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 2024 results
Roche 2024 results Basel, 30 January 2025
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: 2024: Strong business performance in both divisions
2024: Strong business performance in both divisions FY results all at CER • Group sales growth +7%; base business growth: +9% Group, +9% Pharma and +8% Diagnostics • COVID-19 sales decreased by CHF -1.1bn in line with guidance, and LOE impact was CHF -1.0bn • Core OP growth +14%, Group core OP margi
Slide 7: 2024 guidance exceeded
2024 guidance exceeded Group sales achieved at upper end of guidance and Core EPS exceeds guidance raised at HY Guidance Results Group sales growth1 Mid single digit sales growth +7% High single digit Core EPS growth +12% Core EPS growth1 excl. impact from resolution of tax (+7% incl. impact from re
Slide 8: 2024: Dividend per share increased to CHF 9.70
2024: Dividend per share increased to CHF 9.70 38th year of consecutive dividend increase 9.701 CAGR +11.8% 1989 1994 1999 2004 2009 2014 2019 2024 12024 dividend as proposed by the Board of Directors; Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary i
Slide 9: 2024: Group sales growth at +7% with base business at +9%
2024: Group sales growth at +7% with base business at +9% Both divisions with continued strong momentum; no COVID-19 impact going forward 2024 2023 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 46.2 44.3 4 8 9 Diagnostics Division 14.3 14.5 -1 4 8 Roche Group 60.5 58.7 3 7 9 1B
Slide 10: 2024: Continued strong growth momentum
2024: Continued strong growth momentum Consistent high single-digit growth achieved in the last three quarters Group sales growth Group base business sales growth1 %CER %CER +15% +15% +11% +10% +9% +9% +9% +9% +10% +9% +9% +8% +7% +5% +5% +2% +2% +3% +3% +1% +1% 0% 0% -3% COVID-19 Pandemic COVID-19
Slide 11: Key growth drivers of the Roche portfolio
Key growth drivers of the Roche portfolio 17 medicines achieved blockbuster status in 20241 Diagnostics: +8% base business growth +4% FY 2024 sales driven by Core Lab, Molecular Lab and (+8%)2 (CHFbn, YoY CER growth) Pathology Lab Phesgo: Conversion rate climbing to 46% 14.3 Alecensa: Geographic exp
Slide 12: Performance Outlook
Performance Outlook
Slide 13: Overview of key strategic initiatives
Overview of key strategic initiatives Strategic review completed and in implementation Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Operational
Slide 14: Comprehensive platform strategy in Near Patient Care
Comprehensive platform strategy in Near Patient Care Accu-Chek® LumiraDx cobas® liat cobas® vital cobas® sense SmartGuide CGM • Multimodal technology • 14 day real-time glucose • Lab equivalent PCR testing • Reliable and sustainable • Lab equivalent (clinical chemistry, sensor at the PoC BGE platfor
Slide 15: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term Two NMEs launched in 2024: Itovebi in HR+ BC and PiaSky in PNH CHFm % of Pharma Sales2 30.0 56% 25.0 51% 44% 20.0 35% 15.0 1 10.0 5.0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 0.0 FY 2021 FY 2022 FY 2023 FY 2024 Cotellic Alecensa
Slide 16: 2025 Pharma pipeline
2025 Pharma pipeline Peak sales potential of key assets New Molecular Entities (NME) giredestrant fenebrutinib vamikibart HR+ BC RMS, PPMS DME/UME Itovebi (inavolisib) Elevidys1 CT-388 Pi3Km BC DMD Obesity +/- T2D • 7+ NMEs with CHF >3bn peak divarasib GYM 329 CT-868 KRAS+ NSCLC, CRC SMA, FSHD T1D w
Slide 17: 2025 Pharma pipeline
2025 Pharma pipeline 12 key pivotal readouts including 4 NMEs expected New Molecular Entities (NME) 2 giredestrant Ph III persevERA 2 fenebrutinib Ph III FENhance 1/2 1 vamikibart Ph III HR+ BC Ph III evERA RMS, PPMS Ph III FENtrepid DME/UME SANDCAT/MEERKAT Itovebi (inavolisib) Elevidys CT-388 Pi3Km
Slide 18: 2025 Pharma pipeline
2025 Pharma pipeline 7 NMEs with Ph III enabling readouts expected New Molecular Entities (NME) giredestrant fenebrutinib vamikibart HR+ BC RMS, PPMS DME/UME Itovebi (inavolisib) Elevidys CT-388 Pi3Km BC DMD Obesity +/- T2D divarasib GYM 329 CT-868 KRAS+ NSCLC, CRC SMA, FSHD T1D with BMI ≥25 tiragol
Slide 19: 2025 guidance
2025 guidance LOE impact of CHF 1.2bn expected for 2025 Group sales growth1 Mid single digit sales growth Core EPS growth1 High single digit Core EPS growth Dividend outlook Further increase dividend in Swiss francs 1At CER=Constant Exchange Rates (avg full year 2024); LOE=loss of exclusivity includ
Slide 20: Finance
Finance Alan Hippe Chief Financial Officer
Slide 21: Results, Cash & balance sheet, Currency guidance & outlook
Results Cash & balance sheet Currency guidance & outlook
Slide 22: 2024: Group performance
2024: Group performance Sales increase of +7% and Core EPS increase of +7% (+12% excl. 2023 resolution of tax disputes) 2024 2023 Change in % CHFm CHFm CHF CER Sales 60,495 58,716 3 7 Core operating profit 20,823 19,240 8 14 as % of sales 34.4 32.8 Core net income 16,011 15,804 1 7 as % of sales 26.
