Risk Factors Update Summary

• Expanded risk factors include potential failure of due diligence processes to identify significant problems, liabilities.
• Over the last several years all of our product revenues were derived from sales of our CF medicines. If we are not successful in commercializing CASGEVY, our revenue growth could be limited.
• Added risks related to challenges of acquired companies, products, or technology, including intellectual property issues.
• If we are unable to successfully develop, obtain approval, and commercialize treatments for acute and neuropathic pain, our business could be materially harmed.
• Increased risk of supply interruptions leading to higher operating expenses and dilutive issuances.
• Sales of our products depend on the successful development of our CF medicines, including TRIKAFTA/KAFTRIO, and securing additional approvals and reimbursements. This could impact future net product revenues.
• Enhanced risks related to patent protection uncertainty and potential infringement claims by third parties.
• The IRA Inflation Reduction Act establishes a Drug Price Negotiation Program, potentially impacting revenue.
• Added risks associated with cyber-attacks, data breaches, and inadequate insurance coverage for security breaches.
• Failure to advance product candidates through clinical trials, such as VX-864 for AATD, could impact business operations.
• Increased risk of intellectual property disputes and potential impact on business operations and reputation.
• The regulatory approval process for cell and genetic therapies involves additional consultations, costs, and potentially longer timelines compared to small molecules.
• Expanded risks related to stock price fluctuations and market volatility affecting investor perceptions.
• Achieving the anticipated benefits of any transaction and successfully integrating acquired businesses or technologies involves risks, including delays or inability to progress programs.