Moderna (MRNA) 10-K risk factor changes: FY2025 vs FY2024
The 2025-12-31 10-K against the 2024-12-31 one, compared heading by heading and sentence by sentence.
Item 1A211 rewritten98 added109 removed690 unchanged
All filing items1,238 rewritten786 added783 removed2,590 unchanged
Summary
counted, not written
- Item 1A lists 75 risk factor headings: 10 new, 10 reworded and 55 unchanged since FY2024. 7 headings from FY2024 no longer appear.
- Sentence by sentence, 786 added, 783 removed, 1,238 rewritten and 2,590 unchanged across 19 items that differ.
New Item 1A headings (10)
- Regulatory and market uncertainty have and may continue to impact our business and the markets for our products.
- We may experience difficulties executing our near-term strategy and prioritized pipeline.
- 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.
- 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.
- 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.
- Failure to comply with the covenants in our credit agreement could adversely affect our business
- We may encounter difficulties in managing changes to the size, structure and scope of our company.
- Evolving environmental, social and governance (ESG) standards and expectations may expose us to numerous risks.
- We do not expect to pay cash dividends for the foreseeable future.
- Changes in tariffs and other governmental trade policies could negatively affect our business and results of operations.Tariffs
Removed Item 1A headings (7)
- 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.
- We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts.
- We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus.
- mRNA drug development has substantial clinical development and regulatory risks due to the novel nature of this new class of medicines, and the negative perception of the efficacy, safety or tolerability profile of any product candidates that we or others develop could adversely affect our ability to conduct our business, advance our product candidates or obtain regulatory approvals.
- We may encounter difficulties in managing the development and expansion of our company.
- Our aspirations, goals and disclosures related to environmental, social and governance (ESG) matters expose us to numerous risks.
- 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 Item 1A headings (10)
- The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may
[removed: not][added: be unable to] compete effectively in the market for existing or new products, treatment methods or technologies. - We have experienced commercial challenges and
[removed: are likely to][added: may] experience additional challenges in the future. - As we grow as a commercial company and our drug development pipeline
[removed: increases and]matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate.[removed: We rely on third-party service providers, all of whom have inherent risks in their operations.] - Our manufacturing facilities or those of
[removed: our]third-party manufacturers or suppliers may fail to meet regulatory[removed: requirements. Failure to meet cGMP requirements][added: requirements, which] could delay approval of or increase production costs for our products. - Our
[removed: INT][added: intismeran autogene] product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production. - We have
[removed: entered, and may enter into,][added: entered into] strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected. - We may seek to establish additional strategic alliances and, if we are unable to
[removed: establish them][added: 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. - We incurred net losses in
[removed: 2024][added: 2025] and[removed: 2023,][added: 2024,] and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability. - Our use of
[removed: GenAI][added: generative AI ("GenAI")] and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies. - Provisions in our organizational
[removed: documents, as well as provisions of][added: documents and] Delaware[removed: law,][added: 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.
A heading is new when no FY2024 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2025; struck-through words were in FY2024. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
211 rewritten, 98 added, 109 removed, 690 unchanged
Vaccination rates in the future may also be lower than our [removed: expectations, and are likely] [added: expectations due] to [removed: be impacted by a number of] [added: other] factors, including [removed: public health authority recommendations, medical need,] viral [removed: evolution] [added: evolution, medical need] and consumer motivation to vaccinate.
We have experienced commercial challenges and [removed: are likely to] [added: may] experience additional challenges in the future.
[removed: For example, in 2024, we faced] [added: In the past,] commercial challenges [removed: that] [added: have] led to lower-than-expected sales and required us to adapt our business strategy.
The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may [removed: not] [added: be unable to] compete effectively in the market for existing or new products, treatment methods or technologies.
We compete with [removed: well-established, larger] [added: larger, well-established and experienced] pharmaceutical companies for sales of our products, including against Pfizer and Sanofi for sales of our COVID [removed: vaccine] [added: vaccines] and Pfizer and GSK for our RSV vaccine.
We may also be adversely affected by similar market practices outside of the United [added: States.]
For example, we are developing a seasonal flu vaccine, for which there is a well-developed market, and we may [removed: be unsuccessful in developing a product or achieving] [added: need to offer more favorable terms to gain] market [removed: share.][added: share (which we may be unable to do), which may negatively impact our profitability.]
Additionally, [removed: any] [added: our] products [removed: that we develop] may struggle to compete against [removed: those of our competitors] [added: competitors’ products] for a variety of reasons, including relative safety and effectiveness, degree of any side effects, shelf-life, ease of administration and the extent to which patients accept relatively new routes of administration, the timing and scope of regulatory approvals, the availability and cost of manufacturing, distribution, marketing and sales capabilities, price, reimbursement coverage and patent protection.
Even if our products demonstrate superiority to [removed: those of competitors, consumers, retailers] [added: competitors’ products, consumers] and [removed: the public] [added: retailers] may fail to appreciate that benefit, or existing purchase commitments [removed: for a competitor’s product] [added: with competitors] may discourage them from purchasing from us.
[removed: Our] [added: Furthermore, our] broad clinical success and [removed: recent] [added: post-pandemic] commercial challenges have necessitated a more selective and paced approach to our research and development investment.
If we do not successfully implement our cost efficiency and prioritization programs, we may fail to meet our cash breakeven [removed: goals.][added: goal.]
[removed: Furthermore,] [added: Additionally,] as we pursue [removed: and fund the] development of our prioritized programs, we may forego or delay pursuit of other opportunities that could [removed: later] prove to have greater commercial potential.
If our prioritized programs are unsuccessful, or not as successful as [removed: other programs] [added: others] could have been, we may be unable to realize a sustainable return on our investments and or achieve long-term growth.
[removed: Additionally,] [added: Furthermore,] our decisions regarding [added: seasonal] vaccine [removed: development] [added: development, including for COVID-19,] will be informed by [added: annual] guidance from the FDA and foreign regulators, which may impact the timing of development for our COVID vaccines.
[removed: If] [added: Additionally, if] our efforts to develop variant-specific vaccines are [added: delayed or] not as successful as our competitors’, we could suffer reputational harm, loss of market share and adverse financial results.
[removed: Additionally, we] [added: We] may expend significant resources adapting our vaccines or conducting clinical trials to protect against variants, but a market for our adapted vaccines may fail to develop or demand may not align with our projections or cost expenditures.
- whether our product presentation meets customer [removed: demand (e.g., for single-dose presentations, or combination vaccines);][added: demand;]
Even if a [removed: potential] product [removed: displays] [added: candidate shows] a favorable efficacy and safety profile in clinical trials, market acceptance will be unknown until after it is launched.
Sales of pharmaceutical products [removed: in general depends to a significant extent] [added: depend] on adequate coverage, pricing and reimbursement from third-party payors.
Additionally, target patient populations for some of our product candidates may be small (e.g., for rare [removed: genetic] diseases) or require individual customization (e.g., for [removed: our INTs).][added: intismeran autogene).]
[removed: Inadequate] [added: Further, inadequate] reimbursement for [removed: such] services [added: related to our products (e.g., for administration to patients)] may discourage physicians from prescribing or recommending our products, adversely affecting our ability to market or sell those products.
We focus certain of our research and [removed: product] development activities on treatments for severe rare genetic diseases, where [removed: the] patient populations are [added: small and] difficult to [removed: ascertain or small.][added: ascertain.]
Our estimates of addressable patient populations are based on our [removed: beliefs,] [added: beliefs] and [removed: have been] [added: are] derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect.
The FDA and [added: comparable] foreign regulators have substantial discretion in the approval process and may refuse to accept any marketing approval application or may decide that our data are insufficient for marketing approval and require additional preclinical, clinical or other studies.
We and our strategic collaborators also may experience unforeseen events during, or as a result of, [removed: any] clinical trials that [removed: we or they conduct that] could delay or prevent us or them from successfully developing our product candidates and gaining approval from regulators.
- 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 [removed: our INT product candidate, mRNA-4157);][added: intismeran autogene);]
There are many clinical and manufacturing challenges specific to [removed: our INT product candidates] [added: intismeran autogene] and any other neoantigen [removed: cancer vaccines] [added: therapies] we may develop.
These [removed: risks] include a rapid production turn-around time measured in weeks in order to supply patients [removed: in our clinical trials] before further progression and mutation of their tumors, the significant costs incurred in making individualized medicines and potential lack of immune responses due to the biology of the tumor or [added: patient’s] immune [removed: status of the patient.][added: status.]
These risks apply to [removed: our INT product candidates] [added: intismeran] and other neoepitope investigational medicine programs.
In addition, the [removed: uncertain] translatability of target selection from preclinical animal [removed: models, including mouse and non-human primate models,] [added: models] to successful clinical trial results [added: is uncertain and] may [removed: be impossible,] [added: fail,] particularly for systemic therapies and cancer [removed: vaccines.][added: antigen therapies.]
