Risk Factors Update Summary

• The company completed a $575 million offering of 1.75% Notes in April 2023 and used $488.2 million of the net proceeds to repurchase $504.4 million of 0.125% Notes. This financial restructuring may impact future financing.
• The company must continue to invest significant financial and management resources to scale-up internal support functions. This may result in substantial expenditures to build a new manufacturing facility and train additional staff.
• The company's accumulated deficit was approximately $1.48 billion as of December 31, 2023. This historical loss may impact financial stability and future operations.
• The company's cash, cash equivalents, and short-term investments decreased from $2.3 billion in 2022 to $2.0 billion in 2023. This decrease may impact the ability to meet commercialization goals.
• The company relies on third parties for manufacturing and clinical trials. Failures of these third parties could impact marketing authorization and commercialization, potentially harming revenues.
• The closing market price of the company's common stock ranged from $48 to $82 per share in the 12 months preceding December 31, 2023. This volatility may affect the price of securities.
• The company's operations are subject to extensive legal and regulatory requirements, including federal and state anti-kickback laws. Compliance with these laws is crucial for business operations.