Roche Holding Ltd · SIX:RO
Roche — YTD September 2021 Earnings Presentation
169 slides from Roche's earnings presentation, Oct 20, 2021
Slide 1: Roche
Slide 2: Roche YTD September 2021 sales
Roche YTD September 2021 sales Basel, 20 October 2021
Slide 3: 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 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: YTD Sep 2021 performance; Outlook
YTD Sep 2021 performance Outlook 5
Slide 6: YTD Sep 2021: Continued strong performance; Guidance raised
YTD Sep 2021: Continued strong performance; Guidance raised • Guidance raised: Sales growth to “mid-single digit” from “low- to mid-single digit”, Core EPS growth broadly in line with sales growth • Group sales up +8% – Diagnostics with double digit growth in Q3 (+18%), despite high base, strong rec
Slide 7: YTD Sep 2021: Sales growth driven by Diagnostics Division
YTD Sep 2021: Sales growth driven by Diagnostics Division 2021 2020 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 33.4 34.3 -3 0 Diagnostics Division 13.3 9.7 38 39 Roche Group 46.7 44.0 6 8 CER=Constant Exchange Rates 7
Slide 8: Q3 2021: Strong sales growth
Q3 2021: Strong sales growth 16% 14%* 14% 13% 12% 10% 9% 9% 8% 8% 7% 7% 7% 7% 6% 6% 6% 6% 6% 6% 6% 8% 6% 5% 5% 7% 8% 4% 6% 4% 5% 5% 4% 4% 4% 4% 3% 2% 3% 3% 1% 1% 0% -2% -4% -4% -6% 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 Q2 Q3 Q4 Q1 Q2 Q3 13 13 13 13 14
Slide 9: Q3 2021: Strong business momentum
Q3 2021: Strong business momentum % CER 1st wave 2nd wave 3rd wave +60% Pharmaceuticals +50% +55% +48% +50% • Recovery in Q3 2021 expected to continue in Q4 2021 +40% +40% +32% +28% +29% • Impact from biosimilars, expected to flatten in the +30% +25% +18% coming quarters +20% +18% +24% +7% +20% +10%
Slide 10: YTD Sep 2021 Pharma: New products compensating for biosimilar impact
YTD Sep 2021 Pharma: New products with continued momentum compensating for biosimilar impact CHFm % of Pharma Sales CHFm +8% at CER 21,000 +4,018 +3,717 18,000 52% -118 -951 15,000 40% 12,000 29% -3,961 9,000 21% 46,684 43,979 6,000 3,000 0 YTD Sep 2018 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 YTD 202
Slide 11: YTD Sep 2021 performance; Outlook
YTD Sep 2021 performance Outlook 11
Slide 12: Pharma: Significantly advancing patient care
Pharma: Significantly advancing patient care 39 Breakthrough Therapy Designations received since 2013 Year Molecule Indication 14 new Ph III studies initiated YTD gantenerumab Alzheimer’s disease 2021 Venclexta + azacitidine higher-risk MDS Kadcyla + Tecentriq (KATE 3) in 2L+ HER2+ PDL1+ mBC tiragol
Slide 13: 2021 outlook raised
2021 outlook raised Sales growth to “mid-single digit” from “low- to mid-single digit” Group sales growth1 • Mid-single digit (from low- to mid-single digit) Core EPS growth1 • Broadly in line with sales growth Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates
Slide 14: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 15: YTD Sep 2021: Pharmaceuticals Division sales
YTD Sep 2021: Pharmaceuticals Division sales New products compensating for biosimilars despite COVID-19 impact 2021 2020 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 33,379 34,317 -3 0 United States 16,707 18,389 -9 -5 Europe 6,610 6,268 5 3 Japan 3,186 2,802 14 20 International 6,876 6,85
Slide 16: Continued portfolio rejuvenation
YTD Sep 2021: Continued portfolio rejuvenation >50% of sales from new products* Ronapreve n/a Hemlibra 42% Actemra / RoActemra 30% Ocrevus 17% Tecentriq 27% Evrysdi >500% Phesgo >500% Kadcyla 16% Alecensa 19% Perjeta 4% Enspryng >500% Polivy 35% Gazyva 8% Xolair 2% Xofluza -120% Esbriet -4% US TNKas
Slide 17: Pharma growth dynamic excl. AHR further improving
Pharma growth dynamic excl. AHR* further improving Quarterly sales development Pharmaceuticals Division (excl. AHR) CHFm 12,000 10,000 Pharma other 8,000 Infectious diseases Ophthalmology 6,000 Immunology Haemophilia A 4,000 Neuroscience Oncology 2,000 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 18: Oncology still impacted by biosimilars & COVID-19
YTD Sep 2021: Oncology still impacted by biosimilars & COVID-19 YoY CER growth HER2 franchise Phesgo (>500%) • Kadcyla (+16%) with growth in all regions due to adjuvant BC HER2 franchise Herceptin Perjeta (+4%) -6% • Perjeta (+4%) growth cannibalized by Phesgo launch Kadcyla (+16%) Tecentriq Tecentr
Slide 19: Hematology franchise: first positive Ph III in curative setting
Hematology franchise First positive Ph III (POLARIX) in a curative setting in the last 20 years Ph III (POLARIX) trial design in 1L DLBCL Shaping the standard of care in NHL • Positive Ph III (POLARIX) results for Polivy + R-CHP in 1L DLBCL • Early filings for glofit in 3L+ DLBCL in Q1 2022 and for
Slide 20: Giredestrant: encouraging Ph II neoadjuvant interim results
HR+/HER2- breast cancer: Giredestrant a next generation SERD Encouraging Ph II neoadjuvant interim results presented Selective ER degrader Ph II (coopERA) interim results in Trial program (SERD) neoadjuvant setting Ki67 reduction and complete cell cycle arrest (CCCA) • Potentially best-in-class effi
Slide 21: Tecentriq overview
Tecentriq overview: Growth driven by first-in-class indications Landmark results in adj. NSCLC filed globally and US approval achieved CHFm YoY CER growth Tecentriq Q3 update 1,000 +23% 900 +31% Lung franchise (NSCLC, SCLC) +49% +26% 800 +99% +54% +35% • EU: Growth driven by 1L SCLC 700 +136% 600 •
Slide 22: Hemophilia A Franchise: Hemlibra growing strongly
