Financial Data and Key Metrics Changes - The company reported a loss from continuing operations, net of tax, of $166 million for the quarter [23] - Cash and cash equivalents stood at $4.4 billion, with no debt on the balance sheet, indicating a strong capital position [23][24] Business Line Data and Key Metrics Changes - The company has initiated potentially registrational trials in multiple indications, including Graves' disease, myasthenia gravis, CIDP, and others, indicating a robust pipeline [6][8] - The NDA filing for BREPO is on track for the first half of next year, which is expected to be the first novel oral therapeutic in dermatomyositis if approved [4][10] Market Data and Key Metrics Changes - The patient population for Graves' disease is significant, with approximately 880,000 diagnosed patients in the U.S., highlighting a large unmet medical need [18] - The company noted that 75% of dermatomyositis patients are currently on either steroids or immunosuppressive therapies, indicating a substantial market opportunity for new treatments [10][11] 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 [7][8] - The management emphasized the importance of addressing the unmet needs in various disease areas, particularly in Graves' disease and dermatomyositis, as part of their strategic direction [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming investor day on December 11, where they plan to provide more insights into the company's future and strategic direction [3][24] - The competitive landscape in Graves' disease is evolving, with other companies entering the space, but management believes their product has a strong competitive profile [32][63] Other Important Information - The company has a favorable marketing ruling in the Pfizer case and is making progress in the LNP litigation, with a jury trial in the Moderna case scheduled for March 2026 [6][23] - The company is considering various strategies for FDA approval and patient access for BREPO, reflecting a proactive approach to market entry [56] 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 [27][28] Question: How does Argenx stepping into Graves affect the strategy for 1402? - Management acknowledged the competitive landscape but expressed confidence in their data and the significant patient population, suggesting that increased competition could benefit all players in the space [31][33] Question: What to expect from the investor day? - Management stated that the investor day will focus on the transformation of the business and may include new data or strategic updates [35][36] Question: Can you clarify the 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 optimistic about the data from the ongoing studies [41][44] Question: What is the status of the TED study and its competitive landscape? - Management highlighted the competitive intensity in TED and indicated that they are looking forward to data that will inform their development strategy [82][83]

Financial Data and Key Metrics Changes - The company reported a loss from continuing operations, net of tax, of $166 million for the quarter [26] - Cash and cash equivalents stood at $4.4 billion, with no debt on the balance sheet, indicating a strong capital position [26][27] Business Line Data and Key Metrics Changes - The company has initiated potentially registrational trials in multiple areas including Graves' disease, myasthenia gravis, CIDP, and others, indicating a robust pipeline [6][8] - The NDA filing for BREPO is on track for the first half of next year, which could be the first novel oral therapeutic in dermatomyositis if approved [5][7] Market Data and Key Metrics Changes - The company highlighted a significant unmet need in the dermatomyositis patient population, with 75% of patients currently on either steroids or immunosuppressive therapies [11][12] - In Graves' disease, there are approximately 880,000 diagnosed patients in the U.S., with a significant portion unable to achieve well-controlled status [20][21] 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 [7][8] - The management emphasized the importance of addressing the unmet medical needs in various diseases, particularly in Graves' disease and dermatomyositis [18][19] Management Comments on Operating Environment and Future Outlook - Management expressed excitement about the transformative data from recent trials and the potential for future growth [4][9] - The company plans to provide more detailed insights into its future strategy during the upcoming investor day on December 11, 2025 [27][28] Other Important Information - The company has a favorable marketing ruling in the Pfizer case and is making progress in ongoing litigation related to LNP [6][25] - The TED study is on track to conclude this year, with top-line data expected to be reported in conjunction with data from a second study [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 be competitive [30][31] Question: Expectations for the upcoming investor day? - Management stated that the investor day will provide a comprehensive overview of the company's transformation and future opportunities [34] Question: Impact of high-dose batoclimab on remission rates in Graves' disease? - Management noted that deeper IgG reductions are expected to drive better outcomes, but they will be cautious in discussing specifics due to competition [36] Question: Update on the competitive landscape in Graves' disease? - Management highlighted the increasing competition but expressed confidence in their FcRn mechanism and the potential for their treatment to be a first-line option [44][45] Question: Plans for exploring other myositis subtypes with BREPO? - Management confirmed that they are considering various indications for BREPO and are excited about the potential opportunities [62]

Summary of Roivant Sciences Conference Call Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: BofA Global Healthcare Conference - **Date**: September 24, 2025 Key Points Industry Context - **Focus Area**: Dermatomyositis (DM) and related therapies - **Significance**: The DM treatment landscape has historically been challenging, with many drugs failing to achieve regulatory approval. The introduction of a novel therapy, BREPO, marks a significant advancement in this field [6][7][8]. BREPO Data and Implications - **Clinical Data**: The recent data from the BREPO study is viewed as a major breakthrough for the DM community, providing hope for patients who have limited treatment options [6][7]. - **Patient Impact**: BREPO offers a once-daily oral alternative to cumbersome IVIG treatments, which are difficult for patients to manage alongside their daily lives [7][8]. - **Steroid Reduction**: The study demonstrated a meaningful benefit in reducing steroid dosages for patients, which is crucial given that 75% of DM patients are treated with steroids and immunosuppressants [8]. Adoption and Market Strategy - **Adoption by Clinicians**: It is anticipated that clinicians will initially prescribe steroids and immunosuppressants before considering BREPO as a treatment option. Patients on high doses of steroids are likely to seek alternatives [10][11]. - **Target Patient Population**: Approximately 35,000 to 40,000 patients with DM are currently treated, many of whom may be eligible for BREPO [11]. - **Market Approach**: The launch strategy focuses on building strong relationships with a concentrated group of 200 referral centers, emphasizing medical engagement over traditional promotional methods [21][22]. Future Pipeline and Indications - **Additional Indications**: Roivant is studying BREPO in other indications, including non-infectious uveitis and cutaneous sarcoidosis, with plans for further exploration in rare disease settings [25][26]. - **Intellectual Property**: The company holds patent extensions for BREPO through 2039, providing a solid foundation for future development [25]. Competitive Landscape - **Market Position**: Roivant believes it occupies a unique position in the JAK inhibitor market, particularly in rare and orphan diseases, with limited direct competition in the late-stage development of JAK1/TYK2 dual inhibitors [29][30]. Regulatory Considerations - **FDA Engagement**: Discussions with the FDA regarding dosing for non-infectious uveitis have been positive, with a focus on achieving effective outcomes for patients with severe conditions [31][34]. Challenges and Considerations - **Market Dynamics**: The company acknowledges the challenges faced by previous therapies in the DM space and aims to differentiate BREPO through compelling clinical data and patient support initiatives [21][22]. - **Long-term Treatment Plans**: The approach to treatment duration will vary by patient, with some potentially requiring long-term therapy based on their individual responses [46][48]. Conclusion - Roivant Sciences is positioned to make a significant impact in the treatment of dermatomyositis and related conditions with the introduction of BREPO, supported by strong clinical data and a focused market strategy. The company is also exploring additional indications and maintaining a robust intellectual property portfolio to support future growth.