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 2024 sales
Roche Q1 2024 sales Basel, 24 April 2024
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: Q1 2024: Strong base business growth in both divisions
Q1 2024: Strong base business growth in both divisions Good pipeline progress, COVID-19 and currency headwinds diminishing Group sales +2% at CER driven by strong base business of +7% • Strong Pharma (+7% at CER) and Diagnostics (+8% at CER) base business growth • COVID-19 sales decreased by CHF -0.
Slide 7: Q1 2024: Base business growing at +7%
Q1 2024: Base business growing at +7% Both divisions with continued strong momentum 2024 2023 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 10.9 11.6 -6 2 7 Diagnostics Division 3.5 3.7 -6 2 8 Roche Group 14.4 15.3 -6 2 7 1Base business=Pharma excluding Ronapreve and Diagnostic
Slide 8: Q1 2024: Base business overcompensating for COVID-19 and LOE
Q1 2024: Base business overcompensating for COVID-19 and LOE Currency impact of -8%p in Q1, current full year projection of -2%p CHFm +2% at CER -518 +250 +1,080 -385 -194 -1,156 15,322 14,399 2023 Dia Dia Pharma Ronapreve LOE Fx 2024 base COVID-19 (excl. Ronapreve, sales business sales LOE) Base bu
Slide 9: Q1 2024: Strong momentum in the base business for the Group
Q1 2024: Strong momentum in the base business for the Group No material COVID-19 impact going forward Roche Group Annual sales evolution 2018-2024 % CER +10% +9% +9% +8% +7% +5% +3% +3% +2% +1% +1% 0% +2% -3% FY 2019 FY 2020 FY 2021 FY 2022 FY 2023 Q1 2024 Group sales growth Group sales growth (base
Slide 10: Q1 2024: Base businesses in both divisions grow high single digit
Q1 2024: Base businesses in both divisions grow high single digit No material COVID-19 impact going forward Pharma* Diagnostics* Quarterly sales evolution 2022-2024 Quarterly sales evolution 2022-2024 % CER % CER +30% +30% +24% +20% +20% +12% +9% +9% +7% +10% +8% +8% +8% +10% +6% +7% +7% +10% +7% +8
Slide 11: Pipeline update: Strengthening the Pharma pipeline
Pipeline update: Strengthening the Pharma pipeline Portfolio shaping ongoing: Focus on high-impact projects led to termination of 20% of total NMEs since Q3 23 NME changes in Q1 NME and LE (QoQ change, Q1 24 vs Q4 23) ±0 2 ±0 6 9 +1 Phase Indication LepB inhibitor -1 11 8 ±0 I UTI (RG6436) ±0 5 2 ±0
Slide 12: Vacaville sale: Optimizing our Pharma manufacturing network
Vacaville sale: Optimizing our Pharma manufacturing network • Vacaville site sold for USD ~1.2bn* • Global network investment to Hillsboro Mannheim enable portfolio evolution Basel Penzberg South San Philadelphia Kaiseraugst Francisco Vacaville Shanghai Tokyo • Building capabilities in new Oceanside
Slide 13: Optimizing manufacturing network to address portfolio evolution
Optimizing manufacturing network to address portfolio evolution Addressing the demands of producing diverse molecules with smaller volume production needs Biologics portfolio evolution 15 Bubble size corresponds to total annual volume (kL) needed per product 2025 - 2035 Large volume production in 12
Slide 14: Realizing synergies in Diagnostics and the Group
Realizing synergies in Diagnostics and the Group Acting on opportunities across the Group to improve operational performance FMI Near Patient Care* Shift of FMI from Pharma to Diagnostics Division Integration of Point of Care and Diabetes Care Leverage complementary patient/customer Combine our Diag
Slide 15: Performance Outlook
Performance Outlook
Slide 16: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term Two NME approvals expected for 2024: PiaSky (crovalimab) in PNH1 and inavolisib in HR+ breast cancer CHFm % of Pharma Sales3 7,000 50% 55% 6,000 5,000 42% 4,000 32% 3,000 2 2,000 1,000 0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Q1 202
Slide 17: Declining COVID-19 related headwinds in 2024
Declining COVID-19 related headwinds in 2024 Q1 2024 is the final quarter materially impacted by declining COVID-19 sales, minor impact expected in Q4 CHFbn CER CHF ~1.1bn erosion expected 1.0 COVID-19 Tests Ronapreve 0.8 0.8 CHF 0.7bn erosion 0.6 0.4 0.3 0.2 0.1 0.1 0.1 0.0 Q1 23 Q2 23 Q3 23 Q4 23
Slide 18: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 19: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 20: Positive 2024 outlook
Positive 2024 outlook Sales drivers1 Continued strong base business growth in both divisions Group sales growth1 Mid single digit sales growth COVID-19 sales expected to decline by roughly CHF 1.1bn LOE2 impact of roughly CHF 1.6bn expected Base business=Pharma excluding Ronapreve and Diagnostics ex