Hemophilia A Franchise: Hemlibra growing strongly 31% US/EU-5 patient share reached CHFm YoY CER growth 900 800 +37% +58% Hemophilia Q3 update 700 +45% +33% • US/EU: Gaining market share in non-inhibitors +57% 600 +146% • #1 prescribed prophylaxis in the US for people with +59% 500 +313% Hemophilia
Slide 23: Immunology franchise remains impacted by COVID-19
Immunology franchise remains impacted by COVID-19 CHFm YoY CER growth Immunology Q3 update 2,500 +13% Actemra (+57%) +5% +7% +1% • WHO recommends IL-6 inhibitors for hospitalized COVID-19 patients 2,000 • Remains leading RA monotherapy in EU-5; shift from IV to SC 1,500 Esbriet (-5%) • COVID-19 impa
Slide 24: MS franchise: Ocrevus US market share increases
MS franchise: Ocrevus total US market share increases to 29% MS late stage development programs progressing well CHFm YoY CER growth 1,500 Q3 update +7% • US impacted by SARS-CoV-2 delta wave +37% +16% +31% 1,250 +38% +55% +10% • Higher dose Ocrevus: Ph III (MUSETTE) in RMS and Ph III +48% +12% 1,00
Slide 25: SMA franchise: Evrysdi with strong launches
SMA franchise: Evrysdi with strong US and EU launches Most prescribed US treatment with ~20% total share after <14 months CHFm YoY CER growth Q3 update 200 • ~4,000 patients treated world wide (commercial, clinical trials, >500% compassionate use) 150 • US: >550 HCPs from >400 sites have prescribed
Slide 26: SMA franchise: Anti-latent myostatin recycling antibody
SMA franchise: Anti-latent myostatin recycling antibody Ph II/III combination study with Evrysdi initiated Anti-latent myostatin recycling Preclinical GYM329 data in mouse models of muscle disease antibody (GYM329) Efficient inhibition of latent Increase in muscle mass and strength myostatin, but no
Slide 27: Our replace and extend strategy is progressing well
Our replace and extend strategy is progressing well Entering new Replace ongoing franchises franchises Strong news flow ahead (data readout) tiragolumab + Tec (SKY-1) Oncology: in 1L PDL1-high NSCLC Gazyva, Tecentriq (mUC, SCLC, tiragolumab + Tec (SKY-2) Venclexta, HCC, mM, adj. NSCLC), in 1L ES-SCL
Slide 28: 2021: Key late-stage news flow
2021: Key late-stage news flow* Compound Indication Milestone Xofluza Healthy patients; High risk patients; Post exposure EU approval Evrysdi SMA type 1/2/3 EU approval faricimab DME/nAMD US/EU joint filing (DME+AMD) Regulatory Tecentriq 1L PDL1+ NSCLC EU approval Venclexta + azacitidine 1L unfit AM
Slide 29: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 30: YTD Sep 2021: Diagnostics Division sales
YTD Sep 2021: Diagnostics Division sales Very strong growth driven by COVID-19 and routine testing 2021 2020 Change in % CHFm CHFm CHF CER Diagnostics Division 13,305 9,662 38 39 Core Lab 5,610 4,487 25 26 Molecular Lab 3,454 2,578 34 36 Point of Care 2,058 541 280 279 Diabetes Care 1,294 1,261 3 4
Slide 31: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Maintaining strong routine testing growth 55% 48% Diagnostics Division sales growth 31% 28% Routine sales growth 1 18% 17% 18% 5% 11% 2% 1% -2% -5% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 -17% COVID-19 Q2: Q3: Q4: Q1: Q2: Q3: Q1: 0.1bn sales 0.6bn 0.6bn
Slide 32: Diagnostics Division regional sales
YTD Sep 2021: Diagnostics Division regional sales Very strong growth in all regions North America +18% EMEA1 ~24% of divisional sales +54% ~43% of divisional sales Asia Pacific Latin America +35% +63% ~27% of divisional sales ~6% of divisional sales Growth rates at CER (Constant exchange Rates); 1 E
Slide 33: Diagnostics Division highlights
YTD Sep 2021: Diagnostics Division highlights Very strong growth across all businesses YoY CER growth Core Lab1 +26% • Immunodiagnostics (+29%) • Clinical Chemistry (+21%) Molecular +36% • Virology (+34%) Lab • POC Molecular (+565%) Point of • POC Immunodiagnostics (+1,469%) +279% Care Diabetes +4%
Slide 34: Elecsys GAAD receives CE mark
Elecsys® GAAD receives CE mark First IVD algorithm for early detection of hepatocellular carcinoma Diagnosis of early stage HCC: AFP vs. GAAD1 HCC N=71, Control N=208 • 830K deaths per year caused by hepatocellular carcinoma2 • Algorithm combines gender and age with the results of two blood-based bi
Slide 35: Claim extension of Elecsys Brahms PCT assay
Claim extension of Elecsys® Brahms PCT assay Monitoring patients on antibiotic therapies improves outcomes and reduces cost of care Higher patient impact More patient benefit Strongly increasing our outreach Better care and treatment for patients on antibiotics NEW 50 420 million1 million2 Diagnosis
Slide 36: Launch of three respiratory test panels on cobas 6800/8800
Launch of three respiratory test panels on cobas 6800/8800 Breaking the barriers of syndromic testing Empowered by TAGS 5 channels = 15 targets • High unmet medical need: TAGS1 differential diagnosis between viruses • Utilizes the cobas® 6800/8800 installed base Channel 1 Channel 2 Channel 3 Channel
Slide 37: Definitive share purchase agreement with TIB Molbiol
Definitive share purchase agreement with TIB Molbiol1 >45 CE IVD & >100 RUO tests available on existing Roche platforms Respiratory Gastroenteritis Carbapenemase Tropical Coronavirus Mutations Mutations Cont. Influenza Resp. Virus Parasites Bacteria Virus KPC Zika* MERS Coronavirus SARS-CoV-2 Spike
Slide 38: Roche Digital Pathology
