Roche Holding Ltd · SIX:RO
Roche — Investor Day (March 2026)
42 slides from Roche's investor day presentation, Mar 9, 2026
Slide 1: Slide 1
Slide 2: SLEuro 2026 Virtual IR Event
SLEuro 2026 Virtual IR Event March 9th 2026
Slide 3: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 4: Welcome
Welcome Bruno Eschli Head of Investor Relations
Slide 5: Agenda
Agenda Welcome Bruno Eschli, Head of Investor Relations Immune-mediated kidney & rheumatological diseases pipeline update Jay Garg, VP Global Franchise Head of Nephrology Ph III ALLEGORY Gazyva in systemic lupus erythematosus (SLE) Richard A. Furie, MD Chief, Division of Rheumatology, Northwell Heal
Slide 6: Roche set to lead in immune mediated kidney & rheumatological diseases
Immunology Roche set to lead in immune mediated kidney & rheumatological diseases Gazyva peak sales in immune mediated diseases is estimated to be 2bn plus Global market growth for Consensus sales growth (24-29)* Potential up-side SLE/LN, IgAN, MN by 20301 Vabysmo 2.5bn US/EU5/Japan market size SLE/
Slide 7: Immunology pipeline
Immunology Immunology pipeline Broad development portfolio across several disease areas Phase I Phase II Phase III Registration CD19 x CD3 Lunsumio Gazyva Gazyva RG6382 SLE RG7828 RG7159 Membranous nephropathy RG7159 SLE SLE selnoflast afimkibart Gazyva RG6418 Asthma RG6631 RG7159 Atopic dermatitis
Slide 8: Immune-mediated kidney & rheumatological diseases pipeline update
Immune-mediated kidney & rheumatological diseases pipeline update Jay Garg VP Global Franchise Head of Nephrology
Slide 9: Immune-mediated kidney & rheumatological diseases strategy
Immunology Immune-mediated kidney & rheumatological diseases strategy Our Ambition Our Vision Long-lasting remission in immune-mediated kidney & rheumatological diseases Our Priorities Become a global leader in immune- Deliver patient & health Achieve differentiated therapeutic mediated kidney & rhe
Slide 10: Roche's legacy in the treatment of renal and rheumatic diseases
Immunology Roche´s legacy in the treatment of renal and rheumatic diseases 1995 2007 2011 2021 Cellcept Mircera Rituxan/MabThera Actemra (organ transplant rejection) (anemia due to CKD) (GPA/MPA) (SSc-ILD) 2006 2010 2017 2025 Rituxan/MabThera (RA) Actemra (RA) Actemra (GCA) Gazyva (LN) CKD: Chronic
Slide 11: Gazyva approved in LN, additional positive Ph III readouts since 2024
Immunology Gazyva approved in LN, 4 additional positive Ph III readouts since 2024 Immune mediated kidney & rheumatological diseases portfolio Molecule Indication Ph I Ph II Ph III Status LN REGENCY Approved in US/EU SLE/LN ALLEGORY Filed in US/EU Gazyva MN MAJESTY 2026 INS INShore 2025 PiaSky aHUS
Slide 12: Addressing unmet need in Chronic Kidney Disease (CKD)
Immunology Addressing unmet need in Chronic Kidney Disease (CKD) Aiming to prevent progression to end-stage kidney disease and subsequent need for dialysis/transplantation CKD to become the 5th leading cause of death Immune-mediated diseases are a leading cause of globally by 20401 acquired CKD SLE/
Slide 13: SLE is a chronic disease that can affect nearly every organ system
Immunology SLE is a chronic disease that can affect nearly every organ system Up to 50% of patients develop LN after a diagnosis of SLE; majority in the first 5 years1-3 SLE results in organ damage and kidney disease4 LN: A severe organ manifestation of SLE 140 Risk for kidney disease for LN pts ove
Slide 14: High unmet need in treatment of SLE to achieve better disease control
Immunology High unmet need in treatment of SLE to achieve better disease control Increasing use of a "treat-to-target" strategy, which may include using biologics earlier in the disease1 Unmet need in SLE (US survey, n = 106 KOLs)2 Biologics use expected to rise in the future Long-term efficacy 35%
Slide 15: Gazyva: Deeper B-cell depletion key to improved clinical response
Immunology Gazyva: Deeper B-cell depletion key to improved clinical response First glycoengineered type II aCD20 for LN, SLE, MN, INS to directly target B cells, an underlying cause of disease Type II anti-CD20 mAbs binding capabilities result in superior direct cell death B cell depletion vs Rituxa
Slide 16: Gazyva: First type II aCD20 achieving complete renal response in LN
