Roche Holding Ltd · SIX:RO

Roche — Q1 2025 Earnings Presentation

167 slides from Roche's earnings presentation, Apr 24, 2025

  1. Slide 1: Roche

  2. 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

  3. Slide 3: Roche Q1 2025 sales

    Roche Q1 2025 sales Basel, 24 April 2025

  4. Slide 4: Group

    Group Thomas Schinecker Chief Executive Officer

  5. Slide 5: Performance Outlook

    Performance Outlook

  6. Slide 6: Q1 2025: Group sales growth at +6%

    Q1 2025: Group sales growth at +6% Q1 sales all at CER ▪ Group sales growth +6%, +8% Pharma and 0% for Diagnostics (healthcare pricing reforms in China) ▪ LOE impact in line with guidance Key milestones achieved in Q1 ▪ Pharma regulatory: EU approval Columvi in 2L+ DLBCL, US approval Susvimo in DME

  7. Slide 7: Q1 2025: Strong Pharma sales driving Group growth

    Q1 2025: Strong Pharma sales driving Group growth Diagnostics impacted by healthcare pricing reforms in China Q1 2025 Q1 2024 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 11.9 10.9 9 8 Diagnostics Division 3.5 3.5 0 0 Roche Group 15.4 14.4 7 6 CER: Constant Exchange Rates (avg full year

  8. Slide 8: Q1 2025: Consistent strong growth in the last four quarters

    Q1 2025: Consistent strong growth in the last four quarters Group sales growth %CER +15% China Diagnostics healthcare pricing reforms +10% +9% +9% +9% +9% +6% +5% +2% +2% +1% +1% 0% COVID-19 pandemic Pandemic phase out Post-pandemic Base business: +1%* Base business: +8%* Business growth: +8%* -5% 2

  9. Slide 9: Key growth drivers of the Roche portfolio

    Key growth drivers of the Roche portfolio Diagnostics: Molecular Lab and Q1 2025 sales Pathology Lab driving growth; China 0% (CHFbn, YoY CER growth) impacted by healthcare pricing reforms Phesgo: Conversion rate climbing to 47% 3.5 Alecensa: Geographic expansion in adj. ALK+ NSCLC 6.0 +6% 0.9 CHF 1

  10. Slide 10: Young portfolio to drive growth in the near- to mid-term

    Young portfolio to drive growth in the near- to mid-term 4 key pivotal NME readouts expected in 2025 CHFbn % of Pharma Sales2 8.0 59% 7.0 50% 55% 6.0 5.0 42% 4.0 1 3.0 2.0 1.0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 0.0 Q1 2022 Q1 2023 Q1 2024 Q1 2025 Pivotal NME readouts • astegolima

  11. Slide 11: Roche with full Pharma and Diagnostics value chains in the US

    Roche with full Pharma and Diagnostics value chains in the US Commitment to invest USD 50bn into R&D and PP&E in the US until the end of the decade 13+1* manufacturing and 15+1* R&D sites in the US Biologics productivity evolution 2000 to 2030 ▪ US investments of USD 67bn over the last 10 years, inc

  12. Slide 12: Performance Outlook

    Performance Outlook

  13. Slide 13: Roche Sequencing Solution

    Roche Sequencing Solution1 Combination of two powerful innovations creates a leap forward in sequencing Presented at AGBT High-throughput sensor module SBX chemistry Unique benefits + = ▪ 8 million microwell array CMOS chip ▪ Novel chemistry from Stratos turns DNA ▪ Accuracy: High accuracy, fit for

  14. Slide 14: Roche's commitment to become a leader in CVRM

    Roche’s commitment to become a leader in CVRM Complementing our obesity portfolio and laying the foundation for future innovation in CVRM Pharmaceuticals Diagnostics * ** CT-173 (PYY) CT-388 (GLP-1/GIP RA) CT-868 (GLP-1/GIP RA) CT-996 (GLP-1 RA) Petrelintide (Long-acting amylin analogue) GYM 329 (an

  15. Slide 15: 2025 Pharma pipeline

    2025 Pharma pipeline Q1 key updates: Ph III Go for trontinemab in AD and for NXT007 in hemophilia A; Zealand Pharma collaboration New Molecular Entities (NME) giredestrant fenebrutinib vamikibart HR+ BC RMS, PPMS DME, UME Itovebi (inavolisib) Elevidys1 CT-388 Pi3Km BC DMD Obesity +/- T2D divarasib G

  16. Slide 16: 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 1. At CER: Constant Exchange Rates (avg full year 2024); LOE: Loss of exclusivity in

  17. Slide 17: Finance

    Finance Alan Hippe Chief Financial Officer

  18. Slide 18: Q1 2025: Group growth at +6%

    Q1 2025: Group growth at +6% Pharma Division driving growth, Diagnostics Division stable due to healthcare pricing reforms in China +6% at CER CHFm +1,141 +117 -222 +141 -136 15,440 14,399 2024 China Dia Pharma LOE Fx 2025 healthcare pricing (excl. China) (excl. LOE) reforms CER: Constant Exchange R

  19. Slide 19: Exchange rate impact on sales growth

    Exchange rate impact on sales growth Positive impact driven by the USD -0.6%p 1.5%p 0.0%p -0.1%p 0.1%p -0.1%p CER CHF sales growth sales growth 2025 2025 vs. +7.2% vs. 2024 +6.4% 2024 CER EUR APAC USD LATAM JPY Other CHF CER: Constant Exchange Rates (avg. full year 2024) 19