Slide 23: 2024: Group sales growth
2024: Group sales growth Base business growth exceeds COVID-19 and LOE impact CHFm +7% at CER -522 -952 +5,078 -2,328 +1,055 -552 58,716 60,495 FY 2023 Dia Dia Pharma Ronapreve LOE Fx FY 2024 base COVID-19 (excl. Ronapreve, sales business sales LOE) Base business=Pharma excluding Ronapreve and Diagn
Slide 24: 2024: Group core operating profit
2024: Group core operating profit Core operating profit higher by +14% driven by higher sales and effective cost management 2024 2024 vs. 2023 CHFm abs. CER CER growth Sales 60,495 +4,107 7% Other revenue 1,900 +215 12% Cost of sales -15,398 -720 5% R&D -13,042 -128 1% SG&A -13,758 -625 5% OOI&E 626
Slide 25: 2024: Core operating profit and margin
2024: Core operating profit and margin 45.7% 47.7% % of sales +2.1%p¹ 32.8% 34.4% +2.1%p¹ +13%¹ CHFm +14%¹ 16.7% 16.8% 22,014 20,823 20,240 +1.3%p¹ 19,240 +12%¹ 2,417 2,402 2023 2024 Roche Group Pharma Division Diagnostics Division Note: Group Core operating profit includes -3.6bn from Corporate (-3
Slide 26: 2024: Core net financial result
2024: Core net financial result Decrease mainly driven by increased interest expenses CHFm • Net financial result decreased by -394m / +31% at CER • Interest expenses1 increased by 442m / +55% at CER -1,300 -1,610 +67 +28 -413 +8 FY 2023 Equity Net interest Interest Other FY 2024 securities income e
Slide 27: 2024: Core tax rate
2024: Core tax rate Tax rate up due to the higher impact from resolution of tax disputes in 2023 and Pillar Two top-up tax in 2024 +4.8%p Impact from resolution of tax disputes Effective tax rate excl. impact from Pillar Two top-up tax and resolution of tax disputes Impact of Pillar Two top-up tax +
Slide 28: 2024: Core EPS development
2024: Core EPS development Core EPS driven by operations growth partially offset by higher interest expenses, taxes & lower product disposals +12.4% + 17.4%p - 1.1%p 20.26 - 2.3%p - 1.2%p - 0.4%p 18.99 -0.97 18.02 FY 2023 Effects of FY 2023 Operations1 Product disposals Financial Tax rate change All
Slide 29: 2024: Non-core and IFRS income
2024: Non-core and IFRS income Non-core operating expenses higher vs. PY mainly due to higher goodwill impairments of CHF 3.2bn 2023 2024 Var. Change in % CHFm CHFm at CER CHF CER Core operating profit 19,240 20,823 +2,684 +8 +14 Global restructuring plans -2,038 -1,891 +126 Amortisation of intangib
Slide 30: Results, Cash & balance sheet, Currency guidance & outlook
Results Cash & balance sheet Currency guidance & outlook
Slide 31: 2024: Group operating free cash flow
2024: Group operating free cash flow OFCF up by +34% driven by higher cash operating profit, and favorable NWC movement +2,187 CHFm +76 +878 -594 +1,309 -1,092 +3,713 21,213 20,121 15,831 OFCF up by +34%/+5,382m at CER FYstart 2023 Op netOP, net ofadjustment of cash cashNTWCNTWC Other Other movement
Slide 32: 2024: Operating free cash flow and margin
2024: Operating free cash flow and margin 48.3% 40.8% % of sales +7.4%p¹ 33.3% 26.9% +6.8%p¹ 9.3% 12.1% +28%¹ +34%¹ +3.9%p¹ 22,288 20,121 CHFm 18,055 15,768 +48%¹ 1,350 1,734 2023 2024 Roche Group Pharma Division Diagnostics Division Note: Group Operating free cash flow includes -3.9bn from Corporat
Slide 33: 2024: Group net debt development
2024: Group net debt development Net debt lower by CHF 1.4bn vs. YE 2023 Free Cash Flow CHF +15.3 [PY: +11.3] CHFbn [PY: -15.6] [PY: +15.8] [PY: -4.5] [PY: -14.4] [PY: -18.7] -4.8 Taxes -3.7 Treasury -1.1 Dividends paid -8.0 M&A & All. trans. -3.1 Curr. Transl. & Oth. -1.7 Trans. own eq. inst. -1.1
Slide 34: Balance sheet 31 December 2024
Balance sheet 31 December 2024 Equity ratio at 36% (31 Dec 2023: 37%) % change in CER % change in CER vs 31 Dec 2023 vs 31 Dec 2023 CHFbn 101.8 +10% 101.8 +10% Cash and 90.5 17.3 90.5 marketable +65% 27.0 10.5 17% +6% securities 12% 27% Current 24.8 22.7 -3% 27% Other 23.0 liabilities 22% current 25
Slide 35: Results, Cash & balance sheet, Currency guidance & outlook
Results Cash & balance sheet Currency guidance & outlook
Slide 36: 2024: Currency impact and outlook
2024: Currency impact and outlook USD / CHF In 2024 impact1 is (%p): -6% -3% -2% -2% 0.93 Q1 Q2 Q3 Q4 0.91 0.90 0.90 Sales -8 -2 -3 -3 0.87 0.89 0.88 0.88 Q1 HY Sep FY 0.86 0.88 0.89 0.91 0.91 0.89 0.89 0.86 0.85 0.86 0.88 0.89 YTD Monthly avg fx rates 2024 Average YTD 2024 Average YTD 2023 Sales -8
Slide 37: 2024: Core EPS
2024: Core EPS Core EPS 2024 of CHF 19.33 is basis for Core EPS outlook 2025 at CER CHF 19.33 18.80 +0.53 Core EPS 2024 2024 foreign Core EPS 2024 basis as reported exchange losses: for outlook Core EPS Core EPS impact growth 2025 at CER CER=Constant Exchange Rates 37
Slide 38: 2025 guidance
2025 guidance LOE impact of CHF 1.2bn expected for 2025 Group sales growth1 Mid single digit sales growth Core EPS growth1 High single digit Core EPS growth Dividend outlook Further increase dividend in Swiss francs 1At CER=Constant Exchange Rates (avg full year 2024); LOE=loss of exclusivity includ
Slide 39: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 40: 2024: Pharmaceuticals sales
2024: Pharmaceuticals sales Strong growth in US, EU and International 2024 2023 Change in % CER w/o CHFm CHFm CHF CER Ronapreve Pharmaceuticals Division 46,171 44,265 4 8 9 United States 24,774 23,259 7 9 9 Europe 8,832 8,306 6 8 8 Japan 2,874 3,745 -23 -16 -2 International 9,691 8,955 8 17 17 CER=C
Slide 41: 2024: Pharmaceuticals core operating profit
2024: Pharmaceuticals core operating profit Core operating profit higher by +13%, driven by higher sales and effective cost management 2024 2024 vs. 2023 CHFm abs. CER CER growth Sales 46,171 +3,604 8% Other revenue 1,871 +263 16% Cost of sales -8,457 -640 8% R&D -11,096 -98 1% SG&A -7,036 -319 5% O
Slide 42: 2024: Young portfolio delivering strong growth
2024: Young portfolio delivering strong growth Polivy now one of 17 blockbusters in 2024* Vabysmo 68% Phesgo 62% Ocrevus 9% Hemlibra 12% Xolair 16% Polivy 39% Evrysdi 18% Elevidys n/a Columvi >500% Gazyva 16% Actemra / RoActemra 5% Alecensa 7% Enspryng 30% Xofluza 75% Perjeta 1% Tecentriq 0% US Luns
Slide 43: Itovebi EU approval expected in H1 2025
Oncology/Hematology Itovebi EU approval expected in H1 2025 Phesgo conversion rate climbing to 46% in 55 launch countries* Itovebi Q4 update CHFm 8 / N/A Others • Phesgo: Strong uptake across all regions CHFm 671 / -9% Avastin • Perjeta: Phesgo conversion ongoing CHFm 1,233 / -17% Tecentriq CHFm 3,6
Slide 44: Polivy US patient share in 1L DLBCL reaching 29%
Oncology/Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) reaching 29% Bi-specifics moving into 2L DLBCL: Columvi (STARGLO) approval and Lunsumio Ph III (SUNMO) readout in 2025 Q4 update Lunsumio Columvi CHFm 71 / +25% • Hemlibra: Strong Q4 growth across all regions and pts segments CHFm 172
