Slide 1: Slide 1
Slide 2: Forward-looking statements
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, str
Slide 3: Roche Q1 2023 sales
Roche Q1 2023 sales Basel, 26 April 2023
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Q1 2023 performance, Outlook
Q1 2023 performance Outlook
Slide 6: Q1 2023: Strong underlying sales excluding COVID-19 decline
Q1 2023: Strong underlying sales excluding COVID-19 decline Group sales -3% driven by expected decline in COVID-19 testing • Strong Pharma performance (+9%) driven by ongoing portfolio rejuvenation • Good Diagnostics base business growth (+4%) • COVID-19 sales decline in line with FY 2023 expectatio
Slide 7: Q1 2023: Group sales decline driven by COVID-19 sales erosion
Q1 2023: Group sales decline driven by COVID-19 sales erosion 2023 2022 Change in % Excl. 1 CHFbn CHFbn CHF CER C19 Pharmaceuticals Division 11.7 11.2 5 9 9 Diagnostics Division 3.6 5.3 -31 -28 4 Roche Group 15.3 16.4 -7 -3 8 CER=Constant Exchange Rates; totals may include differences due to roundin
Slide 8: Q1 2023: Portfolio diversification ongoing
Q1 2023: Portfolio diversification ongoing CHFm -3% at CER Diversification of Roche portfolio +146 +48 Q1 2018 Q1 2023 CHF 13.6bn CHF 15.3bn -1’626 +1’262 -333 -620 16’445 15’322 Diagnostics Neuroscience Oncology Other pharma Hemophilia A Immunology Ophthalmology Infectious diseases AHR Q1 2022 Dia
Slide 9: Q1 2023: Strong underlying growth in Pharma and Diagnostics
Q1 2023: Strong underlying growth in Pharma and Diagnostics Pharma Diagnostics Quarterly sales evolution 2022-2023 Quarterly sales evolution 2022-2023 % CER % CER +30% +30% +24% +20% +20% +7% +8% +10% +9% +9% +3% +4% +10% +10% +6% +4% +9% +0% -2% +3% 0% +0% +2% 0% -10% -4% -9% -10% -6% -20% -28% -20
Slide 10: Portfolio rejuvenation progressing; new launches with >50% of sales
Portfolio rejuvenation progressing; new launches with >50% of sales Columvi (glofitamab): first NME launch in 2023* CHFm % of Pharma Sales*** 7,000 50% 6,000 5,000 42% 4,000 31% 3,000 22% 2,000 1,000 0 Q1 2020 Q1 2021 Q1 2022 Q1 2023 Cotellic Alecensa Tecentriq Ocrevus Hemlibra Luxturna Xofluza Poli
Slide 11: 2023 performance, Outlook
2023 performance Outlook
Slide 12: 2023: Upcoming newsflow
2023: Upcoming newsflow Pharma Diagnostics Tiragolumab + Tecentriq in 1L PDL1+ NSCLC Glofitamab + GemOx in 2L+ DLBCL Modular transportation system, integrated CCM Vertical into existing cobas connection modules Tiragolumab + Tecentriq + chemo in 1L Lunsumio + Polivy in 2L+ DLBCL* Esophageal Flexible
Slide 13: Corporate Executive Committee
Corporate Executive Committee Since April 2023 *Co-chair late stage pipeline committee (LSPC); pRED=Pharma Research & Early Development; gRED=Genentech Research & Early Development 13
Slide 14: 2023 sales outlook
2023 sales outlook Sales drivers1 Pharma: Key products with strong growth and momentum from ongoing launches Diagnostics: Base business with solid growth Group sales growth1 Low single digit decline COVID-19 sales for Diagnostics and Pharma expected to decline by roughly CHF 5bn AHR2 sales expected
Slide 15: 2023 outlook
2023 outlook Group sales growth1 Low single digit decline Core EPS growth1 Broadly in line with sales decline Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 15
Slide 16: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 17: Q1 2023: Pharmaceuticals Division sales
Q1 2023: Pharmaceuticals Division sales All regions delivering strong growth 2023 2022 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 11,699 11,159 5 9 United States 5,853 5,489 7 6 Europe 2,071 2,072 0 5 Japan 1,390 1,337 4 18 International 2,385 2,261 5 13 CER=Constant Exchange Rates 17
Slide 18: Q1 2023: Strong momentum for key growth drivers
Q1 2023: Strong momentum for key growth drivers Vabysmo leading growth contributor after only 5 quarters Vabysmo >500% Ocrevus 14% Hemlibra 24% Evrysdi 62% Tecentriq 15% Perjeta 11% Phesgo 72% Tamiflu >500% Polivy 96% TNKase / Activase 23% Ronapreve 9% Gazyva 24% Alecensa 9% Kadcyla 5% Xolair 5% Xof
Slide 19: Q1 2023: Oncology portfolio growing +4%
Q1 2023: Oncology portfolio growing +4% YoY CER growth Phesgo (+72%) HER2 franchise HER2 franchise Herceptin Perjeta (+11%) +6% • Kadcyla (+5%) with growth ex-US in adj. BC; China NRDL listing granted Kadcyla (+5%) • Perjeta (+11%) driven by US & International Tecentriq +15% Polivy (+96%) • Phesgo (
Slide 20: Polivy in 1L DLBCL: FDA approval granted
Polivy in 1L DLBCL: FDA approval granted Comprehensive NHL development program ongoing Uptake in 1L DLBCL accelerating NHL development program progressing 1L DLBCL approved in >70 countries Polivy quarterly sales Indication Regimen Ph I Ph II Ph III YoY CER growth CHF Mn +96% 2L+ DLBCL (SCT ineligib
Slide 21: Phesgo: Conversion rate in early launch countries climbing to 35%
Phesgo: Conversion rate in early launch countries climbing to 35% Phesgo reduces administration time & costs Phesgo with strong global launch Global Phesgo conversion rate** 40% 35% 30% 20% 10% Phesgo 0% Q4’20 Q1’21 Q2’21 Q3’21 Q4’21 Q1’22 Q2’22 Q3’22 Q4’22 Q1’23 • 85% of patients preferred Phesgo f
Slide 22: Divarasib in CRC: Positive early combination data at AACR
Divarasib in CRC: Positive early combination data at AACR Potential for best-in-class profile Divarasib (KRAS G12Ci) Ph Ib results for divarasib + cetuximab in advanced or metastatic CRC in vitro proliferation assay ORR results Best SLD Change from Baseline (%) Divarasib Sotorasib Adagrasib • Irreve
Slide 23: Tecentriq: Solid growth across all regions
Tecentriq: Solid growth across all regions First PD-(L)1 with pivotal SC results filed and PDUFA set for September 15th CHFm YoY CER growth Q1 update 1,100 • Ph III (IMbrave050) results in adjuvant HCC presented at AACR; 1,000 +15% RFS primary endpoint met but OS immature 900 +8% • Ph III (IMpassion
Slide 24: Hemophilia A: Hemlibra the global standard of care
Hemophilia A: Hemlibra the global standard of care 37% US/EU-5 patient share reached CHFm YoY CER growth Q1 update 1,200 • ~20,000 patients treated globally +24% • Hemlibra continues to penetrate across all approved patient 1,000 segments +30% • EU: Label extension to moderate patients (HAVEN 6) gra