These processing steps may differ between individuals or tissues, potentially leading to variable levels of therapeutic protein, [removed: variable] activity, immunogenicity or [removed: variable] distribution to tissues for a therapeutic effect.
Difficulties or delays in enrolling a sufficient number of [removed: clinical trial] participants [removed: may result in increased] [added: could increase] costs or [removed: affect] [added: impact] the timing or outcome of our planned clinical trials, which could prevent trial completion and adversely affect our ability to advance the development of and obtain regulatory approval for our product candidates.
- [added: 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;
- [added: availability of competing therapies and clinical trials, and] clinicians’ and [removed: trial] participants’ perceptions [removed: as to] [added: of] the [removed: potential advantages] [added: relative advantages, risks] and side effects of [removed: the] [added: our] product [removed: candidate being studied in relation] [added: candidates compared] to other available therapies, including any new drugs or [removed: treatments that may be approved for the indications we are investigating;][added: treatments;]
- adverse results or other [removed: adverse] safety signals in our trials or related to other product candidates, and [removed: the] [added: any] resulting negative publicity, [added: which] could discourage potential [removed: clinical trial] participants and their [removed: doctors] [added: physicians] from participating in our trials; and
mRNA drug development [removed: has] [added: involves] substantial clinical [removed: development] and regulatory [removed: risks due to the novel nature of this new class of medicines,] [added: risks,] and [removed: the] negative [removed: perception of the efficacy, safety or tolerability profile] [added: perceptions] of [removed: any] [added: our platform, products and] product candidates [removed: that we or others develop] could adversely affect our [added: business and] ability to [removed: conduct our business, advance our product candidates or] obtain regulatory approvals.
[removed: Very few] [added: Few] mRNA medicines have been [removed: authorized or] approved to date by the FDA or other regulators, and efficacy, [removed: safety] [added: safety, tolerability] and immunogenicity data and real-world evidence with respect to mRNA medicines continue to accumulate.
We may observe new, more frequent or more severe adverse events in [removed: subjects participating in ongoing] clinical [removed: trials] [added: trial participants] or among [removed: individuals] vaccinated [removed: with mRNA vaccines.][added: individuals.]
For example, some studies have suggested that [removed: our COVID vaccine] [added: Spikevax] may be associated with higher rates of myocarditis and pericarditis in young males compared to other COVID vaccines.
[added: In addition, the FDA and other regulators may interpret data from our] clinical trials differently than we do and such agencies may require us to conduct additional studies or analyses, which could delay or prevent us from obtaining full regulatory approvals in certain jurisdictions or for certain demographics.
Regulatory and market uncertainty have and may continue to impact our business and the markets for our products.
Our ability to successfully commercialize our approved vaccines and any future products depends in part on evolving regulatory requirements, public health recommendations and market acceptance.
In 2025, changes at U.S. regulatory agencies impacted policies and priorities related to our industry.
For example, changes in FDA regulatory policies, post-marketing safety monitoring, and evidentiary expectations, as well as CDC and Advisory Committee on Immunization Practices (ACIP) recommendations regarding eligibility, target populations, and vaccination practices, may have affected and may continue to affect demand for our vaccines.
Some of these changes, including new post-marketing commitments, have impacted and may in the future impact our costs.
Ongoing regulatory uncertainty and evolving regulatory and public health guidance could impact future approvals, advisory committee recommendations, acceptance and demand for our existing or future products.
These and other factors may make it difficult to accurately forecast vaccination rates for our products.
Beyond COVID, we have experienced challenges in the RSV market, in part due to advisory committee recommendations that were more limited than anticipated.
We may experience difficulties executing our near-term strategy and prioritized pipeline.
While we expect to launch multiple new products over the next several years, our ability to commercialize our pipeline is subject to many risks, including those described elsewhere in these *Risk Factors* under “Risks related to our pipeline, product development and regulatory review” and “Risks related to the manufacturing of our commercial products and product candidates.” If we do not successfully execute our near-term plan for growing our infectious disease vaccine franchise, our ability to invest in our pipeline, including our oncology and rare disease programs, may suffer.
Additionally, we have been excluded from selling our COVID vaccines in many European markets due to a competitor’s contract with the European Commission, which does not lapse until year-end 2026.
More generally, the pharmaceutical market is highly competitive and certain of the disease areas we are targeting present particularly high competitive risk.
For example, the oncology market is intensely competitive, innovative and fast-moving.
In oncology, standards of care often evolve rapidly, and changes during the development or commercialization of our product candidates could reduce their clinical relevance, complicate clinical trial design, increase development costs or timelines, or limit commercial adoption, even for programs that show promising early results.
See “Business—Government Regulation—Coverage and reimbursement.”
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.
On May 12, 2025, President Trump issued an executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. and directing the Secretary of Health and Human Services (HHS) to communicate price targets to pharmaceutical manufacturers to align prices with those in comparably developed nations, an approach commonly referred to as "most-favored-nation" (MFN) pricing and, in the event significant progress towards MFN pricing is not delivered, to propose rulemaking to impose MFN pricing.
MFN pricing models in the U.S. could also affect our international pricing strategy and future decisions on reimbursement and commercialization in certain jurisdictions.
If our U.S. pricing becomes tied to international reference prices, we may face decisions regarding pricing in foreign markets that could result in reduced patient access internationally, affect our relationships with foreign regulatory authorities and payers, or impact our ability to obtain or maintain reimbursement approvals in ex-U.S. markets.
These reforms remain subject to change, potential legal challenges, or expansion through additional rulemaking or sub‑regulatory guidance, creating uncertainty for our overall pricing strategy.
It remains to be seen whether and how these drug pricing initiatives will apply to our products, how they will affect the broader pharmaceutical industry, and whether similar reform measures may be adopted in the future.
For example, recent FDA policy updates regarding COVID vaccine approvals and the evidence expected for certain populations could require additional clinical data or trials to support broader indications, delay approvals or supplemental applications, or result in more limited labeled populations, which could adversely affect the timing and scope of commercialization for our COVID vaccines, including updated or variant-adapted formulations.
Such events could include:
mRNA medicines may elicit innate or adaptive immune responses to the mRNA, delivery vehicle (such as an LNP) or the encoded protein, which could result in adverse events or reduced tolerability.
In certain settings, immune responses to the encoded protein limit the effectiveness or durability of treatment, including upon repeat administration, or require changes to dosing, formulation or clinical development plans.
Even if we or our collaborators successfully enroll participants, some may not be dosed or complete the trial.
Myocarditis and pericarditis have also been reported following vaccination with other COVID vaccines, including mNEXSPIKE.
For many rare diseases, few clinical trials have been attempted.
In certain other countries, such as Japan, mRNA therapies have not yet been classified.
In addition, regulators may increasingly rely on post-approval studies or real-world evidence to determine whether to maintain, modify or expand approved indications or population eligibility, which could increase costs, delay commercialization or limit the scope of approved use of our products.
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.
The sponsor of an application for a rare pediatric disease drug product may be eligible for a voucher that can be used or sold to obtain a priority review for a subsequent application submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
We received rare pediatric disease designation from the FDA for mRNA-3927.
We may, in the future, apply for rare pediatric disease designation from the FDA for future product candidates that may qualify for designation.
Vouchers for rare pediatric disease drugs are awarded for qualifying applications when the drug receives approval.
Under current law, after September 30, 2029, the FDA may not award any rare pediatric disease priority review vouchers, although the FDA's authority to do so could be extended by Congress in the future.
We may also experience wasted stock from other factors such as volatile demand forecasts or our inability to scale down for products that have low demand.
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 testing of raw materials, components, parts and consumables, and we may need to engage additional third parties in the future to meet capacity needs.
In addition, third-party manufacturers may experience production interruptions due to factors such as production cost pressures, scale-up challenges, shortages of qualified personnel, availability of raw materials and supplies, quality control failures, compliance with regulatory requirements or lack of capital funding.
- ineffective corrective or preventative actions taken to address such deviations as processes scale;
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.
There is significant uncertainty around the amount of future revenue we will recognize from sales of our COVID vaccine—which is our primary source of revenue—as well as sales of RSV and other respiratory vaccines.
Accurately forecasting vaccination rates for our products, which directly impacts overall market size, has been difficult, and these difficulties may persist.
Additionally, the recent Presidential election in the U.S. may impact policies and priorities related to our industry.
In 2024, we recognized $3.1 billion of product sales, compared to $6.7 billion, $18.4 billion and $17.7 billion in 2023, 2022 and 2021, respectively.
Beyond COVID vaccines, in 2024, the overall RSV vaccine market was smaller than anticipated, in part due to recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) regarding the frequency of vaccination and recommendations related to who, in terms of age or risk factors, should receive an RSV vaccine.
These recommendations were more limited than anticipated and future advisory committee recommendations (including with respect to RSV re-vaccination and age group recommendations) may continue to negatively impact the size of the market.
