the Horizon acquisition,and such benefits,synergies or opportunities may take longer to realize than expected.We maynot be able to successfully integrate Horizon,and such integration may take longer,be more difficult or cost more than

23、expected.A breakdown,cyberattack or information security breach of ourinformation technology systems could compromise the confidentiality,integrity and availability of our systems and our data.Our stock price is volatile and may be affected by a number of events.Ourbusiness and operations may be neg

24、atively affected by the failure,or perceived failure,of achieving our environmental,social and governance objectives.The effects of global climate change andrelated natural disasters could negatively affect our business and operations.Global economic conditions may magnify certain risks that affect

25、our business.Our business performance could affect orlimit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.We may not be able to access the capital and credit markets on termsthat are favorable to us,or at all.SAFE HARBOR ST

26、ATEMENT3Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.3Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-lookin

27、g statements,actual results may vary materially;Amgen disclaims any duty to update.GENERAL MEDICINEONCOLOGYRARE DISEASEMigraineChronic Kidney DiseaseObesityChronic Heart FailureOsteoporosisSecondary HyperparathyroidismHeart AttackStrokeAcute Lymphoblastic LeukemiaANCA-associated VasculitisThyroid Ey

28、e DiseaseUncontrolled GoutNeuromyelitis Optica Spectrum Disorder(NMOSD)Severe MalignantOsteopetrosisNephropathic CystinosisUrea Cycle DisordersMelanomaAdjuvant Breast CancerMultiple MyelomaNon-small Cell Lung CancerColorectal CancerImmune ThrombocytopeniaNon-Hodgkins LymphomaCrohns DiseaseRheumatoid

29、 ArthritisBehets DiseaseSevere AsthmaINFLAMMATIONWE ARE ADDRESSING AN ARRAY OF SERIOUS DISEASES.Plaque PsoriasisPsoriatic ArthritisActive Ankylosing SpondylitisChronic Granulomatous Disease4Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking stat

30、ements,actual results may vary materially;Amgen disclaims any duty to update.4Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.GENERAL MEDICINEONCOLOGYRARE DISEAS

31、EINFLAMMATION.WITH A NUMBER OF NOVEL MEDICINES5Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.Delivered double-digit volume growth across products and geographi

32、esAdvanced a broad and deep pipelineCreated Rare Disease business to include Horizon and TAVNEOSAdvanced our biosimilars portfolioContinued our track record of uninterrupted supply and manufacturing excellenceDelivered attractive financial returnsPositioned to accelerate innovation through convergen

33、ce of biotech and tech2023:ANOTHER YEAR OF PERFORMANCE AND PROGRESS6Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.FOUR PILLARS DRIVING LONG-TERM GROWTHGENERAL

34、MEDICINEONCOLOGYINFLAMMATIONRARE DISEASEMarketed ProductsInnovative PipelineBiosimilarsY7Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.One out of three deaths

35、worldwide are due to cardiovascular disease1oRepathais global PCSK9 market leader with broad accessMore than 200 million people worldwide suffer from osteoporosis2oProliaand EVENITYare stronger together in reducing osteoporotic fracturesOUR FIRST-IN-CLASS MEDICINES ARE DRIVING VOLUME GROWTH ACROSS P

36、RODUCTS AND GEOGRAPHIESSources:1.World Health Organization.Cardiovascular Diseases(CVDs)Fact Sheet.https:/www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).Accessed January 2,2023.2.Register JY,Burlet N.Osteoporosis:A still increasing prevalence.Bone.2006;38(2 Suppl 1):S4-S9

37、.PCSK9=proprotein convertase subtilisin/kexin type 9.GENERAL MEDICINE:KEY MARKETED PRODUCTS8Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.Obesity and Related C

38、omorbiditiesoMariTide(maridebart cafraglutide)in Phase 2 with potential for differentiated profileoAMG 786 oral small molecule in Phase 1oAdditional preclinical programsCardiovascular DiseaseoRepathaPhase 3 primary prevention trial in high-risk cardiovascular patientsoOlpasiran rapidly enrolling Pha

