Risk Factors Update Summary

• Filed additional lawsuits against Pfizer and Moderna seeking damages for infringing U.S. Patent No. 11,590,229, added U.S. Patent Nos. 11,633,479, 11,633,480, and 11,612,657. This may result in significant legal costs and potential damages.
• Delays in obtaining supplies for pre-clinical studies could impair completion and delay submissions.
• Material risks added include the need for substantial funds for research, development, and commercialization activities.
• Serious adverse events may lead to the suspension or termination of clinical trials, impacting timelines.
• Legislative and regulatory proposals may impact pharmaceutical pricing, potentially reducing prices and affecting reimbursement.
• The IRA includes provisions impacting business, such as potential rebates for Medicare Part B or D drugs.
• The company may require greater funds than estimated, potentially leading to critical limitations or scaling back activities.
• Markman hearing held in the U.S. District Court for the District of Delaware to consider disputed terms in patents. Jointly agreed to final judgment of non-infringement of two patents with Moderna. Appeal filed against claim construction ruling. This legal process may impact the company's intellectual property rights and financials.
• The ongoing utilization of facilities could impede ongoing supply, impacting revenues and business.
• Difficulty enrolling in clinical trials due to existing treatments could result in increased costs and longer development times.
• Proposed measures by the Biden administration could lower prescription drug prices, impacting pricing strategies.
• Loss of senior management could significantly delay workforce growth and impact commercialization efforts.
• Risks related to dependence on third parties for alliances, collaborations, and potential delays in product development.
• Delays in manufacturing processes could result in supply delays, affecting meeting commercial demands.
• Sales of common stock fluctuated between $148.10 and $242.39 per share in 2023. The market price volatility could be influenced by various factors, including financial results, product developments, and market conditions.
• Risks related to the need to continue growing manufacturing capabilities and resources, incurring significant costs.
• Issued $1.02 billion in aggregate principal amount of 1% Convertible Senior Notes due 2027, later increased to $1.04 billion. The interest rate for the Notes may impact the company's debt obligations and financial flexibility.
• State governments are implementing regulations to control pharmaceutical pricing, affecting product pricing and access.
• Failure by third-party service providers to meet deadlines could result in delays or termination.
• Risks associated with limited manufacturing experience and reliance on third-party manufacturers for drug substance supply.
• Faces competition in the pharmaceutical market from companies with substantially greater resources, experience, and approved products. Competitors' products may be more effective, safer, or marketed better, impacting the company's market position.
• Increasingly aggressive measures by governments and hospitals may reduce demand for products and pressure pricing.
• Competes with companies developing RNAi and antisense-based drugs. Competitors' advancements in delivery technologies could affect the successful commercialization of the company's products. Intense competition may impact the company's ability to execute its business plan.
• Ongoing initiatives in the U.S. may increase pressure on drug pricing, affecting revenues and product development.
• Risks related to the limited number of CMOs with expertise to manufacture synthetic siRNAs, potentially impacting clinical trials and commercial supply.
• Holders of the Notes have the right to convert them into cash or common stock. The conversion feature may affect the company's balance sheet classification and diluted earnings per share calculations.
• Compliance with anti-corruption laws is crucial, with potential fines, penalties, and reputational harm for violations.
• Risks associated with the need to secure alternative suppliers for synthetic siRNAs due to limited availability, potentially leading to delays or supply shortages.