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1、This presentation contains certain forward-looking statements.These forward-looking statements may be identified by words such as believes,expects,anticipates,projects,intends,should,seeks,estimates,future or similar expressions or by discussion of,among other things,strategy,goals,plans or intentio
2、ns.Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation,among others:1pricing and product initiatives of competitors;2legislative and regulatory developments and economic conditions;3 delay or in
3、ability in obtaining regulatory approvals or bringing products to market;4 fluctuations in currency exchange rates and general financial market conditions;5 uncertainties in the discovery,development or marketing of new products or new uses of existing products,including without limitation negative
4、results of clinical trials or research projects,unexpected side-effects of pipeline or marketed products;6 increased government pricing pressures;7 interruptions in production;8 loss of or inability to obtain adequate protection for intellectual property rights;9 litigation;10 loss of key executives
5、 or other employees;and11 adverse publicity and news coverage.Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roches earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the histo
6、rical published earnings or earnings per share of Roche.For marketed products discussed in this presentation,please see full prescribing information on our website All mentioned trademarks are legally protected.Entering the next growth cycle Alan Hippe|CFO RocheJ.P.Morgan Healthcare Conference,9 Jan
7、uary 2024Innovation strategyUpcoming opportunities:-Pharma-DiagnosticsOutlook1 based on FY 2022 sales(Evaluate/Bloomberg);2Patient View,2023;3CBInsight,2023;AI=artificial intelligence;RMS=relapsing;PPMS=primary progressive multiple sclerosis;AMD=age-related macular degeneration;DME=diabetic macular
8、edema;RVO=retinal vein occlusion;SMA=spinal muscular atrophyOur achievementsPharma in AI readiness3#1top pharma as ranked by rare disease patient groups2#1in neurology and hemophilia A1#1in in vitro diagnostics1#1in oncology1#3blockbuster drugs in 2022,up from 7 in 201216First and only therapy appro
9、ved for RMS and PPMSFirst ever RNA splicing modifier for treatment of SMAFirst bispecific VEGF/Ang2 antibody in AMD,DME and RVOFirst and only prophylactic treatment for hemophilia A with/without inhibitorsA legacy of patient and business impactwith a track record of establishing standard of care acr
10、oss new therapeutic areasRoche is continuously shifting the standard of careyears of CHF dividend increases366Young marketed and diversified portfolio driving Pharma growthKeeping historic launch momentum with two NMEs approved in 202323%34%42%50%02,0004,0006,0008,00010,00012,00014,00016,00018,000 Y
11、TD Sep 2020 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023CotellicAlecensaTecentriqOcrevusHemlibraLuxturnaXofluzaPolivyRozlytrekEnspryngPhesgoEvrysdiGavretoRonapreveSusvimoVabysmoLunsumioColumviYoung portfolio defined as all launches since end of 2015;*Elevidys:Accelerated US approval by partner company Sar
12、epta;*Venclextasales booked by AbbVie and therefore not includedCHFm%of Pharma Sales*Potential NME approvals in 2024:crovalimab filed in PNH inovalisib to be filed in 1L HR+/HER2-/PI3Km mBC7Note:Effective 1 January 2023,the Group made presentational and cost allocation changes to the income statemen
13、t.The comparative information for 2022 was restated accordinglyReallocating significant resources to R&DWhile defending margins and managing an exceptional patent cliffRoche Group growth FY 2022 vs.FY 20188*NMEs that are neither first-in-class or best-in-disease,or without disclosed MoA,are grouped
14、as Others;Peer 1-12 are other large-cap PharmaSource:Pharmaprojects(March 2023)Pharma pipeline assets segmented by innovation potentialRoche ranks#2 having 36 NMEs with first-in-class potential45363433292520820219323543Peer 5Peer 6Peer 9Peer 4Peer 1Peer 2P