39、se 3 in cardiovascular patients with high levels of Lp(a)PIPELINE FOCUSED ON POTENTIALLY BEST-IN-CLASS THERAPIES IN LARGE PATIENT POPULATIONSLp(a)=lipoprotein(a).GENERAL MEDICINE:SELECTED PIPELINE PROGRAMS9Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forw

40、ard-looking statements,actual results may vary materially;Amgen disclaims any duty to update.Strong commercial execution driving double-digit growth in 2023BLINCYTOand Vectibixachieved record quarterly sales in Q3 2023Kyprolis,Nplate,and XGEVAeach at blockbuster levels in 2023BROAD PORTFOLIO PROVIDE

41、S IMPORTANT TREATMENT OPTIONS FOR PATIENTS AND PROVIDERSONCOLOGY:KEY MARKETED PRODUCTS1 IN 5 CANCER PATIENTS RECEIVES AN AMGEN MEDICINE10Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen discl

42、aims any duty to update.Tarlatamab priority regulatory review underway in advanced small cell lung cancerBLINCYTO moving into frontline1B-ALL treatment and developing subcutaneous administrationXaluritamig rapidly enrolling Phase 1 dose expansion in prostate cancerAMG 193 responses across seven tumo

43、r types in Phase 1LUMAKRASadvancing Phase 3 studies in first-line non-small cell lung cancer and first-line colorectal cancerBemarituzumab rapidly enrolling Phase 3 in first-line gastric cancerPIPELINE FOCUSED ON HIGH-CONVICTION TARGETS,DIFFERENTIATED THERAPIES,AND LARGE EFFECT SIZEONCOLOGY:SELECTED

44、 PIPELINE PROGRAMSB-ALL=B-cell precursor acute lymphoblastic leukemia.Xaluritamig,formerly AMG 509,is being developed pursuant to a research collaboration with Xencor,Inc.1.Frontline consolidation for adult and adolescent/young adult B-ALL patients,regardless of minimal residual disease status,age,o

45、r Philadelphia-chromosome status as well as ECOG 1910 as a frontline regimen.11Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.PDUFA date of June 12,2024Response

46、 rate of 40%,with 6-month survival of 73%in advanced small cell lung cancer Initiating Phase 3 trials in earlier linesFirst T-cell engager to demonstrate activity in a common solid tumorTARLATAMAB:A POTENTIAL BREAKTHROUGH IN ADVANCED SMALL CELL LUNG CANCERDLL3-delta-like ligand 3;CD3=cluster of diff

47、erentiation 3;Fc=fragment crystallizable;SCLC=small cell lung cancer;PDUFA=Prescription Drug User Fee Act.U.S.DRUG-TREATED POPULATION OF 35K ACROSS ALL LINES OF DISEASEONCOLOGY:SELECTED PIPELINE PROGRAMS12Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forwa

48、rd-looking statements,actual results may vary materially;Amgen disclaims any duty to update.TEZSPIRErecently launched and is first-in-class novel therapyoSerious asthma exacerbations require 1.6M emergency room visits per year in the U.S.alone1Expect Otezlagrowth driven by differentiatedprofile and

49、increased investment 20 years of leadership in inflammationINNOVATIVE MEDICINES PROVIDE STRONG FOUNDATION FOR GROWTHSources:1.Nunes C,et al.Asthma Res Pract.2017;3:2-11.TEZSPIREis being developed in collaboration with AstraZeneca.INFLAMMATION:KEY MARKETED PRODUCTS13Provided January 8,2024,as part of

50、 an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.TEZSPIRE:pursuing additional indicationsoChronic rhinosinusitis with nasal polyps Phase 3oEosinophilic esophagitis Phase 3oChronic obstructive pulm

51、onary disease Phase 2Rocatinlimab:potentially first-in-class atopic dermatitis therapyoOver 2,000 patients enrolled in seven-study ROCKET Phase 3 programoInitial ROCKET Phase 3 data readout this yearoPlanning to initiate Phase 2 in asthmaPIPELINE FOCUSED ON DIFFICULT-TO-TREAT DISEASES WITH HIGH UNME