Slide 45: Hematology: Portfolio further strengthened by allogeneic CAR-Ts
Oncology/Hematology Hematology: Portfolio further strengthened by allogeneic CAR-Ts Moving into autoimmune diseases including MS and SLE Roche/Poseida allogeneic CAR-Ts key features Allogeneic CAR-T pipeline Robust healthy donor screening system Development Molecule TA Indication status Non-viral ge
Slide 46: Ocrevus Zunovo (SC) launched with high share of naive patients
Neurology Ocrevus Zunovo (SC) launched with high share of naive patients Elevidys Ph III (EMBARK) 2-year data reinforce functional benefit and will be shared with regulators Q4 update Elevidys • Ocrevus: #1 new to brand in US; Zunovo with >2,500 patients CHFm 189 / N/A Others CHFm 392 / +5% worldwid
Slide 47: Elevidys providing clinically meaningful benefits in DMD
Neurology Elevidys providing clinically meaningful benefits in DMD Ph III (EMBARK) 2-year data reinforce sustained functional benefit and will be shared with regulators Ph III (EMBARK) Part 1 two-year data* Key development projects Endpoint Elevidys EC LSMean difference (95% CI) p-value Ph I Ph II P
Slide 48: Parkinson's Disease: Prasinezumab next steps to be determined in 2025
Neurology Parkinson’s Disease: Prasinezumab next steps to be determined in 2025 Ph IIb (PADOVA) prasinezumab missed primary endpoint, but suggests possible clinical benefit Prasinezumab (α-synuclein Ab) Ph IIb (PADOVA) trial design Placebo IV Q4W Open-label extension Prasinezumab IV Q4W Randomise (1
Slide 49: Xolair with strong launch uptake in food allergy
Immunology Xolair with strong launch uptake in food allergy US/EU filings for Gazyva in lupus nephritis submitted, approvals expected in 2025 Q4 update • Xolair: Strong food allergy launch with 40k patients on treatment Others CHFm 951 / -7% • Additional growth driven by strong CSU performance • No
Slide 50: Anti-TL1A: Expanding the development program beyond IBD
Immunology Anti-TL1A: Expanding the development program beyond IBD RG6631 with best-in-disease potential in IBD; Additional trials in atopic dermatitis and MASH to initiate in Q1 2025 Anti-TL1A implicated in inflammatory and fibrotic processes1,2 RG6631 (anti-TL1A) development program DR3 Receptor D
Slide 51: Vabysmo US market share expansion in nAMD, DME and RVO continues
Ophthalmology Vabysmo US market share expansion in nAMD, DME and RVO continues Vabysmo pre-filled syringe approved in EU, with US reaching >85% conversion Q4 update Luxturna CHFm 18 / -59% Susvimo • Vabysmo: Continued market share gains across early launch Lucentis CHFm 4 / +44% countries and ongoin
Slide 52: Strengthening our Pharma pipeline: Two deals closed since Q3
Strengthening our Pharma pipeline: Two deals closed since Q3 Pipeline changes since Q2’23 siRNA targeting AGT in Allogeneic CAR-T in hypertension Onco/Heme, Immuno and Neuro 8 -8 24 Additions 81 4 -3 1 -5 • 14 Ph I additions from 3 -4 3 pRED/gRED/Chugai -9 5 -5 71 • 10 Ph I/Ph II NMEs acquired as Du
Slide 53: 2024: Key newsflow
2024: Key newsflow* Compound Indication Milestone Alecensa Adjuvant ALK+ NSCLC US/EU approval Itovebi + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC US/EU filing Tecentriq Subcutaneous administration US/EU approval PiaSky (crovalimab) PNH US/EU approval Elevidys DMD EU filing Ocrevus 6m SC RMS/PPM
Slide 54: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone Itovebi + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephritis US/EU fili
Slide 55: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 56: 2024: Diagnostics sales
2024: Diagnostics sales Strong base business growth more than offsetting decline in COVID-19 sales 2024 2023 Change in % Excl. CHFm CHFm CHF CER C191 Diagnostics Division 14,324 14,451 -1 4 8 Core Lab 8,004 7,750 3 8 Molecular Lab 2,590 2,567 1 4 Near Patient Care 2,167 2,746 -21 -17 Pathology Lab 1
Slide 57: 2024: Diagnostics highlights
2024: Diagnostics highlights Strong base business growth more than offsetting decline in COVID-19 sales CHFbn YoY CER growth Core Lab • Immunodiagnostics (+9%) +8% • Clinical Chemistry (+8%) • COVID-19 (-60%) Molecular Lab +4% • Virology base business (+10%) • Blood Screening (+17%) Near Patient • C
Slide 58: 2024: Diagnostics regional sales
2024: Diagnostics regional sales North America +6% EMEA ~30% of divisional sales +5% ~34% of divisional sales Asia Pacific Latin America -5% +22% ~29% of divisional sales ~7% of divisional sales Base business=excluding COVID-19-related products; Growth rates at Constant Exchange Rates (avg full year
Slide 59: 2024: Diagnostics core operating profit
2024: Diagnostics core operating profit Strong core operating profit growth of +12% 2024 2024 vs. 2023 CHFm abs. CER CER growth Sales 14,324 +503 4% Other revenue 29 -47 -61% Cost of sales -6,941 -79 1% R&D -1,946 -30 2% SG&A -3,136 -90 3% OOI&E 72 +16 27% Core operating profit 2,402 +273 12% Core O
Slide 60: cobas Mass Spectrometry solution
Core Lab cobas® Mass Spectrometry solution CE mark for the first fully integrated IVD platform for clinical mass spectrometry cobas® Mass Spectrometry solution Market opportunity • The current total mass spectrometry market is CHF 3bn, primarily composed of laboratory developed tests1 • Roche Diagno
Slide 61: cobas 6800/8800 version 2.0
Molecular Lab cobas® 6800/8800 version 2.0 CE mark for the updated systems with increased testing flexibility, higher throughput and automation cobas® 6800/8800 version 2.0 Market needs and opportunity • Extend competitive differentiation of installed base, fully compatible with existing menu and ne
Slide 62: Clinical study results for Elecsys Amyloid Plasma Panel
Core Lab Clinical study results for Elecsys®Amyloid Plasma Panel Strong rule out performance (NPV > 90%) in a prospective multicenter study Elecsys® Amyloid Plasma Panel testing Unmet need • >55 million people live with Alzheimer’s disease, 75% of people experiencing symptoms remain undiagnosed1 Ele
Slide 63: Diagnostics key launches 2024
Diagnostics key launches 2024 Area Product Description Markets Status i601 mass spectrometry Launch of an unique total solution for clinical mass spectrometry testing: fully automated, integrated and CE system IVD-compliant Core Lab cobas® c703 Introducing high-throughput clinical chemistry testing
Slide 64: Diagnostics key launches 2025
Diagnostics key launches 2025 Area Product Description Market Status Elecsys® pTau181 Non-invasive blood-based biomarker to enable earlier detection and rule out amyloid pathology CE Elecsys® high-sensitivity High-sensitive test with greater precision at lower measurement ranges, enabling HCPs to co
Slide 65: Invitation to Roche Diagnostics upcoming IR events
