Risk Factors Update Summary

• Roxadustat has been approved in the European Union and the United States. Roxadustat is now being developed for anemia in patients with myelodysplastic syndromes (MDS). This expansion could significantly increase the market potential for roxadustat.
• Geopolitical tensions in China may impact market demand, with potential supplier consequences. Legislation risks expanding.
• The termination of the AstraZeneca U.S./RoW Agreement on February 23, 2024, may impact the development and commercialization of roxadustat. This termination eliminates potential milestones and payments, affecting revenue projections.
• Roxadustat's inclusion in China's National Reimbursement Drug List led to a 7% price reduction.
• The company is investing in new drug programs to expand its early-stage oncology pipeline. While these programs show potential value, success is not guaranteed, and they are years away from development.
• Risk of roxadustat tender in China could constrain market access and further reduce prices.
• The company is transitioning its manufacturing responsibilities to another party, which poses risks during and after the transition. This change could lead to unforeseen financial losses and operational disruptions.
• Sales of roxadustat in China may be limited due to pricing controls and potential competition.
• The company faces substantial competition in the pharmaceutical industry, especially as patents expire, allowing generic competition. This competition could lead to a rapid reduction in sales and operating income for the company's branded products.
• Long-lived asset impairment risk could adversely affect financial performance and results of operations.
• The company relies heavily on third parties for manufacturing, distribution, and other operations. Any disruptions or failures by these third parties could impact the company's business operations and financial condition.
• Financing agreements with NovaQuest and Morgan Stanley impose performance obligations and financial risks.
• The company is subject to evolving data privacy and security laws globally, which could increase compliance costs and legal risks. Non-compliance with these laws may lead to investigations, enforcement actions, and adverse consequences.
• Data breach risks include potential competitive exposure and operational disruptions, despite current impact uncertainty.