Roche Holding Ltd · SIX:RO
Roche — YTD Sep 2022 Earnings Presentation
184 slides from Roche's earnings presentation, Oct 18, 2022
Slide 1: Roche
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 YTD September 2022 sales
Roche YTD September 2022 sales Basel, 18 October 2022
Slide 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: YTD Sep 2022 performance, Outlook
YTD Sep 2022 performance Outlook
Slide 6: YTD Sep 2022: Group sales +2% despite COVID-19 decline in Q3
YTD Sep 2022: Group sales +2% despite COVID-19 decline in Q3 Group sales +2% driven by Diagnostics division • Pharma with stable performance, key products compensating for LOEs and declining COVID-19 sales • Diagnostics with good growth momentum (+6%) including good base business growth (+6%) Key pr
Slide 7: Group sales growth driven by Diagnostics Division
YTD Sep 2022: Group sales growth driven by Diagnostics Division 2022 2021 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 33.2 33.4 -1 0 Diagnostics Division 13.8 13.3 4 6 Roche Group 47.0 46.7 1 2 CER=Constant Exchange Rates; totals may include differences due to rounding 7
Slide 8: Quarterly sales performance: COVID-19 sales coming down
Quarterly sales performance: COVID-19 sales coming down 15% 14%* 13% 12% 11% 10% 9% 9% 7% 7% 7% 6% 6% 6% 6% 6% 8% 8% 5% 4% 7% 6% 5% 5% 4% 4% 1% 3% 3% 3% 1% 0% 0% -5% -4% -6% -10% AHR1 impact -15% COVID-19 impact Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q
Slide 9: Portfolio rejuvenation ongoing
YTD Sep 2022: Portfolio rejuvenation ongoing CHFm +2% at CER Diversification of Roche business YTD Sep 2017 YTD Sep 2022 -383 CHF 39.4bn CHF 47.0bn + 2’397 -612 +217 -1,460 + 621 -427 AHR AHR 46’684 47’037 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophili
Slide 10: Solid underlying sales growth in both divisions
YTD Sep 2022: Solid underlying sales growth in both divisions Pharma Diagnostics Quarterly sales evolution 2021-2022 Quarterly sales evolution 2021-2022 % CER % CER +55% +55% +48% +45% +55% +45% +35% +35% +31% +24% +25% +25% +17% +18% +15% +14% +15% +9% +7% +4% +5% +6% +6% +3% +5% +2% +5% +11% +10%
Slide 11: YTD Sep 2022 performance, Outlook
YTD Sep 2022 performance Outlook
Slide 12: Continuous increase in pipeline breadth and depth
Continuous increase in pipeline breadth and depth All-time high for Ph III AIs and industry-leading number of NMEs in the clinic Projects in Ph III & registration Record number of NMEs and AIs (YTD Sep 2022) 18 Phase I Phase II 2 NMEs 8% 2% 3% 10% 14 3 13 13 11% 2 38% 2 1 3% 62 11 3 29 11% 31% 1 4 6
Slide 13: 2022/23: Upcoming Pharma newsflow
2022/23: Upcoming Pharma newsflow 2022 2023 Vabysmo in RVO Tiragolumab + Tecentriq in 1L PDL1+ NSCLC Susvimo in DME Tiragolumab + Tecentriq in 1L Esophageal Susvimo in DR Tecentriq in adjuvant HCC Venclexta in R/R MM (t11;14) Tecentriq in adjuvant SCCHN Gantenerumab in Alzheimer’s disease Tecentriq
Slide 14: R&D focus area Alzheimer's disease
R&D focus area Alzheimer’s disease Clinical results for gantenerumab and blood-based biomarkers to be presented at CTAD Pharmaceuticals gantenerumab • Nearly two decades of scientific investigation with Diagnostics nearly 7000 patient years on treatment • GRADUATE I/II: Patients with early AD (FDA B
Slide 15: 2022 outlook confirmed
2022 outlook confirmed Group sales growth1 • Stable to low-single digit Core EPS growth1 • Low- to mid-single digit Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 15
Slide 16: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 17: Pharmaceuticals Division sales
YTD Sep 2022: Pharmaceuticals Division sales New products compensate for loss-of-exclusivity and COVID-19 sales decline 2022 2021 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 33,189 33,379 -1 0 United States 17,199 16,707 3 -1 Europe 6,100 6,610 -8 -1 Japan 3,029 3,186 -5 7 International 6
Slide 18: Portfolio diversification accelerating
YTD Sep 2022: Portfolio diversification accelerating Ocrevus 17% Hemlibra 28% Evrysdi 101% Phesgo 150% Vabysmo n/a Tecentriq 10% Alecensa 16% Kadcyla 11% Perjeta 5% Xolair 10% Polivy 79% Enspryng 108% Gazyva 8% Tamiflu 56% Gavreto 299% Esbriet -25% US Lucentis -25% Herceptin -18% Europe Ronapreve -3
Slide 19: Oncology portfolio rejuvenation on-going
YTD Sep 2022: Oncology portfolio rejuvenation on-going YoY CER growth Phesgo (+150%) HER2 franchise HER2 franchise Herceptin Perjeta (+5%) +4% • Kadcyla (+11%) with growth ex-US due to adjuvant BC Tecentriq +10% Kadcyla (+11%) • Perjeta (+5%) driven by International, especially APAC Hematology Poliv
Slide 20: HER2+ franchise: Continued growth
HER2+ franchise: Continued growth Multiple Ph III combination trials initiated Phesgo’s strong global launch continues Kadcyla growth driven by adjuvant setting Global Phesgo conversion rate* 50% Neoadjuvant Adjuvant cont. PCR (55%) 40% 50% Surgery 30% 30% 20% Residual Disease (45%) 10% HER2+ Adjuva
Slide 21: Giredestrant: Early data support continued development in ER+ BC
