Roche Holding Ltd · SIX:RO
Roche — ASOPRS/AAO 2025 Virtual IR Event
46 slides from Roche's conference presentation, Oct 21, 2025
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: ASOPRS/AAO 2025 Virtual IR Event
ASOPRS/AAO 2025 Virtual IR Event October 21 2025
Slide 4: Welcome
Welcome Bruno Eschli Head of Investor Relations
Slide 5: Agenda
Agenda Welcome Bruno Eschli, Head of Investor Relations Ophthalmology Franchise Update Nilesh Mehta, Franchise Head Ophthalmology, Global Product Strategy Ph III (SANDCAT/MEERKAT) vamikibart in UME Dr. Nisha Acharya Professor and Director, Ocular Inflammatory Disease and Uveitis Clinic, University o
Slide 6: 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 / (US/EU) Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephritis
Slide 7: 2026: Key newsflow outlook
2026: Key newsflow outlook* Compound Indication Milestone Lunsumio + Polivy 2L+ DLBCL US approval giredestrant + everolimus post CDKi ER+/HER2- mBC US/EU filing/ US approval Susvimo nAMD EU approval Regulatory Susvimo DME EU filing vamikibart UME US/EU filing divarasib 2L KRASG12C+ NSCLC Ph III KRAS
Slide 8: Ophthalmology Franchise Update
Ophthalmology Franchise Update Nilesh Mehta Franchise Head Ophthalmology, Global Product Strategy
Slide 9: Ophthalmology strategy highlights
Ophthalmology Ophthalmology strategy highlights Amplify leading position in retina through next generation innovation and expand to Glaucoma and Dry eye End-to-end disease areas RVD (nAMD, DME, RVO, DR) GA, iAMD OUR AMBITION Where we play Breakthrough innovation Product leadership (e.g., Dry eye dis
Slide 10: Ophthalmology: Aiming to alter the trajectory of vision loss
Ophthalmology Ophthalmology: Aiming to alter the trajectory of vision loss Earlier stage disease Later stage disease Improve outcome across all stages of ocular diseases iAMD, nAMD, GA, Retinitis early glaucoma glaucoma pigmentosa Prevention Earlier stage disease: Vision preservation ▪ Supplement cu
Slide 11: Ophthalmology pipeline
Ophthalmology Ophthalmology pipeline Further improving the standard of care and expanding in new indications Phase I Phase II Phase III Data to be presented vamikibart Data to be discussed VEGF x IL6 DutaFab vamikibart at future medical RG6179 RG6209 RG6179 UME with health authorities DME DME congre
Slide 12: Vamikibart: Targeting IL-6 to achieve better visual outcomes
Ophthalmology Vamikibart: Targeting IL-6 to achieve better visual outcomes Ph III (SANDCAT/MEERKAT) results in UME show vision improvement Il-6 is a key pro-inflammatory cytokine Development plan in the pathogenesis of uveitis and retinal diseases Vamikibart Molecule Indication Ph I Ph II Ph III Sta
Slide 13: VEGFxIL6 DutaFab: A next generation bispecific for DME
Ophthalmology VEGFxIL6 DutaFab: A next generation bispecific for DME Ph II (BARDENAS) establishes role of IL-6 inhibition in DME Ph II (BARDENAS): Anti-IL-6 (vamikibart) + anti-VEGF (ranibizumab) Accelerating development of showed superior efficacy in DMEa VEGFxIL6 DutaFab Primary endpoint: Change f
Slide 14: Satralizumab: Potential to be the first SC therapy in TED
Ophthalmology Satralizumab: Potential to be the first SC therapy in TED Ph III (SatraGO-1/2) results show differentiated benefit-risk profile Satralizumab Preclinical studies show that IL-6 signaling contributes to the (Anti-IL-6 receptor mAb) immunopathology of TED IL-6 levels are elevated in peopl
Slide 15: Ph III (SANDCAT/MEERKAT) vamikibart in UME
Ph III (SANDCAT/MEERKAT) vamikibart in UME Dr. Nisha Acharya Professor and Director, Ocular Inflammatory Disease and Uveitis Clinic, University of California, San Francisco
Slide 16: Phase 3 MEERKAT/SANDCAT Trials: Vamikibart in UME