15、eer 12Peer 3Peer 7Peer 8Peer 10Peer 11Fast-followerFirst-in-classOthers*Total number of pipeline assets by innovation potential*,#989R&D focus areas to speed up delivery of our medicines456123Access the best external innovationOptimize R&D engines and invest in emerging technologiesEvolve talent,cul
16、ture and mindset to achieve objectivesSet ambitious R&D objectivesStrengthen portfolio frameworkTransform portfolio management&governance10Lab in a loop:Integrating our levers to build the portfolio of the futureHuman biology&therapeutic modalitiesAI/MLHigh resolutionExtreme scale11*Table shows clin
17、ical stage NME deals completed 2021-2023 YTD;TA=therapeutic area;mCRPC=metastatic castrations-resistant prostate cancer;AR=androgen receptor;IgAN=immunuglobululinA nephropathy;ASO=antisense oligonucleotide;IPF=idiopathic pulmonary fibrosis;SSC-ILD=systemic sclerosis-interstitial lung disease;w/wo=wi
18、th and without;T2D=type 2 diabetes;T1D=type 1 diabetesPipeline acceleration via partneringDeals of the past two years increasingly focused on clinical stage NMEs*Oncology/HematologyOphthalmologyImmunologyCardiovascular&MetabolismDevelopment stage at time of dealCurrent development stagePositive proo
19、f of concept dataH2 2023 12VabysmoOcrevusEvrysdiHemlibraTecentriqVenclextaAlecensaPhesgoColumviLunsumioPolivyVabysmoOcrevusEvrysdiHemlibraTecentriqVenclextaAlecensaPhesgoColumviLunsumioPolivySusvimoGazyvaastegolimabdivarisibElevidysEnspryngfenebrutinibcrovalimabtiragolumabinavolisibgiredestrantEmerg
20、ing assets from early pipeline and BDanti-IL6 mAbASO Factor BzilebesiranCT-388/CT-996/CT-868SPK-8011tobemstomigtrontinemabanti-latent myostatinmAbSusvimoGazyvaastegolimabanti-TL1AdivarasibElevidysEnspryngfenebrutinibcrovalimabtiragolumabinavolisibgiredestrantVabysmoOcrevusEvrysdiHemlibraTecentriqVen
21、clextaAlecensaPhesgoColumviLunsumioPolivyCVM=cardiovascular/metabolism;*mid-term defined as filing 2024-2026,*long-term defined as filing 2027-2030Building blocks for future growth through the end of the decadeRecent acquisitions add significant upside potentialOncology/HematologyNeuroscienceOphthal
22、mologyImmunologyCVMLaunched portfolioMid-term opportunities*Long-term opportunities*Telavant acquisitionCarmot TherapeuticsacquisitionAlnylam partnershipInnovation strategyUpcoming opportunities:-Pharma-DiagnosticsOutlook14Sept YTD reported sales;Growth rates at CER(Constant Exchange Rates)Roche por
23、tfolio:Diversifying&establishing leadership positions Leadership through medicines setting new standards of care OncologyNeuroscienceImmunologyHaemophilia AOphthalmologyInfectious diseasesOther pharmaDiagnostics15Roche portfolio:Diverse growth opportunities aheadMalignant Hematology:Malignant Hemato
24、logy:oLunsumio,Columvi,Polivy in NHLLunsumio,Columvi,Polivy in NHLSolid tumors:Solid tumors:oInovalisibInovalisiband giredestrant in and giredestrant in breast cancerbreast canceroTiragolumab in solid tumorsTiragolumab in solid tumorsoD Divarasib in solid tumorsivarasib in solid tumorsElevidys in DM
25、DElevidys in DMDFenebrutinib in MSFenebrutinib in MSEnspryng in gMGEnspryng in gMGTrontinemab in ADTrontinemab in ADPrasinezumab in PDPrasinezumab in PDAntiAnti-latent myostatin Ab in SMAlatent myostatin Ab in SMAMass spectrometryMass spectrometryCGMCGMNGSNGSGazyva in LNGazyva in LNAntiAnti-TL1a TL1
26、a in in IBD(UC,CD)IBD(UC,CD)and and other autoimmune diseasesother autoimmune diseasesAstegolimab in COPDAstegolimab in COPDSusvimo in AMD,DME,DRSusvimo in AMD,DME,DRAntiAnti-IL6 in DMEIL6 in DMEASO factor B in GAASO factor B in GAKey pipeline projects with upcoming near-term news flow Crovalimab in
27、 PNHCrovalimab in PNHNHL=non hodgkins lymphoma;DMD=Duchenne muscular dystrophy;MS=multiple sclerosis;gMG=generalized myasthenia gravis;AD=Alzheimers disease;PD=Parkinsonss disease;LN=lupus nephritis;UC=ulcerative colitis;CD=Crohns disease;COPD=chronic obstructive pulmonary disease;AMD=age-related ma
