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]

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]