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]