  20. Slide 20: Expected 2025 currency impact

    Expected 2025 currency impact FY 2025 impact of -5%p on Group sales expected assuming 23 Apr 2025 rates remain stable until the end of 2025 USD / CHF Assumed avg. YTD 2025 +3% 0% +1% +1% Assuming the 31 March 2025 exchange rates remain stable until end of 2025, 0.90 0.89 0.89 0.89 2025 impact1 is ex

  21. Slide 21: 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 1. At CER: Constant Exchange Rates (avg. full year 2024); LOE: Loss of exclusivity i

  22. Slide 22: Pharmaceuticals Division

    Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals

  23. Slide 23: Q1 2025: Pharmaceuticals sales

    Q1 2025: Pharmaceuticals sales Continued strong growth in US, EU and International; Japan returning to growth Q1 2025 Q1 2024 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 11,949 10,921 9 8 United States 6,224 5,692 9 6 Europe 2,320 2,200 5 5 Japan 671 649 3 3 International 2,734 2,380 15 1

  24. Slide 24: Q1 2025: Young portfolio delivering strong growth

    Q1 2025: Young portfolio delivering strong growth Growth across all regions with strong performance in International Phesgo 52% Vabysmo 18% Xolair 26% Hemlibra 11% Xofluza 234% Polivy 42% Ocrevus 6% Evrysdi 18% Elevidys >500% Alecensa 11% Columvi 138% Gazyva 15% Enspryng 27% Lunsumio 25% Tecentriq 0

  25. Slide 25: Oncology growing +2% in Q1 driven by HER2 franchise

    Oncology/Hematology Oncology growing +2% in Q1 driven by HER2 franchise Phesgo conversion rate climbing to 47% in 58 launch countries* Q1 update Itovebi Avastin CHF 14m / N/A ▪ Phesgo: Strong uptake across all regions; strong growth in China CHF 274m / -15% Others following NRDL listing Herceptin CH

  26. Slide 26: Polivy with strong global growth driven by 1L DLBCL

    Oncology/Hematology Polivy with strong global growth driven by 1L DLBCL Positive Lunsumio Ph III (SUNMO) results in 2L+ DLBCL; Columvi EU approval achieved in 2L+ DLBCL Q1 update Lunsumio Columvi CHF 21m / +25% ▪ Hemlibra: Strong Q1 growth across all patient segments; US CHF 60m / +138% PiaSky impac

  27. Slide 27: NXT007: Next-gen Factor VIIIa mimetic bispecific mAb

    Oncology/Hematology NXT007: Next-gen Factor VIIIa mimetic bispecific mAb Ph II data to be presented in 2025; Ph III program, including H2H vs. Hemlibra, to initiate in 2026 NXT007 (FVIIIa mimetic bispecific mAb) Clinical development Structure and function1 NXT007, Hemlibra and FVIII thrombin generat

  28. Slide 28: Ocrevus Zunovo permanent J-Code granted on April 1st

    Neurology Ocrevus Zunovo permanent J-Code granted on April 1st Achieved US approval for Evrysdi tablet formulation Q1 update Elevidys ▪ Ocrevus: ~50% Zunovo US starts naïve to Ocrevus CHF 43m / + * Others CHF 91m / -7% ▪ Evrysdi: US approval for tablet formulation achieved; 5-year Enspryng CHF 83m /

  29. Slide 29: Trontinemab: Rapid and deep amyloid clearance in AD

    Neurology Trontinemab: Rapid and deep amyloid clearance in AD 81% of patients on 3.6 mg/kg dose achieved amyloid PET negative within 28 weeks Trontinemab (Brainshuttle Ph I/IIb (BrainshuttleTM-AD): Updated results1 bispecific 2+1 anti-Aβ mAb) Efficacy (Amyloid clearance) Safety (ARIA) Blood BBB Brai

  30. Slide 30: Prasinezumab: Delay of confirmed motor progression in PD

    Neurology Prasinezumab: Delay of confirmed motor progression in PD Additional OLE data and decision on next steps around mid-year Prasinezumab (α-synuclein Ab) Ph IIb (PADOVA) results3 Time to ≥5 points on MDS-UPDRS Part III OFF (L-DOPA population, n=435) 100 HR (95% CI)=0.79 (0.63, 0.99) Prasinezum

  31. Slide 31: Xolair with strong launch uptake in food allergy

    Immunology Xolair with strong launch uptake in food allergy Three afimkibart (anti-TL1A) trials initiated: Ph III in Crohn’s disease, Ph II in atopic dermatitis and Ph I in MASH Q1 update ▪ Xolair: Strong food allergy launch with >50k patients on treatment Others CHF 234m / +1% Actemra ▪ Updated Ph

  32. Slide 32: Gazyva: Ph III results in LN show superiority over standard of care

    Immunology Gazyva: Ph III results in LN show superiority over standard of care Ph III results in SLE and INS expected in 2025 Ph III (REGENCY) results: CRR at Week 761 Clinical development 60 Treatment Difference Patients Achieving CRR at Week 76 (% ±95% CI) Primary Endpoint: CRR at 13.4% (95% CI: 2

