Roivant Sciences (ROIV) investor relations material

Key clinical progress and data highlights

• Achieved significant milestones in 2025, with transformative progress across two main programs, including FCRN and brepocitinib franchises.

• FCRN franchise showed deep IgG suppression and clinical benefit in myasthenia gravis, CIDP, and clinical remission in Graves' disease.

• Brepocitinib demonstrated extraordinary benefit in dermatomyositis, hitting all primary and secondary endpoints, and is on a path to registration.

• Phase II data in non-infectious uveitis (NIU) showed a treatment failure rate under 30%, outperforming HUMIRA.

• Multiple studies in FCRN, brepocitinib, and mosliciguat are set to read out in 2026, including proof-of-concept and phase II/III trials.

Market opportunity and launch strategy

• Brepocitinib targets an orphan disease market with 40,000–70,000 treated patients and will be priced at an orphan rare disease price point.

• Launch expected to be gradual, with significant opportunity at peak penetration and a need for physician education and market access work.

• High physician enthusiasm for brepocitinib, with expectations for broad adoption, especially among severe and refractory dermatomyositis patients.

• Familiarity with JAK inhibitors among specialists is expected to support adoption, with brepocitinib offering an on-label alternative.

• Additional indications for brepocitinib are being pursued, including cutaneous sarcoid and NIU, with further expansion into orphan inflammatory diseases.

Pipeline catalysts and investor perspectives

• 2026 catalysts include readouts in cutaneous sarcoid, CLE, rheumatoid arthritis, and PH-ILD, as well as a Moderna litigation jury trial.

• Mosliciguat for PH-ILD is seen as a major underappreciated opportunity, with phase II-B data expected to be transformative.

• PH-ILD market is large and well-understood, with inhaled vasodilators like mosliciguat positioned to address significant unmet need.

• Open-label RA study for FCRN aims to identify signal in difficult-to-treat, autoantibody-positive patients, with high bar for moving to phase III.

• Investors currently focus on front-line indications, but management sees significant upside in less-appreciated pipeline assets.