Roche (ROG) Status Update summary

Ophthalmology franchise performance and market trends

• Sales in Q1 reached CHF 0.9 billion, up 58% year-over-year, driven by Vabysmo.

• Retinal diseases are the fastest-growing segment in ophthalmology, with the global retina market exceeding $15 billion and increasing due to aging and diabetes prevalence.

• Vabysmo is approved in 98 countries, reimbursed in 35, with strong market share growth in AMD, DME, and RVO, and over 40% share among treatment-naïve patients in the US.

• Susvimo's US relaunch has generated strong interest, with ongoing commercial rollout and ex-US approvals expected in 2025+.

• Vabysmo’s flexible dosing and strong real-world data support its rapid adoption and extended treatment intervals.

Clinical and real-world data updates

• RHONE-X four-year data for Vabysmo in DME shows >90% absence of DME and robust vision/CST improvements, with ~80% on ≥Q12W dosing.

• Faricimab (Vabysmo) demonstrated a favorable safety profile over four years, consistent with parent trials.

• TRUCKEE real-world study confirms Vabysmo's efficacy and safety in both naive and previously treated patients, with significant reductions in retinal fluid and extended treatment intervals.

• SUMMIT study shows Susvimo maintains visual acuity and CST over one year, with a mean refill duration of 8.6 months and no cases of endophthalmitis.

• Safety data from both studies align with clinical trials, with low rates of adverse events.

Pipeline and innovation

• Roche’s ophthalmology pipeline includes next-generation bispecifics (DutaFabs), cell and gene therapies, and new indications such as UME, GA, and TED.

• Vamicibart (IL-6) in phase 3 for UME and phase 2/3 for DME; Enspryng (satralizumab) in phase 3 for thyroid eye disease.

• OpRegen allogeneic cell therapy in phase 2 for geographic atrophy, showing potential for structural and functional improvement at 24 months.

• Port delivery platform expanding with new molecules, including zifibancimig (Dutafab/VEGF-Ang2 bispecific), in clinical development.

• Nine positive phase 3 readouts have enabled robust commercial and R&D execution.