Slide 1: Roche
Slide 2: Roche YTD September 2020 sales
Roche YTD September 2020 sales Basel, 15 October 2020
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 2020 performance; Outlook
YTD Sep 2020 performance Outlook 5
Slide 6: Growth despite significant COVID-19 and biosimilar impact
Growth despite significant COVID-19 and biosimilar impact Pharmaceuticals • Gradual recovery since Q2 2020; end of Q3 2020 back to pre-COVID-19 levels, some uncertainty remains • Launch of NMEs, readouts & pivotal trial starts on track • Continued good growth momentum of new products in Q3 2020 (+32
Slide 7: YTD Sep 2020: Sales growth driven by Diagnostics Division
YTD Sep 2020: Sales growth driven by Diagnostics Division 2020 2019 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 34.3 36.6 -6 -1 Diagnostics Division 9.7 9.5 2 9 Roche Group 44.0 46.1 -5 1 CER=Constant Exchange Rates 7
Slide 8: Q3 2020: Business recovery – back to growth
Q3 2020: Business recovery – back to growth 16% 14% 13% 12% 10% 9% 9% 8% 8% 7% 7% 7%7% 7% 6% 6%6% 6% 6% 6% 6% 6% 8% 6% 6% 6% 5% 4% 5% 5% 5% 4% 2% 4% 4% 4% 4% 4% 1% 3% 3% 2% 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 12
Slide 9: YTD Sep 2020: Group sales – recovery started in June
YTD Sep 2020: Group sales – recovery started in June % +60% Pharmaceuticals +50% +50% • Recovery in Q3 2020 expected to continue in Q4 2020 +40% • Severe impact from biosimilars +32% +30% +25% +20% +18% Diagnostics +10% +7% +2% • Recovery started in June 2020 with easing of +5% +0% -6% restrictions
Slide 10: Group sales – slow recovery in China
YTD Sep 2020: Group sales – slow recovery in China CHFm 2,000 -7% 1,500 +1% Pharmaceuticals -6% • Stable performance in 2020 despite COVID-19 • Healthcare system capacity still constrained 1,000 500 Diagnostics • Solid improvement quarter over quarter in 2020 0 Q1 Q2 Q3 Q4 2019 2020 All values and g
Slide 11: Good sales growth in International and Europe
YTD Sep 2020: Good sales growth in International and Europe Pharma new products and Diagnostics with strong momentum -2% +14% CHFbn CER growth CHFm Diagnostics Pharma -4% nal US YTD values reported in CHFm and variances in CERm; 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tece
Slide 12: Pharma: New products with strong momentum
Pharma: New products with strong momentum Accelerated rejuvenation in Q3 2020 Pharma sales mix CHFm % of Pharma Sales YTD 2019 15,000 40% 29% 42% 12,000 29% 9,000 29% 21% YTD 2020 6,000 15% 31% 3,000 40% 0 29% YTD Sep 2017 YTD Sep 2018 YTD Sep 2019 YTD Sep 2020 Erivedge Perjeta Kadcyla Gazyva New pr
Slide 13: Pharma: Significantly advancing patient care
Pharma: Significantly advancing patient care 36 Breakthrough Therapy Designations (BTD) since 2013 Year Molecule Indication New pivotal study starts in 2020 YTD mosunetuzumab 3L+ FL mNSCLC (Ph III: SKYSCRAPER-01), ES-SCLC (Ph III: SKYSCRAPER-02), stage III 2020 Tecentriq unresectable or metastatic A
Slide 14: Diagnostics: Comprehensive portfolio launched in a short time
Diagnostics: Comprehensive portfolio launched in a short time1 Clinical Labs • cobas® SARS-CoV-2 Capacity increased to 20 million tests Launched Molecular • cobas® SARS-CoV-2 & Influenza A/B per month; further ramp-up planned Launched solutions • TIB MOLBIOL LightMix® Modular SARS-CoV-2 for 2021 Lau
Slide 15: YTD Sep 2020 performance; Outlook
YTD Sep 2020 performance Outlook 15
Slide 16: 2020 outlook confirmed
2020 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 17: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 18: Pharmaceuticals Division sales
YTD Sep 2020: Pharmaceuticals Division sales Good growth in International and Europe 2020 2019 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 34,317 36,559 -6 -1 United States 18,389 20,036 -8 -4 Europe 6,268 6,310 -1 4 Japan 2,802 3,076 -9 -6 International 6,858 7,137 -4 6 CER=Constant Exch
Slide 19: New medicines compensating for biosimilar erosion
YTD Sep 2020: New medicines compensating for biosimilar erosion Tecentriq 64% Ocrevus 29% Hemlibra 79% Actemra / RoActemra 33% Perjeta 17% Kadcyla 37% Alecensa 35% Polivy >500% Gazyva 27% Esbriet 9% Xolair 2% TNKase / Activase 3% Xofluza 286% Lucentis -14% US Avastin -22% Europe MabThera -27% Japan
Slide 20: New products account for >43% of Pharma sales
New products account for >43% of Pharma sales* 4 NME approvals in 2020: GAVRETO and EVRYSDI approved in Q3 * Venclexta sales are booked by partner AbbVie and therefore not included 20