Slide 25: Crovalimab: Positive Ph III results in PNH
Crovalimab: Positive Ph III results in PNH Expanding into additional diseases: Ph I in LN initiated Ph III (COMMODORE 3) results in PNH Crovalimab development program Normalization of LDH Indication Ph I Ph II Ph III COMPOSER Paroxysmal COMMODORE 1 (switch) PNH nocturnal hemoglobinuria COMMODORE 2 (
Slide 26: Immunology: Actemra COVID-19 sales declining and Esbriet LOE
Immunology: Actemra COVID-19 sales declining and Esbriet LOE Xolair autoinjector approval and Ph III food allergy readout expected in 2023 Q1 updates CHFm YoY CER growth • Ph III (REGENCY) Gazyva in LN fully recruited; read out expected in 2024 • Ph III (INShore) Gazyva in PNS initiated 2,500 +9% Ac
Slide 27: Multiple Sclerosis: Ocrevus reaching 22% patient share
Multiple Sclerosis: Ocrevus reaching 22% patient share Ph III results for 6M SC Ocrevus expected in 2023 CHFm YoY CER growth Q1 update 1,750 +14% +18% • >300k patients treated globally 1,500 • #1 treatment in US and EU-5, both in total share and new to +16% 1,250 +38% brand share 1,000 • Higher rete
Slide 28: Spinal Muscular Atrophy: Evrysdi market leader in US and Japan
Spinal Muscular Atrophy: Evrysdi market leader in US and Japan Increasing penetration in treatment-naive patient segment CHFm YoY CER growth Q1 update 450 • >8,500 patients treated worldwide; retention rate in first 12 400 +62% months of ~90% globally 350 • US: Growth driven by switch and naive pati
Slide 29: Evrysdi: 4 year data reinforce strong efficacy and safety profile
Evrysdi: 4 year data reinforce strong efficacy and safety profile Ph II/III (SUNFISH) results in SMA Ph II/III (SUNFISH) safety in SMA 3 Motor function score 900 AE rates SUNFISH Part 1 800 SUNFISH Part 2 Mean change from baseline 2 in MFM32 total score*† 700 1 600 AEs per 100PY* 0 500 -1 400 -2 300
Slide 30: Ophthalmology: Excellent Vabysmo launch continues
Ophthalmology: Excellent Vabysmo launch continues Double-digit US market share in nAMD and mid single-digit in DME* Angiogenesis 2023 Q1 update CHFm YoY CER growth Vabysmo 500 >500% • US: Strong uptake with switches primarily from aflibercept; use in 400 naive patients further accelerating • >860k v
Slide 31: Vabysmo: Positive results in RVO presented at Angiogenesis 2023
Vabysmo: Positive results in RVO presented at Angiogenesis 2023 Improvement in macular leakage compared to aflibercept Ph III (BALATON/COMINO) results in RVO BCVA1 CST2 Macular leakage3 A flib e r c e p t 2 .0 m g (n = 2 7 7 ) F a r ic im a b 6 .0 m g (n = 2 7 6 ) 100% A flib e r c e p t 2 .0 m g (n
Slide 32: 2023: Key late-stage news flow
2023: Key late-stage news flow* Compound Indication Milestone Hemlibra Moderate hemophilia A EU approval Polivy + R-CHP 1L DLBCL US approval Vabysmo RVO US approval/EU filing Regulatory Tecentriq Subcutaneous administration US approval/EU filing EU filing Columvi (glofitamab) 3L+ DLBCL US/EU approva
Slide 33: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 34: Q1 2023: Diagnostics Division sales
Q1 2023: Diagnostics Division sales Good base business growth, partially offsetting COVID-19 sales decrease 2023 2022 Change in % CHFm CHFm CHF CER Diagnostics Division 3,623 5,286 -31 -28 Core Lab 1,928 1,896 2 7 Molecular Lab 593 1,189 -50 -48 Point of Care 397 1,466 -73 -72 Diabetes Care 376 417
Slide 35: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Good base business growth in Q1 2023 55% 48% 31% 24% 17% 18% 9% 10% 8% 7% 3% 4% 11% 8% 0% -4% Diagnostics Division sales growth -9% Base business sales growth1 -28% Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 1.2bn 1.3bn 1.0bn 1.2bn 1.9bn 1.2bn
Slide 36: Q1 2023: Diagnostics Division highlights
Q1 2023: Diagnostics Division highlights Good base business growth, partially offsetting COVID-19 sales decrease CHFbn YoY CER growth • Immunodiagnostics (+9%) Core Lab +7% • Clinical Chemistry (+9%) • Custom biotech (-9%) • Virology base business (+12%) • Blood Screening (+15%) Molecular Lab -48% •
Slide 37: Q1 2023: Diagnostics Division regional sales
Q1 2023: Diagnostics Division regional sales Strong base business growth across all regions impacted by lower COVID-19 sales North America -39% EMEA ~28% of divisional sales -30% ~35% of divisional sales Asia Pacific Latin America -15% -8% ~30% of divisional sales ~7% of divisional sales Growth rate
Slide 38: Largest installed base worldwide with significant growth potential
Largest installed base worldwide with significant growth potential +4% cobas® 4000/6000/80001 +122% cobas® pro / pure +3% Lab SW Solutions +9% Preanalytics / Connectivity HE600 +12% +30% cobas® 5800/6800/8800 BenchMark ULTRA/ ULTRAPLUS +10% +7% LightCycler / MagnaPure DP200/DP600 +29% +24% cobas® Li
Slide 39: Core Lab menu expansion driving future growth
Core Lab menu expansion driving future growth >240 assays running on >100k installed cobas® serum work area instruments Launches in 2021, 2022 and upcoming4 Immuno chemistry assays Clinical chemistry assays EBV EBNA IgG (CE) IGRA SARS-CoV-2 (CE) Anti-HEV IgG and Anti-HEV Fentanyl3 (CE, US) Benz 22 (
Slide 40: navify Marketplace and Algorithm Suite
navify Marketplace and Algorithm Suite Roll-out of two new digital solutions which will drive operational and clinical excellence Customer base Customer access to Portal/Marketplace2 Access to applications3 navify Algorithm Suite navify Inventory Roche instruments 3rd party devices cobas infinity Ce
Slide 41: VENTANA FOLR1 (FOLR1-2.1) RxDx assay
VENTANA FOLR1 (FOLR1-2.1) RxDx assay First FDA approved FOLR1 companion diagnostic test for ovarian cancer chemo or First Line chemo + bevacizumab • 322k estimated cases of ovarian cancer worldwide Treatment (2021)1 Progression for 80% of patients • First FDA-approved IHC companion diagnostic test f
Slide 42: Diagnostics key launches 2023
Diagnostics key launches 2023 Area Product Description Markets Status Modular transportation system, integrated into the existing cobas connection modules, allowing for overhead CCM Vertical Global sample transportation over different work areas or different floors enabling effective use of lab spac
Slide 43: Finance