Slide 21: 2024 guidance confirmed
2024 guidance confirmed Group sales growth1 Mid single digit sales growth Broadly in line with sales growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Further increase dividend in Swiss francs 1At Constant Exchange Rates (CER) 21
Slide 22: Finance
Finance Alan Hippe Chief Financial Officer
Slide 23: Q1 2024: Regional Pharma and Diagnostics sales bridge
Q1 2024: Regional Pharma and Diagnostics sales bridge CER Group sales increase of +2% +5% +11% +12% -45% +2% +2% -6% Pharma Division +2% +2% +272 -567 +215 +56 +56 +257 +233 -1,156 -923 1 United States Europe International Chugai Dia Division Group Fx ¹ Group (Japan) CER CHF Absolute values in CHFm
Slide 24: Pharma: Optimizing our manufacturing network
Pharma: Optimizing our manufacturing network Working on and protecting profitability Successful diversification and rejuvenation of Broadly stable manufacturing costs despite Pharma portfolio strong volume growth and diversification 60 180 +68% +20% Volume and COGS+PC development1 160 50 Sales devel
Slide 25: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the USD, JPY, CNY (APAC) and EUR -0.7%p +1.6% -1.4%p CER CHF sales growth -2.6%p sales growth YTD Mar 2024 YTD Mar 2024 vs. vs. YTD Mar 2023 YTD Mar 2023 -6.0% -0.5%p -1.3%p -0.5%p -0.6%p CER EUR APAC USD LATAM JPY Other Other CHF Europe
Slide 26: Expected 2024 currency impact
Expected 2024 currency impact USD / CHF Assumed avg. YTD 2024 -6% -3% -1% 0% Assuming the 29 March 2024 exchange rates remain stable 0.93 until end of 2024, 0.91 0.90 0.90 2024 impact1 is expected to be (%p): 0.87 0.89 0.89 0.89 Q1 Q2 Q3 Q4 0.86 0.88 0.89 0.90 0.90 0.90 0.90 0.90 0.90 0.90 0.90 0.90
Slide 27: 2024 outlook confirmed
2024 outlook confirmed Group sales growth1 Mid single digit sales growth Broadly in line with sales growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Further increase dividend in Swiss francs 1At Constant Exchange Rates (CER) 27
Slide 28: Diagnostics: New customer area structure 2024
Diagnostics: New customer area structure 2024 Changes effective 1 Jan, 2024, comparative information for 2023 has been restated accordingly Pharma Division FMI Diagnostics Division Diagnostics Division Core Lab Core Lab Molecular Lab 1 Molecular Lab Pathology Lab 2 Near Patient Care Point of Care Pa
Slide 29: Restatements to be applied in 2024
Restatements to be applied in 2024 Foundation Medicine shifted to the Diagnostics Division effective 1 Jan, 2024 Income statement (Core) Half Year 2023 Full Year 2023 Pharmaceuticals Division - CHFm Published Delta Restated Published Delta Restated Sales 22,681 -170 22,511 44,612 -347 44,265 Other r
Slide 30: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts Diagnostics Day Oncology/ASCO Ophthalmology/ASRS Pharma Day May 22 May 31 Jul 23 Sep 30 • Deep-dive into the current • Oncology solid tumors pipeline • Ophthalmology franchise • Update on Group & Pharma product portfolio update (tira
Slide 31: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 32: Q1 2024: Pharmaceuticals sales
Q1 2024: Pharmaceuticals sales All regions ex-Japan delivering strong growth, Japan impacted by Ronapreve sales in Q1 2023 2024 2023 Change in % CER w/o CHFm CHFm CHF CER Ronapreve Pharmaceuticals Division 10,921 11,608 -6 2 7 United States 5,692 5,763 -1 5 5 Europe 2,200 2,071 6 11 11 Japan 649 1,3
Slide 33: Q1 2024: Young portfolio delivering strong growth
Q1 2024: Young portfolio delivering strong growth Phesgo now second strongest growth driver; Vabysmo excellent growth momentum continues Vabysmo 108% Phesgo 70% Ocrevus 8% Polivy 81% Hemlibra 8% Xolair 10% Xofluza 185% Gazyva 16% Columvi n/a Evrysdi 7% Enspryng 37% Alecensa 4% Tecentriq 1% Lunsumio
Slide 34: US filing for inavolisib in 1L PIK3CA-mut HR+ BC completed
Oncology solid tumors US filing for inavolisib in 1L PIK3CA-mut HR+ BC completed Strong Phesgo launch continues, conversion rate climbing to 41%* Others Q1 update Avastin CHFm 146 / -10% CHFm 324 / -15% • Perjeta: Ongoing conversion to Phesgo, partially offset by growth in International Perjeta Alec
Slide 35: Polivy US patient share in 1L DLBCL climbing to 23%
Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) climbing to 23% Positive Ph III (STARGLO) of Columvi in 2L+ DLBCL met primary endpoint of overall survival Columvi CHFm 25 / N/A Lunsumio Q1 update CHFm 16 / +21% • Hemlibra: Continued penetration across all approved patient Gazyva CHFm 213 /
Slide 36: Hemlibra: New convenience options planned for 2024/2025
