Roche Holding Ltd · SIX:RO
Roche — Q1 2021 Earnings Presentation
175 slides from Roche's earnings presentation, Apr 21, 2021
Slide 1: Slide 1
Slide 2: Roche Q1 2021 Sales
Roche Q1 2021 Sales Basel, 21 April 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: Q1 2021 performance; Outlook
Q1 2021 performance Outlook 5
Slide 6: Responding quickly and broadly to the pandemic
Responding quickly and broadly to the pandemic SARS-CoV-2 Rapid Antigen Nasal Test Casirivimab + imdevimab (nAb cocktail) • Reliably identifies highly infectious individuals in 15 minutes • Emergency use ongoing in US/EU for mild/moderate COVID-19 (Sensitivity: 89.6% at Ct≤30; Specificity 99.1%) at
Slide 7: Q1 2021: Strong Diagnostics Division driving Group sales growth
Q1 2021: Strong Diagnostics Division driving Group sales growth 2021 2020 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 10.6 12.3 -14 -9 Diagnostics Division 4.3 2.9 50 55 Roche Group 14.9 15.1 -1 3 CER=Constant Exchange Rates 7
Slide 8: Q1 2021: Successfully managing the transition in a difficult environment
Q1 2021: Successfully managing the transition in a difficult environment Group sales 6% 8% 7% growth (CER) 4% 3% Group 100% sales 10% 80% 35% 41% 60% 16% 40% 20% 28% 20% 29% 21% 0% Q1 17 Q1 18 Q1 19 Q1 20 Q1 21 1 Diagnostics Division Other pharma AHR New products CER=constant exchange rates; AHR=Ava
Slide 9: Q1 2021: Sales growth despite severe biosimilar impact
Q1 2021: Sales growth despite severe biosimilar impact New products accounting for 50% of Pharma sales Pharma sales mix +3% at CER Q1 2020 CHFm +880 33% 37% +1,538 -376 30% -641 Q1 2021 -1,614 15,143 22% 14,930 50% 28% Q1 2020 Pharma Pharma Pharma Diagnostics Fx Q1 2021 New products launched since 2
Slide 10: Q1 2021: Pandemic continues to impact business dynamics
Q1 2021: Pandemic continues to impact business dynamics % CER 1st wave 2nd wave 3rd wave +60% +50% Pharmaceuticals +50% +55% • Continued severe impact from biosimilars and +40% COVID-19, lack of new patients starts in particular +32% +28% +25% in cancer care +30% +20% +20% +18% +24% +10% +7% Diagnos
Slide 11: Q1 2021 performance; Outlook
Q1 2021 performance Outlook 11
Slide 12: Continuing to invest in innovation
Continuing to invest in innovation Diversifying the late stage pipeline & launching new systems Achievements in Q1 2021: Pharma Achievements in Q1 2021: Diagnostics New to Phase II Serum work area systems launches Brain shuttle gantenerumab in Alzheimer’s disease cobas® pure GABA Aa5 PAM in autism s
Slide 13: 2021 outlook confirmed
2021 outlook confirmed Further growing top and bottom line Group sales growth1 • 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 (CER); based on the current assessment of the COVID
Slide 14: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 15: Q1 2021: Pharmaceuticals Division sales
Q1 2021: Pharmaceuticals Division sales Sales still impacted by COVID-19 and biosimilars 2021 2020 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 10,600 12,262 -14 -9 United States 5,292 6,616 -20 -14 Europe 2,175 2,264 -4 -6 Japan 852 948 -10 -7 International 2,281 2,434 -6 0 CER=Constant E
Slide 16: Q1 2021: Continued portfolio rejuvenation
Q1 2021: Continued portfolio rejuvenation Ocrevus 16% Hemlibra 33% Tecentriq 26% Casirivimab + Imdevimab n/a Actemra / RoActemra 22% Evrysdi n/a Kadcyla 17% Alecensa 14% Phesgo n/a Perjeta 2% Enspryng n/a Polivy 18% Gazyva -2% Esbriet -8% Lucentis -7% Xofluza -100% US Xolair -6% Tarceva -56% Europe
Slide 17: Pharma growth dynamic excl. AHR slowed down by COVID-19
Pharma growth dynamic excl. AHR* slowed down by COVID-19 Quarterly sales development Pharmaceuticals Division (excl. AHR) CHFm 9,000 8,000 Pharma other 7,000 Infectious diseases 6,000 Ophthalmology 5,000 Immunology Hemophilia A 4,000 Neuroscience 3,000 Oncology 2,000 1,000 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Slide 18: Milestone achieved: 50% of Pharma sales are new products
Milestone achieved: 50% of Pharma sales are new products* Rolling filings for casirivimab/imdevimab and PDS started CHFm % of Pharma Sales 6,000 5,500 50% 5,000 37% 4,500 4,000 3,500 27% 3,000 2,500 19% 2,000 1,500 1,000 500 0 Q1 18 Q1 19 Q1 20 Q1 21 Erivedge Perjeta Kadcyla Gazyva Esbriet Cotellic
Slide 19: Q1 2021: Oncology -19% due to biosimilars & COVID-19
Q1 2021: Oncology -19% due to biosimilars & COVID-19 YoY CER growth HER2 franchise Phesgo • Kadcyla (+17%) with growth in all regions due to adjuvant BC HER2 franchise Herceptin Perjeta (+2%) -11% • Perjeta (+2%) with growth driven by International Kadcyla (+17%) • Successful Phesgo launch in US and
Slide 20: Tecentriq overview: Growth driven by first-in-class indications