Giredestrant: Early data support continued development in ER+ BC Ph III (persevERA) interim results in 1L ER+ BC expected for 2024 Ph II (acelERA) results in 2/3L ER+/HER- BC Ph II (coopERA) results in neoadjuvant ER+/HER- BC PFS-INV: ESR1m subgroup • PFS benefit was more pronounced in patients with
Slide 22: Tecentriq overview
Tecentriq overview: Adjuvant key trials now to read out in 2023 First PD-(L)1 with pivotal SC results to be filed in 2022 CHFm YoY CER growth Tecentriq Q3 update 1,000 +9% • Positive Ph III (IMscin001) results for SC administration 900 +23% Lung franchise (NSCLC, SCLC) 800 +49% 700 • EU: Strong laun
Slide 23: Hemophilia A franchise: Hemlibra
Hemophilia A franchise: Hemlibra new global standard of care 36% US/EU-5 patient share reached CHFm YoY CER growth Hemophilia Q3 update 1,200 • >18,000 patients treated globally +23% 1,000 • Hemlibra continues to penetrate across all approved patient segments +37% 800 • 2nd generation FIXa x FX bi-s
Slide 24: Immunology franchise
Immunology franchise Actemra COVID-19 sales declining and Esbriet generic competition CHFm YoY CER growth Immunology Q3 updates 2,500 Actemra (-42%) +13% +5% • COVID-19 demand completely washed out in Q3 +1% 2,000 -25% • Submitted to EMA for approval in SSC-ILD 1,500 • Shift from IV to SC ongoing Xo
Slide 25: MS franchise: Ocrevus
MS franchise: Ocrevus #1 treatment in US and now also in EU-5 MS development programs well on track CHFm YoY CER growth Q3 update 1,750 • >250.000 patients treated globally +16% 1,500 • #1 treatment in US and EU-5, both in total share and new to +37% +7% brand share 1,250 • Higher persistence than o
Slide 26: MS franchise: Subcutaneous dosing and higher dose Ocrevus
MS franchise: Subcutaneous dosing and higher dose Ocrevus Q6M SC dosing readout expected in 2023 Ocrevus SC will retain Q6M dosing Ocrevus higher dose vs 600 mg in RMS and PPMS Administration and observation schedule Total time Double-blind treatment (min. of ≥120 weeks) Ocrevus higher dose 1,200/1,
Slide 27: SMA franchise: Evrysdi
SMA franchise: Evrysdi with strong global momentum Well-positioned to become #1 worldwide Q3 update CHFm YoY CER growth • >7,000 patients treated worldwide (commercial, clinical 350 trials, compassionate use) +93% 300 • Retention rate in first 12 months of ~90% globally 250 • US: Growth driven by sw
Slide 28: Ophthalmology franchise: Excellent Vabysmo launch
Ophthalmology franchise: Excellent Vabysmo launch More than 165k vials shipped in the US in the first 7 months Q3 update CHFm Vabysmo 200 • US: Strong uptake with switches primarily from aflibercept and first naïve patient starts 150 • US: Permanent J-code granted on October 1st 100 • EU: Approval g
Slide 29: Vabysmo: Improved overall disease control in DME
Vabysmo: Improved overall disease control in DME Treat & extend study design well-aligned with clinical practice Ph III trial design in DME (YOSEMITE/RHINE) Ph III (YOSEMITE/RHINE) 2 year results 14 YOSEMITE/RHINE Pooled From Baseline, ETDRS Adjusted Mean BCVA 12 10 Change Letters 8 Average of weeks
Slide 30: Vabysmo: 2 year nAMD data presented at ASRS
Vabysmo: 2 year nAMD data presented at ASRS Strong BCVA and CST results sustained over 2 years Ph III trial design in nAMD (TENAYA/LUCERNE) Ph III (TENAYA/LUCERNE) 2 year results Primary Endpointa Change in BCVA from Disease Activity baseline averaged over the week 40, 44, and 48 visits Assessment F
Slide 31: Vabysmo: Disease criteria chosen impact patient allocation
Vabysmo: Disease criteria chosen impact patient allocation Vabysmo nAMD trials use disease criteria reflective of clinical practice1 Different ≥Q12W disease criteria as applied to TENAYA/LUCERNE patients Stringent criteria** Share of patients on ≥Q12W dosing Treatment change if ANY criteria are met
Slide 32: 2022: Key late-stage news flow and upcoming IR events
2022: Key late-stage news flow* and upcoming IR events Compound Indication Milestone Vabysmo nAMD/DME US/EU approval Susvimo nAMD EU approval Delayed Lunsumio (mosunetuzumab) 3L+ FL US/EU approval EU Regulatory Tecentriq Adjuvant NSCLC EU approval Hemlibra Mild to moderate hemophilia A EU approval P
Slide 33: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 34: Diagnostics Division sales
YTD Sep 2022: Diagnostics Division sales Sales increase of +6% driven by base business and COVID-19 testing 2022 2021 Change in % CHFm CHFm CHF CER Diagnostics Division 13,848 13,305 4 6 Core Lab1 5,833 5,677 3 5 Point of Care1 3,086 2,415 28 30 Molecular Lab1 2,735 3,030 -10 -8 Diabetes Care 1,219
Slide 35: Diagnostics Division highlights
YTD Sep 2022: Diagnostics Division highlights Growing from a high base in 2021 CHFbn YoY CER growth • Immunodiagnostics (+6%) Core Lab1,3 +5% • Clinical Chemistry (+8%) • Custom biotech (-8%)3 • POC Immunodiagnostics (+39%) Point of Care3 +30% • POC Molecular3 (+33%) • qPCR&NAP (-28%) Molecular Lab3
Slide 36: Diagnostics Division regional sales