Invitation to Roche Diagnostics upcoming IR events Innovating Diagnostics, shaping healthcare, changing lives Update on sequencing technology Roche Diagnostics Day 20 Feb 2025 27 May 2025 Virtual event London / hybrid event Sequencing by Expansion (SBX) Technology Highlights: • Roche Sequencing solu
Slide 66: Upcoming IR events
Upcoming IR events
Slide 67: IR events currently planned for 2025
IR events currently planned for 2025 Additional events driven by readouts Immunology/WCN Update on NGS Neurology Update Diagnostics Day Pharma Day 7 Feb 20 Feb 4 Apr 27 May 22 Sep 16:30 – 17:30 CET tbd 16:00 – 17:30 CEST 14:00 - 16:30 CEST tbd Virtual event Virtual event Virtual event London & virtu
Slide 68: 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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 69: Changes to the development pipeline
Changes to the development pipeline Q4 2024 update New to phase I New to phase II New to phase III New to registration 5 NMEs: 2 AIs: RGXXXX* P-MUC1C-ALLO1 – solid tumors RG7159 Gazyva - lupus nephritis RG6810 DLL3 ADC – SCLC RG7828 Lunsumio SC - 3L+ FL RG6620 KRAS G12D inhibitor - solid tumors RG65
Slide 70: Roche Group development pipeline
Roche Group development pipeline Phase I (46 NMEs + 7 AIs) Phase II (15 NMEs + 6 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU codrituzumab HCC RG6107 PiaSky sickle cell disease RG6076 englumafusp alfa combos heme tumors CHU CD137 switch solid tumors RG6171 giredestrant endometrial cancer
Slide 71: Roche Group development pipeline
Roche Group development pipeline Phase III (8 NMEs + 30 AIs) Registration US & EU (2 NME + 8 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6026 Columvi + chemo 2L+ DLBCL Columvi + Polivy + R-CHP 1L DLBCL RG6299 sefaxersen (ASO factor B) IgA nephropathy Itovebi (inavolisib) +
Slide 72: Expected regulatory submissions
Expected regulatory submissions* New Molecular Entities: Lead and additional indications anti-latent myostatin RG6237 (GYM 329) + Evrysdi SMA New Molecular Entity (NME) Cardiovascular, Renal & Metabolism anti-latent myostatin Additional Indication (AI) Neurology giredestrant RG6237 (GYM 329) RG6171
Slide 73: Expected regulatory submissions
Expected regulatory submissions* Marketed products: Additional indications New Molecular Entity (NME) Cardiovascular, Renal & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other PiaSky RG6107 ✓ Indicates submission to health authorities has occurred s
Slide 74: Major pending approvals 2024
Major pending approvals 2024 US EU China Japan-Chugai TNKase Itovebi (inavolisib) + palbociclib + Ocrevus Tecentriq fulvestrant RG1594 RMS & PPMS RG7446 Alveolar Soft Part Sarcoma RG3625 stroke RG6114 1L HR+ PIK3CA-mut. mBC Filed March 2024 Filed Jan 2024 Filed June 2023 Filed April 2024 Itovebi (in
Slide 75: Major granted approvals 2024
Major granted approvals 2024 US EU China Japan-Chugai Xolair Tecentriq SC PiaSky PiaSky RG3648 Food allergy RG7446 all approved indications RG6107 PNH RG6107 PNH Feb 2024 Jan 2024 Feb 2024 March 2024 Alecensa Alecensa Vabysmo Vabysmo RG7853 ALK+ NSCLC adj RG7853 ALK+ NSCLC adj RG7716 BRVO/CRVO RG771
Slide 76: Marketed products development programmes
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 77: Alecensa (alectinib)
Alecensa (alectinib, RG7853) CNS-active inhibitor of anaplastic lymphoma kinase Indication Adjuvant ALK+ NSCLC Phase III Phase/study ALINA # of patients N=257 Oncology/Hematology ARM A: Alecensa 600mg BID Design ARM B: Platinum-based chemotherapy Primary endpoint Disease-free survival FPI Q3
Slide 78: Itovebi (inavolisib)
Itovebi (inavolisib, RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA-mutant HR-positive metastatic breast post CDKi HR-positive PIK3CA-mutant PIK3CA mutant solid tumors and metastatic Indication cancer (mBC) breast cancer ER+ HER2-negative breast cancer Phase III P
Slide 79: Itovebi (inavolisib)
Itovebi (inavolisib, RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor Indicatio 1L Endocrine-sensitive PIK3CA-mutated HR+, HER2-, advanced breast 1L HER2-positive PIK3CA mutant metastatic breast cancer (mBC) n cancer Phase/st Phase III Phase III udy INAVO122 INAVO123 # of
Slide 80: Kadcyla
Kadcyla (trastuzumab emtansine, RG3502) First ADC for HER2-positive breast cancer HER2-positive early breast cancer (BC) HER2-positive early breast cancer (BC) Indication high-risk patients high-risk patients Phase III Phase III Phase/study KATHERINE ASTEFANIA # of patients N=1,484 N=1150 ARM A: K
Slide 81: Phesgo
Phesgo (pertuzumab/trastuzumab, RG6264) FDC of Perjeta and Herceptin for subcutaneous administration Indication HER2-positive early breast cancer (BC) Phase III Phase II Phase/study FeDeriCa PHranceSCa # of patients N=500 N=160 Phesgo in combination with chemotherapy in neoadjuvant/adjuvant setting
Slide 82: Tecentriq
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication Periadjuvant NSCLC Phase III Phase/study IMpower030 # of patients N=450 Oncology/Hematology ARM A: Tecentriq plus platinum-based chemotherapy ARM B: Platinum-based chemotherapy Design Primary endpoint Eve
Slide 83: Tecentriq
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L maintenance extensive-stage SCLC Stage IV NSCLC Phase III Phase Ib/III Phase/study IMforte1 IMscin0012 # of patients N=450 N=371 ARM A: Platinum-etoposide + Tecentriq followed by maintenance Phase Ib Tecen
Slide 84: Tecentriq
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – urothelial carcinoma High-risk non-muscle-invasive ctDNA+, high-risk muscle-invasive Indication bladder cancer (NMIBC) bladder cancer (MIBC) Phase III Phase III Phase/study ALBAN IMvigor011 # of patients N=516 N=495 ARM A: BCG indu
Slide 85: Columvi
Columvi (glofitamab, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory Non-Hodgkin’s lymphoma (NHL) Phase/study Phase I Phase Ib Phase I # of patients N=700 N=140 N=18-36 Cohort 1: Single-agent dose escalation study Dose escalation and
Slide 86: Columvi
Columvi (glofitamab, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Non-Hodgkin’s lymphoma (NHL) 2L+ SCT-ineligible DLBCL Phase III Phase/study Phase Ib STARGLO Part I: 15-60 # of patients N=270 Part II: ~66-104 Part I: Dose-finding for the combination o
Slide 87: Columvi
Columvi (glofitamab, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ SCT-eligible DLBCL 2L+ SCT-ineligible DLBCL 1L DLBCL fit (IPI 2-5) Phase III Phase/study Phase Ib Phase Ib SKYGLO # of patients N=40 N=112 N=1130 Columvi plus R-ICE (single-arm study
Slide 88: Columvi
Columvi (glofitamab, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory mantle cell lymphoma (MCL) Phase III Phase/study GLOBRYTE # of patients N=182 ARM A: Columvi monotherapy ARM B: Bendamustine + rituximab or rituximab + lenalidom
