Group 1 - Roivant has been recognized as one of the 2025 Fortune Best Workplaces in BioPharma, ranking 28th in the small & medium category, marking its first appearance on this prestigious list [1][3] - The award is based on survey responses from nearly 40,000 employees at Great Place To Work Certified companies in the biotechnology and pharmaceutical industry, reflecting a comprehensive picture of workplace experiences [2][4] - The selection process involved over 1.3 million survey responses from employees across the U.S., with rankings derived from 60 employee experience questions within the Great Place To Work Trust Index™ Survey [5] Group 2 - The recognition highlights Roivant's commitment to fostering an empowering, high-performance, and talent-oriented culture, as stated by the CEO [3] - The Best Workplaces in BioPharma list is highly competitive, with companies evaluated on their ability to provide positive outcomes for employees across various demographic identifiers [4][5] - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a diverse pipeline targeting various medical conditions [10][11]

Core Insights - Roivant Sciences Ltd. is highlighted as a promising investment opportunity in the healthcare sector, particularly in the biopharmaceutical space [1][4] Company Overview - Roivant Sciences Ltd. (NASDAQ:ROIV) is a clinical-stage biopharmaceutical company that accelerates the development of medicines through its subsidiaries, known as "Vants" [2] - The company focuses on in-licensing drug candidates from larger pharmaceutical firms and advancing them toward commercialization [2] Pipeline and Recent Developments - The current pipeline includes mosliciguat for pulmonary hypertension, brepocitinib for inflammatory diseases, and IMVT-1402 targeting autoimmune conditions [2] - A significant milestone for Roivant is the advancement of mosliciguat, which has received orphan drug designation in Japan, providing regulatory benefits and potential market exclusivity [3] - The Pulmovant subsidiary is positioned to address an underserved market in pulmonary hypertension with limited treatment options [3] Strategic Focus and Market Position - Roivant's brepocitinib program is progressing toward critical Phase 3 data readouts, which is fostering optimism among investors and analysts [4] - The company's strategic focus on rare and immune-mediated diseases enhances its attractiveness as a high-potential biotech investment [4]

Group 1 - Albert Wong is a Managing Director in Investment Banking at Morgan Stanley [1] - The presentation is part of a multi-day event, indicating ongoing engagement and discussions [1] - Attendees are encouraged to maintain their energy levels throughout the event [1] Group 2 - A disclosure regarding important information is mentioned, directing attendees to the Morgan Stanley research disclosure website [1] - There is an invitation for questions, suggesting an interactive component to the presentation [2]

Core Insights - Pulmovant has received orphan drug designation for mosliciguat from Japan's Ministry of Health, Labour and Welfare, highlighting the significant unmet medical need for patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) [1][2] - Mosliciguat is a novel, once-daily, inhaled soluble guanylate cyclase (sGC) activator currently in Phase 2 clinical trials, aiming to provide a targeted treatment option for PH-ILD [1][3] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases and is a subsidiary of Roivant [7] - The company’s lead candidate, mosliciguat, is designed to be a first-in-class inhaled treatment for PH-ILD, with a differentiated mechanism of action [7][5] Clinical Development - Mosliciguat is currently being evaluated in the Phase 2 PHocus clinical study, which is a randomized, double-blind, placebo-controlled trial involving approximately 120 adult patients [3][6] - The Phase 1b ATMOS study demonstrated that inhaled mosliciguat was well tolerated and resulted in a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38% [5] Market Context - PH-ILD is a progressive and life-threatening condition affecting up to 200,000 patients in the U.S. and Europe, with limited or no approved treatment options available [4] - The orphan drug designation provides Pulmovant with regulatory benefits, including priority consultation and up to 10 years of market exclusivity post-approval [2][6]

Summary of Roivant Sciences (ROIV) Update - Immunovant Graves Disease Data Update Company and Industry Overview - **Company**: Roivant Sciences (specifically focusing on Immunovant) - **Industry**: Biopharmaceuticals, specifically targeting autoimmune diseases such as Graves' disease Key Points and Arguments 1. **Data Presentation**: The call presented follow-up data from a study on Graves' disease, highlighting significant findings from a Phase II trial of birtoclimab, an anti-FcRn antibody [5][31] 2. **Patient Response**: 80% of patients (17 out of 21) remained responders six months after stopping treatment, indicating potential disease-modifying effects [6][20] 3. **Remission Rates**: Nearly 50% of responders (8 out of 17) were off antithyroid drugs (ATDs) while remaining controlled at the six-month follow-up [21][31] 4. **Unmet Need**: Approximately 25-30% of Graves' disease patients in the U.S. are uncontrolled on existing therapies, highlighting a significant market opportunity for new treatments [10][14] 5. **Safety Profile**: Birtoclimab was well tolerated with no new safety signals reported, consistent with previous findings for anti-FcRn antibodies [27] 6. **Phase III Trials**: Two registrational studies for IMBT-1402 are underway, with expectations for improved efficacy due to optimized dosing strategies [28][30] 7. **Long-term Effects**: The company plans to evaluate longer duration off-treatment effects and the potential for sustained benefits in patients [60][61] 8. **Commercial Strategy**: The data suggests a diversity of treatment effects, with some patients potentially requiring chronic therapy while others may achieve remission [61][62] Additional Important Content 1. **Disease Background**: Graves' disease is an autoimmune disorder leading to hyperthyroidism, with significant comorbidities including cardiovascular risks and thyroid cancer [9][12] 2. **Patient Population**: The study focused on patients who were uncontrolled despite standard treatments, emphasizing the severity of the disease [15][31] 3. **Biological Mechanism**: The therapy appears to disrupt feedback loops in Graves' disease, leading to sustained reductions in TRAB levels even after treatment cessation [43][60] 4. **Enrollment and Interest**: There is strong enthusiasm from both patients and physicians regarding the ongoing trials, which may enhance enrollment [44] 5. **Statistical Power**: The Phase III studies are designed with sufficient power to detect significant differences in remission rates, with stringent endpoints [102] This summary encapsulates the critical insights from the conference call regarding the advancements in treatment for Graves' disease and the strategic direction of Roivant Sciences in this therapeutic area.