Tecentriq overview: Growth driven by first-in-class indications Landmark results in adjuvant NSCLC announced Tecentriq Q1 update CHFm YoY CER growth Lung franchise (NSCLC, SCLC) 900 • US/EU/Japan: Growth driven by 1L SCLC and 1L NSCLC +26% 800 +49% +35% • BTD for tiragolumab + Tecentriq in PDL1+ NSC
Slide 21: Hemophilia A franchise: Hemlibra growing strongly
Hemophilia A franchise: Hemlibra growing strongly 29% total US patient share and 26% total EU-5 patient share reached CHFm YoY CER growth Hemophilia Q1 update 800 • US/EU: Gaining market share in non-inhibitors 700 +33% +45% • >11,000 patients treated globally 600 +57% +146% +59% • #1 prescribed pro
Slide 22: Immunology franchise impacted by COVID-19
Immunology franchise impacted by COVID-19 Immunology Q1 update CHFm YoY CER growth Esbriet (-8%) • COVID-19 impact on new patient starts 2,500 +9% • BTD in unclassifiable interstitial lung disease (uILD) +6% -5% +4% 2,000 Actemra (+22%) • Sales driven by COVID-19; Additional positive study results 1
Slide 23: MS franchise: Ocrevus with 26% total US market share
MS franchise: Ocrevus with 26% total US market share Market leadership maintained CHFm YoY CER growth Q1 update • Ocrevus EU label update to include delay in time to wheelchair 1,500 for PPMS 1,250 +37% +16% +55% +38% +10% • Higher dose Ocrevus: Ph III (MUSETTE) in RMS and Ph III 1,000 +59% +48% +12
Slide 24: SMA franchise: Strong US launch; EU approval achieved
SMA franchise: Strong US launch; EU approval achieved ~1,600 US patients treated (>15% total share) after less than 8 months Broad uptake across all patient types in the US US access enabled by compelling value proposition • ~75% of lives covered due to active payer engagement Patients treated with
Slide 25: SMA franchise: 2-year efficacy update presented at AAN
SMA franchise: 2-year efficacy update presented at AAN Primary and secondary outcomes keep improving Ph III (FIREFISH) 2-year efficacy results in type 1 SMA: Ability to sit without support over 24 months CHOP-INTEND scores over 24 months • Follow up results for Evrysdi in SMA type 1 patients keep im
Slide 26: Ophthalmology franchise: Benefitting patients globally
Ophthalmology franchise: Benefitting patients globally Faricimab: Positive results in DME & nAMD Ph III (YOSEMITE/RHINE) results in DME BCVA gains at Q8W or up to Q16W Improved anatomic outcomes: Improved durability: non-inferior to aflibercept Q8W Change in CST * >70% on Q12W (with 50% on Q16W) * •
Slide 27: Ophthalmology franchise: PDS approval in the US on track for Q4
Ophthalmology franchise: Benefitting patients globally PDS approval in the US on track for Q4 Phase III (ARCHWAY) 72 week results in nAMD: PDS maintained BCVA through Week 72 ~5x Times fewer treatments in Strong preference for PDS PDS patients amongst patients 3.9 • Ph III (ARCHWAY) data in nAMD sho
Slide 28: Infectious diseases: SARS-CoV-2 development program
Infectious diseases: SARS-CoV-2 development program Positive Ph IIIs for nAb cocktail; First EU shipments in Q1 • Casirivimab+imdevimab: Ph III studies in outpatient setting (Study 2067) and in prevention/prophylaxis setting (Study 2069) positive; Efficacy for high and low dose in the outpatient set
Slide 29: 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 30: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 31: Q1 2021: Diagnostics Division sales
Q1 2021: Diagnostics Division sales Very strong growth driven by COVID-19 and routine testing 2021 2020 Change in % CHFm CHFm CHF CER Diagnostics Division 4,330 2,881 50 55 Core Lab 1,765 1,382 28 31 Molecular Lab 1,107 614 80 86 Point of Care 716 190 277 281 Diabetes Care 460 425 8 13 Pathology Lab
Slide 32: Q1 2021: Diagnostics Division regional sales
Q1 2021: Diagnostics Division regional sales Very strong growth in all regions North America +34% EMEA1 ~24% of divisional sales +62% ~46% of divisional sales Asia Pacific +62% ~24% of divisional sales Latin America +71% ~6% of divisional sales All growth rates at Constant Exchange Rates (CER); 1 Eu
Slide 33: Q1 2021: Diagnostics Division highlights
Q1 2021: Diagnostics Division highlights Very strong growth across all businesses YoY CER growth +31% • Immunodiagnostics (+40%) Core Lab1 • Clinical Chemistry (+13%) • Virology (+198%) Molecular +86% • LightMix Systems (+55%) Lab • POC Molecular (+130%) Point of +281% • POC Immunodiagnostics (+1,53
Slide 34: SARS-CoV-2 diagnostics portfolio
SARS-CoV-2 diagnostics portfolio1 Comprehensive and growing portfolio of tests and digital solutions Clinical Labs Near Patient • cobas® SARS-CoV-2 Launched • cobas® SARS-CoV-2 Variant Launched Molecular • cobas® SARS-CoV-2 & Influenza A/B Launched • cobas® SARS-CoV-2 & Influenza A/B Launched soluti
Slide 35: COVID-19 integrated testing solution
COVID-19 integrated testing solution SARS-CoV-2 Rapid Antigen Nasal Test NAVIFY® Pass Convenient and fast testing experience for patients COVID-19 test results provided directly to individuals • Reliably identifies highly infectious individuals in 15 minutes • Allows patient to receive test results