If we cannot effectively manage evolving market dynamics, our business, financial condition, results of operations and prospects may suffer.
We experienced difficulties maintaining our COVID vaccine market share and gaining market share in the U.S. for our RSV vaccine, where we were third to market.
These competitors (and others against whom we may compete now or in the future) have greater resources and experience than us across all stages of drug development and commercialization.
For example, in 2024, our share of the COVID vaccine market declined due in part to increased commercial competition.
Additionally, we faced continued exclusion from many European markets by a pandemic-era competitor contract with the European Commission.
States.
More generally, the pharmaceutical market is intensely competitive and evolving.
We may need to offer more favorable terms to gain market share (which we may be unable to do), which may negatively impact our profitability.
We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts.
We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus.
New SARS-CoV-2 strains may be more transmissible or cause more severe disease than earlier strains.
Our COVID vaccines could be ineffective, or less effective than desired, in protecting against these new variants.
The manner and level at which reimbursement is provided for services related to our products (e.g., for administration to patients) is also important.
Events that might prevent us from proceeding with clinical trials could include:
Additionally, there may be challenges in delivering an adequate quantity of active pharmaceutical ingredient (API) required to drive efficacy due to the limitation in volume of API that can be delivered to a specific location, like a tumor or injured tissue.
Our investigational therapies for local injections often require specialized skills for conducting a clinical trial that could delay clinical trials or slow or impair commercialization of a product due to the poor adoption of injected local therapeutics.
Gene therapies and mRNA medicines may activate one or more immune responses against any and all components of the drug product (e.g., the mRNA or the delivery vehicle, such as an LNP) as well as against the encoded protein, giving rise to potential immune reaction related adverse events.
Eliciting an immune response against the encoded protein may impede our ability to achieve a pharmacologic effect upon repeat administration or a side effect.
- size of the patient population;
- availability of competing therapies and clinical trials;
Even if we or our strategic collaborators can enroll clinical trial participants, there is no guarantee that such participants will ultimately be dosed as part of, or complete, a clinical trial.
In addition, the FDA and other regulators may interpret data from our
For example, in October 2021, the FDA requested that we explore a lower dosage for our COVID vaccine in adolescents, which extended the length of clinical trials in this population prior to receiving regulatory authorization.
We constantly make business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology and manufacturing processes, which ultimately may be unsuccessful.
For instance, for many of the rare diseases for which we are developing treatments, few clinical trials have been attempted, and there are no approved drugs to treat these diseases.
Further, even if we achieve the pre-
specified criteria, our clinical trials may produce unpredictable or inconsistent results compared against the more traditional efficacy endpoints in the trial.
In certain countries, mRNA therapies have not yet been classified or any such classification is not known to us; for example, in Japan, the Pharmaceuticals and Medical Devices Agency has not taken a position on the regulatory classification of mRNA therapies.
For instance, a clinical hold on gene therapy products may apply to our mRNA product candidates irrespective of the differences between gene therapies and mRNA.
Physicians, health care providers and third-party payors often are slow to adopt new products, technologies and treatment practices, particularly those that may also require additional upfront costs and training.
labeling, or manufacturing process.
Our COVID vaccine is still subject to an emergency use authorization (EUA) for pediatric populations, and this EUA could be revoked for a variety of reasons, including if the FDA determines that the underlying health emergency no longer exists or warrants such authorization.
We must also complete extensive work on Chemistry, Manufacturing, and Controls (CMC) activities to be included in an IND submission.
An excerpt. Shown here: 40 of 211 rewritten, 40 of 98 added and 40 of 109 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2025 filing and the FY2024 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
133 rewritten, 109 added, 121 removed, 174 unchanged
We are developing medicines across [removed: four franchises: respiratory virus vaccines, latent and other virus] [added: infectious disease] vaccines, oncology therapeutics and rare disease therapeutics.
We [added: also] have a diverse [removed: and extensive] development pipeline of [removed: 34] [added: 25] development candidates across our [removed: 44] [added: 35] development [removed: programs, of which 41 are] [added: programs currently] in clinical [removed: studies currently.][added: studies.]
[removed: 2024] [added: 2025] Business Highlights
[removed: *Net Product Sales] [added: *Total Revenue] and [removed: Net (Loss) Earnings] [added: Loss] Per Share*
For the year ended December 31, [removed: 2024,] [added: 2025,] we recognized [removed: net product sales] [added: total revenue] of [removed: $3.1] [added: $1.9] billion [removed: from sales of our COVID and RSV vaccines,] compared to [removed: $6.7] [added: $3.2] billion and [removed: $18.4] [added: $6.8] billion for the years ended December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] respectively.
Loss per share was [removed: $(9.28)] [added: $(7.26)] for the year ended December 31, [removed: 2024,] [added: 2025,] compared to [removed: (loss) earnings] [added: loss] per share of [removed: $(12.33)] [added: $(9.28)] and [removed: $20.12] [added: $(12.33)] for the years ended December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] respectively.
[removed: *•RSV vaccine:* We received regulatory approval of our] [added: *•mRESVIA*: Our] RSV vaccine [removed: mRESVIA (mRNA-1345)] [added: has been approved] for adults aged 60 years and older in [removed: 2024.][added: 40 countries.]
*•Methylmalonic acidemia (MMA) therapeutic:* [removed: Our investigational therapeutic for MMA (mRNA-3705)] [added: mRNA-3705] has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot [removed: program.][added: program, with a registrational study expected to begin in 2026.]
[removed: In May 2024,] [added: mRESVIA was approved by] the FDA [removed: approved mRESVIA to protect] [added: in May 2024 for] adults aged 60 years and [removed: older from] [added: older, and in June 2025, the approved use was expanded to include adults aged 18 through 59 years who are at increased risk for] lower respiratory tract disease [added: (LRTD)] caused by [removed: RSV infection.][added: RSV.]
| | | | | | | | | | | | | | | | | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |
| United States | | | | | | | | | | | | | | | | | | $ | [removed: 1,726] [added: 1,165] | | | | | $ | [removed: 1,720] [added: 1,726] | | | | | $ | [removed: 4,405] [added: 1,720] | |
| Europe | | | | | | | | | | | | | | | | | | [removed: 573] [added: 50] | | | | | | [removed: 1,353] [added: 573] | | | | | | [removed: 6,732] [added: 1,353] | | |
| Rest of world | | | | | | | | | | | | | | | | | | [removed: 810] [added: 603] | | | | | | [removed: 3,598] [added: 810] | | | | | | [removed: 7,298] [added: 3,598] | | |
| Total | | | | | | | | | | | | | | | | | | $ | [removed: 3,109] [added: 1,818] | | | | | $ | [removed: 6,671] [added: 3,109] | | | | | $ | [removed: 18,435] [added: 6,671] | |
| | | | | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |
| COVID [added: (1)] | | | | | | $ | [removed: 3,084] [added: 1,810] | | | | | $ | [removed: 6,671] [added: 3,084] | | | | | $ | [removed: 18,435] [added: 6,671] | |
| RSV | | | | | | [removed: 25] [added: 8] | | | | | | [removed: —] [added: 25] | | | | | | — | | |
| Total | | | | | | $ | [removed: 3,109] [added: 1,818] | | | | | $ | [removed: 6,671] [added: 3,109] | | | | | $ | [removed: 18,435] [added: 6,671] | |
As of December 31, [removed: 2024,] [added: 2025,] we have [removed: two] [added: three] commercial [removed: products authorized for use,] [added: products,] our COVID [removed: vaccine] [added: vaccines, Spikevax] and [added: mNEXSPIKE, and] our RSV [removed: vaccine.][added: vaccine, mRESVIA.]
In the third quarter of 2023, we commenced sales of [removed: our COVID vaccine] [added: Spikevax] to the U.S. commercial market, in addition to continuing sales to foreign governments and [removed: international organizations.][added: organizations, and subsequently expanded our commercial COVID vaccine portfolio with the launch of mNEXSPIKE in the third quarter of 2025.]
| Gross product sales | | | | | | | | | | | | | | | | | | $ | [removed: 4,517] [added: 3,304] | | | | | $ | [removed: 8,203] [added: 4,517] | | | | | $ | [removed: 18,435] [added: 8,203] | |
| Wholesaler chargebacks, discounts and fees | | | | | | | | | | | | | | | | | | [removed: (1,141)] [added: (1,037)] | | | | | | [removed: (976)] [added: (1,141)] | | | | | | [removed: —] [added: (976)] | | |
| Returns, rebates and other fees | | | | | | | | | | | | | | | | | | [removed: (267)] [added: (449)] | | | | | | [removed: (556)] [added: (267)] | | | | | | [removed: —] [added: (556)] | | |
| Total product sales provision(1) | | | | | | | | | | | | | | | | | | $ | [removed: (1,408)] [added: (1,486)] | | | | | $ | [removed: (1,532)] [added: (1,408)] | | | | | $ | [removed: —] [added: (1,532)] | |
| Net product sales | | | | | | | | | | | | | | | | | | $ | [removed: 3,109] [added: 1,818] | | | | | $ | [removed: 6,671] [added: 3,109] | | | | | $ | [removed: 18,435] [added: 6,671] | |
(1)Includes an adjustment of approximately $216 million [removed: for the full year] [added: in] 2024, reflecting a reduction in prior year provision estimates, primarily related to returns and chargebacks for the previous COVID vaccine season.