Hematology Hemlibra: New convenience options planned for 2024/2025 Global SoC in Hemophilia A with extensive real-world data Hemlibra’s extensive clinical and real-world evidence base Sustained bleed protection ~80% of patients with Efficacy in RWD Vabysmo at ARVO*2024 (May 5-9) with low ABR (mean/m
Slide 37: EU filing of Elevidys in DMD planned for 2024
Neurology EU filing of Elevidys in DMD planned for 2024 Ocrevus market leader in US/EU5 with 24% global patient share Others Q1 update Enspryng CHFm 103 / +12% CHFm 65 / +37% • Ocrevus: Remaining #1 in new to brand in US; higher retention rate than other MS medicines Evrysdi • Evrysdi: Global market
Slide 38: Achieved US approval for Xolair in food allergy
Immunology Achieved US approval for Xolair in food allergy Gazyva Ph III (REGENCY) in lupus nephritis to readout in 2024 Q1 update Others • Xolair: Growth driven by strong CSU performance; market CHFm 233 / -19% shares in Asthma declining; food allergy launch commencing • Positive Ph III (OUtMATCH)
Slide 39: Xolair: First medicine to reduce allergic reactions to multiple foods
Immunology Xolair: First medicine to reduce allergic reactions to multiple foods Potential to redefine the way food allergies are managed Ph III (OUtMATCH) in food allergy1,* Primary endpoint Key secondary endpoints Difference, 60 Difference, 56 Difference, 67 Difference, 38 100 % of patients who co
Slide 40: Vabysmo US market share further expanding in nAMD and DME
Ophthalmology Vabysmo US market share further expanding in nAMD and DME Strong momentum for US launch of Vabysmo in RVO reaching 8% market share after only 4 months* Susvimo CHFm 1 / +11% Luxturna Q1 update Lucentis CHFm 1 / -61% • Vabysmo: Continued market share gains across early launch CHFm 49 /
Slide 41: Vabysmo improved anatomic results vs. aflibercept 8mg in NMA
Ophthalmology Vabysmo improved anatomic results vs. aflibercept 8mg in NMA Greater CST improvements vs aflibercept 2mg and 8mg after the monthly loading phase (week 12) Comparative efficacy of Vabysmo: A Systematic Literature Review and Network Meta-Analysis1 Mean difference in CST change from basel
Slide 42: Vabysmo: Real-world insights substantiate treatment benefits
Ophthalmology Vabysmo: Real-world insights substantiate treatment benefits Rapidly growing body of RWD confirming drying effect and durability seen in the pivotal studies Vabysmo’s growing real-world evidence base >10 FARETINA Selected RWD studies FARWIDE VOYAGER Vabysmo RWD Real-world data nAMD / D
Slide 43: Positive Ph II (KARDIA-2) for zilebesiran as add-on to SoC
Cardiovascular & Metabolism Positive Ph II (KARDIA-2) for zilebesiran as add-on to SoC Single SC dose showed clinically significant reduction in 24h mean ambulatory and office SBP at 3 months Ph II (KARDIA-2) results in hypertension1 Primary endpoint: Change in baseline to month 3 in Secondary endpo
Slide 44: 2024: Key newsflow
2024: Key newsflow* Compound Indication Milestone Alecensa Adjuvant ALK+ NSCLC US/EU approval US inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC US/EU filing US Tecentriq Subcutaneous administration US/EU approval EU crovalimab PNH US/EU approval Elevidys DMD EU filing Ocrevus 6m SC RMS/
Slide 45: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 46: Q1 2024: Diagnostics Division sales
Q1 2024: Diagnostics Division sales Strong base business growth more than offsetting decline in COVID-19 sales 2024 2023 Change in % Excl. CHFm CHFm CHF CER C191 Diagnostics Division 3,478 3,714 -6 2 8 Core Lab 1,925 1,928 0 9 2 Molecular Lab 620 683 -9 -3 3 Near Patient Care 570 774 -26 -20 Patholo
Slide 47: Q1 2024: Diagnostics highlights
Q1 2024: Diagnostics highlights Strong base business growth more than offsetting decline in COVID-19 sales CHFbn YoY CER growth • Immunodiagnostics (+10%) Core Lab +9% • Clinical Chemistry (+8%) • Custom biotech (+5%) • COVID-19 (-72%) Molecular Lab1 -3% • Blood Screening (+11%) • Virology base busi
Slide 48: Q1 2024: Diagnostics regional sales
Q1 2024: Diagnostics regional sales Strong base business growth across all regions North America -1% EMEA ~30% of divisional sales +2% ~34% of divisional sales Asia Pacific Latin America +1% +14% ~29% of divisional sales ~7% of divisional sales Base business=excluding COVID-19-related products; Grow
Slide 49: Largest installed base with significant growth potential
Largest installed base with significant growth potential +3% SWA analytical units of which: cobas® pro / pure +77% +2% Lab SW Solutions +14% Preanalytics / Connectivity HE600 +12% BenchMark ULTRA/ +20% cobas® 5800/6800/8800 ULTRAPLUS +10% DP200/DP600 +29% +6% cobas® Liat 2023 Growth rates – from 31.