28、cular degeneration;DME=diabetic macular edema;DR=diabetic retinopathy;GA=geographic atrophy;PNH=paroxysmal noctural hemoglobinuria;CGM=continuous glucose monitoring;NGS=next generation sequencing16Roche portfolio:Diverse growth opportunities aheadMalignant Hematology:Malignant Hematology:oLunsumio,C
29、olumvi,Polivy in NHLLunsumio,Columvi,Polivy in NHLSolid tumors:Solid tumors:oInovalisibInovalisiband giredestrant in and giredestrant in breast cancerbreast canceroTiragolumab in solid tumorsTiragolumab in solid tumorsoD Divarasib in solid tumorsivarasib in solid tumorsElevidys in DMDElevidys in DMD
30、Fenebrutinib in MSFenebrutinib in MSEnspryng in gMGEnspryng in gMGTrontinemab in ADTrontinemab in ADPrasinezumab in PDPrasinezumab in PDAntiAnti-latent myostatin Ab in latent myostatin Ab in SMASMAMass spectrometryMass spectrometryCGMCGMNGSNGSGazyva in LNGazyva in LNAntiAnti-TL1a TL1a in in IBD(UC,C
31、D)IBD(UC,CD)and and other autoimmune diseasesother autoimmune diseasesAstegolimab in COPDAstegolimab in COPDSusvimo in AMD,DME,DRSusvimo in AMD,DME,DRAntiAnti-IL6 in DMEIL6 in DMEASO factor B in GAASO factor B in GAKey pipeline projects with upcoming near-term news flow Crovalimab in PNHCrovalimab i
32、n PNHNHL=non hodgkins lymphoma;DMD=Duchenne muscular dystrophy;MS=multiple sclerosis;gMG=generalized myasthenia gravis;AD=Alzheimers disease;PD=Parkinsonss disease;LN=lupus nephritis;UC=ulcerative colitis;CD=Crohns disease;COPD=chronic obstructive pulmonary disease;AMD=age-related macular degenerati
33、on;DME=diabetic macular edema;DR=diabetic retinopathy;GA=geographic atrophy;PNH=paroxysmal noctural hemoglobinuria;CGM=continuous glucose monitoring;NGS=next generation sequencing1702,0004,0006,0008,00010,00012,0002020202120222023E*2026E*CHFmMabThera/RituxanGazyva/GazyvaroHemlibraPolivyLunsumioColum
34、viOther rare blood*Source:Estimates are based on Post Q3 2023 consensus collected by FTI Consulting on behalf of Roche;all values in CHF reported;*Venclextasales are not included as booked by partner AbbvieHematology:Portfolio rejuvenation leading to growth reboundDriven by diverse portfolio and bro
35、ad pipeline-10%-8%+9%YoY CER growthRoche hematology franchise sales*CAGR:+14%CAGR:+14%Hematology181 Datamonitor:incidence rates includes the 7 major markets(US,Japan,France,Germany,Italy,Spain,UK);*including FL;*In collaboration with Poseida Therapeutics;MM=Multiple myeloma;iNHL=indolent non-hodgkin
36、s lymphoma;DLBCL=Diffuse large B-cell lymphoma;MDS=Myelodysplastic syndromes;AML=Acute myeloid leukemia;CLL=Chronic lymphocytic leukemia;NHL=Non-hodgkins lymphoma;FL=Follicular LymphomaMalignant hematology:Growing diversified portfolio17%37%14%7%9%12%3%MMiNHL*DLBCLMDSAMLCLLALLOn-market portfolioPipe
37、line moleculescevostamabEnglumafusp alfa forimtamigIL15/IL15Ra-FcCD19 x CD28P-BCMA-ALLO1*Taking Columvi and Lunsumio into earlier lines,as well as 6 NMEs into new indications Ph IPh IIPh IIIColumvi+chemo Columvi+chemo(STARGLO)in 2L+DLBCLLunsumio+lenalidomide Lunsumio+lenalidomide(CELESTIMO)in 2L+FLL
38、unsumio+Polivy Lunsumio+Polivy(SUNMO)in 2L+DLBCLPh III clinical development overviewHematologic tumor cases by subtype1Venclexta+azacitidine Venclexta+azacitidine(VERONA)in 1L MDSHematology20242024202419Lunsumio and Columvi:Strong launches in 3L+settingOff-the-shelf,fixed duration treatments with si
39、mple dosing scheduleEstablishing as new SoC in 3L+FLSoC=Standard of Care;FL=Follicular Lymphoma;CR=Complete Responses;DLBCL=Diffuse Large B-cell Lymphoma;CAR-T=Chimeric Antigen Receptor T cell;HCP=Healthcare Professional;CRS=Cytokine Release Syndrome;R-CHP=Rituxan+cyclophosphamide+hydroxydaunorubici
40、n+prednisoneSuccessful launch in 3L+DLBCL=data expected 2024Lunsumio+lenalidomide(CELESTIMO)Lunsumio+Polivy(SUNMO)2L+DLBCL2L+FLColumvi+GemOx(STARGLO)2L+DLBCLColumvi+Polivy+R-CHP(SKYGLO)1L DLBCLPh III development programs moving into earlier lines and new indicationColumvi(GloBryte)R/R MCL Approvedin
