Moderna (MRNA) risk factors, FY2024 10-K

Risks related to commercialization and our products

1. 01Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines, and respiratory vaccines more generally, have in the past impacted and are likely to continue to impact our financial results
2. 02We have experienced commercial challenges and are likely to experience additional challenges in the future
3. 03The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may not compete effectively in the market for existing or new products, treatment methods or technologies
4. 04States. In some instances, our competitors have been able to offer more attractive terms than we can, and they may continue to do so in the future
5. 05We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts
6. 06We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus
7. 07The commercial success of our products depends on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community
8. 08Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules
9. 09We focus certain of our research and product development activities on treatments for severe rare genetic diseases, where the patient populations are difficult to ascertain or small. Additionally, our products may only be approved for certain populations or lines of treatment

Risks related to our pipeline, product development and regulatory review

1. 10If we cannot obtain, or are delayed in obtaining, regulatory approvals and advisory committee recommendations, we will be unable to effectively commercialize, or will be delayed in commercializing, our product candidates
2. 11Clinical development is lengthy and uncertain, and our clinical programs may be delayed or terminated, or may be more costly to conduct than we anticipate
3. 12There are risks unique to each of our programs and modalities and risks applicable across programs and modalities, which may delay or prevent our ability to advance one or more of our programs in clinical development, obtain regulatory approval or commercialize our products
4. 13We may experience delays in enrolling participants in our clinical trials
5. 14Because we are developing some of our product candidates for the treatment of diseases in which there is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA or other regulators may not consider the endpoints of our clinical trials to provide clinically meaningful results
6. 15Certain mRNA therapies are classified as gene therapies by the FDA and the EMA. The association of our products with gene therapies could result in increased regulatory burdens, impair the reputation of our products or negatively impact our platform or our business
7. 16Our products are, and any future products will be, subject to regulatory scrutiny
8. 17Preclinical development is lengthy and uncertain, especially for mRNA medicines

Risks related to the manufacturing of our commercial products and product candidates

1. 18We or our third-party manufacturers may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping for any of our products
2. 19As we grow as a commercial company and our drug development pipeline increases and matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate. We rely on third-party service providers, all of whom have inherent risks in their operations
3. 20We are subject to operational risks associated with the physical and digital infrastructure at our manufacturing facilities and those of our external service providers
4. 21costs, cause us to fail to meet certain product volume or delivery timing obligations, or may require us to identify, qualify and establish an alternative manufacturing site, which could adversely affect our business
5. 22Our products and product candidates are sensitive to shipping and storage conditions, which, in some cases, requires cold-chain logistics and subjects them to risk of loss or damage
6. 23Our manufacturing facilities or those of our third-party manufacturers or suppliers may fail to meet regulatory requirements. Failure to meet cGMP requirements could delay approval of or increase production costs for our products
7. 24we rely on foreign contract manufacturers, we are subject to additional risks, including the need to comply with import and export regulations
8. 25Our INT product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production

Risks related to our reliance on third parties

1. 26We are dependent on single-source suppliers for some of the components and materials used in, and the manufacturing processes required to develop and commercialize, our products and product candidates
2. 27We have entered, and may enter into, strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected
3. 28We may seek to establish additional strategic alliances and, if we are unable to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans. Certain of our strategic alliance agreements may restrict our ability to develop certain products

Risks related to our intellectual property

1. 29We may be unable to obtain and enforce patent protection for our discoveries and the intellectual property rights therein, or protect the confidentiality of our trade secrets
2. 30Failure to obtain and maintain all available regulatory exclusivities and broad patent scope and to maximize patent term restoration or extension on patents covering our products may lead to loss of exclusivity and early biosimilar entry resulting in a loss of market share or revenue
3. 31Uncertainty over IP in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes, which is inherently costly and unpredictable and can have adverse financial and freedom-to-operate consequences
4. 32We are, and may in the future become, involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages or be required to stop our product development and commercialization efforts
5. 33If third-party owners of any patent rights that we license do not properly or successfully obtain, maintain or enforce the patents underlying such licenses, our competitive position and business prospects may be harmed
6. 34If we fail to comply with our obligations in the agreements under which we license IP rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
7. 35We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
8. 36We may be subject to claims challenging the inventorship or ownership of our patents and other IP
9. 37Changes in U.S. patent and regulatory law could impair our ability to protect our products
10. 38We may be unable to protect our IP rights throughout the world

Risks related to our financial condition and results of operations

1. 39We incurred net losses in 2024 and 2023, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability
2. 40Our quarterly and annual operating results may fluctuate. As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline and negatively impact our financing or funding ability, as well as our ability to exist as a standalone company
3. 41The investment of our cash, cash equivalents and investments is subject to risks which may cause losses and affect the liquidity of these investments

Risks related to our business and operations

1. 42We may encounter difficulties in managing the development and expansion of our company
2. 43We are subject to the risks of doing business outside of the United States
3. 44Our failure to maintain our enterprise resource planning (ERP) system could adversely impact our business and results of operations
4. 45Our success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel
5. 46If we cannot maintain our corporate culture, we could lose the innovation, teamwork and passion that we believe contribute to our success
6. 47Our internal computer systems and physical premises, or those of third parties with which we share sensitive data or information, may fail or suffer security breaches, including from cybersecurity incidents, which could materially disrupt our product development programs and manufacturing operations
7. 48We may use our financial and human capital to pursue a particular research program or product candidate and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success
8. 49If we are not successful in discovering, developing and commercializing additional products, our ability to expand our business and achieve our strategic objectives would be impaired
9. 50Our business could be harmed if we suffer damage to our reputation, including as a result of a product recall
10. 51Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of our products
11. 52Federal legislation and actions by federal, state and local governments may permit reimportation into the United States of drugs from foreign countries where the drugs are sold at lower prices
12. 53Healthcare legislative reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business
13. 54We are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and false claims laws. If we cannot comply, or have not fully complied, with such laws, we could face substantial penalties
14. 55We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could result in fines or criminal penalties and damage our reputation
15. 56Our use of GenAI and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies
16. 57We could be adversely affected by outbreaks of epidemic, pandemic or other contagious diseases
17. 58Engaging in acquisitions, joint ventures or strategic collaborations may increase our capital requirements, dilute our shareholders and cause us to incur debt or assume contingent liabilities
18. 59The illegal distribution and sale by third parties of counterfeit or stolen versions of mRNA products could negatively impact our financial performance or reputation
19. 60Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations and financial condition
20. 61Our aspirations, goals and disclosures related to environmental, social and governance (ESG) matters expose us to numerous risks
21. 62If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

Risks related to ownership of our common stock

1. 63The price of our common stock has been volatile, which could result in substantial losses for shareholders
2. 64Our principal shareholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval
3. 65Provisions in our organizational documents, as well as provisions of Delaware law, could make it more difficult or costly for a third party to acquire us or remove our current management, even if doing so would benefit our shareholders
4. 66Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
5. 67Our employees, principal investigators and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
6. 68We could face unfavorable U.S. or global economic conditions, including as a result of disease outbreak, war, conflict or other political instability, or geopolitical risks
7. 69Employee litigation and unfavorable publicity could negatively affect our future business
8. 70Ineffective internal controls could adversely impact our business and operating results
9. 71Changes in tax law could adversely affect our business and financial condition
10. 72The increasing use of social media platforms presents risks and challenges