Moderna (MRNA) FY2025 10-K Risk Factors: 10 New, 9 Dropped

What the changes say

Regulatory uncertainty, vaccine demand, pricing policy and trade restrictions now receive greater emphasis.
Execution risk centers on launching infectious-disease products while funding oncology and rare-disease programs through cost controls.
Organizational restructuring, credit-agreement compliance and manufacturing-network complexity add company-specific financial and operational pressure.

What changed since the prior 10-K

New

NewRisks related to commercialization and our products
Regulatory and market uncertainty have and may continue to impact our business and the markets for our products
Changing FDA policies, post-marketing requirements, CDC/ACIP recommendations and vaccination behavior could reduce vaccine approvals, demand or increase costs.
NewRisks related to commercialization and our products
We may experience difficulties executing our near-term strategy and prioritized pipeline
Failure to launch infectious-disease products and execute cost reductions could impair pipeline investment and prevent Moderna from reaching cash breakeven.
NewRisks related to commercialization and our products
Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models and other, similar regulatory actions could impact our product revenues and materially harm our business
U.S. most-favored-nation or reference pricing could reduce product revenue and complicate international pricing, reimbursement and market access.
NewRisks related to our pipeline, product development and regulatory review
mRNA drug development involves substantial clinical and regulatory risks, and negative perceptions of our platform, products and product candidates could adversely affect our business and ability to obtain regulatory approvals
Unexpected safety findings, including myocarditis or pericarditis, could damage confidence in Moderna’s mRNA platform and delay other programs.
NewRisks related to our pipeline, product development and regulatory review
Although we have obtained rare pediatric disease designation for mRNA-3927, we may not be eligible to receive a priority review voucher in the event the FDA determines we no longer meet the criteria for designation, revokes the designation or FDA approval does not occur by September 30, 2029
mRNA-3927 may lose rare pediatric disease eligibility or fail to gain approval before September 30, 2029, eliminating a potential priority review voucher.
NewRisks related to our financial condition and results of operations
Failure to comply with the covenants in our credit agreement could adversely affect our business
Credit-agreement covenant violations could trigger default, accelerate secured debt and allow lenders to pursue Moderna’s collateral.
NewRisks related to our business and operations
We may encounter difficulties in managing changes to the size, structure and scope of our company
Restructuring and portfolio changes could weaken management capacity, employee retention, institutional knowledge and execution across multiple therapeutic areas.
NewRisks related to our business and operations
Evolving environmental, social and governance (ESG) standards and expectations may expose us to numerous risks
Evolving ESG standards and customer expectations could increase reporting complexity, affect investor inclusion and reduce competitiveness in non-U.S. tenders.
NewRisks related to ownership of our common stock
We do not expect to pay cash dividends for the foreseeable future
Moderna expects no cash dividends, while credit restrictions may limit distributions and shareholder returns depend primarily on stock appreciation.
NewRisks related to ownership of our common stock
Changes in tariffs and other governmental trade policies could negatively affect our business and results of operations
Tariffs and retaliatory trade measures could increase supply costs, delay materials or require supplier changes, reducing margins and profitability.

Dropped

DroppedRisks related to commercialization and our products
Uncertainty 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
Uncertainty in COVID, RSV and respiratory-vaccine demand and revenue forecasting.
DroppedRisks related to commercialization and our products
States. 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
DroppedRisks related to commercialization and our products
We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts
DroppedRisks related to commercialization and our products
We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus
Competitors offering more attractive commercial terms.
DroppedRisks related to the manufacturing of our commercial products and product candidates
costs, 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
Failure to execute cost-efficiency and portfolio-prioritization programs.
DroppedRisks related to the manufacturing of our commercial products and product candidates
we rely on foreign contract manufacturers, we are subject to additional risks, including the need to comply with import and export regulations
Delays or reduced effectiveness in updating COVID vaccines for new variants.
DroppedRisks related to our business and operations
We may encounter difficulties in managing the development and expansion of our company
DroppedRisks related to our business and operations
Our aspirations, goals and disclosures related to environmental, social and governance (ESG) matters expose us to numerous risks
DroppedRisks related to ownership of our common stock
Because 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