41、 38 countries including China,reimbursed in 4 countries including US,Germany,and UK Best-in-class efficacy potential,high and durable CR rates comparable to CAR-Ts resonating well with HCPs,well tolerated with low grade,predictable CRS 32 months follow-up data continues to demonstrate high response
42、rates and durable remissions across subgroups Approvedin 46 countries,reimbursed in 8 countries including US,Germany,and Italy High CR rate and durable responses with favorable tolerability(no hospitalization required)best positioned for outpatient setting 3-year follow-up data continues to demonstr
43、ate durable complete responses and B-cell recovery1L FLLunsumio(MorningLyte)Hematology20Panse J et al,ASH 2023;Rth et al.,ASH 2023;*Based on COMMODORE 1;patients randomized to eculizumab who switched to crovalimab following primary analysis,and who completed a preference survey;PNH=Paroxysmal noctur
44、nal hemoglobinuria;SC=Subcutaneous;IV=Intravenoussurvey;PNH=Paroxysmal nocturnal hemoglobinuria;PNH=Paroxysmal Nocturnal Hemoglobinuria;PRO=Patient Reported Outcomes;aHUS=Atypical hemolytic uremic syndrome;SCD=Sickle Cell Disease;LN=Lupus Nephritis;FACIT=Functional Assessement of Chronic Illness The
45、rapy;conducted for patients 18 years of age;admim=administration;Q4W=Every 4 WeeksCrovalimab:Global filing in PNH,first approval expected H1 2024 PRO and pooled safety data reinforce positive Ph III(COMMODORE)resultsTreatment benefit in PNH supported by PRO and safety data FACIT-Fatigue scores showe
46、d clinically meaningful improvement from baseline in C5 inhibitor-naive patients(COMMODORE 2),and were maintained in C5 inhibitor-experienced patients(COMMODORE 1)Pooled safety data from COMMODORE1,2,3 confirm that crovalimabis well tolerated in patients with PNH Ph III(COMMODORE 1,2,3)filed globall
47、y including US,EU,China,Japan,and Brazil(priority review)Fast5 min per admin.Low frequencyQ4WEasy admin.SCPatient preference*:96%preferred crovalimab over eculizumabBroad development programPNHaHUSSCDLNPhase 1Phase 2Phase 3FiledLow volume4-6 mL per admin.Crovalimab is being investigated in a broad r
48、ange of immune-mediated diseases including PNH,aHUS,SCD and LN Next Ph III readout in aHUS expected in 20252025ASH 2023FACIT-Fatigue scores from baseline to Week 25C5i-nave patients(COMMODORE 2)C5i-experienced patients(COMMODORE 1)Hematology211Cancer Stats Facts:Female Breast Cancer Subtypes.Nationa
49、l Cancer institute.Available at:https:/seer.cancer.gov/statfacts/html/breast-subtypes.html(Access date:May 24,2022;HER2=Human Epidermal growth factor Receptor 2;HR=Hormone receptor;TNBC=Triple negative breast cancer;SERD=Selective estrogen receptor degrader;ER=Estrogen receptor;PI3K=Phosphoinositide
50、 3-Kinase;TKI=Tyrosine kinase inhibitorBreast cancer:Opportunities emerging to expand beyond HER2+Novel mechanisms and technologies7%4%10%10%69%UnknownHR/HER2+HR+/HER2+TNBCHR+/HER2On-market portfolioPipeline moleculesgiredestrant(SERD)runimotamab(HER2xCD3)inavolisib(PIK3CAi)ZN-1041(HER2 TKI)Ph III c
51、linical development overviewBreast cancer cases by subtype12 NMEs(giredestrant;inovalisib)in Ph III development in HR+BC,including Phesgo combinationsGiredestrant+palbociclibGiredestrant+palbociclib(perservERA)in 1L ER+/HER2-mBCGiredestrantGiredestrant(lidERA)in adjuvant ER+BCGiredestrant+Phesgo Gir
52、edestrant+Phesgo(heredERA)in 1L maint ER+/HER2+Inavolisib+palbo+fulvInavolisib+palbo+fulv(INAVO120)in 1L HR+/HER2-/PI3Km mBCInavolisib+fulv Inavolisib+fulv(INAVO121)post CDK4/6i HR+/HER2-/PI3Km BCInavolisib+Phesgo Inavolisib+Phesgo(INAVO122)in 1L HER2+/PI3Km BCPh IPh IIPh IIIGiredestrant+CDK4/6Gired
53、estrant+CDK4/6(pionERA)in 1L ER+/HER2-mBCOncology solid tumorsPositive data22KalinskyK.et al.,AACR 2017;Jhaveri,K.,et al,SABCS 2019;Jhaveri KL et al.,SABCS 2023;H2H=head-to-head;inh=inhibitor;ET=endocrine therapy;HR=hormone receptor;mBC=metastatic breast cancer;FPI=first patient in;PI3K=Phosphoinosi
