Roivant Sciences (ROIV) investor relations material

Key milestones and strategic priorities

• Achieved positive phase II results for mosliciguat in PH-ILD and approval of brepocitinib (LISRAYA) in dermatomyositis, with additional clinical readouts expected by year-end.

• Focused on successful commercial launch of LISRAYA, emphasizing a slow and steady approach and prioritizing net sales as the key metric.

• Upcoming phase III data for brepocitinib in non-infectious uveitis could lead to a second registered indication if successful.

• FcRn programs at Immunovant will see updates in CLE and difficult-to-treat RA, with major registration data in myasthenia gravis and Graves' disease expected next year.

• Plans to initiate new studies and expand indications across the portfolio, especially in pulmonary hypertension and other orphan diseases.

Commercial and competitive landscape

• Early launch feedback for LISRAYA in dermatomyositis is positive among key opinion leaders, but it is too early for definitive sales metrics.

• Competitive developments, such as argenx's myositis data, are seen as potentially beneficial, with the belief that increased innovation will expand the market.

• In non-infectious uveitis, strong phase II data positions brepocitinib as a promising option, with commercial opportunity likely in TNF-refractory patients.

• For Graves' disease, the addressable market is estimated at 350,000 uncontrolled patients in the U.S., with significant commercial potential if even a small share is captured.

Clinical development and regulatory strategy

• For difficult-to-treat RA, open-label phase I data for IMVT-1402 was strong, but phase II may be less informative due to study design; regulatory discussions will determine the phase III path.

• CLE is viewed as an optional bet, with a high bar for advancing to phase III; success would open a new opportunity for FcRn, but failure is not seen as a setback.

• In Graves' disease, phase III studies are designed to assess both hormone normalization and drug-free remission, with a focus on patients not adequately controlled by methimazole.

• Deeper IgG suppression with FcRn inhibitors is believed to correlate with better outcomes across multiple autoimmune diseases, with ongoing studies to refine patient selection.