Certain [removed: of these] agreements [removed: entitle us to] [added: may include] upfront [removed: deposits] [added: payments] for our [removed: COVID] vaccine supply, initially recorded as deferred revenue.
Other revenue comprises grant revenue, collaboration revenue, [removed: and] licensing and royalty [added: revenue and stand-ready manufacturing] revenue.
[added: Grant and collaboration revenues have been primarily derived from government-sponsored and private organizations including the Biomedical Advanced Research and] Development Authority (BARDA), the Defense Advanced Research Projects Agency (DARPA) and the Gates Foundation and from strategic alliances with Merck & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated and Vertex Pharmaceuticals (Europe) Limited (together, Vertex) and others to discover, develop, and commercialize potential mRNA medicines.
| Grant revenue | | | | | | | | | | | | | | | | | | $ | [removed: 37] [added: 22] | | | | | $ | [removed: 94] [added: 37] | | | | | $ | [removed: 388] [added: 94] | |
| Collaboration revenue | | | | | | | | | | | | | | | | | | [removed: 48] [added: 13] | | | | | | [removed: 83] [added: 48] | | | | | | [removed: 440] [added: 83] | | |
| Licensing and royalty revenue | | | | | | | | | | | | | | | | | | [removed: 42] [added: 11] | | | | | | [removed: —] [added: 42] | | | | | | — | | |
| Total other revenue | | | | | | | | | | | | | | | | | | $ | [removed: 127] [added: 126] | | | | | $ | [removed: 177] [added: 127] | | | | | $ | [removed: 828] [added: 177] | |
Cost of sales includes raw materials, [removed: personnel and] [added: personnel,] facility and other [added: indirect overhead] costs associated with manufacturing our commercial products.
Cost of sales also includes shipping costs, [removed: indirect overhead costs associated with our product sales during the period,] third-party royalties on net sales of our products, and charges for inventory valuation, excess and obsolete inventory and losses on firm purchase commitments.
The following table reflects our research and development expenses, including direct program specific expenses summarized by therapeutic area and indirect or shared operating costs summarized under other research and development expenses during the years ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022] [added: 2023] (in millions):
| | | | [removed: 2024] | | | | | | [removed: 2023] | | | | | | [removed: 2022] | | | [added: 2025 | | | | | | 2024 | | | | | | 2023 | | |]
| Oncology | | | [removed: 154] [added: 201] | | | | | | [removed: 62] [added: 154] | | | | | | [removed: 28] [added: 62] | | |
[removed: | Rare disease and other therapeutics | | | 82 | | | | | | 67 | | | | | | 12 | | |][added: Rare Disease Therapeutics]
| Total program-specific expenses by therapeutic area(1) | | | $ | [removed: 1,533] [added: 896] | | | | | $ | [removed: 2,032] [added: 1,533] | | | | | $ | [removed: 1,536] [added: 2,032] | |
We currently have three commercial products—Spikevax® and mNEXSPIKE®, our COVID vaccines, and mRESVIA®, our vaccine against respiratory syncytial virus (RSV).
*U.S. Manufacturing Capabilities Expansion*
In November 2025, we announced the expansion of our U.S. manufacturing capabilities through the onshoring of drug product manufacturing to our existing Moderna Technology Center in Norwood, Massachusetts.
Upon completion, this expansion will enable end-to-end mRNA manufacturing in the United States, supporting both commercial and clinical supply needs.
This expansion is part of our continued investment in U.S.-based manufacturing infrastructure to support our mRNA vaccine and therapeutic pipeline.
Construction for the new drug product manufacturing capability has commenced, with completion targeted in the first half of 2027.
*$1.5 Billion Five-Year Credit Facility*
In November 2025, we entered into a five-year term loan facility providing for up to $1.5 billion of capital to enhance our balance sheet and provide increased financial flexibility.
The facility includes a $600 million initial term loan funded at closing, a $400 million delayed draw term loan facility available through November 2027, and an additional $500 million delayed draw term loan facility available through November 2028, subject to the achievement of specified regulatory milestones.
Infectious Disease Vaccines
*•COVID vaccines:* We have received approval in 40 countries for our 2025-2026 formula for Spikevax.
We have also received U.S. Food and Drug Administration (FDA) approval of our 2025-2026 formula for mNEXSPIKE, our second COVID vaccine, in all adults aged 65 and older, as well as individuals aged 12 to 64 years with at least one underlying risk factor.
mNEXSPIKE is also approved in Europe, Canada and Australia and we have filed and are targeting 2026 approvals in Japan and Taiwan.
It is also approved in 31 of those countries for individuals 18 to 59 years of age who are at increased risk for disease.
- *Seasonal flu vaccine:* Our mRNA-1010 regulatory filings are under review in the United States, Europe, Canada and Australia.
In February 2026, in response to a prior Refusal-to-File letter, we engaged with the FDA in a Type A meeting and submitted an amended biologics license application (BLA) outlining a revised regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.
Following the meeting and submission of the amended application, the FDA accepted our BLA for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026.
*•Seasonal flu + COVID vaccine:* Our mRNA-1083 regulatory filing is under review in Europe and Canada.
We are awaiting further guidance from the FDA on refiling.
- *Norovirus vaccine:* We recently completed enrollment of a second Northern Hemisphere season (2025-2026) cohort in our ongoing Phase 3 study for our norovirus vaccine candidate (mRNA-1403).
- *Intismeran autogene:* We are advancing intismeran (mRNA-4157), our mRNA-based individualized neoantigen therapy, in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma.
In January 2026, we and Merck announced five-year data from the Phase 2b study of intismeran in combination with KEYTRUDA, which demonstrated sustained improvement in recurrence-free survival in patients with high-risk melanoma (stage III/IV) following complete resection.
- *mRNA-4359:* Our Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing.
The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and we expect a potential Phase 2 data readout in 2026.
- *Propionic acidemia (PA) therapeutic:* mRNA-3927 is in a registrational study and target enrollment has been reached.
In January 2026, we entered into a strategic collaboration with Recordati, an international pharmaceutical group, to advance mRNA-3927 through the final stages of clinical development and, if approved, global commercialization.
During the third quarter of 2025, our mRNA manufacturing facilities in Australia and the United Kingdom were licensed and became operational.
These facilities were established under long-term strategic agreements with the respective governments to support domestic mRNA manufacturing and pandemic preparedness.
The facilities will enable local supply of our mRNA vaccines and provide rapid response capabilities in the event of future public health emergencies.
In September 2025, we delivered the first mRNA vaccines fully manufactured in Canada from our facility in Laval, Quebec, marking a significant milestone in our collaboration with the Government of Canada.
The site, which received its Drug Establishment License from Health Canada in 2024, now produces the drug substance for our updated Spikevax targeting the LP.8.1 variant.
Fill-and-finish of the vaccine, including the new single-use pre-filled syringes, is completed by Novocol Pharma in Cambridge, Ontario.
This milestone demonstrates the execution of our end-to-end manufacturing strategy and our ability to provide timely access to locally manufactured mRNA vaccines through collaboration with government and industry.
In December 2025, we entered into an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) under which CEPI will provide up to $54 million in funding to support a pivotal Phase 3 clinical trial for our investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, which is expected to begin in early 2026.
If licensure is granted and in the event of an influenza pandemic, Moderna is committed to working to provide people around the world with rapid, equitable access to the resulting H5 vaccine, including, as part of this agreement, allocating 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing.
(1)Includes sales of Spikevax and mNEXSPIKE.
We launched commercial sales of mRESVIA in the third quarter of 2024.
In May 2025, mNEXSPIKE was approved for use in adults aged 65 years and older, as well as individuals aged 12 through 64 years with at least one underlying risk factor.
We launched commercial sales of mNEXSPIKE in the third quarter of 2025.
We sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations.
Our COVID vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®.
Our original vaccine, mRNA-1273, targeted the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated.
In May 2024, the U.S. Food and Drug Administration (FDA) granted approval for mRESVIA® (mRNA-1345), our mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection.
This marks our second approved mRNA product and underscores our ongoing commitment to delivering solutions for patients by addressing global public health threats related to infectious diseases.
*Respiratory Vaccines*
During the fourth quarter of 2024, we achieved significant milestones in our respiratory vaccine portfolio.
We filed for regulatory approval with the FDA for our next-generation COVID vaccine (mRNA-1283), supported by positive Phase 3 efficacy and immunogenicity data, leveraging a priority review voucher, and have been assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.
