Slide 1: Roche
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: ASRS 2024 Virtual IR Event
ASRS 2024 Virtual IR Event July 23 2024
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 Ophthalmology pipeline Christopher Brittain, Global Head of Ophthalmology, Product Development RHONE-X - Vabysmo 4 year follow-up data in DME TRU
Slide 6: Roche establishing leadership in Ophthalmology
Ophthalmology Roche establishing leadership in Ophthalmology Susvimo relaunch in the US has generated excitement among patients and physicians Q1 2024 sales (YoY CER growth) Vabysmo: • Approved in 98 countries, reimbursed in 35 countries (including EU5) • US market share* reached 27% in nAMD, 19% in
Slide 7: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Intense news flow remaining in 2024; ASO factor B discontinued in GA, Ph III (IMAGINATION) in IgAN continues Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC Final Ph III data H2 2024 Total solution for clinical ma
Slide 8: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts CVM/EASD Pharma Day Neurology/CTAD Digitalization Day Sep 13 Sep 30 Oct/Nov Nov/Dec • Key data presented at EASD: • Group & Pharma strategy • Key data presented at CTAD: • Roche digital efforts in Pharma • CT-388 (Ph I cohort 11 & 12
Slide 9: Ophthalmology franchise update
Ophthalmology franchise update Nilesh Mehta Franchise Head Ophthalmology, Global Product Strategy
Slide 10: Retinal diseases are the fastest growing segment of the ophthalmology market
Retinal diseases are the fastest growing segment of the ophthalmology market Ophthalmology market1 Global retina market >15 bn USD and growing1 Total Market (2023) ~$24 Billion 20 Global Sales USD bn nAMD, DME, RVO 15 14% 3% Glaucoma 10 9% Dry Eye 10% 64% 5 Ocular inflammation/infections 0 Others 20
Slide 11: Optimal outcomes need longer treatment intervals and improved anatomic control
Optimal outcomes can be further achieved with longer treatment intervals and improved anatomic control Infrequent dosing with aVEGF monotherapy Drying and longer treatment intervals are the most correlates with poor vision gains in real-world1 important drivers in retinal disease for HCPs2 Drivers f
Slide 12: Vabysmo and Susvimo offer options for optimal vision with fewer treatments
Vabysmo and Susvimo offer options for patients to achieve optimal vision improvements with fewer treatments First and only dual-pathway inhibition in retina, First and only continuous drug delivery treatment** targeting VEGF-A and Ang-2 as an alternative to regular IVT injections nAMD DME nAMD & DME
Slide 13: Vabysmo: Benefits of dual pathway supported by anatomic results
Vabysmo: Benefits of dual pathway supported by anatomic results Comprehensive disease control and extended durability Elevated VEGF-A Elevated Ang-2 leading to Vascular Instability Effects of elevated Primary Effects Primary Effects VEGF-A and Ang-2 on vasculature Neovascularization Vascular Leakage
Slide 14: Vabysmo vs. aflibercept: Indirect analysis of CST reductions
Vabysmo vs. aflibercept: Indirect analysis of CST reductions1 CST improvements vs aflibercept 2mg and 8mg after the monthly loading phase (week 12) favor Vabysmo Comparative efficacy of Vabysmo: A Systematic Literature Review and Network Meta-Analysis1 Mean difference in CST change from baseline for
Slide 15: Vabysmo: Continued strong growth momentum
Vabysmo: Continued strong growth momentum Pre-filled syringe approved by FDA and will become available in the coming months US patient share continues to expand in nAMD, DME, and RVO* Vabysmo performance update • Approved in 98 countries, reimbursed in 35 nAMD DME RVO countries (including EU5) 60% 6
Slide 16: Vabysmo: RWD reflects clinical trials in treatment durability
Vabysmo: RWD reflects clinical trials in treatment durability TENAYA/LUCERNE pooled analysis1 Independent UK Real-World Data2,3 ~80% of faricimab treatment-naïve patients ~75% of faricimab treatment-naïve patients achieved achieve extended intervals by year 1 extended intervals in the real world Yea