Core Insights - Immunovant, Inc. presented six-month off-treatment data for batoclimab in uncontrolled Graves' disease patients, indicating potential disease modification and strong durability of response [1][2][3] Study Details - The proof-of-concept study involved a 24-week treatment with batoclimab, followed by a 24-week off-treatment follow-up, focusing on patients with active Graves' disease [3][4] - Key endpoint was the normalization of free triiodothyronine (T3) and free thyroxine (T4) levels at Week 24 without increasing anti-thyroid drug (ATD) doses from baseline [3] Remission Data - Out of 21 patients in the follow-up, approximately 80% (17/21) maintained normal thyroid function after six months off treatment [6][7] - Among responders, about 50% (8/17) achieved ATD-free remission, while an additional 30% (5/17) were on low ATD doses [6][7] Future Trials - Two potentially registrational trials for IMVT-1402 in Graves' disease are currently enrolling, with topline readouts expected in 2027 [5][6]

分组1 - Roivant Sciences Ltd. reported a quarterly loss of $0.18 per share, better than the Zacks Consensus Estimate of a loss of $0.23, representing an earnings surprise of +21.74% [1] - Montes Archimedes Acquisition posted revenues of $2.17 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 71.42%, compared to year-ago revenues of $55.13 million [2] - The stock of Montes Archimedes Acquisition has underperformed, losing about 2.9% since the beginning of the year, while the S&P 500 gained 8.6% [3] 分组2 - The current consensus EPS estimate for Montes Archimedes Acquisition is -$0.25 on revenues of $7.59 million for the coming quarter and -$1.01 on revenues of $28.53 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the bottom 41% of over 250 Zacks industries, indicating potential underperformance compared to the top 50% [8] - Adherex Technologies Inc., another company in the same industry, is expected to report a quarterly loss of $0.06 per share, with revenues projected at $9.49 million, reflecting a year-over-year increase of 30.7% [9]

Financial Data and Key Metrics Changes - The company reported an adjusted net loss of $170 million for the quarter, with cash utilization of approximately $200 million outside of the share repurchase program [25][26] - The balance sheet remains strong with $4.5 billion in cash and no debt, alongside a significantly reduced share count due to the share repurchase program [25][26] Business Line Data and Key Metrics Changes - The company is focused on the development of IVT-1402 and Immunovant, aiming to establish a best-in-class anti-FcRn antibody [6] - The registrational data for brepcitinib in dermatomyositis is expected in the second half of the year, which is crucial for the commercial launch of the drug [6][19] - The company has multiple ongoing registrational trials, with five trials for IVT-1402 currently in progress [9] Market Data and Key Metrics Changes - The company is preparing for a pivotal trial in Graves' disease, with expectations for significant data to be released soon [19][27] - The competitive landscape includes multiple programs from other companies, but the company believes its oral therapy will provide a unique advantage [19][96] Company Strategy and Development Direction - The company aims to expand its commercial footprint significantly over the next few years, starting with pivotal data in dermatomyositis and subsequent launches across its FcRn portfolio [10][19] - The company is actively engaging in business development, looking for transformational late-stage opportunities, particularly in the current choppy market [48][54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data and its potential impact on the company's commercial strategy, particularly in Graves' disease [27][76] - The company is focused on ensuring successful clinical execution and is confident in its ability to meet timelines for upcoming trials [71][72] Other Important Information - The company completed a $1 billion share repurchase program, reducing its share count by over 15% [10] - An additional $500 million repurchase program has been authorized for opportunistic use as market conditions fluctuate [10] Q&A Session Summary Question: Data availability at the time of top line results for brepcitinib - Management expects to have top line and key secondary data available contemporaneously with the results, with a potential filing for approval at the beginning of next year [29][31] Question: Trial design for the Graves' disease study - The rationale for testing a lower dose in the second Graves' trial is to ensure FDA approval and advocate for a minimally efficacious dose [32][33] Question: Definition of a flare in the trial - Management indicated that the definition of a flare and treatment protocols are designed to ensure accurate identification of patients who are worsening [35][38] Question: Context around upcoming Graves' remission data - Any amount of meaningful remission would be considered practice-changing for doctors treating Graves' disease patients [44][45] Question: Business development outlook - The company remains opportunistic in its business development strategy, particularly in the current market environment [48][54] Question: Enrollment status for ongoing studies - Enrollment for IVT-1402 trials is on track, with the team actively engaged and enthusiastic about the indications [70][71] Question: Importance of upcoming data at ATA - The data is expected to highlight the transformative potential of the drug for Graves' patients, which could significantly impact enrollment and physician enthusiasm [75][76] Question: Roadmap for pivotal development and potential filing year for NIU - The company is on track to generate data for NIU in 2027, with plans for a supplemental NDA filing shortly thereafter [83][84]