Finance Alan Hippe Chief Financial Officer
Slide 44: Q1 2023: Highlights
Q1 2023: Highlights Sales • Group sales decline of -3% resulting from erosion of COVID-19 related sales • Solid Pharma and Diagnostics underlying business growth Currency impact on sales • Negative currency impact of -4%p primarily by the JPY, EUR and CNY Growth rates at CER (Constant exchange Rates
Slide 45: Q1 2023: Regional Pharma and Group sales bridge
Q1 2023: Regional Pharma and Group sales bridge +6% +5% +13% +18% -28% -3% -7% Pharma Division -28% +9% +224 +101 +286 +366 -1,480 -503 -1,123 -620 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CHF Absolute values in CHFm at Constant Exchange Rates (avg full year 2022); 1
Slide 46: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the JPY, EUR and CNY -3.1% -0.7p -6.8% CER -0.9p +0.1p CHF sales growth sales growth Q1 2023 -0.4p Q1 2023 vs. -1.2p vs. Q1 2022 Q1 2022 -0.2p -0.4p CER EUR APAC USD LATAM JPY Other Other CHF Europe CER = Constant Exchange Rates (avg ful
Slide 47: Expected 2023 currency impact
Expected 2023 currency impact CHF / USD Assumed avg. YTD 2023 0% -3% -4% -4% 0.94 0.95 0.95 Assuming the 31 March 2023 exchange rates remain 0.92 stable until end of 2023, 2023 impact1 is expected to be (%p): 0.93 0.92 0.92 0.92 Q1 HY Sep FY 0.92 0.92 0.93 0.91 0.91 0.91 0.91 0.91 0.91 0.91 0.91 0.9
Slide 48: 2023 outlook
2023 outlook Group sales growth1 Low single digit decline Core EPS growth1 Broadly in line with sales decline Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 48
Slide 49: Upcoming virtual ESG IR event on environmental sustainability
Upcoming virtual ESG IR event on environmental sustainability Roche ESG Event on May 23 Environmental Sustainability 15:30 - 17:00 CEST / 14:30 – 16:00 BST 09:30 – 11:00 am EDT / 6:30 – 8:00 am PDT 49
Slide 50: Doing now what patients need next
Doing now what patients need next
Slide 51: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 52: Changes to the development pipeline
Changes to the development pipeline Q1 2023 update New to phase I New to phase II New to phase III New to registration 1AI: 2 NMEs: 1 NME: RG6107 crovalimab - lupus nephritis RG6501 OpRegen – geographic atrophy RG6149 astegolimab (Anti-ST2) – COPD RG6341 NME – chronic cough 1 AI: 1 AI: RG7159 Gazyva
Slide 53: Roche Group development pipeline
Roche Group development pipeline Phase I (50 NMEs + 12 AIs) Phase II (23 NMEs + 9 AIs) RG6007 HLA-A2-WT1 x CD3 AML RG7802 cibisatamab ± T solid tumors RG6026 Columvi (glofitamab) + chemo 1L ctDNA high risk DLBCL Columvi (glofitamab) RG7827 FAP-4-1BBL monotherapy + combos solid tumors tiragolumab + T
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase III (9 NMEs + 40 AIs) Registration US & EU (1 NME + 3 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG3648 Xolair food allergy RG6026 Columvi (glofitamab) 3L+ DLBCL RG6026 Columvi (glofitamab) + chemo 2L+ DLBCL RG6149 astegolimab (Anti-ST2) COPD RG7446 Tecentriq
Slide 55: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III Columvi (glofitamab) + divarasib balovaptan RG6026 chemo RG6330 (KRAS G12 C) RG7314 post-traumatic stress 1L ctDNA+ high risk DLBCL 2L NSCLC disorder tiragolumab + T astegolimab alogabat RG6058 1L PD-L1+ cervical RG6149 (a
Slide 56: AI submissions for existing products
AI submissions for existing products Projects in phase II and III New Molecular Entity (NME) Metabolism Additional Indication (AI) Neuroscience Oncology / Hematology Ophthalmology Immunology Other Infectious Diseases Tecentriq + Avastin Kadcyla + Tecentriq RG7446 RG3502 HCC adj HER-2+ eBC high-risk
Slide 57: Major pending approvals 2023
Major pending approvals 2023 US EU China Japan-Chugai Tecentriq SC Evrysdi Evrysdi Phesgo RG7446 all approved indications RG7916 SMA presymptomatic pediatric <2mo RG7916 SMA presymptomatic pediatric <2mo RG6264 HER-2+ BC/CC Filed Nov 2022 Filed Nov 2021 Filed June 2022 Filed Sept 2022 Columvi (glofi
Slide 58: Major granted approvals 2023
Major granted approvals 2023 US EU China Japan-Chugai Polivy Xofluza Polivy RG7596 1L DLBCL (US) RG6152 influenza pediatric RG7596 1L DLBCL April 2023 Jan 2023 Jan 2023 Hemlibra Polivy RG6013 moderate hemophilia A RG7596 r/r DLBCL Jan 2023 Jan 2023 Xofluza RG6152 influenza pediatric 5 to <12 years M
Slide 59: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 60: Hemophilia
Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Hemophilia A patients Hemophilia A patients with and without inhibitors to Factor VIII, dosing Indication without inhibitors to factor VIII every 4 weeks Phase III Phase III Phase/study HAVEN 3 HAVEN 4 # of patients N=13
Slide 61: Hemophilia
Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Hemophilia A mild to moderate patients without inhibitors to Indication Hemophilia A patients with and without inhibitors to Factor VIII Factor VIII Phase III Phase III Phase/study HAVEN 5 HAVEN 6 # of patients N=85 N=70
Slide 62: Oncology
Alecensa (alectinib, RG7853) New CNS-active inhibitor of anaplastic lymphoma kinase Treatment-naïve Indication Adjuvant ALK+ NSCLC ALK+ advanced NSCLC Phase III Phase III Phase/study ALEX ALINA # of patients N=286 N=255 ARM A: Alecensa 600mg BID ARM A: Alecensa 600mg BID Design ARM B: Crizotin
Slide 63: Oncology
Kadcyla (trastuzumab emtansine, RG3502) First ADC for HER2-positive breast cancer HER2-positive early breast cancer (BC) HER2-positive early breast cancer (BC) Indication high-risk patients high-risk patients Phase III Phase III Phase/study KATHERINE ASTEFANIA # of patients N=1,484 N=1,700 ARM A:
Slide 64: Oncology
Phesgo (pertuzumab/trastuzumab, RG6264) FDC of Perjeta and Herceptin for subcutaneous administration Indication HER2-positive early breast cancer (BC) HER2-positive breast cancer (BC) Phase III Phase II Phase/study Pivotal Phase I1 FeDeriCa PHranceSCa # of patients N=500 N=160 N=144 Phesgo in combin
Slide 65: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication Adjuvant NSCLC Periadjuvant NSCLC Phase III Phase III Phase/study IMpower010 IMpower030 # of patients N=1,280 N=450 Following adjuvant cisplatin-based chemotherapy ARM A: Tecentriq plus platinum-based chemoth