Slide 17: Susvimo: Blockbuster potential with relaunch ongoing
Susvimo: Blockbuster potential with relaunch ongoing The first and only approved nAMD treatment shown to maintain vision with x2 treatments/yr in the vast majority of patients Stronger vision outcomes nAMD relaunch in the US with potential for extended ≥Q6M dosing • FDA has approved updates to the S
Slide 18: Susvimo in DME and DR: Efficacy maintained at year 2
Susvimo in DME and DR: Efficacy maintained at year 2 DME and DR filed with FDA; approval expected in Q1 2025 Ph III (PAGODA) in DME1 Ph III (PAVILION) in DR2 Change in BCVA Over 112 Weeks ≥2-Step DRSS Improvement Over 100 Weeks PDS Q24W (n=381) PDS Q36Wb (n=106) Patients With ≥ 2-Step Improvement Fr
Slide 19: Ophthalmology pipeline
Ophthalmology pipeline Christopher Brittain Senior Vice President and Global Head of Ophthalmology, Product Development
Slide 20: Aiming to alter the trajectory of vision loss
Ophthalmology pipeline Aiming to alter the trajectory of vision loss as experienced today 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
Slide 21: Ophthalmology R&D focus areas
Ophthalmology R&D focus areas Improving patient outcomes and reducing treatment burden Extended durability, Novel MOAs, Digital capabilities and PHC Future technologies New Indications Long acting delivery Novel MOAs Biomarker and data analytics • Port Delivery Platform • Vabysmo first dual pathway
Slide 22: Ophthalmology pipeline gaining momentum
Ophthalmology pipeline gaining momentum Further improving the standard of care and expanding in new indications Phase I Phase II Phase III Registration NME vamikibart vamikibart Susvimo RG6351 RG6179 RG6179 UME RG6321 Retinal disease DME DME NME OpRegen1 Enspryng Susvimo RG6209 RG6501 RG6168 TED RG6
Slide 23: Vamikibart in UME and DME
Vamikibart in UME and DME Addressing the inflammatory component (IL-6) in macular edema IL-6 is involved in many pathways, including Ph I (DOVETAIL) data in UME: Improved vision and retinal inflammation thickness in all dosing cohort 1 Change from baseline in BCVA Patients with absense of retinal fl
Slide 24: Enspryng in thyroid eye disease
Enspryng in thyroid eye disease Potential to be the first SC therapy in TED with a well-established safety profile IL-6 and IL-6R play a key role in the pathogenesis of thyroid eye disease1 Clinical evidence supports IL-6 signaling inhibition in TED3 TED disease progression In TED, IL-6 expression c
Slide 25: OpRegen in GA: Replenishing the retinal pigment epithelium
OpRegen in GA: Replenishing the retinal pigment epithelium Potential to slow, stop, or reverse GA disease progression Ph I/IIa data: Visual function and retinal structure improvements Potential to counteract RPE loss in GA sustained through month 241-2 OpRegen subretinal Retina treated with Cohort 4
Slide 26: Continuing to innovate on Port Delivery Platform
Continuing to innovate on Port Delivery Platform Ph I/II (BURGUNDY) zifibancimig (VEGF-Ang-2 DutaFab) in nAMD ongoing, data expected 2026 Port Delivery Platform DutaFabs: Next generation bispecifics compatible with Port Delivery Platform, designed for increased durability DutaFab bispecific Fab High
Slide 27: RHONE-X, TRUCKEE and SUMMIT data
RHONE-X - Vabysmo 4 year follow-up data in DME TRUCKEE - Vabysmo updated real-world data in nAMD SUMMIT - Susvimo real-world data in nAMD Arshad M. Khanani MD, MA, FASRS Retina Specialist and Clinical Investigator
Slide 28: Four-year outcomes of faricimab in DME: RHONE-X
FOUR-YEAR OUTCOMES OF FARICIMAB IN DME: FIRST TIME SAFETY AND EFFICACY RESULTS FROM THE RHONE-X LONG-TERM EXTENSION TRIAL Arshad M Khanani, MD, MA, FASRS Sierra Eye Associates, Reno, NV Aachal Kotecha, PhD; Emma Harrell, BSc; Francis Abreu, PhD; Yannan Tang, PhD; Jeffrey Willis, MD, PhD; Dawn A. Sim
Slide 29: Methods: RHONE-X extension trial design
