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Wall Street Has a Mixed Opinion on Roivant Sciences Ltd (ROIV)
Yahoo Finance· 2025-10-21 09:52
Core Viewpoint - Roivant Sciences Ltd. (NASDAQ:ROIV) is recognized as one of the best growth stocks under $25, with mixed opinions from Wall Street following positive results from its Phase 3 VALOR study for Brepocitinib in dermatomyositis [1] Group 1: Analyst Ratings - Brian Cheng from J.P. Morgan has reiterated a Buy rating on Roivant Sciences with a price target of $20 [2] - Chi Meng Fong from Bank of America Securities has maintained a Hold rating with a price target of $16.5 [2] Group 2: Study Progress and Market Concerns - The Phase 3 VALOR study has shown promising progress, but Fong anticipates limited immediate growth potential due to the launch targeting only a limited referral center [3] - Fong also expressed concerns regarding the competitive market for IMVT-1402, which is being developed for Graves' disease and other autoimmune diseases [4] - The ongoing LNP litigation against major players like Pfizer and Moderna could adversely affect Roivant Sciences' financial health [4] Group 3: Company Overview - Roivant Sciences is a biotechnology company focused on accelerating the development and commercialization of important medicines [5]
Roivant Sciences(ROIV) - 2025 Q4 - Earnings Call Presentation
2025-05-29 11:05
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]
Roivant Sciences (ROIV) FY Earnings Call Presentation
2023-01-09 22:15
Pipeline Highlights - VTAMA became the 1 most prescribed branded topical for psoriasis within 8 weeks of launch[10], and a major PBM/payer contract was executed[10] - RVT-3101, an anti-TL1A antibody, is Phase 3-ready for Ulcerative Colitis and Crohn's Disease, with final Phase 2b data expected in 1H 2023[19, 12] - Brepocitinib, a TYK2/JAK1 inhibitor, has initiated a Phase 3 trial in Dermatomyositis and completed enrollment in a global Phase 2B trial in SLE, with topline data expected in 2H 2023[10, 12] - IMVT-1402, a next-generation anti-FcRn, unveiled with initial Phase 1 data expected in mid-2023[10, 12] RVT-3101 Efficacy and Safety - RVT-3101 demonstrated statistically significant and clinically meaningful effects in a UC Phase 2b trial, with a placebo-adjusted delta (Pbo-adj Δ) of 21% for clinical remission and 27% for endoscopic improvement in the all-comers pooled group[22] - In biomarker-positive patients, RVT-3101 showed a Pbo-adj Δ of 41% for clinical remission and 46% for endoscopic improvement at the expected Phase 3 dose[22, 29] - RVT-3101 was well-tolerated in the Phase 2b study, with 45% of participants experiencing AEs in the pooled group, 2% with severe AEs, and 4% with serious AEs[37] VTAMA Market and Clinical Development - VTAMA leads other branded topicals in weekly TRx and became the 1 most prescribed branded topical for psoriasis 8 weeks into launch[44] - Phase 3 trials in atopic dermatitis (ADORING program) are underway, with topline data expected in 1H 2023[12, 48] - In a Phase 2b trial for atopic dermatitis, 49% of patients achieved IGA response and 51% achieved EASI75 response at week 8[56] Anti-FcRn Franchise (Batoclimab and IMVT-1402) - Batoclimab has multiple pivotal trials ongoing in Myasthenia Gravis (MG), Thyroid Eye Disease (TED), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)[63] - IMVT-1402 is designed for maximum IgG reduction with minimal impact on LDL levels, with initial Phase 1 data expected in mid-2023[68, 65] Market Opportunities - Roivant is targeting multiple large I&I markets, including Psoriasis ($223 billion), Atopic Dermatitis ($122 billion), Crohn's Disease ($93 billion), and Ulcerative Colitis ($69 billion)[15]