Slide 36: Launch of cobas SARS-CoV-2 Variant Set test (RUO)
Launch of cobas® SARS-CoV-2 Variant Set test (RUO)1 Support in understanding the prevalence of COVID-19 variants COVID-19 Variants South Africa ● Qualitative detection and differentiation of (501Y-V2)1 SARS-CoV-2 mutations for set of variants: − E484K − N501Y − Deletion HV-69/70 U.K (501Y-V1)1 ● Und
Slide 37: Roche molecular solutions portfolio
Roche molecular solutions portfolio GenMark1 Diagnostics fills the portfolio gap in molecular multiplexing Throughput cobas® Liat® GenMark cobas® 58002 cobas® 6800 cobas® 8800 Molecular Molecular Molecular Molecular high throughput point-of-care multiplexing medium throughput 1 GenMark Diagnostics o
Slide 38: Serum work area systems launches
Serum work area systems launches Enabling comparable results in different size laboratories cobas® pure cobas pro® (high throughput) Optimising efficiency for small size laboratories Increasing scalability and flexibility • Integrates three diagnostic technologies1 on a • Flexibility to add up to 4
Slide 39: FDA BDD for Elecsys GDF-15
FDA BDD for Elecsys GDF-151 Addressing unintentional weight loss in cancer patients • Breakthrough device designation as a companion diagnostic with Pfizer • Detects weight loss (cachexic) patients with solid tumors eligible for investigational drug PF-06946860 • Cachexia is a highly prevalent compl
Slide 40: Improving care for transplant patients
Improving care for transplant patients Launch of Elecsys® EBV tests panel for organ characterization and donor & recipient screening Pre-transplantation Post-transplantation EBV1 serology to determine the infection stage of donor Viral load tests (NAT) are used to monitor high risk and recipients tr
Slide 41: 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 42: Finance
Finance Alan Hippe Chief Financial Officer
Slide 43: Q1 2021: Highlights
Q1 2021: Highlights Sales • Group sales growth (+3%) driven by Diagnostics (+55%) • Growth dynamic still impacted by COVID-19 M&A • Definitive merger agreement to acquire GenMark Diagnostics for USD 24.05 per share Currency impact on sales • Negative currency impact due to most currencies, particula
Slide 44: Group sales Q1 2021
Group sales Q1 2021 CER sales increase of +3% driven by Diagnostics -14% -6% 0% -7% +3% -1% Pharma Division Dia Division -9% +55% +55% +1,538 +428 -641 -213 -918 -126 -4 -62 PY: +62 11 United States Europe Intl. Chugai Dia Division Group Fx Group (Japan) CHF Absolute values in CHFm at Constant Excha
Slide 45: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact due to most currencies, driven by the USD +0.4p 0.0p CER CHF sales growth +2.9% -3.2p sales growth Q1 2021 Q1 2021 vs. vs. Q1 2020 Q1 2020 -1.4% -0.8p -0.3p -0.2p -0.2p CER EUR APAC USD LATAM JPY Other Other CHF Europe CER=Constant Exchange Rates
Slide 46: Currency impact expected to reduce as 2021 progresses
Currency impact expected to reduce as 2021 progresses CHF / USD -7% -4% -2% -1% 0.97 0.97 Average YTD 2020 0.95 0.94 Assuming the 31 March 2021 exchange rates remain stable until end of 2021, 0.90 0.93 0.93 0.92 Assumed average YTD 2021 2021 impact 1 is expected to be (%p): 0.89 0.90 0.93 0.94 0.94
Slide 47: 2021 outlook confirmed
2021 outlook confirmed Further growing top and bottom line Group sales growth1 • 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 (CER); based on the current assessment of the COVID
Slide 48: Slide 48
Slide 49: Changes to the development pipeline
Changes to the development pipeline Q1 2021 update New to phase I New to phase II New to phase III New to registration 1 NME: 3 NMEs: 1 NME: RG6433 SHP2i – solid tumors RG6102 Brain shuttle gantenerumab - Alzheimer’s RG6354 rhPTX-2 (PRM-151) - IPF RG6346 HBV siRNA - HBV RG7816 GABA Aa5 PAM – autism
Slide 50: Roche Group development pipeline
Roche Group development pipeline Phase I (45 NMEs + 12 AIs) Phase II (23 NMEs + 13 AIs) RG6007 HLA-A2-WT1 x CD3 AML CHU FIXa x FX haemophilia giredestrant (SERD) neoadjuvant ER+ BC RG6171 RG6026 glofitamab monotherapy and combos heme tumors CHU glypican-3 x CD3 solid tumors giredestrant (SERD) 2/3L
Slide 51: Roche Group development pipeline
Roche Group development pipeline Phase III (15 NMEs + 37 AIs) Registration (3 NMEs + 5 AIs) RG3502 Kadcyla + T 2L+ HER-2+ PD-L1+ mBC RG6268 Rozlytrek ROS1+ 1L NSCLC Gavreto (pralsetinib) 1 RET+ NSCLC RG6396 RG6013 Hemlibra mild to moderate hemophilia A Venclexta r/r MM t(11:14) Gavreto (pralsetinib)
Slide 52: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III glofitamab + chemo RG6026 2L DLBCL rhPTX-2 tiragolumab + T semorinemab RG6058 RG6354 (PRM-151) RG6100 1L PD-L1+ cervical ca Alzheimer’s myelofibrosis tiragolumab + T ipatasertib + fulv + brain shuttle mosunetuzumab glofita