YTD Sep 2022: Diagnostics Division regional sales Strong base business growth across all regions North America +20% EMEA1 ~28% of divisional sales -13% ~33% of divisional sales Asia Pacific Latin America +28% -3% ~33% of divisional sales ~6% of divisional sales Growth rates at CER (Constant exchange
Slide 37: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Strong base business growth 55% Diagnostics Division sales growth 48% Base business sales growth 1 28% 31% 24% 18% 17% 18% 9% 10% 7% 5% 2% 11% 3% 1% -2% 8% -5% -4% 0% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 -17% 0.1bn 0.6bn 0.6bn
Slide 38: Our contribution against COVID-19
Our contribution against COVID-19 Roche has enabled access to >1.8 billion tests to fight the COVID-19 pandemic 20+ solutions >1.8 billion COVID-19 Responsible pricing to ~2’000 cobas® 6800/8800 tests enable access instruments placed1 Broad portfolio of COVID-19 Conducted with our products Costs sho
Slide 39: Roche Digital LightCycler
Roche Digital LightCycler® Filling the gap between standard PCR and sequencing • Digital PCR system with IVD label & superior performance • Key differentiators: – Powerful analytical software & simpler workflow - no more emulsions Analyzer Partition engine – Flexibility to tailor assays from high se
Slide 40: PRAME immunohistochemistry assay
PRAME immunohistochemistry assay Enabling optimal patient prognosis via early & accurate diagnosis and treatment of melanoma 5 year survival rates • >300k new cases and ~60k death per year caused by Melanoma cancer3 99% Localized • Key immunohistochemistry assay to: Melanoma survival Help differen
Slide 41: Elecsys Amyloid Plasma Panel clinical results
Elecsys® Amyloid Plasma Panel clinical results Addressing the unmet need of early detection of Alzheimer’s disease pathology 1 2 3 Triage Confirmation Therapy Patients undergoing initial evaluation Patients referred for amyloid Patients identified for future for non-specific cognitive decline1 confi
Slide 42: Key launches 2022
Key launches 2022 Area Product Description Market Status Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with Pathology Lab BenchMark ULTRA PLUS US & CE enhanced software capabilities, workflow and testing efficiency DP600 High capacity pathology slide scanner f
Slide 43: Finance
Finance Alan Hippe Chief Financial Officer
Slide 44: YTD Sep 2022: Highlights
YTD Sep 2022: Highlights Sales • Group sales growth of +2% • Solid Pharma and Diagnostics underlying growth Currency impact on sales • Negative currency impact especially in Q3, particularly weaker EUR and JPY, only partially offset by stronger USD Growth rates at CER (Constant exchange Rates) 44
Slide 45: Portfolio rejuvenation ongoing
YTD Sep 2022: Portfolio rejuvenation ongoing CHFm +2% at CER Diversification of Roche business YTD Sep 2017 YTD Sep 2022 -383 CHF 39.4bn CHF 47.0bn + 2’397 -612 +217 -1,460 + 621 -427 AHR AHR 46’684 47’037 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophili
Slide 46: Regional sales development
YTD Sep 2022: Regional sales development -1% -1% 0% +7% +6% +2% +1% Pharma Division +6% 0% -427 +838 780 353 -239 +236 +18 -73 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CER CHF Absolute values in CHFm at Constant Exchange Rates (avg full year 2021); 1 avg. full year 2
Slide 47: YTD exchange rate swings
YTD exchange rate swings Negative impact driven by the EUR, JPY and other Europe, partially offset by USD -0.1p -1.0p CER CHF sales growth sales growth +1.9p +0.1p YTD Sep 2022 YTD Sep 2022 vs. vs. YTD Sep 2021 -1.2p -0.7p YTD Sep 2021 +1.7% +0.1p +0.8% CER EUR APAC USD LATAM JPY Other Other CHF Eur
Slide 48: Expected currency impact 2022
Expected currency impact 2022 CHF / USD Average YTD 2022 +2% +4% +4% +5% 0.94 0.95 0.96 Assuming the 30 September 2022 exchange rates 0.92 remain stable until end of 2022, 0.90 0.91 0.91 0.91 2022 impact1 is expected to be (%p): Average YTD 2021 0.92 0.92 0.93 0.94 0.98 0.97 0.97 0.96 0.97 0.98 0.98
Slide 49: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit Core EPS growth1 • Low- to mid-single digit Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 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 Q3 2022 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 4 AIs: 1 NME (First filed in China*): RG6536 vixarelimab – immunology RG7314 balovaptan – post-traumatic stress RG6168 Enspryng – MOG-AD RG6017 crovalimab - PNH RG653
Slide 53: Roche Group development pipeline
Roche Group development pipeline Phase I (51 NMEs + 11 AIs) Phase II (21 NMEs + 8 AIs) RG6007 HLA-A2-WT1 x CD3 AML RG7827 FAP-4-1BBL monotherapy + combos solid tumors RG6026 glofitamab + chemo 1L ctDNA high risk DLBCL RG6026 glofitamab monotherapy + combos heme tumors Lunsumio (mosunetuzumab) tirago
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase III (10 NMEs + 46 AIs) Registration US & EU (3 NMEs + 7AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC RG3648 Xolair food allergy RG6013 Hemlibra1 mild to moderate hemophilia A RG3502 Kadcyla + T HER-2+ eBC high-risk RG6354 zinpentraxin alfa (PRM-151 ) IPF RG6026 glofit
