1、42nd AnnualJ.P.Morgan HealthcareConferenceStefan OelrichMember of the Board of Management of Bayer AGPresident PharmaceuticalsJanuary 9,2024RENEW TOPLINEREALLOCATE RESOURCESBayer Pharmas Strategic Agenda3Drive continued sales momentum and ensure blockbuster potential of Nubeqa and KerendiaMaximize t

2、he full commercial value of the current portfolio,notably Eylea and RadiologyContinued shift of resources towards launch brands and assets with high innovation potentialStringent cost managementProgress late-stage pipelineReplenishment of early pipeline with increased contributions from platform com

3、panies/42ndAnnual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsREBUILD PIPELINENet Sales%yoy(cpa1)-1%0%EBITDA Margin229.1%28%On Track to Deliver on 2023 Guidance While Managing Significant ChallengesFINANCIAL PERFORMANCE9M 2023ActualFY 2023GuidanceKey Sales Drivers of 9M 2023 Performance+10

4、5%(cpa1)0.6bn+5%(cpa1)2.4bn+220%(cpa1)0.2bnRadiology+8%(cpa1)1.5bn4/42ndAnnual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals1currency and portfolio adjusted 2EBITDA Margin before special itemsFinancials2023 REVIEWStrong launch uptakeof Nubeqa and KerendiaPositive topline results of Elinzane

5、tantEylea 8mg positive CHMP opinionInitial successes from platform companiesEarly pipeline replenishmentin full swingAchievementsChallengesChina business headwindsPressure on XareltoAsundexianOCEANIC-AF study terminationUnfavourableproduct mix Inflationary pressuresShort to Mid-term2022Solid underly

6、ing business momentum:New launches to largely compensate for Loss of ExclusivitySALES BAYER PHARMACEUTICALSNubeqa,KerendiaXarelto Radiology andOther Late Lifecycle AssetsEyleaNubeqa andKerendia:Growth excellenceXareltoMajor decline Stable:Ongoing growth in Radiologybalancing shortfalls in other asse

7、tsEylea Franchise:StableFinancials5Differentiated pipeline assets to potentially fuel long-term growthRenewed portfolioSteady base businessLong-term/42ndAnnual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsElinzanetant,Asundexian StrokeElinzanetant and Asundexian Stroke:Launch excellence(ill

8、ustrative)19.3bn0.6bn4.5bn11.0bn3.2bnNubeqa and Kerendia Demonstrate Strong Sales Uptake;Next Phase III Readouts in 2024 6/42ndAnnual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsNubeqa1ARI:Androgen Receptor Inhibitor 2mHSPC:metastatic hormone sensitive prostate cancer 3 US Market includes

9、NBRx linked to T2D and CKD4 CKD:Chronic Kidney Disease 5HFmr/pEF:Heart Failure with mildly reduced/preserved ejection fraction:LVEF 40%6Peak Sales Potential KerendiaPeak63bnPeak63bnGlobal Sales Development(bn)202120222023e2024e0.20.50.81Becoming a blockbusterproduct in 2024Nubeqa continues to be the

10、 fastest growing ARI1in the USEx-US,additional approvals driving further growthReadout of Phase III study ARANOTE in mHSPC2in 2024Global Sales Development(bn)202120222023e2024e00.10.30.5Continuedlaunch momentum in 2024 Kerendia outperforming NBRx market growth in the US3Extension of clinical program

11、 in CKD4and Heart Failure Readout of Phase III study FINEARTS-HF in HFmr/pEF5in 2024Renew ToplineUnprecedented Eylea 8mg Data Reinforce Leading Clinical Profile of Eylea/Maintaining strong market leadership as the#1 anti-VEGF treatment/Eylea 2mg(Aflibercept 2mg)is the standard of care in retinal dis