Roche Digital Pathology Launching new breast panel algorithms and providing a powerful open environment for AI integration for pathologists Expanding portfolio offering • Enables the integration of third party algorithms into the NAVIFY Digital Pathology software1 Launched in 2021 • Provides a broad
Slide 39: Key launches 2021
Key launches 2021 Area Product Description Market1 cobas® pure integrated solutions Low-to-medium volume SWA CE Core Lab cobas® pro integrated solutions New high throughput configurations of the cobas pro instrument US & CE Point of Care cobas® pulse Successor of Accu-Chek® Inform II CE Instruments
Slide 40: Finance
Finance Alan Hippe Chief Financial Officer
Slide 41: YTD Sep 2021: Highlights
YTD Sep 2021: Highlights Sales • Group sales growth (+8%) driven by Diagnostics (+39%) Currency impact on sales • Negative currency impact due to most currencies, particularly USD Growth rates at CER (Constant exchange Rates) 41
Slide 42: YTD Sep 2021: Group Sales
YTD Sep 2021: Group Sales CER sales up by +8% driven by Diagnostics Division Absolute values in CHFm at Constant Exchange Rates (avg full year 2020); 1 avg. full year 2021 to avg. YTD September 2021 fx impact 42
Slide 43: Currency impact expected to reduce as 2021 progresses
Currency impact expected to reduce as 2021 progresses CHF / USD -7% -6% -5% -4% 0.97 0.97 0.95 Average YTD 2020 0.94 Assuming the 30 Sep 2021 exchange rates remain stable until end of 2021, 0.91 0.91 0.92 0.90 2021 impact 1 is expected to be (%p): Assumed avg. YTD 2021 0.89 0.90 0.93 0.92 0.90 0.91
Slide 44: Upcoming Virtual Event: Digitalization along the value chain
Upcoming Virtual Event Presenters: Digitalization along Alan Hippe, Chief Financial and IT Officer Roche Mark McCarthy, Executive Director Human Genetics, gRED the value chain Christian Gossens, Digital Biomarkers, Global Area Head, pRED Wednesday, 17 November 2021 Jacqueline Law, Vice President, He
Slide 45: 2021 outlook raised
2021 outlook raised Sales growth to “mid-single digit” from “low- to mid-single digit” Group sales growth1 • Mid-single digit (from low- to mid-single digit) Core EPS growth1 • Broadly in line with sales growth Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates
Slide 46: Changes to the development pipeline
Changes to the development pipeline Q3 2021 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 2 NMEs: 2 AIs: 1 NME: RG6035 brainshuttle (BS)-CD20 - multiple RG6149 astegolimab (Anti-ST2) - chronic RG6171 giredestrant (SERD) – ER+ adj BC RG6413+RG6412 Ronapreve sclero
Slide 47: Roche Group development pipeline
Roche Group development pipeline Phase I (41 NMEs + 12 AIs) Phase II (26 NMEs + 12 AIs) RG6007 HLA-A2-WT1 x CD3 AML CHU FIXa x FX haemophilia tiragolumab + T NSCLC RG6026 glofitamab monotherapy and combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T + chemo 1L non-squamous NSCLC RG6
Slide 48: Roche Group development pipeline
Roche Group development pipeline Phase III (13 NMEs + 39 AIs) Registration (4 NMEs + 4 AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC Venclexta r/r MM t(11:14) Gavreto (pralsetinib) 1 RET+ NSCLC RG3502 RG7601 RG6396 Kadcyla + T HER-2+ eBC high-risk Venclexta + azacitidine 1L MDS Gavreto (pralsetinib) 2 RET+
Slide 49: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III RG6026 glofitamab + chemo 2L DLBCL RG6180 autogene cevumeran 1L melanoma rhPTX-2 tiragolumab + T semorinemab RG6058 RG6354 (PRM-151) RG6100 1L PD-L1+ cervical ca Alzheimer’s myelofibrosis tiragolumab + T brain shuttle glof
Slide 50: AI submissions for existing products
AI submissions for existing products Projects in phase II and III Xofluza RG6152 direct transmission Xofluza New Molecular Entity (NME) Immunology Neuroscience RG6152 influenza, pediatric Additional Indication (AI) Infectious Diseases Ophthalmology (0-1 year) Oncology / Hematology Metabolism Other X
Slide 51: Major pending approvals 2021
Major pending approvals 2021 US EU China Japan-Chugai PDS with ranibizumab Gavreto (pralsetinib) Tecentriq faricimab RG6321 wAMD RG6396 RET+ NSCLC RG7446 NSCLC adj RG7716 DME Filed April 2021 Filed May 2020 Filed June 2021 Filed June 2021 faricimab Tecentriq faricimab RG7716 DME RG7446 NSCLC adj RG7
Slide 52: Major granted approvals 2021
Major granted approvals 2021 US EU China Japan-Chugai Alecensa (BFAST) Xofluza Xofluza Polivy RG7853 1L NSCLC ALK+ RG6152 influenza, otherwise healthy RG6152 influenza, otherwise healthy RG7596 r/r DLBCL Jan 2021 Jan 2021 April 2021 March 2021 Actemra Xofluza Xofluza Evrysdi RG1569 SSc-ILD RG6152 in
Slide 53: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 53
Slide 54: Hemlibra
Hemlibra Factor VIII mimetic for treatment of hemophilia A Hemophilia A patients Hemophilia A patients with and without inhibitors to Factor VIII, Indication without inhibitors to factor VIII dosing every 4 weeks Phase III Phase III Phase/study HAVEN 3 HAVEN 4 # of patients N=135 N=46 Patients on FV
Slide 55: Hemlibra
Hemlibra 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 Patients with Hemoph
Slide 56: Alecensa
Alecensa 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 600 mg BID Design Oncology ARM B: Crizotinib 250mg B
Slide 57: Kadcyla
Kadcyla First ADC for HER2-positive breast cancer HER2-positive early breast cancer HER2-positive early breast cancer Indication 2L+ HER-2 positive PD-L1 positive mBC high-risk patients high-risk patients Phase III Phase III Phase III Phase/study KATHERINE KATE 3 ASTEFANIA # of patients N=1,484 N=35
Slide 58: Perjeta
