Roivant Sciences (ROIV) Wells Fargo 21st Annual Healthcare Conference summary

PH-ILD and mosliciguat clinical update

• Phase IIb PHocus trial in PH-ILD showed unprecedented 56% placebo-adjusted improvement in pulmonary vascular resistance and positive functional outcomes, with less cough than placebo and simple once-daily dosing.

• Phase III trial for mosliciguat in PH-ILD is already enrolling, with design similar to phase IIb but allowing some concurrent Tyvaso use to avoid label restrictions; timeline for data readout not yet disclosed.

• Market opportunity estimated at tens to hundreds of thousands of PH-ILD patients in the U.S., with potential for frontline use due to strong efficacy and favorable administration profile.

• Data may support expansion into other pulmonary hypertension indications, including PAH and IPF, given the compelling results.

LISRAYA (brepocitinib) launch in dermatomyositis

• LISRAYA recently approved for dermatomyositis, addressing a severe disease with limited modern treatment options; strong clinical benefit and steroid-sparing effect observed.

• Launch strategy focuses on concentrated specialty clinics, leveraging high physician and patient enthusiasm, with early prescription uptake and robust patient support for access.

• Net sales will be the primary KPI shared for launch progress; early feedback indicates significant potential even without high market penetration.

• Steroid sparing is a major benefit, with data showing patients on LISRAYA can achieve much lower steroid doses than placebo, addressing a key unmet need.

FcRn pipeline and IMVT-1402 development

• Deeper IgG suppression with IMVT-1402 correlates with better clinical benefit across multiple indications, including MG, CIDP, RA, and Graves'.

• Difficult-to-treat RA program targets patients who have failed multiple advanced therapies; phase III planning underway, aiming for a focused late-line population.

• Commercial opportunity in difficult-to-treat RA estimated at 75,000+ eligible patients, with easy access to autoantibody testing and high unmet need.

• CLE proof-of-concept trial is ongoing; strong data could lead to phase III, while broader FcRn applicability is being explored for additional autoimmune indications.