  33. Slide 33: Vabysmo now the most prescribed therapy in nAMD in the US

    Ophthalmology Vabysmo now the most prescribed therapy in nAMD in the US Vabysmo continues to expand market shares across regions; US impacted by contraction of branded market Q1 update Luxturna CHF 34m / + * Susvimo ▪ Vabysmo: Continued market share gains across early launch Lucentis CHF 2m / +171%

  34. Slide 34: Petrelintide: BIC potential as monotherapy and FDC with CT-388

    Cardiovascular, Renal & Metabolism Petrelintide: BIC potential as monotherapy and FDC with CT-388 Strengthening our growing CVRM portfolio with a long-acting amylin analog Petrelintide Ph I results: Change in body weight from baseline SAD trial6 MAD trial – Part 17 MAD trial – Part 28 (% change, Day

  35. Slide 35: Petrelintide complementing our growing CVRM portfolio

    Cardiovascular, Renal & Metabolism Petrelintide complementing our growing CVRM portfolio Several molecules to move ahead in 2025 Obesity/Diabetes portfolio Roche obesity portfolio: Potential to address unmet needs* Ph I Ph II Roche 1 CT-388 103/104 (Obesity +/- T2D) Unmet need A Current weight loss

  36. Slide 36: 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 (EU approval) Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephri

  37. Slide 37: Diagnostics Division

    Diagnostics Division Matt Sause CEO Roche Diagnostics

  38. Slide 38: Q1 2025: Diagnostics sales

    Q1 2025: Diagnostics sales Diagnostics Division stable due to healthcare pricing reforms in China Q1 2025 Q1 2024 Change in % CHFm CHFm CHF CER Diagnostics Division 3,491 3,478 0 0 Core Lab1 1,904 1,926 -1 -1 Molecular Lab 634 611 4 2 Near Patient Care 536 569 -6 -5 Pathology Lab 417 372 12 11 CER:

  39. Slide 39: Q1 2025: Diagnostics highlights

    Q1 2025: Diagnostics highlights Diagnostics Division stable due to healthcare pricing reforms in China CHFbn YoY CER growth ▪ Immunodiagnostics (-3%) Core Lab -1% ▪ Clinical Chemistry (+4%) ▪ Infectious diseases (-5%) Molecular Lab +2% ▪ Blood Screening (+6%) Near Patient ▪ BGM (-7%) Care -5% ▪ liat

  40. Slide 40: Q1 2025: Diagnostics regional sales

    Q1 2025: Diagnostics regional sales Strong growth in North America, EMEA and Latin America North America +7% EMEA ~33% of divisional sales +4% ~35% of divisional sales Asia Pacific Latin America -15% +11% ~24% of divisional sales ~7% of divisional sales EMEA: Europe, Middle East and Africa; Growth r

  41. Slide 41: Instrument placements

    Instrument placements Continued strong growth of instrument placements in 2024 Non-exhaustive Core Lab Molecular Lab Pathology Lab Near Patient Care +10% +7% BenchMark cobas® liat ULTRA/ULTRAPLUS +22% cobas® 5800/6800/8800 analytical units +36% +65% DP200/600 cobas® pro and pure analytical units +4%

  42. Slide 42: cobas Mass Spec solution

    cobas® Mass Spec solution The first fully automated IVD solution will revolutionize the Mass Spec segment of the clinical lab Key milestones Customer testimonials • Achieved CE launch for system and steroid 1 assays in “This represents one of the most December 2024 and for Vitamin D assays in Februa

  43. Slide 43: Roche Sequencing solution

    Roche Sequencing solution Customer data demonstrates potential of SBX technology ahead of the 2026 commercial launch Early evaluation example: WGS in under 7 hours Market opportunity ▪ The NGS market is valued at USD 6.4bn (2024) and is projected to grow at +9% CAGR from 2024 to 2027¹ ▪ Strong growt

  44. Slide 44: cobas liat CT/NG

    cobas® liat CT/NG First FDA cleared/CLIA waived molecular point of care diagnostic for CT/NG cobas® liat assay menu Market opportunity ▪ The molecular STI market is valued at CHF 1bn (2023) and is cobas® liat CT/NG and CT/NG/MG projected to grow at +10% CAGR from 2023 to 2028¹ cobas® liat SARS-CoV-2

  45. Slide 45: Diagnostics key launches 2025

    Diagnostics key launches 2025 Area Product Description Market Status Elecsys® pTau 181 Non-invasive blood-based biomarker to enable earlier detection and rule out amyloid pathology CE Elecsys® Troponin-T hs High-sensitive test with greater precision at lower measurement ranges, enabling HCPs to conf

  46. Slide 46: Invitation to Roche Diagnostics Day 2025

    Invitation to Roche Diagnostics Day 2025 Highlights: ▪ Deep-dive into the product portfolio and pipeline ▪ Roche SBX Sequencing solution updates and applications Presenters include: ▪ Matt Sause, CEO Roche Diagnostics ▪ Palani Kumaresan, Head of RDS ▪ Moritz Hartmann, Head of RIS Roche Sequencing so

  47. Slide 47: 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 Hematology Update Pharma Day 7 Feb 20 Feb 4 Apr 27 May 23 June 22 Sep 16:30-17:30 CET 20:30-21:30 CET 16:00-17:30 CEST 14:00-16:45 CEST 19:00-20:15 CEST tbd Virtual