Perjeta First-in-class HER2 dimerization inhibitor Indication Adjuvant HER2-positive breast cancer HER2-positive early breast cancer subcutaneous co-formulation Phase III Phase III Phase II Phase/study APHINITY FeDeriCa PHranceSCa # of patients N=4,803 N=500 N=160 ARM A: Perjeta (840mg loading, 42
Slide 59: Tecentriq – lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L extensive-stage SCLC 2L NSCLC previously treated with an immune checkpoint inhibitor Phase III Phase/study Phase Ib CONTACT-01 # of patients N=62 N=350 Carboplatin and etoposide +/- Tecentriq followed by maintenance ARM A: Tec
Slide 60: Tecentriq – lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer Indication Adjuvant NSCLC Neoadjuvant 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 chemotherapy ARM A: Tecentriq
Slide 61: Tecentriq – lung cancer
Tecentriq 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 N=660 N=375 Cohort A: ALK+ (Alecensa) Phase Ib Cohort B: RET+ (Alecensa) Dose finding, Tecentriq SC followed by Tecentriq IV Cohort
Slide 62: Tecentriq – SCCHN and melanoma
Tecentriq Anti-PD-L1 cancer immunotherapy – SCCHN and melanoma First-line BRAFv600 mutation-positive metastatic or unresectable Indication Adjuvant squamous cell carcinoma of the head and neck locally advanced melanoma Phase III Phase III Phase/study IMvoke010 IMspire150 TRILOGY1 # of patients N=400
Slide 63: Tecentriq – UC
Tecentriq Anti-PD-L1 cancer immunotherapy – UC High-risk non-muscle-invasive ctDNA+, high-risk muscle-invasive Indication 1L metastatic urothelial carcinoma bladder cancer bladder cancer Phase III Phase III Phase III Phase/study IMvigor130 ALBAN IMvigor011 # of patients N=1,200 N=516 N=495 ARM A:
Slide 64: Tecentriq – renal cell cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – renal cell cancer Advanced renal cell carcinoma after immune checkpoint inhibitor Indication Adjuvant renal cell carcinoma treatment Phase III Phase III Phase/study IMmotion010 Contact-031 # of patients N=778 N=500 ARM A: Tecentriq monotherapy ARM A: T
Slide 65: Tecentriq – HCC
Tecentriq Anti-PD-L1 cancer immunotherapy – HCC Indication 1L hepatocellular carcinoma Adjuvant hepatocellular carcinoma Phase III Phase III Phase/study IMbrave150 IMbrave050 # of patients N=501 N=662 ARM A: Tecentriq plus Avastin ARM A: Tecentriq plus Avastin ARM B: Sorafenib ARM B: Active
Slide 66: Tecentriq – breast cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – breast cancer Previously untreated metastatic Indication triple negative breast cancer Phase III Phase III Phase/study IMpassion130 IMpassion132 # of patients N=900 N=572 ARM A: Tecentriq plus nab-paclitaxel ARM A: Tecentriq plus capecitabine or carbo/
Slide 67: Tecentriq – breast cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – breast cancer Indication Neoadjuvant triple negative breast cancer Adjuvant triple negative breast cancer Phase III Phase III Phase/study IMpassion031 IMpassion030 # of patients N=324 N=2,300 ARM A: Tecentriq plus nab-paclitaxel ARM A: Tecentriq + pacl
Slide 68: Venclexta – CLL
Venclexta Novel small molecule Bcl-2 selective inhibitor – CLL Untreated CLL patients with Indication Relapsed or refractory CLL Untreated fit CLL patients coexisting medical conditions Phase III Phase III Phase III Phase/study CLL14 MURANO CristaLLo # of patients N=432 N=391 N=165 ARM A: Venclext
Slide 69: Venclexta – MM
Venclexta Novel small molecule Bcl-2 selective inhibitor – MM Indication Relapsed or refractory multiple myeloma Phase III Phase/study Phase I Phase Ib/II CANOVA # of patients N=166 N=120 N=244 Dose escalation cohort: Venclexta plus carfilzomib plus dexamethasone Venclexta plus dexamethazone v
Slide 70: Venclexta – AML
Venclexta Novel small molecule Bcl-2 selective inhibitor – AML Indication Relapsed or refractory AML Relapsed or refractory hematological malignancies Phase/study Phase I Phase I # of patients N=52 N=86 Venclexta in combination with gilteritinib Venclexta plus AMG176 dose escalation Dose expan
Slide 71: Venclexta – MDS
Venclexta Novel small molecule Bcl-2 selective inhibitor – MDS Relapsed or refractory myelodysplastic Newly diagnosed higher-risk Indication Treatment-naive myelodysplastic syndromes syndromes myelodysplatic syndrome Phase III Phase/study Phase Ib Phase Ib VERONA # of patients N=70 N=137 N=500 Cohor
Slide 72: Polivy
Polivy (polatuzumab vedotin) ADC targeting CD79b to treat B cell malignancies Relapsed or refractory Indication 1L DLBCL FL and DLBCL Phase III Phase/study Phase Ib/II POLARIX # of patients N=329 N=875 PIb: Dose escalation ARM A: Polatuzumab vedotin plus R-CHP PhII: Polatuzumab vedotin plus BR
Slide 73: Rozlytrek
Rozlytrek (entrectinib) CNS-active and selective inhibitor of NTRK/ROS1 Locally Advanced or Metastatic tumors with Locally Advanced or Metastatic tumors with Pediatric tumors with NTRK 1/2/3, ROS-1 Indication ROS1 gene rearrangement NTRK1/2/3 gene rearrangement or ALK rearrangement Phase II Phase II
Slide 74: 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 1: Gavreto 30-600mg dose-escalation Arm
Slide 75: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized mAb 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 treatment period: 96
Slide 76: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized mAb selectively targeting CD20+ B cells Relapsing and primary progressive multiple sclerosis (RMS & Indication Primary progressive multiple sclerosis (PPMS) PPMS) Phase IIIb Phase IIIb Phase/study ENSEMBLE PLUS ORATORIO-HAND # of patients N=1225 N ~ 1000 • Sub
