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]

Core Insights - Roivant reported financial results for the fourth quarter and fiscal year ended March 31, 2025, highlighting significant progress in its clinical pipeline and financial position [1][34] - The company is focused on advancing its late-stage clinical programs, particularly brepocitinib and IMVT-1402, with several upcoming milestones expected in 2025 and 2026 [2][8] Financial Summary - As of March 31, 2025, Roivant had cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.9 billion, supporting its cash runway into profitability [9][14] - Research and development (R&D) expenses for the fourth quarter increased by $37.7 million to $145.2 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [10][11] - For the fiscal year ended March 31, 2025, R&D expenses rose by $110.5 million to $550.4 million, primarily due to increases in program-specific costs and personnel-related expenses [12][13] - General and administrative (G&A) expenses for the fourth quarter increased by $39.0 million to $147.1 million, largely due to share-based compensation expenses [17][19] - The company reported a loss from continuing operations of $252.4 million for the fourth quarter, compared to a loss of $95.0 million in the same quarter of the previous year [22] Clinical Developments - Roivant's brepocitinib program is progressing well, with rapid enrollment in a Phase 3 study for non-infectious uveitis and a proof-of-concept trial for cutaneous sarcoidosis [5][6] - Immunovant announced positive results from its batoclimab studies, with significant improvements in Myasthenia Gravis Activities of Daily Living scores and responder rates in chronic inflammatory demyelinating polyneuropathy [4][6] - The company is actively enrolling potentially registrational trials for IMVT-1402 in multiple indications, including Graves' disease and Sjögren's disease, expected to start in summer 2025 [5][7] Share Repurchase and Equity - Roivant repurchased $1.3 billion of its shares as of March 31, 2025, reducing outstanding shares by 14% from the previous year [14][21] - The company reported a net loss attributable to Roivant of $206.5 million for the fourth quarter, compared to a net loss of $151.1 million in the same quarter of the previous year [28]

Company Overview - Roivant is a biopharmaceutical company focused on improving patient lives by accelerating the development and commercialization of important medicines [3] - The company's pipeline includes several product candidates such as IMVT-1402 and batoclimab for autoimmune indications, brepocitinib for various inflammatory conditions, and mosliciguat for pulmonary hypertension [3] Upcoming Events - Roivant will host a live conference call and webcast on May 29, 2025, at 8:00 a.m. ET to report its financial results for the fourth quarter and fiscal year ended March 31, 2025, and to provide a business update [1] Access Information - Interested parties can access the conference call by registering online, with details available on Roivant's investor website [2]

Summary of Roivant Sciences (ROIV) Conference Call Company Overview - **Company**: Roivant Sciences (ROIV) - **Event**: BofA Annual Healthcare Conference - **Date**: May 14, 2025 Key Points Immunovant and Clinical Focus - Roivant is transitioning its focus to IVD 1402, a next-generation program, after late-stage studies in betoclimab for MG and CIDP [8] - Eric Vanker has taken over as CEO of Immunovant, emphasizing patient enrollment in Graves' disease as the top priority [9] - Graves' disease is identified as a unique opportunity with a large patient population and high unmet need [11] Market Dynamics and Patient Population - Approximately 350,000 Graves' patients in the US are refractory to current treatments, primarily methimazole [25] - The current treatment landscape for Graves' disease has not seen a novel drug in 70 years, creating a significant opportunity for Roivant [29] - The company aims to address the operational challenges of enrolling patients in clinical trials due to the lack of recent novel therapies [30] Value Proposition of Therapy - The therapy aims to improve patient quality of life by reducing reliance on methimazole and potentially achieving drug-free remission [36] - Evidence from phase two data shows that 76% of patients on high doses achieved T3 and T4 normalization, with 56% able to discontinue anti-thyroid drugs [46] - The company is also exploring the potential to reduce the onset of Thyroid Eye Disease (TED) in hyperthyroid patients with proptosis [38] Regulatory and Clinical Trial Insights - The FDA has shown enthusiasm for new therapies in Graves' disease, indicating a supportive regulatory environment [51] - The first GRAVE study will treat patients for six months before randomization to assess remission rates [41] - The company is optimistic about the potential for accelerated approval based on positive clinical outcomes [85] Myasthenia Gravis (MG) and CIDP Challenges - Roivant acknowledges the challenges of entering the MG market, dominated by Argenx, and recognizes the need for deeper clinical data to compete effectively [58] - The company aims to shift the focus in MG from treatment response to deeper remission endpoints, which could favor their drug's profile [61] Dermatomyositis and Other Programs - Roivant is preparing for a phase three trial in dermatomyositis, with expectations for regulatory approval based on statistical significance [78] - The company is also developing a pulmonary hypertension program, with data expected in the second half of next year [87] Legal Matters - Roivant is involved in litigation regarding intellectual property related to lipid nanoparticles used in COVID vaccines, with a jury trial scheduled for September 2025 [90] - Potential damages from the case could be substantial, given the scale of global COVID vaccine sales [93] Additional Insights - The company is focused on executing its current indications before exploring new opportunities, indicating a disciplined approach to R&D investment [66] - Roivant is evaluating its pipeline continuously and may announce new indications as they progress [66] This summary encapsulates the key discussions and insights from the Roivant Sciences conference call, highlighting the company's strategic focus, market opportunities, and ongoing challenges in the biopharmaceutical landscape.