Slide 66: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L maintenance extensive-stage SCLC Stage IV NSCLC Phase III Phase Ib/III Phase/study IMforte1 IMscin0012 # of patients N=450 N=371 ARM A: Platinum-etoposide + Tecentriq followed by maintenance Phase Ib Tecen
Slide 67: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – SCCHN Indication Adjuvant squamous cell carcinoma of the head and neck (SCCHN) Phase III Phase/study IMvoke010 # of patients N=406 ARM A: Tecentriq 1200mg q3w ARM B: Placebo Oncology Design Event-free survival and overall survi
Slide 68: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – urothelial carcinoma High-risk non-muscle-invasive ctDNA+, high-risk muscle-invasive Indication bladder cancer (NMIBC) bladder cancer (MIBC) Phase III Phase III Phase/study ALBAN IMvigor011 # of patients N=516 N=495 ARM A: BCG indu
Slide 69: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – renal cell cancer Indication Advanced renal cell carcinoma (RCC) after immune checkpoint inhibitor treatment Phase III Phase/study Contact-03 # of patients N=500 ARM A: Tecentriq plus cabozantinib ARM B: Cabozantinib Design Oncol
Slide 70: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – hepatocellular carcinoma Indication Adjuvant hepatocellular carcinoma (HCC) Phase III Phase/study IMbrave050 # of patients N=668 ARM A: Tecentriq plus Avastin ARM B: Active surveillance Oncology Design Primary endpoint Recurren
Slide 71: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – breast cancer Previously untreated metastatic Indication triple negative breast cancer (TNBC) Phase III Phase III Phase/study IMpassion130 IMpassion132 # of patients N=902 N=572 ARM A: Tecentriq plus nab-paclitaxel ARM A: Tecentr
Slide 72: Oncology
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – breast cancer Indication Neoadjuvant triple negative breast cancer (TNBC) Adjuvant triple negative breast cancer (TNBC) Phase III Phase III Phase/study IMpassion031 IMpassion030 # of patients N=333 N=2,300 ARM A: Tecentriq plus nab
Slide 73: Oncology
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – chronic lymphocytic leukemia Untreated chronic lymphocytic leukemia Relapsed or refractory chronic lymphocytic Untreated fit chronic lymphocytic leukemia Indication (CLL) patients with leukemia (CLL) (CLL) patients coexi
Slide 74: Oncology
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – multiple myeloma Indication Relapsed or refractory multiple myeloma (MM) Phase III Phase/study Phase I CANOVA # of patients N=117 N=244 Dose escalation cohort: Venclexta dose escalation ARM A: Venclexta plus dexameth
Slide 75: Oncology
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – myelodysplastic syndromes Relapsed or refractory myelodysplastic Treatment-naive myelodysplastic syndromes Newly diagnosed higher-risk Indication syndromes (MDS) (MDS) myelodysplatic syndrome (MDS) Phase III Phase/study
Slide 76: Oncology
Polivy (polatuzumab vedotin, RG7596) ADC targeting CD79b to treat B cell malignancies Indication 1L DLBCL Phase III Phase/study POLARIX # of patients N=879 ARM A: Polivy plus R-CHP ARM B: R-CHOP Design Oncology Primary endpoint Progression-free survival Data presented at ASH 2021 and 2022
Slide 77: Oncology
Gavreto (pralsetinib, RG6396) Highly selective RET inhibitor RET+ NSCLC, thyroid cancer and Indication 1L RET fusion-positive, metastatic NSCLC other advanced solid tumors Phase I/II Phase III Phase/study ARROW AcceleRET Lung # of patients N=647 N=250 Part I: Gavreto 30-600mg dose escalation ARM
Slide 78: Oncology
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously 3L+ FL, 3L+ DLBCL & other relapsed or refractory Indication 1L DLBCL Relapsed or refractory DLBCL NHL Phase/study Phase I/II Phase Ib/II Phase Ib/II # of patients N=746 N=160 N=262
Slide 79: Oncology
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L DLBCL & 2L DLBCL following 1L induction Relapsed or refractory 2L+ FL Phase/study Phase I Phase Ib # of patients N=188 N=27 Cohort A: Lunsumio monotherapy (after a res
Slide 80: Oncology
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ FL Relapsed or refractory CLL Phase III Phase/study Phase Ib/II CELESTIMO # of patients N=400 N=56 ARM A: Lunsumio plus lenalidomide Lunsumio monotherapy (3L+ CLL)
Slide 81: Oncology
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ SCT ineligible DLBCL Phase III Phase/study SUNMO # of patients N=222 ARM A: Lunsumio plus Polivy ARM B: R + GemOx Oncology Design Progression-free survival Primar
Slide 82: Oncology
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory Non-Hodgkin’s lymphoma (NHL) Phase/study Phase I Phase Ib Phase I # of patients N=700 N=140 N=18-36 Cohort 1: Single-agent dose escalation study Dose escal
Slide 83: Oncology
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Non-Hodgkin’s lymphoma (NHL) 2L+ SCT-ineligible DLBCL 1L ctDNA high risk DLBCL Phase III Phase/study Phase Ib Phase II STARGLO Part I: 15-60 # of patients N=270 N=40 Part II: ~66
Slide 84: Oncology
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ SCT-eligible DLBCL 2L+ SCT-ineligible DLBCL Phase/study Phase Ib Phase Ib # of patients N=40 N=112 Columvi plus R-ICE (single-arm study) Columvi IV plus CELMoD (CC-220 an
Slide 85: Neuroscience
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Primary progressive Indication Relapsing multiple sclerosis (RMS) multiple sclerosis (PPMS) Phase III Phase III Phase III Phase/study OPERA I OPERA II ORATORIO # of patients N=821 N=835 N=732 96-week trea
Slide 86: Neuroscience
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Relapsing and primary progressive multiple sclerosis (RMS & PPMS) Primary progressive multiple sclerosis (PPMS) Phase IIIb Phase IIIb Phase/study ENSEMBLE PLUS ORATORIO-HAND # of patients N=1,2
Slide 87: Neuroscience
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Primary progressive multiple sclerosis Indication Relapsing multiple sclerosis (RMS) PPMS & RMS (PPMS) Phase IIIb Phase IIIb Phase III Phase/study GAVOTTE MUSETTE Ocarina II1 # of patients N ~ 699 N ~ 786
Slide 88: Neuroscience