Immunology Gazyva: First type II aCD20 achieving complete renal response in LN Gazyva in LN was approved in US/EU in Q4 2025 Ph III in LN (REGENCY): Primary and key secondary endpoints met Primary Endpoint: CRR at Week 76 Exploratory Analysis: Time to Lupus Nephritis Flare From wk24- wk76 25 23.5% a
Slide 17: Gazyva: First type II aCD20 reducing disease activity in SLE
Immunology Gazyva: First type II aCD20 reducing disease activity in SLE Gazyva in SLE was filed in the US and EU in Q1 2026 Ph III in SLE (ALLEGORY): Primary and key secondary endpoints met PH III ALLEGORY trial design SLE disease activity: Adjusted treatment difference (%p) Experimental arm Primary
Slide 18: Gazyva: Best in disease potential for MN and childhood onset INS
Immunology Gazyva: Best in disease potential for MN and childhood onset INS Two positive Ph III readouts announced, data to be presented, filing expected in 2026 Ph III MAJESTY met primary endpoint, first global Ph III Ph III INShore met primary endpoint, study of a targeted therapy in MN first glob
Slide 19: Multiple B cell depletion approaches for SLE/LN in development
Immunology Multiple B cell depletion approaches for SLE/LN in development Initiating Ph II study for Lunsumio and Ph I study for P-CD19CD20-ALLO1 Bispecifics: Allogeneic CAR-T: Lunsumio (CD20 x CD3) & CD19 x CD3 P-CD19CD20-ALLO1 Minimal B cells detected in spleen at Day 211 Transposon-based CAR in
Slide 20: Positive results for PiaSky in aHUS (COMMUTE-a/p)
Immunology Positive results for PiaSky in aHUS (COMMUTE-a/p) Filing in 2026, innovative recycling technology may allow for monthly, low-dose subcutaneous treatment PiaSky (C5 complement inhibitor) Development program of PiaSky in aHUS Ph III trial design Ph III (COMMUTE-a) in adults Ph III (COMMUTE-
Slide 21: Sefaxersen: First ASO for selective complement suppression in IgAN
Immunology Sefaxersen: First ASO for selective complement suppression in IgAN Convenient monthly dosing with robust Ph II clinical outcomes; Ph III (IMAGINATION) results expected 2026 Sefaxersen (ASO Factor B) Clinical development program in IgAN Alternative complement pathway Early Ph II results3 P
Slide 22: Ph III ALLEGORY Gazyva in systemic lupus erythematosus (SLE)
Ph III ALLEGORY Gazyva in systemic lupus erythematosus (SLE) Richard A. Furie MD, Chief, Division of Rheumatology, Northwell Health, Marilyn and Barry Rubenstein Chair in Rheumatology and Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Slide 23: Efficacy and Safety of Obinutuzumab in Active SLE: Topline Results of ALLEGORY
Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus: Topline Results of the Phase III ALLEGORY Trial Richard A. Furie,1 Maria Dall’Era,2 Edward M. Vital,3 Jay P. Garg,4 Adolfina E. Zuta Santillán,5 Mittermayer B. Santiago,6 Stella Botha,7 Piotr Leszczyński,8 Viviane Angelina d
Slide 24: Disclosures
Disclosures This study was funded by F. Hoffmann-La Roche Ltd. Editorial assistance was provided by Nucleus Global and funded by F. Hoffmann-La Roche Ltd. • R.A. Furie has received research support and consulting fees from Chugai Pharmaceutical Co., Ltd., F. Hoffmann-La Roche Ltd, Genentech, Inc. an
Slide 25: Background
Background • Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease, with women of reproductive age most commonly affected1 • Abnormalities in B cells caused by breaches in central and peripheral tolerance play a pivotal role in the pathogenesis of SLE2,3 • Obinutuzumab is a rec
Slide 26: Obinutuzumab Mechanism of Action
Obinutuzumab Mechanism of Action NK, natural killer. aCompared with type I anti-CD20 antibodies. 26
Slide 27: ALLEGORY Phase III Trial Design
ALLEGORY Phase III Trial Design Obinutuzumab (n=151) Primary Endpoint Open-label treatmenta SLE Responder Index 4 (SRI-4) at Week 52 Key Secondary Endpoints Screening R • British Isles Lupus Assessment Group Methylprednisolone 80 mg IV (≤28 days) 1:1 (BILAG)-based Composite Lupus Assessment (BICLA)
Slide 28: Baseline Demographic and Clinical Characteristics
Baseline Demographic and Clinical Characteristics Obinutuzumaba Placeboa (n=151) (n=152) Mean age (SD), years 41.1 (12.3) 41.4 (12.6) Female sex, n (%) 139 (92.1) 135 (88.8) Hispanic or Latino ethnic group,b n (%) 75 (49.7) 86 (56.6) SLE Disease Activity Index 2000 (SLEDAI-2K) Mean global score (SD)