We also submitted a regulatory application for our respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), for high-risk adults aged 18 to 59, following positive Phase 3 data and using a priority review voucher, and have been assigned a PDUFA goal date of June 12, 2025.
Additionally, we filed for FDA approval of our flu+COVID combination vaccine (mRNA-1083), based on positive Phase 3 immunogenicity data in adults aged 50 years and older.
As of December 31, 2024, eleven of our 44 development programs are in late-stage development, including nine programs in Phase 3 and two rare disease programs that are expected to generate pivotal data in 2025.
Respiratory Vaccines
*•Next-generation COVID vaccine:* We shared positive Phase 3 vaccine efficacy and immunogenicity data for our next-generation COVID vaccine (mRNA-1283) at our 2024 R&D Day event in September 2024.
We have filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher.
The FDA has accepted our Biologics License Application (BLA) for mRNA-1283 and has assigned a PDUFA goal date of May 31, 2025.
We shared positive Phase 3 data for mRNA-1345 in high-risk adults aged 18 to 59 at our 2024 R&D Day event and have since submitted an application to the FDA for regulatory approval using a priority review voucher, and have been assigned a PDUFA goal date of June 12, 2025.
- *Seasonal flu + COVID vaccine:* We shared positive Phase 3 immunogenicity data for our flu+COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at our 2024 R&D Day event.
We have filed with the FDA for regulatory approval of mRNA-1083, which may require vaccine efficacy data from our ongoing Phase 3 seasonal flu vaccine study.
- *Seasonal flu vaccine:* We have shared positive Phase 3 immunogenicity and safety data for our seasonal flu vaccine (mRNA-1010).
We are conducting a two-season Phase 3 efficacy study (P304), where the timing of the efficacy readout depends on case accrual and could happen in the current season.
Latent and Other Vaccines
- *Cytomegalovirus (CMV) vaccine:* The pivotal Phase 3 study of our CMV vaccine candidate (mRNA-1647) is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age.
The Data Safety Monitoring Board (DSMB) met to review the initial study data and has informed us that the criterion for early efficacy was not met.
The DSMB recommended that the study continue as planned.
We remain blinded and anticipate final efficacy data from the study in 2025.
- *Norovirus vaccine:* The two-season Phase 3 study evaluating the efficacy, safety and immunogenicity of our trivalent vaccine candidate against norovirus (mRNA-1403) is fully enrolled in the Northern Hemisphere and we are preparing second season enrollment in the Southern Hemisphere.
The trial is currently on FDA clinical hold following a single adverse event report of Guillain-Barré syndrome, which is currently under investigation.
We do not expect an impact on the study's efficacy readout timeline as enrollment in the Northern Hemisphere has already been completed.
The timing of the Phase 3 readout will be dependent on case accruals.
- *Individualized Neoantigen Therapy (INT):* We continue to demonstrate the potential clinical benefit of our INT (mRNA-4157).
In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled.
Two Phase 3 studies for non-small cell lung cancer are enrolling.
A randomized Phase 2 study for high-risk muscle invasive bladder cancer is enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is enrolling.
Rare Diseases
- *Propionic acidemia (PA) therapeutic:* In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, our investigational therapeutic (mRNA-3927) has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria.
Early results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study.
We began generating registrational trial data in 2024.
We and the FDA have agreed on the pivotal study design.
We expect to start a registrational study in the first half of 2025.
In March 2024, we entered into a development and commercialization funding agreement with Blackstone Life Sciences (Blackstone) to advance our flu program.
As part of the agreement, Blackstone has committed up to $750 million in funding to support development efforts.
An excerpt. Shown here: 40 of 133 rewritten, 40 of 109 added and 40 of 121 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2025 filing and the FY2024 filing.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
12 rewritten, 5 added, 1 removed, 16 unchanged
As of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] we had cash, cash equivalents, restricted cash, and investments in marketable securities of [removed: $9.5] [added: $8.1] billion and [removed: $13.3] [added: $9.5] billion, respectively.
If market interest rates were to increase immediately and uniformly by one percentage point from levels at December 31, [removed: 2024,] [added: 2025,] the net fair value of our marketable securities would decrease by approximately [removed: $53] [added: $47] million.
[removed: Therefore,] [added: As a result,] we are exposed to [removed: certain] risks arising from [added: changes in foreign currency exchange rates driven by] both our business operations and economic conditions.
For the year ended December 31, [removed: 2024,] [added: 2025, approximately 27% of] our revenue [added: was denominated in foreign currencies, although our revenue] generating activities and operations continued to be primarily denominated in U.S. dollars.
In addition, [added: during 2025] we [removed: operate in foreign countries] [added: established] and [removed: are establishing] [added: expanded] manufacturing [removed: facilities] [added: operations] in [removed: Canada, Australia, and] the United Kingdom, [added: Canada and Australia,] where we also transact in foreign currencies.
[removed: Collectively, these factors expose us] [added: These developments are expected] to [removed: risks associated with fluctuations] [added: result] in [added: higher levels of] foreign currency [removed: exchange rates,] [added: denominated revenues and expenses on an annualized basis in the future,] which may [added: increase our exposure to fluctuations in foreign currency exchange rates and could] impact our results of operations and cash flows.
While cash flow hedging programs are in place, there were no foreign currency cash flow hedging activities during [removed: 2024.][added: 2025.]
We enter into foreign currency forward contracts to hedge fluctuations associated with foreign currency denominated monetary assets and liabilities, primarily cash, receivables, payables and lease liabilities in the Australian dollar, [removed: Brazilian real,] British pound, [removed: and] Canadian dollar, [added: and Euro] that are not designated for hedge accounting treatment.
Therefore, these forward contracts are accounted for as derivatives whereby the fair value of the contracts are reported as prepaid expenses and other current assets or other current liabilities in our consolidated balance sheets, and gains and losses resulting from changes in the fair value are recorded as a component of other [removed: expense,] [added: income (expense),] net, in our consolidated statements of operations.
The gains and losses on these foreign currency forward contracts generally offset the gains and losses in the underlying foreign currency denominated assets and liabilities, which are also recorded to other [removed: expense,] [added: income (expense),] net, in our consolidated statements of operations.
As of December 31, [removed: 2024,] [added: 2025,] our outstanding balance sheet hedging derivatives, carried at fair value, had maturities of less than three months.
As of December 31, [removed: 2024,] [added: 2025,] a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in balance sheet hedging of approximately [removed: $36] [added: $58] million.
In November 2025, we entered into a variable-rate Credit Agreement providing for borrowings of up to $1.5 billion, under which outstanding amounts bear interest at rates based on Term SOFR plus a margin of 5.50% or a base rate plus a margin of 4.50%, at our option.
As a result, our interest expense is exposed to changes in market interest rates.
As of December 31, 2025, we had $600 million outstanding under this facility.
See [Note 11](#i151f4968467f44d985f22077f4372877_2066) to the consolidated financial statements for additional details.
Our foreign currency revenue exposure in 2025 was primarily associated with the Canadian dollar, Euro, Korean won, and Mexican peso markets.
However, we maintained a significant exposure to foreign currency risk, particularly in the Australian dollar, Brazilian real, British pound, and Canadian dollar markets.
Item 1. Business
269 rewritten, 263 added, 398 removed, 569 unchanged
Moderna is a [added: pioneer and] leader in the [removed: creation of the] field of [removed: messenger RNA (mRNA)] [added: mRNA] medicine.
Through the advancement of [removed: mRNA technology,] [added: our technology platform,] we are reimagining how medicines are made [removed: and transforming] [added: to transform] how we treat and prevent [removed: disease for everyone.][added: diseases.]
[removed: Our] [added: Since our founding, our] mRNA platform has enabled the development of [removed: medicines across four franchises: respiratory virus vaccines, latent and other virus vaccines, oncology therapeutics] [added: vaccine] and [added: therapeutic candidates across infectious disease, oncology,] rare disease [removed: therapeutics.][added: and more.]
With a [removed: unique culture and a] global team [added: and a unique culture,] driven by [removed: the Moderna] [added: our] values and [removed: mindsets to responsibly change the future of human health, we strive] [added: mindsets, our mission is] to deliver the greatest possible impact to people through mRNA medicines.
][added: (26).jpg](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/mrna-20251231_g2.jpg)]
[removed: ][added: ]
Our success in developing, manufacturing and commercializing [removed: vaccines against COVID-19 and RSV] [added: mRNA medicines] demonstrates the potential of [removed: mRNA medicines] [added: our platform] to help people and patients in far-reaching ways that could exceed the impact of traditional approaches to medicine.
We are currently focused on [removed: three] [added: four] strategic priorities:
Over the last decade, we have advanced in parallel a diverse development pipeline that currently consists of [removed: 44] [added: 35] therapeutic and vaccine programs, [removed: eleven] [added: 6] of which are in late-stage development.
