Roivant Sciences (ROIV) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Mosliciguat clinical data and market potential

• Mosliciguat showed the deepest-ever PVR reduction in pulmonary hypertension studies, with strong concordance between hemodynamic and clinical endpoints.

• The positive data has broadened consideration for additional indications beyond PH-ILD, including IPF and PAH.

• The PH-ILD market is estimated at 30,000–100,000 U.S. patients, with potential for further expansion as new therapies enter.

• Phase III planning for mosliciguat began six months ago, and patient enrollment is now underway.

• Intellectual property protection for mosliciguat extends into the mid-2040s, supporting a long-term development strategy.

Brepocitinib launch and growth strategy

• Early physician feedback on brepocitinib's launch in dermatomyositis (DM) is positive, with expectations for a slow and steady uptake.

• High unmet need in DM and strong clinical data are driving enthusiasm among doctors and patients.

• Access is managed patient-by-patient, with support programs in place to facilitate drug initiation and coverage.

• Brepocitinib's dual JAK1/TYK2 inhibition differentiates it from generic JAK inhibitors, with physicians valuing its on-label status and robust data.

• Market estimates for brepocitinib in DM range from $2–4 billion, with potential for multiple indications to drive significant franchise value.

Pipeline catalysts and regulatory outlook

• Upcoming data for brepocitinib in non-infectious uveitis (NIU) is seen as a major catalyst, with commercial success likely if statistical significance is achieved.

• The FcRN program (IMVT-1402) in difficult-to-treat RA is progressing, with future studies planned regardless of part two results due to strong initial efficacy.

• Regulatory strategy for FcRN in RA will depend on FDA feedback, with potential for large market impact in multi-mechanism failure populations.

• Graves' disease studies are underway, with first readouts expected before 2027; the approach targets autoantibodies, and study design is a key risk factor.

• The company maintains flexibility to adjust study designs as data emerges, aiming to maximize value and minimize risk.