Financial Position - As of December 31, 2024, the company had cash and cash equivalents, and marketable securities of $149.8 million, down from $267.4 million as of December 31, 2023[696]. - The company has a total indebtedness payable at maturity of $505.0 million as of December 31, 2024[706]. - As of December 31, 2024, the company had $143.4 million in cash and cash equivalents and $6.4 million in its investment portfolio[763]. - Cash and cash equivalents, and restricted cash at the end of 2024 were $143.912 million, down from $265.787 million at the end of 2023, reflecting a decrease of 46%[803]. - Total assets decreased to $382.933 million in 2024 from $504.452 million in 2023, reflecting a 24.1% decline[786]. - Total liabilities were $871.062 million in 2024, down from $1.090 billion in 2023, a reduction of 20.1%[786]. - Total stockholders' deficit as of December 31, 2024, was $488.129 million, compared to $585.937 million as of December 31, 2023, indicating a reduction of approximately 17%[798]. Operating Performance - For the year ended December 31, 2024, net cash used in operating activities was $391.2 million, compared to $366.8 million for the year ended December 31, 2023[710][711]. - The company reported a net loss of $413.6 million for the year ended December 31, 2024, compared to a net loss of $583.9 million for the year ended December 31, 2023[710][711]. - The net loss for the year ended December 31, 2024, was $413.645 million, a decrease from the net loss of $583.852 million in 2023, representing a 29% improvement[801]. - The net loss for 2024 was $413.645 million, an improvement compared to a net loss of $583.852 million in 2023[790]. - The company reported a net loss per share of $0.59 for 2024, compared to $1.15 in 2023, indicating an improvement in loss per share[788]. Revenue Generation - Total revenue for 2024 was $14.745 million, a significant increase from $622 thousand in 2023[788]. - Product revenue for 2024 reached $14.150 million, while there was no product revenue reported in 2023[788]. - The company began generating revenue from ANKTIVA after receiving FDA approval in April 2024, with commercial distribution starting in May 2024[720]. - Revenue from the sale of ANKTIVA began to be recognized in accordance with ASC 606 following its FDA approval[823]. - Future revenue generation from ANKTIVA is uncertain, with expectations for significant revenue taking time to establish[720]. - For the year ended December 31, 2024, approximately 92% of total gross revenue was generated from the top three customers, with the largest customer accounting for 38% of total revenue[838]. Financing Activities - During 2024, institutional holders exercised a total of 22,242,740 warrants at an exercise price of $3.2946 per share, resulting in proceeds of $73.3 million[699]. - The company recorded $281.6 million in financing activities, a decrease from $558.3 million in 2023[709]. - Net cash provided by financing activities for the year ended December 31, 2024, was $281.6 million, a decrease from $558.3 million in 2023[716][717]. - The financing activities in 2024 included $111.4 million from equity offerings and $97.0 million from payments received under the RIPA[716]. - The company raised $111.357 million from equity offerings in 2024, an increase from $100.561 million in 2023[802]. - The company may seek additional financing through equity offerings or subordinated debt to support future operations and product commercialization[821]. Research and Development - Research and development costs include cash compensation, clinical trial costs, and other expenses, which are expensed as incurred[749]. - Research and development expenses for 2024 were $190.144 million, down from $232.366 million in 2023, indicating an 18.1% decrease[788]. - The company classifies its research and development expenses as either external or internal, with external expenses supporting various preclinical and clinical programs[892]. - Research and development costs include clinical trial and research expenses based on contracts with research institutions and clinical research organizations[893]. Stock-Based Compensation - Stock-based compensation expense for 2024 was $34.432 million, down from $49.163 million in 2023, showing a reduction of 30%[801]. - The company recognizes stock-based compensation expense over the vesting period, with performance-based awards assessed for milestone achievement probability[759]. - Stock-based compensation is accounted for under ASC 718, with fair value estimated using the Black-Scholes option pricing model[894]. Debt and Interest - The company has a $505.0 million variable-rate loan outstanding, maturing on December 31, 2027, with a weighted-average interest rate of 12.34%[766][767]. - A hypothetical 100-basis point increase in the Term SOFR rate would increase future interest payments by $15.2 million[767]. - The company evaluates debt modifications based on changes in cash flows and fair value, applying extinguishment accounting if changes exceed 10%[757]. Regulatory and Compliance - The FDA approved the company's lead product, ANKTIVA, on April 22, 2024, for the treatment of adult patients with BCG-unresponsive NMIBC, and commercial distribution began in May 2024[813]. - The company recognizes product revenue when ANKTIVA is delivered to the end user, with revenue recorded at wholesale acquisition cost, net of variable considerations[826]. Risk Management - The company maintains regular communication with existing customers to ensure alignment with business objectives, mitigating risks associated with dependency on a limited number of customers[839]. - The company has not incurred any material effects from foreign currency changes on contracts, and a 10% adverse change in exchange rates would not have been material[769]. - The company does not believe inflation has had a material effect on its business or financial condition for any period presented[772].
ImmunityBio(IBRX) - 2024 Q4 - Annual Report