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- **Breakthrough DM Data**: Brepocitinib Phase III success sets up 2026 launch, targeting $1B+ peak sales in DM.
- **Graves' Dominance**: Batoclimab 80% remission rate vs. ATDs; 75% on low/no therapy at 6 months.
- **Pipeline Powerhouse**: 11 registrational trials across 1402, with $4.4B cash to fuel growth.
- **Litigation Risk Management**: 1498 defense limits Moderna damages exposure; international trials could accelerate resolution.

**【CEO Summary Section】**
- **Brepocitinib (DM) Milestone**: Phase III VALOR trial met all primary and secondary endpoints with 30mg dose showing rapid, deep, and broad efficacy. NDA submission for DM expected in H1 2026, with potential launch in H2 2026.
- **Graves' Disease Progress**: Batoclimab Phase II data showed 80% of patients achieved remission off ATDs at 6 months, with 75% on low/no ATD therapy. POC trial in CLE and Phase III in RA/Sjögren's to read out in 2026-2027.
- **Pipeline Expansion**: 11 registrational trials across DM, RA, Graves', and other autoimmune diseases. $4.4B cash position supporting pipeline through profitability.
- **Litigation Update**: Favorable Markman ruling in Pfizer case; Moderna trial scheduled for March 2026. International cases progressing in Europe, Japan, and Canada.

**【Q&A Highlights】**
- **Competitive Strategy**: Emphasized FcRn's safety/tolerability advantage vs. IGF-1R therapies in Graves'. 1402's deeper IgG reduction (70%+ cutoff) linked to better remission rates.
- **LNP Litigation**: Moderna U.S. sales <50% of global; 1498 defense arguments narrow damages scope. International trials could yield 2026 decisions.
- **Investor Day Preview**: Focus on commercial strategy for DM, Graves', and pipeline expansion. Will share new data from Sjögren's, RA, and CLE trials.
- **Business Development**: Actively evaluating BD opportunities for high-impact assets, prioritizing programs with blockbuster potential.

Roivant Sciences Ltd. (ROIV) Q2 2026 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

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Research and Development Expenses

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Loss on Disposal of Assets

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Operating Income

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Other Non-Operating Income (Loss)

Net Interest Expense

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Net Income

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Total Comprehensive Income Attributable to Owners of the Company

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ROIV

ROIV fundamentals

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