Slide 89: Lunsumio
Lunsumio (mosunetuzumab, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 3L+ FL, 3L+ DLBCL & other relapsed or refractory NHL Relapsed or refractory LBCL & MCL Phase/study Phase I/II Phase Ib/II # of patients N=713 N=235 Dose escalation of Lunsumio monoth
Slide 90: Lunsumio
Lunsumio (mosunetuzumab, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ SCT ineligible DLBCL Phase III Phase/study SUNMO # of patients N=222 ARM A: Lunsumio plus Polivy ARM B: R + GemOx Oncology/Hematology Design Progression-free survival Primary
Slide 91: Lunsumio
Lunsumio (mosunetuzumab, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L DLBCL & 2L DLBCL following 1L induction FL Phase/study Phase I/II Phase Ib/II # of patients N=187 N=183 Cohort A: Lunsumio monotherapy (after a response to prior systemic Non-Rand
Slide 92: Lunsumio
Lunsumio (mosunetuzumab, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ FL Relapsed or refractory CLL Phase III Phase/study Phase Ib/II CELESTIMO # of patients N=474 N=137 ARM A: Lunsumio plus lenalidomide Lunsumio monotherapy (3L+ CLL) ARM B: Ri
Slide 93: Polivy
Polivy (polatuzumab vedotin, RG7596) ADC targeting CD79b to treat B cell malignancies Indication 1L DLBCL Phase III Phase/study POLARIX # of patients N=879 Oncology/Hematology ARM A: Polivy plus R-CHP ARM B: R-CHOP Design Progression-free survival Primary endpoint Data presented at ASH 2021
Slide 94: Venclexta
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – chronic lymphocytic leukemia Newly diagnosed higher-risk Indication Untreated fit chronic lymphocytic leukemia (CLL) patients myelodysplastic syndromes (MDS) Phase III Phase III Phase/study CristaLLo VERONA # of patients
Slide 95: Hemlibra
Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Hemophilia A mild to moderate patients without inhibitors to Indication Hemophilia A patients with and without inhibitors to Factor VIII Factor VIII Phase III Phase III Phase/study HAVEN 5 HAVEN 6 # of patients N=85 N=70
Slide 96: PiaSky
PiaSky (crovalimab, RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a C5 inhibitor Phase III Phase/study COMMODORE 1 # of patients N=89 (ARMs A/B) ARM A: PiaSky ARM B: Eculizumab Oncology/Hematology
Slide 97: PiaSky
PiaSky (crovalimab, RG6107, SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) Indication C5 inhibitor naive patients C5 inhibitor naive patients (China only) Phase III Phase III Phase/study COMMODORE 2 COM
Slide 98: PiaSky
PiaSky (crovalimab, RG6107, SKY59) A humanized monoclonal antibody against complement C5 Atypical hemolytic uremic syndrome (aHUS) Atypical hemolytic uremic syndrome (aHUS) Indication - adults - paediatric Phase III Phase III Phase/study COMMUTE-a COMMUTE-p # of patients N=90 N=35 Single-arm study o
Slide 99: PiaSky
PiaSky (crovalimab, RG6107, SKY59) A humanized monoclonal antibody against complement C5 Sickle cell disease (SCD) Sickle cell disease (SCD) Indication acute treatment chronic VOC prevention Phase Ib Phase IIa Phase/study CROSSWALK-a CROSSWALK-c # of patients N=30 N=90 ARM A: PiaSky ARM A: PiaSk
Slide 100: Elevidys
Elevidys (delandistrogene moxeparvovec, RG6356, SRP-9001) rAAVrh74.MHCK7.Micro-dystrophin gene therapy Indication Duchenne muscular dystrophy (DMD) Phase II Phase/study ENVOL # of patients N=21 Open label single arm study in 0 to <4 year old DMD boys who will receive a single intravenous (IV) infusi
Slide 101: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Myelin oligodendrocyte glycoprotein antibody disease (MOG- Indication Autoimmune encephalitis (AIE) AD) Phase III Phase III Phase/study METEOROID CIELO # of patients N=152 N=152 ARM A: Enspryng at weeks 0, 2, 4
Slide 102: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II/III Phase II/III Phase/study FIREFISH SUNFISH # of patients N=21 (Part 1), 41 (Part 2) N=51 (Part 1), 180 (Part 2) Infants with type 1 SMA Adult & pediatric patients with type 2 or 3 SMA: Design
Slide 103: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II Phase II Phase/study RAINBOWFISH JEWELFISH # of patients N=25 N=174 Infants aged from birth to 6 weeks who have been genetically Adult and pediatric patients with previously treated SMA type
Slide 104: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Phase IIIb Phase/study ORATORIO-HAND # of patients N ~ 1,000 120-week treatment period: ARM A: Ocrevus 600mg IV Q24W Neurology Design ARM B: Pl
Slide 105: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) PPMS & RMS Phase IIIb Phase IIIb Phase III Phase/study GAVOTTE MUSETTE Ocarina II1 # of patients N ~ 699 N ~ 786
Slide 106: Gazyva
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Lupus nephritis Membranous nephropathy Phase II Phase III Phase III Phase/study NOBILITY REGENCY MAJESTY # of patients N=126 N=252 N=140 ARM A: Gazyva 1000mg IV plus MMF / ARM A: Gazyva 1000mg IV (6 doses through ARM A: Ga
Slide 107: Gazyva
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Systemic lupus erythematosus (SLE) Childhood onset idiopathic nephrotic syndrome* Phase III Phase III Phase/study ALLEGORY INShore # of patients N=300 N=80 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM A: Gazy
Slide 108: Lunsumio
Lunsumio (mosunetuzumab, RG7828, CD20 x CD3) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Systemic lupus erythematosus (SLE) Phase/study Phase I # of patients N=50 ARM A: Lunsumio SC on either Day 1 or on Days 1 and 8 ARM B: Fractionated (divided) dose of mo
Slide 109: Xolair
Xolair (omalizumab, RG3648) Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=180 Xolair by SC injection either Q2W or Q4W for 16 to 20 weeks Immunology Design Primary endpoint Proportion of participants that succe
Slide 110: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Thyroid eye disease Phase III Phase III Phase/study SatraGo-1 SatraGo-2 # of patients N=120 N=120 ARM A: Satralizumab at weeks 0, 2, 4 (loading doses) and maintenance ARM A: Satralizumab at weeks 0
Slide 111: Susvimo
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication Wet age-related macular degeneration (wAMD) Phase III Phase II+III extension Phase IIIb Phase/study Archway Portal Velodrome # of patients N=418 N=1,000 N=442 ARM A: PDS 100mg/mL Q24W Ex-LADDE
Slide 112: Susvimo
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Diabetic retinopathy (DR) without Indication Diabetic macular edema (DME) center-involved diabetic macular edema (DME) Phase III Phase III Phase/study Pagoda Pavilion # of patients N=634 N=174 ARM A: Intra
Slide 113: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (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: Vabysmo 6.0 mg Q8W ARM A:
Slide 114: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (Ang-2 and VEGF-A) Indication Wet age related macular degeneration (wAMD) Phase III Phase III Phase/study TENAYA LUCERNE # of patients N=671 N=658 ARM A: Vabysmo 6.0mg Q16W flexible after
Slide 115: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (Ang-2 and VEGF-A) Indication Macular edema (ME) secondary to branch retinal vein occlusion (RVO) Macular edema (ME) secondary to central retinal vein occlusion (RVO) Phase III Phase III Ph
Slide 116: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (Ang-2 and VEGF-A) Indication Myopic choroidal neovascularization (CNV) Phase III Phase/study POYANG # of patients n=280 ARM A: Vabysmo 6.0 mg Q4W PRN ARM B: Ranibizumab 0.5 mg Q4W PRN
Slide 117: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase III Phase IIIb Phase/study miniSTONE 1 (0-1 year old) miniSTONE 2 (1- <12 years old ) CENTERSTONE # of patients N=30 N=176 N=3,160 Healthy pediatric patients
Slide 118: Roche Pharma global development programmes
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 119: Divarasib
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Indication 1L NSCLC 2L NSCLC 1L NSCLC Phase/stu Phase Ib Phase III Phase III dy KRASCENDO 170 KRASCENDO 1 KRASCENDO 2 # of N=60 N=320 N=600 patients Cohort A: Combi
Slide 120: Divarasib
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Advanced or metastatic solid tumors with a KRAS G12C Indication 1L metastatic colorectal cancer (mCRC) mutation Phase Ib Phase/study Phase I INTRINSIC # of patients N
Slide 121: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator ER+ HER2-negative metastatic breast cancer ER+ HER2-negative Stage I-III operable breast Indication Neoadjuvant ER-positive breast cancer (BC) (mBC) cancer (BC) Phase II Phase/study Phase I Phase I coop
Slide 122: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication Grade 1 endometrial cancer 1L ER-positive metastatic breast cancer (mBC) Adjuvant ER-positive breast cancer (BC) Phase II Phase III Phase III Phase/study endomERA persevERA Breast Cancer lidE
Slide 123: Giredestrant
Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator post-CDK4/6 ER-positive/HER2-negative 1L ER-positive/HER2-positive breast cancer ET resistant ER+/HER2-negative breast cancer Indication breast cancer (BC) (BC) (BC) Phase III Phase III Phase III Phase/
Slide 124: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Stage III unresectable 1L NSCLC Locally advanced esophageal cancer (EC) 1L HCC Phase III Phase III Phase III Phase/study SKYSCRAPER-03 SKYSCRAPER-07 SKYSCRAPER-14 # of patients
Slide 125: Dirloctocogene Samoparvovec
Dirloctocogene Samoparvovec (SPK-8011, RG6357) Unique gene therapy platform Dirloctocogene Samoparvovec (SPK-8011) Molecule (RG6357) Indication Hemophilia A Phase/study Phase I Phase I/II # of patients N=100 N=30 Long term follow up study of patients who have received SPK-8011 in Gene transfer,
Slide 126: NXT007
NXT007 (FIXa x FX, RG6512) Bispecific antibody which targets Factor IXa and Factor X Indication Severe or Moderate Hemophilia A Phase I/II Phase/study (multiple-ascending dose) # of patients N=40 Two loading doses of NXT007 SC (Q2W) followed by Q4W maintenance dosing Design Oncology/Hematology Pri
Slide 127: Anti-latent myostatin
Anti-latent myostatin (RG6237, GYM 329) Recycling and antigen-sweeping monoclonal anti-latent myostatin antibody Facioscapulohumeral Muscular Indication Spinal muscular atrophy (SMA) Obesity Dystrophy (FSHD) Phase II Phase II/III Phase/study Phase Ib MANOEUVRE MANATEE1 # of patients N=48 N=180 N=30-
Slide 128: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Primary progressive multiple sclerosis Indication Relapsing multiple sclerosis (RMS) (PPMS) Phase III Phase III Phase III Phase/study FENtrepid FENhance 1 FENhance 2 # of patients N=985 N=736 N=751
Slide 129: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Relapsing multiple sclerosis (RMS) Phase II (Biomarker study) Phase/study FENopta # of patients N=109 Neurology ARM A: Fenebrutinib ARM B: Placebo Design Total number of new gadolini
Slide 130: Tominersen
Tominersen (HTT ASO, RG6042) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase II Phase/study GENERATION HD2 # of patients N=300 Patients aged 25 to 50 years with prodromal (very early subtle signs of HD) or early manifest HD Neurology ARM A: Tominersen
Slide 131: Astegolimab
Astegolimab (Anti-ST2, RG6149) A monoclonal antibody that selective binds to ST2 Indication Chronic obstructive pulmonary disease (COPD) Phase IIb Phase III Phase/study ALIENTO ARNASA # of patients N=1,290 N=1,290 ARM A: SC astegolimab Q2W ARM A: SC astegolimab Q2W ARM B: SC astegolimab Q4W
Slide 132: Sefaxersen
Sefaxersen (ASO factor B, RG6299) Antisense oligonucleotide that targets factor B Indication IgA nephropathy (IgAN) Phase III Phase/study Phase II* IMAGINATION # of patients N=23 N=428 Sefaxersen SC at week 1 following Q4W dosing through week 25 ARM A: Sefaxersen SC at week 1, 3, 5 following Q4W
Slide 133: Anti-TL1A
Anti-TL1A (RG6631) A monoclonal antibody targeting TL1A, blocking TH1 and TH17 pathways Indication Moderate to severe ulcerative colitis Moderate to severe ulcerative colitis Phase III Phase III Phase/study AMETRINE-1 AMETRINE-2 # of patients N=400 N=350 ARM A: Anti-TL1A IV induction followed by S
Slide 134: Vamikibart
Vamikibart (anti-IL-6; RG6179) A monoclonal antibody that potently binds interleukin-6 (IL-6) cytokine Diabetic macular edema (DME) and Uveitic Indication Diabetic macular edema (DME) macular edema (UME) Phase I Phase II Phase II Phase/study DOVETAIL BARDENAS ALLUVIUM # of patients N=90 N=210-230 N=
Slide 135: Vamikibart
Vamikibart (anti-IL-6; RG6179) A monoclonal antibody that potently binds interleukin-6 (IL-6) cytokine Indication Uveitic macular edema (UME) Phase III Phase III Phase/study MEERKAT SANDCAT # of patients N=225 N=225 ARM A: Vamikibart low-dose Q4W to week 12, followed by PRN ARM A: Vamikibart low
Slide 136: CT-388
CT-388 (GLP-1/GIP RA, RG6640) Once-weekly subcutaneous injectable dual GLP-1/GIP receptor agonist Overweight/obesity with or without type 2 Overweight/obesity without type 2 Overweight/obesity with type 2 Indication diabetes diabetes diabetes Phase/study Phase I Phase II Phase II # of patients N=129
Slide 137: CT-996
CT-996 (GLP-1 RA, RG6652) Once-daily oral small molecule GLP-1 receptor agonist Indication Overweight/obesity with or without type 2 diabetes Phase/study Phase I # of patients N=118 Single ascending dose, multiple ascending dose, multiple part study, with low to high doses of CT-996 vs placebo up
Slide 138: CT-868
CT-868 (GLP-1/GIP RA, RG6641) Once-daily subcutaneous injectable dual GLP-1/GIP receptor agonist Indication Type 1 diabetes with BMI ≥ 27 Phase/study Phase II # of patients N=96 ARM A: CT-868 low dose ARM B: CT-868 medium dose Cardiovascular, Renal & Metabolism Design ARM C: CT-868 high dose
