Roivant Reports Financial Results for the First Quarter Ended June 30, 2025, and Provides Business Update

Core Insights - Roivant reported financial results for Q1 ended June 30, 2025, highlighting clinical progress and a completed $1.5 billion share repurchase program [1][2] - The company is preparing for the potential launch of brepocitinib, which targets high unmet medical needs [2][4] Recent Developments - The VALOR Phase 3 study for brepocitinib in dermatomyositis is on track for topline data readout in H2 2025, with the last patient visit completed in July [4][5] - Rapid enrollment is ongoing for brepocitinib in non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in H1 2027 and H2 2026, respectively [4][5] - Immunovant initiated two potentially registrational studies for IMVT-1402 in Graves' disease and Sjögren's disease in June 2025 [5] Financial Summary - As of June 30, 2025, Roivant had consolidated cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.5 billion [6][8] - Research and development expenses increased by $32.4 million to $152.9 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [9][10] - General and administrative expenses rose by $34.1 million to $134.0 million, primarily due to increased share-based compensation [12][14] Share Repurchase Program - Roivant completed its initial $1.5 billion share repurchase program, including $208 million in repurchases for the quarter, reducing outstanding shares by over 15% from March 31, 2024 [4][6] - A new $500 million share repurchase program was approved by the board in June 2025 [6] Upcoming Milestones - Topline data from the ongoing Phase 3 trial of brepocitinib in dermatomyositis is expected in H2 2025 [13] - Remission data from the batoclimab proof-of-concept study in Graves' disease will be reported at the American Thyroid Association Annual Meeting in September 2025 [13]