54、tide 3-Kinase;ET=Endocrine therapy;HR=Hormone receptor;HER2=Human Epidermal growth factor Receptor 2;CDK4/6i=Cyclin-dependent kinase 4 and 6 inhibitors;BC=Breast cancerInavolisib in PI3K-mutant HR+breast cancerPositive Ph III results in 1L with a PFS HR of 0.43 to be filed in US/EUPotential best-in-
55、class PI3K inhibitorPh III(INAVIO120)results:Differentiated from existing PI3K inhibitors:More potent and selective for PI3Ksubunit Better in vivo efficacy Greater safety margins allow for combination withET+/-CDK4/6i at standard doses 40%of HR+/HER2-patients with PI3Kmutations PhIII(INAVO120)Inavol
56、isib+palbociclib+fulvestrantin 1L HR+/PI3Km mBCreduced the risk of disease progression by 57%(HR=0.43);OS was immature,but with clear positive trend(HR=0.64)PhIII INAVO121 post-CDKi(head-to-head vs.alpelisib)achieved FPI in Q2 2023 Ph III INAVO122 in 1L HER2+/PI3Km BC(combination with Phesgo)achieve
57、d FPI in Q3 20230070PI3K selectivity vs.PI3K selectivity vs.PI3K selectivity vs.Pi3K potencyInavolisibAlpelisibFold change(inavolisib vs.alpelisib)1Progeression free survival(PFS)32x26x6x58x1111Potency/selectivity(inavolisib vs.alpelisib)Oncology solid tumors23mAb=monoclonal antibody;NSCL
58、C=Non-Small Cell Lung Cancer;ESCC=esophageal squamous cell carcinoma;NSq=non-squamous;HCC=hepatocellular carcinoma;uHCC=unresectablehepatocellular carcinoma;SCCHN=squamous cell carcinoma of head and neck;OS=Overall survival;LPI=last patient in;PVR=Poliovirus receptorSolid tumors:Tiragolumab program
59、continues to expandContinued confidence in aTIGIT biological activity based on evidence to dateFirst-in-class anti-TIGIT mAb Tiragolumabblocks the binding of TIGIT to its ligand PVR Tiragolumabactivates T-cells and also modifies the tumor microenvironment by decreasing suppressive T-regsand activati
60、ng myeloid cells via its intact Fc region This could lead to an enhanced anti-tumor immune response when combined with PD-L1 blockade Comprehensive development program ongoing Ph III SKYSCRAPER-14/IMbrave152 in 1L unresectableHCC initiated Ph III SKYSCRAPER-01 continues to final OS analysis expected
61、 in H2 2024(event-driven)Clinical development programOncology solid tumors24Roche portfolio:Diverse growth opportunities aheadMalignant Hematology:Malignant Hematology:oLunsumio,Columvi,Polivy in NHLLunsumio,Columvi,Polivy in NHLSolid tumors:Solid tumors:oInovalisibInovalisiband giredestrant in and
62、giredestrant in breast cancerbreast canceroTiragolumab in solid tumorsTiragolumab in solid tumorsoD Divarasib in solid tumorsivarasib in solid tumorsElevidys in DMDElevidys in DMDFenebrutinib in MSFenebrutinib in MSEnspryng in gMGEnspryng in gMGTrontinemab in ADTrontinemab in ADPrasinezumab in PDPra
63、sinezumab in PDAntiAnti-latent myostatin Ab in SMAlatent myostatin Ab in SMAMass spectrometryMass spectrometryCGMCGMNGSNGSGazyva in LNGazyva in LNAntiAnti-TL1a TL1a in in IBD(UC,CD)IBD(UC,CD)and and other autoimmune diseasesother autoimmune diseasesAstegolimab in COPDAstegolimab in COPDSusvimo in AM
64、D,DME,DRSusvimo in AMD,DME,DRAntiAnti-IL6 in DMEIL6 in DMEASO factor B in GAASO factor B in GAKey pipeline projects with upcoming near-term news flow Crovalimab in PNHCrovalimab in PNHNHL=non hodgkins lymphoma;DMD=Duchenne muscular dystrophy;MS=multiple sclerosis;gMG=generalized myasthenia gravis;AD
65、=Alzheimers disease;PD=Parkinsonss disease;LN=lupus nephritis;UC=ulcerative colitis;CD=Crohns disease;COPD=chronic obstructive pulmonary disease;AMD=age-related macular degeneration;DME=diabetic macular edema;DR=diabetic retinopathy;GA=geographic atrophy;PNH=paroxysmal noctural hemoglobinuria;CGM=co
66、ntinuous glucose monitoring;NGS=next generation sequencing251.Whole-brain imaging highlights the distribution of classical IgG vs.BrainshuttleTMIgG targeting a neuronal target in mouse brains.Mouse brains were perfused and chemically fixed 5 days after a single IV dose of fluorescently-labelled Brai
