Roche Holding Ltd · SIX:RO
Roche — H1 2022 Earnings Presentation
80 slides from Roche's earnings presentation, Jul 21, 2022
Slide 1: Slide 1
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 3: Roche HY 2022 results
Roche HY 2022 results Basel, 21 July 2022
Slide 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: HY 2022 performance; Outlook
HY 2022 performance Outlook
Slide 6: HY 2022: Good Group performance
HY 2022: Good Group performance Group sales +5% driven by both divisions • Pharma portfolio performing well (+3%) outgrowing biosimilar erosion • Diagnostics with strong growth momentum (+11%) including good base business growth (+6%) Key products growing strongly; new launches with significant sale
Slide 7: HY 2022: Group sales driven by both divisions
HY 2022: Group sales driven by both divisions 2022 2021 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 22.3 21.7 3 3 Diagnostics Division 9.9 9.0 10 11 Roche Group 32.3 30.7 5 5 CER=Constant Exchange Rates; totals may include differences due to rounding 7
Slide 8: Quarterly sales performance
Quarterly sales performance: As guided COVID-19 sales coming down in Q2 16% 14%* 14% 13% 12% 12% 11% 10% 9% 9% 8% 7% 6% 6% 7% 7% 6% 6% 6% 8% 8% 6% 7% 4% 6% 4% 5% 5% 4% 4% 3% 2% 3% 3% 1% 1% 0% -2% 0% -4% -6% -4% AHR1 impact -8% -10% COVID-19 impact Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q
Slide 9: HY 2022: Portfolio diversification progressing
HY 2022: Portfolio diversification progressing CHFm +5% at CER Diversification of Roche business +64 -987 HY 2017 HY 2022 +627 + 1,576 + 392 -90 CHF 26.3bn CHF 32.3bn AHR AHR 30,713 32,295 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophilia A HY Diagnostic
Slide 10: Good underlying business momentum for both divisions
HY 2022: Good underlying business momentum for both divisions Pharma Diagnostics Quarterly sales evolution 2021-2022 Quarterly sales evolution 2021-2022 % CER % CER +55% +55% +48% +55% +45% +45% +35% +35% +31% +24% +25% +25% +17% +18% +15% +14% +15% +9% +4% +5% +6% +4% 3% +5% +5% +11% +10% +8% +8% -
Slide 11: Growth of profitability and Core EPS
HY 2022: Growth of profitability and Core EPS Benefit from Ultomiris patent settlement and share repurchase Core operating profit Core EPS Operating free cash flow 40.2% 39.2% 30.3% 37.9% 26.4% % of sales 17.2% +9% at CER +11% at CER +21% at CER CHFbn 12.7 CHF 11.76 CHFbn 9.8 11.8 11.7 10.44 10.56 8
Slide 12: NMEs launched in 2022: Vabysmo and Lunsumio
2 NMEs launched in 2022: Vabysmo and Lunsumio First-in-class bispecifics launched in ophthalmology and malignant hematology Roche: Leading in bispecific antibodies • First bispecific mAb that bridges activated factor IX (FIXa) and FX to restore function of missing FVIII 2017 • Approved for severe, m
Slide 13: HY 2022 performance; Outlook
HY 2022 performance Outlook
Slide 14: 2022: Upcoming newsflow
2022: Upcoming newsflow Pharma Diagnostics Vabysmo in DME/nAMD Real-time PCR molecular testing for low cobas® 5800 (FDA) volume labs Ongoing and Susvimo in nAMD upcoming Serum work area analyzer for low-to-medium cobas® pure (FDA) launches Polivy in 1L DLBCL sized labs Device combining glucose meter
Slide 15: 2022 sales outlook confirmed
2022 sales outlook confirmed Sales drivers1 Pharma: New products with accelerating growth Diagnostics: Base business with strong growth • Guidance stable to low-single digit group sales growth • Group sales to grow high-single digit if COVID-19 sales and AHR AHR2 biosimilars: Roughly CHF -2.5 bn sal