Financial Data and Key Metrics Changes - The company reported an adjusted net loss of $170 million for the quarter, with cash utilization of approximately $200 million outside of the share repurchase program [23] - The balance sheet remains strong with $4.5 billion in cash as of June 30, 2025, and no debt [23] Business Line Data and Key Metrics Changes - The company is focused on the development of IVT-1402 and Immunovant, aiming to establish a best-in-class anti-FcRn antibody [5] - The registrational data for brepcitinib in dermatomyositis is expected to be released in the second half of the year, which is crucial for the commercial launch [5][6] - The company has completed a $1 billion share repurchase program, reducing the share count by over 15% [8][9] Market Data and Key Metrics Changes - The company is actively involved in ongoing litigation related to LNP technology with Moderna, with a trial scheduled for March 2026 [19] - The competitive landscape includes multiple programs targeting dermatomyositis, with the company positioned as the only oral therapy in late-stage development [17][92] Company Strategy and Development Direction - The company aims to expand its commercial footprint significantly over the next few years, starting with pivotal data in dermatomyositis [7] - The focus is on clinical execution and advancing multiple registrational trials, particularly for IVT-1402 and brepcitinib [10][11] - The company is looking for opportunistic business development opportunities, especially in a choppy market [46][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data and its potential impact on the company's commercial strategy [24] - The management highlighted the importance of engaging with the physician community to ensure successful product launches [95] Other Important Information - The company is preparing for a potential launch in dermatomyositis and is actively engaging with the physician community [92][95] - The company has a robust pipeline with multiple ongoing registrational trials and is focused on clinical execution [10][68] Q&A Session Summary Question: Data availability at the time of top-line results for brepcitinib - Management expects to share top-line data along with key secondary and major safety data contemporaneously [28] Question: Trial design for the Graves trial and rationale for lower dose testing - The trial design aims to ensure FDA approval with a focus on a minimally efficacious dose [31] Question: Definition of a flare in the trial and treatment protocols - The management indicated that the definition of a flare and treatment protocols are designed to ensure accurate patient management [34][37] Question: Context around upcoming Graves remission data - Management emphasized that any meaningful remission would be practice-changing for patients and doctors [43] Question: Business development outlook and interest in the China market - The company is agnostic in its asset hunting and is actively exploring opportunities in the Chinese market [52] Question: Enrollment status for ongoing studies - Management reported that enrollment for IVT-1402 trials is on track and progressing well [68] Question: Importance of upcoming data presentation at ATA - The management aims to highlight the transformative potential of the drug for Graves' patients [72] Question: Roadmap for pivotal development and potential filing year for NIU - The company is on track to generate data for NIU by 2027, with plans for a subsequent filing [80]

Business Highlights - Roivant completed a $1.5 billion share repurchase program in June 2025, repurchasing approximately 149 million shares at an average price of $10.09, reducing the share count by over 15%[23] - The company expanded its pipeline by initiating 6 potentially registrational studies and 3 proof-of-concept (POC) studies[23] - Roivant increased shareholder exposure to clinical and litigation catalysts over the next 36 months[23] Brepocitinib Program - Topline data from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is expected in the second half of 2025[20, 27] - The VALOR study enrolled 241 adults with active DM, with 38% from the US, 32% from the EU, and 30% from the rest of the world[35] - Approximately 40% of subjects taking oral corticosteroids (OCS) at baseline in the VALOR study were able to eliminate OCS entirely by the end of the study[45] LNP Litigation - Summary judgment phase is ongoing in the US Moderna case, with a jury trial scheduled for March 2026[18, 27, 52] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing, with a decision potentially in 2025[18, 27, 52] Financial Update - Research and development (R&D) expense was $153 million, with an adjusted R&D expense of $141 million (non-GAAP)[58] - General and administrative (G&A) expense was $134 million, with an adjusted G&A expense of $63 million (non-GAAP)[58] - Roivant had $4.5 billion in cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025[58]