Slide 139: Roche Pharma research and early development (pRED)
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 140: pRED oncology development programs
pRED oncology development programs Molecule Indication Phase # of patients Status CT Identifier Oncology Part I: FPI Q3 2019 Part II: FPI Q3 2020 englumafusp alfa R/R B cell non-Hodgkin’s lymphoma I 498 Part III: FPI Q3 2024 NCT04077723 (CD19-4-1BBL, RG6076) Combination study with Columvi Data prese
Slide 141: pRED neurology development programs -1
pRED neurology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neurology FPI Q1 2021 trontinemab Part 1 data showing rapid, robust amyloid Alzheimer's disease IIa ~210 NCT04639050 (BS-anti-Aβ mAb, RG6102) depletion presented at ADPD 2024 and CTAD 2024 ISRCTN16295
Slide 142: pRED neurology development programs -2
pRED neurology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Neurology alogabat NCT05630066 Angelman syndrome II 56 FPI Q3 2023 (GABA-Aa5 PAM, RG7816) (Aldebaran) MAGL inhibitor (RG6182) Multiple sclerosis I Up to 36 FPI Q3 2023 selnoflast* Parkinson’s disease
Slide 143: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology selnoflast* Asthma Ib 60 FPI Q1 2024 (NLRP3i, RG6418) CD19 x CD3 (RG6382) SLE I 70 FPI Q4 2023 NCT05835986 NME (RG6377) IBD I FPI Q2 2024 ISRCTN15555964 Ophthalmology zifiba
Slide 144: Genentech research and early development (gRED)
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 145: gRED oncology development programs -1
gRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q3 2017 R/R multiple myeloma I 355 LPI Q2 2023 NCT03275103 Data presented at ASH 2020-2024 R/R multiple myeloma I 120 FPI Q2 2021 NCT04910568 cevostamab BCMA-experienced R/R MM I/II 140 FP
Slide 146: gRED oncology development programs -2
gRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology AR degrader (RG6537)1 mCRPC I ~160 FPI Q2 2023 NCT05800665 anti-latent TGFβ1 Solid tumors Ib 120 FPI Q3 2023 NCT05867121 (SOF10; RG6440) NME (RG6468) Solid tumors I 110 FPI Q4 2023 NCT06031441
Slide 147: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology FPI Q2 2023 NME (RG6287, GDC-8264) Acute graft versus host disease Ib 40 NCT05673876 Study closed Q4 2023 FPI Q1 2023 NME (RG6315, MTBT1466A) Systemic sclerosis Ib 100 NCT05
Slide 148: Pharma sales appendix
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 149: 2024: Pharma Division sales
2024: Pharma Division sales Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 6,744 9 4,819 5 1,306 14 - - 619 29 Hemlibra 4,503 12 2,654 9 926 11 367 8 556 41 Vabysmo 3,864 68 2,940 57 622 128 125 40 177 168 Tecentriq 3,640 0 1,763 -
Slide 150: 2024: Pharma Division sales
2024: Pharma Division sales Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 41 -13 17 -21 11 0 - - 13 -12 Alecensa 1,548 7 525 15 284 -1 198 3 541 7 Tecentriq 3,640 0 1,763 -7 863 4 380 0 634 23 Ocrevus 6,744 9 4,819 5
Slide 151: 2024: Pharma Division sales
2024: Pharma Division sales Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 6,744 9 4,819 5 1,306 14 - - 619 29 Hemlibra 4,503 12 2,654 9 926 11 367 8 556 41 Vabysmo 3,864 68 2,940 57 622 128 125 40 177 168 Te
Slide 152: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Global top 20 products Q1/23 Q2/23 Q3/23 Q4/23 Q1/24 Q2/24 Q3/24 Q4/24 Ocrevus 14 15 12 9 8 9 11 7 Hemlibra 24 17 17 9 8 6 14 21 Vabysmo * * 309 160 108 81 59 43 Tecentriq 15 8 10 5 1 2 0 -1 Perjeta 11 6 0 -11 -3 -1 2 9 Actemra / RoActemra -12 2 21 13 -2 8 7 4
Slide 153: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Ocrevus 5 6 9 0 8 15 11 21 - - - - 28 27 23 37 Hemlibra -1 3 12 20 17 12 3 15 2 4 4 22 51 16 64 36 Vabysmo 91 68 49 35 224 153 104 88 33 38 40 46 397 281 180
Slide 154: CER sales growth in %
CER sales growth in % Quarterly development 2023 vs. 2022 2024 vs. 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pharmaceuticals Division 9 7 11 -2 2 9 10 12 United States 7 8 11 5 5 6 9 15 Europe 5 5 9 3 11 10 2 10 Japan 18 8 1 -50 -45 -3 1 1 International 13 6 17 16 12 23 22 11 Diagnostics Division -28 -17 -5 4 2
Slide 155: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 7.0 +9% US +5% 6.0 5.0 4.0 3.0 Europe +14% 2.0 International +29% 1.0 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 6,744m • US: Moving into earlier lines displacing orals; #1 in US for both dynamic and total share • EU: Movi
Slide 156: Hemlibra
Hemlibra CHFbn Global sales CER growth Regional sales CER growth 4.8 +12% US +9% 4.2 Europe +11% 3.6 3.0 Japan +8% 2.4 1.8 International +41% 1.2 0.6 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 4,503m • US: Continued share gains in non-inhibitor patients • EU: Continued share gains in n
Slide 157: Vabysmo
Vabysmo Global sales CER growth Regional sales CER growth CHFbn 4.0 +68% 3.0 US +57% 2.0 Europe +128% Japan +40% 1.0 International +168% 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 3,864m • US: Increasing penetration in naive patients; expanding market shares in nAMD, DME and RVO • EU:
Slide 158: Tecentriq
Tecentriq CHFbn Global sales CER growth Regional sales CER growth 4.2 0% US -7% 3.6 Europe +4% 3.0 2.4 Japan 0% 1.8 1.2 International +23% 0.6 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 3,640m • US: 1L HCC and adj. NSCLC competitive pressure intensifying • EU: Growth driven by 1L HCC;
Slide 159: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 4.2 +1% US +3% 3.6 Europe -15% 3.0 Japan -40% 2.4 1.8 1.2 International +15% 0.6 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 3,616m • US: Increasing conversion to Phesgo • EU: Conversion to Phesgo • Japan: Conversion to Phe
Slide 160: Actemra/RoActemra
Actemra/RoActemra Global sales CER growth Regional sales CER growth CHFbn 4.0 +5% US +11% 3.5 3.0 Europe -14% 2.5 2.0 1.5 Japan +9% 1.0 0.5 International +19% 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 2,645m • US: Biosimilar launches slower than expected • EU: Decline due to biosimila
Slide 161: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 2.5 +16% 2.0 1.5 US +16% 1.0 0.5 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 2,470m • US: Strong food allergy launch with >40k patients on treatment; Strong CSU performance driving additional growth CER=Constant Exchange Rat
Slide 162: Kadcyla
Kadcyla CHFbn Global sales CER growth Regional sales CER growth +7% 2.5 US +3% 2.0 Europe -1% 1.5 1.0 Japan +5% International +23% 0.5 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,998m • US: Growth in adjuvant BC compensating for share decline in metastatic BC due to competition • EU:
Slide 163: Phesgo