Slide 16: 2022 outlook confirmed
2022 outlook confirmed Group sales growth1 • Stable to low-single digit Core EPS growth1 • Low- to mid-single digit Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 16
Slide 17: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 18: HY 2022: Pharmaceuticals Division sales
HY 2022: Pharmaceuticals Division sales New products compensate for biosimilar erosion 2022 2021 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 22,347 21,671 3 3 United States 11,363 10,802 5 1 Europe 4,104 4,485 -8 -4 Japan 2,202 1,808 22 34 International 4,678 4,576 2 2 CER=Constant Exchan
Slide 19: HY 2022: Pharmaceuticals Division
HY 2022: Pharmaceuticals Division Core operating profit growth driven by patent settlement 2022 2022 vs. 2021 CHFm % sales CER growth Sales 22,347 100 3% Royalties & other op. inc. 1,918 8.6 41% Cost of sales -4,430 -19.8 14% COGS + PC: +9% M&D -3,096 -13.9 4% R&D -5,729 -25.6 -3% G&A -692 -3.1 -8%
Slide 20: Pharma product sales growth by product
HY 2022: Portfolio diversification progressing Hemlibra 30% Ocrevus 17% Evrysdi 106% Phesgo 241% Tecentriq 11% Kadcyla 14% Alecensa 19% Vabysmo n/a Perjeta 5% Xolair 11% Polivy 91% Ronapreve 11% Enspryng 132% Gazyva 8% Gavreto n/a Esbriet -14% US Lucentis -17% Europe Actemra / RoActemra -10% Hercept
Slide 21: Oncology portfolio rejuvenation on-going
HY 2022: Oncology portfolio rejuvenation on-going YoY CER growth Phesgo (+241%) HER2 franchise HER2 franchise Herceptin Perjeta (+5%) +6% • Kadcyla (+14%) with growth ex-US due to adjuvant BC Tecentriq +11% Kadcyla (+14%) • Perjeta (+5%) driven by International Hematology Polivy (+91%) • Phesgo (CHF
Slide 22: HER2+ franchise: High efficacy and safety bar
HER2+ franchise: High efficacy and safety bar established in eBC Perjeta conversion rate at 27% in early launch countries Phesgo with strong global launch Continuing to build on existing standard of care Global Perjeta conversion rate* Ph III (heredERA) in 1L HER2+/ER+ mBC Induction Randomization Ma
Slide 23: Tecentriq overview: Adjuvant program
Tecentriq overview: Adjuvant program to read out in 2022/23 Tecentriq Q2 update CHFm YoY CER growth • Ph III (IMvoke010) in adjuvant SCCHN continues to final analysis 1,000 +13% • Japan: Sales impacted by mandatory price cut 900 +31% Lung franchise (NSCLC, SCLC) 800 +54% • EU: Approval in adjuvant P
Slide 24: Hematology franchise: Setting new standards of care
Hematology franchise: Setting new standards of care First-in-class EU approvals in 1L DLBCL and 3L+ FL Ph III (POLARIX) Polivy + R-CHP in 1L DLBCL Ph I/II step up dosing (GO29781) Lunsumio in 3L+ FL Progression free survival (PFS) Best percentage change from baseline in tumor SPD • 60% CR rate (grea
Slide 25: Hematology franchise development program
Hematology franchise development program Potential first-in-class & best-in-class combinations Ph II (NP30179) glofitamab Most advanced clinical development program in 3L+ DLBCL Duration of DLBCL FL complete response by IRC 1L R/R 3L+ 1L 2L+ 3L+ Polivy + Polivy + glofitamab G + chemo G + benda Lunsu
Slide 26: Hemophilia A franchise: Hemlibra