Slide 55: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III glofitamab + chemo autogene cevumeran bepranemab RG6026 1L ctDNA+ high risk RG6180 RG6416 1L melanoma Alzheimer's New Molecular Entity (NME) Metabolism DLBCL Additional Indication (AI) Neuroscience tiragolumab + T zinpentr
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 Phesgo OBI RG6264 Infectious Diseases HER2+ BC Gavreto Kadcyla + Tecentriq RG6396 RG3502 Tumor agnostic
Slide 57: Major pending approvals 2022
Major pending approvals 2022 US EU China Japan-Chugai Lunsumio (mosunetuzumab) Susvimo (PDS) Polivy Gazyva RG7828 3L+ FL RG6321 wAMD RG7596 1L DLBCL RG7159 1L CLL Filed Dec 2021 Filed April 2021 Filed Nov 2021 Filed March 2022 Actemra Hemlibra Polivy Phesgo RG1569 COVID-19 pneumonia RG6013 mild to m
Slide 58: Major granted approvals 2022
Major granted approvals 2022 US EU China Japan-Chugai Vabysmo (faricimab) Polivy Tecentriq Actemra RG7716 DME RG7596 1L DLBCL RG7446 NSCLC adj RG1569 COVID-19 pneumonia Jan 2022 May 2022 March 2022 Jan 2022 Vabysmo (faricimab) Tecentriq Actemra Vabysmo (faricimab) RG7716 wAMD RG7446 NSCLC adj RG1569
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
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
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
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
Kadcyla (trastuzumab emtansine, RG3502) First ADC for HER2-positive breast cancer HER2-positive early breast cancer (BC) 2L+ HER-2 positive PD-L1 positive metastatic HER2-positive early breast cancer (BC) Indication high-risk patients breast cancer (mBC) high-risk patients Phase III Phase III Phase
Slide 64: Oncology: Perjeta
Perjeta (pertuzumab, RG1273) First-in-class HER2 dimerization inhibitor Indication Adjuvant HER2-positive breast cancer (BC) Phase III Phase/study APHINITY # of patients N=4,803 ARM A: Perjeta (840mg loading dose, 420mg q3w) plus Herceptin for 52 weeks plus chemotherapy (6-8 cycles) ARM B: Place
Slide 65: Oncology: Phesgo
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 Phase I1 FeDeriCa PHranceSCa # of patients N=500 N=160 N=144 FDC of Perjeta and Herce
Slide 66: 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 67: Oncology: Tecentriq lung cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L maintenance extensive-stage SCLC 2L NSCLC previously treated with an immune checkpoint inhibitor Phase III Phase III Phase/study IMforte1 CONTACT-012 # of patients N=450 N=366 ARM A: Platinum-etoposide + T
Slide 68: Oncology: Tecentriq lung cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L NSCLC Stage IV NSCLC Phase II/III Phase Ib/III Phase/study B-FAST IMscin0011 # of patients Modular design N=371 Cohort A: ALK+ (Alecensa) Phase Ib Cohort B: RET+ (Alecensa) Dose finding, Tecentriq SC f
Slide 69: Oncology: Tecentriq SCCHN
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – SCCHN and melanoma 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
Slide 70: 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 1L metastatic urothelial carcinoma (UC) bladder cancer (MIBC) bladder cancer (MIBC) Phase III Phase III Phase III Phase/study IMvigor130
Slide 71: Oncology: Tecentriq renal cell cancer
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-031 # of patients N=500 ARM A: Tecentriq plus cabozantinib ARM B: Cabozantinib Design Onco
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) 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 75: Oncology: Venclexta CLL
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 76: Oncology: Venclexta multiple myeloma
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 plus dexamethazone vs pomalidomide plus Vencle
Slide 77: Oncology: Venclexta MDS
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 78: 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 Design Oncology Primary endpoint Progression-free survival FPI Q4 2017 Recruitment completed Q2
Slide 79: Oncology: Gavreto
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 80: 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 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 81: 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 Relapsed or refractory 2L+ FL Phase/study Phase I Phase Ib # of patients N=92 + 80 (cohort C) N=27 Cohort A: Lunsumio monothera
Slide 82: 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 FL Relapsed or refractory CLL Phase III Phase/study Phase Ib/II Phase Ib/II CELESTIMO # of patients N=400 N=118 N=56 ARM A: Lunsumio plus le
Slide 83: 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 84: Neuroscience: Ocrevus
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 85: Neuroscience: Ocrevus
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 86: Neuroscience: Ocrevus
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 87: Neuroscience: 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 Open-label study in infants with type 1 SMA Randomized
