Roivant Sciences (ROIV) Q3 2026 earnings summary

Executive summary

• Positive Phase II results for brepocitinib in cutaneous sarcoidosis demonstrated rapid, deep, and sustained efficacy with a strong safety profile, marking a breakthrough 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 IIb study for IMVT-1402 in difficult-to-treat rheumatoid arthritis and Phase II study for mosliciguat in PH-ILD, with pivotal data expected in the second half of 2026.

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

• Multiple pivotal readouts and commercial launches anticipated over the next few years, with a catalyst-rich 2026 expected.

Financial highlights

• R&D expenses for the quarter were $165.4 million, with adjusted non-GAAP R&D at $146.7 million.

• G&A expenses were $175.1 million, adjusted non-GAAP at $71.0 million, including a $17.1 million impairment loss from HQ relocation.

• 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.

• Cash position of $4.5 billion as of December 31, 2025, with no debt on the balance sheet.

Outlook and guidance

• 2026 expected to be a catalyst-rich year with multiple pivotal data readouts and potential NDA/BLA filings across several indications.

• Phase III studies for brepocitinib in cutaneous sarcoidosis and NIU to commence, with data expected in the second half of 2026.

• Topline data for IMVT-1402 in D2T RA and CLE, and for mosliciguat in PH-ILD, expected in H2 2026.

• 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.