Hemophilia A franchise: Hemlibra new global standard of care 35% US/EU-5 patient share reached CHFm YoY CER growth 1,200 Hemophilia Q2 update +31% 1,000 • Nearly 18,000 patients treated globally • Hemlibra continues to penetrate across all approved patient 800 +58% segments 600 • Ph III (HAVEN 6) st
Slide 27: Immunology franchise
Immunology franchise Actemra COVID-19 sales declining and first Esbriet generic competition Immunology Q2 update CHFm YoY CER growth • Gazyva: Ph III (INShore) in PNS initiated 2,500 Actemra (-23%) +7% +2% +1% 2,000 -12% • Strong decline of COVID-19 driven sales • Remains leading RA monotherapy in E
Slide 28: MS franchise: Ocrevus market share
MS franchise: Ocrevus global market share reaches 21% Fenebrutinib development programs in RMS and PPMS well on track CHFm YoY CER growth +17% Q2 update 1,500 • >250.000 patients treated globally 1,300 +31% • No.1 treatment in US and EU-5 1,100 +12% +59% • Highest persistence amongst MS medicines 90
Slide 29: SMA franchise: Evrysdi momentum
SMA franchise: Evrysdi with strong global momentum US with >20% and Germany with >30% share Q2 update CHFm YoY CER growth • >5,000 patients treated world wide (commercial, clinical 300 trials, compassionate use) +65% 250 • Retention rate of ~90% due to treatment satisfaction +189% 200 +347% • US: Gr
Slide 30: Duchenne muscular dystrophy franchise update
Duchenne muscular dystrophy franchise update Pivotal Ph III development program expected to read out in 2023 Delandistrogene moxeparvovec Ph Ib ENDEAVOR (Study 103) Ph I (Study 101) Functional results: LSM change from NSAA total score over 4 years in treated NSAA baseline patients vs. EC (unadjusted
Slide 31: Ophthalmology franchise: Excellent Vabysmo launch
Ophthalmology franchise: Excellent Vabysmo launch Building a global ophthalmology franchise Vabysmo in nAMD and DME Global retina market growing to USD 15 bn • First IVT therapy inhibiting two distinct disease anti-Ang2 anti-VEGF pathways by simultaneously binding to Ang-2 and VEGF-A • Potentially i
Slide 32: Ophthalmology franchise: Vabysmo in nAMD
Ophthalmology franchise: Vabysmo in nAMD At 112 weeks Q16W dosing increases to ≥ 60% Ph III (LUCERNE, TENAYA) in nAMD: Dosing intervals of patients at year 1 and 2 48 weeks 112 weeks TENAYA LUCERNE TENAYA LUCERNE Q8W Q8W 20.3% 22.2% Q16W Q16W 45.7% 44.9% Q12W Q12W 34.0% 32.9% Q12W + Q16W Q12W + Q16W
Slide 33: 2022: Key late-stage news flow and IR events
2022: Key late-stage news flow* and upcoming IR events Compound Indication Milestone Vabysmo nAMD/DME US/EU approval US Susvimo nAMD EU approval 2023 Lunsumio (mosunetuzumab) 3L+ FL US/EU approval EU Regulatory Tecentriq Adjuvant NSCLC EU approval Hemlibra Mild to moderate hemophilia A EU approval P
Slide 34: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 35: HY 2022: Diagnostics Division sales
HY 2022: Diagnostics Division sales Sales increase of +11% driven by COVID-19 testing and base business 2022 2021 Change in % CHFm CHFm CHF CER Diagnostics Division 9,948 9,042 10 11 Core Lab1 3,875 3,770 3 4 Point of Care1 2,609 1,798 45 46 Molecular Lab1 1,980 1,990 -1 1 Diabetes Care 832 894 -7 -
Slide 36: Diagnostics Division regional sales
HY 2022: Diagnostics Division regional sales Very strong growth in Asia Pacific and North America North America +34% EMEA1 ~29% of divisional sales -14% ~33% of divisional sales Asia Pacific Latin America +39% +2% ~32% of divisional sales ~6% of divisional sales Growth rates at CER (Constant exchang
Slide 37: Diagnostics Division highlights