  48. Slide 48: Doing now what patients need next

    Doing now what patients need next

  49. Slide 49: 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

  50. Slide 50: Changes to the development pipeline

    Changes to the development pipeline Q1 2025 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 2 NMEs: 2 AIs: RG6662 HTT miRNA GT (SPK-10001) – RG6351 anti-Tie2 agonist - retinal disease RG6631 afimkibart (anti-TL1A) - Crohn’s Huntington's disease RG6287 NME - immunol

  51. Slide 51: Roche Group development pipeline

    Roche Group development pipeline Phase I (44 NMEs + 8 AIs) Phase II (17 NMEs + 7 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU CD137 switch solid tumors RG6107 PiaSky sickle cell disease RG6076 englumafusp alfa combos heme tumors CHU paluratide (RAS inhibitor) solid tumors RG6171 giredest

  52. Slide 52: Roche Group development pipeline

    Roche Group development pipeline Phase III (8 NMEs + 31 AIs) Registration US & EU (2 NME + 6 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6026 Columvi + chemo1 2L+ DLBCL Columvi + Polivy + R-CHP 1L DLBCL RG6299 sefaxersen (ASO factor B) IgA nephropathy RG6114 Itovebi + palb

  53. Slide 53: Expected regulatory submissions

    Expected regulatory submissions* New Molecular Entities: Lead and additional indications New Molecular Entity (NME) Cardiovascular, Renal & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other *Filing timelines reflect the anticipated filing of a poten

  54. Slide 54: 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 ✓ Indicates submission to health authorities has occurred Unless stated o

  55. Slide 55: Major pending approvals 2025

    Major pending approvals 2025 US EU China Japan-Chugai Susvimo Itovebi + palbociclib + fulvestrant Columvi + chemo Elevidys RG6321 DR (US) RG6114 1L HR+ PIK3CA-mut. mBC RG6026 2L DLBCL RG6356 DMD Filed April 2024 Filed April 2024 Filed August 2024 Filed August 2024 Columvi + chemo Elevidys Vabysmo RG

  56. Slide 56: Major granted approvals 2025

    Major granted approvals 2025 US EU China Japan-Chugai TNKase Columvi + chemo Lunsumio Tecentriq RG3625 stroke RG6026 2L DLBCL RG7828 3L+ FL RG7446 Alveolar Soft Part Sarcoma Feb 2025 April 2024 Dec 2024 Feb 2025 Susvimo Itovebi + palbociclib + fulvestrant RG6321 DME (US) RG6114 1L HR+ PIK3CA-mut. mB

  57. Slide 57: 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

  58. Slide 58: Alecensa (alectinib, RG7853)

    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

  59. Slide 59: Itovebi (inavolisib, RG6114, GDC-0077)

    Itovebi (inavolisib, RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA-mutant HR-positive metastatic post CDKi HR-positive PIK3CA-mutant breast PIK3CA mutant solid tumors and metastatic Indication breast cancer (mBC) cancer ER+ HER2-negative breast cancer Phase III P

  60. Slide 60: Itovebi (inavolisib, RG6114, GDC-0077)

    Itovebi (inavolisib, RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor 1L endocrine-sensitive PIK3CA-mutated HR+, HER2-, advanced breast Indication 1L HER2-positive PIK3CA mutant metastatic breast cancer (mBC) cancer Phase III Phase III Phase/study INAVO122 INAVO123 # of pa

  61. Slide 61: Kadcyla (trastuzumab emtansine, RG3502)

    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

  62. Slide 62: Tecentriq (atezolizumab, RG7446)

    Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication Periadjuvant NSCLC 1L maintenance extensive-stage SCLC Phase III Phase III Phase/study IMpower030 IMforte1 # of patients N=450 N=450 Oncology/Hematology ▪ ARM A: Tecentriq plus platinum-based chemotherapy ▪ ARM

  63. Slide 63: Tecentriq (atezolizumab, RG7446)

    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 induct

  64. Slide 64: Columvi (glofitamab, RG6026)

    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

  65. Slide 65: Columvi (glofitamab, RG6026)

    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

  66. Slide 66: Columvi (glofitamab, RG6026)

    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

  67. Slide 67: Columvi (glofitamab, RG6026)

    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 Oncology/Hematology ▪ ARM B: Bendamustine + rituximab or r

  68. Slide 68: Lunsumio (mosunetuzumab, RG7828)

    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

  69. Slide 69: Lunsumio (mosunetuzumab, RG7828)

    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 Oncology/Hematology ▪ ARM B: R + GemOx Design ▪ Progression-free survival Primary

  70. Slide 70: Lunsumio (mosunetuzumab, RG7828)

    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

  71. Slide 71: Lunsumio (mosunetuzumab, RG7828)

    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) Oncology/He

  72. Slide 72: Polivy (polatuzumab vedotin, RG7596)

    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

  73. Slide 73: Venclexta (venetoclax, RG7601)

    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

  74. Slide 74: Hemlibra (emicizumab, RG6013)

    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

  75. Slide 75: PiaSky (crovalimab, RG6107, SKY59)

    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 ▪

  76. Slide 76: PiaSky (crovalimab, RG6107, SKY59)

    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

  77. Slide 77: PiaSky (crovalimab, RG6107, SKY59)

    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

  78. Slide 78: PiaSky (crovalimab, RG6107, SKY59)

    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 Oncology/Hematology ▪ ARM A: P