Corporate Strategy & Leadership - Eric Venker, MD, was appointed CEO, and Tiago Girao was appointed CFO, signaling a management transition[12] - Immunovant is focused on executing in six announced indications currently underway, including Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE)[12] - The current cash balance provides runway for announced indications into Graves' readout expected in 2027[11] IMVT-1402 Clinical Development & Potential - IMVT-1402 is expected to reach approximately 80% IgG reduction with continued weekly dosing of 600 mg, based on Phase 1 data[20] - A potentially registrational trial for IMVT-1402 in Sjögren's Disease (SjD) is expected to start in Summer 2025[12, 20] - A proof-of-concept study in Cutaneous Lupus Erythematosus (CLE) has been initiated for IMVT-1402, with early positive data[12, 20] - IMVT-1402 has strong patent protection covering composition of matter, method of use, and methods for manufacturing to 2043[20] Market Opportunity & Competitive Landscape - Approved FcRn products generated over $2.4 billion in net sales in their second year post-launch, more than double TNF agents at a similar timepoint[22] - In the US, approximately 90,000 people with Sjögren's Disease with anti-Ro/SSA antibodies represent a target addressable population[26, 38] - In the US, approximately 75,000 people with Cutaneous Lupus Erythematosus uncontrolled on standard of care represent a target addressable population[26, 49] - Up to 50% of SCLE/CCLE patients failing standard of care, represent an untapped market opportunity[54]

Core Viewpoint - Immunovant, Inc. is entering a new growth phase with leadership changes and expanded development of IMVT-1402 into Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) [1][2] Leadership Changes - Eric Venker, M.D. has been appointed as the new CEO of Immunovant, bringing over 20 years of clinical and operational experience [2][6] - Pete Salzmann, M.D. has retired from his role as CEO and Director, while Tiago Girao has been appointed as the new CFO [2][6] - George Migausky has stepped down from the board, with Robert Susman and Jacob Bauer joining [3] Strategic Transition - The leadership changes are part of a broader strategic transition, with Roivant increasing its operational involvement and oversight of Immunovant [2][6] - Development activities for batoclimab are concluding, while those for IMVT-1402 are ramping up [2][6] Clinical Development Updates - The IND for IMVT-1402 in SjD has been cleared, marking it as the fifth indication for the drug, with a study expected to initiate in summer 2025 [6] - A proof-of-concept study for IMVT-1402 in CLE has been initiated, based on promising efficacy data from previous studies [6] - Current cash balance is sufficient to support the announced indications through the expected readout for Graves' Disease in 2027 [6] Market Need - Sjögren's Disease is characterized by severe dryness and has no approved therapies specifically targeting it, indicating a significant market opportunity [7] - Cutaneous Lupus Erythematosus (CLE) has a high unmet need, with up to 50% of patients not optimally managed by current therapies, and no new therapies approved in over 50 years [8]

