US FDA might not decide on Philip Morris: IQOS Iluma until 2026

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