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1、J.P.Morgan HealthcareConference41st AnnualJanuary 10,2023Stefan OelrichMember of the Board of Management of Bayer AGPresident PharmaceuticalsDriving our strategic agenda2/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsGrow potential blockbustersCapture the full commercial value of
2、 the current portfolio1Renew toplineBuild&grow US businessShift in marketing&R&D towards growth driversReallocate resources2Progress late-stage pipelineStrengthen early pipelinethrough increasing contributions from platform companies as well as partneringRebuild pipeline3Investing in future growth w
3、hile managing our P&Lalong the projected trajectory/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsEBITDA margin*(cpa*)Balance LoEs&drive late-stage pipelineReturn to above average growthSales Growth(cpa*)2023e-2026e 2027e10yrs average:32%Label expansions,guideline inclusions&cont
4、inued rollouts of Nubeqa and KerendiaCompetitive profile of key assets further strengthenedBuild-up of US organization completedStrong LCM newsflow,Asundexian moved into PIIIContinued pipeline pruning and advancements of new gene therapies into Phase I9M 2022*EBITDA before special items,cpa=currency
5、 and portfolio adjusted;LCM:Lifecycle management;LoE:Loss of exclusivity 3 3In 9M 2022 we have absorbed significant headwinds that emerged during the year4/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsSalesPrice pressure EuropeChina:VBP and COVID lockdownsEBITDA*marginLower sale
6、sCost increases in raw materialsAdverse FX impactsImpact on Bayer Pharmaceuticals in 9M 2022reported30.8%+8%War in UkraineInflationSupply chain disruptionsNegative market dynamics,e.g.COVID-19(China)EUR devaluationLimited or no ability to react on increasing COGS Reimbursement&pricing pressure acros
7、s the globe,e.g.VBP*,IRA*,etc.New health patterns(IUD*)Reward for incremental innovation increasingly limitedIndustry dynamicsGeopolitical¯oeconomic events*EBITDA before special items,cpa=currency and portfolio adjusted;IRA:US Inflation Reduction Act;IUD:Intrauterine device;VBP:Volume-based proc
8、urement;FY guidance based on constant currencies and portfolioFY guidance*32%+3-4%cpa*32%+3%Pressure on sales and margin to continue in 2023 and beyondNubeqa at#2 in nmCRPC already,further share gains and label expansions confirm 3bn peak sales potential5/41st Annual J.P.Morgan Healthcare Conference
9、/Bayer PharmaceuticalsBCR:Biochemical relapse;CT:Chemotherapy;mHSPC:metastatic hormone sensitive prostate cancer;nmCRPC:non-metastatic castration resistant prostate cancerContinued market share gains in nmCRPCmHSPC approvals in EU,JP,CN and other major regionsPotential to become foundational drug ac
10、ross prostate cancer indicationsSales drivers 20232027BCR adjuvant(DaSL-HiCap)2024mHSPC w/o CT(ARANOTE/ARASEC)Phase 3 Clinical development program2019nmCRPC(ARAMIS)2022mHSPC+CT(ARASENS)Expanding market share in the US to 30%in nmCRPCUS label extension in August 2022 to treat patients with mHSPCSales
11、 more than doubling in 202220212022e2023eEx-USUS0.40.2Peak sales potential 3bnx20.8bnx2Kerendia with strong launch momentum,ongoing guideline inclusions&potential label extensions to push peak sales to 3bn6/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsBroad utility and relevance
12、 across GPs and specialistsOngoing US market penetration&upcoming reimbursements ex-USPotential for further inclusion in treatments guidelinesSales drivers 20232025CKD/ND(FIND-CKD)Clinical development program2020CKD/T2D(FIDELIO/FIGARO)2024HFmr/pEF(FINEARTS-HF)One of the strongest launch dynamics in