Slide 50: Accu-Chek SmartGuide CGM solution
Accu-Chek SmartGuide CGM solution Enabling better decision-making for people with diabetes Accu-Chek SmartGuide CGM solution Improving diabetes management and care continuum • Data released at ATTD shows strong performance of first Roche CGM • 14 days of reliable and accurate real-time glucose senso
Slide 51: FDA approval for cobas malaria test
FDA approval for cobas® malaria test First molecular donor screening test to protect the blood supply from malaria infection Unmet medical need and medical value • Transfusion-transmitted malaria infection can cause serious complications and death in recipients • Increases blood safety in endemic co
Slide 52: FDA BDD granted for pTau217 blood test
FDA BDD granted for pTau217 blood test1 Alzheimer’s blood tests will substantially improve disease diagnosis Elecsys CSF ratios Elecsys Amyloid Plasma Panel Rule-in blood test2 • tTau, pTau181 & Abeta42 • Biomarkers pTau181 & ApoE4p • Biomarker pTau217 • Sensitivity 90%±3% • Minimize false negatives
Slide 53: Diagnostics key launches 2024
Diagnostics key launches 2024 Area Product Description Markets Status i601 mass spectrometry Launch of an unique total solution for clinical mass spectrometry testing: fully automated, integrated and CE system IVD-compliant Core Lab cobas c703 Introducing high-throughput clinical chemistry testing t
Slide 54: Invitation to Roche Diagnostics Investor Day 2024
Invitation to Roche Diagnostics Investor Day 2024 Innovating Diagnostics, shaping healthcare, changing lives Highlights: • Deep-dive into the current product portfolio • Updates on key development projects and upcoming launches, including mass spectrometry, CGM, NGS Presenters include: • Matt Sause,
Slide 55: Doing now what patients need next
Doing now what patients need next
Slide 56: Changes to the development pipeline
Changes to the development pipeline Q1 2024 update New to phase I New to phase II New to phase III New to registration 2 AIs: 1 AI (US): RG6058 tiragolumab + Tecentriq - NSCLC adj. RG3625 TNKase - stroke RG7716 Vabysmo - myopic choriodial neovascularization (CNV) Removed from phase I Removed from ph
Slide 57: Roche Group development pipeline
Roche Group development pipeline Phase I (48 NMEs + 8 AIs) Phase II (20 NMEs + 10 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC RG6058 tiragolumab combos solid tumors CHU codrituzumab HCC RG6058 tiragolumab + T + chemo NSCLC periadjuvant
Slide 58: Roche Group development pipeline
Roche Group development pipeline Phase III (9 NMEs + 40 AIs) Registration US & EU (1 NME + 6 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6107* PiaSky (crovalimab) PNH Columvi + chemo 2L+ DLBCL RG6299 ASO factor B IgA nephropathy RG7446 Tecentriq SC1 all approved indication
Slide 59: Expected regulatory submissions
Expected regulatory submissions* New Molecular Entities: Lead and additional indications anti-latent myostatin + giredestrant New Molecular Entity (NME) Cardiovascular & Metabolism RG6171 RG6237 Evrysdi endometrial cancer SMA Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology g
Slide 60: Expected regulatory submissions
Expected regulatory submissions* Marketed products: Additional indications New Molecular Entity (NME) Cardiovascular & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other Infectious Diseases Lunsumio + lenalidomide RG7828 2L FL+ Lunsumio + Polivy ✓ In
Slide 61: Major pending approvals 2024
Major pending approvals 2024 US EU China Japan-Chugai Tecentriq SC PiaSky (crovalimab) Vabysmo Alecensa RG7446 all approved indications RG6107 PNH RG7716 BRVO/CRVO RG7853 ALK+ NSCLC adj Filed Nov 2022 Filed June 2023 Filed March 2023 Filed Dec 2023 PiaSky (crovalimab) Vabysmo Ocrevus Evrysdi RG6107
Slide 62: Major granted approvals 2024
Major granted approvals 2024 US EU China Japan-Chugai Xolair Tecentriq SC PiaSky (crovalimab) PiaSky (crovalimab) RG3648 Food allergy RG7446 all approved indications RG6107 PNH RG6107 PNH Feb 2024 Jan 2024 Feb 2024* March 2024 Alecensa Vabysmo RG7853 ALK+ NSCLC adj *First worldwide appoval RG7716 BR
Slide 63: 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 64: Hemophilia: Hemlibra
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 65: Hemophilia: Hemlibra
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 66: Oncology: Alecensa
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=257 Oncology ARM A: Alecensa 600mg BID ARM A: Alecensa 600mg BID Design ARM B:
Slide 67: Oncology: Kadcyla
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 68: Oncology: Phesgo
Phesgo (pertuzumab/trastuzumab, RG6264) FDC of Perjeta and Herceptin for subcutaneous administration Indication HER2-positive early breast cancer (BC) Phase III Phase II Phase/study FeDeriCa PHranceSCa # of patients N=500 N=160 Phesgo in combination with chemotherapy in neoadjuvant/adjuvant setting
Slide 69: Oncology: Tecentriq lung cancer
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 70: Oncology: Tecentriq lung cancer
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 71: Oncology: Tecentriq urothelial carcinoma
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 72: Oncology: Tecentriq hepatocellular carcinoma
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 73: Oncology: Tecentriq breast cancer
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 74: Oncology: Tecentriq breast cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – breast cancer Indication Neoadjuvant triple negative breast cancer (TNBC) Phase III Phase/study IMpassion031 # of patients N=333 ARM A: Tecentriq plus nab-paclitaxel ARM B: Placebo plus nab-paclitaxel Oncology Design Primary endp
Slide 75: Oncology: Venclexta CLL
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – chronic lymphocytic leukemia Untreated chronic lymphocytic leukemia (CLL) patients with Indication Untreated fit chronic lymphocytic leukemia (CLL) patients coexisting medical conditions Phase III Phase III Phase/study C