Phase 3 MEERKAT/SANDCAT Trials: Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema (UME) Professor Nisha Acharya, MD, MS Francis I. Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, CA Presented at the American Academy of Ophthalmology
Slide 17: Uveitis is a Leading Cause of Vision Loss
Uveitis is a Leading Cause of Vision Loss Uveitis is inflammation of the uvea, the middle layer of the eye, and adjacent ocular tissues Most cases are non-infectious, with an autoimmune pathogenesis Primarily working age population, but affects all age ranges. Prevalence ~121 per 100,000 in adults1
Slide 18: Uveitic Macular Edema is the Leading Cause of Vision Loss in Uveitis
Uveitic Macular Edema is the Leading Cause of Vision Loss in Patients with Uveitis1 ● Uveitic macular edema (UME) is macular retinal thickening due to fluid accumulation ● Affects around one third of uveitis patients ● Corticosteroids are the mainstay treatment but have safety limitations: ○ Risk of
Slide 19: UME Treatment Landscape
UME Treatment Landscape Local steroid treatment is utilized alone or as an adjunct to systemic therapies Topical steroid drops Intravitreal Steroid Non-steroid strategies injections/implants & Periocular/ Local Suprachoroidal steroid injections ● Limited efficacy ● Anti-VEGF: Off label use is rare,
Slide 20: IL-6 Plays a Key Role in UME Pathogenesis
IL-6 Plays a Key Role in UME Pathogenesis a Presented by Tsui et al at AUS Spring 2025 (DOVETAIL, NCT06771271). ECM, extracellular matrix; IL-6, interleukin-6; Th17, T-helper 17 cell; Treg, regulatory T cell; UME, uveitic macular edema. 1. Yang et al. Int J Mol Sci. 2023;24:4676. 2. Mesquida et al.
Slide 21: Vamikibart Is the First and Only Anti–IL-6 mAb Engineered for IVT Delivery
Vamikibart Is the First and Only Anti–IL-6 mAb Engineered for IVT Delivery 21 a Preliminary data. b Pooled dose data presented by Tsui et al. at AUS Spring 2025 (DOVETAIL, NCT06771271). AH, aqueous humor; Fc, fragment crystallizable; IgG2, immunoglobulin G2 isotype; IL-6, interleukin-6; IVT, intravi
Slide 22: MEERKAT and SANDCAT: Identical Phase 3 Trials in UME
MEERKAT and SANDCAT: Identical Phase 3 Trials in UME 22 MEERKAT (NCT05642312) and SANDCAT (NCT05642325). Rescue/prohibited therapies prior to week 16 handled as nonresponders. BCVA, best-corrected visual acuity; CST, central subfield thickness; D, day; ETDRS, Early Treatment Diabetic Retinopathy Stu
Slide 23: Baseline Patient Demographics Were Balanced Across Treatment Arms
Baseline Patient Demographics Were Balanced Across Treatment Arms 23 a Unless stated. b Includes American Indian or Alaska Native, Black or African American, multiple, not reported, and unknown. SD, standard deviation; Vami, vamikibart.
Slide 24: Baseline Ocular Characteristics Were Balanced Across Treatment Arms
Baseline Ocular Characteristics Were Balanced Across Treatment Arms a Unless stated. b Nonanterior types include intermediate, panuveitis, and posterior. c Inactive: ACC and VH < 1+; active: ACC and/or VH ≥ 1+. ACC, anterior chamber cells; BCVA, best-corrected visual acuity; CST, central subfield 24
Slide 25: Higher Proportion of Patients Receiving Vamikibart Had BCVA Gains
A Higher Proportion of Patients Receiving Vamikibart Had ≥ 15-Letter BCVA Gains 25 Patients are set as nonresponders after the receipt of rescue/prohibited treatment. Analysis was performed using the CMH method stratified by baseline BCVA (≥ 55 ETDRS letters vs ≤ 54 ETDRS letters) and region (North
Slide 26: Rapid and Clinically Meaningful Improvements in BCVA
Rapid and Clinically Meaningful Improvements in BCVA 26 P values vs sham. BCVA, best-corrected visual acuity; CI, confidence interval; D, day; ETDRS, Early Treatment Diabetic Retinopathy Study; MMRM, mixed-model for repeated measures.