52、T NEEDTEZSPIREis being developed in collaboration with AstraZeneca.Rocatinlimab,formerly AMG 451/KHK4083,is being developed in collaboration with Kyowa Kirin.INFLAMMATION:SELECTED PIPELINE PROGRAMS14Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-loo

53、king statements,actual results may vary materially;Amgen disclaims any duty to update.First and only thyroid eye disease treatmentFirst and only uncontrolled gout treatmentFastest-growing biologic in neuromyelitis optica spectrum disorder Only complement inhibitor for ANCA-associated vasculitisRARE

54、DISEASE BUSINESS CREATES FOURTH PILLAR OF LONG-TERM GROWTHRARE DISEASE:KEY MARKETED PRODUCTSANCA=antineutrophil cytoplasmic antibody.15Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclai

55、ms any duty to update.TEPEZZA enrolling Phase 3 in Japan for chronic/low clinical activity score thyroid eye disease.Advancing subcutaneous administration.UPLIZNAexpecting Phase 3 data in myasthenia gravis and IgG4-related diseaseDazodalibep initiated Phase 3 for Sjogrens syndromeDaxdilimab pursuing

56、 Phase 2 for discoid lupus erythematosus and dermatomyositis and anti-synthetase inflammatory myositisAMG 670(formerly HZN 825)conducting Phase 2 in idiopathic pulmonary fibrosis and diffuse cutaneous systemic sclerosisMULTIPLE PIPELINE PROGRAMS TO DRIVE ADDITIONAL GROWTHRARE DISEASE:SELECTED PIPELI

57、NE PROGRAMSIgG4=Immunoglobulin G4.16Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.IMPORTANT PIPELINE MILESTONES ANTICIPATED IN 2024GENERAL MEDICINEMariTideoPha

58、se 2 obesity dataOlpasiranoComplete Phase 3 enrollmentAMG 786 oPhase 1 obesity dataONCOLOGYTarlatamaboPDUFA(June)oInitiate additional Phase 3 studiesBLINCYTOoPhase 3 early-stage B-ALL submissionoInitiate Phase 3 subcutaneous administration studyLUMAKRASoPhase 3 third-line CRC U.S.submissionoInitiate

59、 Phase 3 in first-line CRCNplateoPhase 3 chemo-induced thrombocytopenia dataINFLAMMATIONTEZSPIREoPhase 2 COPD data oPhase 3 chronic rhinosinusitis with nasal polyps dataRocatinlimaboPhase 3 HORIZON study dataRARE DISEASEYTEPEZZAoJapan submissionoInitiate Phase 3 subcutaneous administration studyUPLI

60、ZNAoPhase 3 myasthenia gravis dataoPhase 3 IgG4-related disease dataAMG 670(formerly HZN 825)oPhase 2 idiopathic pulmonary fibrosis dataPDUFA=Prescription Drug User Fee Act;B-ALL=B-cell precursor acute lymphoblastic leukemia;CRC=colorectal cancer;COPD=chronic obstructive pulmonary disease;IgG4=Immun

61、oglobulin G4.Xaluritamig,formerly AMG 509,is being developed pursuant to a research collaboration with Xencor,Inc.TEZSPIREis being developed in collaboration with AstraZeneca.Rocatinlimab,formerly AMG 451/KHK4083,is being developed in collaboration with Kyowa Kirin.17Provided January 8,2024,as part

62、of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.ONCOLOGYGlobal leader in biosimilarsoLeading in the five markets that comprise 80%of total global revenueAdvancing next wave of opportunities oNe

63、xt three launches:Stelara,Soliris,EyleaoABP 206,an investigational biosimilar to OPDIVOoTwo additional undisclosed opportunitiesBIOSIMILARS PORTFOLIO HAS ACHIEVED BLOCKBUSTER RESULTS AND WILL GROW WITH NEW LAUNCHESINFLAMMATIONRARE DISEASEYSTELARA is a registered trademark of Janssen Biotech,Inc.;EYL

