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Roche Pharma Research & Early Development) Gred (Genentech Research & Early Development) Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Roche Group Q1 2018 results Diagnostics Foreign exchange rate information 48 Changes to the development pipeline Q1 2018 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 2 AIs: 1 AI: RG6148 NME –HER2+ BC RG6268 entrectinib – NSCLC ROS1+ RG7446 Tecentriq + Avastin – 1L HCC RG105 MabThera/Rituxan – pemphigus RG6173 NME – asthma RG7446 Tecentriq – SCCHN adj vulgaris 1 AI: 1 NME from Chugai: RG6268 entrectinib – NTRK1 pan tumor CHU NME - endometriosis 3 AIs: RG7421 Cotellic + Tecentriq – RCC, UC, H&N cancer RG7440 ipatasertib + Tecentriq + taxane - TNBC RG7601 Venclexta + Cotellic ± Tecentriq - MM Removed from phase I Removed from phase II Removed from phase III Removed from registration 1 NME: 1 NME: 1 NME following EU approval: RG7945 NME - glaucoma RG3637 lebrikizumab ± Esbriet – IPF RG6013 Hemlibra – hemophilia A FVIII inh 1 AI following US approval: RG3645 Lucentis 0.3mg PFS – DME/DR 49 Status as of April 26, 2018 Roche Group development pipeline Phase I (45 NMEs + 26 AIs) RG6264 Perjeta + Herceptin FDC SC HER2+ BC T + Cotellic solid tumors RG6069 anti-fibrotic agent fibrosis RG6026 CD20 TCB heme tumors T + ipi/IFN solid tumors RG6107 C5 inh MAb PNH RG6058 tiragolumab (TIGIT) ± T solid tumors T + Tarceva/Alecensa NSCLC RG6151 - asthma RG6109 - AML T + anti-CD20 combos heme tumors RG6173 - asthma RG6114 mPI3K alpha inh HR+ BC T ± lenalidomide ± daratumumab MM RG6174 - inflammatory diseases RG6146 BET inh combos solid + heme tumors RG7446 T + K/HP HER2+ BC RG7835 IgG-IL2 FP autoimmune diseases RG6148 - HER2+ BC T + HMA MDS RG7880 IL-22Fc inflammatory diseases RG6160 - multiple myeloma T + radium 223 mCRPC RG7990 - asthma RG6171 SERD (3) ER+ (HER2neg) mBC T + guadecitabine AML RG6004 HBV LNA HBV RG6180 personalized cancer vaccine ± T oncology T + rucaparib ovarian ca RG6080 nacubactam bact. infections RG6185 pan-RAF inh + Cotellic solid tumors T + Gazyva/tazemetostat r/r DLBCL + FL RG7854 TLR7 agonist (3) HBV emactuzumab + T solid tumors RG7461 FAP IL2v FP combos solid tumors RG7861 anti-S. aureus TAC infectious diseases RG7155 emactuzumab + selicrelumab solid tumors Venclexta + Cotellic/idasanutlin AML RG7907 HBV Capsid (2) HBV RG7159 anti-CD20 combos heme tumors RG7601 Venclexta ± azacitadine r/r MDS RG7992 FGFR1/KLB MAb metabolic diseases RG7386 FAP-DR5 biMAb solid tumors Venclexta + Cotellic ± T MM RG6000 - ALS Cotellic + Zelboraf + T melanoma RG7741 ChK1 inh solid tumors RG6029 Nav1.7 inh (2) pain RG7421 Cotellic + T 2L BRAF WT mM RG7802 CEA TCB ± T solid tumors RG6042 ASO Huntington’s Cotellic + T RCC, UC, H&N ca RG7813 CEA IL2v FP* + T solid tumors RG7816 GABA Aa5 PAM autism RG7440 ipatasertib + taxane + T TNBC RG7828 CD20 TDB ± T heme tumors RG7906 - psychiatric disorders Tecentriq solid tumors selicrelumab (CD40) + T solid tumors RG6147 - geographic atrophy RG7876 Tecentriq NMIBC selicrelumab + vanucizumab solid tumors PTH1 recep. ago hypoparathyroidism RG7446 T-based Morpheus platform solid tumors RG7882 MUC16 ADC ovarian ca CHU - hyperphosphatemia