Slide 53: AI submissions for existing products
AI submissions for existing products Projects in phase II and III New Molecular Entity (NME) Immunology Neuroscience Additional Indication (AI) Infectious Diseases Ophthalmology Oncology / Hematology Metabolism Other Xofluza Xofluza RG6152 influenza, pediatric RG6152 direct transmission (1-12 yrs) A
Slide 54: Major pending approvals 2021
Major pending approvals 2021 US EU China Japan-Chugai Esbriet Enspryng (satralizumab) Evrysdi (risdiplam) Evrysdi (risdiplam) RG6062 UILD RG6168 NMOSD RG7916 SMA RG7916 SMA Filed Nov 2020 Filed Aug 2019 Filed March 2020 Filed Oct 2020 Tecentriq Enspryng (satralizumab) RG7446 1L non-sq + sq NSCLC Dx+
Slide 55: Major granted approvals 2021
Major granted approvals 2021 US EU China Japan-Chugai Alecensa (BFAST) Xofluza Polivy RG7853 1L NSCLC ALK+ RG6152 influenza RG7596 r/r DLBCL Jan 2021 Jan 2021 March 2021 Actemra Xofluza RG1569 SSc-ILD RG6152 influenza, high risk March 2021 Jan 2021 Xolair Xofluza RG3648 Self-injection RG6152 post ex
Slide 56: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 56
Slide 57: Hemophilia: 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 58: Hemophilia: Hemlibra
Hemlibra Factor VIII mimetic for treatment of hemophilia A Hemophilia A mild to moderate patients without inhibitors to Factor Indication Hemophilia A patients with and without inhibitors to Factor VIII VIII Phase III Phase III Phase/study HAVEN 5 HAVEN 6 # of patients N=85 N=70 Patients with Hemoph
Slide 59: Oncology: 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 60: Oncology: Kadcyla
Kadcyla First ADC for HER2-positive breast cancer HER2-positive early breast cancer Indication 2L+ HER-2 positive PD-L1 positive mBC high-risk patients Phase III Phase III Phase/study KATHERINE KATE 3 # of patients N=1,484 N=350 ARM A: Kadcyla 3.6mg/kg q3w ARM A: Kadcyla plus Tecentriq ARM B:
Slide 61: Oncology: Perjeta
Perjeta First-in-class HER2 dimerization inhibitor Indication Adjuvant HER2-positive breast cancer Neoadjuvant HER2-positive breast cancer Phase III Phase III Phase/study APHINITY IMpassion050 # of patients N=4,803 N=453 ARM A: Perjeta (840mg loading, 420 q3w) plus Herceptin for 52 weeks ARM A:
Slide 62: Oncology: Perjeta
Perjeta First-in-class HER2 dimerization inhibitor Indication HER2-positive early breast cancer subcutaneous co-formulation Phase III Phase II Phase/study FeDeriCa PHranceSCa # of patients N=500 N=160 Fixed-dose combination (FDC) of Perjeta (P) and Herceptin (H) for ARM A: PH IV followed by FDC SC
Slide 63: Oncology: Tecentriq lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer 1L non-squamous and squamous NSCLC Indication 1L non-squamous NSCLC 1L extensive-stage SCLC PD-L1-selected patients Phase III Phase III Phase/study Phase Ib IMpower132 IMpower110 # of patients N=568 N=570 N=62 ARM A: Tecentriq plus carboplati
Slide 64: Oncology: Tecentriq lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer 2L NSCLC previously treated with an Indication Adjuvant NSCLC Neoadjuvant NSCLC immune checkpoint inhibitor Phase III Phase III Phase III Phase/study IMpower010 IMpower030 CONTACT-01 # of patients N=1,280 N=450 N=350 Following adjuvant cisplati
Slide 65: Oncology: 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 66: Oncology: 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 67: Oncology: Tecentriq UC
Tecentriq Anti-PD-L1 cancer immunotherapy – UC High-risk non-muscle-invasive Indication 1L metastatic urothelial carcinoma bladder cancer Phase III Phase III Phase/study IMvigor130 ALBAN # of patients N=1,200 N=516 ARM A: Tecentriq plus gemcitabine and carboplatin or cisplatin ARM A: BCG inducti
Slide 68: Oncology: 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 69: Oncology: Tecentriq CRC and HCC
Tecentriq Anti-PD-L1 cancer immunotherapy – CRC and 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:
Slide 70: Oncology: 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 71: Oncology: 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 72: Oncology: 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 73: Oncology: 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 74: Oncology: Venclexta AML
Venclexta Novel small molecule Bcl-2 selective inhibitor – AML Treatment-naïve AML not eligible for Relapsed or refractory hematological Indication Relapsed or refractory AML standard induction therapy malignancies Phase III Phase/study Phase I Phase I Viale-A # of patients N=52 N=86 N=443 Venclex
Slide 75: Oncology: 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 76: Oncology: Venclexta breast cancer
Venclexta Novel small molecule Bcl-2 selective inhibitor – breast cancer Indication ≥2L HR+ breast cancer Phase II Phase/study VERONICA # of patients N=103 ARM A: Venclexta plus fulvestrant ARM B: Fulvestrant Design Oncology Clinical benefit lasting equal or more than 24 weeks Primary endpoint
