ImmunityBio, Inc. reported a net loss of $413.6 million for the year ended December 31, 2024, compared to a net loss of $583.8 million in 2023. The company's total revenue for 2024 was $14.7 million, a significant increase from $0.6 million in 2023. This increase is primarily attributed to $14.1 million in net product revenue from ANKTIVA, which received FDA approval in April 2024 and began commercial distribution in May 2024. Other revenues remained relatively consistent year-over-year.
Research and development expenses decreased by $42.2 million in 2024 compared to 2023, primarily due to a reduction in external expenses. Conversely, selling, general, and administrative expenses increased by $39.2 million, largely driven by higher legal expenses, increased consulting fees, and higher salary and benefit costs. Other income (expense), net, improved significantly, increasing by $152.2 million, primarily due to changes in the fair value of convertible notes and warrant liabilities.
Significant developments since the September 30, 2024 quarterly report include the assignment of a J-code for ANKTIVA, resulting in a 97% increase in February 2025 unit sales compared to December 2024. Marketing Authorization Applications (MAAs) for ANKTIVA were submitted to the UK's MHRA and the EU's EMA in late 2024 and accepted for review in early 2025. A collaboration agreement with BeiGene (to be renamed BeOne Medicines) was announced for a Phase 3 clinical trial combining tislelizumab and ANKTIVA. Finally, the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA and PD-L1 t-haNK in combination with chemotherapy/radiotherapy for the treatment of metastatic pancreatic cancer.
ImmunityBio's pipeline includes cytokine fusion proteins (ANKTIVA), DNA and vaccine vectors (hAd5), and cell therapies (t-haNK and M-ceNK). The company's strategy focuses on advancing ANKTIVA commercialization, accelerating product candidates with registrational intent, refining its pipeline, and cultivating collaborations. As of December 31, 2024, ImmunityBio employed 680 people across the U.S. and Italy. The company's financial condition includes significant debt, including a $505 million convertible promissory note held by a related party and a revenue interest liability exceeding $300 million resulting from a revenue interest purchase agreement. The company anticipates needing additional financing to fund its operations and commercialization efforts. The company's outlook includes several planned regulatory submissions in 2025 and beyond, including potential BLAs for additional ANKTIVA indications and other product candidates.
About ImmunityBio, Inc.
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