12、eases/Demographic trends expected to drive future category growthEylea 8mg:Key Phase III dataPatient proportion achieving last assigned intervals 4 months at 96 week78%achieved q16388%achieved q163PULSAR(nAMD)1PHOTON(DME)2Eylea 2mg(Q8W)5Eylea 8mg(Q16W)nAMD1DME21314887/42ndAnnual J.P.Morgan Healthcar

13、e Conference/Bayer PharmaceuticalsDME:diabetic macular edema;nAMD:neovascular age-related macular degeneration 1 Source:https:/ Source:https:/ randomized to 8q16 group 4Rounded figures 5Fixed dose arm without potential to be extendedRenew ToplineMean#of injections through week 964/Unprecedented dura

14、bility with only 3 loading doses and as few as 8 injections over 2 years/Comparable efficacy and safety compared to Eylea 2mg/Eylea 8mg approval in Europe received in January 2024/Eylea 8mg is the only drug that is approved for extended treatment intervals of up to 5 months for patients with nAMD an

15、d DMEBecome New Standard of CarePromising Future53%achieved q20347%achieved q203Elinzanetant:Both Pivotal Phase III Studies From OASIS Program Met All Primary And Key Secondary Endpoints8/42ndAnnual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals1 Induced Vasomotor Symptoms Comprehensive clin

16、ical development programElinzanetant:Non-hormonal,oral,first dual neurokinin-1,3 receptor antagonistOASIS 1VMS:26 WeekEfficacyStudyOASIS 2VMS:26 WeekEfficacyStudyOASIS 3VMS:52 WeekSafety/EfficacyStudyOASIS 4iVMS1 due tobreast cancertherapyNIRVANAPh II,Sleep Disturbanceassociated with menopause Expec

17、ted Readouts:Renew ToplineQ1 202420252025All primary and key secondary endpoints metMenopause-related sleep and quality of life/Improvement of sleep disturbance/Improvement of quality of life Moderate to severe hot flashes/Reduction in frequency/Reduction in severity/Effect already at week 1 Next Mi

18、lestone:/Readout of OASIS-3 in Q1 2024/Regulatory submission will be based on OASIS1-3 study resultsElinzanetant as Investigational Non-hormonal Treatment Option in The Menopause with Blockbuster Potential9/42ndAnnual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals1 Source:Market Research-IPS

19、OS-Global VMS Women Segmentation 2Source:NIH.https:/www.ncbi.nlm.nih.gov/books/NBK507826 3Source:Project Heat Market Research,2018 SHA VMS Prescriber analysis 4Peak Sales Potential Menopause Market/Potential to address most common and disruptive symptoms during menopause such as hot flashes and slee

20、p disturbances/High unmet need as many women experiencing symptoms associated with menopause remain untreated/Opportunity to leverage leading global footprint in Womens Health for fast penetration in key markets/Potential launch:2025Multiple symptoms during menopause1Market opportunity(US)2/3 of wom

21、en not choosing hormone therapy364Mwomen impacted by menopause2Renew ToplinePeak41bnSleep disturbanceHot flashes60%of women will experience sleep disturbance80%of women will experience vasomotor symptomsCommercialization1.3Mwomen entering menopause transition annually2Executing on New R&D Priorities

22、 to Build a Highly Differentiated Pipeline for Long-Term Growth Focusing on High Unmet NeedBroadened range of modalities:Currently 60%of Phase I assets are new modalities vs 80%of SMOLs(in Phase I)ReallocateResourcesResearch focus in four areas based on/Value&differentiation/Feasibility&risk/Leading

23、 capabilitiesOncologyCardiovascular+1Neurology&Rare DiseasesImmunologyReplenishment of Early Pipeline in Full Swing;Numerous First-In-Class Pipeline Candidates to Potentially Transition into Phase IIFeeding from Researchinto Phase IRejuvenate mid-/late-stage pipeline with several potential blockbust