Slide 88: Neuroscience: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II Phase II/III Phase/study RAINBOWFISH MANATEE # of patients N=25 N=180 Open-label, single-arm, multicenter study in infants aged from birth ARM A: to 6 weeks who have been genetically diagnosed
Slide 89: Neuroscience: 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 90: Neuroscience: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Myelin oligodendrocyte glycoprotein antibody Indication Generalised myasthenia gravis (MG) Autoimmune encephalitis (AE) disease (MOG-AD) Phase III Phase III Phase III Phase/study Luminesce METEOROID CIELO # of pa
Slide 91: 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 mycophenolate ARM A: Gazyva 1000mg IV (6 doses through A
Slide 92: Immunology: Gazyva
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Systemic lupus erythematosus (SLE) Phase III Phase/study ALLEGORY # of patients N=200 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM B: Placebo IV Immunology Design Percentage of participants who achieve Syst
Slide 93: Immunology: Actemra/RoActemra
Actemra/RoActemra (tocilizumab, RG1569) Interleukin 6 receptor inhibitor Indication Adult hospitalised with severe COVID-19 pneumonia Phase III Phase III Phase/study COVACTA1 REMDACTA2 # of patients N=450 N=650 ARM A: Actemra plus standard of care ARM A: Remdesivir plus Actemra ARM B: Placebo
Slide 94: Immunology: Actemra/RoActemra
Actemra/RoActemra (tocilizumab, RG1569) Interleukin 6 receptor inhibitor Indication Adult hospitalised with severe COVID-19 pneumonia Phase II Phase III Phase/study MARIPOSA EMPACTA # of patients N=100 N=379 ARM A: 8 mg/kg Actemra plus standard of care Conducted in sites known to provide critical
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=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: 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: Lunsumio SC on either Day 1 or on Days 1 and 8 ARM B: Fractionated (divided) dose of Lu
Slide 97: 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: Port delivery system with ra
Slide 98: 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=545 N=160 ARM A: Port
Slide 99: Ophthalmology: Vabysmo
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 100: Ophthalmology: Vabysmo
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 101: Ophthalmology: Vabysmo
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 102: 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 Xofluza on Day 1 (based o
Slide 103: 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 104: Oncology: Ipatasertib
Ipatasertib (RG7440, GDC-0068) Highly selective small molecule inhibitor of Akt Indication 1L castration-resistant prostate cancer (CRPC) Phase III Phase/study IPATential150 # of patients N=1,100 ARM A: Ipatasertib plus abiraterone ARM B: Placebo plus abiraterone Design Oncology rPFS in patien
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 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 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 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 109: Oncology: Glofitamab
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 escalation and
Slide 110: Oncology: Glofitamab
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 combination
Slide 111: Oncology: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L ctDNA high risk DLBCL Phase/study Phase II # of patients N=40 Glofitamab plus R-CHOP (glofitamab is introduced as a consolidation to R-CHOP at cycle 3-8 in patients ctDNA+ at cycle 2
Slide 112: Oncology: Inavolisib
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 113: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator ER+ HER2-neg Stage I-III operable breast Indication ER+ HER2-neg metastatic breast cancer (mBC) Neoadjuvant ER+ breast cancer (BC) cancer (BC) Phase II Phase/study Phase I Phase I coopERA Breast Cancer #
Slide 114: Oncology: Giredestrant
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 115: Oncology: Giredestrant
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 116: Immunology: Zinpentraxin alfa
Zinpentraxin alfa (PRM-151, RG6354) Recombinant human innate immunity protein pentraxin-2 Indication Idiopathic pulmonary fibrosis (IPF) Myelofibrosis Phase III Phase/study Phase II Phase II STARSCAPE # of patients N=117 N=658 N=125 Randomized, double-blind, placebo- Randomized, double-blind, pl
Slide 117: Immunology: Crovalimab
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=250 Health
Slide 118: Immunology: Crovalimab
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 119: Immunology: Crovalimab
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 120: Immunology: Crovalimab
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 121: Neuroscience: Crenezumab
Crenezumab (RG7412) Humanized monoclonal antibody targeting all forms of Ab 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 122: Neuroscience: Gantenerumab
Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of Aß Indication Prodromal to mild Alzheimer’s disease Phase III Phase III Phase II Phase/study GRADUATE 1 GRADUATE 2 GRADUATION # of patients N=1,016 N=1,016 N=192 104-week SC treatment period: 104-week SC treatment peri
Slide 123: Neuroscience: Gantenerumab
Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of Aß Cognitively unimpaired participants at risk for or Indication Prodromal Alzheimer’s disease Mild Alzheimer’s disease at the earliest stages of Alzheimer’s disease Phase II/III Phase III Phase III Phase/study SCarlet
Slide 124: Neuroscience: Tominersen
Tominersen (RG6042, HTT ASO ) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase II Phase/study Phase I/IIa OLE # of patients N=46 N=46 Multiple ascending doses of tominersen administered intrathecally to Patients from phase I are enrolled into OLE adu
Slide 125: Neuroscience: Tominersen
Tominersen (RG6042, HTT ASO ) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase III Phase III Phase/study Generation HD1 GEN-EXTEND # of patients N=791 N=1,050 ARM A: Tominersen 120mg q2w OLE study in patients participating in prior Roche and Genentech
Slide 126: Neuroscience: 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=946 N=736 N=736
Slide 127: Neuroscience: Balovaptan
Balovaptan (RG7314) Small molecule antagonist of the V1A vasopressin receptor Indication Post-traumatic stress disorder (PTSD) Phase/study Phase II # of patients N=252 ARM A: Balovaptan (IV) once a day for 12 weeks ARM B: Placebo matched control Design Neuroscience Primary endpoint Change from
Slide 128: Neuroscience: TNKase
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 endp
Slide 129: 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 130: 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 Part
Slide 131: pRED oncology development programs -2
pRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Solid tumors I 110 FPI Q4 2019 NCT04158583 CD25 (RG6292) Advanced and metastatic solid Part I: FPI Q1 2021 I 160 NCT04642365 tumors Part II: FPI Q4 2021 FPI Q4 2020 Anti-GPRC5D (RG6234) Multip
Slide 132: pRED neuroscience development programs -1
pRED neuroscience development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neuroscience Brain Shuttle-gantenerumab (BS- Alzheimer's disease IIa ~120 FPI Q1 2021 NCT04639050 gantenerumab, RG6102) Brain Shuttle-CD20 (BS-CD20, ISRCTN16295 Multiple sclerosis I 30 FPI Q3 2021
Slide 133: 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) Partner: 1Proth
Slide 134: 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 Ib 102 FPI Q2 2022 (NLRP3i, RG6418) disease Ophthalmology DME, UME I 90 FPI Q3 2019 DOVETAIL NCT05151744 II ~210 FPI Q4 2021 Anti-IL
Slide 135: pRED infectious diseases development programs
pRED infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Infectious Diseases FPI Q4 2016 TLR7 agonist (3) (RG7854) Chronic hepatitis B I 150 NCT02956850 Data presented at APASL 2019 TLR7 agonist (3)/ siRNA/ PDL1 LNA NCT04225715 Chronic hepatitis B II
Slide 136: 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 137: gRED oncology development programs -1
gRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology Metastatic solid tumors with KRAS FPI Q3 2020 KRAS G12C (RG6330) I 270 NCT04449874 G12C mutation Data presented at WCLC 2022, ESMO 2022 FPI Q3 2017 cevostamab R/R multiple myeloma I 300 NCT032
Slide 138: gRED oncology development programs -2
gRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q2 2021 belvarafenib (RG6185)4 nRASmt CPI-experienced melanoma Ib 83 NCT04835805 Data presented at ESMO 2021 ISRCTN92655 NME (RG6392) Oncology I 60 FPI Q4 2021 801 Partner: 1Xencor, 2BioNT
Slide 139: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology efmarodocokin alfa aGVHD lb 18 FPI Q4 2020 NCT04539470 (IL-22Fc, RG7880) FPI Q1 2020 Inflammatory bowel disease I 68 EUDRACT201 NME (RG6287, GDC-8264) Recruitment completed
Slide 140: gRED neuroscience and infectious diseases development programs
gRED neuroscience and infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience FPI Q4 2017 Prodromal to mild NCT03289143 II 457 Primary endpoint not met Q3 2020 Alzheimer’s disease (TAURIEL) Data presented at CTAD 2020 semorinemab (RG6100)1 F
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: Hemophilia: Spark gene therapy
Hemophilia A Unique gene therapy platform 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 Gene transfer, dose-finding
Slide 143: Metabolic Diseases: 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 144: 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 145: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm YTD Sep 2021 YTD Sep 2022 % change CER Pharmaceuticals Division 33,379 33,189 0 United States 16,707 17,199 -1 Europe 6,610 6,100 -1 Japan 3,186 3,029 +7 International 6,876 6,861 0 Diagnostics Division 13,305 13,848 +6 United States 2,845 3,471
Slide 146: Pharma Division sales YTD Sep 2022: Top products