67、nshuttleTM-IgG(3 mg/kg)or two consecutive IV doses of IgG(2x 6 mg/kg).Images show a 3D volume rendering of the whole brain acquired with a light-sheet microscope;AD=Alzheimers disease;TfR1=Transferrin receptor protein 1;IgG=Immuno-globulin G;BBB=blood brain barrier;mAb=monoclonal antibody;A=Amyloid;
68、Ab=Antibody;Tf=Transferrin;CNS=Central nervous system;ADCC=Antibody dependent cell mediated cytotoxicityTrontinemab in Alzheimers diseaseFirst dose finding data for BrainshuttleTManti-Apresented at CTADTrontinemab(BrainshuttleTManti-AAb)Trontinemab is a novel molecular entity,based on Roches proprie
69、tary BrainshuttleTMtechnology,combining an Abinding mAbwith a transferrin receptor(TfR1)shuttle moduleTrontinemab is designed for efficient transport across the BBB to target aggregated forms of Aand remove amyloid plaques in the brainBBBBrain tissueBloodAggregated ATransferrinreceptor 1Brain shuttl
70、emoduleA binderActive TfR1 transport at the capillary level BrainshuttleTMtechnology results in increased CNS exposure and broader,more homogeneous brain distribution1 leading to deep and fast amyloid clearance The inverted TfR1 binding Fab fragment prevents undesired TfR1 targeted immune responses(
71、ADCC)via“steric hindrance”leading to an improved safetyprofile Full Fc effector function is preserved to induce effective microglia activation and Fc mediated phagocytosis of Aplaques in the brain which is essential for efficacyStandard IgG1Brainshuttle IgG1Inverted TfR1 binding Fab fragmentFull Fc
72、effector functionHomogeneous brain exposureFc-mediated phagocytosisAggregatedAActivation of microgliaTrontinemab is differentiated from conventional anti-A mAbsand other brain delivery technologiesNeuroscienceBrain shuttlemoduleTransferrinreceptor 1A binderTransferrin26Trontinemab clears amyloid mor
73、e rapidly than conventional mAbsGantenerumab GRADUATE I/II:presentation at CTAD 2022,publication in preparation;LecanemabCLARITY AD:N EnglJ Med 2023;388:9-21;DonanemabTRAILBLAZER-ALZ-2:JAMA.2023;330(6):512-527;AD=Alzheimers disease;CL=Centiloidunit;PET=Positron Emission Tomography;mAb=Monoclonal ant
74、ibody;A=Amyloid;q4w=Every 4 weeksBrainshuttleTMAD study results in comparison to other anti-AmAb PhIIItrial resultsAmyloid PET positivity treshold(24 CL)Neuroscience27Roche portfolio:Diverse growth opportunities aheadMalignant Hematology:Malignant Hematology:oLunsumio,Columvi,Polivy in NHLLunsumio,C
75、olumvi,Polivy in NHLSolid tumors:Solid tumors:oInovalisibInovalisiband giredestrant in and giredestrant in breast cancerbreast canceroTiragolumab in solid tumorsTiragolumab in solid tumorsoD Divarasib in solid tumorsivarasib in solid tumorsElevidys in DMDElevidys in DMDFenebrutinib in MSFenebrutinib
76、 in MSEnspryng in gMGEnspryng in gMGTrontinemab in ADTrontinemab in ADPrasinezumab in PDPrasinezumab in PDAntiAnti-latent myostatin Ab in latent myostatin Ab in SMASMAMass spectrometryMass spectrometryCGMCGMNGSNGSGazyva in LNGazyva in LNAntiAnti-TL1a TL1a in in IBD(UC,CD)IBD(UC,CD)and and other auto
77、immune diseasesother autoimmune diseasesAstegolimab in COPDAstegolimab in COPDSusvimo in AMD,DME,DRSusvimo in AMD,DME,DRAntiAnti-IL6 in DMEIL6 in DMEASO factor B in GAASO factor B in GAKey pipeline projects with upcoming near-term news flow Crovalimab in PNHCrovalimab in PNHNHL=non hodgkins lymphoma
78、;DMD=Duchenne muscular dystrophy;MS=multiple sclerosis;gMG=generalized myasthenia gravis;AD=Alzheimers disease;PD=Parkinsonss disease;LN=lupus nephritis;UC=ulcerative colitis;CD=Crohns disease;COPD=chronic obstructive pulmonary disease;AMD=age-related macular degeneration;DME=diabetic macular edema;
79、DR=diabetic retinopathy;GA=geographic atrophy;PNH=paroxysmal noctural hemoglobinuria;CGM=continuous glucose monitoring;NGS=next generation sequencing281In collaboration with Lineage Cell Therapeutics(LCTX);2 In collaboration with Ionis;nAMD=neovascular age-related macular degeneration;DME=diabetic m
