Roivant Sciences (NasdaqGS:ROIV) 2025 Investor Day December 11, 2025 08:00 AM ET Company ParticipantsNone - Video Narrator 3Lindsay Androski - CEONone - Video Narrator 5Matt Gline - CEOUmer Raffat - Senior Managing DirectorNone - Video Narrator 9Richard Pulik - CFONone - Video Narrator 6None - Video Narrator 1None - Video Narrator 10Frank Torti - Vant ChairBen Zimmer - CEONone - Video Narrator 4Iris Gao - Equity Research Senior AssociateNone - Video Narrator 7Eric Venker - PresidentCorinne Jenkins - VPNone ...

Core Insights - Roivant Sciences Ltd. is a late-stage company focused on autoimmune and rare diseases, with three subsidiaries known as Vants: Priovant, Immunovant, and Pulmovant [1] Group 1: Company Overview - Priovant is developing Brepocitinib, currently in Phase 3 for dermatomyositis (DM), with a New Drug Application (NDA) targeted for the first half of 2026 [1] - Immunovant is working on IMVT-1402, although specific details on its development stage were not provided [1]

Financial Data and Key Metrics Changes - The company reported a loss from continuing operations net of tax of $166 million for the quarter [24] - Cash and cash equivalents stood at $4.4 billion with no debt on the balance sheet, indicating a strong capital position [24][25] Business Line Data and Key Metrics Changes - The NDA filing for Brepocitinib in dermatomyositis (DM) is on track for the first half of next year, with significant data showing it hit all 10 ranked endpoints in the VALOR study [5][10] - The Graves' disease trial for Batoclimab demonstrated disease-modifying potential, with a significant portion of patients responding positively to therapy [19][20] Market Data and Key Metrics Changes - The company highlighted a large patient population for Graves' disease, with approximately 880,000 diagnosed patients in the U.S., of which 330,000 are uncontrolled or intolerant to current treatments [19] - The competitive landscape in Graves' disease is evolving, with multiple companies recognizing the importance of this market [33][60] Company Strategy and Development Direction - The company is focused on expanding its late-stage pipeline, with 11 potentially registrational trials and indications with blockbuster potential [8] - The upcoming investor day on December 11, 2025, is expected to provide a comprehensive overview of the company's strategy and future opportunities [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the transformative data from recent trials and the potential for significant market impact [4][9] - The company is optimistic about its competitive positioning in the Graves' disease market, emphasizing the importance of FcRn therapy [60] Other Important Information - The company is involved in ongoing litigation related to LNP technology, with a jury trial in the Moderna case scheduled for March 2026 [24] - The company has a favorable marketing ruling in the Pfizer case, which is expected to influence future developments [7][24] Q&A Session Summary Question: What should be watched next regarding Pfizer litigation? - Management indicated that the scheduling process for the Pfizer case is underway, and more information about the timeline, including a potential trial date, will be available soon [29] Question: Thoughts on Argenx entering the Graves' market? - Management acknowledged the competitive landscape but expressed confidence in their data and the potential for their treatment to stand out [33][34] Question: Expectations for the investor day? - Management stated that the investor day will focus on the transformation of the business and may include new data or strategic directions [36][38] Question: Impact of high-dose Batoclimab on remission rates in Graves' disease? - Management noted that deeper IgG reductions are expected to drive better outcomes, and they are cautious about discussing competitive implications [42][44] Question: Status of LNP litigation and international cases? - Management confirmed ongoing international litigations, with important hearings expected in 2026 [72][73] Question: Insights on Sjögren's disease market opportunity? - Management expressed excitement about the Sjögren's market and the potential for their treatment to be first in class [54][55] Question: Update on overseas studies with 1402? - Management indicated that ongoing studies are being used to inform indication selection and design decisions for larger studies [98]

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]

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]

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]

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]