13、CV despite initial COVID restrictionsReimbursed access for majority of commercially insured and Medicare Part D patients Recommended by ADA,AACE,KDIGOContinued US market uptake1Renew toplineTRx development01,0002,0003,000293337 ENTRESTO KERENDIASales 2022e:100mPeak sales potential 3bnweek
14、AACE:American Association of Clinical Endocrinology;ADA:American Diabetes Association;CKD:Chronic kidney disease;HFmr/pEF:Heart failure with mildly reduced/preserved ejection fraction;ND:Non-diabeticStrong Aflibercept 8mg data reinforce leading clinical profile and competitive position of the Eylea
15、franchise7/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsLeading medicine in wAMD and DME treatment2001920202021 2022e17%CAGRAflibercept 8mgShare of patients maintaining on dosing interval1)PHOTON(DME)PULSAR(wAMD)91%79%89%77%Commercial potential substantially strengthe
16、nedEylea Volume Development(vials+prefilled syringes)Unparalleled clinical data further raising the barShare in ex-US markets60%Gold standard in efficacy and safetyHigh competitive hurdle:8 million of treated years for patients and physiciansFirst biosimilar launches expected in 2023(CA,JP)Significa
17、nt prolongation of injection intervals without compromising efficacy and safetySet to become new standard of care despite increasing competitive dynamicsSubmissions in major markets in 2023,launch by 2024every 16 weeksevery 12 weeksInjection1)Comparator arms:Eylea every 8 weeksDME:diabetic macular e
18、dema;wAMD:wet age-related macular degeneration Continued shift of resources towards growth drivers/41st Annual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals8Geographical FootprintLow commercial attractivenessHigh commercial attractivenessMarketing investmentsMature portfolioLaunch brandsR&D
19、 investmentsLow innovation potentialHigh innovation potentialElinzanetants unique clinical profile can offer a transformative approach for the treatment of vasomotor symptoms9/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsMarketAmong most commonly-reported menopausal symptoms Lim
20、ited treatment options available,only 1/3 of adoptionVasomotor Symptoms(VMS)First-in-class,non-hormonal,oral OD neurokinin-1,3 receptor antagonist(dual mode of action)May reduce hyperactivity of KNDy neuronal network involved in thermoregulationDemonstrated significant and rapid improvement in VMS i
21、n Phase II and was well-toleratedFour Phase III studies(OASIS-1 OASIS-4)Investigating the efficacy and safety of elinzanetant120mg once daily in menopausal women with VMSExpected first study readouts:2023Elinzanetant characteristicsHotflashesNightsweatsSleepdisturbance16m womeneach in U.S.and EUPhas
22、e III OASIS ProgramPeak sales potential 1bnPotential launch:2025Landmark Phase III program started with oral factor XIa inhibitor Asundexian peak sales of 5bn projected10/41st Annual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsAsundexian characteristicsMarketNon-cardioembolic9m diagnosed p
23、atients in key 7 marketsStandard of care:Single/Dual APTIschemic Stroke by typesOther 5%75%20%Cardioembolic13m diagnosed AF patients in key 7 marketsStandard of care:DOACs(or VKA)40%of eligible patients un(der)treatedAF:Atrial fibrillation;APT:Antiplatelet therapy;DOAC:Direct oral anticoagulant;FPFV