Slide 21: Oncology down -8% due to biosimilars & COVID-19
YTD Sep 2020: Oncology down -8% due to biosimilars & COVID-19 HER2 franchise • Kadcyla and Perjeta with strong global uptake in adjuvant BC Avastin franchise • Biosimilar erosion momentum in EU Hematology franchise* • Venclexta: Strong growth in 1L AML and 1L CLL • Gazyva: Growth in 1L CLL and 1L FL
Slide 22: HER2 franchise: Growth for Perjeta and Kadcyla
HER2 franchise: Growth for Perjeta and Kadcyla CHFm YoY CER growth 4,000 HER2 franchise Q3 update 3,500 • Strong recovery in Q3 following COVID-19 impact in Q2 • Perjeta (+17%): Global growth driven by eBC (APHINITY) and 3,000 +9% +5% +7% early uptake in China 2,500 -11% • Kadcyla (+33%): Growth in
Slide 23: Hematology franchise: Growth from Venclexta, Gazyva, and Polivy
Hematology franchise: Growth from Venclexta, Gazyva, and Polivy CHFm YoY CER growth Hematology franchise Q3 update 2,000 CD20 franchise • MabThera/Rituxan (-34%): Biosimilar erosion in US as expected and market contraction due to COVID-19 0% 1,500 -6% +3% • Gazyva (+15%): Growth driven by 1L CLL (CL
Slide 24: Tecentriq overview: Growth driven by first-in-class indications
Tecentriq overview: Growth driven by first-in-class indications 17% US patient share in 1L HCC after 4 months Tecentriq Q3 update Lung franchise (NSCLC, SCLC) • US/EU/Japan: Growth driven by 1L SCLC and 1L NSCLC Breast franchise (TNBC) • US/EU: Growth driven by 1L PDL1+ TNBC GI franchise (HCC) • US:
Slide 25: Lung franchise: Gavreto new SOC in RET+ mNSCLC
Lung franchise: Gavreto new SOC in RET+ mNSCLC Strong and durable responses including CNS disease control RET inhibitor Ph I/II (ARROW) results in RET fusion+ mNSCLC Tumor responses CNS responses • Oral small molecule kinase inhibitor • Highly selective for RET fusions and mutations, including predi
Slide 26: Hemophilia A franchise: Hemlibra with strong rebound in Q3
Hemophilia A franchise: Hemlibra with strong rebound in Q3 25% total US patient share; Strong launch momentum in EU-5 Hemophilia Q3 update • US: Gaining market share in non-inhibitors; patients on treatment stay on treatment, COVID-19 impact in Q2, but recovery of new patient starts in Q3 • EU-5: No
Slide 27: SMA franchise: Strong virtual US launch of Evrysdi
SMA franchise: Strong virtual US launch of Evrysdi Patient starts across all segments including Type I and switchers Broad uptake across segments in first 2 months Access supported by responsible pricing 25% discount to current SOC over 5-yrs (at max Evrysdi price) Patients treated with all SMA type
Slide 28: Immunology franchise: Growth for Actemra, Esbriet and Xolair
Immunology franchise: Growth for Actemra, Esbriet and Xolair CHFm YoY CER growth 2,500 Immunology Q3 update +5% +7% Esbriet (+5%) +8% +1% 2,000 • Growth in mild/moderate segments; remains EU market leader 1,500 Actemra (+27%) • Sales positively impacted by COVID-19 1,000 Xolair (+3%) • Remains leade
Slide 29: MS franchise: Ocrevus with strong rebound in Q3
MS franchise: Ocrevus with strong rebound in Q3 Market leadership momentum in US back to pre-COVID-19 levels Ocrevus Q3 update • COVID-19 impact in April/May due to reduced new patient starts and delayed dosing for existing patients • Strong rebound in Q3 driven by both returning patients and new pa
Slide 30: Ophthalmology franchise
Ophthalmology franchise PDS filing in nAMD & faricimab results in DME expected in Q4 Port delivery system (PDS) Faricimab (anti-VEGF/Ang-2 biMab) • Ph III (ARCHWAY) results in nAMD show more than 98% of • Robust Ph II data in DME and nAMD patients were able to go six months between treatments • COVI
Slide 31: Infectious diseases: Neutralizing Ab cocktail against SARS-CoV-2
Infectious diseases: Neutralizing Ab cocktail against SARS-CoV-2 Promising for treatment and prophylaxis REGN-COV2 (nAb cocktail) nAb cocktails for treatment & prophylaxis REGN10987 REGN10933 • Two potent, virus-neutralizing Abs binding non-competitively to Currently enrolling trials: the critical r
Slide 32: Neutralizing Ab cocktail: early data show reduced viral load
Infectious diseases: Neutralizing Ab cocktail against SARS-CoV-2 Early data show reduced viral load & time to symptom alleviation* Ph I/II/III (Study 2067) results in outpatients Viral load over time (copies/ml) Alleviation of symptoms • The REGN-COV2 nAb cocktail reduced viral load and symptoms vs.
