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Tag: guidance

  • Altria Revenue Down 3.1%, Forecasts Growth Amid Smoke-Free Push

    Altria Revenue Down 3.1%, Forecasts Growth Amid Smoke-Free Push

    Altria Group reported 2025 adjusted diluted EPS of $5.42, up 4.4% year over year, as the company highlighted momentum in its smoke-free portfolio and $8 billion in total shareholder returns through dividends and share repurchases. Full-year net revenues declined 3.1% to $23.3 billion, while revenues net of excise taxes fell 1.5% to $20.1 billion. In the fourth quarter, Altria repurchased $288 million in stock and paid $1.8 billion in dividends. The company also noted recent FDA marketing authorizations for additional on! PLUS nicotine pouch variants and continued progress under its multi-year Optimize & Accelerate cost-savings initiative.

    Altria expects 2026 adjusted diluted EPS in a range of $5.56 to $5.72, representing projected growth of 2.5% to 5.5%. Guidance assumes continued investment in smoke-free products, limited enforcement impact from illicit e-vapor products, and that NJOY ACE will not return to the market in 2026. The company reaffirmed its long-term strategy of building an FDA-authorized smoke-free portfolio while maintaining leadership in traditional tobacco, targeting mid-single-digit earnings and dividend growth through 2028.

  • New Guidance on Perception/Intention Studies

    New Guidance on Perception/Intention Studies

    The U.S. Food and Drug Administration Today issued a final guidance on guidance perception and intention studies.

    The guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).

    TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.

    These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.

    The final guidance addresses several scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:

    • Developing study aims and hypotheses
    • Designing quantitative and qualitative studies
    • Selecting and adapting measures of study constructs
    • Determining study outcomes
    • Selecting and justifying study samples
    • Analyzing study results

    The guidance document is intended to provide clarity to applicants regarding existing requirements under the law, according to FDA.

    “FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited,” the release states.