Slide 77: Oncology: 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 78: Oncology: Polivy
Polivy (polatuzumab vedotin) ADC targeting CD79b to treat B cell malignancies Indication Relapsed or refractory FL or DLBCL Phase/study Phase I/II Phase I/II # of patients N=134 N=128 • Dose escalation cohort: Dose escalation cohort: Polatuzumab vedotin plus Gazyva plus Venclexta1 Polatuzumab vedo
Slide 79: Oncology: 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 80: 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 1: Gavreto 30-600mg dose-escalation Arm
Slide 81: Neuroscience: 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 82: Neuroscience: 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 83: Neuroscience: 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 84: Neuroscience: 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 85: Neuroscience: 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 86: 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 Sakura Star Sakura Sky # of patients N=95 N=70 (adults); N=6 (adolescents) Satralizumab as monotherapy: Add-on therapy of
Slide 87: Immunology: Gazyva
Gazyva (obinutuzumab) Immunology development program Indication Lupus nephritis Phase II Phase III Phase/study NOBILITY REGENCY # of patients N=126 N=252 ARM A: Obinutuzumab 1000mg IV plus mycophenolate mofetil / ARM A: Obinutuzumab 1000 mg IV (six doses through Week 52) plus mycophenolic acid m
Slide 88: Immunology: 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 89: Immunology: 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 90: Immunology: 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 91: Infectious Diseases: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188 ) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase III Phase/study CAPSTONE-1 CAPSTONE-2 # of patients N=1,436 N=2,184 Randomized, double-blind study of a single dose of Xofluza Randomized, double-blind
Slide 92: Infectious Diseases: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188 ) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase III Phase/study miniSTONE 1 (0-1 year old) miniSTONE 2 (1-12 years old ) # of patients N=30 N=176 • Xofluza on Day 1 (based on body weight and age) in healt
Slide 93: Infectious Diseases: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase IIIb Phase/study BLOCKSTONE CENTERSTONE N=752 N=3,160 # of patients Post exposure prophylaxis to prevent disease onset in household Reduction of direct t
Slide 94: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 94
Slide 95: Oncology: 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 96: Oncology: Ipatasertib
Ipatasertib (RG7440, GDC-0068) Highly selective small molecule inhibitor of Akt Indication 1L HR+ mBC Phase Ib/III Phase/study IPATunity150 # of patients N=370 ARM A: Ipatasertib plus fulvestrant and palbociclib ARM B: Placebo plus fulvestrant and palbociclib Design Oncology Primary endpoint P
Slide 97: Oncology: 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 98: 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 Phase II Phase II Phase II Phase/study SKYSCRAPER-04 SKYSCRAPER-05 SKYSCR
Slide 99: 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 1L esophageal cancer squamous cell head and neck carcinoma Phase III Phase III Phase II Phase/study SKY
Slide 100: Oncology: 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 101: Oncology: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultanously Indication Relapsed or refractory Non-Hodgkin’s lymphoma Non-Hodgkin’s lymphoma Phase/study Phase I Phase Ib Phase Ib Part I: 15-60 # of patients N=700 N=140 Part II: ~66-104 Cohort 1: Single-agent d
Slide 102: Oncology: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultanously Relapsed/refractory DLBCL and High-Grade Large B-Cell Indication 2L+ SCT-ineligible DLBCL Lymphoma Phase III Phase/study Phase Ib STARGLO # of patients N=20 N=270 Glofitamab plus gemcitabine and ox
Slide 103: Oncology: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultanously Indication 3L+ FL, 3L+ DLBCL & other R/R NHL 1L DLBCL R/R DLBCL Phase/study Phase I Phase Ib/II Phase Ib # of patients N=746 N=160 N=262 Dose escalation study of mosunetuzumab as Mosunetuzumab
Slide 104: Oncology: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultanously 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 pri
Slide 105: Oncology: 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 106: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication ER+ HER2-neg metastatic breast cancer ER+ HER2-neg Stage I-III operable breast cancer Phase/study Phase I Phase I # of patients N=220 N=75 Dose escalation and expansion at recommended phase