METHODS: RHONE-X Extension Trial Assessed the Long- Term Safety and Efficacy of Faricimab Treat & Extend in Patients With DME Phase 3, multicenter, open-label, long-term extension trial Faricimab treat & extend in RHONE-X • Patients with DME who completed either the YOSEMITE or RHINE • Patients in R
Slide 30: Results: Vision and CST improvements maintained in RHONE-X
RESULTS: Robust Vision and CST Improvements Were Maintained in RHONE-X With >90% of Patients Achieving Absence of DME (CST< 325 µm) with Faricimab up to Q16W by End of Study Safety: Faricimab was well tolerated through years 3 and 4 of RHONE-X with the nature of AEs consistent with the YOSEMITE/RHIN
Slide 31: Discussion: Long-term safety and efficacy outcomes in DME
DISCUSSION: Long-term Safety and Efficacy Outcomes in DME With Faricimab ► RHONE-X is the largest DME long-term extension study to date and had excellent patient retention (81.7%) ► Faricimab was well tolerated with a safety profile that was consistent with the YOSEMITE/RHINE parent trials ► BCVA an
Slide 32: Backup: Faricimab well tolerated through years 3 and 4 of RHONE-X
Backup: Faricimab Was Well Tolerated Through Years 3 and 4 of RHONE-X With the Nature of AEs Consistent With the YOSEMITE/RHINE Parent Trials Faricimab T&E Faricimab T&E Faricimab T&E (prior Q8W) (prior aflibercept) AEs Through Study End, Patients With ≥ 1 AE, n (%)a n = 491 n = 500 n = 473 Ocular A
Slide 33: Real-world efficacy and safety of faricimab in nAMD: TRUCKEE 2-year results
The Real-World Efficacy Co-Authors: Aamir A. Aziz, MSIII; Hannah and Safety of Faricimab Khan, MPH; Ashkan M. Abbey, MD; Robert L. Avery, MD; Himanshu K. Banda, MD; in Neovascular Age- Mark R. Barakat, MD; Ramanath Bhandari, MD; Emmanuel Y. Chang, MD, PhD; Giulia Related Macular Corradetti, MD; Carl
Slide 34: TRUCKEE and SUMMIT are clinician-directed studies with no industry sponsor
The TRUCKEE and SUMMIT Studies are a collaborative clinician directed and organized study with no industry sponsor across multiple sites in the US.
Slide 35: TRUCKEE Study: Design
TRUCKEE Study: Design Evaluating efficacy and safety of faricimab in real- world patients with nAMD Target Patient Population • Treatment-naïve AND previously-treated patients Ongoing Data Collection • Demographics • Prior treatment history • Efficacy (vision, central subfield thickness, retinal flu
Slide 36: TRUCKEE Results: Demographics
TRUCKEE Results: Demographics Population (N = 2756 patients, 3412 eyes) Variable Mean Range Age (years) 80.24 47 - 100 Variable Groups N (%) Gender (patients) Female 1521 (55.2%) Male 1087 (39.4%) Not Reported 148 (5.4%) Last anti-VEGF Aflibercept 1461 (42.8%) injection (eyes) Bevacizumab 391 (11.5%
Slide 37: Efficacy after three injections of faricimab in all-switched patients
Efficacy After Three Injections of Faricimab in All- Switched Patients Population with Follow-up (N = 1735 eyes) Previous Interval: 45.5 days Current Interval: 54.5 days Increase in interval post-faricimab: + 9.0 days Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (letters)*
Slide 38: Efficacy after three injections in aflibercept-switched patients
Efficacy After Three Injections of Faricimab in Aflibercept-Switched Patients Population with Follow-up (N = 1005 eyes) Previous Interval: 44.4 days Current Interval: 52.8 days Increase in interval post-faricimab: + 8.4 days Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (let
Slide 39: Efficacy after three injections in treatment-naïve patients
Efficacy After Three Injections of Faricimab in Treatment-Naïve Patients Population with Follow-up (N = 186 eyes) Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (letters)* 60.02 (0.13) 62.78 (0.12) +2.76 letters 0.003 CST (μM) 381.83 (0.87) 297.85 (0.75) -83.98 μM < 0.0001 PE
Slide 40: Resolution of fluid after three injections of faricimab
Resolution of Fluid After Three Injections of Faricimab 900 500 100 450 90 NUMBER OF PATIENTS WITH FLUID NUMBER OF PATIENTS WITH FLUID NUMBER OF PATIENTS WITH FLUID 800 94 90 773 400 431 80 700 -29.4% 350 70 600 -30.6% 300 60 -44.4% 500 541 -23.7% 546 298 -25.2% 298 250 50 400 50 413 200 223 40 -66.
