Clinical Development Failure and R&D Risk: The inherent uncertainty and high failure rate in pharmaceutical research and development mean that significant investments in drug candidates may not result in approved products, leading to substantial financial losses and delayed revenue streams.

Patent Expiration and Generic Competition Risk: Key BMY products face or will face patent expiration, exposing them to competition from lower-cost generic or biosimilar versions, which can lead to significant declines in sales and market share.

Regulatory Approval and Compliance Risk: Delays or failure to obtain necessary regulatory approvals from health authorities worldwide for new drug candidates or expanded indications can prevent market entry, while evolving regulatory requirements increase compliance costs and risks of enforcement actions.