T + Avastin + Cotellic 2/3L CRC Raf/MEK dual inh solid tumors - endometriosis CHU T ± Avastin ± chemo HCC, GC, PaC glypican-3/CD3 biMAb solid tumors New Molecular Entity (NME) CardioMetabolism RG-No Roche/Genentech *INN: cergutuzumab amunaleukin Additional Indication (AI) Neuroscience CHU Chugai managed **out-licensed to Galderma and Maruho AD Oncology Ophthalmology PRO Proximagen managed *** Ph2 pivotal Immunology Other NOV Novimmune managed T=Tecentriq Infectious Diseases RG1569 Branded as RoActemra (EU) TCB=T cell bispecific TDB=T cell dependent bispecific 50 Status as of April 26, 2018 Roche Group development pipeline Phase II (19 NMEs + 10 AIs) Phase III (9 NMEs + 36 AIs) entrectinib NSCLC ROS1+ Kadcyla HER2+ BC adj RG7446/RG7853 Tecentriq or Alecensa 1L NSCLC Dx+ RG6268 RG3502 entrectinib NTRK1 pan tumor Kadcyla + Perjeta HER2+ BC adj Venclexta + Gazyva 1L CLL RG7388 idasanutlin polycythemia vera Hemlibra hemophilia A w/o FVIII inh Venclexta + bortezomib MM RG6013 RG7601 RG7421 Cotellic + T ± taxane TNBC Hemlibra Q4W hemophilia A Venclexta + azacitidine 1L AML RG7440 ipatasertib TNBC neoadj RG7388 idasanutlin + chemo AML Venclexta + LDAC 1L AML RG7596 polatuzumab vedotin r/r DLBCL + FL ipatasertib + abiratorone 1L CRPC RG7604 taselisib + fulvestrant ER+(HER2-neg) mBC Venclexta + Rituxan DLBCL RG7440 ipatasertib + chemo 1L TNBC/HR+ BC RG7601 Venclexta + Rituxan r/r FL RG105 MabThera pemphigus vulgaris Cotellic+Zelboraf+T 1L BRAFm melanoma RG1569 Actemra systemic sclerosis Venclexta + azacitadine 1L MDS RG7421 RG7604 taselisib + letrozole (HER2-neg) BC neoadj Cotellic + T 1L BRAF WT melanoma RG3648 Xolair nasal polyps RG7686 codrituzumab HCC RG7596 polatuzumab vedotin 1L DLBCL etrolizumab ulcerative colitis RG7413 RG6125 Cadherin-11 MAb RA Tecentriq NSCLC adj etrolizumab Crohn’s RG6149 ST2 MAb asthma Tecentriq MIBC adj RG6152 baloxavir marboxil influenza RG7159 obinutuzumab lupus Tecentriq Dx+ 1L sq + non-sq SCLC RG1450 gantenerumab Alzheimer’s RG7625 Cat-S antag autoimmune diseases Tecentriq RCC adj RG6168 satralizumab NMO RG7845 fenebrutinib (BTK inh) RA, lupus, CSU T + nab-paclitaxel 1L non-sq NSCLC RG6206 anti-myostatin adnectin DMD CHU nemolizumab** pruritus in dialysis patients T + chemo+ Avastin 1L ovarian cancer RG7412 crenezumab Alzheimer’s PRO VAP-1 inh inflammatory disease T + chemo + Avastin 1L non-sq NSCLC NOV TLR4 MAb autoimmune diseases T + pemetrexed 1L non-sq NSCLC CHU URAT1 inh gout T + nab-paclitaxel 1L sq NSCLC Registration (5 AIs) RG1662 basmisanil CIAS RG7446 T ± chemo SCCHN adj RG435 Avastin1 ovarian FL RG1678 bitopertin beta thalassemia T + paclitaxel 1L TNBC RG1273 Perjeta + Herceptin2 HER2+ BC adj RG6083 olesoxime SMA T + nab-paclitaxel 1L TNBC RG7601 Venclexta + Rituxan r/r CLL RG6100 Tau MAb Alzheimer’s T + nab-paclitaxel TNBC neoadj RG1569 Actemra auto injector3 RA RG7314 balovaptan autism T + Avastin RCC RG105 MabThera/Rituxan pemphigus vulgaris RG7916 SMN2 splicer(2)*** SMA T + Avastin 1L HCC 1 2 3 RG7935 α-synuclein MAb Parkinson's T + Cotellic 3L CRC US only, Approved in US, Approved in EU RG3645 ranibizumab PDS wAMD See previous page for legend T ± chemo 1L mUC RG7716 VEGF-ANG2 biMAb wAMD, DME T + chemo 1L