24、er assetsAdvanced 6 new INDs into Phase I in 2023(vs.4/year between 2020-2022)VVD Keap1 Act(Advanced solid tumors)First Phase I asset from Vividions chemoproteomics platformPSMA-TAC Cancer(Advanced Prostate Cancer)FIC/BIC opportunity in targeted radiotherapiesBemdaneprocel(Parkinsons Disease)PSC-der

25、ived dopaminergic cell therapy with positive data in Parkinsons Disease;FIC potential11#Pipeline assets1Start Phase I in 2023Expected transition into Phase II in 2024Phase IPhase IIPhase IIIExpected transitions to mid-and late-stage pipeline in 2024:Anti-Alpha2-Antiplasmin mAB(Ischemic Stroke)Effect

26、ive thrombolytic with no increase in bleeding risk;FIC potential RebuildPipeline/42ndAnnual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals1 Pipeline status as of Dec 19,2023Selected examples:Selected examples:Key Catalysts 202412RENEW TOPLINEREALLOCATE RESOURCESREBUILD PIPELINEContinue leade

27、rship in Ophthalmology with first approvals and launches of Eylea 8mg Continue strong launch uptakeof Nubeqa and KerendiaPrepare for potential launch of Elinzanetant in 20251Continue reallocationof marketing resources towards launch investmentsEnsure sustainable pipeline progression through executio

28、n of R&D strategy and resource shift to key prioritiesNubeqa mHSPC:Readout of Phase III ARANOTE study Finerenone HFmr/pEF:Readout of Phase III FINEARTS-HF studyReplenish mid-and late-stage pipeline by advancing multiple potential blockbuster assetsDSO2Implement new operating model to improve organiz

29、ational efficiency and productivity1 provided successful completion of OASIS-3 study 2 Dynamic Shared Ownership/42ndAnnual J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals01.Appendix/Numerous First-In-Class Pipeline Candidates to Potentially Transition Into Mid-And Late-Stage SoonProgram(Indic

30、ation)OncologyCardiovascular+including Precision CV,Nephrology&Acute CareNeurology&Rare DiseasesSelected assets with expected upcoming phase transition14Potential Launch between 2028-2032Current Phasea2AP ant mAb(Ischemic Stroke)mEGFR/HER2i(Lung Cancer)Bemdaneprocel(Parkinsons)AB-1005(Parkinsons)Run

31、caciguat(NDPR)sGC Activator Oral(Chronic Kidney Disease)Phase IPhase IPhase IPhase IPhase IFICFDA fast track,FICFIC/BICFICFIC/BICFIC/BICPhase II/42ndAnnual J.P.Morgan Healthcare Conference/Bayer PharmaceuticalsSeveral Pipeline Milestones Expected in Upcoming Quarters/42ndAnnual J.P.Morgan Healthcare

32、 Conference/Bayer Pharmaceuticals15Major R&D MilestonesNew LCMPrimary CompletionOncologyCardiovascular+3ImmunologyOthers1 Remaining HY1 after January 8th2 OASIS-1,-2 and-3 primary completion achieved,OASIS-4 expected H1 2024 3 Including Precision Cardiovascular,Nephrology&Acute CareHY1 2024e1Darolut

33、amide/ADT mHSPC:Primary compl.phase III(ARANOTE)VVD STAT3 Inh:Start Phase IElinzanetant VMS:Primary compl.Phase III(OASIS program)2Finerenone CKD in T1D:Start Phase III(FINE-ONE)First Submission/ApprovalPhase transition(FPFV)PSMA SMOL-TAC:Start Phase IsGC Activator oral CKD:Start Phase IIbRuncacigua

34、t NPDR:Primary compl.Phase IIaBemdaneprocel PD:Start Phase IIPhase IPhase IIPhase IIISubmission/ApprovalSema3A mAB:Primary compl.Phase ISOS1 inh:Start Phase IHY2 2024eFinerenone HFmr/pEF:Primary compl.phase III(FINEARTS-HF)Gadoquatrane:Pplet.phase III(QUANTI-CNS/-OBR)Aflibercept RVO:8 mg Primary com