Slide 77: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized mAb selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) Phase IIIb Phase IIIb Phase/study GAVOTTE MUSETTE # of patients N ~ 699 N ~ 786 120-week treatment period: 120-week treatment pe
Slide 78: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy 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 spinal muscular Rand
Slide 79: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy Phase II Phase/study RAINBOWFISH # of patients N=25 Open-label, single-arm, multicenter study in infants aged from birth to 6 weeks who have been genetically diagnosed with SMA but are not yet presenting with
Slide 80: 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=70 (adults); N=6 (adolescents) Satralizumab as monotherapy: Add-on therapy of sa
Slide 81: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Generalised Myasthenia Gravis Phase III Phase/study Luminesce # of patients N=240 • Group A: Satralizumab plus SoC • Group B: Placebo plus SoC Design Neuroscience Mean change from baseline in total M
Slide 82: Gazyva
Gazyva (obinutuzumab) 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: Obinutuzumab 1000mg IV plus ARM A: Obinutuzumab 1000 mg IV (six doses ARM A: Obinutuzu
Slide 83: Actemra/RoActemra
Actemra/RoActemra (RG-1569) 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: tocilizumab plus standard of care Arm A: remdesivir plus tocilizumab Arm B: placebo plus
Slide 84: Actemra/RoActemra
Actemra/RoActemra (RG-1569) 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 tocilizumab plus standard of care Conducted in sites known to provide critical care to
Slide 85: Xolair
Xolair Humanized mAb that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=225 • Xolair by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks Immunology Design Primary endpoint • Number of participants who successfully cons
Slide 86: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188 ) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase/stud Phase III Phase III Phase IIIb y miniSTONE 1 (0-1 year old) miniSTONE 2 (1-12 years old ) CENTERSTONE # of N=3,160 N=30 N=176 patients • Xofluza on Day 1 (based
Slide 87: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 87
Slide 88: Ipatasertib
Ipatasertib (RG7440, GDC-0068) Highly selective small molecule inhibitor of Akt Prostate cancer previously treated with Indication 1L castration-resistant prostate cancer Advanced prostate cancer and solid tumors androgen receptor-targeted therapy Phase III Phase/study Phase Ib Phase Ib IPATential15
Slide 89: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication 1L NSCLC PD-L1 TPS>50% 1L ES-SCLC Stage III unresectable 1L NSCLC Phase III Phase III Phase III Phase/study SKYSCRAPER-01 SKYSCRAPER-02 SKYSCRAPER-03 # of patients N=500-560 N=4
Slide 90: 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 Phase II Phase II Phase II Phase/study SKYSCRAPER-04 SKYSCRAPER-05 SKYSCR
Slide 91: 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 1L esophageal cancer squamous cell head and neck carcinoma Phase III Phase III Phase II Phase/study SKY
Slide 92: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT R/R Multiple Myeloma (MM) or R/R B-cell Indication Solid tumors NSCLC NHL Phase II Phase/study Phase I Phase l CITYSCAPE # of patients N=540 N=135 N=52 Phase Ia: Dose escalation and expa
Slide 93: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory Non-Hodgkin’s lymphoma 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 expan
Slide 94: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Relapsed/refractory DLBCL and High-Grade Indication Non-Hodgkin’s lymphoma 2L+ SCT-ineligible DLBCL Large B-Cell Lymphoma Phase III Phase/study Phase Ib Phase Ib STARGLO Part I: 15-60 # of patients
Slide 95: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 3L+ FL, 3L+ DLBCL & other R/R NHL 1L DLBCL R/R DLBCL Phase/study Phase I/II Phase Ib/II Phase Ib # of patients N=746 N=160 N=262 Dose escalation study of mosunetuzumab as Mosunetuz
Slide 96: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L DLBCL & 2L DLBCL following 1L induction R/R 2L+ FL Phase/study Phase I Phase Ib # of patients N=92 + 80 (cohort C) N=27 Cohort A: Mosunetuzumab monotherapy (after a response to pr
Slide 97: Inavolisib
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA mutant solid tumors and metastatic Indication PIK3CA-mutant HR+ mBC ER+ HER2-neg breast cancer Phase III Phase/study Phase I INAVO120 # of patients N=400 N=156 Arm A: GDC-0077 plus palbociclib plus fulve
Slide 98: 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 Neoadjuvant ER+ breast cancer cancer Phase II Phase/study Phase I Phase I coopERA Breast Cancer # of patients N=2
Slide 99: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator 2L/3L ER+/HER2-negative Indication 1L ER+ metastatic breast cancer Adjuvant ER+ breast cancer metastatic breast cancer Phase II Phase III Phase III Phase/study acelERA Breast Cancer persevERA Breast Can
Slide 100: rhPTX-2
rhPTX-2 (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-controlled Randomized, double-blind, placebo-con
Slide 101: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase inhibitor Indication (BTKi) Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) Phase III Phase III Phase III Phase/study FENtrepid FENhance 1 FENhance 2 # of patients N=
Slide 102: Etrolizumab