Slide 76: Oncology: Venclexta MDS
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – myelodysplastic syndromes Newly diagnosed higher-risk Indication myelodysplastic syndromes (MDS) Phase III Phase/study VERONA # of patients N=500 ARM A: Venclexta plus azacitidine ARM B: Placebo plus azacitidine Onco
Slide 77: Oncology: Polivy
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 Oncology Design Primary endpoint Progression-free survival Data presented at ASH 2021 and 2022
Slide 78: Oncology: Lunsumio
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously 3L+ FL, 3L+ DLBCL & other relapsed or Indication 1L DLBCL Relapsed or refractory DLBCL refractory NHL Phase/study Phase I/II Phase Ib/II Phase Ib/II # of patients N=713 N=117 N=235
Slide 79: Oncology: Lunsumio
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 80: Oncology: Lunsumio
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 FL Phase/study Phase I/II Phase Ib/II # of patients N=187 N=183 Cohort A: Lunsumio monotherapy (after a response to prior syste
Slide 81: Oncology: Lunsumio
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=412 N=8 ARM A: Lunsumio plus lenalidomide Lunsumio monotherapy (3L+ CLL)
Slide 82: Oncology: Columvi
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
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 Phase III Phase/study Phase Ib STARGLO Part I: 15-60 # of patients N=270 Part II: ~66-104 Part I: Dose-finding for the com
Slide 84: Oncology: Columvi
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 1L DLBCL fit (IPI 2-5) Phase III Phase/study Phase Ib Phase Ib SKYGLO # of patients N=40 N=112 N=1130 Columvi plus R-ICE (single
Slide 85: Oncology: Columvi
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory mantle cell lymphoma (MCL) Phase III Phase/study GLOBRYTE # of patients N=182 ARM A: Columvi monotherapy ARM B: Bendamustine + rituximab or rituximab +
Slide 86: Neurology: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Phase IIIb Phase/study ORATORIO-HAND # of patients N ~ 1,000 120-week treatment period: ARM A: Ocrevus 600mg IV Q24W Neurology Design ARM B: Pl
Slide 87: Neurology: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) PPMS & RMS Phase IIIb Phase IIIb Phase III Phase/study GAVOTTE MUSETTE Ocarina II1 # of patients N ~ 699 N ~ 786
Slide 88: Neurology: Evrysdi
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: Neurology: Evrysdi
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 Neurology Design Proportio
Slide 90: Neurology: Enspryng
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: Neurology: Enspryng
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
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 MMF / ARM A: Gazyva 1000mg IV (6 doses through ARM A: Ga
Slide 93: Immunology: Gazyva
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Systemic lupus erythematosus (SLE) Childhood onset idiopathic nephrotic syndrome* Phase III Phase III Phase/study ALLEGORY INShore # of patients N=300 N=80 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM A: Gazy
Slide 94: Immunology: Lunsumio
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: Mosunetuzumab SC on either Day 1 or on Days 1 and 8 ARM B: Fractionated (divided) dose
Slide 95: Immunology: Xolair
Xolair (omalizumab, RG3648) Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=180 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
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
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=634 N=174 ARM A: Intra
Slide 98: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (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: Faric
Slide 99: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (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 aft
Slide 100: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (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 Ph
Slide 101: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (Ang-2 and VEGF-A) Indication Myopic choriodial neovascularization (CNV) Phase III Phase/study POYANG # of patients n=280 ARM A: Faricimab 6.0 mg Q4W PRN ARM B: Ranibizumab 0.5 mg Q4W P
Slide 102: Ophthalmology: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Thyroid eye disease Phase III Phase III Phase/study SatraGo-1 SatraGo-2 # of patients N=120 N=120 ARM A: Satralizumab at weeks 0, 2, 4 (loading doses) and maintenance ARM A: Satralizumab at weeks 0
Slide 103: Infectious Diseases: Xofluza
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 patients
Slide 104: 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 105: Oncology: Tiragolumab
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 106: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Neoadjuvant and adjuvant NSCLC 1L non-squamous NSCLC Adjuvant NSCLC Phase II Phase III Phase III Phase/study SKYSCRAPER-05 SKYSCRAPER-06 SKYSCRAPER-15 # of patients N=82 N=540 n
Slide 107: Oncology: Tiragolumab
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 108: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Locally advanced, recurrent or metastatic solid tumors 1L HCC Phase II Phase III Phase/study SKYSCRAPER-11 SKYSCRAPER-14 # of patients N=60 N=650 Tiragolumab plus Tecentriq IV
Slide 109: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Solid tumors NSCLC Phase II Phase/study Phase I CITYSCAPE # of patients N=540 N=135 Phase Ia: Dose escalation and expansion of tiragolumab ARM A: Tecentriq plus tiragolumab
Slide 110: Oncology: Inavolisib
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA-mutant HR-positive metastatic breast post CDKi HR-positive PIK3CA-mutant breast PIK3CA mutant solid tumors and metastatic Indication cancer (mBC) cancer ER+ HER2-negative breast cancer Phase III Phase III
Slide 111: Oncology: Inavolisib
