Immunovant(IMVT) - 2024 Q4 - Annual Results

Corporate and Clinical Development Updates Immunovant strategically prioritizes IMVT-1402 for broad autoantibody-driven diseases, planning extensive late-stage clinical expansion and securing a key U.S. patent General Clinical Development Updates Immunovant prioritizes IMVT-1402 for autoantibody-driven diseases, planning 4-5 registrational studies by March 2025 and securing a U.S. patent until 2043 - Immunovant is prioritizing the development of IMVT-1402 as its lead asset, citing its potential best-in-class features for treating a wide range of autoantibody-driven indications[4] - The company plans to initiate 4-5 potentially registrational programs for IMVT-1402 by March 31, 2025, and expand to a total of 10 indications by March 31, 2026, covering areas like Endocrinology and Neurology[5][7] - A new U.S. Patent (No. 11,926,669) has been awarded for IMVT-1402, covering its composition of matter, with the patent term extending until June 2043[6] - Key data readouts are expected in the current fiscal year, including topline data for batoclimab in Myasthenia Gravis (MG) and detailed results for Graves' disease in the fall of 2024[7] Neurology Clinical Development Updates Immunovant plans a registrational program for IMVT-1402 in MG this fiscal year, while extending the batoclimab CIDP trial to optimize future IMVT-1402 studies - A potentially registrational program for IMVT-1402 in Myasthenia Gravis (MG) is expected to be initiated this fiscal year, with a final decision based on topline results from the current batoclimab trial, expected by March 31, 2025[8] - The company is extending the ongoing batoclimab CIDP trial by about two quarters before unblinding, aiming to use data from this trial and learnings from other CIDP studies to optimize the design of a future IMVT-1402 CIDP trial[9][10] Endocrinology Clinical Development Updates Detailed batoclimab Graves' disease results and IMVT-1402 program overview are due in fall 2024, with a TED asset decision expected in early 2025 - Detailed results from the batoclimab study in Graves' disease and an overview of the IMVT-1402 development program are expected to be announced in the fall of 2024[11] - For Thyroid Eye Disease (TED), a decision on which asset (batoclimab or IMVT-1402) to advance to registration will be made in the first half of calendar year 2025, coinciding with the release of topline data from the current batoclimab TED program[12] Financial Results Immunovant reported increased net losses for both the fourth quarter and full fiscal year 2024, primarily driven by higher R&D expenses, while maintaining a strong cash position Fourth Quarter Fiscal Year 2024 Financial Highlights Immunovant reported a $75.3 million net loss for Q4 FY2024, driven by increased R&D expenses, while maintaining a strong $635 million cash position - As of March 31, 2024, the company's cash and cash equivalents totaled approximately $635 million[13] Fourth Quarter Fiscal Year 2024 Financial Metrics | Financial Metric | Three Months Ended March 31, 2024 (Millions USD) | Three Months Ended March 31, 2023 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $66.1 | $51.8 | | G&A Expenses | $14.8 | $12.4 | | Net Loss | $75.3 | $59.4 | | Net Loss per Share | $0.52 | $0.46 | Fiscal Year 2024 Financial Highlights Immunovant's full fiscal year 2024 net loss widened to $259.3 million, primarily due to increased R&D and G&A expenses, alongside acquired in-process R&D costs Fiscal Year 2024 Financial Metrics | Financial Metric | Fiscal Year Ended March 31, 2024 (Millions USD) | Fiscal Year Ended March 31, 2023 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $212.9 | $160.3 | | IPR&D Expenses | $12.5 | $10.0 | | G&A Expenses | $57.3 | $48.0 | | Net Loss | $259.3 | $211.0 | | Net Loss per Share | $1.88 | $1.71 | Consolidated Financial Statements Immunovant's consolidated financial statements reflect increased operating expenses and a widened net loss for fiscal year 2024, alongside a strengthened balance sheet with higher assets and equity Consolidated Statements of Operations Total operating expenses increased to $282.7 million in fiscal year 2024, leading to a net loss of $259.3 million, primarily due to higher R&D and G&A costs Consolidated Statements of Operations (Thousands USD) | (In thousands) | Year Ended March 31, 2024 | Year Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $212,928 | $160,257 | | Acquired in-process R&D | $12,500 | $10,000 | | General and administrative | $57,281 | $48,019 | | Total operating expenses | $282,709 | $218,276 | | Interest income | ($24,948) | ($7,578) | | Net loss | ($259,336) | ($210,960) | Consolidated Balance Sheets Immunovant's total assets grew to $666.4 million by March 31, 2024, driven by increased cash and equivalents, resulting in a substantial rise in stockholders' equity Consolidated Balance Sheets (Thousands USD) | (In thousands) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $635,365 | $376,532 | | Total current assets | $665,770 | $404,333 | | Total assets | $666,365 | $405,838 | | Liabilities and Equity | | | | Total current liabilities | $48,608 | $43,297 | | Total liabilities | $48,608 | $43,344 | | Total stockholders' equity | $617,757 | $362,494 | | Total liabilities and stockholders' equity | $666,365 | $405,838 |