ImmunityBio reported strong preliminary results for Q4 FY2025, driven by significant year-over-year growth in net product revenue for ANKTIVA® and positive regulatory updates, including its first global approval for a new indication and administration route.
Full year preliminary net product revenue of approximately $113.0 million, a ~700% increase year-over-year.
positiveQ4 preliminary net product revenue of approximately $38.3 million, a 20% quarter-over-quarter increase and a 431% increase over the prior year quarter.
positiveANKTIVA Unit Growth: 750% unit sales volume growth in 2025 compared to 2024.
positiveSaudi FDA granted approval of ANKTIVA® in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC), marking the Company’s first global approval for this indication and the first approval for subcutaneous administration.
positiveSaudi FDA also approved ANKTIVA® in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer CIS.
positiveEnrollment in the ongoing Phase 2b QUILT-2.005 trial evaluating ANKTIVA® plus intravesical BCG in first-line, BCG-naïve NMIBC is progressing ahead of internal expectations.
positiveThe reported financial results are preliminary estimates and may differ materially from the actual results once finalized.
attentionThe company is still in the commercial stage and relies heavily on the success and adoption of ANKTIVA, with limited diversification of revenue streams.
attentionMargin metrics will be available once backend extracts data from insights_json
"We delivered strong quarter-over-quarter revenue growth, reflecting accelerating adoption of ANKTIVA and the continued execution of our commercial strategy."
"This momentum is further reinforced by the approval of ANKTIVA plus BCG in Saudi Arabia, building on existing approvals in the U.S. and U.K, as well as conditional approval in the EU."
The SFDA’s approval of ANKTIVA in combination with a checkpoint inhibitor for non-small cell lung cancer marks the world’s first approval of an IL-15 superagonist used in combination with checkpoint therapy.
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