Moderna (MRNA) Risk Factor Changes

The FDA’s ability to review and approve new products can be affected by a variety of factors, including government priorities, budget and funding levels, the ability to hire and retain key personnel and accept the pay…

Our results of operations could be adversely affected by general conditions in the global economy and financial markets, including disruptions caused by pandemic, war, conflict or other political instability.

We are exposed to the risk of fraud or other misconduct by our employees, principal investigators leading our clinical trials and consultants.

We do not currently intend to declare or pay cash dividends on our capital stock and instead intend to retain any future earnings to finance the growth and development of our business or to return cash to shareholders…

Provisions 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.

As of February 13, 2026, our executive officers, directors and affiliated shareholders owned, directly or indirectly, approximately 8% of our outstanding common stock.

•announcement by us or our competitors of the commencement or termination of significant acquisitions, strategic collaborations, joint ventures or capital commitments.

The stock market generally, and the biopharmaceutical sector in particular, has experienced significant volatility that may be unrelated to company operating performance, and you may be unable to sell your shares at o…

Our stock price has been, and is expected to continue to be, subject to substantial volatility.

Evolving environmental, social and governance (ESG) standards and expectations may expose us to numerous risks.

The Clinical Trials Regulation (EU) No.

Additionally, many foreign jurisdictions have passed or are considering various proposals for data privacy and protection laws, and data privacy remains an evolving landscape at the domestic and international levels,…

The EU GDPR and UK GDPR are wide-ranging in scope and impose numerous requirements on companies that process personal data, including imposing special requirements in respect of the processing of health and other sens…

We are subject to data privacy and security laws and regulations in the United States, Europe and other jurisdictions where we operate or collect personal information.

Payments made to physicians in certain EU Member States must be publicly disclosed, and agreements with physicians often are the subject of prior notification and approval by the physician’s employer, competent profes…

The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is prohibited in the EU and the UK.

Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products.

There is also significant economic pressure on state budgets that may result in states increasingly seeking to achieve budget savings through mechanisms that limit coverage or payment for drugs or that would allow for…

We may be unable to maintain our product liability insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability.

With respect to our COVID vaccine, although the U.S.

and intellectual property.

It may be increasingly difficult to maintain our culture, which we have invested substantial resources in building.

Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends on our ability to attract and retain highly qualified managerial, scientific, technical, quality-control, manufactur…

Our business is subject to risks associated with doing business globally.

We may encounter difficulties in managing changes to the size, structure and scope of our company.

As of December 31, 2025, we had approximately $8.1 billion in cash, cash equivalents and investments, which includes a $600 million draw down from our term loan facility, which is subject to general credit, liquidity,…

We have incurred, and expect to continue to incur, significant costs associated with commercializing our products and our clinical development activities.

We incurred net losses of $2.8 billion and $3.6 billion in 2025 and 2024, respectively, and other than in 2022 and 2021, we have incurred net losses in each year since our inception.

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.

•impose manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;

Contracts and grants funded by the U.S.

Additionally, many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

U.S.

We may become party to licenses that give us rights to third-party IP necessary or useful for our business and our success may depend in part on the ability of our licensors to obtain, maintain and enforce patent prot…

We have issued patents and pending patent applications in the United States and in key markets globally that claim many different methods, compositions and processes relating to the discovery, development, manufacture…

Our success depends, in part, on our ability to protect proprietary methods and technologies that we develop under the patent and other IP laws of the United States and other countries, so that we can prevent others f…

If third parties do not successfully carry out their contractual duties or meet expected deadlines, we may need to replace them, which could delay clinical trials, drug development or other activity.

Our development programs and the potential commercialization of our product candidates will require substantial cash to fund expenses.

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.

We have entered into strategic alliances with collaborators that have provided funding, intellectual property licenses and other resources for developing, manufacturing and commercializing our product candidates.

There are, in general, few alternative sources of supply for substitute components.

We have purpose-built our facility in Marlborough, Massachusetts for intismeran, and it may encounter difficulties or it take longer than anticipated to scale up the facility to meet future commercial demand, if intis…

We custom design and manufacture intismeran tailored for each patient.

Our intismeran autogene product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production.

We and our manufacturing partners also may encounter problems hiring and retaining the experienced scientific, quality control and manufacturing personnel, which could result in delays in production or difficulties in…

In addition, we may not have direct control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.

In addition, the manufacturing processes for our products are subject to regulatory approval, and if we or our third-party manufacturers are unable to reliably produce products or product candidates to specifications…

Regulators typically require representative manufacturing site inspections to assess compliance with cGMP and manufacturing controls.

•failures of raw materials, components or consumables, including due to ineffective supplier qualification or regulatory compliance issues at critical suppliers; and

The manufacturing of medicines for clinical trials or commercial sale is subject to extensive regulation, and components of such products must be manufactured in accordance with cGMP requirements.

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.

As we expand our development and commercial capacities, we have and expect that we will continue to establish additional manufacturing capabilities in our global network.

Our facilities and infrastructure or those of our contract manufacturers or other third-parties may also be subject to attacks or acts of sabotage by outside actors, contractors or employees.