The scope of our pipeline reflects the breadth of biology addressable using mRNA technology, and spans [removed: four] [added: three] franchises: [removed: respiratory virus vaccines, latent and other] [added: infectious disease] vaccines, oncology therapeutics, and rare disease therapeutics.
][added: pipeline_021726.jpg](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/mrna-20251231_g4.jpg)]
We have [removed: two] [added: three] commercial respiratory [removed: virus] vaccines—Spikevax [added: and mNEXSPIKE] (our COVID [removed: vaccine)] [added: vaccines)] and mRESVIA (our RSV vaccine for older [removed: adults).][added: adults and high-risk adults ages 18-59).]
[removed: We have a total of 15] [added: Our current] respiratory programs [removed: in our current portfolio,] [added: are] summarized below.
COVID vaccines (Spikevax/mRNA-1273, [removed: next-generation mRNA-1283)][added: mNEXSPIKE/mRNA-1283)]
The risk of mortality increases with [removed: age] [added: age,] and the risk of severe disease and mortality [removed: increases for persons] [added: is higher among individuals] with certain pre-existing [removed: diseases or comorbid] conditions, [removed: such as] [added: including] cardiovascular disease, diabetes, chronic lung disease and obesity.
As the SARS-CoV-2 virus continues to evolve, [removed: Spikevax continues] [added: our COVID vaccines continue] to be [removed: a] key [removed: tool] [added: tools] in fighting COVID-19.
As part of our strategy to continue to combat COVID-19, we develop and assess variant-specific versions of our COVID [removed: vaccine.][added: vaccines.]
We [removed: developed JN.1] [added: pursue updated vaccine compositions based on guidance from the FDA,] and [removed: KP.2 formulations of mRNA-1273 in accordance with] [added: other] regulatory [removed: guidance,] [added: bodies including European Medicines Agency (EMA) and the World Health Organization (WHO),] with the goal of broadening vaccine-induced immunity and providing protection against circulating SARS-CoV-2 variants.
The FDA has approved [added: our 2025-2026] Spikevax [removed: for individuals 12 years and older, and granted Emergency Use Authorization] [added: formula] for [added: high-risk] individuals aged six months through [removed: 11 years.][added: 64 years and all adults 65 years of age and older.]
[removed: Respiratory syncytial virus (RSV)] [added: RSV] is one of the most common causes of lower respiratory disease in children under the age of five and in older adults.
In the United States, it is estimated that [removed: over two million children younger than five receive medical attention and] up to 80,000 [added: children] are hospitalized due to RSV infection annually.
We [removed: are developing] [added: have developed] an RSV vaccine [removed: (mRNA-1345)] [added: (mRNA-1345 or mRESVIA)] for [removed: children, pregnant women and] adults.
[removed: mRNA-1345] [added: mRESVIA] encodes an engineered form of the RSV F protein stabilized in the prefusion conformation and is formulated in our proprietary LNP.
Subsequently, the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for all unvaccinated people aged 75 years and older and unvaccinated people aged 60 to 74 who are at increased risk for [removed: RSV to receive the vaccine for the prevention of RSV-associated LRTD and acute respiratory disease.][added: RSV.]
[added: mRESVIA was approved in] the EU in August 2024 and in Canada in November [removed: 2024 for the same indication and ages.][added: 2024.]
The [removed: World Health Organization (WHO)] [added: WHO] estimates that seasonal influenza viruses cause three to five million cases of severe illness and 290,000 to 650,000 deaths each year, resulting in a severe challenge to public health.
Our [removed: first-generation] seasonal influenza vaccine candidate (mRNA-1010) encodes for the hemagglutinin (HA) proteins of the strains recommended by the WHO.
We [removed: also] aim to work with the WHO, regulators and public health authorities to enable strain selection closer to the influenza season to provide a better match to the circulating viruses.
In September 2023, we announced the P303 immunogenicity and safety study of mRNA-1010 met all [removed: 8] [added: eight] co-primary endpoints with an updated [removed: formulation] [added: composition] that was able to generate an improved immune response to influenza B strains.
[removed: We also] [added: Consequently, we] announced that we [removed: are no longer pursuing an accelerated approval pathway for mRNA-1010, and plan] [added: were planning] to start a confirmatory vaccine efficacy study, [added: P304,] funded by project financing through Blackstone Life Sciences, a [removed: partnership] [added: collaboration] we announced [removed: earlier] in 2024.
[removed: mRNA-1083, our next-generation] [added: Our] COVID and seasonal influenza combination [removed: vaccine,] [added: vaccine (mRNA-1083),] encodes the same antigens as our [removed: updated] seasonal influenza vaccine (mRNA-1010) and [removed: our next-generation COVID vaccine (mRNA-1283).][added: mNEXSPIKE.]
We [removed: have also] filed [removed: mRNA-1083] for [added: FDA] approval [added: for mRNA-1083] in [added: November 2024 and also submitted regulatory applications in] other [removed: geographies] [added: geographies,] including the EU, Canada, Australia and the UK.
[removed: Safety] [added: In addition, safety] follow-up continues in our Phase 1 study for [removed: mRNA-1365] [added: mRNA-1365, our RSV and human metapneumovirus (hMPV) combination vaccine,] in children five to 23 months of age.
We [added: are] also [removed: plan to evaluate] [added: evaluating] an updated version of [removed: mRNA-1365, our RSV and hMPV combination vaccine] [added: mRNA-1365] in older adults.
An influenza pandemic is a global outbreak of a new influenza A virus that is very different from [removed: current and] recently circulating human seasonal influenza A viruses.
[removed: Pandemic] [added: Historically, pandemic] strains [removed: can arise] [added: have arisen] by antigenic shift, which is [added: a major change in an influenza A virus caused by] the exchange of genetic segments between a [removed: (non-human)] [added: non-human] influenza virus with another influenza virus; this can occur through a simultaneous infection of an animal (e.g., swine) or humans with multiple influenza viruses.
We are developing a pandemic influenza vaccine candidate that encodes for hemagglutinin (HA) [removed: glycoproteins with the support of Biomedical Advanced Research and Development Authority (BARDA).][added: glycoproteins.]
The study [removed: includes] [added: included] vaccine candidates against H5 and H7 avian influenza viruses.
[removed: LATENT AND OTHER FRANCHISE][added: Latent and Other Vaccines]
[removed: We have a total of 14] [added: Our current] latent and other [removed: virus] vaccines programs [removed: in our current portfolio,] [added: are] summarized below.
We currently have three commercial products—Spikevax and mNEXSPIKE (our COVID vaccines) and mRESVIA (our vaccine against respiratory syncytial virus (RSV)).
mNEXSPIKE, which we launched commercially in the third quarter of 2025, is now our leading product in the U.S. retail channel.
In 2025, we achieved total revenue of $1.9 billion, largely from sales of our COVID vaccines.
Beyond our commercial products, we continue to demonstrate the potential of our platform technology and are advancing a pipeline of development candidates across oncology, rare disease and infectious disease.
In January 2026, we and Merck announced five-year data from the Phase 2b study of intismeran autogene (mRNA-4157), our mRNA-based individualized neoantigen therapy, in combination with Merck’s pembrolizumab (KEYTRUDA®), which demonstrated sustained improvement in recurrence-free survival in patients with high-risk melanoma (stage III/IV) following complete resection.
We are advancing intismeran in collaboration with Merck, with eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types.
In oncology, we are also advancing mRNA-4359, a cancer antigen therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells.
In infectious disease, we have regulatory filings under review for our seasonal flu+COVID combination vaccine candidate (mRNA-1083) in Europe and Canada, and for our seasonal flu vaccine candidate (mRNA-1010) in the United States, Europe, Canada and Australia.
For mRNA-1010, in response to a prior Refusal-to-File letter, we engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and submitted an amended biologics license application (BLA) outlining a revised regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.
Following the meeting and submission of the amended application, the FDA accepted our BLA for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026.
In addition, we recently completed enrollment of a second Northern Hemisphere season (2025-2026) cohort in our ongoing Phase 3 study for our norovirus candidate (mRNA-1403).
In rare disease, our propionic acidemia therapeutic (mRNA-3927) has reached target enrollment in a registrational study.
In January 2026, we entered into a strategic collaboration with Recordati, an international pharmaceutical group, to advance mRNA-3927 through the final stages of clinical development and, if approved, global commercialization.
In addition, we expect the registrational study for our methylmalonic acidemia therapeutic (mRNA-3705) to begin in 2026.
Since 2022, we have streamlined our production sites into a global manufacturing network to support new product launches and deliver products for multi-year collaborations.
In 2025, we announced new drug product capabilities in the U.S. and we have added three Moderna-built and managed facilities in the UK, Canada and Australia to enable local access to mRNA vaccines.
Additionally, our Marlborough, Massachusetts facility was purpose-built for intismeran and began clinical batch supply in September 2025.
1.Deliver sales growth. Our commercial growth drivers include geographic expansion and new product launches.