Slide 29: Primary Endpoint: SRI-4 at Week 52
Primary Endpoint: SRI-4 at Week 52 Adjusted Treatment Differenceb (Percentage Points) Primary Endpoint: 23.1 (95% CI, 12.5 to 33.6) SRI-4 at Week 52 P<0.001 Defined as all of the following: • ≥4-point reduction in SLEDAI-2K score from baseline • No new BILAG A or >1 new BILAG B domain score compared
Slide 30: Secondary Endpoints
Secondary Endpoints Response, % (95% CI) Adjusted Treatment Differenceb Obinutuzumabb Placebob (Percentage Points) P-valuec (n=151) (n=152) or Hazard Ratio (95% CI) Key Secondary Endpointsa BICLA at Week 52d 62.0 (54.2 to 69.8) 40.1 (32.1 to 48.1) 21.9 (10.8 to 32.9) <0.001 Glucocorticoid reduction
Slide 31: Time to First BILAG Flare
Time to First BILAG (1A or 2B) Flare Flare: Occurrence of ≥1 new BILAG A or ≥2 new BILAG B manifestations from the previous visit 100 Obinutuzumab Percentage of Patients Who Have Placebo Not Experienced BILAG Flare Censored 90 80 70 60 HR, 0.58 95% CI, 0.4 to 0.8 50 P=0.002 0 4 8 12 16 20 24 28 32 3
Slide 32: SLEDAI-2K Scores Over Time
SLEDAI-2K Scores Over Time Obinutuzumab (n=151) Placebo (n=152) 12 Average Observed SLEDAI–2K Score 9 6 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time (weeks) Patients, n Obinutuzumab 151 146 146 145 146 146 139 139 139 144 144 141 140 143 Placebo 152 150 145 146 141 139 136 128 139 135 134 132 134 132
Slide 33: Additional Secondary Endpoints
Additional Secondary Endpoints DORIS and LLDAS scores, measures of remission and low lupus disease activity state, improved with obinutuzumab DORIS, Definition of Remission in SLE; LLDAS, Lupus Low Disease Activity State; PGA-VAS, Physician’s Global Assessment-Visual Analogue Scale; SLEDAI-2K, Syste
Slide 34: B-cell Depletion in Peripheral Blood
B-cell Depletion in Peripheral Blood Peripheral B-cell depletion with obinutuzumab to <10 cells/μL occurred more frequently and was more sustained than with rituximab in EXPLORER aPlus standard therapy in the ALLEGORY trial. B-cell depletion was defined an absolute CD19-positive B-cell count lower t
Slide 35: Safety
Safety AEs Through Week 52 in the Safety Population Obinutuzumab Placebo Patients (n=151) (n=151) Any AE, n (%) 134 (88.7) 123 (81.5) [Total events] [568] [468] Any serious AE, n (%) 24 (15.9) 18 (11.9) Deaths, n (%) 1 (0.7) 3 (2.0) AE leading to trial withdrawal, n (%) 1 (0.7) 2 (1.3) AEs, n (%) No
Slide 36: Conclusions
Conclusions • Obinutuzumab plus standard therapy was superior to placebo (standard therapy alone) in achieving the primary and all five key secondary endpoints • Robust B-cell depletion by obinutuzumab may have contributed to the enhanced clinical responses • No new safety signals were identified •
Slide 37: We thank all study participants and investigators
We thank all study participants and their families as well as the study investigators and their staff.
Slide 38: Results published in the New England Journal of Medicine
Results published in the New England Journal of Medicine! NEJM Article Oral Presentation To access the article, scan To access this presentation, the QR code scan the QR code or go to the following URL: https://go.roche.link/wkyona
Slide 39: Appendix
APPENDIX
Slide 40: ALLEGORY Phase III Trial Design
ALLEGORY Phase III Trial Design Obinutuzumab (n=151) Open-label treatment Study follow-up 56 ≥12 months Screening R Week 54 56 78 104 (≤28 days) 1:1 Placebo (n=152) Study OPEN-LABEL TREATMENT follow-up SLE therapies managed at ≥12 months investigator’s discretion Week 0 2 24 26 52 SCREENING WEEK 0 t
Slide 41: Flares: BILAG Category A and Category 2B
Flares: BILAG Category A and Category 2B Obinutuzumaba Placeboa Total Patients with flares, n (n=51) (n=74) (n=125) Category A 32 41 73 Category B 12 14 26 Intercurrent eventsb (classified as flare) 7 19 26 BILAG, British Isles Lupus Assessment Group. aPlus standard therapy of antimalarial and/or im
Slide 42: Safety: Serious Adverse Events and Deaths
Safety: Serious Adverse Events and Deaths • The most frequent serious adverse events observed among obinutuzumab-treated patients (>1%) were: − Pneumonia (2.0%) − Upper respiratory tract infection (1.3%) − Urinary tract infection (1.3%) − Infusion-related reactions (1.3%) • The most frequent serious