Core Insights - Immunovant, Inc. is entering a new growth phase with leadership changes and expanded development of IMVT-1402 into Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) [1][2] Leadership Changes - Eric Venker, M.D. has been appointed as the new CEO of Immunovant, bringing over 20 years of clinical and operational experience [2][6] - Pete Salzmann, M.D. has retired from his role as CEO and Director, while Tiago Girao has been appointed as the new CFO [2][6] - The board of directors has seen changes with George Migausky stepping down and Robert Susman and Jacob Bauer joining [3] Strategic Transition - The leadership changes are part of a broader strategic transition, with Roivant increasing its operational involvement and oversight of Immunovant [2][6] - Development activities for batoclimab are concluding, while those for IMVT-1402 are ramping up [2][6] Clinical Development Updates - The IND for IMVT-1402 in SjD has been cleared, marking it as the fifth indication for the drug, with a study expected to initiate in summer 2025 [6] - A proof-of-concept study for IMVT-1402 in CLE has been initiated, based on promising efficacy data from previous studies [6] - Current cash reserves are sufficient to support the announced indications through the expected readout for Graves' Disease in 2027 [6] Market Needs - Sjögren's Disease is characterized by severe dryness and has no approved therapies specifically targeting it, indicating a significant market opportunity for new treatments [7] - Cutaneous Lupus Erythematosus (CLE) has a high unmet need, with up to 50% of patients not optimally managed by existing therapies, and no new therapies approved in over 50 years [8]

"I want to extend my deepest thanks to Pete Salzmann for his leadership of the company through a period of significant growth and transformation. Under Pete, Immunovant has shown compelling efficacy data in clinical trials for batoclimab in Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyneuropathy, Graves' Disease and Thyroid Eye Disease, while developing the IMVT-1402 program to a total of six indications, now including Sjögren's and CLE," said Eric Venker, M.D., CEO of Immunovant and President ...

Core Insights - Immunovant, Inc. reported positive topline results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial results from its Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [1][2] Phase 3 Study in MG - The Phase 3 study was a randomized, quadruple-blind, placebo-controlled trial assessing batoclimab's efficacy and safety in adults with moderate to severe MG [3] - The primary endpoint was the mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, with significant improvements observed in both dosing arms [8] - The higher dose (680mg weekly) achieved a 5.6 point improvement in MG-ADL with a 74% mean IgG reduction, while the lower dose (340mg weekly) showed a 4.7 point improvement with a 64% mean IgG reduction [7][8] Phase 2b Study in CIDP - The Phase 2b study is also a randomized, quadruple-blind, placebo-controlled trial designed to evaluate batoclimab's efficacy and safety in active CIDP [4] - Initial results from Period 1 indicated a mean improvement of 1.8 points in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score, with an 84% responder rate among patients achieving an IgG reduction greater than 70% [9] Efficacy and Safety Results - In the MG study, deeper IgG reductions correlated with better clinical outcomes across various assessments [7] - Safety and tolerability profiles were consistent with previous batoclimab studies, indicating a favorable safety profile [10] Future Plans - Immunovant plans to initiate potentially registrational studies for both MG and CIDP with its lead asset IMVT-1402, having received clearance for Investigational New Drug (IND) applications [11] - The company does not intend to seek regulatory approval for batoclimab in MG or CIDP at this time, focusing instead on leveraging data from these studies to inform its programs with IMVT-1402 [12]

Group 1 - Immunovant, Inc. will host an investor webcast on March 19, 2025, at 8:00 a.m. ET to review results from its Phase 3 study of batoclimab in myasthenia gravis (MG) and initial results from its Phase 2b study in chronic inflammatory demyelinating polyneuropathy (CIDP) [1] - The webcast will feature Pete Salzmann, M.D., MBA, Chief Executive Officer of Immunovant, alongside Matt Gline, Chief Executive Officer of Roivant [2] - The live webcast will be accessible on Roivant's investor website, with an archived version available post-event [3] Group 2 - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a pipeline that includes IMVT-1402 and batoclimab targeting autoimmune diseases, brepocitinib for dermatomyositis and other conditions, and mosliciguat for pulmonary hypertension [4]