Roivant Sciences (ROIV) investor relations material

Business model evolution and core competencies

• Maintains a portfolio model with each program in its own company, enabling strong execution and asset selection.

• Improved clinical development and execution capabilities over the past five to six years.

• Focused on launching a late-stage drug within the next 12 to 18 months.

Commercialization and launch strategy

• Brepocitinib, a dual JAK1/TYK2 inhibitor, is the lead asset with a PDUFA date in September 2026 for dermatomyositis.

• Plans to cover all major academic referral centers with a field force in the tens, leveraging relationships from clinical trials.

• Pricing expected between $200,000 and $600,000 annually, referencing IVIG and fcarotimod as benchmarks.

• Peak penetration not expected to be high; even 30% would be significant due to the rare disease market size.

Pipeline and indication expansion

• Brepocitinib is in development for three additional indications: non-infectious uveitis, cutaneous sarcoidosis, and lichen planopilaris.

• Non-infectious uveitis phase III data expected in the second half of the year; cutaneous sarcoidosis pivotal study starting; lichen planopilaris in phase II/III.

• Each indication targets orphan inflammatory diseases with limited treatment options.