Roivant Sciences Ltd. Q1 FY2025 earnings call

Key managerial messages include: Progress with IMVT-1402 and Immunovant, with etokimab data and ongoing clinical execution for various indications. Registrational data from brepocitinib is imminent, with the pivotal trial for dermatomyositis (DM) having completed last patient last visit, and data expected in the second half. Updates on LNP litigation with Moderna and Pfizer, including pretrial processes and upcoming trial in March 2026. Completion of the $1.5 billion share repurchase program, with Board authorizing an additional $500 million. Pipeline progress includes brepocitinib in multiple indications, IMVT-1402 in Grave's disease study, and continued advancements across the portfolio.

Brepocitinib registrational data expected in the second half. Board authorized an additional $500 million share repurchase program. Guidance on cash utilization and spend for R&D and G&A, with confidence in hitting time lines and cash guidance.

Risks related to LNP litigation, including summary judgment motions and potential liability issues. Risks associated with clinical trial outcomes, such as potential imbalances in steroid doses affecting endpoints.

Q: Talk about data from brepocitinib top line, filing timeline, and gating factors.

A: Expect top line soon, filing in early next year, with normal NDA prep activities being the main gating factors.

Q: Rationale for lower dose in second Grave's trial.

A: To ensure FDA approval with a minimally efficacious dose, advocating for it with the FDA.

Q: Flare definition, steroid rescue treatment, impact of steroid taper.

A: Managed patients carefully, steroid taper is a precautionary measure to maximize trial opportunity, and the 40% steroid elimination is a blinded pool number.

Q: Context around Graves remission data, BD outlook.

A: Meaningful remission is practice changing for Grave's patients, and BD remains opportunistic with a strong balance sheet.

Q: Flare treatment, BD in China.

A: Rescue therapy is managed consistently, and Roivant is agnostic in BD, noting China has high-quality assets.

Q: Efficacy bar for brepocitinib in DM, leverage of batoklimab data.

A: The bar is a statistical trial, and batoklimab data informs Grave's disease development.

Q: Steroid taper goal, expectations for 15mg dose.

A: Goal to get patients off steroids by week 36, focused on the 30mg dose for brepocitinib.

Q: Enrollment update for 1402 studies, spend rate.

A: Enrollment for 1402 studies is on track, with spend stable and cash guidance maintained.

Q: Expectations for Graves ATA data, importance.

A: Hopes to highlight transformative impact on Grave's patients, changing their treatment paradigm.

Q: Roadmap for brepocitinib in NIU, filing year.

A: Data for NIU expected in first half 2027, with an SNDA filing shortly after.

Q: Informative value of peficitinib prior data.

A: Comforting but Phase III data is needed for approval determination.

Q: Navigating competitive market for brepocitinib, launch preparations.

A: Being first is helpful, with active engagement with the physician community in launch preparations.