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II/III Phase II/III Phase II Phase/study FIREFISH SUNFISH JEWELFISH # of patients N=21 (Part 1), 41 (Part 2) N=51 (Part 1), 180 (Part 2) N=174 Infants with type 1 SMA Adult & pediatric patients wit
Slide 89: Neuroscience
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II Phase/study RAINBOWFISH # of patients N=25 Infants aged from birth to 6 weeks who have been genetically diagnosed with SMA but are not yet presenting with symptoms Neuroscience Design Propor
Slide 90: Neuroscience
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Neuromyelitis optica spectrum disorder (NMOSD) Phase III Phase III Phase/study SAkuraStar SAkuraSky # of patients N=95 N=83 Enspryng monotherapy: Add-on therapy of Enspryng: ARM A: Enspryng 120mg SC
Slide 91: Neuroscience
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Myelin oligodendrocyte glycoprotein antibody Indication Generalised myasthenia gravis (MG) Autoimmune encephalitis (AIE) disease (MOG-AD) Phase III Phase III Phase III Phase/study Luminesce METEOROID CIELO # of p
Slide 92: Immunology
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Lupus nephritis Membranous nephropathy Phase II Phase III Phase III Phase/study NOBILITY REGENCY MAJESTY # of patients N=126 N=252 N=140 ARM A: Gazyva 1000mg IV plus MFF / ARM A: Gazyva 1000mg IV (6 doses through ARM A: Ga
Slide 93: Immunology
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Systemic lupus erythematosus (SLE) Pediatric nephrotic syndrome (PNS) Phase III Phase III Phase/study ALLEGORY INShore # of patients N=200 N=80 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM A: Gazyva plus oral
Slide 94: Immunology
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Systemic lupus erythematosus (SLE) Phase/study Phase I # of patients N=50 ARM A: Lunsumio SC on either Day 1 or on Days 1 and 8 ARM B: Fractionated (divided) dose of Lu
Slide 95: Immunology
Xolair (omalizumab, RG3648) Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=225 Xolair by SC injection either q2w or q4w for 16 to 20 weeks Immunology Design Primary endpoint Number of participants who successful
Slide 96: Ophthalmology
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication Wet age-related macular degeneration (wAMD) Phase III Phase II+III extension Phase IIIb Phase/study Archway Portal Velodrome # of patients N=418 N=1,000 N=442 ARM A: PDS q24w Patients from LAD
Slide 97: Ophthalmology
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Diabetic retinopathy (DR) without Indication Diabetic macular edema (DME) center-involved diabetic macular edema (DME) Phase III Phase III Phase/study Pagoda Pavilion # of patients N=545 N=160 ARM A: PDS q
Slide 98: Ophthalmology
Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Center-involving diabetic macular edema (CI-DME) Phase III Phase III Phase/study YOSEMITE RHINE # of patients N=940 N=951 ARM A: Faricimab q8w ARM A: Faricimab q8w ARM B: Faricimab PTI up to q16w
Slide 99: Ophthalmology
Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Wet age related macular degeneration (wAMD) Phase III Phase III Phase/study TENAYA LUCERNE # of patients N=671 N=658 ARM A: Faricimab 6.0mg q16w flexible after 4 IDs ARM A: Faricimab 6.0mg q16w fle
Slide 100: Ophthalmology
Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Macular edema (ME) secondary to branch retinal vein occlusion (RVO) Macular edema (ME) secondary to central retinal vein occlusion (RVO) Phase III Phase III Phase/study BALATON COMINO # of patients N=5
Slide 101: Infectious Diseases
Xofluza (baloxavir marboxil, RG6152, S-033188 ) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase III Phase IIIb Phase/study miniSTONE 1 (0-1 year old) miniSTONE 2 (1- <12 years old ) CENTERSTONE # of patients N=30 N=176 N=3,160 Healthy pediatric patient
Slide 102: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 103: Oncology
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication 1L NSCLC PD-L1 TPS>50% Stage III unresectable 1L NSCLC Phase III Phase III Phase/study SKYSCRAPER-01 SKYSCRAPER-03 # of patients N=500-560 N=800 ARM A: Tiragolumab plus Tecent
Slide 104: Oncology
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Metastatic and/or recurrent PD-L1+ Indication Neoadjuvant and adjuvant NSCLC 1L non-squamous NSCLC cervical cancer (CC) Phase II Phase II Phase III Phase/study SKYSCRAPER-04 SKYSCRAPER-05
Slide 105: Oncology
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT 1L recurrent/metastatic PD-L1 positive Indication Locally advanced esophageal cancer (EC) 1L esophageal cancer (EC) squamous cell head and neck carcinoma (SCCHN) Phase III Phase III Phase
Slide 106: Oncology
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Relapsed or refractory multiple myeloma (MM) Indication Solid tumors NSCLC or r/r B-cell NHL Phase II Phase/study Phase I Phase I CITYSCAPE # of patients N=540 N=135 N=52 Phase Ia: Dose
Slide 107: Oncology
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA mutant solid tumors and metastatic Indication PIK3CA-mutant HR+ metastatic breast cancer (mBC) ER+ HER2-neg breast cancer Phase III Phase/study Phase I INAVO120 # of patients N=400 N=256 ARM A: Inavolisi
Slide 108: Oncology
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator ER+ HER2-neg Stage I-III operable breast cancer Indication ER+ HER2-neg metastatic breast cancer (mBC) Neoadjuvant ER+ breast cancer (BC) (BC) Phase II Phase/study Phase I Phase I coopERA Breast Cancer #
Slide 109: Oncology
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication 1L ER+ metastatic breast cancer (mBC) Adjuvant ER+ breast cancer (BC) Phase III Phase III Phase/study persevERA Breast Cancer lidERA Breast Cancer # of patients N=978 N=4,100 ARM A: Giredest
Slide 110: Oncology
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication 1L ER+/HER2-positive breast cancer (BC) Phase III Phase/study heredERA # of patients N=812 Induction Phesgo plus taxane followed by maintenance with either: ARM A: Giredestrant plus Phesgo D
Slide 111: Oncology
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Advanced or metastatic solid tumors with a Indication 2L NSCLC 2L, 1L metastatic colorectal cancer (mCRC) KRAS G12C mutation Phase II/III Phase Ib Phase/study Phase I