Reworded

86% rewrittenRisks related to our pipeline, product development and regulatory review
We may experience delays in enrolling participants in our clinical trials
Enrollment risk is materially unchanged, but the wording consolidates patient-population and eligibility factors and shortens the list of examples.
81% rewrittenRisks related to commercialization and our products
The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may be unable to compete effectively in the market for existing or new products, treatment methods or technologies
The risk now specifies European COVID-market exclusion through year-end 2026 and adds competitors’ bundling, supply-chain and purchasing-power advantages.
Was: The 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
79% rewrittenRisks related to our business and operations
Our use of generative AI ("GenAI") and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies
The risk adds the EU AI Act, high-risk AI obligations, potential fines, operational restrictions and required business-practice changes.
Was: Our use of GenAI and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies
77% rewrittenRisks related to the manufacturing of our commercial products and product candidates
Our manufacturing facilities or those of third-party manufacturers or suppliers may fail to meet regulatory requirements, which could delay approval of or increase production costs for our products
The wording removes the FDA inspection reference and emphasizes that manufacturing-quality failures could significantly delay clinical development.
Was: Our 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
74% rewrittenRisks related to the manufacturing of our commercial products and product candidates
As we grow as a commercial company and our drug development pipeline matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate
The focus shifts from bringing plants online in 2025 to operating Australia, Canada and U.K. facilities and optimizing the global network.
Was: As 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
64% rewrittenRisks related to our business and operations
If we cannot maintain our corporate culture, we could lose the innovation, teamwork and passion that we believe contribute to our success
The risk no longer specifically mentions workforce growth, recruitment or strategic-plan execution, focusing more generally on culture-related success.
60% rewrittenRisks related to our business and operations
We 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
The risk is streamlined, removing explicit references to evolving laws and criminal penalties while retaining broad personal-data compliance requirements.
50% rewrittenRisks related to the manufacturing of our commercial products and product candidates
We are subject to operational risks associated with the physical and digital infrastructure at our manufacturing facilities and those of our external service providers
No substantive change; the risk continues to cover automated manufacturing systems, AI, outages, cybersecurity and vulnerabilities from system upgrades.
46% rewrittenRisks related to our pipeline, product development and regulatory review
Because 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
46% rewrittenRisks related to the manufacturing of our commercial products and product candidates
Our intismeran autogene product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production
Was: Our INT product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production
44% rewrittenRisks related to our financial condition and results of operations
We incurred net losses in 2025 and 2024, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability
Was: We incurred net losses in 2024 and 2023, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability
41% rewrittenRisks related to our pipeline, product development and regulatory review
There 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
41% rewrittenRisks related to our pipeline, product development and regulatory review
Certain 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
40% rewrittenRisks related to our financial condition and results of operations
The investment of our cash, cash equivalents and investments is subject to risks which may cause losses and affect the liquidity of these investments
39% rewrittenRisks related to the manufacturing of our commercial products and product candidates
Our 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
35% rewrittenRisks related to ownership of our common stock
Ineffective internal controls could adversely impact our business and operating results
34% rewrittenRisks related to our reliance on third parties
We may seek to establish additional strategic alliances and, if we are unable to do so 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
Was: We 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
32% rewrittenRisks related to our business and operations
Federal 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
28% rewrittenRisks related to our pipeline, product development and regulatory review
Preclinical development is lengthy and uncertain, especially for mRNA medicines
28% rewrittenRisks related to ownership of our common stock
The price of our common stock has been volatile, which could result in substantial losses for shareholders
27% rewrittenRisks related to our business and operations
Healthcare 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
27% rewrittenRisks related to commercialization and our products
We have experienced commercial challenges and may experience additional challenges in the future
Was: We have experienced commercial challenges and are likely to experience additional challenges in the future
26% rewrittenRisks related to our business and operations
We 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
25% rewrittenRisks related to our reliance on third parties
We 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
24% rewrittenRisks related to ownership of our common stock
Our employees, principal investigators and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
23% rewrittenRisks related to our pipeline, product development and regulatory review
Our products are, and any future products will be, subject to regulatory scrutiny
23% rewrittenRisks related to ownership of our common stock
Our 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

All 73 risk factors

Headings as the filing states them, in filing order.