Slide 27: Rapid and Clinically Meaningful Improvements in CST
Rapid and Clinically Meaningful Improvements in CST 27 P values vs sham. CI, confidence interval; CST, central subfield thickness; D, day; MMRM, mixed-model for repeated measures.
Slide 28: Low Incidence of Treatment-Related Ocular AEs
Low Incidence of Treatment-Related Ocular AEs 28 AE, adverse event; SAE, serious adverse event; Vami, vamikibart.
Slide 29: Low Rates of Intraocular Inflammation and No Retinal Occlusive Vasculitis
Low Rates of Intraocular Inflammation and No Events of Retinal Occlusive Vasculitis 29 a Protocol-defined selected ocular AEs (prespecified AE groups capturing similar or synonymous terms in single categories). MedDRA Preferred Terms. AE, adverse event; IOI, intraocular inflammation; IOP, intraocula
Slide 30: Vamikibart Offers a Novel Nonsteroid IVT Treatment Option for UME
Vamikibart Offers a Novel Nonsteroid IVT Treatment Option for Patients With UME 30 AE, adverse event; IL-6, interleukin-6; IOI, intraocular inflammation; IVT, intravitreal; UME, uveitic macular edema.
Slide 31: Ph III (SatraGo-1/SatraGo-2) satralizumab in TED
Ph III (SatraGo-1/SatraGo-2) satralizumab in TED César A. Briceño, MD Associate Professor of Ophthalmology, Surgery, and Dermatology, Perelman School of Medicine, University of Pennsylvania
Slide 32: Primary Results of the Phase 3 SatraGO-1 and SatraGO-2 Trials
Primary Results of the Phase 3 SatraGO-1 and SatraGO-2 Trials: Efficacy and Safety of Satralizumab in Thyroid Eye Disease César A. Briceño, MD1 Santiago Ortiz-Perez, MD, FRCOph, PhD2-4 On behalf of all SatraGO investigators 1 Department of Ophthalmology, Scheie Eye Institute, Perelman School of Medi
Slide 33: Unmet Need in Thyroid Eye Disease (TED)
Unmet Need in Thyroid Eye Disease (TED) TED is a complex inflammatory autoimmune disease with limited durable treatment options – Current treatments targeting the IGF-1 pathway are associated with serious adverse events and relapse of disease activity1-3 There is an unmet need for targeted therapi
Slide 34: SatraGO-1 and SatraGO-2: Identically Designed Phase 3 Studies
SatraGO-1 and SatraGO-2: Identically Designed, Phase 3, Randomized, Placebo-Controlled, Multicenter Studies Key Eligibility Criteria Participants With Active + Inactive TED • Age ≥ 18 years with TED diagnosis • SatraGO-1: n = 131 (n = 101 active) • Euthyroid, or mild hypo- or hyperthyroidism • Satra
Slide 35: Baseline Demographics and Clinical Characteristics
Baseline Demographics and Clinical Characteristics Active + Inactive TED SatraGO-1 SatraGO-2 Satralizumab Placebo Satralizumab Placebo Characteristic, n (%)a n = 68 n = 63 n = 64 n = 63 Age, years, mean (SD) 50.8 (11.6) 51.8 (12.3) 46.6 (13.3) 48.5 (13.2) Sex, female 53 (77.9) 39 (61.9) 48 (75.0) 38
Slide 36: Proptosis Response Higher in Participants Receiving Satralizumab
Proptosis Response Was Observed in a Higher Proportion of Participants Receiving Satralizumab Proptosis Response at Week 24 ≥ 2-mm reduction in proptosis in the study eye, without ≥ 2-mm worsening in the fellow eye Active TED Active + Inactive TED 100 Primary endpoint 100 Key secondary endpoint Prop
Slide 37: Satralizumab Improved Proptosis Response Over Time in Active TED