Slide 33: 2020: Key late-stage news flow
2020: Key late-stage news flow* Additional 2020 news flow: • REGN-CoV2: Positive Ph I/II/III results in outpatients; US EUA filed • Gavreto: US approval in RET fusion positive mNSCLC • Actemra: Positive Ph III (EMPACTA) in severe COVID-19 related pneumonia • Gavreto: US priority review and RTOR for
Slide 34: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 35: Diagnostics Division sales
YTD Sep 2020: Diagnostics Division sales Strong growth driven by Molecular Diagnostics 2020 2019 Change in % CHFm CHFm CHF CER Diagnostics Division 9,662 9,507 2 9 Centralised and Point of Care Solutions 5,028 5,766 -13 -7 Molecular Diagnostics 2,578 1,547 67 77 Diabetes Care 1,261 1,395 -10 -2 Tiss
Slide 36: Diagnostics Division regional sales
YTD Sep 2020: Diagnostics Division regional sales Growth driven by North America & EMEA, partially offset by Asia Pacific Japan North America +5% +22% EMEA1 ~4% of divisional sales ~28% of divisional sales +9% ~38% of divisional sales Asia Pacific Latin America -4% +12% ~24% of divisional sales ~6%
Slide 37: Diagnostics Division highlights
YTD Sep 2020: Diagnostics Division highlights Strong growth driven by Molecular Diagnostics YoY CER growth Centralised • Immunodiagnostics (-8%) and Point -7% • Clinical Chemistry (-12%) of Care Solutions • POC3 Immunodiagnostics (+120%) • Virology (+156%) Molecular +77% • LightMix Systems (+188%) D
Slide 38: SARS-CoV-2 diagnostics portfolio
SARS-CoV-2 diagnostics portfolio1 Comprehensive portfolio of tests and digital solutions Clinical Labs Near Patient • TIB MOLBIOL LightMix® Modular SARS-CoV-2 Launched Molecular • cobas® SARS-CoV-2 & Influenza A/B Launched • cobas® SARS-CoV-2 Launched solutions • cobas® SARS-CoV-2 & Influenza A/B La
Slide 39: New COVID-19 tests in near-patient setting
New COVID-19 tests in near-patient setting Fast answers to support clinical decision making SARS-CoV-2 Rapid Antigen Test cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® Liat® System • Rapid chromatographic immunoassay detecting specific antigens • Highly sensitive and specific multiple
Slide 40: cobas 6800/8800 menu expansion driving growth in molecular
cobas® 6800/8800 menu expansion driving growth in molecular More than 1000 systems installed Antimicrobial Donor Screening Infectious Disease Sexual Health Transplant Respiratory Stewardship MPX HIV-1 HPV CMV MTB MTB-RIF/INH Not available in the US Not available in the US WNV HBV CT/NG EBV MAI DPX H
Slide 41: Improving care for transplant patients
Improving care for transplant patients FDA authorized cobas® EBV & cleared cobas® BKV; the first quantitative PCR tests Pre-transplantation Post-transplantation EBV* serology to determine the infection stage of donor Viral load tests (NAT) are used to monitor high risk and recipients transplant pati
Slide 42: Improving diagnostics for HIV/AIDS
Improving diagnostics for HIV/AIDS FDA approval for cobas® HIV-1/2 Qual & Elecsys® HIV Duo Blood / Plasma Diagnosis Early Infant Confirmatory Baseline and Donor Screening Diagnosis Monitoring Molecular cobas® MPX1 on cobas® cobas® HIV-12 Qual on cobas® 6800/8800 Systems solutions 6800/8800 Systems c
Slide 43: Key launches 2020
Key launches 2020 Area Product Description Market1 Workflow cobas® prime Next generation pre-analytical platform to support cobas® 6800/8800 Systems CE Instruments/ Devices Diabetes Accu-Chek Solo Diabetes Integration of the Accu-Chek Guide test strip technology into the Accu-Chek CE Care Manager So