HY 2022: Diagnostics Division highlights Strong growth despite a high base in HY 2021 CHFbn YoY CER growth • Immunodiagnostics (+6%) Core Lab1,2 +4% • Clinical Chemistry (+8%) • Custom biotech (-12%) • POC Immunodiagnostics (+54%) Point of Care2 +46% • POC Molecular3 (+75%) Molecular Lab2 +1% • Viro
Slide 38: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Strong COVID-19 sales and base business growth Diagnostics Division sales growth 55% Base business sales growth 1 48% 28% 31% 24% 18% 17% 18% 9% 10% 5% 3% 2% -2% 11% 1% -5% 8% 0% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 -17% 0.1bn 0.6bn
Slide 39: HY 2022: Diagnostics Division
HY 2022: Diagnostics Division Strong core operating profit growth of +11% 2022 2022 vs. 2021 CHFm % sales CER growth Sales 9,948 100 11% Royalties & other op. inc. 25 0.3 -46% Cost of sales -4,875 -49.1 14% M&D -1,363 -13.7 3% R&D -899 -9.0 11% G&A -276 -2.8 2% Core operating profit 2,560 25.7 11% +
Slide 40: Upcoming launch of Elecsys IGRA SARS-CoV-2
Upcoming launch of Elecsys® IGRA SARS-CoV-2 Improving the understanding of immunity against SARS-CoV-2 Testing workflow Step1 Step 2 T-Cell Stimulation Quantification of IFN-𝝲 • Detects T-cell mediated immune response by measuring IFN-γ (on Roche IA instrument) release upon stimulation with 189…
Slide 41: TIB-Molbiol SARS-CoV-2 menu for new variants
TIB-Molbiol SARS-CoV-2 menu for monitoring new variants Detecting major variants in hours vs a week for sequencing BA.1 & BA.1.1 XF BA.3 XE Delta BA.2 & BA.2.2 BA.2.12.1 BA.2.75 BA.5 BA.4 BA.5 is becoming the dominant SARS-CoV-2 variant 41
Slide 42: Monkeypox assays supplied to WHO
Monkeypox assays supplied to WHO Three assays developed in record time to monitor epidemiologic spread of the virus LightMix® Modular Orthopox Viruses New Detects all orthopox viruses (e.g. monkeypox, cowpox, camelpox) LightMix® Modular Monkeypox Viruses New Detects all variants of monkeypox viruses
Slide 43: cobas HPV self-sampling solution
cobas® HPV self-sampling solution Increasing screening adherence to potentially reach 1.7bn women globally cobas® HPV self- cobas® HPV test CINtec® Plus Cytology CINtec® Histology iThemba Life® 342,000 women sampling solution1 die per year of cervical cancer, ~90% in LMIC with majority unscreened 2
Slide 44: Elecsys HCV DUO Immunoassay
Elecsys® HCV DUO Immunoassay1 Early diagnosis of hepatitis C virus (HCV) enables optimal treatment Diagnostic window period2 • 58m people being chronically infected globally (80% unaware3) and about 1.5m new infections per year 6-12 weeks • Hepatitis C leading cause for liver cancer and curative rel
Slide 45: BenchMark ULTRA PLUS system
BenchMark ULTRA PLUS system1 Next instrument generation for tissue advanced staining Optimized workflow Flexible solutions • Shortened reagent validation • View, manage, complete and print • Reduced turnaround time system data remotely • Fewer manual interventions • Optimized protocols and slide sta
Slide 46: VENTANA DP 600 slide scanner
VENTANA DP 600 slide scanner Enhancing digital pathology with high volume slide scanner High volume scanning Leverages optical system of DP 200 240 slide capacity (40x more than DP200) consistent image quality Flexible workflows Continuous loading improve efficiency walk-away automation Slide scanne
Slide 47: Roche analyst virtual event on diagnostics division
