Roivant Sciences Ltd. Q3 FY2025 earnings call

Key Highlights

• Phase II Results: Positive Phase II data for brepocitinib in cutaneous sarcoidosis (CS) with placebo-adjusted almost 22 points delta in CSAMI, 100% of patients on brepo 45mg had 10-point improvement, and safety/tolerability consistent with prior data.
• NDA and Enrollments: NDA for brepo in dermatomyositis filed; Phase IIb study for 1402 D2T RA fully enrolled; Phase II study for mostly in PH-ILD fully enrolled.
• Financing: Immunovant offering completed, securing funds for Graves' launch.
• 2026 Outlook: Busy year ahead with brepo NIU Phase III, Phase III study in brepo and CS, Phase IIb data for mostly in PH-ILD and D2t RA, proof-of-concept data in 1402 and CLE, and jury trial against Moderna starting March 9.
• Financials: R&D expense $165M (adjusted non-GAAP $147M); G&A $175M (adjusted non-GAAP $71M); total non-GAAP net loss $167M; cash $4.5B consolidated.

Forward-Looking Statements

• Phase III study in brepo and CS to commence in 2026.
• Phase IIb data for mostly in PH-ILD and D2t RA expected in second half 2026.
• Proof-of-concept data in 1402 and CLE anticipated in 2026.
• Jury trial against Moderna set to begin March 9, 2026.
• Strong cash position with $4.5B to support operations.

Risks

• Litigation: Uncertainties related to the Moderna jury trial, including Daubert motions and potential outcomes.
• Clinical Trials: Potential erosion of efficacy in larger Phase III trials, and uncertainties in trial design and outcomes.
• Regulatory: Uncertainties in obtaining FDA approvals and favorable regulatory decisions.
• Commercialization: Pricing and market acceptance uncertainties for brepocitinib in various indications.

Q&A Session

• Q: Corinne Johnson asks about further development expansion for brepocitinib and sizing the opportunity set. A: Matthew Gline and Benjamin Zimmer discuss enthusiasm for further development, noting large orphan market opportunity for brepocitinib.
• Q: Dave Risinger asks about CSAMI baseline characteristics and FDA timeline for dermatomyositis (DM). A: Matthew Gline talks about baseline differences in the CS study and potential for priority review for DM.
• Q: Yaron Werber asks about pricing of brepocitinib and Pfizer's ownership. A: Matthew Gline states price not decided yet, discusses minority interest accounting for Pfizer's ownership.
• Q: Brian Cheng asks about Phase III size, dose, and efficacy stability. A: Matthew Gline and Benjamin Zimmer discuss Phase III design considerations and efficacy cushion from Phase II data.
• Q: Anthea (for Dennis Ding) asks about Daubert in Moderna trial and PH-ILD competitive landscape. A: Matthew Gline talks about Daubert motions and potential for sotatercept in PH-ILD.
• Q: Yasmeen Rahimi asks about 1402 study readout and filing. A: Matthew Gline says stay tuned on 1402 data and filing plans, noting high unmet need in RA.
• Q: Prakhar Agrawal asks about market opportunity for brepo in CS and Phase III design. A: Matthew Gline discusses market size and Phase III design considerations, noting CS as a high unmet need indication.
• Q: Samantha Semenkow asks about patient organ involvement in CS study and expansion into other sarcoidosis forms. A: Benjamin Zimmer talks about organ involvement in the CS study and potential expansion of brepocitinib into other sarcoidosis forms.
• Q: Yatin Suneja asks about brepo data deepening and Phase III study size. A: Matthew Gline reiterates Phase III design discussions with FDA, emphasizing need to align with regulatory input.
• Q: Douglas Tsao asks about breadth of brepocitinib's opportunity and capital allocation. A: Matthew Gline and Benjamin Zimmer discuss broad opportunity for brepocitinib in high unmet need areas and capital allocation to top opportunities.
• Q: Derek Archila asks about read-through from SLE data to cutaneous lupus erythematosus (CLE) and commercial synergy between brepo and 1402. A: Matthew Gline talks about SLE read-through and commercial considerations for brepo and 1402.
• Q: Ash Verma asks about TED data and Graves' disease readout translation. A: Matthew Gline discusses TED data and Graves' disease study plans, noting significant lead in Graves' disease.
• Q: Thomas Smith asks about 1402 data timing and commercial strategy in Graves'. A: Matthew Gline talks about 1402 data release and Graves' disease lead, emphasizing significant lead in the indication