80、acular edema;UME=Uveitic macular edema;DR=diabetic retinopathy;BRVO=branch retinal vein occlusion;CRVO=central retinal vein occlusion;GA=geographic atrophy;DutaFabs=dual targeting fragment antigen-binding;VEGF=vascular endothelial growth factor;Ang-2=angiopoietin-2;IL-6=inter-leukin-6;TED=Thyroid ey
81、e disease;PDS=Port delivery system;ASO=Antisense oligonucleotideOphthalmology:Pipeline gaining momentum with new data in 2024Susvimo to be relaunched in AMD and filed in DME and DR in 2024 in the USPhase IPhase IRG7921RG7921NMENMERVORG6120RG6120Zifibancimig Zifibancimig(VEGF-Ang2 DutaFab)nAMDRG6351R
82、G6351NMENMERetinal diseasePhase IIPhase IIRG6179RG6179antianti-IL IL-6 6DMERG6299RG6299ASO factor BASO factor B2 2GAPhase IIIPhase IIIRG7716RG7716VabysmoVabysmoBRVORG7716RG7716VabysmoVabysmoCRVORG6321RG6321SusvimoSusvimoDMERG6321RG6321SusvimoSusvimoDRLaunchedLaunchedRG7716RG7716VabysmoVabysmonAMDRG6
83、321RG6321SusvimoSusvimonAMDRG7716RG7716VabysmoVabysmoDMERG6501RG6501OpRegenOpRegen1 1GARG6179RG6179antianti-IL IL-6 6UMERG6209RG6209NMENMERetinal diseaseRG6168RG6168s satralizumabatralizumabTEDGAGADME/UMEDME/UMERVORVODRDRnAMDnAMDRetinal diseaseRetinal diseaseFDA approvalFDA approvalFiled in US&EUFil
84、ed in US&EUTEDTEDAntibodyAntibodyDutaFabDutaFabAntisense oligonucleotideAntisense oligonucleotideStem cell therapyStem cell therapyPDSPDSOphthalmologyPh2 results for anti-IL6 in DME and for ASO factor B in GA expected in 202429Roche portfolio:Diverse growth opportunities aheadMalignant Hematology:Ma
85、lignant Hematology:oLunsumio,Columvi,Polivy in NHLLunsumio,Columvi,Polivy in NHLSolid tumors:Solid tumors:oInovalisibInovalisiband giredestrant in and giredestrant in breast cancerbreast canceroTiragolumab in solid tumorsTiragolumab in solid tumorsoD Divarasib in solid tumorsivarasib in solid tumors
86、Elevidys in DMDElevidys in DMDFenebrutinib in MSFenebrutinib in MSEnspryng in gMGEnspryng in gMGTrontinemab in ADTrontinemab in ADPrasinezumab in PDPrasinezumab in PDAntiAnti-latent myostatin Ab in SMAlatent myostatin Ab in SMAMass spectrometryMass spectrometryCGMCGMNGSNGSGazyva in LNGazyva in LNAnt
87、iAnti-TL1a TL1a in in IBD(UC,CD)IBD(UC,CD)and and other autoimmune diseasesother autoimmune diseasesAstegolimab in COPDAstegolimab in COPDSusvimo in AMD,DME,DRSusvimo in AMD,DME,DRAntiAnti-IL6 in DMEIL6 in DMEASO factor B in GAASO factor B in GAKey pipeline projects with upcoming near-term news flow
88、 Crovalimab in PNHCrovalimab in PNHNHL=non hodgkins lymphoma;DMD=Duchenne muscular dystrophy;MS=multiple sclerosis;gMG=generalized myasthenia gravis;AD=Alzheimers disease;PD=Parkinsonss disease;LN=lupus nephritis;UC=ulcerative colitis;CD=Crohns disease;COPD=chronic obstructive pulmonary disease;AMD=
89、age-related macular degeneration;DME=diabetic macular edema;DR=diabetic retinopathy;GA=geographic atrophy;PNH=paroxysmal noctural hemoglobinuria;CGM=continuous glucose monitoring;NGS=next generation sequencing301.Furie R,et al.Ann Rheum Dis 2022;81:100-107;2.Furie R et al.Lupus Science&Medicine 2020
90、;7(Suppl 1):A27;3.Furie R.etal;ACR 2019;mAb=monoclonal antibody;LN=lupus nephritis;MMF=mycophenolate mofetil;MN=membranous nephropathy;SLE=systemic lupus erythematosus;INS=Idiopathic nephrotic syndrome(Childhood onset INS also known as PNS=Pediatric nephrotic syndrome);CDC=complement-dependent cytot
91、oxicity;ADCC=antibody-dependent cell-mediated cytotoxicity;ADCP=antibody-dependent cellular phagocytosis;CRR=complete renal response;IV=intravenousImmunology:Gaza Ph III results in lupus nephritis in 2024Potential benefit in autoimmune diseases through sustained B cell depletionPh II(NOBILITY)result
92、s in LN1Greater potency than Rituxanin depleting peripheral and tissue B-cellsStudies suggest that tissue based B-cells play a major role in lupus nephritisPh II(NOBILITY)in LN met both primary and key secondary endpoints with no new safety signals;Placebo-corrected CRR of 22%at week 762,3Ph III(REG