Roche analyst virtual event on diagnostics division AACC 2022 in Chicago Speakers: • Thomas Schinecker, CEO Roche Diagnostics • Ann Costello, Global Head Roche Diagnostics Solutions July 26, 6-7:15pm CDT • Cindy Perettie, Head of Roche Molecular Labs • Palani Kumaresan, Head of Research & Developmen
Slide 48: Key launches 2022
Key launches 2022 Area Product Description Market Status Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with BenchMark ULTRA PLUS US & CE Pathology Lab enhanced software capabilities, workflow and testing efficiency DP600 High capacity pathology slide scanner f
Slide 49: Finance
Finance Alan Hippe Chief Financial Officer
Slide 50: HY 2022 results; cash and balance sheet; Outlook
HY 2022 results Focus on cash and balance sheet Outlook 50
Slide 51: HY 2022: Highlights
HY 2022: Highlights Business • Group sales growth of +5% driven by good performance of Pharmaceuticals and Diagnostics division • Pharma established products and new launches performing well; Diagnostics continuing with strong double-digit sales • Core operating profit up +9% and Core EPS growth +11
Slide 52: HY 2022: Overall strong Group performance
HY 2022: Overall strong Group performance 2022 2021 Change in % CHFm CHFm CHF CER Sales 32,295 30,713 5 5 Core operating profit 12,668 11,652 9 9 as % of sales 39.2 37.9 Core net income 10,160 9,527 7 7 as % of sales 31.5 31.0 Core EPS (CHF) 11.76 10.56 11 11 IFRS net income 9,161 8,216 12 12 as % o
Slide 53: Growing topline compensating biosimilar erosion
HY 2022: Growing topline compensating biosimilar erosion CHFm +5% at CER +64 +627 + 1,576 -987 + 392 -90 30,713 32,295 HY Diagnostics Diagnostics Pharma Ronapreve AHR Fx HY base COVID-19 underlying sales erosion1 2021 business sales business 2022 HY 2021 and HY 2022 values in reported CHFm, variance
Slide 54: HY 2022: Core EPS development
HY 2022: Core EPS development Strong EPS development driven by growth in operations and accretion effect +11.0% CHF +6.1 p -1.5p +2.9 p +3.5 p 11.83 10.66 HY 2021 Operations1 Ultomiris 2 Net accretion Other 4 HY 2022 patent settlement Novartis share repurchase 3 At Constant Exchange Rates (CER); 1 C
Slide 55: HY 2022: Group operating performance
HY 2022: Group operating performance Core OP up +9% driven by higher gross profit and ROOI, OPEX stable 2022 2022 vs. 2021 CHFm abs. CER CER growth Sales 32,295 +1,672 5% Royalties & other op. inc. 1,943 +536 38% Cost of sales -9,305 -1,119 14% M&D -4,459 -159 4% R&D -6,628 +85 -1% G&A -1,178 +63 -5
Slide 56: Royalties and other operating income
HY 2022: Royalties and other operating income Higher income mainly driven by Ultomiris patent settlement CHFm +25 -146 +687 -43 1,943 1,420 Royalties and other operating income increased by +38% at CER HY 2021 Royalty income Out-licensing Other operating Income from HY 2022 Income (incl. income disp
Slide 57: HY 2022: Group Core cost of sales
HY 2022: Group Core cost of sales (COS) Increase due to PP&E reversal in 2021, volume growth and change in the Pharma/Diagnostics sales mix 839 165 9,322 CHFm 8,203 184 8,387 -69 Pharma Division’s proportion of Group sales declines from 71% to 69% COS as % of group 26.7% 27.3% 29.0% 28.8% sales COS
Slide 58: Core operating profit and margin
HY 2022: Core operating profit and margin 47.2% 46.2% % of sales 44.1% 40.2% 37.9% 39.2% +2.3%p¹ +1.4%p¹ 25.7% 25.7% 16.8% 0.0%p¹ +9%¹ CHFm 12,668 +8%¹ 11,766 11,652 10,961 10,318 9,562 +11%¹ 2,324 2,560 1,022 2020 2021 2022 Roche Group Pharma Division Diagnostics Division 1 At CER=Constant Exchange