In 2026, we expect to drive revenue growth from the annualized impact of our long-term partnerships in the UK, Canada and Australia, as well as continued strong uptake of mNEXSPIKE in the U.S. In addition, we expect multiple growth opportunities in 2027 and 2028.
2.Deliver cost efficiency across the business. Throughout 2025, we maintained disciplined cost management, improving productivity across manufacturing, R&D and SG&A.
We expect to further reduce costs in 2026 and 2027.
We plan to leverage our global production network, artificial intelligence (AI) and digital tools to improve cost efficiency.
3.Execute on our prioritized pipeline. We anticipate pivotal trial data readouts in 2026 across our oncology, rare disease and infectious disease portfolios.
We expect to launch several new infectious disease products over the next few years (flu, flu+COVID combination and Norovirus), which would expand our infectious disease vaccine franchise to as many as six approved products.
We expect to invest the cash generated from these products into oncology and rare disease therapeutics.
4.Continue to advance our early pipeline and platform technology. We continue to advance our early-stage pipeline.
This includes our early-stage oncology programs, which expand our oncology portfolio across cancer antigen therapies, T-cell engagers and cell-therapy enhancers, as well as multiple early-stage vaccine programs.
INFECTIOUS DISEASE FRANCHISE
Respiratory Vaccines
Additionally, we have regulatory filings under review for our seasonal flu+COVID vaccine (mRNA-1083) in Europe and Canada and for our seasonal flu vaccine (mRNA-1010) in the United States, Europe, Canada and Australia.
We currently have two approved COVID vaccines: Spikevax (our original COVID vaccine) and mNEXSPIKE.
mNEXSPIKE was approved by the FDA in May 2025 for individuals 65 years of age and older, and individuals 12 through 64 years of age who are at high risk for severe COVID-19.
mNEXSPIKE focuses immune responses to the domains of the SARS-CoV-2 spike protein that are critical for neutralizing antibody and T cell responses.
mNEXSPIKE’s mRNA dose is one-fifth that of Spikevax.
In April 2025, we shared Phase 3 data showing non-inferior vaccine efficacy relative to Spikevax, and a 13.5% relative vaccine efficacy (rVE) compared to Spikevax in participants 65 years of age and older.
Our 2025-2026 formulas for Spikevax and mNEXSPIKE target the LP.8.1 variant of SARS-CoV-2.
We have received approval of our 2025-2026 Spikevax formula in 40 countries.
The FDA has approved our 2025-2026 mNEXSPIKE formula for high-risk individuals 12 through 64 years of age and all adults 65 years of age and older.
We have also received approvals of mNEXSPIKE in Europe, Canada and Australia.
Adults 18 to 59 years of age with certain comorbidities also face a significant disease burden that is similar to that of older adults.
By working at the intersection of science, technology and health for more than a decade, we have developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID vaccines.
Our first commercial product, Spikevax (our COVID vaccine), has helped hundreds of millions of people worldwide combat COVID-19.
SARS-CoV-2, the virus that causes COVID-19, continues to evolve, and in 2023, the COVID vaccine market shifted from a pandemic to an endemic, seasonal commercial market.
In 2024, we became a multi-product company with the approval of our second commercial product, mRESVIA, our mRNA respiratory syncytial virus (RSV) vaccine for older adults.
In 2024, we achieved net product sales of $3.1 billion, largely from sales of Spikevax.
Beyond our commercial products, we continue to demonstrate the potential of our platform technology.
In 2024, we shared four positive Phase 3 data readouts across our respiratory portfolio—for our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, our seasonal flu+COVID combination vaccine and our seasonal flu vaccine.
In the area of oncology therapeutics, we continue to demonstrate the potential clinical benefit of our individualized neoantigen therapy (INT) (mRNA-4157), which is being developed in collaboration with Merck.
We and Merck have rapidly expanded clinical studies to several tumor types and completed enrollment of the Phase 3 clinical trial for adjuvant melanoma in 2024.
Additionally, in 2024, we also took steps to move two of our rare disease therapeutics programs—targeting propionic acidemia (PA) and methylmalonic acidemia (MMA)—toward registrational trials.
We also achieved milestones in our latent and other vaccines franchise, including the initiation of a Phase 3 study of our norovirus vaccine.
Our success in research and development is a testament to our platform.
Moving forward, we are taking a paced approach to our research and development investment.
We entered 2025 with a focus on a prioritized portfolio addressing our four franchises where there is unmet need.
Table of Contents
Our success in developing one of the earliest and most effective COVID vaccines, at unprecedented speed and efficiency, demonstrates the promise of mRNA medicine.
Our COVID vaccine has helped hundreds of millions of people worldwide combat COVID-19.
Beyond COVID, our platform continues to be highly productive, with our RSV vaccine representing our second commercial product and eleven programs in late-stage development.
1.Driving use of Spikevax and mRESVIA. Spikevax and mRESVIA are the foundation of our respiratory vaccine portfolio and we expect to participate in the full contracting season in the United States for both in 2025 for the first time.
We will continue to work with all market channels to maximize the availability of Spikevax.
Internationally, we plan to bring manufacturing plants online in Australia, Canada and the United Kingdom (UK) in 2025, subject to execution of manufacturing plant licensures.
With a full season of RSV contracting in 2025, our goal is to increase mRESVIA’s market share in the United States and market access globally.
2.Focusing on ten product approvals over the next three years to drive sales growth. Our prioritized programs span our four franchises: respiratory, latent and other virus, oncology and rare diseases.
We expect execution of this priority to drive
sales growth and fund our next wave of research and development investment.
For nine of these programs, we have near-term milestones, including up to three potential 2025 approvals for our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older.
We also anticipate up to six upcoming registrational data readouts for our cytomegalovirus (CMV), seasonal flu, norovirus, INT for adjuvant melanoma, PA and MMA product candidates.
3.Delivering cost efficiency across the business. We plan to continue improving efficiency by further reducing our research and development and selling, general and administrative expenses in 2025.
By 2027, we expect to decrease annual research and development expenses by approximately $1.0 billion compared to 2024.
On cost of sales, we will work to continue to drive efficiency through manufacturing productivity improvements to achieve operating leverage.
We are currently focusing our efforts on delivering up to ten prioritized products over the next three years to drive sales growth and fund the next wave of research and development investment.
The diversity of proteins made from mRNA within our development pipeline is shown in the figure below.

RESPIRATORY FRANCHISE
Additionally, we have achieved four positive Phase 3 data readouts for our next-generation COVID vaccine (mRNA-1283), our RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), our seasonal flu+COVID vaccine (mRNA-1083), and our seasonal flu vaccine (mRNA-1010).
Spikevax is approved for use in jurisdictions globally.
In August and September 2024, we received regulatory approvals in major markets for our updated COVID vaccine, targeting the JN.1 (mRNA-1273.167) and KP.2 (mRNA-1273.712) subvariants of SARS-CoV-2, based on the new variant composition requests from different public health bodies.
We have also observed preliminary clinical trial data showing that these vaccines generate a robust immune response (cross-neutralization) against currently circulating variants of SARS-CoV-2.
Spikevax has also been authorized for individuals six months and older in other key markets, including the European Union (EU), Canada and Japan.
Forward-looking references to our COVID vaccine in this Annual Report on Form 10-K may include future modifications to mRNA-1273 or other product candidates that are designed to provide protection against variants of the SARS-CoV-2 virus.
An excerpt. Shown here: 40 of 269 rewritten, 40 of 263 added and 40 of 398 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2025 filing and the FY2024 filing.
Item 3. Legal Proceedings
19 rewritten, 41 added, 18 removed, 18 unchanged
The case has been stayed pending the outcome of two Inter Partes [removed: Proceedings] [added: Review proceedings] (IPRs) [removed: pending] before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) regarding the validity of two of the three asserted [removed: patents in this lawsuit.][added: patents.]
Also in August 2022, we initiated patent infringement proceedings in [removed: Germany] [added: the UK] (in the [removed: Dusseldorf Regional Court),] [added: High Court of Justice of England & Wales),] the Netherlands (in the District Court of The Hague) and [removed: the UK] [added: Germany] (in the [removed: High Court of Justice of England & Wales)] [added: Dusseldorf Regional Court),] against Pfizer, BioNTech and [added: related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses.]
In May 2023, we initiated patent infringement proceedings in Ireland (in the High Court) and Belgium [removed: (Brussels] [added: (in the Brussels] Business Court) against Pfizer, BioNTech and related entities with respect to the same European patents.
Pfizer Inc. and BioNTech SE have [removed: also] filed [removed: an action] [added: oppositions] seeking revocation of [removed: certain Moderna] [added: the ‘949 and ‘565] patents [removed: in] [added: at] the [removed: UK.][added: European Patent Office.]
