US FDA might not decide on Philip Morris: IQOS Iluma until 2026
ByAinvest
Tuesday, Jul 22, 2025 9:56 am ET1min read
US FDA might not decide on Philip Morris: IQOS Iluma until 2026
Philip Morris International (PMI) has recently seen a delay in the U.S. Food and Drug Administration (FDA) decision regarding its IQOS Iluma heated tobacco device. The FDA has not yet made a final determination on the product's marketing application, which was submitted by PMI in 2023. This delay could potentially impact PMI's revenue and market share in the U.S. heated tobacco market [1].The IQOS Iluma is part of PMI's broader strategy to transition from traditional cigarettes to reduced-risk products. The device uses heated tobacco technology to deliver nicotine without combustion. PMI had initially expected the FDA to make a decision on the product by the end of 2025. However, the agency has yet to provide a timeline for its review [1].
The delay in the FDA's decision comes at a critical time for PMI, as the company has been investing heavily in its heated tobacco and nicotine pouch businesses. In the first quarter of 2025, PMI reported a 25% increase in revenue from its heated tobacco and nicotine pouch products. However, the company's overall earnings per share (EPS) for the quarter were $1.91, slightly above the FactSet estimate of $1.86 [1].
The delay in the FDA's decision could also have implications for PMI's stock price. Investors have been closely watching the agency's review process for the IQOS Iluma, as a positive decision could open up a significant new market for PMI. However, the delay could lead to uncertainty and potentially impact investor sentiment [1].
In the meantime, PMI continues to focus on expanding its heated tobacco and nicotine pouch businesses globally. The company recently launched its IQOS Curious X campaign in the Philippines, which aims to introduce new consumers to the IQOS heated tobacco system [1].
References:
[1] https://www.marketscreener.com/news/earnings-flash-pm-philip-morris-international-inc-posts-q2-adjusted-eps-1-91-per-share-vs-fact-ce7c5cdcd089ff26
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue
Comments
No comments yet