24、:First patient first visit;SAPT:Single antiplatelet therapy;TIA:transient ischemic attack;VKA:Vitamin K AntagonistPotential first-in-class,once-daily,oral small molecule FXIa inhibitorNew potential treatment in thrombosis preventionBroad Phase II study program PACIFIC confirmed consistent safety and
25、 near maximum FXIa inhibitionPhase III OCEANIC ProgramOCEANIC AFAsundexian vs.apixaban in atrial fibrillationFPFV in December 2022OCEANIC STROKEAsundexian+APT in acute non-cardioembolic ischemic stroke or high-risk TIA vs.placeboExpected study readouts:2025Peak sales potential 5bnPotential launch:20
26、26Launch assets and late-stage pipeline expected to more than offsetlosses of exclusivity and drive long-term growth/41st Annual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals1120212024e2027eStable/moderate growthe.g.Radiology,Eylea&8mg aflibercept,Womens HealthOther late lifecycle assetse.g
27、.Nexavar,Adalat,Hematology franchise Launch assetsNubeqa,Kerendia,VitrakviPhase 3 pipeline assetsAsundexian,ElinzanetantProjected Sales Bayer Pharmaceuticals(indicative)XareltoCell&Gene Therapies0.6bn4.7bn6.4bn6.6bnTotal 2021:18.3bnPeak salespotential6bn6bnGlobal rightsGlobal rightsGlobal rightsPlat
28、form companies with industry-leading technologies increasingly contributing to replenishment of early pipeline/41st Annual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals12TechnologyClinical pipelineFueled with 25%of global R&D budget in 2023AAV-based gene therapy&manufacturing platform Chemo
29、proteomics platform(Direct functional modulators,protein degraders)5 assets in Phase I in rare and pathway diseases:Parkinsons DiseaseMultiple System Atrophy Huntingtons DiseasePompe DiseasesCongestive Heart Failure2 new INDs planned in 2023high profile immunology and oncology targetsCell platform b
30、ased on pluripotent stem cellsPhase I Parkinsons Disease(DA01)Pluripotent stem cell-derived dopaminergic neurons implanted into the brainFirst results expected in HY2 2023IND:Investigational new drugOur Strategy is geared towards sustainable growth13/41st Annual J.P.Morgan Healthcare Conference/Baye
31、r Pharmaceuticals1Renew toplineNubeqa and Kerendia starting to become key growth driversCombined peak sales potential for Nubeqa and Kerendia raised to 6bnEylea franchise well positioned to continue leadershipReallocate resources2Continuous shift of resources towards growth drivers From low commerci
32、al attractive markets to high commercial attractive marketsFrom mature portfolio to launch brandsFrom low innovation potential to high innovation potentialRebuild pipeline3Elinzanetant Potential transformative approach for the treatment of vasomotor symptomsLandmark Phase III clinical program for as
33、undexian started-Peak sales potential 5bnFirst study results from our C> Platform expected in 2023J.P.Morgan HealthcareConferenceAppendix41st AnnualJanuary 10,2023Pharmaceuticals Pipeline Overview1(as of Dec 13,2022)/Bayer Pharmaceuticals/Pipeline Overview December 13,202215Phase IElimusertib(ATR
34、Inhibitor)(BAY 1895344)AhR Inhibitor(BAY 2416964)mEGFR Inhibitor(BAY 2927088)Trastuzumab corixetan(HER2 TTC)(BAY 2701439)DGKzeta Inhibitor(BAY 2965501)CCR8 Ab(BAY 3375968)Congestive Heart Failure Gene Therapy(NAN-101)sGC Activator(BAY 3283142)Anti-a2AP(BAY 3018250)P2X4 Antagonist(BAY 2328065)BDKRB1
35、Receptor Antagonist(BAY 2395840)Zabedosertib(IRAK4 Inhibitor)(BAY 1834845)sGC Activator(BAY 1211163)Parkinsons Disease Cell Therapy(BRT-DA-01)Parkinsons Disease Gene Therapy(AAV2-GDNF-PD)Multiple System Atrophy Gene Therapy(AAV2-GDNF-MSA)Pompe Disease Gene Therapy(ACTUS-101)Huntingtons Disease Gene