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor Indication 1L HER2-positive PIK3CA mutant metastatic breast cancer (mBC) Phase III Phase/study INAVO122 # of patients N=230 ARM A: Inavolisib plus Phesgo after induction therapy with Phesgo + taxane ARM B: Pl
Slide 112: Oncology: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator ER+ HER2-negative metastatic breast cancer ER+ HER2-negative Stage I-III operable breast Indication Neoadjuvant ER-positive breast cancer (BC) (mBC) cancer (BC) Phase II Phase/study Phase I Phase I coop
Slide 113: Oncology: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication 1L ER-positive metastatic breast cancer (mBC) Adjuvant ER-positive breast cancer (BC) Phase III Phase III Phase/study persevERA Breast Cancer lidERA Breast Cancer # of patients N=978 N=4,100
Slide 114: Oncology: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator 1L ER-positive/HER2-positive breast cancer ET resistant ER+/HER2-negative breast cancer Indication Grade 1 endometrial cancer (BC) (BC) Phase III Phase II Phase III Phase/study heredERA endomERA pionERA
Slide 115: Oncology: Divarasib
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 116: Oncology: Divarasib
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Indication 1L NSCLC Phase Ib Phase/study KRASCENDO 170 # of patients N=60 Cohort A: Combination of divarasib plus pembrolizumab (PD-L1+ NSCLC) Cohort B: Combinati
Slide 117: Oncology: PiaSky (crovalimab)
PiaSky (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=8
Slide 118: Oncology: PiaSky (crovalimab)
PiaSky (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 CO
Slide 119: Oncology: PiaSky (crovalimab)
PiaSky (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
Slide 120: Oncology: PiaSky (crovalimab)
PiaSky (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:
Slide 121: Immunology: PiaSky (crovalimab)
PiaSky (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 patien
Slide 122: Immunology: Astegolimab
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=1,290 N=1,290 Astegolimab SC 490mg Q4W for 48 weeks ARM A: SC astegolim
Slide 123: Immunology / Ophthalmology: ASO factor B
ASO factor B (RG6299) Antisense oligonucleotide that targets factor B Indication IgA nephropathy (IgAN) Geographic atrophy (GA) Phase III Phase II* Phase/study Phase II* IMAGINATION GOLDEN STUDY # of patients N=25 N=428 N=330 ASO factor B SC at week 1 following Q4W ARM A: ASO factor B SC at week
Slide 124: Ophthalmology: Vamikibart
Vamikibart (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=
Slide 125: Ophthalmology: Vamikibart
Vamikibart (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-d
Slide 126: Neurology: Elevidys
Elevidys (delandistrogene moxeparvovec, SRP-9001, RG6356) rAAVrh74.MHCK7.Micro-dystrophin gene therapy Indication Duchenne muscular dystrophy (DMD) Phase II Phase/study ENVOL # of patients N=21 Open label single arm study in 0 to <4 year old DMD boys who will receive a single intravenous (IV) infusi
Slide 127: Neurology: Tominersen
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 128: Neurology: Fenebrutinib
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=985 N=736 N=751
Slide 129: Neurology: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Relapsing multiple sclerosis (RMS) Phase II (Biomarker study) Phase/study FENopta # of patients N=109 ARM A: Fenebrutinib ARM B: Placebo Neurology Design Primary endpoint Total numbe
Slide 130: Neurology: Anti-latent myostatin
Anti-latent myostatin (RG6237, GYM329) Recycling and antigen-sweeping monoclonal anti-latent myostatin antibody Facioscapulohumeral Muscular Indication Spinal muscular atrophy (SMA) Obesity Dystrophy (FSHD) Phase II Phase II/III Phase/study Phase Ib MANOEUVRE MANATEE1 # of patients N=48 N=180 N=30-3
Slide 131: 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 132: pRED oncology development programs -1
pRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology 3L+ MSS metastatic colorectal FPI Q3 2021 FAP-4-1BBL (RG7827) Ib 80 NCT04826003 cancer Combination study with cibisatamab FPI Q4 2019 Solid tumors I 320 Data presented at ESMO 2022 NCT04140500
Slide 133: pRED oncology development programs -2
pRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Part I: FPI Q2 2020; recruitment completed Q4 eciskafusp alfa 2021 Solid tumors Ib 256 NCT04303858 (PD1-IL2v, RG6279) Part II: FPI Q1 2022 Part III: FPI Q1 2023 vopikitug Advanced and metastat
Slide 134: pRED neurology development programs -1
pRED neurology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neurology trontinemab FPI Q1 2021 Alzheimer's disease IIa ~210 NCT04639050 (BS-anti-Aβ mAb, RG6102) Data presented at ADPD 2024 ISRCTN16295 BrainshuttleTM-CD20 (RG6035) Multiple sclerosis I 30-63 FPI
Slide 135: pRED neurology development programs -2
pRED neurology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Neurology MAGL inhibitor (RG6182) Multiple sclerosis I Up to 36 FPI Q3 2023 selnoflast* Parkinson’s disease Ib 48 FPI Q3 2022 (NLRP3i, RG6418) *molecule also in gRED development: Phase Ic in coronary
Slide 136: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology selnoflast* Asthma Ib 60 FPI Q1 2024 (NLRP3i, RG6418) NME (RG6382) SLE I 70 FPI Q4 2023 NCT05835986 Ophthalmology zifibancimig NCT04567303 nAMD I 251 FPI Q4 2020 (VEGF-Ang2
Slide 137: 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/ xalnesiran1/ NCT04225715 PDL1 LNA Chronic h
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: gRED oncology development programs -1
gRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q3 2017 R/R multiple myeloma I 300 NCT03275103 Data presented at ASH 2020, 2021 & 2022 R/R multiple myeloma I 120 FPI Q2 2021 NCT04910568 cevostamab BCMA-experienced R/R MM I/II 140 FPI Q4
Slide 140: gRED oncology development programs -2
gRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology runimotamab FPI Q2 2018 Metastatic HER2-expressing cancers I 440 NCT03448042 (HER2 x CD3, RG6194) Study closed Q1 2024 Solid tumors Ib ~125 FPI Q3 2022 NCT05487235 FPI Q4 2021 migoprotafib KRA