Slide 44: Finance
Finance Alan Hippe Chief Financial Officer
Slide 45: YTD Sep 2020: Highlights
YTD Sep 2020: Highlights Sales • Group sales growth (+1%); driven by Diagnostics Division (+9%), Pharma International (+6%) and Pharma Europe (+4%) • Gradual recovery since Q2 2020 Currency impact on sales • Negative currency impact due to all currencies, particularly USD All growth rates at Constan
Slide 46: Group sales YTD Sep 2020
Group sales YTD Sep 2020 CER sales increase of +1% driven by Diagnostics Division, Pharma International & Europe; Fx impact of -6%p -4% +4% +6% -6% +1% -5% Pharma Division Dia Division -1% +9% +9% +815 +535 +436 -788 -185 +257 -2,622 -2,087 PY: -63 11 United States Europe Intl. Chugai Dia Division G
Slide 47: High currency impact expected in 2020
High currency impact expected in 2020 CHF / USD Average -3% -3% -4% -5% YTD 2019 0.99 1.00 1.00 1.00 Assuming the 30 September 2020 exchange rates 0.95 0.94 remain stable until end of 2020, 0.97 0.97 2020 impact 1 is expected to be (%p): Assumed average YTD 2020 0.97 0.97 0.96 Q1 HY Sep FY 0.97 0.97
Slide 48: 2020 outlook confirmed
2020 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 49: Changes to the development pipeline
Changes to the development pipeline Q3 2020 update New to phase I New to phase II New to phase III New to registration 7 NMEs: 2 NMEs: 4 NMEs: 1 NME: RG6091 UBE3A LNA - Angelman syndrome RG7992 FGFR1 x KLB - NASH RG6107 crovalimab - PNH RG6396 Gavreto (pralsetinib) - RET fusion- RG6286 NME - colorec
Slide 50: Roche Group development pipeline
Roche Group development pipeline Phase I (45 NMEs + 17 AIs) Phase II (21 NMEs + 14 AIs) RG6026 glofitamab combos heme tumors RG7769 PD1 x TIM3 solid tumors RG6171 SERD (3) neoadjuvant HR+ BC RG6058 tiragolumab combos heme & solid tumors RG7802 cibisatamab ± T solid tumors RG6180 iNeST* + pembrolizum
Slide 51: Roche Group development pipeline
Roche Group development pipeline Phase III (12 NMEs + 34 AIs) Registration (5 NMEs + 11 AIs) RG6013 Hemlibra mild to moderate hemophilia A RG7446/ Tecentriq bTMB-high RG6264 Phesgo 1 Perjeta + Herceptin FDC SC HER2+ BC 1L NSCLC tiragolumab + T + chemo 1L SCLC RG6268 or entrectinib ROS1+ Gavreto (pra
Slide 52: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III Port Delivery System tiragolumab + TLR7 ago (3) RG7907+ RG6321 with ranibizumab RG6058 Tecentriq (T) + CpAM (2) 1L PD-L1+ cervical ca RG7854 wAMD HBV Xofluza ✓ rhPTX-2 RG6413+ REGN-COV2 Crovalimab tiragolumab + T FGFR1 x K
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 CardioMetabolism Other Tecentriq + Avastin RG7446 HCC adj Xolair ✓ Tecentriq SC RG3648 RG7446 Asthma
Slide 54: Major pending approvals 2020
Major pending approvals 2020 US EU China Japan-Chugai Xolair Enspryng (satralizumab) CellCept Polivy RG3648 nasal polyps RG6168 NMOSD RG99 lupus nephritis RG7596 r/r DLBCL Filed Sept 2019 Filed Aug 2019 Filed Aug 2018 Filed June 2020 Alecensa (BFAST) Tecentriq Avastin RG7853 1L NSCLC ALK+ RG7446 1L
Slide 55: Major granted approvals 2020
Major granted approvals 2020 US EU China Japan-Chugai Venclexta+Gazyva Polivy Kadcyla Rozlytrek (entrectinib) RG7601 1L CLL RG7596 r/r DLBCL RG3502 HER2+ eBC RG6268 ROS1+ NSCLC Mar 2020 January 2020 Jan 2020 Feb 2020 Tecentriq + Avastin Venclexta+Gazyva Tecentriq + chemo Alecensa RG7446 1L HCC RG760
Slide 56: Doing now what patients need next
Doing now what patients need next