35、pl.Phase III (QUASAR)Anti-a2 AP Thrombolysis:Start Phase IIa(SIRIUS)Cong.HF rAAV Gene Therapy:Start Phase IIPD rAAV Gene Therapy:Start Phase IIHER2/mEGFR Inhibitor:Start phase IIINeurology&Rare DiseasesPharmaceuticals Pipeline Overview1(as of Dec 19,2023)1 Bayer and partner sponsored+3rd party label

36、 enabling studies with first patient first visit2 Conducted by Merck&Co 3 Including Precision Cardiovascular,Nephrology&Acute CareLife cycle managementNew molecular entityPhase IIIDarolutamide(AR Inhibitor)Prostate Cancer(mHSPC)(ARANOTE)Adjuvant Prostate Cancer(DASL-HiCaP)Prostate Cancer with Bioche

37、mical Recurrence after Curative Radiotherapy(ARASTEP)Finerenone(MR Antagonist)Heart Failure(HFmr/pEF)(FINEARTS-HF)Non-diabetic CKD(FIND-CKD)Vericiguat(sGC Stimulator)Heart Failure(HFrEF)(VICTOR2)Asundexian(FXIa Inhibitor)2 Stroke Prevention(OCEANIC-STROKE)Elinzanetant(Neurokinin-1,3 Rec Antagonist)V

38、asomotor Symptoms(OASIS)Aflibercept 8mg(VEGF Inhibitor)Retinal Vein Occlusion(QUASAR)Gadoquatrane(High Relaxivity Contrast Agent)Magnetic Resonance Imaging (QUANTI-CNS,QUANTI-OBR)SubmissionsAflibercept 8mg(VEGF-Inhibitor)EU,JP:Diabetic Macular Edema(DME)EU,JP,CN:Neovasc.Age-rel.Macular Degen.(nAMD)O

39、ncologyCardiovascular+3Neurology&Rare DiseasesImmunologyOthersPhase IIRegorafenib(combi Nivolumab)(BAY 734506)Solid tumors(recurrent or metastatic)AB-1002 rAAV Gene TherapyNon-Ischemic NYHA Class III Heart Failure(GenePHIT)Zabedosertib(IRAK4 Inh.)(BAY 1834845)Atopic Dermatitis(DAMASK)Runcaciguat(sGC

40、 Activator)(BAY 1101042)Non-prolif.Diabetic Retinopathy(NPDR)(NEON-NPDR)Protein TherapeuticsCell TherapyContrast AgentGenetic MedicineRadionuclide TherapySmall MoleculePhase IHER2/mEGFR Inhibitor(BAY 2927088)DGKzeta Inhibitor(BAY 2965501)CCR8 Ab(BAY 3375968)VVD KEAP1 Act(VVD-13307 aka NRF2 Inh,BAY 3

41、605349)DGKalpha Inh(BAY 2862789)PSMA TAC(BAY 3546828)sGC Activator Oral(BAY 3283142)Anti-a2AP(BAY 3018250)SEMA 3a(BAY 3401016)Anti-coagulant(BAY 3389934)Bemdaneprocel(Parkinsons Disease Cell Therapy)(BRT-DA01)Parkinsons Disease rAAV Gene Therapy(AB-1005 aka AAV2-GDNF-PD)Multiple System Atrophy rAAV

42、Gene Therapy(AB-1005 aka AAV2-GDNF-MSA)Pompe Disease rAAV Gene Therapy(ACTUS-101)Huntingtons Disease rAAV Gene Therapy(AB-1001 aka BV-101)LGMD2I/R9 rAAV Gene Therapy(AB-1003 aka LION-101)GPR84 Antagonist(BAY 3178275)BAY 2701250Full pipeline package available for download under:https:/ J.P.Morgan Healthcare Conference/Bayer Pharmaceuticals16