Etrolizumab (RG7413) Humanized mAb against beta 7 integrin Indication Moderately to severely active Crohn’s disease Moderately to severely active Crohn’s disease Phase III Phase III Phase/study BERGAMOT JUNIPER Induction and maintenance study Open label extension study for BERGAMOT # of patients N=1
Slide 103: Crovalimab
Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) Phase I/II Phase/study COMPOSER # of patients N=59 Healthy volunteers and treatment naïve and pretreated patients with PNH: Part 1: single ascending dose study in h
Slide 104: Crovalimab
Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal Nocturnal Hemoglobinuria Paroxysmal Nocturnal Hemoglobinuria Paroxysmal Nocturnal Hemoglobinuria Indication (PNH) patients switching from a C5 (PNH) (PNH) inhibitor C5 inhibitor naive patients C5 inhibitor na
Slide 105: Crenezumab
Crenezumab (RG7412) Humanized mAb targeting all forms of A 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 ARM B: PSEN1 E280A mutation carriers receive placebo Design
Slide 106: Gantenerumab
Gantenerumab (RG1450) Fully human mAb binding aggregated forms of A 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 subcutaneous treatment period: 104-week subcutaneous treatment
Slide 107: Gantenerumab
Gantenerumab (RG1450) Fully human mAb binding aggregated forms of A Indication Prodromal Alzheimer’s disease Mild Alzheimer’s disease Phase II/III Phase III Phase/study SCarlet RoAD Marguerite RoAD # of patients N=799 N=389 104-week subcutaneous treatment period: 104-week subcutaneous treatment per
Slide 108: 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 RG6042 administered intrathecally to adult Patients from phase I are enrolled into OLE p
Slide 109: 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: RG6042 120mg bimonthly Open-Label Extension study in patients participating in prior R
Slide 110: Faricimab
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 ARM B:
Slide 111: Faricimab
Faricimab (RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Neovascular age related macular degeneration (nAMD) Phase III Phase III Phase/study TENAYA LUCERNE # of patients N=671 N=658 ARM A: Faricimab 6.0mg Q16 flex after 4 initiating doses (IDs) ARM A: Faricimab 6
Slide 112: Faricimab
Faricimab (RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Macular edema secondary to branch retinal vein occlusion Macular edema secondary to central retinal vein occlusion Phase III Phase III Phase/study BALATON COMINO # of patients N=570 N=750 ARM A: Faricimab, q4
Slide 113: Port Delivery System with ranibizumab
Port Delivery System with ranibizumab First eye implant to achieve sustained delivery of a biologic medicine Indication wAMD Phase III Phase II+III extension Phase IIIb Phase/study Archway Portal Velodrome # of patients N=418 N=500 N=442 ARM A: PDS with ranibizumab every 24 weeks Patients from L
Slide 114: Port Delivery System with ranibizumab
Port Delivery System with ranibizumab First eye implant to achieve sustained delivery of a biologic medicine Diabetic retinopathy without Indication DME center-involved diabetic macular edema Phase III Phase III Phase/study Pagoda Pavilion # of patients N=545 N=160 ARM A: PDS with ranibizumab ever
Slide 115: AT-527
AT-527 (RG6422) Viral RNA polymerase inhibitor Indication Non-hospitalised adult patients with mild or moderate COVID-19 Adult patients SARS-COV-2 positive in an outpatient setting Phase II Phase III Phase/study MOONSONG MORNINGSKY # of patients N=220 N=1,386 ARM A: AT-527 Arm A: AT-527 550mg BI
Slide 116: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 116
Slide 117: pRED oncology development programs -1
pRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology TYRP1 x CD3 (RG6232) Melanoma I 210 FPI Q4 2020 NCT04551352 FPI Q2 2018 Solid tumors I ~150 Data presented at ESMO 2020 FAP-4-1BBL (RG7827) Recruitment completed Q2 2021 FPI July 2021 3L+ MSS
Slide 118: 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 I 160 FPI Jan 2021 NCT04642365 tumors TLR7 agonist (4) (RG6115) Hepatocellular carcinoma I 100 FPI July 2
Slide 119: pRED neuroscience development programs
pRED neuroscience development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience Brain Shuttle-gantenerumab Alzheimer's disease II ~120 FPI Q1 2021 NCT04023994 (BS-gantenerumab, RG6102) Brain Shuttle-CD20 (BS-CD20, ISRCTN16295 Multiple sclerosis I 30 FPI Q3 2021 RG603
Slide 120: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology Ulcerative Colitis Ib 65 FPI Q2 2019 NCT03943550 IgG-IL2 (RG7835) NCT04790916 Autoimmune diseases II 84 FPI Q2 2021 GOLDSTONE Ophthalmology NME (RG6179)1 DME I 50 FPI July 2
Slide 121: 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 FPI Q4 2016 Data presented at EASL 2018, 2019 & 2020 I/II 192 Part 1
Slide 122: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 122
Slide 123: gRED oncology development programs
gRED oncology development programs Molecule Indication Phase # of patients Status CT Identifier Oncology Metastatic solid tumors with KRAS KRAS G12C (RG6330) I 108 FPI Q3 2020 NCT04449874 G12C mutation cevostamab FPI Q3 2017 R/R multiple myeloma I 300 NCT03275103 (anti-FcRH5 x CD3; RG6160) Data pres
Slide 124: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology Inflammatory diseases Ib 90 FPI Q2 2016 NCT02749630 efmarodocokin alfa Inflammatory bowel disease II 195 FPI Q4 2018 NCT03558152 (IL-22Fc, RG7880) aGVHD lb 18 FPI Q4 2020 NC
Slide 125: gRED neuroscience and metabolic diseases development programs