  79. Slide 79: Elevidys (delandistrogene moxeparvovec, RG6356)

    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 Neurology Open label single arm study in 0 to <4 year old DMD boys who will receive a single intravenous (

  80. Slide 80: Enspryng (satralizumab, RG6168, SA237)

    Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Myelin oligodendrocyte glycoprotein antibody Indication Autoimmune encephalitis (AIE) Duchenne Muscular Dystrophy (DMD) disease (MOG-AD) Phase III Phase III Ph II Phase/study METEOROID CIELO SHIELD DMD # of patie

  81. Slide 81: Evrysdi (risdiplam, RG7916)

    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

  82. Slide 82: Ocrevus (ocrelizumab, RG1594)

    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 Neurology 120-week treatment period: ▪ ARM A: Ocrevus 600mg IV Q24W ▪ ARM B: Placebo D

  83. Slide 83: Ocrevus (ocrelizumab, RG1594)

    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

  84. Slide 84: Gazyva (obinutuzumab, RG7159)

    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

  85. Slide 85: Gazyva (obinutuzumab, RG7159)

    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

  86. Slide 86: Lunsumio (mosunetuzumab, RG7828, CD20 x CD3)

    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=15 ▪ ARM A: Lunsumio SC on either Day 1 or on Days 1 and 8 Immunology ▪ ARM B: Fractionated (divided)

  87. Slide 87: Xolair (omalizumab, RG3648)

    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

  88. Slide 88: Enspryng (satralizumab, RG6168, SA237)

    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

  89. Slide 89: Susvimo (PDS, RG6321)

    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

  90. Slide 90: Susvimo (PDS, RG6321)

    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

  91. Slide 91: Vabysmo (faricimab, RG7716)

    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:

  92. Slide 92: Vabysmo (faricimab, RG7716)

    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

  93. Slide 93: Vabysmo (faricimab, RG7716)

    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

  94. Slide 94: Vabysmo (faricimab, RG7716)

    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 Ophthalmology ▪ ARM A: Vabysmo 6.0 mg Q4W PRN ▪ ARM B: Ranibizumab 0

  95. Slide 95: Xofluza (baloxavir marboxil, RG6152, S-033188)

    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

  96. Slide 96: 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

  97. Slide 97: Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036)

    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 Ib Phase III Phase III Phase/study KRASCENDO 170 KRASCENDO 1 KRASCENDO 2 # of patients N=60 N=320 N=600 ▪ Cohort A: Combin

  98. Slide 98: Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036)

    Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Indication Advanced or metastatic solid tumors with a KRAS G12C mutation 1L metastatic colorectal cancer (mCRC) Phase Ib Phase/study Phase I INTRINSIC # of patients N

  99. Slide 99: Giredestrant (SERD (3), RG6171, GDC-9545)

    Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication ER+ HER2-negative metastatic breast cancer (mBC) Phase/study Phase I # of patients N=181 ▪ Dose escalation and expansion at RPTD ▪ Giredestrant monotherapy and in combination with palbociclib

  100. Slide 100: Giredestrant (SERD (3), RG6171, GDC-9545)

    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

  101. Slide 101: Giredestrant (SERD (3), RG6171, GDC-9545)

    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/

  102. Slide 102: Tiragolumab (anti-TIGIT, RG6058, MTIG7192A)

    Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Stage III unresectable 1L NSCLC 1L HCC Phase III Phase III Phase/study SKYSCRAPER-03 SKYSCRAPER-14 # of patients N=800 N=650 Oncology/Hematology ▪ ARM A: Tiragolumab plus Tecent

  103. Slide 103: NXT007 (FIXa x FX, RG6512)

    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 Oncology/Hematology ▪ Two loading doses of NXT007 SC (Q2W) followed by Q4W maintenance dosing Design ▪ S

  104. Slide 104: Anti-latent myostatin (RG6237, GYM 329)

    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=259 N=30-

  105. Slide 105: Fenebrutinib (RG7845, GCD-0853)

    Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Relapsing multiple sclerosis (RMS) Phase III Phase III Phase II (Biomarker study) Phase/study FENhance 1 FENhance 2 FENopta # of patients N=746 N=751 N=109 ARM A: Fenebrutinib twice daily

  106. Slide 106: Fenebrutinib (RG7845, GCD-0853)

    Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Primary progressive multiple sclerosis (PPMS) Phase III Phase/study FENtrepid # of patients N=985 Neurology ▪ ARM A: Fenebrutinib twice daily oral ▪ ARM B: Ocrevus 2x300mg IV Q24W Design ▪

  107. Slide 107: Tominersen (HTT ASO, RG6042)

    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 Neurology Patients aged 25 to 50 years with prodromal (very early subtle signs of HD) or early manifest HD ▪ ARM A: Tominersen

  108. Slide 108: Trontinemab (BS-anti-Aβ mAb, RG6102)

    Trontinemab (BS-anti-Aβ mAb, RG6102) A novel BrainshuttleTM bispecific 2+1 monoclonal antibody targeting Aβ Indication Prodromal or mild to moderate Alzheimer's Disease Phase/study Phase I/II # of patients N=210 Neurology ▪ PART 1 (dose escalation): Q4W trontinemab or placebo for 28w (5 dosing cohor

