ImmunityBio sees Q1 sales surge, submits FDA applications

Published 15/04/2025, 13:10
ImmunityBio sees Q1 sales surge, submits FDA applications

CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ: IBRX), a biotechnology firm specializing in immunotherapy, reported a significant increase in sales and has made key regulatory submissions to the U.S. Food and Drug Administration (FDA). The company’s stock has shown strong momentum, gaining over 19% in the past week according to InvestingPro data, though trading at a relatively high revenue multiple. The company announced that its first-quarter sales for 2025 surged by 129% compared to the final quarter of 2024, with estimated net product revenue reaching approximately $16.5 million. This growth aligns with the company’s impressive revenue CAGR of 46% over the past five years, though InvestingPro analysis indicates the company is currently burning through cash rapidly with negative free cash flow of $398 million in the last twelve months.

The sales boost follows the award of a permanent J-code in January 2025, which has evidently contributed to a 150% growth in ANKTIVA unit sales volume over the previous quarter. ANKTIVA, ImmunityBio’s immunotherapy product, has also seen a 69% month-over-month increase in sales volume for March compared to February.

Regarding regulatory advancements, ImmunityBio completed a supplemental Biologics License Application (sBLA) in Q1 for ANKTIVA combined with Bacillus Calmette-Guérin (BCG) to address BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with a focus on papillary disease. The sBLA submission includes clinical data indicating that the combination therapy may help avoid radical cystectomy, a surgery with high morbidity and mortality rates. Research suggests that ANKTIVA plus BCG may lead to durable complete remissions in a significant number of patients with papillary NMIBC.

In addition, the company has submitted an Expanded Access Protocol (EAP) for ANKTIVA to treat lymphopenia, which often results from chemotherapy, radiation, and other cancer treatments. The EAP, if authorized, would allow early access to ANKTIVA for patients and physicians. This comes after ImmunityBio received a Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA in treating lymphopenia earlier in Q1.

The company’s investor day will feature discussions on ImmunityBio’s platform with thought leaders in the medical field. The financial figures reported are preliminary estimates and are subject to final adjustments, which will be disclosed in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

This news is based on a press release statement from ImmunityBio, Inc. and does not constitute an endorsement of the company or its products. With the next earnings report due on May 8, 2025, investors seeking deeper insights into ImmunityBio’s financial health and growth prospects can access additional analysis and 8 more exclusive ProTips through InvestingPro.

In other recent news, ImmunityBio, Inc. reported impressive fourth-quarter financial results, with an adjusted loss of $0.09 per share, surpassing analyst expectations of a $0.17 loss per share. Revenue for the quarter rose to $7.2 million, significantly higher than the previous year and above the forecasted $6.16 million, driven by sales of its ANKTIVA therapy. The company also secured $75 million in gross proceeds from a direct offering, with potential additional funds from warrants. This financial move aims to support ongoing clinical programs and operational goals. In a strategic shift, ImmunityBio appointed Deloitte & Touche LLP as its new independent auditor, replacing Ernst & Young LLP. Meanwhile, H.C. Wainwright maintained a Buy rating for the company, setting a price target of $8.00, reflecting confidence in ImmunityBio’s market strategy. The firm’s analysis emphasized the importance of the FDA’s Expanded Access Program for recombinant BCG, addressing a significant treatment shortage. These developments mark critical progress for ImmunityBio as it continues to expand its therapeutic offerings.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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