gRED neuroscience and metabolic 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) Semorinemab (RG6100)1 Data presented at CTAD 2020 Mi
Slide 126: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 126
Slide 127: Hemophilia A 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 128: Choroideremia
Choroideremia Unique gene therapy platform SPK-7001 Molecule (RG6367) Indication Choroideremia Phase/study Phase I/II # of patients N=15 Safety study in subjects with CHM (choroideremia) gene mutations Ophthalmology Design Safety and tolerability Primary endpoint FPI Q1 2015 Status Recruitme
Slide 129: 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 Metabolic diseases Gene transfer study for late-onset Pompe disease Design Safety Primary endpoint Status FPI Q4 2020 CT Identifier NCT04093349 129
Slide 130: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 130
Slide 131: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm YTD Sep 2020 YTD Sep 2021 % change CER Pharmaceuticals Division 34,317 33,379 0 United States 18,389 16,707 -5 Europe 6,268 6,610 +3 Japan 2,802 3,186 +20 International 6,858 6,876 +2 Diagnostics Division 9,662 13,305 +39 United States 2,503 2,84
Slide 132: Pharma Division sales YTD Sep 2021 Top products
Pharma Division sales YTD Sep 2021 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 3,721 17 2,779 11 689 37 - - 253 50 Perjeta 2,974 4 1,079 -1 847 -3 200 -4 848 24 Actemra / RoActemra 2,690 30 1,300 44 663 14 285 12 442 29 Tecentri
Slide 133: Pharma Division sales YTD Sep 2021 New products
Pharma Division sales YTD Sep 2021 New products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Erivedge 196 -3 128 -5 44 -6 - - 24 18 Perjeta 2,974 4 1,079 -1 847 -3 200 -4 848 24 Kadcyla 1,460 16 613 4 508 23 94 57 245 26 Gazyva 501 8 232 9 167 5 47 -3 5
Slide 134: Pharma Division CER sales growth: Global top products
Pharma Division CER sales growth1 in % Global top 20 products Q1/20 Q2/20 Q3/20 Q4/20 Q1/21 Q2/21 Q3/21 Ocrevus 38 12 37 10 16 31 7 Perjeta 22 12 17 20 2 7 2 Actemra / RoActemra 30 40 27 29 22 12 57 Tecentriq 99 54 49 35 26 31 23 Avastin -13 -24 -30 -35 -40 -40 -37 Hemlibra 146 59 57 45 33 58 37 Her
Slide 135: 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 5 9 28 0 20 37 40 36 - - - - 55 77 41 35 Perjeta 0 -2 -3 2 4 -3 2 -8 0 -11 -2 0 135 23 34 16 Actemra / RoActemra 19 10 3 143 24 12 20 10 1 -2 15 25 1
Slide 136: CER sales growth (%) Quarterly development
CER sales growth (%) Quarterly development CER=Constant Exchange Rates 136
Slide 137: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 4.0 +17% US +11% 3.5 3.0 2.5 2.0 Europe +37% 1.5 1.0 International +50% 0.5 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 3,721m • US: Moving into earlier lines displacing orals; COVID-19 impact still felt •
Slide 138: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 3.5 +4% US -1% 3.0 Europe -3% 2.5 2.0 1.5 Japan -4% 1.0 International +24% 0.5 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 2,974m • US: Patients with residual disease being switched to Kadcyla; Cannibalizat
Slide 139: Actemra / RoActemra
Actemra / RoActemra Global sales CER growth Regional sales CER growth CHFbn 3.0 +30% US +44% 2.5 Europe +14% 2.0 1.5 Japan +12% 1.0 0.5 International +29% 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 2,690m • US: Increased demand for SC formulation (home administration)
Slide 140: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 3.0 +27% US +14% 2.5 Europe +17% 2.0 1.5 Japan +81% 1.0 International +66% 0.5 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 2,477m • US: Growth driven by first-in-class launches in 1L HCC and 1L SCLC • EU:
Slide 141: Avastin
Avastin Global sales CER growth Regional sales CER growth CHFbn 6.0 -39% US -48% Europe -69% 5.0 4.0 Japan -1% 3.0 2.0 International -12% 1.0 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 2,390m • US: Decline due to biosimilars • EU: Decline due to biosimilars • Japan: Li
Slide 142: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 2.5 +42% US +35% Europe +65% 2.0 1.5 Japan +21% 1.0 International +138% 0.5 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 2,172m • US: Continued share gains in non-inhibitor patients • EU: Continued share ga
Slide 143: Herceptin
Herceptin CHFbn Global sales CER growth Regional sales CER growth 6.0 -32% US -55% Europe -24% 5.0 Japan -39% 4.0 3.0 2.0 International -15% 1.0 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 2,061m • US: Biosimilar erosion; Switching of patients with residual disease to K
Slide 144: MabThera / Rituxan
MabThera / Rituxan CHFbn Global sales CER growth Regional sales CER growth 6.0 -41% US -47% 5.0 Europe -35% 4.0 Japan -34% 3.0 2.0 International -26% 1.0 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 1,968m • US: Decline due to biosimlars • EU: Decline due to biosimlars •
Slide 145: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +16% US +4% 1.6 1.4 1.2 1.0 Europe +23% 0.8 0.6 Japan +57% 0.4 0.2 International +26% 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 1,460m • US: Uptake in adjuvant eBC in patients with residual disease after
Slide 146: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 1.6 +2% 1.4 1.2 1.0 US +2% 0.8 0.6 0.4 0.2 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 1,416m • US: Xolair remains market leader in growing biologics asthma market; Growth driven by chronic idiopathic urtica
Slide 147: Ronapreve