Slide 107: Oncology: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator 2L/3L ER+/HER2-negative Indication Neoadjuvant ER+ breast cancer 1L ER+ metastatic breast cancer metastatic breast cancer Phase II Phase III Phase II Phase/study coopERA Breast Cancer persevERA Breast C
Slide 108: Oncology: rhPTX-2
rhPTX-2 (RG6354) Recombinant human innate immunity protein pentraxin-2 Indication Myelofibrosis Phase/study Phase II # of patients N=125 • Multiple dose study of rhPTX-2 Oncology Design • Bone marrow response rate Primary endpoint Study completed Q1 2021 Status CT Identifier NCT01981850 108
Slide 109: Immunology: rhPTX-2
rhPTX-2 (RG6354) Recombinant human innate immunity protein pentraxin-2 Indication Idiopathic pulmonary fibrosis (IPF) Phase/study Phase II Phase III # of patients N=117 N=658 Randomized, double-blind, placebo-controlled trial: 4-week screening Randomized, double-blind, placebo-controlled trial:
Slide 110: Immunology: 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 111: Immunology: 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 112: Immunology: 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 113: Immunology: 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 114: Neuroscience: 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 115: Neuroscience: Gantenerumab
Gantenerumab (RG1450) Fully human mAb binding aggregated forms of A Indication Prodromal to mild Alzheimer’s disease Phase III Phase III Phase/study GRADUATE 1 GRADUATE 2 # of patients N=1,016 N=1,016 104-week subcutaneous treatment period: 104-week subcutaneous treatment period: ARM A: Ganteneru
Slide 116: Neuroscience: 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 117: 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 RG6042 administered intrathecally to adult Patients from phase I are enrolled into OLE p
Slide 118: 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=1050 ARM A: RG6042 120mg bimonthly Open-Label Extension study in patients participating in prior Ro
Slide 119: Ophthalmology: Faricimab
Faricimab (RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Center-involving diabetic macular edema Indication Neovascular age related macular degeneration (nAMD) (CI-DME) Phase II Phase II Phase II Phase/study AVENUE STAIRWAY BOULEVARD # of patients N=271 N=75 N=210 ARM A: SoC
Slide 120: Ophthalmology: 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 (RG7716) q8w/PTI ARM
Slide 121: Ophthalmology: 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 122: Ophthalmology: 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 123: Ophthalmology: 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 124: Ophthalmology: 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 125: Infectious Diseases: AT-527
AT-527 (RG6422) Viral RNA polymerase inhibitor Indication Non-hospitalised adult patients with mild or moderate COVID-19 Phase II Phase/study MOONSONG # of patients N=220 ARM A: AT-527 ARM B: Placebo Infectious Diseases Design Primary endpoint Change from baseline in the amount of severe acute
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 Q1 2021 sales Diagnostics Foreign exchange rate information 126
Slide 127: pRED oncology development programs
pRED oncology development programs Molecule Indication Phase # of patients Status CT Identifier Oncology TYRP1 x CD3 (RG6232) Melanoma I 210 FPI Q4 2020 NCT04551352 FPI Q2 2018 FAP-4-1BBL (RG7827) Solid tumors I 200 Data presented at ESMO 2020 CD19-4-1BBL (RG6076) R/R B cell non-Hodgkin’s lymphoma I
Slide 128: pRED neuroscience and immunology development programs
pRED neuroscience and immunology development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience Brain Shuttle gantenerumab Alzheimer's disease II ~120 NCT04639050 NCT04023994 (RG6102) II 36 FPI Q4 2018; Recruitment completed Q3 2019 NCT03669640 ralmitaront II 247 FPI
Slide 129: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology IgG-IL2 FP (RG7835) Ulcerative Colitis Ib 65 FPI Q2 2019 NCT03943550 Ophthalmology NME (RG6179)1 DME I 50 FPI July 2019 VEGF-Ang2 DutaFab (RG6120) nAMD I 50 FPI Q4 2020 NCT0
Slide 130: 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 131: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 131
Slide 132: 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 R/R multiple myeloma I 300 FPI Q3 2017 NCT03275103 (anti-FcRH5 x CD3; RG6160) Metastati
Slide 133: gRED immunology development programs
gRED immunology 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 270 FPI Q4 2018 NCT03558152 (IL-22Fc, RG7880) aGVHD lb FPI Q4 2020 NCT04539470 NME (RG6287
Slide 134: gRED neuroscience, ophthalmology and metabolic diseases programs
gRED neuroscience, ophthalmology 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 at CTAD 20
Slide 135: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 135