64、EA is a registered trademark of Regeneron Pharmaceuticals,Inc.;SOLIRIS is a registered trademark of Alexion Pharmaceuticals,Inc.;OPDIVO is a registered trademark of Bristol-Myers Squibb Company.18Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-lookin

65、g statements,actual results may vary materially;Amgen disclaims any duty to update.Positioned at the forefront of the new opportunityInvesting in artificial intelligence across the enterpriseAdvancing our world-class human data effortsOur generative biology platform and multispecificstrategy are del

66、ivering transformational impactCONVERGENCE OF BIOTECHNOLOGY AND TECHNOLOGY WILL UNLEASH THE NEXT WAVE OF INNOVATIONOUR RESEARCH AND INNOVATION POSITION US FOR GROWTH BEYOND THIS DECADE19Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statemen

67、ts,actual results may vary materially;Amgen disclaims any duty to update.Tracking toward carbon neutrality in our operations by 2027Investing in the next generation of innovators through the Amgen FoundationWorking to strengthen healthcare systems in low-and middle-income countriesCOMMITTED TO GOOD

68、CORPORATE CITIZENSHIP20Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.Driving volume growth with our existing innovative products,balanced across our four thera

69、peutic areas and three regionsRare Disease business provides growth that is additive to our planUnprecedented pipeline innovation and breadthMotivated staff in a strong patient-focused cultureSUCCESSFULLY IMPLEMENTING OUR STRATEGY TO DELIVER LONG-TERM GROWTHDRIVING INNOVATION AT SPEED AND SCALEAPPEN

70、DIX22Provided January 8,2024,as part of an oral presentation and is qualified by such,contains forward-looking statements,actual results may vary materially;Amgen disclaims any duty to update.IMPORTANT PIPELINE MILESTONES ANTICIPATED IN 2024GENERAL MEDICINEMariTide Phase 2 data readout late 2024AMG

71、786 Phase 1 data readout H1 2024Olpasiran Phase 3 enrollment completion H1 2024ONCOLOGYTarlatamab PDUFA date of 6/12/24Tarlatamab additional Phase 3 studies in 1L ES-SCLC and LS-SCLC to be initiated H1 2024BLINCYTOglobal regulatory submissions for Phase 3 early-stage B-ALL H1 2024BLINCYTOPhase 3 sub

72、cutaneous administration study in B-ALL initiation H2 2024LUMAKRASPhase 3 third-line CRC U.S.submission in H1 2024LUMAKRASPhase 3 study in first-line CRC initiation H1 2024NplatePhase 3 chemotherapy-induced thrombocytopenia in GI malignancies data readout H2 2024INFLAMMATIONTEZSPIREPhase 2 COPD data

73、 readout H1 2024 TEZSPIREchronic rhinosinusitis with nasal polyps Phase 3 primary analysis H2 2024Rocatinlimab Phase 3 HORIZON study data readout H2 2024RARE DISEASEYTEPEZZAJapan submission anticipated H1 2024TEPEZZAPhase 3 study in TED subcutaneous administration initiation H1 2024UPLIZNAPhase 3 my

74、astheniagravis data readout H2 2024UPLIZNAPhase 3 IgG4-related disease data readout H2 2024AMG 670(formerly HZN 825)Phase 2 IPF data readout H2 2024PDUFA=Prescription Drug User Fee Act;ES=extensive stage;SCLC=small cell lung cancer;LS=limited stage;B-ALL=B-cell precursor acute lymphoblastic leukemia

75、;CRC=colorectal cancer;GI=gastrointestinal;COPD=chronic obstructive pulmonary disease;TED=thyroid eye disease;IgG4=Immunoglobulin G4;IPF=idiopathic pulmonary fibrosis.Xaluritamig,formerly AMG 509,is being developed pursuant to a research collaboration with Xencor,Inc.TEZSPIREis being developed in collaboration with AstraZeneca.Rocatinlimab,formerly AMG 451/KHK4083,is being developed in collaboration with Kyowa Kirin.ROBERT A.BRADWAY,CHAIRMAN AND CHIEF EXECUTIVE OFFICER42ND ANNUAL J.P.MORGAN HEALTHCARE CONFERENCEJanuary 8,2024