93、ENCY)in LN fully recruited with results expected in 2024MN,SLE and INS:Complementary indications of the Gazyva program,with best-in-disease potential in MN,SLE and childhood onset INSGazyva(glycoengineered anti-CD20 mAb)Clinical trial programType II anti-CD20 regionIncreased direct cell deathDecreas
94、ed CDCReduced internalizationGlycoengineered Fc regionHigher FcR affinityIncreased ADCC/ADCPComplete renal response35%23%40%18%p0.2p0.0541%23%p40 key parameters at launch CE launch planned for end of 2024(FDA approval expected in 2025)Continuous glucose monitoring(CGM)Subcutaneously inserted sensor
95、to measure glucose values in interstitial fluid Personalized management of diabetes Digital tools to support disease management for users and healthcare professionalsCore&Molecular Lab Menu expansion driving growth,averaging 25 assay launches/approvals per year1 240 assays running on 100k installed
96、cobas serum work area instruments 2.5k installed cobas 6800/8800/5800 instrumentsNext generation sequencing(NGS)Unique sequencing by expansion technology,significantly improving nanoporeperformance Nanoporesystem delivers flexible run size at competitive cost33MS=multiple sclerosis;AD=Alzheimers dis
97、ease;RWD=real-world data;AI/ML=artificial intelligence and machine learning;DLBCL=diffuse large B-cell lymphoma;PNH=Paroxysmal nocturnal hemoglobinuriaIR Diagnostics Day in London on May 22ndRoche Pharma DayLondonMon,11 Sep10:30-14:30 BSTDigitalization DayVirtualWed,29 Nov13:30-15:30 CETRoche ESG Da
98、yVirtualTue,23 May15:30-17:00 CESTASH 2023Virtual Tue,12 Dec18:00-19:00 CETAngiogenesis 2023Virtual Mon,13 Feb16:30-18:00 CETEHA 2023VirtualMon,12 Jun16:30-17:30 CESTNeuroscience UpdateVirtualMon,30 Oct17:00-18:15 CETDiagnostics DayVirtual/hybridWed,22 May 2024 TBADigitalization Day Nov 29Virtual ev
99、ent Presenting Roche digital efforts in Pharma and Diagnostics,covering big data/RWD collections and data mining approaches using AI/ML Highlighting use cases across the value chain,including early R&D,clinical development,regulatory,manufacturing,supply chain and commercializationDiagnostics Day Ma
100、y 22,2024London&virtual Deep-dive into the current product portfolio Updates on key development projects,including mass spectrometry,continuous glucose monitoring(CGM)and other products in developmentNeuroscience Update Oct 30Virtual event Covering ECTRIMS&CTAD data:OcrevusPhIII(OCARINA II)in MS fen
101、ebrutinibPhII(FENopta)in MS trontinemabPhI dose escalation in AD GSM(Gamma secretase modulator)PhI in ADASH UpdateDec 12Virtual event Key data submitted:Ph Ib Lunsumio combo in DLBCL Ph Ib Columvi combo in 1L DLBCL Ph III(POLARIX)for Polivy in different genetic subtypes Ph III(COMMODORE 1&2)for crov
102、alimab in PNHInnovation strategyUpcoming opportunities:-Pharma-DiagnosticsOutlook35*8 with 2bn+opportunities;LE=line extensionsPipeline outlook:Key late-stage assets with 1bn+sales potential*tiragolumabNSCLC,HCC,ESCC,SCCHNgiredestrantHR+BCdivarasibKRAS+NSCLC,CRCinavolisibPi3KmBCcrovalimabPNH,aHUS,SC
103、D,LNOncology,HematologyElevidysDMDfenebrutinibRMS,PPMSanti-latent myostatinmAbSMA,FSHDzilebesiranhypertensionNeuroscience,Cardiometabolic9 late-stage NMEs with CHF2 bn each in peak sales potential4 late-stage NMEs with CHF 1bn each in peak sales potentialTecentriqAdj.SCCHN/HCC,tira combo Columvi2L D
104、LBCL,1L DLBCLLunsumio2L DLBCL,R/R FL,1LFLOcrevusSC,high doseEnsprynggMG,MOGAD,AIE,TEDastegolimabCOPDASO Factor BIgAN,GAanti-IL-6 UME,DMEImmunology,OphthalmologyGazyvaLN,SLE,MN1bn+sales potential2bn+sales potential2 marketed products with LEs that could add CHF2 bneach in peak sales potential4 market
105、ed products with LEs that could add CHF1 bneach in peak sales potentialOncology/HematologyNeuroscienceOphthalmologyImmunologyCVManti-TL1AUC,CD36FY 2023 guidance confirmed1 At Constant Exchange Rates(CER)Group sales growth1Core EPS growth1Dividend outlookLow single digit declineBroadly in line with sales declineFurther increase dividend in Swiss francs Doing now what patients need next