36、Therapy(BV-101)1 Bayer and partner sponsored+3rd party label enabling studies with first patient first visit 2 Pre-clinical selected assets on path to IND 3 Conducted by Merck&Co 4 Conducted by Regeneron PharmaceuticalsLife cycle managementNew therapeutic entityPhase 02DGKalpha Inh(BAY 2862789)PSMA
37、TAC(BAY 3546828)PSMA SMOL TAC(BAY 3563254)VVD NRF2 Inh(BAY 3605349)VVD STAT3 Inh(BAY 3630914)SEMA 3(BAY 3401016)LGMD2i Gene Therapy(LION-101)Next Generation Liver MRI(BAY 3393081)Submission in preparationAflibercept 8MGDiabetic Macular Edema(DME)(PHOTON4)Neovasc.Age-rel.Macular Degen.(nAMD)(PULSAR)P
38、hase IIRegorafenib(combi Nivolumab)(BAY 734506)Solid tumors(recurrent or metastatic)Asundexian(FXIa Inhibitor)(BAY 2433334)/2 Stroke Prevention(PACIFIC-STROKE)/Major Adverse Cardiac Events Prevention(PACIFIC-AMI)Runcaciguat(sGC Activator)(BAY 1101042)Chronic Kidney Disease(CKD)(CONCORD)Non-prolif.Di
39、abetic Retinopathy(NPDR)(NEON-NPDR)BDKRB1 Receptor Antagonist(BAY 2395840)Neuropathic Pain(BRADiNP)Gadoquatrane(High Relaxivity Contrast Agent)(BAY 1747846)Magnetic Resonance Imaging(HRCA-PAT)Adrenomedullin Pegol(PEG-ADM)(BAY 1097761)Acute Resp.Distress Syn.(ARDS)(SEAL)Phase IIICopanlisib(PI3K Inhib
40、itor)Non-Hodgkin Lymphoma(CHRONOS-4)Darolutamide(AR Inhibitor)Prostate Cancer(mHSPC)(ARANOTE)Adjuvant Prostate Cancer(DASL-HiCaP)Finerenone(MR Antagonist)Heart Failure(HFmr/pEF)(FINEARTS-HF)Non-diabetic CKD(FIND-CKD)Vericiguat(sGC Stimulator)Heart Failure(HFrEF)(VICTOR3)Asundexian(FXIa Inhibitor)Str
41、oke Prevention in Atrial Fibrillation(OCEANIC-AF)Elinzanetant(Neurokinin-1,3 Rec Antagonist)Vasomotor Symptoms(OASIS)Aflibercept 8MGDiabetic Macular Edema(DME)(PHOTON4)Neovasc.Age-rel.Macular Degen.(nAMD)(PULSAR)BiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall MoleculeOncology
42、Cardiovascular DiseasesWomens HealthOthersSubmissionsDarolutamide(AR Inhibitor)/ADT with ChemotherapyEU,Japan,China:mHSPCAflibercept(VEGF inhibitor)EU:Retinopathy of prematurityPharmaceuticals Pipeline Details Phase III1(as of Dec 13,2022)/Bayer Pharmaceuticals/Pipeline Overview December 13,202216Th
43、erapeutic AreaCandidate medicationModalityCompound OriginIndicationCt.gov IdentifierEstimated/actual primary completionStatusOncology Copanlisib(PI3K Inhibitor)BayerNon-Hodgkin Lymphoma(CHRONOS-4)NCT02626455Q1 2023Study ongoingDarolutamide(AR Inhibitor)OrionProstate Cancer(mHSPC)(ARANOTE)NCT04736199
44、Q1 2024Study ongoingAdjuvant Prostate Cancer(DASL-HiCaP)NCT04136353Q1 2028Study ongoingCardiovascular DiseasesFinerenone(MR Antagonist)BayerHeart Failure(HFmr/pEF)(FINEARTS-HF)NCT04435626Q3 2024Study ongoingNon-diabetic CKD(FIND-CKD)NCT05047263Q1 2026Study ongoingVericiguat(sGC Stimulator)BayerHeart
45、 Failure(HFrEF)(VICTOR3)NCT05093933Q1 2025Study ongoingAsundexian(FXIa Inhibitor)BayerStroke Prevention in Atrial Fibrillation(OCEANIC-AF)NCT05643573Q3 2025Study ongoingWomens HealthElinzanetant(Neurokinin-1,3 Rec Antagonist)KaNDyVasomotor Symptoms(OASIS-1,OASIS-2,OASIS-3,OASIS-4)NCT05042362NCT05099
46、159NCT05030584NCT05587296Q2 2023Q2 2023Q1 2023Q1 2024Studies ongoingOthersAflibercept 8MGRegeneronDiabetic Macular Edema(DME)(PHOTON4)NCT04429503Q2 2022Primary completion date achieved.Data presented at AAO in Oct.2022Neovasc.Age-rel.Macular Degen.(nAMD)(PULSAR)NCT04423718Q3 20221 Bayer and partner