Ronapreve CHFbn Global sales CER growth Regional sales CER growth n/a 1.2 1.0 Europe n/a 0.8 0.6 Japan n/a 0.4 0.2 International n/a 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 1,084m • EU: Government sales mainly in Germany, Italy, France • Japan: Government sales star
Slide 148: Lucentis
Lucentis Global sales CER growth Regional sales CER growth CHFbn 1.6 -5% 1.4 1.2 1.0 US -5% 0.8 0.6 0.4 0.2 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 1,017m • Volume growth off-set by price decline; First biosimilar expected by mid 2022 • Overall market shares stable
Slide 149: Alecensa
Alecensa CHFbn Global sales CER growth Regional sales CER growth +19% US +7% 1.0 Europe +12% 0.8 0.6 Japan +10% 0.4 0.2 International +47% 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 988m • US: Patient share in 1L growing >70% • EU: Growth driven by 1L; EU-5 new patient
Slide 150: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 1.2 -5% US -5% 1.0 0.8 0.6 0.4 International +4% 0.2 0.0 YTD Sep 18 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 2021 sales of CHF 921m • US: Decline due to COVID-19 impact CER=Constant Exchange Rates 150
Slide 151: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 151
Slide 152: Diagnostics Division CER growth by region and customer area
YTD Sep 2021: Diagnostics Division CER growth By Region and Customer Area (vs. 2020) Global EMEA¹ North America Asia-Pacific Latin America % CER % CER % CER % CER % CER CHFm growth CHFm growth CHFm growth CHFm growth CHFm growth 2 Core Lab 5,610 26 1,977 28 1,006 17 2,237 25 390 47 Molecular Lab 3,4
Slide 153: Diagnostics Division quarterly sales and CER growth
Diagnostics Division quarterly sales and CER growth1 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab 2 1,439 -17 1,666 -3 1,707 -2 1,765 31 1,961 36 1,884 12 Molecular Lab 944 91 1,020 109 1,182 125 1,107 86 1,109 19 1,238 21 Point of Ca
Slide 154: Diagnostics Division regional sales
YTD Sep 2021: Diagnostics Division regional sales Growth driven by EMEA and Asia Pacific CER = Constant Exchange Rates (avg. full year 2020); * Europe, Middle East and Africa 154
Slide 155: Core Lab
Core Lab 2021 vs. 2020 CHF bn CER growth +26% 6.0 +16% 5.0 +21% 4.0 3.0 2.0 +29% 1.0 0.0 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates; underlying growth of Core Lab excluding Roche Information Solutions: +25% 155
Slide 156: Molecular Lab
Molecular Lab 2021 vs. 2020 CHF bn CER growth +36% 3.8 3.6 3.4 3.2 +54% 3.0 2.8 2.6 +22% 2.4 2.2 +5% 2.0 1.8 +31% 1.6 1.4 +10% 1.2 1.0 0.8 0.6 +34% 0.4 0.2 0.0 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 Virology Blood Screening MD Systems Microbiology Cervical Cancer Other CER=Constant Exchange Rates 15
Slide 157: Pathology Lab
Pathology Lab 2021 vs. 2020 CHF bn CER growth +14% 1.0 0.9 0.8 +3% 0.7 +18% 0.6 0.5 0.4 +15% 0.3 0.2 0.1 0.0 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 157
Slide 158: Diabetes Care
Diabetes Care 2021 vs. 2020 CHF bn CER growth +4% 1.6 1.4 1.2 -11% 1.0 +6% 0.8 0.6 0.4 0.2 0.0 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 Blood Glucose Monitoring Other CER=Constant Exchange Rates 158
Slide 159: Point of Care
Point of Care 2021 vs. 2020 CHF bn CER growth +279% 2.2 2.0 -10% 1.8 +12% 1.6 1.4 1.2 1.0 >500% 0.8 0.6 0.4 0.2 0.0 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 Other Coagulation & Urinalysis Hospital Glucose Clinical Chemistry & Immunodiagnostics CER=Constant Exchange Rates 159
Slide 160: Pipeline summary
Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Spark Roche Group YTD Sep 2021 sales Diagnostics Foreign exchange rate information 160
Slide 161: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact due to most currencies and driven by the USD CER CHF sales growth sales growth YTD Sep 2021 YTD Sep 2021 vs. vs. YTD Sep 2020 YTD Sep 2020 CER = Constant Exchange Rates (avg full year 2020) 161
Slide 162: CHF/USD
CHF/USD Monthly averages 1.00 1% 0.90 -3% -5% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 Q H Q Year-To-Date averages F 1.00 0.90 -7% -6% -4% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 162
Slide 163: CHF/USD
CHF/USD 1.00 Sep YTD 2021 -3% 0.98 0.96 0.94 0.92 0.90 0.88 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2020 avg full year 2021 monthly avg 2020 monthly avg 2021 163
Slide 164: CHF/EUR
CHF/EUR Monthly averages 1.13 2% 1% 1.08 4% 1.03 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Y 2020 2021 Q H Year-To-Date averages Q 1.13 F 2% 3% 2% 1.08 1.03 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 164
Slide 165: CHF/EUR
CHF/EUR 1.13 Sep YTD 2021 2% 1.11 1.09 1.07 1.05 1.03 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2020 avg full year 2021 monthly avg 2020 monthly avg 2021 165
Slide 166: Average CHF Exchange Rates
Average CHF Exchange Rates Sep YTD Sep YTD Sep YTD 2021 vs. Sep YTD 2020 2021 2020 USD 0.91 0.95 -4% EUR 1.09 1.07 2% JPY 0.84 0.88 -5% -10% -5% 0% 5% 10% 166
Slide 167: Exchange rate impact on sales growth
Exchange rate impact on sales growth YTD Sep 2021: negative impact of USD and JPY, positive impact of EUR CER = Constant Exchange Rates (avg full year 2020) 167
Slide 168: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q3 2021: negative impact of JPY and USD, positive impact of EUR CER = Constant Exchange Rates (avg full year 2020) 168
Slide 169: Doing now what patients need next
Doing now what patients need next
Roche Holding — YTD September 2021 Earnings Presentation on 6ix