Phesgo Global sales CER growth Regional sales CER growth CHFbn 1.8 +62% US +38% 1.5 1.2 Europe +40% 0.9 0.6 Japan >500% 0.3 International +111% 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,740m • US: Strong growth driven by adjuvant BC, switching of patients from Perjeta+Herceptin to P
Slide 164: Evrysdi
Evrysdi Global sales CER growth Regional sales CER growth CHFbn 2.0 +18% US +19% 1.6 Europe +14% 1.2 0.8 Japan +10% International +25% 0.4 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,631m • US: Strong uptake across all patient segments; including treatment-naïve patients • EU: Continu
Slide 165: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn 1.6 +7% US +15% 1.2 Europe -1% 0.8 Japan +3% 0.4 International +7% 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,548m • US: Market leadership in 1L ALK+ NSCLC is maintained • EU: Market leadership in 1L ALK+ NSCLC is maint
Slide 166: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 3.2 -11% US -18% 2.8 Europe -13% 2.4 Japan -50% 2.0 1.6 1.2 International -6% 0.8 0.4 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,381m • US: Biosimilar erosion slowing; Switching of patients with residual disease to Kad
Slide 167: MabThera/Rituxan
MabThera/Rituxan CHFbn Global sales CER growth Regional sales CER growth 2.8 -13% US -13% 2.4 2.0 Europe -15% 1.6 Japan -25% 1.2 International -10% 0.8 0.4 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,379m • US: Biosimilar erosion slowing • EU: Biosimilar erosion bottoms out • Japan: B
Slide 168: Avastin
Avastin CHFbn Global sales CER growth Regional sales CER growth 3.2 -17% US -19% Europe -11% 2.8 2.4 2.0 Japan -32% 1.6 1.2 0.8 International -10% 0.4 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,233m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: Ongoing bi
Slide 169: TNKase/Activase
TNKase/Activase Global sales CER growth Regional sales CER growth CHFbn 1.4 +5% US +5% 1.2 1.0 0.8 0.6 0.4 International +5% 0.2 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,202m • Spontaneous TNKase use in AIS early time window CER=Constant Exchange Rates 169
Slide 170: Polivy
Polivy Global sales CER growth Regional sales CER growth CHFbn 1.2 +39% 1.0 US +70% 0.8 0.6 Europe +13% 0.4 0.2 Japan -4% 0.0 International +76% FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 1,121m • US: Strong growth following approval in 1L DLBCL • EU: Strong growth following approval in 1L
Slide 171: Gazyva
Gazyva Global sales CER growth Regional sales CER growth CHFbn 1.2 +16% US +20% 1.0 Europe +9% 0.8 0.6 Japan -15% 0.4 International +23% 0.2 0.0 FY 2021 FY 2022 FY 2023 FY 2024 FY 2024 sales of CHF 910m • US: Strong growth driven by combination therapies in 1L CLL • EU: Strong growth driven by combi
Slide 172: Diagnostics sales appendix
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 173: 2024: Diagnostics Division CER growth
2024: Diagnostics Division CER growth By Region and Customer Area (vs. 2023) Reported Restatement Global EMEA North America Asia-Pacific Latin America Global EMEA North America Asia-Pacific Latin America CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % C
Slide 174: 2024: Diagnostics Division quarterly sales and CER growth
2024: Diagnostics Division quarterly sales and CER growth1 Reported Restatement Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHF
Slide 175: 2024: Diagnostics Division regional sales
2024: Diagnostics Division regional sales Growth across all regions except Asia-Pacific CER=Constant Exchange Rates (avg full year 2023); *Europe, Middle East and Africa 175
Slide 176: Core Lab
Core Lab 2024 vs. 2023 CHFbn CER growth +8% 10.0 8.0 +4% +8% 6.0 +9% 4.0 2.0 0.0 FY 2022 FY 2023 FY 2024 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates (avg full year 2023) 176
Slide 177: Molecular Lab
Molecular Lab 2024 vs. 2023 CER growth CHFbn +4% 4.0 3.2 +8% 0% 2.4 +1% +12% 1.6 -3% 0.8 +17% -3% 0.0 FY 2022 FY 2023 FY 2024 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates (avg full year 2023) 177
Slide 178: Near Patient Care
Near Patient Care 2024 vs. 2023 CHFbn CER growth -17% 6.0 4.5 - -3% 3.0 -5% -6% 1.5 +1% -71% 0.0 FY 2022 FY 2023 FY 2024 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis Diabetes Care POC MDx Other CER=Constant Exchange Rates (avg full year 2023) 178
Slide 179: Pathology Lab
Pathology Lab 2024 vs. 2023 CHFbn CER growth +17% 1.8 1.5 +41% +9% 1.2 +12% 0.9 0.6 0.3 0.0 FY 2022 FY 2023 FY 2024 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates (avg full year 2023) 179
Slide 180: Foreign exchange rates information
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) Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information
Slide 181: CHF/USD
CHF/USD Monthly averages 0.94 0.92 -4% 3% 0.90 0.88 -1% 0.86 -6% 0.84 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 Year-To-Date averages 0.93 0.91 -6% -3% 0.89 -2% -2% 0.87 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 181
Slide 182: CHF/USD
CHF/USD 0.93 FY 2024 -2% 0.92 0.91 0.90 0.89 0.88 0.87 0.86 0.85 0.84 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2023 avg full year 2024 monthly avg 2023 monthly avg 2024 182
Slide 183: CHF/EUR
CHF/EUR Monthly averages 1.00 0.98 0.96 -1% -3% -1% 0.94 -2% 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 Year-To-Date averages 1.00 0.98 -4% 0.96 -2% -2% 0.94 -2% 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 183
Slide 184: CHF/EUR
CHF/EUR 1.00 FY 2024 -2% 0.99 0.98 0.97 0.96 0.95 0.94 0.93 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2023 avg full year 2024 monthly avg 2023 monthly avg 2024 184
Slide 185: Average CHF Exchange Rates
Average CHF Exchange Rates FY 2024 FY 2023 FY 2024 vs. FY 2023 USD 0.88 0.90 -2% EUR 0.95 0.97 -2% JPY 0.58 0.64 -9% -10% -5% 0% 185
Slide 186: Exchange rate impact on sales growth
Exchange rate impact on sales growth 2024: Negative impact of JPY, CNY, USD and EUR Development of average exchange rates versus prior year period Q1 HY YTD Sep FY CHF / USD -5.6% -2.5% -2.3% -2.1% CHF / EUR -4.4% -2.5% -2.0% -2.0% CHF / JPY -15.8% -13.6% -10.8% -9.1% CHF / CNY -10.2% -6.5% -4.7% -3
Slide 187: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q4 2024: Negative impact of JPY, EUR, USD and CNY Development of average exchange rates versus prior year period Q1 Q2 Q3 Q4 CHF / USD -5.6% 0.6% -2.0% -1.1% CHF / EUR -4.4% -0.6% -1.0% -1.9% CHF / JPY -15.8% -11.4% -5.0% -4.0% CHF / CNY -10.2% -2.7% -0.9% -0.7%
Slide 188: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the USD, JPY, CNY (APAC) and EUR -0.3%p -0.5%p -1.1%p -0.8%p CER CHF sales growth -0.6%p sales growth 2024 2024 +7% -0.7%p vs. vs. 2023 2023 +3% CER EUR APAC USD LATAM JPY Other CHF CER=Constant Exchange Rates (avg full year 2023) 188
Slide 189: Doing now what patients need next
Doing now what patients need next