47、sponsored+3rd party label enabling studies with first patient first visit 3 Conducted by Merck&Co 4 Conducted by Regeneron PharmaceuticalsBiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall MoleculePharmaceuticals Pipeline Details Phase II1(as of Dec 13,2022)/Bayer Pharmaceutical
48、s/Pipeline Overview December 13,202217Therapeutic AreaCandidate medicationModalityCompound OriginIndicationCt.gov IdentifierEstimated/actual primary completionStatusOncology Regorafenib(combi Nivolumab)(BAY 734506)BayerSolid tumors(recurrent or metastatic)NCT04704154Q1 2023Study ongoingCardiovascula
49、r DiseasesAsundexian(FXIa Inhibitor)(BAY 2433334)Bayer2 Stroke Prevention(PACIFIC-STROKE)NCT04304508Q1 2022Studies completed;data presented at ESC in Aug.2022Major Adverse Cardiac Events Prevention(PACIFIC-AMI)NCT04304534Q1 2022Runcaciguat(sGC Activator)(BAY 1101042)BayerChronic Kidney Disease(CKD)(
50、CONCORD)NCT04507061Q1 2022Study completed;detailed evaluation ongoingOthersBDKRB1 Receptor Antagonist(BAY 2395840)Bayer/EvotecNeuropathic Pain(BRADiNP)NCT05219812Q4 2022Study ongoingGadoquatrane(High RelaxivityContrast Agent)(HRCA)(BAY 1747846)BayerMagnetic Resonance Imaging(HRCA-PAT)NCT04307186Q4 2
51、022 Study ongoingRuncaciguat(sGC Activator)(BAY 1101042)BayerNon-prolif.Diabetic Retinopathy(NPDR)(NEON-NPDR)NCT04722991Q4 2023 Study ongoingAdrenomedullin Pegol(PEG-ADM)(BAY 1097761)BayerAcute Resp.Distress Syn.(ARDS)(SEAL)NCT04417036Q4 2024Study ongoing1 Bayer and partner sponsored+3rd party label
52、 enabling studies with first patient first visitBiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall Molecule/Bayer Pharmaceuticals/Pipeline Overview December 13,202218Therapeutic AreaCandidate medicationModalityCompound OriginIndicationCt.gov IdentifierEstimated/actual primary co
53、mpletionStatusOncologyElimusertib(ATR Inhibitor)(BAY 1895344)BayerAdvanced solid tumors,Non-Hodgkins Lymphoma,Mantle Cell LymphomaNCT03188965NCT04095273NCT04267939Q4 2022/Q1 2025Studies ongoingAhR Inhibitor(BAY 2416964)Bayer/DKFZAdvanced solid tumorsNCT04069026NCT04999202Q1 2025/Q2 2025Studies ongoi
54、ngmEGFR Inhibitor(BAY 2927088)Bayer/Broad InstituteAdvanced Non-small Cell Lung Cancer with EGFR Mutation and/or HER2 MutationNCT05099172Q4 2025Study ongoingTrastuzumab corixetan(HER2 TTC)(BAY 2701439)BayerCancers with HER2 ExpressionNCT04147819Q3 2026Study ongoingDGKzeta Inhibitor(BAY 2965501)Bayer
55、/DKFZCancerNCT05614102Q3 2026Study ongoingCCR8 Ab(BAY 3375968)BayerAdvanced solid tumorsNCT05537740Q4 2026Study ongoingCardiovascular DiseasesCongestive Heart Failure Gene Therapy(NAN-101)AskBioCongestive Heart FailureNCT04179643Phase I study and planning activities for subsequent phases ongoingsGC
56、Activator(BAY 3283142)BayerChronic Kidney Disease(CKD)NCT05491642Q1 2023Study ongoingAnti-a2AP(BAY 3018250)BayerAcute Ischemic Stroke;Pulmonary EmbolismQ2 2023Study plannedWomens HealthP2X4 Antagonist(BAY 2328065)BayerEndometriosisNCT03427788NCT04027192NCT04851483Q4 2018/Q3 2020/Q4 2021Phase II deci
57、sion expected in HY1 2023BDKRB1 Receptor Antagonist(BAY 2395840)Bayer/EvotecEndometriosisNCT05517746Q4 2020Phase II decision expected in HY1 2023OtherZabedosertib(IRAK4 Inhibitor)(BAY 1834845)BayerPelvic Inflammatory Disease;PsoriasisQ4 2017/Q3 2020Studies completed.Phase II decision taken for Atopi
58、c DermatitissGC Activator(BAY 1211163)BayerAcute Respiratory Distress SyndromeNCT04609943Q2 2023Study ongoingParkinsons Disease Cell Therapy(BRT-DA-01)BlueRockParkinsons DiseaseNCT04802733Q2 2023Study ongoingParkinsons Disease Gene Therapy(AAV2-GDNF-PD)AskBioParkinsons DiseaseNCT04167540Q4 2023Study