Slide 141: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology FPI Q2 2023 NME (RG6287, GDC-8264) Acute graft versus host disease Ib 40 NCT05673876 Study closed Q4 2023 NME (RG6315, MTBT1466A) Systemic sclerosis Ib 100 FPI Q1 2023 NCT05
Slide 142: gRED infectious diseases development program
gRED infectious diseases development program Molecule Indication Phase # of patients Status CT Identifier Infectious Diseases LepB inhibitor (RG6436)* Complicated urinary tract infection I 104 FPI Q2 2024 ISRCTN18049481 *moving forward with alternative LepB inhibitor (previously RG6319) 142
Slide 143: 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 144: Hemophilia A gene therapy
Hemophilia A Unique gene therapy platform Dirloctogene Samoparvovec (SPK-8011) Molecule (RG6357) Indication Hemophilia A Phase/study Phase I Phase I/II # of patients N=100 N=30 Hemophilia Long term follow up study of patients who have received SPK-8011 in any Gene transfer, dose-finding safety,
Slide 145: Cardiovascular and Metabolism: 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 Cardiovascular and Metabolism Gene transfer study for late-onset Pompe disease Design Safety Primary endpoint FPI Q4 2020 Status Recruitment compl
Slide 146: 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 147: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm Q1 2023 Q1 2024 % change CER Pharmaceuticals Division 11,608 10,921 +2 United States 5,763 5,692 +5 Europe 2,071 2,200 +11 Japan 1,390 649 -45 International 2,384 2,380 +12 Diagnostics Division 3,714 3,478 +2 United States 1,027 937 -3 Europe 995
Slide 148: Pharma Division sales Q1 2024
Pharma Division sales Q1 2024 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,658 8 1,180 5 310 8 - - 168 28 Hemlibra 1,040 8 592 -1 231 17 79 2 138 51 Perjeta 936 -3 343 -7 171 -19 36 -19 386 14 Tecentriq 865 1 436 -9 210 12 86 -
Slide 149: Pharma Division sales Q1 2024
Pharma Division sales Q1 2024 Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 10 -6 4 -14 3 -4 - - 3 3 Alecensa 355 4 104 4 72 3 43 3 136 5 Tecentriq 865 1 436 -9 210 12 86 -4 133 34 Ocrevus 1,658 8 1,180 5 310 8 - - 1
Slide 150: Pharma Division sales Q1 2024
Pharma Division sales Q1 2024 Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,658 8 1,180 5 310 8 - - 168 28 Hemlibra 1,040 8 592 -1 231 17 79 2 138 51 Perjeta 936 -3 343 -7 171 -19 36 -19 386 14 Tecentriq 8
Slide 151: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Global top 20 products Q1/23 Q2/23 Q3/23 Q4/23 Q1/24 Ocrevus 14 15 12 9 8 Hemlibra 24 17 17 9 8 Perjeta 11 6 0 -11 -3 Tecentriq 15 8 10 5 1 Vabysmo * * 309 160 108 Actemra / RoActemra -12 2 21 13 -2 Xolair 5 4 3 7 10 Kadcyla 5 -5 5 13 3 Phesgo 72 67 61 58 70 He
Slide 152: 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 14 10 8 5 16 10 11 8 - - - - 23 50 22 28 Hemlibra 14 15 8 -1 18 22 8 17 19 5 5 2 31 39 14 51 Perjeta 6 -6 -35 -7 -12 0 -21 -19 5 6 3 -19 18 4 21 14 T
Slide 153: CER sales growth (%)
CER sales growth (%) Quarterly development 2023 vs. 2022 2024 vs. 2023 Q1 Q2 Q3 Q4 Q1 Pharmaceuticals Division 9 7 11 -2 2 United States 7 8 11 5 5 Europe 5 5 9 3 11 Japan 18 8 1 -50 -45 International 13 6 17 16 12 Diagnostics Division -28 -17 -5 4 2 Roche Group -3 0 7 0 2 CER=Constant Exchange Rate
Slide 154: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 2.0 +8% US +5% 1.6 1.2 Europe +8% 0.8 International +28% 0.4 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 1,658m • US: Moving into earlier lines displacing orals; #1 in US for both dynamic and total share • EU: Moving into earlier l
Slide 155: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 1.2 +8% US -1% 1.0 Europe +17% 0.8 Japan +2% 0.6 0.4 International +51% 0.2 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 1,040m • US: Continued share gains in non-inhibitor patients • EU: Continued share gains in non-inhibitor pati
Slide 156: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 1.2 -3% US -7% 1.0 Europe -19% Japan -19% 0.8 0.6 0.4 International +14% 0.2 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 936m • US: Increasing conversion to Phesgo • EU: Conversion to Phesgo • JP: Conversion to Phesgo • Internation
Slide 157: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 1.0 +1% US -9% 0.8 Europe +12% 0.6 Japan -4% 0.4 International +34% 0.2 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 865m • US: 1L HCC nearing peak penetration; adj. NSCLC competitive pressure intensifying • EU: Growth driven by a
Slide 158: Vabysmo
Vabysmo Global sales CER growth Regional sales CER growth CHFbn 1.0 +108% US +91% 0.8 Europe +224% 0.6 Japan +33% 0.4 International +397% 0.2 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 847m • US: Increasing penetration in naïve patients; strong momentum for RVO launch • EU: Similar uptake dyna
Slide 159: Actemra / RoActemra
Actemra /Q1RoActemra 21 Q1 22 Q1 23 Q1 24 CHFbn Global sales CER growth Regional sales CER growth 1.0 -2% US -1% 0.8 Europe +1% 0.6 0.4 Japan +5% 0.2 International -15% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 618m • US: Ongoing patient shift from Actemra IV to SC in RA • EU: Stable sales de
Slide 160: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 0.6 +10% 0.5 0.4 US +10% 0.3 0.2 0.1 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 496m • US: Growth driven by uptake in CSU; Food allergy approval achieved CER=Constant Exchange Rates 160
Slide 161: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +3% 0.6 US -1% 0.5 0.4 Europe -2% 0.3 Japan -4% 0.2 0.1 International +19% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 483m • US: Share decline in metastatic BC due to competition • EU: Share decline in metastatic BC due to competi
Slide 162: Phesgo