Slide 112: Haematology
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a Indication Paroxysmal nocturnal hemoglobinuria (PNH) C5 inhibitor Phase I/II Phase III Phase/study COMPOSER COMMODORE 1 # of patients N=59 N=89 (ARMs A
Slide 113: Haematology
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) Indication C5 inhibitor naive patients C5 inhibitor naive patients (China only) Phase III Phase III Phase/study COMMODORE 2 COMMODORE 3
Slide 114: Haematology
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Atypical hemolytic uremic syndrome (aHUS) Atypical hemolytic uremic syndrome (aHUS) Indication study 1 - adults study 2 - paediatrics Phase III Phase III Phase/study COMMUTE-a COMMUTE-p # of patients N=90 N=35 Single-ar
Slide 115: Haematology
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Sickle cell disease (SCD) Sickle cell disease (SCD) Indication acute treatment chronic VOC prevention Phase Ib Phase IIa Phase/study CROSSWALK-a CROSSWALK-c # of patients N=30 N=90 ARM A: Crovalimab ARM A: Crovalima
Slide 116: Immunology
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Lupus nephritis (LN) Phase/study Phase I # of patients N=15 Single-arm study of patients with active class III, IV, or V lupus nephritis and urine protein-to-creatinine ratio >=1.5 g/g All patients to rec
Slide 117: Immunology
Astegolimab (RG6149, Anti-ST2) A monoclonal antibody that selective binds to ST2 Indication Chronic obstructive pulmonary disease (COPD) Phase II Phase IIb Phase III Phase/study COPD-ST2OP ALIENTO ARNASA # of patients N=81 N=930 N=1,290 Astegolimab SC 490mg q4w for 48 weeks ARM A: SC astegolimab
Slide 118: Neuroscience
Crenezumab (RG7412) Humanized monoclonal antibody targeting all forms of Aß Indication Alzheimer’s prevention initiative (API) Colombia Phase II Phase/study Cognition study # of patients N=252 ARM A: PSEN1 E280A mutation carriers receive crenezumab SC or IV ARM B: PSEN1 E280A mutation carriers r
Slide 119: Neuroscience
Tominersen (RG6042, HTT ASO) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase II Phase/study GENERATION HD2 # of patients N=360 Patients aged 25 to 50 years with prodromal (very early subtle signs of HD) or early manifest HD ARM A: Tominersen 60mg q16w
Slide 120: Neuroscience
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Primary progressive multiple sclerosis Indication Relapsing multiple sclerosis (RMS) (PPMS) Phase III Phase III Phase III Phase/study FENtrepid FENhance 1 FENhance 2 # of patients N=946 N=736 N=736
Slide 121: Neuroscience
Balovaptan (RG7314) Small molecule antagonist of the V1A vasopressin receptor Indication Post-traumatic stress disorder (PTSD) Phase/study Phase II # of patients N=30 ARM A: Balovaptan IV once a day for 12 weeks ARM B: Placebo Design Neuroscience Primary endpoint Change from baseline in the Cl
Slide 122: Neuroscience
TNKase (RG3625, tenecteplase) Small molecule tissue plasminogen activator Indication Stroke patients between 4.5 and 24 hours Phase III Phase/study TIMELESS # of patients N=456 ARM A: Tenecteplase (0.25 mg/kg, maximum 25 mg) single bolus injection ARM B: Placebo Design Neuroscience Primary endpo
Slide 123: Neuroscience
Latent myostatin (RG6237, GYM329) Recycling and antigen-sweeping monoclonal anti-latent myostatin antibody Indication Facioscapulohumeral Muscular Dystrophy (FSHD) Spinal muscular atrophy (SMA) Phase II Phase II/III Phase/study MANOEUVRE MANATEE1 # of patients N=48 N=180 ARM A: 4-week pre-treatmen
Slide 124: Ophthalmology
Anti-IL-6 (RG6179) A monoclonal antibody that potently binds interleukin-6 (IL-6) cytokine Diabetic macular edema (DME) and Uveitic Indication Diabetic macular edema (DME) macular edema (UME) Phase I Phase II Phase II Phase/study DOVETAIL BARDENAS ALLUVIUM # of patients N=90 N=210-230 N=360-400 Pa
Slide 125: Ophthalmology
Anti-IL-6 (RG6179) A monoclonal antibody that potently binds interleukin-6 (IL-6) cytokine Indication Uveitic macular edema (UME) Phase III Phase III Phase/study MEERKAT SANDCAT # of patients N=225 N=225 ARM A: Anti-IL-6 low-dose q4w to week 12, followed by PRN ARM A: Anti-IL-6 low-dose q4w to w
Slide 126: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 127: pRED oncology development programs -1
pRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q2 2018 Solid tumors I ~150 Data presented at ESMO 2020 FAP-4-1BBL (RG7827) Recruitment completed Q2 2021 FPI Q3 2021 3L+ MSS mCRC Ib 80 NCT04826003 Combination study with cibisatamab FPI
Slide 128: pRED oncology development programs -2
pRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Part I: FPI Q3 2019 englumafusp alfa R/R B cell non-Hodgkin’s lymphoma I 362 Part II: FPI Q3 2020 NCT04077723 (CD19-4-1BBL, RG6076) Data presented at ASH 2022 Part I: FPI Q2 2020; recruitment
Slide 129: pRED neuroscience development programs -1
pRED neuroscience development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neuroscience trontinemab Alzheimer's disease IIa ~120 FPI Q1 2021 NCT04639050 (BS-gantenerumab, RG6102) ISRCTN16295 Brain Shuttle-CD20 (BS-CD20, Multiple sclerosis I 30-63 FPI Q3 2021 177 RG6035) N
Slide 130: pRED neuroscience development programs -2
pRED neuroscience development programs -2 Molecule Indication Phase # of patients Status CT Identifier Neuroscience NME (RG6289) Alzheimer's disease I 138 FPI Q4 2021 NME (RG6163) Psychiatric disorders I 84 FPI Q1 2022 selnoflast* Parkinson’s disease Ib 48 FPI Q3 2022 (NLRP3i, RG6418) basmisanil Dup
Slide 131: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology selnoflast* Chronic obstructive pulmonary FPI Q2 2022 Ib 102 (NLRP3i, RG6418) disease Study closed Q3 2022 Ophthalmology zifibancimig nAMD I 200 FPI Q4 2020 NCT04567303 (VEG
Slide 132: pRED infectious diseases development programs
pRED infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Infectious Diseases ruzotolimod FPI Q4 2016 Chronic hepatitis B I 150 NCT02956850 (TLR7 agonist (3) RG7854) Data presented at APASL 2019 ruzotolimod/ xalnesiran/ PDL1 LNA NCT04225715 Chronic he
Slide 133: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 134: gRED oncology development programs -1
gRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q3 2017 cevostamab R/R multiple myeloma I 300 NCT03275103 Data presented at ASH 2020, 2021 & 2022 (anti-FcRH5 x CD3; RG6160) R/R multiple myeloma I 120 FPI Q2 2021 NCT04910568 BCMA-experie
Slide 135: gRED oncology development programs -2
gRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Solid tumors Ia ~50 FPI Q1 2020 NCT04252339 SHP2i (RG6344)1 Solid tumors Ib ~125 FPI Q3 2022 NCT05487235 FPI Q4 2021 KRAS-G12C mutant solid tumors Ib ~500 Arm F of a combination study investig
Slide 136: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology FPI Q1 2020 Inflammatory bowel disease I 68 EUDRACT201 Recruitment completed Q3 2021 9-002613-19 NME (RG6287, GDC-8264) FPI Q4 2021 Inflammatory diseases I 16 Recruitment co
Slide 137: gRED neuroscience and infectious diseases development programs
gRED neuroscience and infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience FPI Q1 2019 Mild-to-moderate Alzheimer’s One of two co-primary endpoints met Q3 2021 NCT03828747 semorinemab (RG6100)1 II 272 disease Data presented at CTAD 2021 (
Slide 138: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 139: Hemophilia A
Hemophilia A Unique gene therapy platform Dirloctogene Samoparvovec (SPK-8011) SPK-8016 Molecule (RG6357) (RG6358) Indication Hemophilia A Hemophilia A with inhibitors to Factor VIII Phase/study Phase I Phase I/II Phase I/II # of patients N=100 N=30 N=30 Long term follow up study of patients who
Slide 140: Pompe disease
Pompe disease Unique gene therapy platform SPK-3006 Molecule (RG6359) Indication Pompe disease Phase I/II Phase/study RESOLUTE # of patients N=20 Gene transfer study for late-onset Pompe disease Metabolic Diseases Design Safety Primary endpoint FPI Q4 2020 Status Recruitment completed Q2 202
Slide 141: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 142: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm Q1 2022 Q1 2023 % change CER Pharmaceuticals Division 11,159 11,699 +9 United States 5,489 5,853 +6 Europe 2,072 2,071 +5 Japan 1,337 1,390 +18 International 2,261 2,385 +13 Diagnostics Division 5,286 3,623 -28 United States 1,465 936 -36 Europe
Slide 143: Pharma Division sales Q1 2023
Pharma Division sales Q1 2023 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,636 14 1,188 13 298 11 - - 150 32 Perjeta 1,049 11 392 8 220 1 53 2 384 22 Hemlibra 1,034 24 631 21 206 27 92 24 105 38 Tecentriq 920 15 507 14 195 11 1
Slide 144: Pharma Division sales Q1 2023
Pharma Division sales Q1 2023 Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 12 -2 5 21 3 -17 - - 4 -9 Alecensa 372 9 106 7 73 3 50 5 143 14 Tecentriq 920 15 507 14 195 11 105 12 113 34 Ocrevus 1,636 14 1,188 13 298 1
Slide 145: Pharma Division sales Q1 2023
Pharma Division sales Q1 2023 Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,636 14 1,188 13 298 11 - - 150 32 Perjeta 1,049 11 392 8 220 1 53 2 384 22 Hemlibra 1,034 24 631 21 206 27 92 24 105 38 Tecentriq
Slide 146: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Global top 20 products Q1/22 Q2/22 Q3/22 Q4/22 Q1/23 Ocrevus 18 17 16 18 14 Perjeta 1 9 5 4 11 Hemlibra 30 31 23 24 24 Tecentriq 8 13 9 24 15 Actemra / RoActemra 3 -23 -42 -22 -12 Ronapreve 272 -91 -92 118 9 Kadcyla 9 18 6 -3 5 Xolair 9 13 8 6 5 Herceptin -19 -
Slide 147: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Ocrevus 10 17 15 13 34 11 26 11 - - - - 62 26 29 32 Perjeta 4 0 13 8 -12 -15 -15 1 -1 -1 3 2 37 30 13 22 Hemlibra 24 16 21 21 29 36 27 27 24 22 14 24 115 53
Slide 148: CER sales growth (%)
CER sales growth (%) Quarterly development 2022 vs. 2021 2023 vs. 2022 Q1 Q2 Q3 Q4 Q1 Pharmaceuticals Division 6 0 -6 9 9 United States 2 1 -6 1 6 Europe -1 -6 4 -3 5 Japan 69 3 -27 69 18 International 0 4 -3 4 13 Diagnostics Division 24 0 -4 -9 -28 Roche Group 11 0 -6 4 -3 CER=Constant Exchange Rat
Slide 149: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 1.8 +14% US +13% 1.5 1.2 0.9 Europe +11% 0.6 International +32% 0.3 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 1,636m • US: Moving into earlier lines displacing orals; #1 in US for both total share and NTB • EU: Moving into earlie
Slide 150: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 1.2 +11% US +8% 1.0 Europe +1% 0.8 Japan +2% 0.6 0.4 International +22% 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 1,049m • US: Growth driven by eBC; increasing cannibalization from Phesgo • EU: Cannibalization from Phesgo • I
Slide 151: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 1.2 +24% US +21% 1.0 Europe +27% 0.8 Japan +24% 0.6 0.4 International +38% 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 1,034m • US: Continued share gains in non-inhibitor patients • EU: Continued share gains in non-inhibitor s
Slide 152: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 1.0 +15% US +14% 0.8 Europe +11% 0.6 Japan +12% 0.4 International +34% 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 920m • US: Growth driven by SCLC and adj NSCLC, continued growth in 1L HCC • EU: Strong adj NSCLC launch, furt
Slide 153: Actemra / RoActemra
Actemra / RoActemra Global sales CER growth Regional sales CER growth CHFbn 1.0 -12% US -22% 0.8 Europe -8% 0.6 0.4 Japan 0% 0.2 International +10% 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 676m • US: Ongoing patient shift from Actemra IV to SC in RA; continued COVID-19 washout • EU: Stable s
Slide 154: Ronapreve
Ronapreve Global sales CER growth Regional sales CER growth CHFbn +9% 0.8 0.6 Japan +33% 0.4 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 567m • Japan: Final sales from governmental order booked in Q1 • No sales outside of Japan CER=Constant Exchange Rates 154
Slide 155: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +5% 0.6 US -3% 0.5 0.4 Europe -6% 0.3 0.2 Japan -8% 0.1 International +42% 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 509m • US: Share decline in metastatic BC due to competition • EU: Share decline in metastatic BC due to competi
Slide 156: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 0.6 +5% 0.5 0.4 US +5% 0.3 0.2 0.1 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 479m • US: Growth driven by growth in CSU CER=Constant Exchange Rates; CSU=Chronic spontaneous urticaria 156
