Financial Data and Key Metrics Changes - The company reported a non-GAAP net loss of $167 million for the quarter, with R&D expenses of $165 million and G&A expenses of $175 million [35][36] - The company maintains a strong cash position with $4.5 billion in consolidated cash, providing ample capital to reach profitability [35][36] Business Line Data and Key Metrics Changes - The NDA for BREPA in dermatomyositis has been submitted, and the phase 2B study for 1402 in DGTRA has fully enrolled [6][7] - The phase 2 study for Moseley and PHLD has also fully enrolled, indicating strong progress across multiple programs [6][7] Market Data and Key Metrics Changes - The company highlighted a significant unmet need in the sarcoidosis market, with no approved therapies currently available for cutaneous sarcoidosis [13][14] - Approximately 40,000 patients are estimated to be eligible for BREPA therapy, indicating a substantial market opportunity [82] Company Strategy and Development Direction - The company is focused on expanding the development of BREPA into additional indications, emphasizing the strong efficacy demonstrated in clinical trials [40][41] - The strategic direction includes pursuing first-in-class therapies in orphan inflammatory diseases, which are areas of high unmet need [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the strong phase 2 data for BREPA, indicating a promising future for the drug in treating sarcoidosis [28][29] - The company anticipates a busy year ahead with multiple pivotal study readouts and potential commercial launches [36][37] Other Important Information - The company is preparing for a jury trial against Moderna scheduled for March 9, with recent favorable decisions regarding summary judgment [35][36] - The company is also exploring further development opportunities for brepocitinib in other forms of sarcoidosis and related conditions [88][99] Q&A Session Summary Question: What are the further development expansion opportunities for brepocitinib? - Management expressed enthusiasm for further development, highlighting the strong efficacy data and the potential for brepocitinib to address high unmet needs in various patient populations [40][41] Question: Can you provide more details on the baseline characteristics of the CSAMI numbers? - Management noted that there were significant differences in baseline characteristics, including disease duration and morphology, which may have influenced the results [48][49] Question: What is the expected pricing strategy for BREPA? - Management indicated that pricing has not been finalized but will likely be positioned as an orphan-priced drug, considering the existing market prices for similar therapies [54][55] Question: How broad is the opportunity for brepocitinib? - Management stated that there are many unexplored indications where JAK inhibitors could be beneficial, emphasizing the unique mechanism of TYK2 and JAK1 inhibition [99][100]

Immunovant (NasdaqGS:IMVT) Q3 2026 Earnings call February 06, 2026 08:00 AM ET Speaker1Good day, and thank you for standing by. Welcome to the Roivant third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your ques ...