59、 ongoingMultiple System Atrophy Gene Therapy(AAV2-GDNF-MSA)AskBioMultiple System AtrophyNCT04680065Q1 2024Study recruitingPompe Disease Gene Therapy(ACTUS-101)AskBioPompe DiseaseNCT03533673Q2 2025Study ongoingHuntingtons Disease Gene Therapy(BV-101)AskBioHuntingtons Disease NCT05541627Q4 2025Study r
60、ecruitingPharmaceuticals Pipeline Details Phase I1(as of Dec 13,2022)1 Bayer and partner sponsored+3rd party label enabling studies with first patient first visitBiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall MoleculeCandidate medicationIndicationModalityCompound OriginPhase
61、 02Phase IPhase IIPhase IIICt.gov IdentifierEstimated/actual primary completionStatusCopanlisib(PI3K Inhibitor)Non-Hodgkin Lymphoma(CHRONOS-4)BayerNCT02626455Q1 2023Study ongoingDarolutamide(AR Inhibitor)Prostate Cancer(mHSPC)(ARANOTE)OrionNCT04736199Q1 2024Study ongoingAdjuvant Prostate Cancer(DASL
62、-HiCaP)NCT04136353Q1 2028Study ongoingRegorafenib(combi Nivolumab)(BAY 734506)Solid tumors(recurrent or metastatic)BayerNCT04704154Q1 2023Study ongoingElimusertib(ATR Inhibitor)(BAY 1895344)Advanced solid tumors,Non-Hodgkins Lymphoma,Mantle Cell LymphomaBayerNCT03188965NCT04095273NCT04267939Q4 2022Q
63、1 202Q1 2025Studies ongoingAhR Inhibitor(BAY 2416964)Advanced solid tumorsBayer/DKFZNCT04069026NCT04999202Q1 2025Q2 2025Studies ongoingmEGFR Inhibitor(BAY 2927088)Advanced Non-small Cell Lung Cancer with EGFR Mutation and/or HER2 MutationBayer/Broad InstituteNCT05099172Q4 2025Study ongoingTrastuzuma
64、b corixetan(HER2 TTC)(BAY 2701439)Cancers with HER2 ExpressionBayerNCT04147819Q3 2026Study ongoingDGKzeta Inhibitor(BAY 2965501)CancerBayer/DKFZNCT05614102Q3 2026Study ongoingCCR8 Ab(BAY 3375968)Advanced solid tumorsBayerNCT05537740Q4 2026Study ongoingDGKalpha Inh(BAY 2862789)CancerBayer/DKFZPSMA TA
65、C(BAY 3546828)Advanced Prostate CancerLantheus(prev.Progenics)PSMA SMOL TAC(BAY 3563254)Advanced Prostate CancerNoriaTherapeutics/PSMA TherapeuticsVVD NRF2 Inh(BAY 3605349)CancerVividionVVD STAT3 Inh(BAY 3630914)CancerVividionPharmaceuticals Pipeline Details Oncology1(as of Dec 13,2022)/Bayer Pharma
66、ceuticals/Pipeline Overview December 13,202219BiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall Molecule1 Bayer and partner sponsored+3rd party label enabling studies with first patient first visit 2 Pre-clinical selected assets on path to INDCandidate medicationIndicationModal
67、ityCompound OriginPhase 02Phase IPhase IIPhase IIICt.gov IdentifierEstimated/actual primary completionStatusFinerenone(MR Antagonist)Heart Failure(HFmr/pEF)(FINEARTS-HF)BayerNCT04435626Q3 2024Study ongoingNon-diabetic CKD(FIND-CKDNCT05047263Q1 2026Study ongoingVericiguat(sGC Stimulator)Heart Failure
68、(HFrEF)(VICTOR3)BayerNCT05093933Q1 2025Study ongoingAsundexian(FXIa Inhibitor)(BAY 2433334)Stroke Prevention in Atrial Fibrillation(OCEANIC-AF)BayerNCT05643573Q3 2025Study ongoing2 Stroke Prevention(OCEANIC-STROKE)NCT04304508Q1 2022Phase II studies completed;data presented at ESC in Aug.2022Major Ad
69、verse Cardiac Events Prevention(PACIFIC-AMI)NCT04304534Q1 2022Runcaciguat(sGC Activator)(BAY 1101042)Chronic Kidney Disease(CKD)(CONCORD)BayerNCT04507061Q1 2022Study completed;detailed evaluation ongoingCongestive Heart Failure Gene Therapy(NAN-101)Congestive Heart FailureAskBioNCT04179643Phase I st
70、udy and planning activities for subsequent phases ongoingsGC Activator(BAY 3283142)Chronic Kidney Disease(CKD)Bayer NCT05491642Q1 2023Study ongoingAnti-a2AP(BAY 3018250)Acute Ischemic Stroke;PulmonaryEmbolismBayerQ2 2023Study plannedSEMA 3(BAY 3401016)Acute Kidney Injury,Alport SyndromeBayer/EvotecP