Slide 157: Herceptin
Herceptin CHFbn Global sales CER growth Regional sales CER growth 1.4 -17% US -37% Europe -17% 1.2 Japan -30% 1.0 0.8 0.6 0.4 International -7% 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 477m • US: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Cannibal
Slide 158: Rituxan / Mabthera
Rituxan / Mabthera CHFbn Global sales CER growth Regional CER growth 1.6 -17% sales US -21% 1.4 1.2 Europe 0% 1.0 Japan -13% 0.8 0.6 International -12% 0.4 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 459m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: Biosimilar
Slide 159: Vabysmo
Vabysmo Regional sales CER growth CHFbn Global sales CER growth 0.5 >500% US >500% 0.4 Europe n/a 0.3 Japan n/a 0.2 International n/a 0.1 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 432m • US: Strong uptake with switches primarily from aflibercept; use in naive patients further accelerating • E
Slide 160: Avastin
Avastin Global sales CER growth Regional sales CER growth CHFbn 1.6 -24% US -25% 1.4 Europe -45% 1.2 1.0 Japan -21% 0.8 0.6 0.4 International -19% 0.2 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 416m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: Ongoing biosimilar e
Slide 161: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn 0.4 +9% US +7% 0.3 Europe +3% 0.2 Japan +5% 0.1 International +14% 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 372m • US: Market leadership in 1L ALK+ NSCLC is maintained • EU: Market leadership in 1L ALK+ NSCLC is maintained • Ja
Slide 162: Evrysdi
Evrysdi Global sales CER growth Regional sales CER growth CHFbn 0.4 +62% US +13% 0.3 Europe +74% 0.2 Japan +47% International +189% 0.1 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 363m • US: Strong uptake across all patient segments; including treatment-naive patients; leading market share with
Slide 163: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 0.5 +23% US +23% 0.4 0.3 0.2 International +17% 0.1 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 302m • Topline data from Ph III (TIMELESS) trial expected in May 2023 CER=Constant Exchange Rates 163
Slide 164: Phesgo
Phesgo Global sales CER growth Regional sales CER growth CHFbn 0.3 +72% US +62% 0.2 Europe +59% 0.1 International +232% 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 241m • US: Strong growth driven by eBC, switching of patients from Perjeta+Herceptin to Phesgo • EU: Strong growth in all regions,
Slide 165: Gazyva
Gazyva Global sales CER growth Regional sales CER growth CHFbn 0.2 +24% US +32% Europe +25% 0.1 Japan -35% International +27% 0.0 Q1 20 Q1 21 Q1 22 Q1 23 Q1 2023 sales of CHF 197m • US: Very strong growth driven by 1L FL and 1L CLL (in combination with Venclexta) • EU: Very strong growth driven by 1
Slide 166: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 167: Q1 2023: Diagnostics Division CER growth
Q1 2023: Diagnostics Division CER growth By Region and Customer Area (vs. 2022) Global EMEA¹ North America Asia-Pacific Latin America CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab2 1,928 7 669 4 337 -3 774 13 148 15 Molecular Lab 593 -48 198 -54 256 -36 120 -55 19 -48 Point of Care
Slide 168: Diagnostics Division quarterly sales and CER growth
Diagnostics Division quarterly sales and CER growth1 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab2 1,896 8 1,979 1 1,958 7 1,942 9 1,928 7 Molecular Lab 1,189 21 791 -20 755 -24 715 -35 593 -48 Point of Care 1,466 84 1,143 15 477 -16 503 -26 397 -72 D
Slide 169: Q1 2023: Diagnostics Division regional sales
Q1 2023: Diagnostics Division regional sales Decline in all regions CER=Constant Exchange Rates; * Europe, Middle East and Africa 169
Slide 170: Core Lab
Core Lab 2023 vs. 2022 CHFbn CER growth +7% 2.5 2.0 -5% 1.5 +9% 1.0 +9% 0.5 0.0 Q1 2021 Q1 2022 Q1 2023 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates 170
Slide 171: Molecular Lab
Molecular Lab 2023 vs. 2022 CHFbn CER growth -48% 1.5 -12% -60% 1.0 +22% -9% -47% 0.5 +15% -65% 0.0 Q1 2021 Q1 2022 Q1 2023 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 171
Slide 172: Point of Care
Point of Care 2023 vs. 2022 CHFbn CER growth -72% 2.0 1.5 1.0 -27% -6% 0.5 +7% -87% 0.0 Q1 2021 Q1 2022 Q1 2023 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis POC MDx CER=Constant Exchange Rates 172
Slide 173: Diabetes Care
Diabetes Care 2023 vs. 2022 CHFbn CER growth -5% 0.5 0.4 -16% 0.3 -4% 0.2 0.1 0.0 Q1 2021 Q1 2022 Q1 2023 Blood Glucose Monitoring Other CER=Constant Exchange Rates 173
Slide 174: Pathology Lab
Pathology Lab 2023 vs. 2022 CHFbn CER growth +7% 0.4 0.3 +11% +8% 0.2 +6% 0.1 0.0 Q1 2021 Q1 2022 Q1 2023 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 174
Slide 175: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 176: CHF/USD
CHF/USD Monthly averages 1.00 0.90 0% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 Year-To-Date averages 1.00 0.90 0% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 176
Slide 177: CHF/USD
CHF/USD 1.00 Mar YTD 2023 -3% 0.98 0.96 0.94 0.92 0.90 0.88 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2022 avg full year 2023 monthly avg 2022 monthly avg 2023 177
Slide 178: CHF/EUR
CHF/EUR Monthly averages 1.10 -3% 1.05 1.00 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 Year-To-Date averages 1.10 -4% 1.05 1.00 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 178
Slide 179: CHF/EUR
CHF/EUR 1.06 Mar YTD 2023 -1% 1.04 1.02 1.00 0.98 0.96 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2022 avg full year 2023 monthly avg 2022 monthly avg 2023 179
Slide 180: Average CHF Exchange Rates
Average CHF Exchange Rates Mar YTD Mar YTD Mar YTD 2023 vs. Mar YTD 2022 2023 2022 USD 0.93 0.92 0% EUR 0.99 1.04 -4% JPY 0.70 0.80 -12% -15% -10% -5% 0% 5% 10% 180
Slide 181: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q1 2023: negative impact of JPY and EUR Development of average exchange rates versus prior year period CHF / USD 0.2% CHF / EUR -4.3% CHF / JPY -12.1% Difference in CHF / CER -3.7% 5.5% 0.0% 0.0% growth Sales growth 2023 -3.1% vs. 2022 -6.8% CER CHF growth growth
Slide 182: Doing now what patients need next
Doing now what patients need next