Pharma Division sales YTD Sep 2022 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 4,427 17 3,283 13 808 25 - - 336 37 Perjeta 3,090 5 1,135 1 661 -16 175 -1 1,119 33 Hemlibra 2,778 28 1,684 22 542 32 277 20 275 76 Tecentriq 2,692 1
Slide 147: Pharma Division sales YTD Sep 2022
Pharma Division sales YTD Sep 2022 Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 4,427 17 3,283 13 808 25 - - 336 37 Perjeta 3,090 5 1,135 1 661 -16 175 -1 1,119 33 Hemlibra 2,778 28 1,684 22 542 32 277 20 2
Slide 148: Pharma Division CER sales growth: Global top products
Pharma Division CER sales growth1 in % Global top 20 products Q1/21 Q2/21 Q3/21 Q4/21 Q1/22 Q2/22 Q3/22 Ocrevus 16 31 7 25 18 17 16 Perjeta 2 7 2 3 1 9 5 Hemlibra 33 58 37 38 30 31 23 Tecentriq 26 31 23 17 8 13 9 Actemra / RoActemra 22 12 57 21 3 -23 -42 Herceptin -35 -35 -26 -6 -19 -11 -23 Avastin
Slide 149: Pharma Division CER sales growth: Top products by region
Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Ocrevus 23 12 10 17 26 34 34 11 - - - - 51 29 62 26 Perjeta -2 -1 4 0 -8 -21 -12 -15 -3 -1 -1 -1 24 32 37 30 Hemlibra 33 28 24 16 53 31 29 36 30 15 24 22 55
Slide 150: CER sales growth (%)
CER sales growth (%) Quarterly development 2021 vs. 2020 2022 vs. 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Pharmaceuticals Division -9 4 5 14 6 0 -6 United States -14 0 0 8 2 1 -6 Europe -6 15 1 19 -1 -6 4 Japan -7 7 60 46 69 3 -27 International 0 4 2 9 0 4 -3 Diagnostics Division 55 48 18 8 24 0 -4 Roche Group 3
Slide 151: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 4.9 +17% US +13% 4.2 3.5 2.8 2.1 Europe +25% 1.4 International +37% 0.7 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 4,427m • US: Moving into earlier lines displacing orals; #1 in US for both total share and
Slide 152: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 3.5 +5% US +1% 3.0 Europe -16% 2.5 2.0 Japan -1% 1.5 1.0 International +33% 0.5 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 3,090m • US: Cannibalization from Phesgo • EU: Cannibalization from Phesgo • Inter
Slide 153: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 3.2 +28% US +22% 2.8 Europe +32% 2.4 2.0 Japan +20% 1.6 1.2 International +76% 0.8 0.4 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 2,778m • US: Continued share gains in non-inhibitor patients • EU: Continu
Slide 154: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 3.2 +10% US +9% 2.8 Europe +19% 2.4 2.0 1.6 Japan -5% 1.2 0.8 International +16% 0.4 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 2,692m • US: Growth driven by first-in-class launches in adjuvant PDL1+ NSC
Slide 155: Actemra / RoActemra
Actemra / RoActemra Global sales CER growth Regional sales CER growth CHFbn 3.0 -23% US -33% 2.5 Europe -3% 2.0 1.5 1.0 Japan +1% 0.5 International -39% 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 2,039m • US: Actemra SC share in RA keeps increasing; COVID-19 sales wash
Slide 156: Herceptin
Herceptin CHFbn Global sales CER growth Regional sales CER growth 5.4 -18% US -28% Europe -13% 4.5 Japan -28% 3.6 2.7 1.8 International -15% 0.9 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,672m • US: Biosimilar erosion slowing; Switching of patients with residual dise
Slide 157: Avastin
Avastin Global sales CER growth Regional sales CER growth CHFbn 6.0 -29% US -36% Europe -51% 5.0 4.0 Japan -15% 3.0 2.0 International -21% 1.0 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,652m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: L
Slide 158: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 1.8 +10% 1.6 1.4 1.2 US +10% 1.0 0.8 0.6 0.4 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,625m • US: Xolair remains market leader in growing biologics asthma market; Growth driven by chronic spontaneous
Slide 159: Rituxan / Mabthera
Rituxan / Mabthera CHFbn Global sales CER growth Regional sales CER growth 5.4 -20% US -20% 4.5 Europe -18% 3.6 Japan -10% 2.7 1.8 International -23% 0.9 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,596m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing
Slide 160: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +11% 1.8 US -3% 1.6 1.4 1.2 Europe +8% 1.0 0.8 0.6 Japan +21% 0.4 0.2 International +50% 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,590m • US: Growth in adjuvant eBC; share decline in metastatic BC due t
Slide 161: Alecensa
Alecensa CHFbn Global sales CER growth Regional sales CER growth 1.2 +16% US +20% 1.0 Europe +6% 0.8 0.6 Japan +5% 0.4 0.2 International +26% 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,127m • US: New patient share in 1L at around 70% • EU: EU-5 new patient share in 1
Slide 162: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 1.2 -8% US -9% 1.0 0.8 0.6 0.4 International +5% 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 881m • US: Sales impacted by COVID-19 and purchasing patterns CER=Constant Exchange Rates 162
Slide 163: Lucentis