Slide 41: Efficacy after six injections in all-switched patients
Efficacy After Six Injections of Faricimab in All- Switched Patients Population with Follow-up (N = 771 eyes) Previous Interval: 43.9 days Current Interval: 56.5 days Increase in interval post-faricimab: + 12.6 days Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (letters)* 60
Slide 42: Efficacy after six injections in aflibercept-switched patients
Efficacy After Six Injections of Faricimab in Aflibercept-Switched Patients Population with Follow-up (N = 448 eyes) Previous Interval: 42.0 days Current Interval: 57.4 days Increase in interval post-faricimab: + 15.4 days Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (lette
Slide 43: Efficacy after six injections in treatment-naïve patients
Efficacy After Six Injections of Faricimab in Treatment-Naïve Patients Population with Follow-up (N = 90 eyes) Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (letters)* 60.13 (0.24) 63.35 (1.94) +3.22 letters 0.001 CST (μM) 395.50 (1.80) 302.34 (1.78) -93.16 μM < 0.0001 PED H
Slide 44: Resolution of fluid after six injections of faricimab
Resolution of Fluid After Six Injections of Faricimab 450 250 60 NUMBER OF PATIENTS WITH FLUID NUMBER OF PATIENTS WITH FLUID NUMBER OF PATIENTS WITH FLUID 400 231 403 50 54 53 350 200 -31.2% -29.0% 300 40 298 150 168 164 -27.5% 275 -26.2% 250 30 -57.4% -54.7% 200 216 124 100 150 20 23 24 100 50 10 5
Slide 45: Efficacy after nine injections in all-switched patients
Efficacy After Nine Injections of Faricimab in All- Switched Patients Population with Follow-up (N = 349 eyes) Previous Interval: 40.4 days Current Interval: 52.6 days Increase in interval post-faricimab: + 12.2 days Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (letters)* 6
Slide 46: Efficacy after nine injections in aflibercept-switched patients
Efficacy After Nine Injections of Faricimab in Aflibercept-Switched Patients Population with Follow-up (N = 224 eyes) Previous Interval: 39.0 days Current Interval: 55.4 days Increase in interval post-faricimab: + 16.4 days Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (lett
Slide 47: Efficacy after nine injections in treatment-naïve patients
Efficacy After Nine Injections of Faricimab in Treatment-Naïve Patients Population with Follow-up (N = 28 eyes) Baseline Follow-Up Change P-Value Variable Mean (SEM) Mean (SEM) ETDRS (letters)* 54.71 (0.87) 63.63 (0.89) +8.92 letters 0.031 CST (μM) 428.73 (5.28) 309.81 (7.35) -118.92 μM 0.002 PED He
Slide 48: Resolution of fluid after nine injections of faricimab
Resolution of Fluid After Nine Injections of Faricimab 200 140 20 180 18 NUMBER OF PATIENTS WITH FLUID NUMBER OF PATIENTS WITH FLUID NUMBER OF PATIENTS WITH FLUID 185 120 18 160 119 16 17 157 100 140 14 -40.0% -31.2% 120 91 -39.5% 12 80 -47.1% -30.8% 100 108 111 10 72 60 80 63 8 9 -66.7% 60 40 6 6 4
Slide 49: TRUCKEE: Fluid quantification sub-study
TRUCKEE: Fluid Quantification Sub-study • Spectralis OCT scans acquired during treatment visit were quantified SRF • Notal OCT Analyzer (NOA)1 is being used for fluid quantification • NOA provides separate IRF quantification of IRF and SRF 1Keenan, Tiarnan DL, et al. "Retinal specialist versus artif
Slide 50: Fluid quantification in eyes with >5 injections
Fluid Quantification in Eyes with >5 Injections PARAMETERS All Eyes Prior Aflibercept Naïve Total number of eyes 181 122 13 Mean time between 35.2 days 37.6 days N/A last treatment and 1st faricimab Mean time between 4th 52.0 days 51.0 days 72.0 days and 5th faricimab Mean change in fluid -120.1 nL
Slide 51: Total fluid reductions over five treatments
Total Fluid Reductions over Five Treatments Total retinal fluid volume reduction in both all eyes and aflibercept-switched patients, demonstrating significant decreases in volume and increases in treatment interval after sustained treatments.