Phesgo Global sales CER growth Regional sales CER growth CHFbn 0.5 +70% US +36% 0.4 Europe +55% 0.3 0.2 Japan n/a 0.1 International +165% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 388m • US: Strong growth driven by eBC, switching of patients from Perjeta+Herceptin to Phesgo • EU: Strong growt
Slide 163: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 0.8 -17% US -22% Europe -17% 0.6 Japan -41% 0.4 0.2 International -14% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 364m • US: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Conversion to Phesg
Slide 164: Evrysdi
Evrysdi CHFbn Global sales CER growth Regional sales CER growth 0.4 +7% US +16% 0.3 Europe +27% 0.2 Japan +13% 0.1 International -29% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 356m • US: Strong uptake across all patient segments; including treatment-naïve patients; leading market share with >
Slide 165: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn 0.5 +4% US +4% 0.4 Europe +3% 0.3 Japan +3% 0.2 International +5% 0.1 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 355m • US: Market leadership in 1L ALK+ NSCLC is maintained • EU: Market leadership in 1L ALK+ NSCLC is maintained •
Slide 166: Rituxan / Mabthera
Rituxan / Mabthera CHFbn Global sales CER growth Regional sales CER growth 1.0 -18% US -21% 0.8 Europe -20% 0.6 Japan -20% 0.4 International -11% 0.2 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 351m • US: Biosimilar erosion slowing • EU: Biosimilar erosion bottoms out • Japan: Biosimilar erosio
Slide 167: Avastin
Avastin CHFbn Global sales CER growth Regional sales CER growth 1.0 -15% US -22% Europe -27% 0.8 Japan -33% 0.6 0.4 International +3% 0.2 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 324m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: Ongoing biosimilar erosion • Inte
Slide 168: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 0.4 +4% US +4% 0.3 0.2 0.1 International +7% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 296m • Spontaneous TNKase use in AIS early time window CER=Constant Exchange Rates 168
Slide 169: Polivy
Polivy Global sales CER growth Regional sales CER growth CHFbn 0.4 +81% 0.3 US +166% 0.2 Europe +42% 0.1 Japan +2% International +181% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 250m • US: Strong growth following approval in 1L DLBCL • EU: Strong growth following approval in 1L DLBCL • Japan:
Slide 170: Gazyva
Gazyva Global sales CER growth Regional sales CER growth CHFbn 0.3 +16% US +7% Europe +17% 0.2 Japan -19% 0.1 International +47% 0.0 Q1 21 Q1 22 Q1 23 Q1 24 Q1 2024 sales of CHF 213m • US: Strong growth driven by combination therapies in 1L CLL • EU: Strong growth driven by combination therapies in
Slide 171: 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 172: Q1 2024: Diagnostics Division CER growth
Q1 2024: Diagnostics Division CER growth By Region and Customer Area (vs. 2023) Reported Restatement Global EMEA North America Asia-Pacific Latin America Global EMEA North America Asia-Pacific Latin America CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm
Slide 173: Q1 2024: Diagnostics Division quarterly sales and CER growth
Q1 2024: Diagnostics Division quarterly sales and CER growth1 Reported Restatement Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab 1,928 7 2,007 12 1,901 8 1,914 9 1,925
Slide 174: Q1 2024: Diagnostics Division regional sales
Q1 2024: Diagnostics Division regional sales Base business growing in all regions Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 3,478 Diagnostics Division 2% GLOBAL 243 / 2% EMEA* 7% -1% NAM 1,188 / 1% APAC 992 / 34% 14% LATAM 29% 1,055 / 30% EMEA* NAM APAC LATAM Base busin
Slide 175: Core Lab
Core Lab 2024 vs. 2023 CHFbn CER growth +9% 2.5 2.0 +4% +8% 1.5 +10% 1.0 0.5 0.0 Q1 2022 Q1 2023 Q1 2024 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates 175
Slide 176: Molecular Lab
Molecular Lab 2024 vs. 2023 CHFbn CER growth -3% 1.5 +5% 1.2 -7% 0.9 -1% +8% 0.6 +8% +11% 0.3 -18% 0.0 Q1 2022 Q1 2023 Q1 2024 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 176
Slide 177: Near Patient Care
Near Patient Care 2024 vs. 2023 CHFbn CER growth -20% 2.0 1.6 1.2 +4% 0.8 -12% -10% 0.4 -5% -68% 0.0 Q1 2022 Q1 2023 Q1 2024 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis Diabetes Care POC MDx CER=Constant Exchange Rates 177
Slide 178: Pathology Lab
Pathology Lab 2024 vs. 2023 CHFbn CER growth +19% 0.4 +47% 0.3 +17% +12% 0.2 0.1 0.0 Q1 2022 Q1 2023 Q1 2024 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 178
Slide 179: 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 180: CHF/USD
CHF/USD Monthly averages 0.93 0.91 -4% 0.89 0.87 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 Year-To-Date averages 0.93 0.91 -6% 0.89 0.87 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 180
Slide 181: CHF/USD
CHF/USD 0.93 Mar YTD 2024 -3% 0.92 0.91 0.90 0.89 0.88 0.87 0.86 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2023 avg full year 2024 monthly avg 2023 monthly avg 2024 181
Slide 182: CHF/EUR
CHF/EUR Monthly averages 1.00 0.98 -3% 0.96 0.94 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 Year-To-Date averages 1.00 0.98 0.96 -4% 0.94 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 182
Slide 183: CHF/EUR
CHF/EUR 1.00 Mar YTD 2024 -2% 0.98 0.96 0.94 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2023 avg full year 2024 monthly avg 2023 monthly avg 2024 183
Slide 184: Average CHF Exchange Rates
Average CHF Exchange Rates Mar YTD Mar YTD Mar YTD 2024 vs. Mar YTD 2023 2024 2023 USD 0.87 0.93 -6% EUR 0.95 0.99 -4% JPY 0.59 0.70 -16% -20% -15% -10% -5% 0% 184
Slide 185: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q1 2024: negative impact driven by the USD, JPY, CNY and EUR Development of average exchange rates versus prior year period Q1 HY YTD Sep FY CHF / USD -5.6% CHF / EUR -4.4% CHF / JPY -15.8% CHF / CNY -10.2% Difference in CHF / CER -7.6% 0.0% 0.0% 0.0% growth 1.6%
Slide 186: Doing now what patients need next
Doing now what patients need next