Satralizumab Improved Proptosis Response Over Time in Participants with Active TED Proptosis Response Over Time: Active TED ≥ 2-mm reduction in proptosis in the study eye, without ≥ 2-mm worsening in the fellow eye SatraGO-1 SatraGO-2 100 Satralizumab 100 Satralizumab Placebo Placebo Proportion of P
Slide 38: Satralizumab Improved Proptosis Response Over Time in Active + Inactive TED
Satralizumab Improved Proptosis Response Over Time in Participants with Active + Inactive TED Proptosis Response Over Time: Active + Inactive TED ≥ 2-mm reduction in proptosis in the study eye, without ≥ 2-mm worsening in the fellow eye SatraGO-1 SatraGO-2 100 Satralizumab 100 Satralizumab Placebo P
Slide 39: Diplopia Was Reduced in a Higher Proportion of Satralizumab Participants
Diplopia Was Reduced in a Higher Proportion of Participants Receiving Satralizumab Diplopia Reduction at Week 24 ≥ 1-grade reduction in diplopia Active TED Active + Inactive TED 100 100 Proportion of Participants, % Proportion of Participants, % 80 80 P = 0.0044 P = 0.0164 17/28 P = 0.0646 19/32 60
Slide 40: CAS Was Reduced in a Higher Proportion of Satralizumab Participants
CAS Was Reduced in a Higher Proportion of Participants Receiving Satralizumab CAS Reduction at Week 24 CAS 0 or 1 at Week 24 ≥ 2-point reduction in CAS Noninflammatory or inactive disease Active TED Active TED P = 0.0009 100 100 P = 0.0120 43/48 90 P = 0.0146 P = 0.0042 Proportion of Participants, %
Slide 41: Overall Response Higher in Participants Receiving Satralizumab
Overall Response Was Observed in a Higher Proportion of Participants Receiving Satralizumab Overall Response at Week 24 ≥ 2-point reduction in CAS and ≥ 2-mm reduction in proptosisa Active TED 100 Proportion of Participants, % 80 P = 0.0006 60 P = 0.0031 24/48 22/50 50 40 44 10/49 20 9/51 20 18 0 Sa
Slide 42: Low Incidence of SAEs and Discontinuations, No Serious Infections
Low Incidence of SAEs and Treatment Discontinuations, and No Serious Infections Active + Inactive TED SatraGO-1 SatraGO-2 Participants Experiencing AEs Through Satralizumab Placebo Satralizumab Placebo Week 24, n (%) n = 67 n = 62 n = 64 n = 62 ≥ 1 AE 48 (71.6) 41 (66.1) 48 (75.0) 50 (80.6) AEs with
Slide 43: Low Rates of Most Common AEs (By Preferred Term)
Low Rates of Most Common AEs (By Preferred Term) Active + Inactive TED SatraGO-1 SatraGO-2 Participants Experiencing AEs Through Satralizumab Placebo Satralizumab Placebo Week 24, n (%) n = 67 n = 62 n = 64 n = 62 Nasopharyngitis 7 (10.4) 4 (6.5) 4 (6.2) 7 (11.3) Headache 6 (9.0) 5 (8.1) 6 (9.4) 7 (
Slide 44: In Summary, Satralizumab Was Efficacious and Well Tolerated in TED
In Summary, Satralizumab Was Efficacious and Well Tolerated in Participants With TED Pooled SatraGO-1 and SatraGO-2 Active TED % of Participants Achieving Week 24 Endpoints Satralizumab Placebo P Value Proptosis response 50.9% 26.8% 0.0004 CAS reduction 83.7% 59.0% 0.0001 CAS of 0 or 1 68.4% 43.0% 0
Slide 45: Totality of SatraGO Clinical Data Supports Satralizumab for TED
The Totality of the Clinical Data Collected in the SatraGO Program Supports Satralizumab for the Treatment of Patients With TED Satralizumab showed clinically meaningful improvements across key efficacy endpoints, including proptosis, diplopia, and CAS in active TED The safety profile of satralizuma
Slide 46: Doing now what patients need next
Doing now what patients need next