Risk Factors Update Summary

• Sales of COVID-19 vaccines declined from $18.4 billion in 2022 to $6.7 billion in 2023.
• Expanding manufacturing capabilities in the United States and other countries, including Africa, Australia, Canada, and the United Kingdom. This expansion may lead to delays in capacity introduction.
• Addition of UK GDPR to compliance activities, reflecting expanded regulatory scope. This change increases compliance complexity.
• Discussion of potential regulatory changes introducing new compliance risks, enforcement actions, and lawsuits.
• Potential implications of final FDA rule allowing import of lower-priced medications from Canada. Enacted legislation could decrease prices received for products.
• Established several analytical assays to assess quality of mRNA product candidates, may need more. This could lead to delays in releasing products until rectified.
• Mention of numerous states passing comprehensive consumer privacy laws, indicating increased regulatory scrutiny.
• Anticipate lower COVID-19 vaccine sales in 2024 due to evolving market dynamics.
• Potential impact of proposed framework allowing price consideration for inventions on drug pricing regulation. The ultimate impact is currently unknown.
• Engaging additional third parties to meet capacity needs, failure could adversely affect development and distribution.
• Noting the disadvantage from competitors' faster adoption of AI technologies, affecting competitiveness.
• Increased focus on privacy and data security regulations, including GDPR and UK GDPR requirements. Non-compliance could result in fines and penalties.
• Introduction of AI Technologies risks, including potential reputational harm and liability exposure.
• Increased costs associated with exiting commitments with suppliers for raw materials and CMOs.
• Acknowledgment of potential disruptions in the supply chain due to epidemic or pandemic impacts.
• Increased investments in manufacturing processes, including the Moderna Technology Center (MTC) and other infrastructure, to support product candidates. This may require ongoing significant investments.
• Potential delays in clinical trials due to difficulty in identifying participants for investigational medicines.
• Highlighting the potential risks of false or biased outputs from AI technologies, impacting business.
• Uncertainty in obtaining and maintaining pricing and reimbursement for products in different countries.
• Potential adverse impact on business if emergency authorizations for COVID-19 vaccines are revoked.
• Risks associated with gene therapy classification of mRNA investigational medicines by regulatory authorities.