Lucentis Global sales CER growth Regional sales CER growth CHFbn 1.5 -25% 1.2 0.9 US -25% 0.6 0.3 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 800m • Impacted by switching to Vabysmo, entrance of biosimilars and order patterns CER=Constant Exchange Rates 163
Slide 164: Evrysdi
Evrysdi Global sales CER growth Regional sales CER growth CHFbn 0.9 +101% US +24% 0.8 0.7 Europe +335% 0.6 0.5 0.4 Japan >500% 0.3 International +100% 0.2 0.1 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 793m • US: Strong growth driven by switch and treatment-naïve patie
Slide 165: Ronapreve
Ronapreve CHFbn Global sales CER growth Regional sales CER growth -36% 1.2 International -49% 1.0 Europe -81% 0.8 0.6 Japan 42% 0.4 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 631m • EU: Limited sales potential left as Ronapreve has low activity against Omicron vari
Slide 166: Esbriet
Esbriet Global sales CER growth Regional sales CER growth CHFbn 0.9 -25% US -34% 0.8 0.7 Europe -1% 0.6 0.5 International -22% 0.4 0.3 0.2 0.1 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 590m • US: Generics have entered the market in Q2, rapid erosion expected • EU: Gen
Slide 167: 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 168: Diagnostics Division CER growth by region and customer area
YTD Sep 2022: Diagnostics Division CER growth By Region and Customer Area (vs. 2021) Reported Restatement3 Global EMEA¹ NOA APAC LATAM Global EMEA¹ NOA APAC LATAM CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER 2,3 Core Lab 5,772 5 1,913 6 1,072 2
Slide 169: Diagnostics Division quarterly sales and CER growth
Diagnostics Division quarterly sales and CER growth1 Reported Restatement3 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm % CER Core Lab2,3 1,884 12 1,863 10 1,873 8 1,961 1 1,938 7 1,907 12 1
Slide 170: Diagnostics Division regional sales
YTD Sep 2022: Diagnostics Division regional sales Growth driven by Asia Pacific and North America Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 13,848 Diagnostics Division 6% GLOBAL 808 / -13% EMEA* 6% 20% NAM 4,595 / 28% APAC 33% -3% LATAM 4,522 / 33% 3,923 / 28% EMEA* NAM
Slide 171: Core Lab
Core Lab 2022 vs. 2021 CHFbn CER growth +5% 7.0 6.0 -4% 5.0 +8% 4.0 +6% 3.0 2.0 1.0 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates; underlying growth of Core Lab excluding Roche Information Solutions: +5% 171
Slide 172: Point of Care
Point of Care 2022 vs. 2021 CHFbn CER growth +30% 3.5 3.0 +33% 2.5 -8% -7% 2.0 +39% 1.5 1.0 0.5 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis POC MDx CER=Constant Exchange Rates 172
Slide 173: Molecular Lab
Molecular Lab 2022 vs. 2021 CHFbn CER growth -8% 3.5 3.0 +12% 2.5 -28% 2.0 0% +19% 1.5 -20% 1.0 +5% 0.5 -7% 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 173
Slide 174: Diabetes Care
Diabetes Care 2022 vs. 2021 CHFbn CER growth -3% 1.5 1.2 +12% -4% 0.9 0.6 0.3 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Blood Glucose Monitoring Other CER=Constant Exchange Rates 174
Slide 175: Pathology Lab
Pathology Lab 2022 vs. 2021 CHFbn CER growth +10% 1.2 1.0 +28% 0.8 +4% 0.6 +8% 0.4 0.2 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 175
Slide 176: 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 177: CHF/USD
CHF/USD Monthly averages 1.00 7% 6% 0.90 0% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 Year-To-Date averages 1.00 4% 4% 0.90 2% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 177
Slide 178: CHF/USD
CHF/USD 1.00 Sep YTD 2022 4% 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 2021 avg full year 2022 monthly avg 2021 monthly avg 2022 178
Slide 179: CHF/EUR
CHF/EUR Monthly averages 1.10 -7% -6% 1.05 1.00 -11% 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 Year-To-Date averages 1.10 -5% -6% 1.05 -7% 1.00 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 179
Slide 180: CHF/EUR
CHF/EUR 1.13 Sep YTD 2022 -6% 1.11 1.09 1.07 1.05 1.03 1.01 0.99 0.97 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2021 avg full year 2022 monthly avg 2021 monthly avg 2022 180
Slide 181: Average CHF Exchange Rates
Average CHF Exchange Rates Sep YTD Sep YTD Sep YTD 2022 vs. Sep YTD 2021 2022 2021 USD 0.95 0.91 4% EUR 1.01 1.09 -7% JPY 0.74 0.84 -12% -15% -10% -5% 0% 5% 10% 181
Slide 182: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q3 2022: negative impact of JPY and EUR, positive impact of USD Development of average exchange rates versus prior year period CHF / USD 2.2% 5.9% 5.2% CHF / EUR -4.9% -6.4% -10.0% CHF / JPY -6.9% -10.6% -16.2% Difference in CHF / CER -1.0% 0.4% -2.1% 0.0% growth
Slide 183: Exchange rate impact on sales growth
Exchange rate impact on sales growth YTD Sep 2022: negative impact of JPY and EUR, positive impact of USD Development of average exchange rates versus prior year period CHF / USD 2.2% 4.0% 4.4% CHF / EUR -4.9% -5.7% -7.2% CHF / JPY -6.9% -8.9% -11.5% Difference in CHF / CER -1.0% -0.2% -0.9% 0.0% gr
Slide 184: Doing now what patients need next
Doing now what patients need next