Slide 59: HY 2022: Core net financial result
HY 2022: Core net financial result Higher net financial expenses driven by loss on Equity securities and higher interest expenses CHFm • Net financial expense increased by -370m at CER -186 • Interest expenses1 increased by +49% at CER -220 -558 +26 -10 -88 -80 HY 2021 Equity Net interest FX G/L Int
Slide 60: HY 2022: Group Core tax rate
HY 2022: Group Core tax rate Tax rate before resolution of tax disputes increased due to higher profits in higher tax jurisdictions +0.8%p 18.5% 17.7% 0.8% 2.4% Tax rate before resolution of tax 16.9% -0.8%p 16.1% disputes Effective tax rate Effective tax rate HY1 2021 HY1 2022 60
Slide 61: HY 2022: Non-core and IFRS income
HY 2022: Non-core and IFRS income Decrease in non-core operating expenses driven by lower amortisation of intangible assets due to Esbriet and lower costs for global restructuring plans 2021 2022 Change in % CHFm CHFm CHFm CHF CER Core operating profit 11,652 12,668 1,017 +9 +9 Global restructuring
Slide 62: HY 2022 results; cash and balance sheet; Outlook
HY 2022 results Focus on cash and balance sheet Outlook 62
Slide 63: Operating free cash flow and margin
HY 2022: Operating free cash flow and margin OFCF of +21% driven by higher OP, net of cash adjustments and NWC movements 38.8% % of sales 33.6% 26.4% 30.3% +5.5%p¹ 23.5% 17.2% +4.0%p¹ 13.0% 15.2% +21%¹ -0.7% +2.1%p¹ 9,782 +20%¹ CHFm 8,667 8,117 7,282 5,454 5,036 +29%¹ 1,178 1,509 2020 2021 2022 -44
Slide 64: Group operating free cash flow
HY 2022: Group operating free cash flow OFCF up by +21% driven by higher Operating Profit, net of cash adjustments CHFm +1 +29 +606 -70 +1,099 9,782 8,117 OFCF higher by +21%/+1,735m at CER HY 2021 OP, net of cash NWC Investments Investments Foreign HY 2022 adjustments movement in PP&E in IA exchang
Slide 65: Group net debt development
HY 2022: Group net debt development Net debt higher by CHF -2.7bn compared to previous YE 2021 CHFbn Free Cash Flow CHF 7.1bn vs. 6.0bn in 2021 Dividends paid -7.7 Taxes -2.5 Trans. own eq. instr. -0.6 Treasury -0.2 M&A & All. trans. 0.0 Curr. Transl. & Other -1.5 -18.2 -2.7 -20.9 +9.8 -9.8 Net debt
Slide 66: Balance sheet 30 June 2022
Balance sheet 30 June 2022 Equity ratio at 33% (YE 2021: 31%) and net debt to assets at 24% (YE 2021: 20%) % change in CER vs % change in CER vs CHFbn 31 Dec 2021 31 Dec 2021 92.3 92.3 86.7 -6% 86.7 -6% Cash and 13.0 14% 6.8 -43% marketable 8% Current securities 38.4 27.4 -28% 22.6 23.5 liabilities
Slide 67: HY 2022 results; cash and balance sheet; Outlook
HY 2022 results Focus on cash and balance sheet Outlook 67
Slide 68: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the EUR, JPY and “other Europe”, partially offset by USD +0.0p -0.8p +0.1p +1.8p -0.6p -1.0p +0.3p CER CHF sales growth sales growth HY 2022 HY 2022 vs. vs. HY 2021 +5.4% +5.2% HY 2021 CER EUR APAC USD LATAM JPY Other Other CHF Europe CE
Slide 69: Low currency impact expected in 2022
Low currency impact expected in 2022 CHF / USD Average YTD 2022 +2% +4% +4% +4% 0.94 0.95 0.95 Assuming the 30 June 2022 exchange rates remain 0.92 stable until end of 2022, 0.90 0.91 0.91 0.91 2022 impact1 is expected to be (%p): Average YTD 2021 0.92 0.92 0.93 0.94 0.98 0.97 0.96 0.96 0.96 0.96 0.