Risks related to commercialization and our products

01Regulatory and market uncertainty have and may continue to impact our business and the markets for our productsNew
02We may experience difficulties executing our near-term strategy and prioritized pipelineNew
03The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may be unable to compete effectively in the market for existing or new products, treatment methods or technologies81% rewritten
04We have experienced commercial challenges and may experience additional challenges in the future27% rewritten
05The commercial success of our products depends on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community
06Sales 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
07Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models and other, similar regulatory actions could impact our product revenues and materially harm our businessNew
08We focus certain of our research and development activities on treatments for severe rare genetic diseases, where patient populations are small and difficult to ascertain. Additionally, our products may only be approved for certain populations or lines of treatment

Risks related to our pipeline, product development and regulatory review

09If 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
10Clinical development is lengthy and uncertain, and our clinical programs may be delayed or terminated, or may be more costly to conduct than we anticipate
11There 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 products41% rewritten
12We may experience delays in enrolling participants in our clinical trials86% rewritten
13mRNA drug development involves substantial clinical and regulatory risks, and negative perceptions of our platform, products and product candidates could adversely affect our business and ability to obtain regulatory approvalsNew
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 results46% rewritten
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 business41% rewritten
16Our products are, and any future products will be, subject to regulatory scrutiny23% rewritten
17Preclinical development is lengthy and uncertain, especially for mRNA medicines28% rewritten
18Although we have obtained rare pediatric disease designation for mRNA-3927, we may not be eligible to receive a priority review voucher in the event the FDA determines we no longer meet the criteria for designation, revokes the designation or FDA approval does not occur by September 30, 2029New

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

19We 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
20As we grow as a commercial company and our drug development pipeline matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate74% rewritten
21We are subject to operational risks associated with the physical and digital infrastructure at our manufacturing facilities and those of our external service providers50% rewritten
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 damage39% rewritten
23Our manufacturing facilities or those of third-party manufacturers or suppliers may fail to meet regulatory requirements, which could delay approval of or increase production costs for our products77% rewritten
24Our intismeran autogene product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production46% rewritten

Risks related to our reliance on third parties

25We 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 candidates25% rewritten
26We have entered into strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected
27We may seek to establish additional strategic alliances and, if we are unable to do so 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 products34% rewritten

Risks related to our intellectual property

28We 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
29Failure 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
30Uncertainty 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
31We 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
32If 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
33If 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
34We 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
35We may be subject to claims challenging the inventorship or ownership of our patents and other IP
36Changes in U.S. patent and regulatory law could impair our ability to protect our products
37We may be unable to protect our IP rights throughout the world

Risks related to our financial condition and results of operations

38We incurred net losses in 2025 and 2024, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability44% rewritten
39Our 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
40The investment of our cash, cash equivalents and investments is subject to risks which may cause losses and affect the liquidity of these investments40% rewritten
41Failure to comply with the covenants in our credit agreement could adversely affect our businessNew

Risks related to our business and operations

42We may encounter difficulties in managing changes to the size, structure and scope of our companyNew
43We are subject to the risks of doing business outside of the United States
44Our failure to maintain our enterprise resource planning (ERP) system could adversely impact our business and results of operations
45Our success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel
46If we cannot maintain our corporate culture, we could lose the innovation, teamwork and passion that we believe contribute to our success64% rewritten
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
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
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
50Our business could be harmed if we suffer damage to our reputation, including as a result of a product recall
51Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of our products
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 prices32% rewritten
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 business27% rewritten
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 penalties26% rewritten
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 reputation60% rewritten
56Our use of generative AI ("GenAI") and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies79% rewritten
57We could be adversely affected by outbreaks of epidemic, pandemic or other contagious diseases
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
59The illegal distribution and sale by third parties of counterfeit or stolen versions of mRNA products could negatively impact our financial performance or reputation
60Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations and financial condition
61Evolving environmental, social and governance (ESG) standards and expectations may expose us to numerous risksNew
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

63The price of our common stock has been volatile, which could result in substantial losses for shareholders28% rewritten
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 approval23% rewritten
65Provisions in our organizational documents and 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
66We do not expect to pay cash dividends for the foreseeable futureNew
67Our employees, principal investigators and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading24% rewritten
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
69Changes in tariffs and other governmental trade policies could negatively affect our business and results of operationsNew
70Employee litigation and unfavorable publicity could negatively affect our future business
71Ineffective internal controls could adversely impact our business and operating results35% rewritten
72Changes in tax law could adversely affect our business and financial condition
73The increasing use of social media platforms presents risks and challenges

Other Moderna 10-Ks

FY2024 10-K risk factors
72 risks
Moderna faces significant risks from revenue uncertainty in COVID and RSV vaccines and intense competition from larger pharmaceutical companies. The company incurred net losses of $3.6 billion in 2024 and $4.7 billion in 2023.
Filed Feb 21, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.