Roivant Sciences (ROIV) Q3 2026 earnings summary

Executive summary

• Positive Phase 2 results for brepocitinib in cutaneous sarcoidosis demonstrated rapid, deep, and sustained efficacy and safety, with all high-dose patients achieving clinically meaningful improvements in a disease with no approved therapies.

• NDA for brepocitinib in dermatomyositis submitted; multiple late-stage clinical programs progressing, including pivotal trials in non-infectious uveitis and other autoimmune diseases.

• Fully enrolled Phase 2b study for IMVT-1402 in difficult-to-treat rheumatoid arthritis and Phase 2 study for mosliciguat in PH-ILD, with top-line data expected in H2 2026.

• $550M Immunovant financing completed, extending cash runway to anticipated commercial launch of Graves' disease therapy.

• Consolidated cash, cash equivalents, restricted cash, and marketable securities of $4.5 billion as of December 31, 2025, supporting a runway into profitability.

Financial highlights

• R&D expenses for the quarter were $165.4 million, up $23.8 million year-over-year; non-GAAP R&D was $146.7 million.

• G&A expenses were $175.1 million, up $33.5 million year-over-year; non-GAAP G&A was $71.0 million.

• Non-GAAP net loss totaled $167 million for the quarter; loss from continuing operations, net of tax, was $313.7 million.

• Revenue for the quarter was $2.0 million, down from $9.0 million year-over-year, primarily from license agreements.

• Cash, cash equivalents, and marketable securities totaled $4.5 billion as of December 31, 2025, with no debt on the balance sheet.

Outlook and guidance

• Multiple pivotal study readouts and NDA/BLA filings expected in the next few years, including Phase 3 data for brepocitinib in NIU and cutaneous sarcoidosis, and topline data for IMVT-1402 and mosliciguat in H2 2026.

• Anticipated commercial launches across 7+ indications by end of 2028.

• Management expects existing liquidity to fund operations and capital expenditures for the foreseeable future.

• Jury trial against Moderna scheduled for March 2026, with recent favorable summary judgment.