  109. Slide 109: Astegolimab (Anti-ST2, RG6149)

    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 ▪

  110. Slide 110: Sefaxersen (ASO factor B, RG6299)

    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

  111. Slide 111: Afimkibart (anti-TL1A, RG6631)

    Afimkibart (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: Afimkibart IV induction

  112. Slide 112: Afimkibart (anti-TL1A, RG6631)

    Afimkibart (anti-TL1A, RG6631) A monoclonal antibody targeting TL1A, blocking TH1 and TH17 pathways Indication Moderate to severe Crohn's Disease Phase III Phase III Phase/study SIBERITE-1 SIBERITE-2 # of patients N=600 N=425 ▪ Treat-through design with no re-randomization after induction ▪ Inductio

  113. Slide 113: Afimkibart (anti-TL1A, RG6631)

    Afimkibart (anti-TL1A, RG6631) A monoclonal antibody targeting TL1A, blocking TH1 and TH17 pathways Indication Atopic dermatitis Metabolic Dysfunction-associated Steatohepatitis (MASH) Phase/study Phase II Phase Ib # of patients N=160 N=50 ▪ ARM A: High dose afimkibart SC ▪ Afimkibart IV at w0, w2,

  114. Slide 114: Vamikibart (anti-IL-6, RG6179)

    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=

  115. Slide 115: Vamikibart (anti-IL-6, RG6179)

    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 Ophthalmology ▪ ARM A: Vamikibart low-dose Q4W to week 12, followed by PRN ▪ ARM A:

  116. Slide 116: CT-388 (GLP-1/GIP RA, RG6640)

    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 Indication Overweight/obesity with type 2 diabetes diabetes diabetes Phase/study Phase I Phase II Phase II # of patients N=129

  117. Slide 117: CT-996 (GLP-1 RA, RG6652)

    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 Cardiovascular, Renal & Metabolism ▪ Single ascending dose, multiple ascending dose, multiple part study, with low to

  118. Slide 118: CT-868 (GLP-1/GIP RA, RG6641)

    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 Cardiovascular, Renal & Metabolism ▪ ARM A: CT-868 low dose ▪ ARM B: CT-868 medium dose Design ▪ ARM C: CT-868 high dose ▪

  119. Slide 119: 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

  120. Slide 120: 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

  121. Slide 121: pRED neurology development programs -1

    pRED neurology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neurology ISRCTN162951 BrainshuttleTM-CD20 (RG6035) Multiple sclerosis I 30-63 FPI Q3 2021 77 NCT05704361 nivegacetor (gamma-secretase Alzheimer's disease II 245 FPI Q2 2024 NCT06402838 modulator, RG6

  122. Slide 122: 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

  123. Slide 123: 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

  124. Slide 124: 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

  125. Slide 125: 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

  126. Slide 126: 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 TGFß1 Solid tumors Ib 120 FPI Q3 2023 NCT05867121 (SOF10; RG6440) NME (RG6468) Solid tumors I 110 FPI Q4 2023 NCT06031441

  127. Slide 127: gRED immunology and ophthalmology development programs

    gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology Cardiac surgery associated acute NME (RG6287, GDC-8264) II 404 FPI Q1 2025 NCT06602453 kidney injury (CS-AKI) TMEM16A potentiator (RG6421, Muco-obstructive respiratory disea

  128. Slide 128: 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

  129. Slide 129: Q1 2025: Pharma Division sales

    Q1 2025: Pharma Division sales Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,778 6 1,247 3 344 11 - - 187 16 Hemlibra 1,165 11 610 0 247 7 82 3 226 72 Vabysmo 1,018 18 718 7 197 42 32 35 71 101 Tecentriq 870 0 411 -8 220 5 81 -5

  130. Slide 130: Q1 2025: Pharma Division sales

    Q1 2025: Pharma Division sales Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 12 23 6 51 3 -11 - - 3 21 Alecensa 397 11 130 21 68 -6 49 12 150 12 Tecentriq 870 0 411 -8 220 5 81 -5 158 21 Ocrevus 1,778 6 1,247 3 344 1

  131. Slide 131: Q1 2025: Pharma Division sales

    Q1 2025: Pharma Division sales Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,778 6 1,247 3 344 11 - - 187 16 Hemlibra 1,165 11 610 0 247 7 82 3 226 72 Vabysmo 1,018 18 718 7 197 42 32 35 71 101 Tecentriq 8

  132. Slide 132: Pharma Division CER sales growth in %

    Pharma Division CER sales growth1 in % Global top 20 products Q1/24 Q2/24 Q3/24 Q4/24 Q1/25 Ocrevus 8 9 11 7 6 Hemlibra 8 6 14 21 11 Vabysmo 108 81 59 43 18 Tecentriq 1 2 0 -1 0 Perjeta -3 -1 2 9 -10 Xolair 10 11 12 29 26 Actemra / RoActemra -2 8 7 4 -1 Phesgo 70 52 55 72 52 Kadcyla 3 9 7 9 5 Evrysd

  133. Slide 133: Pharma Division CER sales growth in %

    Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Ocrevus 6 9 0 3 15 11 21 11 - - - - 27 23 37 16 Hemlibra 3 12 20 0 12 3 15 7 4 4 22 3 16 64 36 72 Vabysmo 68 49 35 7 153 104 88 42 38 40 46 35 281 180 63 101