Our reliance on third-party manufacturers may also result in unforeseen delays or operational problems beyond our control.

To supplement our internal manufacturing infrastructure, we may rely on third parties for product manufacturing, packaging, testing, warehousing, distribution and other logistical services, and the manufacture and tes…

Completion of our trials and commercialization of our products depend on the availability of facilities capable of manufacturing our vaccines at sufficient yields and at commercial scale.

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.

In many cases, we may need to utilize multiple batches of drug substance and drug product to meet the supply requirement of a single preclinical study or clinical trial.

Additionally, our high rate of innovation may result in a high degree of technology change that could negatively impact product comparability during and after clinical development.

Much of our pipeline is in preclinical development, and these programs could be delayed or not advanced into the clinic.

We are required by the FDA to conduct post-marketing studies for mRNA-1273, including to assess the risk of myocarditis and pericarditis and to evaluate outcomes in pregnant women and infants post-vaccination.

Additionally, if any such therapeutic is approved, physicians, health care providers, third-party payors and patients may be slow or fail to accept these novel and personalized treatments.

There are only a few approved gene therapy products in the United States and other jurisdictions, and significant adverse events associated with their testing and use have been reported.

Even if the FDA finds our success criteria to be sufficiently validated and clinically meaningful, we may not achieve the pre-specified endpoint to a degree of statistical significance in our pivotal or other clinical…

There are no pharmacologic therapies approved to treat the underlying causes of many diseases that we are currently attempting to address or may address in the future.

Successful discovery and development of mRNA medicines by us or our strategic collaborators is highly uncertain and depends on many factors beyond our or their control, and our business decisions and development effor…

Few mRNA medicines have been approved to date by the FDA or other regulators, and efficacy, safety, tolerability and immunogenicity data and real-world evidence with respect to mRNA medicines continue to accumulate.

Additionally, we may have limited or no ability to influence enrollment in clinical trials where our collaborators control clinical development.

•adverse results or other safety signals in our trials or related to other product candidates, and any resulting negative publicity, which could discourage potential participants and their physicians from participatin…

•size of the patient population and eligibility criteria for the clinical trial in question, including age-based eligibility criteria limiting subject enrollment to adolescent or pediatric populations;

Enrolling participants in our clinical trials is critical to our success.

There are many clinical and manufacturing challenges specific to intismeran autogene and any other neoantigen therapies we may develop.

•adverse side effects could be observed in future clinical trials where our product candidates are administered in combination with other therapies (such as the co-administration of intismeran autogene);

Clinical testing is expensive, complex and lengthy, and its outcome is inherently uncertain.

Additionally, the process of obtaining marketing approvals is expensive, time-consuming and uncertain, and can vary substantially based on many factors, including the type, complexity and novelty of the product candid…

Additionally, target patient populations for some of our product candidates may be small (e.g., for rare diseases) or require individual customization (e.g., for intismeran autogene).

Sales of pharmaceutical products depend on adequate coverage, pricing and reimbursement from third-party payors.

Even if a product candidate shows a favorable efficacy and safety profile in clinical trials, market acceptance will be unknown until after it is launched.

We face risks and uncertainties related to successfully commercializing our products.

We have experienced commercial challenges and may experience additional challenges in the future.

More generally, the pharmaceutical market is highly competitive and certain of the disease areas we are targeting present particularly high competitive risk.

In addition, certain U.S.

We compete with larger, well-established and experienced pharmaceutical companies for sales of our products, including against Pfizer and Sanofi for sales of our COVID vaccines and Pfizer and GSK for our RSV vaccine.

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.

Furthermore, our broad clinical success and post-pandemic commercial challenges have necessitated a more selective and paced approach to our research and development investment.

Furthermore, our decisions regarding seasonal vaccine development, including for COVID-19, will be informed by annual guidance from the FDA and foreign regulators, which may impact the timing of development for our CO…

Our results of operations could be adversely affected by general conditions in the global economy and financial markets, including disruptions caused by pandemic, war, conflict or other political instability, includin…

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.

If our ESG practices do not meet evolving investor or other stakeholder expectations and standards, then our reputation, our ability to attract or retain employees and our attractiveness as an investment, business par…

Further, the standards for tracking and reporting on ESG matters are relatively new, have not been harmonized and continue to evolve.

announced goals and other objectives related to ESG matters.

Many institutional and individual investors use ESG screening criteria to determine whether we qualify for inclusion in their investment portfolios.

The development and use of GenAI and other AI technologies (collectively, AI Technologies), along with an uncertain regulatory landscape, pose risks that could harm our reputation, expose us to liability or otherwise…

addition, certain state laws govern privacy and security of personal information.

In the United States, at the federal level, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a…

Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products.

coverage exclusion or we do not otherwise meet the conditions for coverage.

Successfully developing products for and fully understanding the regulatory and manufacturing pathways for the many therapeutic areas and diseases we seek to address requires significant depth of talent, resources and…

We have expanded our scope of operations and number of employees rapidly over the last several years and we must continue to implement and improve our managerial, operational and financial systems.

We may become party to licenses that give us rights to third-party IP necessary or useful for our business and our success may depend in part on the ability of our licensors to obtain, maintain and enforce patent prot…