Business Highlights - Roivant anticipates an NDA filing for brepocitinib in dermatomyositis (DM) in the first half of 2026 [14] - Positive Phase 3 VALOR study results for brepocitinib in DM showed statistically significant benefit on all 10 ranked endpoints [13] - Durable remission data in Graves' disease (GD) and positive Phase 3 batoclimab data in Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) were unveiled [13] - A favorable Markman ruling was issued for Genevant in the Pfizer case [13] Pipeline Progress - Registrational trials have been initiated in GD, MG, CIDP, Difficult-to-Treat Rheumatoid Arthritis (D2T RA), and Sjögren's disease (SjD); a Proof of Concept (POC) trial has been initiated in Cutaneous Lupus Erythematosus (CLE) [13] - The company is focusing on clinical trial execution to drive significant potential value, with 11 registrational trials in indications with blockbuster potential [18] - In the VALOR study, brepocitinib 30 mg showed a mean Total Improvement Score (TIS) of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2) [24] - Approximately 50% of responders in the batoclimab Graves' disease study achieved Anti-Thyroid Drug (ATD)-free remission at Week 48 [61] Financial Status - Roivant reported a strong capital position with $4.4 billion in cash balance as of September 30, 2025 [13, 73] - Research and Development (R&D) expense was $165 million, with an adjusted R&D expense of $153 million (non-GAAP) for the three months ended September 30, 2025 [73] - General and Administrative (G&A) expense was $143 million, with an adjusted G&A expense of $72 million (non-GAAP) for the same period [73]

Core Insights - Roivant is experiencing a transformative quarter, highlighted by positive data from brepocitinib in dermatomyositis and Immunovant's remission data in Graves' disease, indicating a promising trajectory for the company [2][3] Recent Developments - Brepocitinib 30 mg showed significant improvement in the Phase 3 VALOR study for dermatomyositis, with an NDA filing planned for the first half of 2026 [3][4] - The brepocitinib program is advancing with rapid enrollment in studies for non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in 2027 and late 2026, respectively [3][4] - Immunovant's study in uncontrolled Graves' disease patients indicated a potentially disease-modifying outcome, with results from Phase 3 thyroid eye disease studies expected in early 2026 [3][4] - Roivant reported consolidated cash and marketable securities of $4.4 billion as of September 30, 2025, providing a strong cash runway [3][4] Financial Summary - Research and development expenses increased by $21.5 million to $164.6 million for Q2 2025, driven by program-specific costs and personnel-related expenses [7][9] - General and administrative expenses decreased by $59.8 million to $143.1 million for Q2 2025, primarily due to reduced personnel-related expenses [10][11] - Loss from continuing operations for Q2 2025 was $166.0 million, an improvement from $236.8 million in Q2 2024 [15][16] Upcoming Milestones - NDA filing for brepocitinib in dermatomyositis is planned for the first half of 2026, with topline data from ongoing trials expected in 2026 and 2027 [13][14] - Immunovant anticipates reporting results from several trials in 2026, including potentially registrational trials for IMVT-1402 [13][14] - Genevant's litigation continues with significant hearings expected in early 2026 [13][14]

VALOR Study Topline Results - The VALOR study of Brepocitinib in Dermatomyositis (DM) succeeded with highly significant, robust, and consistent data across primary and all key secondary endpoints[18] - A consistent dose response was observed between 15 mg and 30 mg, establishing 30 mg as the optimal dose[18] - Brepocitinib 30 mg showed a mean TIS of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2)[18] - Over two-thirds (68%) of brepocitinib 30 mg patients experienced at least a moderate response (TIS40), compared to 44.3% on placebo[37,61] - Nearly half (46.1%) of brepocitinib 30 mg patients experienced a major response (TIS60), compared to 26.4% on placebo[37,61] - Median time to a TIS40 response was approximately 2 months[18] - At week 52, 54.3% of patients achieving TIS40 Response + ≤2.5 mg OCS on Brepocitinib 30mg vs 26.6% on Placebo[61] - At week 52, CDASI-A change from baseline at -11.7 for Brepocitinib 30mg vs -7.0 for Placebo[61] Safety and Regulatory - The safety profile of Brepocitinib 30 mg in VALOR was consistent with prior clinical studies[18] - FDA filing is planned for the first half of 2026[18]

Business Updates - Roivant expects topline data for Brepocitinib in Dermatomyositis (DM) in the second half of 2025 [18, 28, 30, 70] - Immunovant anticipates topline results from Phase 3 trials of Batoclimab in Thyroid Eye Disease (TED) in the second half of 2025 [15, 18, 70] - Immunovant's IMVT-1402 has the potential to reach approximately 80% IgG reduction with continued weekly dosing of 600 mg [37] - Roivant is initiating a potentially registrational trial for IMVT-1402 in Sjögren's Disease (SjD) in Summer 2025 [18, 37, 51, 58] - A potentially registrational trial for IMVT-1402 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is actively enrolling [15, 18, 37, 52, 58] Financial Highlights - Roivant reported cash, cash equivalents, restricted cash, and marketable securities of $4.9 billion as of March 31, 2025 [25, 65] - The company repurchased 1284 million common shares for $13 billion in the fiscal year ended March 31, 2025 [26, 65] - For the year ended March 31, 2025, Roivant's revenue was $29 million, with an adjusted R&D expense of $508 million and an adjusted G&A expense of $348 million [65, 66] - The adjusted loss from continuing operations, net of tax, for the year ended March 31, 2025, was $624 million [65, 66] LNP Litigation - A US jury trial in the Moderna case is pending, with the summary judgment phase expected in the second or third quarter of 2025 [16, 62] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing held in December 2024, with a ruling potentially in 2025 [16, 62, 70]