  134. Slide 134: CER sales growth (%)

    CER sales growth (%) Quarterly development 2024 vs. 2023 2025 vs. 2024 Q1 Q2 Q3 Q4 Q1 Pharmaceuticals Division 2 9 10 12 8 United States 5 6 9 15 6 Europe 11 10 2 10 5 Japan -45 -3 1 1 3 International 12 23 22 11 18 Diagnostics Division 2 8 6 -1 0 Roche Group 2 9 9 9 6 CER: Constant Exchange Rates (

  135. Slide 135: Ocrevus

    Ocrevus Q1 2025 sales of CHF 1,778m ▪ US: Moving into earlier lines displacing orals; SC launch ongoing; #1 in US for both dynamic and total patient share ▪ EU: Moving into earlier lines displacing orals; SC launch ongoing; #1 in EU5 for total patient share CER: Constant Exchange Rates 135

  136. Slide 136: Hemlibra

    Hemlibra Q1 2025 sales of CHF 1,165m ▪ US: Continued share gains in non-inhibitor patients; Buying patterns impacted by large Q4 buy-in ▪ EU: Continued share gains in non-inhibitor patients ▪ Japan: Continued uptake in non-inhibitor patients ▪ International: Accelerating momentum in all regions CER:

  137. Slide 137: Vabysmo

    Vabysmo Q1 2025 sales of CHF 1,018m ▪ US: Increasing penetration in naive patients; expanding market shares in nAMD, DME and RVO; Branded market contraction impacting Q1 sales ▪ EU: Continued strong growth and double-digit market shares in first launch countries ▪ Japan: Double-digit market share ▪

  138. Slide 138: Tecentriq

    Tecentriq Q1 2025 sales of CHF 870m ▪ US: 1L HCC and adj. NSCLC competitive pressure intensifying ▪ EU: Growth driven by 1L HCC; adj. NSCLC at peak penetration ▪ International: Strong growth in all regions CER: Constant Exchange Rates 138

  139. Slide 139: Perjeta

    Perjeta Q1 2025 sales of CHF 840m ▪ US: Increasing conversion to Phesgo ▪ EU: Conversion to Phesgo ▪ Japan: Conversion to Phesgo ▪ International: Conversion to Phesgo CER: Constant Exchange Rates 139

  140. Slide 140: Xolair

    Xolair Q1 2025 sales of CHF 645m ▪ US: Strong food allergy launch with >50k patients on treatment; Strong CSU performance driving additional growth CER: Constant Exchange Rates 140

  141. Slide 141: Actemra/RoActemra

    Actemra/RoActemra Q1 2025 sales of CHF 619m ▪ US: Biosimilar launches slower than expected ▪ EU: Decline due to biosimilars CER: Constant Exchange Rates 141

  142. Slide 142: Phesgo

    Phesgo Q1 2025 sales of CHF 593m ▪ US: Strong growth driven by adjuvant BC, switching of patients from Perjeta+Herceptin to Phesgo ▪ EU: Strong growth in all regions, mainly EU5 ▪ International: Strong uptake in all regions CER: Constant Exchange Rates 142

  143. Slide 143: Kadcyla

    Kadcyla Q1 2025 sales of CHF 506m ▪ US: Growth in adjuvant BC compensating for share decline in metastatic BC due to competition ▪ EU: Share decline in metastatic BC due to competition ▪ Japan: Growth in adjuvant BC partially offsetting for share decline in metastatic BC due to competition ▪ Interna

  144. Slide 144: Evrysdi

    Evrysdi Q1 2025 sales of CHF 420m ▪ US: Strong uptake across all patient segments; including treatment-naïve patients ▪ EU: Continued strong growth and share gains, especially in EU5 ▪ Japan: Market leading position ▪ International: Strong growth in all regions CER: Constant Exchange Rates 144

  145. Slide 145: Alecensa

    Alecensa Q1 2025 sales of CHF 397m ▪ US: Strong position in 1L ALK+ NSCLC is maintained ▪ EU: Strong position in 1L ALK+ NSCLC is maintained, uptake in adj. only partially compensates for competitive pressure in 1L ▪ Japan: Strong position in 1L ALK+ NSCLC is maintained ▪ International: Strong growt

  146. Slide 146: Polivy

    Polivy Q1 2025 sales of CHF 358m ▪ US: Strong growth following approval in 1L DLBCL ▪ EU: Strong growth following approval in 1L DLBCL ▪ Japan: Strong growth following approval in 1L DLBCL; sales impacted by price decrease ▪ International: Strong growth following approval in 1L DLBCL CER: Constant E

  147. Slide 147: MabThera/Rituxan

    MabThera/Rituxan Q1 2025 sales of CHF 298m ▪ US: Biosimilar erosion slowing ▪ EU: Biosimilar erosion bottoms out ▪ Japan: Biosimilar erosion slowing ▪ International: Biosimilar erosion slowing CER: Constant Exchange Rates 147

  148. Slide 148: TNKase/Activase

    TNKase/Activase Q1 2025 sales of CHF 297m ▪ Spontaneous TNKase use in AIS early time window CER: Constant Exchange Rates 148