Slide 136: 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 137: Choroideremia gene therapy
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 138: Pompe disease gene therapy
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 138
Slide 139: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 139
Slide 140: Geographical sales split by divisions and Group
Geographical sales split by divisions and Group* CHFm Q1 2020 Q1 2021 % change CER Pharmaceuticals Division 12’262 10’600 -9 United States 6’616 5’292 -14 Europe 2’264 2’175 -6 Japan 948 852 -7 International 2’434 2’281 0 Diagnostics Division 2’881 4’330 +55 United States 760 947 +33 Europe 1’010 1’
Slide 141: Pharma Division sales Q1 2021: Top products
Pharma Division sales Q1 2021 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,226 16 914 9 217 37 - - 95 77 Perjeta 988 2 360 -2 301 -3 64 -11 263 23 Avastin 863 -40 287 -48 138 -68 161 -8 277 -4 Actemra / RoActemra 779 22 305 10
Slide 142: Pharma Division sales Q1 2021: New products
Pharma Division sales Q1 2021 New products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Erivedge 60 -13 38 -15 15 -15 - - 7 3 Perjeta 988 2 360 -2 301 -3 64 -11 263 23 Kadcyla 478 17 200 5 167 24 27 54 84 28 Gazyva 155 -2 74 0 51 -11 14 1 16 21 Esbriet
Slide 143: 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 Ocrevus 38 12 37 10 16 Perjeta 22 12 17 20 2 Avastin -13 -24 -30 -35 -40 Actemra / RoActemra 30 40 27 29 22 Tecentriq 99 54 49 35 26 Herceptin -24 -33 -38 -43 -35 MabThera -15 -32 -33 -43 -46 Hemlibra 146 59
Slide 144: Pharma Division CER sales growth: Top products by region
Pharma Division CER sales growth1 in % Top 20 products by region 2020 2021 2020 2021 2020 2021 2020 2021 US Europe Japan International Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Ocrevus 9 32 5 9 26 56 20 37 - - - - 43 74 55 77 Perjeta 4 7 0 -2 1 13 4 -3 11 -9 0 -11 50 52 135 23 Avastin -39 -37
Slide 145: CER sales growth: Quarterly development
CER sales growth (%) Quarterly development 2020 vs. 2019 2021 vs. 2020 Q1 Q2 Q3 Q4 Q1 Pharmaceuticals Division 7 -6 -4 -7 -9 United States 3 -10 -5 -13 -14 Europe 14 -3 2 -8 -6 Japan 3 -7 -13 -5 -7 International 16 5 -2 11 0 Diagnostics Division 5 2 18 28 55 Roche Group 7 -4 1 1 3 CER=Constant Excha
Slide 146: Ocrevus
Ocrevus CHFbn Global sales CER growth Regional sales CER growth 1.4 +16% US +9% 1.2 1.0 0.8 Europe +37% 0.6 0.4 International +77% 0.2 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 1,226m • US: Moving into earlier lines displacing orals; COVID-19 impact as vaccination programs are on-going • EU:
Slide 147: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn +2% US -2% 1.2 1.0 Europe -3% 0.8 0.6 Japan -11% 0.4 International +23% 0.2 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 988m • US: Patients with residual disease being switched to Kadcyla; Cannibalization from Phesgo • EU: COVID-19
Slide 148: Avastin
Avastin Global sales CER growth Regional sales CER growth CHFbn 2.0 -40% US -48% 1.8 Europe -68% 1.6 1.4 1.2 Japan -8% 1.0 0.8 0.6 International -4% 0.4 0.2 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 863m • US: Decline due to biosimilars • EU: Decline due to biosimilars • Japan: Limited declin
Slide 149: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 2.0 -35% US -57% 1.8 Europe -25% 1.6 1.4 Japan -43% 1.2 1.0 0.8 0.6 International -16% 0.4 0.2 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 755m • US: Biosimilar erosion; Switching of patients with residual disease to Kadcyla; Can
Slide 150: Actemra / RoActemra
Actemra / RoActemra Global sales CER growth Regional sales CER growth CHFbn +22% US +10% 0.9 0.8 0.7 Europe +12% 0.6 0.5 0.4 Japan -2% 0.3 0.2 0.1 International +134% 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 779m • US: Increased demand for SC formulation (home administration) and due to COVI
Slide 151: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 0.9 +26% US +13% 0.8 Europe +14% 0.7 0.6 0.5 Japan +82% 0.4 0.3 International +84% 0.2 0.1 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 775m • US: Growth driven by first-in-class launches in 1L HCC, 1L SCLC and 1L TNBC • EU: Growt
Slide 152: MabThera / Rituxan
MabThera / Rituxan CHFbn Global sales CER growth Regional sales CER growth 1.8 -46% US -53% 1.6 1.4 Europe -45% 1.2 Japan -37% 1.0 0.8 0.6 International -23% 0.4 0.2 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 705m • US: Decline due to biosimlars and some COVID-19 impact • EU: Decline due to bi
Slide 153: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 0.7 +33% US +21% 0.6 Europe +71% 0.5 0.4 Japan +11% 0.3 International +214% 0.2 0.1 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 661m • US: Continued share gains in non-inhibitors; Some COVID-19 impact • EU: Growth driven by strong