71、harmaceuticals Pipeline Details Cardiov.Diseases1(as of Dec 13,2022)/Bayer Pharmaceuticals/Pipeline Overview December 13,2022201 Bayer and partner sponsored+3rd party label enabling studies with first patient first vist 2 Pre-clinical selected assets on path to IND 3 Conducted by Merck&Co BiologicAn
72、tibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall MoleculePharmaceuticals Pipeline Details Womens Health1(as of Dec 13,2022)/Bayer Pharmaceuticals/Pipeline Overview December 13,202221Candidate medicationIndicationModalityCompound OriginPhase 02Phase IPhase IIPhase IIICt.gov IdentifierEst
73、imated/actual primary completionStatusElinzanetant(Neurokinin-1,3 Rec Antagonist)Vasomotor Symptoms(OASIS-1,OASIS-2,OASIS-3,OASIS-4)KaNDyNCT05042362NCT05099159NCT05030584NCT05587296Q2 2023Q2 2023Q1 2023Q1 2024Studies ongoingP2X4 Antagonist(BAY 2328065)EndometriosisBayerNCT03427788NCT04027192NCT04851
74、483Q4 2018Q3 2020Q4 2021Studies completed;Phase II decision expected in HY1 2023BDKRB1 Receptor Antagonist(BAY 2395840)EndometriosisBayer/EvotecNCT05517746Q4 2020Phase II decision expected in HY1 20231 Bayer and partner sponsored+3rd party label enabling studies with first patient first visit 2 Pre-
75、clinical selected assets on path to IND BiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall MoleculePharmaceuticals Pipeline Details Other Ther.Areas1(as of Dec 13,2022)/Bayer Pharmaceuticals/Pipeline Overview December 13,202222Candidate medicationIndicationModalityCompound Origi
76、nPhase 02Phase IPhase IIPhase IIICt.gov IdentifierEstimated/actual primary completionStatusAflibercept 8MGDiabetic Macular Edema(DME)(PHOTON4)RegeneronNCT04429503Q2 2022Primary completion date achieved.Data presented at AAO in Oct.2022Neovasc.Age-rel.Macular Degen.(nAMD)(PULSAR)NCT04423718Q3 2022BDK
77、RB1 Receptor Antagonist(BAY 2395840)Neuropathic Pain(BRADiNP)Bayer/EvotecNCT05219812Q4 2022Study ongoingGadoquatrane(High Relaxivity Contrast Agent(HRCA)(BAY 1747846)Magnetic Resonance Imaging(HRCA-PAT)BayerNCT04307186Q4 2022Study ongoingRuncaciguat(sGC Activator)(BAY 1101042)Non-prolif.Diabetic Ret
78、inopathy(NPDR)(NEON-NPDR)BayerNCT04722991Q4 2023Study ongoingAdrenomedullin Pegol(PEG-ADM)(BAY 1097761)Acute Resp.Distress Syn.(ARDS)(SEAL)BayerNCT04417036Q4 2024Study ongoingZabedosertib(IRAK4 Inhibitor)(BAY 1834845)Pelvic Inflammatory Disease;PsoriasisBayerStudies completed.Phase II decision taken
79、 for Atopic DermatitissGC Activator(BAY 1211163)Acute Respiratory Distress SyndromeBayerNCT04609943Q2 2023 Study ongoingParkinsons Disease Cell Therapy(BRT-DA-01)Parkinsons DiseaseBlueRockNCT04802733Q2 2023Study ongoingParkinsons Disease Gene Therapy(AAV2-GDNF-PD)Parkinsons DiseaseAskBioNCT04167540Q
80、4 2023Study ongoingMultiple System Atrophy Gene Therapy(AAV2-GDNF-MSA)Multiple System AtrophyAskBioNCT04680065Q1 2024Study recruitingPompe Disease Gene Therapy(ACTUS-101)Pompe DiseaseAskBioNCT03533673Q2 2025Study ongoingHuntingtons Disease Gene Therapy(BV-101)Huntingtons DiseaseAskBioNCT05541627Q4 2
81、025Study recruitingLGMD2i Gene Therapy(LION-101)Limb-Girdle Muscular Dystrophy 2iAskBioNext Generation Liver MRI(BAY 3393081)Contrast MediaBayer1 Bayer and partner sponsored+3rd party label enabling studies with first patient first visit 2 Pre-clinical selected assets on path to IND 4 Conducted by Regeneron PharmaceuticalsBiologicAntibodyCell TherapyContrast AgentGene TherapyRadiotherapySmall Molecule