Slide 70: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit Core EPS growth1 • Low- to mid-single digit Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 70
Slide 71: Doing now what patients need next
Doing now what patients need next
Slide 72: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 73: Changes to the development pipeline
Changes to the development pipeline HY 2022 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 4 AIs: RG6351 NME – retinal disease RG6237 latent myostatin + Evrysdi – SMA RG1594 Ocrevus SC - PPMS & RMS RG6526 camonsertib – solid tumors RG6171 giredestrant + Phe
Slide 74: Roche Group development pipeline
Roche Group development pipeline Phase I (49 NMEs + 11 AIs) Phase II (22 NMEs + 11 AIs) RG6007 HLA-A2-WT1 x CD3 AML Lunsumio (mosunetuzumab) RG6026 glofitamab + chemo 1L ctDNA high risk DLBCL RG7828 heme tumors RG6026 glofitamab monotherapy + combos heme tumors monotheraphy + combos tiragolumab + T
Slide 75: Roche Group development pipeline
Roche Group development pipeline Phase III (10 NMEs + 43 AIs) Registration US & EU (4 NMEs + 8 AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC Venclexta r/r MM t(11:14) RG6013 Hemlibra1 mild to moderate hemophilia A RG3502 RG7601 Kadcyla + T HER-2+ eBC high-risk Venclexta + azacitidine 1L MDS RG6026 glofitam
Slide 76: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III RG6026 glofitamab + chemo 2L DLBCL glofitamab + chemo autogene cevumeran bepranemab RG6026 1L ctDNA+ high risk RG6180 RG6416 1L melanoma Alzheimer's DLBCL tiragolumab + T zinpentraxin alfa alogabat New Molecular Entity (NM
Slide 77: AI submissions for existing products
AI submissions for existing products Projects in phase II and III Phesgo OBI New Molecular Entity (NME) Metabolism RG6264 HER2+ BC Additional Indication (AI) Neuroscience Oncology / Hematology Ophthalmology Gavreto Immunology Other RG6396 Tumor agnostic Infectious Diseases Tecentriq SC RG7446 2L NSC
Slide 78: Major pending approvals 2022
Major pending approvals 2022 US EU China Japan-Chugai Xofluza Susvimo (PDS) Rozlytrek Polivy RG6152 influenza pediatric RG6321 wAMD RG6268 ROS1+ NSCLC RG7596 1L DLBCL Filed March 2020 Filed April 2021 Filed Oct 2021 Filed Dec 2021 Lunsumio (mosunetuzumab) Vabysmo (faricimab) Rozlytrek Gazyva RG7828
Slide 79: Major granted approvals 2022
Major granted approvals 2022 US EU China Japan-Chugai Vabysmo (faricimab) Polivy Tecentriq Actemra RG7716 DME RG7596 1L DLBCL RG7446 NSCLC adj RG1569 COVID-19 pneumonia Jan 2022 May 2022 March 2022 Jan 2022 Vabysmo (faricimab) Tecentriq Actemra Vabysmo (faricimab) RG7716 wAMD RG7446 NSCLC adj RG1569
Slide 80: Doing now what patients need next
Doing now what patients need next