Roivant Sciences(ROIV) - 2026 Q1 - Quarterly Results

Overview and Business Update Roivant reported strong financial results for Q1 2025, highlighted by significant clinical advancements and strategic share repurchases Key Highlights Roivant achieved significant clinical progress, completed a $1.5 billion share repurchase, and maintains a strong $4.5 billion cash position - The Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is on track for a topline data readout in H2 CY2025[3] - Two potentially registrational studies for IMVT-1402 in Graves' disease (GD) and Sjögren's disease (SjD) were initiated in June 2025[3] - A $1.5 billion share repurchase program was completed, with $208 million bought back in the quarter, and a new $500 million program approved[3] - Consolidated cash, cash equivalents, restricted cash, and marketable securities totaled $4.5 billion as of June 30, 2025[3] Major Upcoming Milestones The company anticipates key clinical trial readouts for brepocitinib, batoclimab, and IMVT-1402, alongside progress in Genevant's LNP litigation Key Clinical Trial Readout Timeline | Subsidiary | Drug | Indication | Event | Expected Timing | | :--- | :--- | :--- | :--- | :--- | | Priovant | brepocitinib | Dermatomyositis (DM) | Phase 3 Topline Data | H2 CY2025 | | Priovant | brepocitinib | Non-infectious Uveitis (NIU) | Phase 3 Topline Data | H1 CY2027 | | Priovant | brepocitinib | Cutaneous Sarcoidosis (CS) | Phase 2 Topline Data | H2 CY2026 | | Immunovant | batoclimab | Graves' Disease (GD) | Remission Data | Sep 2025 | | Immunovant | Thyroid Eye Disease (TED) | Phase 3 Data | H2 CY2025 | | Immunovant | IMVT-1402 | Multiple Indications | Topline Results | CY2026 - CY2027 | | Pulmovant | mosliciguat | PH-ILD | Phase 2 Topline Data | H2 CY2026 | - Genevant's LNP litigation against Moderna has a jury trial scheduled for March 2026, with a judge's decision pending in the Pfizer/BioNTech case[6] Financial Results for the First Quarter Ended June 30, 2025 Roivant reported increased R&D and G&A expenses, leading to a significant loss from continuing operations for the quarter Financial Summary Narrative Roivant's R&D and G&A expenses significantly increased year-over-year, resulting in a $273.9 million loss from continuing operations - Consolidated cash, cash equivalents, restricted cash, and marketable securities totaled approximately $4.5 billion as of June 30, 2025[7] Year-over-Year Expense Comparison (Three Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $152.9M | $120.5M | +$32.4M | | G&A Expenses | $134.0M | $99.9M | +$34.1M | - The increase in R&D costs was primarily driven by program-specific costs for the anti-FcRn franchise (up $15.2 million), mosliciguat (up $5.4 million), and brepocitinib (up $4.4 million)[9] - Loss from continuing operations was $273.9 million, or $0.33 per share, for the quarter ended June 30, 2025[14] - Non-GAAP loss from continuing operations was $170.1 million, compared to $107.1 million for the same period in 2024[15] Selected Balance Sheet Data Roivant's balance sheet as of June 30, 2025, shows $5.03 billion in total assets and $4.82 billion in shareholders' equity, with shifts in cash and marketable securities Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $1,248,609 | $2,725,661 | | Marketable securities | $3,264,692 | $2,171,480 | | Total assets | $5,032,602 | $5,436,940 | | Total liabilities | $216,696 | $249,742 | | Total shareholders' equity | $4,815,906 | $5,187,198 | Condensed Consolidated Statements of Operations Roivant reported a $223.4 million net loss for the quarter ended June 30, 2025, a significant decline from the prior year's net income due to increased expenses Condensed Consolidated Statements of Operations (unaudited, in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $2,170 | $7,990 | | Total operating expenses | $287,092 | $220,612 | | Loss from operations | $(284,922) | $(102,235) | | Loss from continuing operations, net of tax | $(273,911) | $(31,603) | | Net (loss) income attributable to Roivant | $(223,355) | $95,297 | | Net (loss) income per common share, basic | $(0.33) | $0.13 | Reconciliation of GAAP to Non-GAAP Financial Measures Roivant's non-GAAP loss from continuing operations was $170.1 million, adjusted primarily for share-based compensation and changes in investment fair value GAAP to Non-GAAP Reconciliation Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Loss from continuing operations, net of tax (GAAP) | $(273,911) | $(31,603) | | Share-based compensation | $82,178 | $47,373 | | Gain on sale of Telavant net assets | — | $(110,387) | | Change in fair value of investments | $19,125 | $(15,226) | | Other Adjustments | $2,485 | $2,739 | | Adjusted loss from continuing operations (Non-GAAP) | $(170,124) | $(107,112) | Corporate Information This section provides details on investor communications, Roivant's business model, and standard forward-looking statement disclaimers Investor Conference Call Information Roivant will host a conference call and webcast on August 11, 2025, to discuss Q1 financial results and provide a corporate update - A conference call and webcast will be held at 8:00 a.m. ET on Monday, August 11, 2025, to discuss the financial results and business update[27] About Roivant Roivant is a biopharmaceutical company developing medicines through its "Vants" subsidiary model, focusing on key pipeline assets for inflammatory and autoimmune diseases - Roivant's key pipeline assets include brepocitinib (TYK2/JAK1 inhibitor), IMVT-1402 and batoclimab (FcRn targeting antibodies), and mosliciguat (sGC activator)[29] - The company utilizes a subsidiary model, creating "Vants" to develop and commercialize its medicines and technologies[29] Forward-Looking Statements This section contains forward-looking statements regarding clinical potential and future results, subject to risks and uncertainties, with no obligation for updates - The press release includes forward-looking statements regarding the clinical and therapeutic potential of product candidates, trial results, and commercial potential[31] - These statements are covered by the safe harbor provisions of the Securities Act and Exchange Act but are subject to significant risks and uncertainties[30][32]