Slide 52: Total fluid reductions over five treatments
Total Fluid Reductions over Five Treatments Total retinal fluid volume n=13 reduction in treatment-naïve patients, demonstrating significant decreases in total fluid after multiple treatments.
Slide 53: Safety outcomes
Safety No cases of retinal vasculitis or retinal artery occlusion have been observed. Outcomes Event Number of Cases Resolved VA Returned to Baseline Retreated with Faricimab Infectious Endophthalm 4 4/4 4/4 4/4 • Number of Patients: 2756 itis 2* • Number of Eyes: 3412 Anterior *One case had Chamber
Slide 54: Conclusions
• In a real-world setting, with 3412 eyes injected, faricimab continues to demonstrate rapid improvement in all anatomic parameters in both treatment naïve and previously-treated patients. • Dual-inhibition of Ang-2 and VEGF-A results in significant decrease in retinal fluid volume and extension of
Slide 55: The SUMMIT Study: Real-world ranibizumab Port Delivery System in nAMD
The SUMMIT Study Real World Efficacy and Safety of the Ranibizumab Port- Delivery System in Neovascular in AMD Arshad M. Khanani, MD, MA, FASRS Hannah Khan, MPH; Aamir A. Aziz, BS; Humza Sulahria, BS; Huma Khan, BS; Sean Nguyen, BS; Anam Akhlaq, MD; Fawad Razai, BS; Greggory Gahn, MD ; David Almeida
Slide 56: SUMMIT Study: Design
SUMMIT Study: Design Real World Efficacy and Safety of the Ranibizumab Port-Delivery System in Neovascular in AMD Target Patient Population • Patients following nAMD diagnosis with response to at least two anti-VEGF intravitreal injections Ongoing Data Collection • Demographics • Prior treatment his
Slide 57: Results: Demographics
Results: Demographics Population (N = 46 patients) Variable Mean Range Age (years) 79.7 59 - 91 Variable Groups N (%) Gender (patients) Female 28 (60.8%) Male 18 (39.2%)
Slide 58: ETDRS changes over time
ETDRS Changes Over Time Vision Maintenance Over 1 Year of Follow-Up ETDRS Changes Over Time 70 N=46 N=41 N=40 N=39 N=42 N=37 N=36 60 N=42 N=43 50 ETDRS Letters N=46 40 30 20 10 0 Baseline Day 1 Follow-Up 1 Follow-Up 2 Follow-Up 3 Follow-Up 4 Follow-Up 5 Follow-Up 6 Follow-Up 7 Follow-Up 8 (8.6) (42.
Slide 59: CST changes over time
CST Changes Over Time Retinal Thickness Well-Controlled Over 1 Year Follow-Up CST Changes Over Time 350 N=46 N=42 N=42 N=41 N=40 N=37 300 N=43 N=39 N=36 N=46 250 CST Values (𝛍M) 200 150 100 50 0 Baseline Day 1 Follow-Up 1 Follow-Up 2 Follow-Up 3 Follow-Up 4 Follow-Up 5 Follow-Up 6 Follow-Up 7…
Slide 60: Excellent durability: Mean refill duration 8.6 months
Excellent Durability: Mean Refill Duration 8.6 Months Time to Refill Variable Days (SEM) Average Days Until First Refill 258.84 (3.27) Supplemental Injections Supplemental Injections N (%) Description Patient presented with disease activity and was due for a refill-exchange but Aflibercept x1 1/46 (
Slide 61: Safety outcomes
Safety Outcomes Adverse Event Ongoing (N) Resolved (N) Subconjunctival Heme X (4/4) N = 46 Descemet’s Folds X (3/3) C/S Bleb Formation X (3/3) No cases of endophthalmitis Moderate Low IOP X (2/2) Anterior Chamber Cells X (4/4) No cases of conjunctival retraction Retinal Detachment X (1/1) Conjunctiv
Slide 62: Conclusions
• PDS demonstrated excellent vision and CST maintenance over 1 year • Average time to first refill was 8.6 months • Efficacy data from the SUMMIT study is consistent with the data from PDS nAMD trials • 11/46 patients experienced surgery related AEs, all of which Conclusions resolved • No cases of e
Slide 63: Doing now what patients need next
Doing now what patients need next