extensive stage SCLC T + enzalutamide CRPC 51 Status as of April 26, 2018 NME submissions and their additional indications Projects currently in phase II and III New Molecular Entity (NME) CardioMetabolism Additional Indication (AI) Neuroscience Oncology Ophthalmology Immunology Other Infectious Diseases ✓ Indicates submission to health authorities has occurred Unless stated otherwise submissions are planned to occur in US and EU gantenerumab RG1450 Alzheimer‘s basmisanil VEGF/ANG2 biMAb RG1662 RG7716 CIAS wAMD/DME bitopertin Cadherin-11 MAb RG1678 RG6125 beta thalassemia RA anti-myostatin adnectin olesoxime ST2 MAb RG6206 RG6083 RG6149 DMD SMA asthma satralizumab SMN2 splicer(2) idasanutlin Tau MAb etrolizumab RG6168 (SA237) RG7916 RG7388 RG6100 RG7413 SMA polycythemia vera Alzheimer’s neuromyelitis optica ulcerative colitis baloxavir marboxil entrectinib ipatasertib+abiratorone ipatasertib balovaptan etrolizumab RG6152 RG6268 RG7440 RG7440 RG7314 RG7413 Influenza NSCLC ROS1+ 1L CRPC TNBC neoadj autism Crohn’s polatuzumab vedotin entrectinib polatuzumab vedotin polatuzumab vedotin crenezumab Cat S antag RG7596 RG6268 RG7596 RG7596 RG7412 RG7625 r/r DLBCL NTRK1 pantumor r/r FL 1L DLBCL Alzheimer’s autoimmune diseases taselisib+fulvestrant taselisib + letrozole idasanutlin ipatasertib +chemo α-synuclein MAb fenebrutinib RG7604 PIK3CAmut ER+ RG7388 RG7440 RG7604 ER+ (HER2-neg) RG7935 RG7845 Parkinson’s autoimmune diseases (HER2-neg) mBC AML 1L TNBC / HR+ BC BC neoadj 2018 2019 2020 2021 and beyond Status as of April 26, 2018 52 AI submissions for existing products; currently in phase II and III MabThera ✓ RG105 pemphigus vulgaris New Molecular Entity (NME) CardioMetabolism Actemra RG1569 Additional Indication (AI) Neuroscience systemic sclerosis Oncology Ophthalmology Actemra auto injector (US) RG1569 Immunology Other RA/GCA ✓ Infectious Diseases Hemlibra RG6013 hemophilia A FVIII non-inh ✓ Indicates submission to health authorities has occurred Unless stated otherwise submissions are planned to occur in US and EU Hemlibra RG6013 hemophilia A, Q4W Venclexta + Rituxan (EU) ✓ RG7601 r/r CLL Venclexta + aza/LDAC RG7601 1L AML Tecentriq + Cotellic ranibizumab PDS RG7446 RG3645 3L CRC wAMD Cotellic + Tecentriq Tecentriq+chemo+Avastin RG7421 obinutuzumab RG7446 1L BRAF WT melanoma RG7159 1L non-sq NSCLC lupus nephritis Cotellic + Tecentriq + Tecentriq + nab-paclitaxel Xolair RG7446/ Tecentriq or Alecensa RG7446 RG7421 Zelboraf RG3648 1L sq NSCLC 1L BRAFmut melanoma nasal polyps RG7853 1L NSCLC Dx+ Tecentriq + nab-paclitaxel Tecentriq Kadcyla Tecentriq RG7446 RG7446 RG3502 RG7446 1L non-sq NSCLC 1L non-sq + sq NSCLC (Dx+) HER2+ BC adj. NSCLC adj Tecentriq + pemetrexed Tecentriq + nab-paclitaxel Kadcyla + Perjeta Venclexta + Rituxan Tecentriq RG7446 RG7446 RG3502 RG7601 RG7446 1L non-sq NSCLC TNBC neoadj HER2+ BC adj. r/r FL MIBC adj Tecentriq + chemo Tecentriq + paclitaxel Tecentriq ± chemo Venclexta + Rituxan Tecentriq RG7446 RG7446 RG7446 RG7601 RG7446 1L extens. stage SCLC 1L TNBC 1L mUC DLBCL RCC adj Tecentriq + Avastin Venclexta + Gazyva Tecentriq + enzalutamide Venclexta + aza Tecentriq + Avastin RG7446
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