Roivant Sciences(ROIV) - 2026 Q2 - Quarterly Results

Financial Performance - Roivant reported consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $4.4 billion as of September 30, 2025, supporting cash runway into profitability[3] - Loss from continuing operations, net of tax was $166.0 million for the three months ended September 30, 2025, compared to $236.8 million for the same period in 2024[13] - Non-GAAP loss from continuing operations, net of tax was $187.8 million for the three months ended September 30, 2025, compared to $218.7 million for the same period in 2024[14] - Basic and diluted loss from continuing operations was $0.17 per share for the three months ended September 30, 2025, compared to $0.25 per share for the same period in 2024[13] - Loss from continuing operations for Q2 2025 was $166,039,000, a decrease from $236,841,000 in Q2 2024, representing a 29.8% improvement[20] - The adjusted loss from continuing operations (Non-GAAP) was $187,779,000 in Q2 2025, compared to $218,665,000 in Q2 2024, a 14.1% improvement[20] Research and Development - Research and development (R&D) expenses increased by $21.5 million to $164.6 million for the three months ended September 30, 2025, compared to $143.1 million for the same period in 2024[6] - Research and development expenses increased to $164,568,000 in Q2 2025 from $143,073,000 in Q2 2024, reflecting a 15.0% rise[20] - Adjusted research and development expenses (Non-GAAP) were $152,896,000 in Q2 2025, up from $132,438,000 in Q2 2024, indicating a 15.5% increase[20] General and Administrative Expenses - General and administrative (G&A) expenses decreased by $59.8 million to $143.1 million for the three months ended September 30, 2025, compared to $202.9 million for the same period in 2024[9] - General and administrative expenses decreased to $143,125,000 in Q2 2025 from $202,881,000 in Q2 2024, a reduction of 29.4%[20] - Adjusted general and administrative expenses (Non-GAAP) were $72,054,000 in Q2 2025, down from $142,344,000 in Q2 2024, a decrease of 49.3%[20] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $307.8 million, compared to $346.2 million for the same period in 2024[18] - The increase of $13.2 million in program-specific costs was primarily driven by an increase of $10.2 million related to the anti-FcRn franchise and $4.2 million related to brepocitinib[7] Pipeline and Future Plans - Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in dermatomyositis (DM), with NDA filing planned for the first half of calendar year 2026[3] - Immunovant's study in uncontrolled Graves' disease patients showed a potentially disease-modifying outcome with six-month off-treatment data, with results from the first of two batoclimab Phase 3 thyroid eye disease studies expected before the end of calendar year 2025[3] - The company plans to host an investor day on December 11, 2025, to provide further updates on its strategies and pipeline[24] - Roivant's pipeline includes several product candidates targeting various autoimmune indications and pulmonary hypertension, indicating ongoing market expansion efforts[25] Investment and Tax Impact - The company reported a change in fair value of investments resulting in a loss of $128,501,000 in Q2 2025 compared to a loss of $48,375,000 in Q2 2024[20] - The estimated income tax impact from adjustments was $3,059,000 in Q2 2025, compared to a tax impact of $(3,986,000) in Q2 2024[20]