ImmunityBio, Inc. SEC 10-Q Report

ImmunityBio, Inc., a biotechnology company focused on developing innovative therapies for cancer and infectious diseases, has released its Form 10-Q report for the first quarter of 2025. The report provides a comprehensive overview of the company's financial and operational performance, including the initial commercial sales of its newly approved product, ANKTIVA.

Financial Highlights

• Total Revenue: $16.5 million, reflecting the initial sales of ANKTIVA following its commercial launch in May 2024.
• Loss from Operations: $(64.4) million, indicating a reduction in operating loss compared to the same period last year.
• Net Loss: $(129.7) million, showing a slight improvement from the previous year's net loss.
• Net Loss Per ImmunityBio Common Share – Basic: $(0.15), compared to $(0.20) in the prior year, reflecting a decrease in net loss per share.

Business Highlights

• Product Revenue Segments: The company reported product revenue from the U.S. sales of ANKTIVA, which began shipping to customers in May 2024. This marks the first quarter of recognized product revenue for ANKTIVA.
• Customer Concentration: During the three months ended March 31, 2025, approximately 99% of total gross revenue was derived from the top four customers, with the largest two customers each accounting for 31% of total revenue.
• New Product Launch: ANKTIVA was approved by the FDA in 2024 for use in the United States with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS. The company began commercial distribution of ANKTIVA in May 2024.
• Operational Challenges: The company is facing significant operational challenges due to its dependency on a few key customers, which exposes it to risks such as potential disruptions in the distribution network and changes in customers' business strategies.
• Future Outlook: The company anticipates the need for additional financing to fund future operations, including the commercialization of its approved product and the development of other product candidates. The company believes that existing cash, cash equivalents, and investments, along with potential equity offerings and borrowing from affiliated entities, will be sufficient to fund operations through the next 12 months.
• Inventory Management: The company has built up inventory in support of ANKTIVA's forecasted sales due to long manufacturing lead times. As of March 31, 2025, no reserve for excess quantities or obsolescence was required.
• Research and Development Focus: The company's core clinical focus is on bladder and lung cancers, with additional efforts in prostate and colorectal cancers, hematologic malignancies, and GBM. These areas are targeted due to high failure rates for existing treatments or lack of effective options.
• Geographical Operations: The company has operations and holds assets in Italy and South Korea, with the functional currency of the Italian subsidiary being the Euro.

SEC Filing: ImmunityBio, Inc. [ IBRX ] - 10-Q - May. 12, 2025