  149. Slide 149: Herceptin

    Herceptin Q1 2025 sales of CHF 292m ▪ US: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Conversion to Phesgo ▪ EU: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Conversion to Phesgo ▪ Japan: Decline due to biosimilars; Conve

  150. Slide 150: Avastin

    Avastin Q1 2025 sales of CHF 274m ▪ US: Biosimilar erosion slowing ▪ EU: Biosimilar erosion slowing ▪ Japan: Ongoing biosimilar erosion ▪ International: Biosimilar erosion slowing CER: Constant Exchange Rates 150

  151. Slide 151: Gazyva

    Gazyva Q1 2025 sales of CHF 249m ▪ US: Strong growth driven by combination therapies in 1L CLL ▪ EU: Growth driven by combination therapies in 1L CLL; Q1 impacted by price cuts ▪ International: Continued growth in all regions CER: Constant Exchange Rates 151

  152. Slide 152: 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

  153. Slide 153: Q1 2025: Diagnostics Division CER growth

    Q1 2025: Diagnostics Division CER growth By Region and Customer Area (vs. 2024) 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

  154. Slide 154: Q1 2025: Diagnostics Division quarterly sales and CER growth

    Q1 2025: Diagnostics Division quarterly sales and CER growth1 Reported Restatement Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab3 1,925 9 2,144 10 1,983 8 1,952 6 1,90

  155. Slide 155: Q1 2025: Diagnostics Division regional sales

    Q1 2025: Diagnostics Division regional sales Growth across regions, offset by APAC Sales growth at CER Diagnostics Division 0% GLOBAL 4% EMEA* 7% NAM -15% APAC 11% LATAM *Europe, Middle East and Africa; CER: Constant Exchange Rates (avg. full year 2024) 155

  156. Slide 156: Core Lab

    Core Lab 2025 vs. 2024 CER growth CHFbn -1% 2.0 +3% +4% 1.5 -3% 1.0 0.5 0.0 Q1 2023 Q1 2024 Q1 2025 Immunodiagnostics Clinical Chemistry Other CER: Constant Exchange Rates 156

  157. Slide 157: Molecular Lab

    Molecular Lab 2025 vs. 2024 CER growth CHFbn +2% 0.7 +17% 0.6 - 0.5 -13% 0.4 +5% 0.3 -5% -10% 0.2 +6% 0.1 -5% 0.0 Q1 2023 Q1 2024 Q1 2025 Infectious Diseases Blood Screening MD Systems Open Molecular Systems Cervical Cancer Sequencing ML PHCS Other CER: Constant Exchange Rates ; ML PHCS: Molecular l

  158. Slide 158: Near Patient Care

    Near Patient Care 2025 vs. 2024 CER growth CHFbn -5% 0.8 +11% 0.6 +6% -7% -10% 0.4 -3% -32% 0.2 0.0 Q1 2023 Q1 2024 Q1 2025 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis BGM POC MDx Other BGM: Blood glucose monitoring; CER: Constant Exchange Rates; MDx: Molecular diagnostic

  159. Slide 159: Pathology Lab

    Pathology Lab 2025 vs. 2024 CER growth CHFbn +11% 0.5 - 0.4 +21% +14% 0.3 +7% 0.2 0.1 0.0 Q1 2023 Q1 2024 Q1 2025 Advanced Staining Primary Staining PL PHCS Other CER: Constant Exchange Rates; PL PHCS: Pathology lab personalized healthcare solutions (equivalent to Companion Diagnostics) 159

  160. Slide 160: 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

  161. Slide 161: CHF/USD

    CHF/USD Monthly averages 0.94 0.92 0.90 0% 0.88 0.86 0.84 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2024 2025 0.93 Year-To-Date averages 3% 0.91 0.89 0.87 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2024 2025 161

  162. Slide 162: CHF/USD

    CHF/USD 0.93 Mar YTD 2025 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 2024 avg full year 2025 monthly avg 2024 monthly avg 2025 162

  163. Slide 163: CHF/EUR

    CHF/EUR Monthly averages 1.00 0.98 0.96 0.94 -1% 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2024 2025 Year-To-Date averages 1.00 0.98 0.96 0% 0.94 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2024 2025 163

  164. Slide 164: CHF/EUR

    CHF/EUR 1.00 Mar YTD 2025 -1% 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 2024 avg full year 2025 monthly avg 2024 monthly avg 2025 164

  165. Slide 165: Average CHF Exchange Rates

    Average CHF Exchange Rates Mar YTD Mar YTD Mar YTD 2025 vs. Mar YTD 2024 2025 2024 USD 0.90 0.87 3% EUR 0.95 0.95 0% JPY 0.59 0.59 0% -2% 0% 2% 4% 165

  166. Slide 166: Exchange rate impact on sales growth

    Exchange rate impact on sales growth Q1 2025: positive impact of USD, CNY and JPY Development of average exchange rates versus prior year period Q1 HY YTD Sep FY CHF / USD 2.9% CHF / EUR -0.3% CHF / JPY 0.1% CHF / CNY 1.7% Difference in CHF / CER 0.8% growth 6.4% 7.2% Sales growth 2025 vs. 2024 CER

  167. Slide 167: Doing now what patients need next

    Doing now what patients need next

Roche Holding — Q1 2025 Earnings Presentation on 6ix