Slide 154: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +17% US +5% 0.6 0.5 0.4 Europe +24% 0.3 0.2 Japan +54% 0.1 International +28% 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 478m • US: Uptake in adjuvant eBC in patients with residual disease after neoadjuvant treatment • EU: Strong
Slide 155: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 0.5 -6% 0.4 0.3 US -6% 0.2 0.1 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 409m • Xolair remains market leader in a growing biologics asthma market; • Growth in chronic idiopathic urticaria (CIU) CER=Constant Exchange Rates 155
Slide 156: Lucentis
Lucentis Global sales CER growth Regional sales CER growth CHFbn 0.5 -7% 0.4 0.3 US -7% 0.2 0.1 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 337m • Decline due to COVID-19 impact; First biosimilar expected in H2 • Overall market shares stable CER=Constant Exchange Rates 156
Slide 157: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 0.5 -17% US -17% 0.4 0.3 0.2 International -10% 0.1 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1 2021 sales of CHF 304m • Decline due to COVID-19 impact CER=Constant Exchange Rates 157
Slide 158: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn Global sales +14% Regional sales CER growth US CER growth-2% CHFbn0.4 0.3 -2% US -10% 0.3 Europe +11% 0.3 Europe -2% 0.2 0.2 Japan +8% 0.2 Japan -32% 0.1 0.1 International +44% 0.1 International +34% 0.0 0.0 Q1 18 Q1 19 Q1 20 Q1 21 Q1
Slide 159: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 159
Slide 160: Q1 2021: Diagnostics Division CER growth by region and customer areas
Q1 2021: Diagnostics Division CER growth By Region and Customer Areas (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 Core Lab2 1,765 31 648 17 330 18 670 65 117 18 Molecular Lab 1,107 86 431 8
Slide 161: Diagnostics Division quarterly sales and CER growth
Diagnostics Division quarterly sales and CER growth1 Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab2 1,382 -2 1,439 -17 1,666 -3 1,707 -2 1,765 31 Molecular Lab 614 29 944 91 1,020 109 1,182 125 1,107 86 Point of Care 190 8 170 -10 181 12 538 212 716 28
Slide 162: Q1 2021: Diagnostics Division regional sales
Q1 2021: Diagnostics Division regional sales Growth driven by EMEA and Asia Pacific Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 4,330 Diagnostics Division 55% GLOBAL 267 / 62% EMEA* 6% 34% NA 62% ASIA-PAC 1,045 / 24% 1,967 / 71% LAM 46% 1,051 / 24% EMEA* NA ASIA-PAC LAM C
Slide 163: Core Lab
Core Lab 2021 vs. 2020 CHF bn CER growth +31% 2.0 1.8 1.6 +32% 1.4 +13% 1.2 1.0 0.8 0.6 +40% 0.4 0.2 0.0 Q1 2019 Q1 2020 Q1 2021 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates 163
Slide 164: Molecular Lab
Molecular Lab 2021 vs. 2020 CHF bn CER growth +86% 1.2 1.0 +53% -5% 0.8 +2% 0.6 +114% -5% 0.4 0.2 +198% 0.0 Q1 2019 Q1 2020 Q1 2021 Virology Blood Screening MD Systems Microbiology Cervical Cancer Other CER=Constant Exchange Rates 164
Slide 165: Point of Care
Point of Care 2021 vs. 2020 CHF bn CER growth +281% 0.8 0.7 -4% 0.6 0.5 0.4 0.3 >500% 0.2 0.1 0.0 Q1 2019 Q1 2020 Q1 2021 Clinical Chemistry & Immunodiagnostics Other CER=Constant Exchange Rates 165
Slide 166: Diabetes Care
Diabetes Care 2021 vs. 2020 CHF bn CER growth +13% 0.5 -18% 0.4 0.3 +17% 0.2 0.1 0.0 Q1 2019 Q1 2020 Q1 2021 Blood Glucose Monitoring Other CER=Constant Exchange Rates 166
Slide 167: Pathology Lab
Pathology Lab 2021 vs. 2020 CHF bn CER growth +9% 0.3 +30% +11% 0.2 0.1 +5% 0.0 Q1 2019 Q1 2020 Q1 2021 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 167
Slide 168: 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 Q1 2021 sales Diagnostics Foreign exchange rate information 168
Slide 169: CHF/USD
CHF/USD Monthly averages 1.00 0.90 -3% 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% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 169
Slide 170: CHF/USD
CHF/USD 1.00 Mar YTD 2021 -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 2020 avg full year 2021 monthly avg 2020 monthly avg 2021 170
Slide 171: CHF/EUR
CHF/EUR Monthly averages 1.13 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% 1.08 1.03 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 171
Slide 172: CHF/EUR
CHF/EUR 1.13 Mar 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 172
Slide 173: Average CHF Exchange Rates
Average CHF Exchange Rates Q1 2021 Q1 2020 Q1 2021 vs. Q1 2020 USD 0.90 0.97 -7% EUR 1.09 1.07 2% JPY 0.85 0.89 -4% -10% -5% 0% 5% 10% 173
Slide 174: Exchange rate impact on sales growth
Exchange rate impact on sales growth In Q1 2021 negative impact of USD and JPY, positive impact of EUR Development of average exchange rates versus prior year period CHF / USD -6.6% CHF / EUR +2.1% CHF / JPY -3.8% Difference in CHF / CER -4.3%p growth 2.9% Sales growth -1.4% 2021 CER CHF vs. 2020 gr
Slide 175: Doing now what patients need next
Doing now what patients need next