8-K: ImmunityBio Reports Strong ANKTIVA Sales Growth Following J-code Issuance, Announces Year-End 2024 Financial Results

ImmunityBio reports significant sales momentum and unit growth for ANKTIVA following the issuance of a permanent J-code in January 2025, along with financial results for the year ended December 31, 2024.

Summary

• ImmunityBio announced a 97% increase in ANKTIVA unit sales volume in February 2025 compared to December 2024, driven by the permanent J-code issuance in January 2025.
• Sales volume in February 2025 increased by 67% compared to January 2025, and the combined sales for January and February 2025 exceeded the total units sold in Q4 2024.
• For the three months ended December 31, 2024, ImmunityBio achieved net product revenue of approximately $7.2 million, a 21% increase compared to the $6.0 million in the prior quarter.
• The FDA authorized expanded access of an alternative source of BCG in February 2025, with over 45,000 doses available to address the BCG shortage.
• Global submissions of marketing authorization applications (MAAs) for ANKTIVA in combination with BCG have been accepted for review by the MHRA and EMA in February 2025.
• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ANKTIVA and CAR-NK in combination with standard-of-care chemotherapy/radiotherapy in February 2025.
• Over 100 participants have been enrolled in a cancer prevention trial evaluating ANKTIVA in subjects with Lynch Syndrome.
• The company had consolidated cash and cash equivalents, and marketable securities of $149.8 million as of December 31, 2024.
• Net loss attributable to ImmunityBio common stockholders was $59.2 million for the three months ended December 31, 2024, compared to $233.4 million for the same period in 2023.
• Net loss attributable to ImmunityBio common stockholders was $413.6 million for the year ended December 31, 2024, compared to $583.2 million for the year ended December 31, 2023.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with strong sales growth, regulatory achievements, and reduced losses. The RMAT designation and global expansion efforts further contribute to a favorable sentiment.

Positives

• The issuance of the permanent J-code for ANKTIVA in January 2025 has driven significant sales growth.
• The FDA authorization of expanded access to recombinant BCG addresses the TICE BCG shortage.
• The RMAT designation from the FDA could expedite the development and review of ANKTIVA and CAR-NK therapy.
• The company is expanding globally with MAA submissions accepted for review in Europe and the UK.
• Net losses have decreased significantly year-over-year and quarter-over-quarter.

Negatives

• The company reported a net loss of $413.6 million for the year ended December 31, 2024.
• Selling, general and administrative expenses increased $39.2 million to $168.8 million during the year ended December 31, 2024.

Risks

• The company's future performance depends on successful commercial launch execution and market access initiatives.
• Regulatory submissions are subject to review and approval processes with uncertain timelines.
• The company's ability to fund ongoing and anticipated clinical trials is a risk.
• Potential product shortages or manufacturing disruptions may impact product availability.
• The company's ability to obtain, maintain, protect, and enforce patent protection is a risk.

Future Outlook

The company anticipates continued growth and execution on its ambitious plans for the year, driven by the approval of ANKTIVA, the permanent J-code, the expanded access of recombinant BCG, global marketing submissions, the collaboration with BeOne, and the RMAT designation.

Management Comments

• Dr. Patrick Soon-Shiong stated that the first quarter of 2025 has been an inflection point for the Company with multiple milestones achieved.
• Dr. Soon-Shiong noted that the RMAT designation positions ANKTIVA to be the backbone of the company's strategy for Immunotherapy 2.0 beyond checkpoints and the potential foundation of this first-in-class IL-15 receptor superagonist as a therapeutic cancer vaccine.

Industry Context

The announcement highlights ImmunityBio's progress in the competitive immunotherapy landscape, particularly in bladder cancer and cancer prevention. The collaboration with BeOne Medicines to combine ANKTIVA with tislelizumab, a PD-1 checkpoint inhibitor, reflects a broader industry trend of combining immunotherapeutic agents to improve overall survival in patients with advanced cancers. The RMAT designation underscores the potential of cell therapies in treating serious diseases.

Comparison to Industry Standards

• The 21% quarter-over-quarter increase in net product revenue is a positive sign, but it's important to compare this growth rate to other companies in the immunotherapy space, such as Bristol Myers Squibb (Opdivo) or Merck (Keytruda), to assess its relative strength.
• The RMAT designation for ANKTIVA and CAR-NK is a significant achievement, placing ImmunityBio in a similar category as companies like Novartis (Kymriah) and Gilead (Yescarta) who have also received RMAT designations for their cell therapies.
• The collaboration with BeOne Medicines to combine ANKTIVA with tislelizumab is similar to other partnerships in the industry, such as AstraZeneca's collaboration with Daiichi Sankyo to combine Enhertu with checkpoint inhibitors, aiming to improve treatment outcomes in cancer patients.
• The availability of 45,000 vials of rBCG to address the BCG shortage is a positive development, but it's important to monitor the actual utilization rate and compare it to the demand for BCG in the United States to assess its impact on patient access.

Stakeholder Impact

• Shareholders: Positive impact due to increased sales, reduced losses, and regulatory achievements.
• Patients: Improved access to treatment options for bladder cancer and potential for new therapies through clinical trials.
• Employees: Positive impact due to company growth and expansion.
• Urologists: Increased adoption of ANKTIVA by urologists for BCG unresponsive non-muscle invasive bladder cancer CIS.

Next Steps

• Continue commercialization efforts for ANKTIVA.
• Advance clinical trials for ANKTIVA and other product candidates.
• Pursue regulatory approvals in Europe and the UK.
• Monitor the utilization of rBCG under the Expanded Access Program.
• Host the Analyst Investor Day Conference in April 2025.

Key Dates