In July 2024, the High Court of Justice of England & Wales [removed: issued a judgment confirming the validity of the] [added: ruled that EP3590949 (the] ‘949 [removed: patent] [added: patent), which relates to chemically-modified mRNA, was valid] and [removed: finding that] [added: infringed by] Pfizer and [removed: BioNTech had infringed the patent.][added: BioNTech.]
The court further [removed: determined] [added: ruled] that [removed: the] [added: EP3718565 (the] ‘565 [removed: patent] [added: patent), which relates to coronavirus mRNA vaccines,] was invalid.
In December 2023, the District Court of The Hague [removed: issued a first instance decision determining] [added: ruled] that the ‘949 patent was [removed: invalid in the Netherlands.][added: invalid.]
In February 2022, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine willfully infringes certain U.S. patents concerning lipid [removed: nanoparticles.][added: nanoparticles but does not seek to prevent or stop the marketing or sales of our COVID vaccines.]
The complaint seeks a judgment of infringement of the asserted patents and monetary [removed: damages, but does not seek to prevent or stop the marketing or sales of our COVID vaccines.][added: damages.]
The Court has set trial to begin [removed: September 24, 2025, subject to the Court’s availability.][added: March 9, 2026.]
In October 2024, GlaxoSmithKline Biologicals SA (GSK) filed [removed: a complaint] [added: two separate complaints] against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID [added: and RSV] vaccines [added: willfully] infringe certain U.S. patents directed to lipid-mRNA vaccine formulation technology.
The complaint seeks a judgment of infringement of the asserted [removed: patents] [added: patent] and unspecified [removed: damages, but does not seek injunctive relief.][added: damages.]
[removed: Also in October 2024, GSK] [added: In February 2026, BioNTech SE] filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of [removed: our RSV vaccine] [added: mNEXSPIKE willfully] infringes [removed: certain] [added: a] U.S. [removed: patents] [added: patent] directed to [removed: lipid-mRNA vaccine formulation technology.][added: modified mRNA compositions encoding a spike protein fragment.]
[removed: The] [added: Each] complaint seeks a judgment of infringement of the asserted [removed: patents,] [added: patents and] unspecified [removed: damages] [added: damages,] and injunctive relief [removed: in the United States.][added: related to RSV after any appeals are decided.]
In August 2024, a putative shareholder class action complaint was filed against [removed: the Company] [added: us] and certain officers in the U.S. District Court for the District of Massachusetts.
The action [removed: is] [added: was] purportedly brought on behalf of a class of shareholders who purchased Moderna common stock between January 18, 2023 and June 25, 2024.
Between September and November 2024, purported shareholder derivative complaints were filed in the U.S. District Court for the District of Massachusetts against certain of our officers and directors and against [removed: the Company] [added: us] as a nominal defendant.
In March 2022 and July 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed two complaints against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine [removed: infringes] [added: infringed] certain U.S. patents concerning cationic lipids.
[removed: In] [added: Relatedly, in] May 2023, Alnylam filed a third complaint against us in the U.S. District Court for the District of Delaware asserting three additional U.S. patents concerning cationic lipids.
U.S. Proceedings
In March 2025, the PTAB found the patents invalid and we appealed to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit).
European Proceedings
In August 2025, the UK Court of Appeal upheld the High Court’s decision that the ‘949 patent is valid and infringed by Pfizer and BioNTech.
In December 2025, the UK Supreme Court denied permission for appeal by Pfizer and BioNTech.
We appealed to the Court of Appeal of The Hague, which held a hearing on September 22, 2025, and is expected to issue its decision on March 31, 2026.
In March 2025, the Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech infringed the ‘949 patent.
Pfizer and BioNTech have appealed to the Higher Regional Court of Dusseldorf, which will hold a hearing November 26, 2026.
In May 2024, the Opposition Division (OD) ruled that the ‘949 patent was valid, and Pfizer and BioNTech appealed to the Technical Appeal Board (TBA), which will hold a hearing on September 8-10, 2026.
In November 2023, the OD ruled that the ‘565 patent was invalid and we appealed to the TBA, which confirmed the invalidity on January 27, 2026.
*Arbutus Patent Litigation*
In March 2025, Arbutus and Genevant filed five international lawsuits asserting that our manufacture and sale of Spikevax and/or mRESVIA infringes certain patents concerning lipid nanoparticles.
The companies filed lawsuits in the Canadian Federal Court, the Tokyo District Court in Japan and the Swiss Federal Patent Court and submitted two lawsuits to the Unified Patent Court (UPC).
The UPC actions seek relief in all UPC member states and in ten additional European Patent Convention contracting states.
Each proceeding identifies Spikevax and mRESVIA as accused products except for the Canadian proceeding, which only identifies Spikevax.
The complaints seek monetary relief and injunctive relief after a trial decision and before any appeals are decided.
Hearings for the UPC actions are set for May 19 and 20, 2026.
The Canadian lawsuit is scheduled for trial beginning in September 2027.
*GSK Patent Litigation*
The Court has set trial to begin on July 19, 2027 with respect to our COVID vaccines, and on August 23, 2027 with respect to our RSV vaccine.
In July 2025, GSK submitted two lawsuits to the UPC asserting that our manufacture and sale of our COVID and RSV vaccines infringe three European patents related to liposomes with specified characteristics for RNA delivery.
The complaints seek monetary and injunctive relief after appeal.
Hearings are set for September 2026.
In December 2025, GSK served us with two separate complaints in the Barcelona Commercial Court and the Madrid Commercial Court (the Spanish Courts) asserting that our manufacture and sale of our COVID and RSV vaccines infringe the same patents asserted in the UPC actions.
The complaints seek monetary and injunctive relief after an appeal decision.
*Northwestern University Patent Litigation*
*Alnylam Patent Litigation*
In the first case, Alnylam appealed and the Federal Circuit decided the appeal in our favor in June 2025.
The complaint sought judgments of infringement of the asserted patents and monetary damages.
Following the June 2025 Federal Circuit decision in our favor, we and Alnylam entered into an agreement in September 2025 to settle all disputes between the parties, including filing a stipulated dismissal of Alnylam’s claims with prejudice.
The settlement did not include payments of any kind by us.
*Bayer CropSciences Patent Litigation*
In January 2026, Bayer CropScience LLC, Monsanto Company and Monsanto Technology, LLC (collectively, Bayer) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccines infringe a U.S. patent directed to methods of modifying gene sequences.
*mNG Bio Patent Litigation*
In January 2026, mNG Bio, LLC (mNG) filed a complaint against us in the U.S. District Court for the District of Massachusetts asserting that certain tests of our COVID vaccines willfully infringe a U.S. patent directed to a yellow-green fluorescent protein.
The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.
*BioNTech Patent Litigation*
The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.
On August 25, 2025, plaintiff filed an amended complaint, which, among other things, narrowed the asserted class period to February 15, 2024 to May 31, 2024.
On October 24, 2025, the Company filed a motion to dismiss, which remains pending.
The PTAB is expected to issue a decision on the IPRs on or before March 6, 2025, which would be subject to appeal.
related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses.
In addition, the Moderna patents being asserted in the European actions are subject to notices of opposition, including by Pfizer and BioNTech SE and others.
These actions seek to revoke the patents, which have been filed at the European Patent Office.
There are two patents at issue in the European patent infringement proceedings–EP3590949 (the ‘949 patent), which relates to chemically-modified mRNA and EP3718565 (the ‘565 patent), which relates to coronavirus mRNA vaccines.
The High Court’s decision related to the ‘949 patent is subject to appeal.
Moderna has appealed this decision to the Court of Appeal of The Hague, with a second instance decision expected in 2025.
In addition, there remain ongoing Opposition Proceedings at the European Patent Office by a number of opponents, including Pfizer and BioNTech related to these two patents.
*Proceedings Related to Patents Owned by Arbutus*
*Proceedings Related to Patents Owned by GSK*
COVID-19 Vaccines
RSV Vaccine
*Proceedings Related to Patents Owned by Northwestern University*
The complaint does not seek injunctive relief.
*Proceedings Related to Patents Owned by Alnylam*
Alnylam has appealed this judgment to the Federal Circuit Court of Appeals.
The complaints seek judgments of infringement of the asserted patents and monetary damages, but do not seek to prevent or stop the marketing or sales of our COVID vaccines.
The decision is subject to appeal.
An excerpt. Shown here: all 19 rewritten, 40 of 41 added and all 18 removed. The counts are complete. For every sentence, read Item 3. Legal Proceedings in the FY2025 filing and the FY2024 filing.
Cover and table of contents
39 rewritten, 7 added, 9 removed, 123 unchanged
For the fiscal year ended December 31, [removed: 2024][added: 2025]
[removed: ][added: ]
The aggregate market value of voting stock held by non-affiliates of the registrant, computed by reference to the closing price as of the last business day of the registrant's most recently completed second fiscal quarter, was approximately [removed: $42.1] [added: $9.9] billion.
As of February [removed: 14, 2025,] [added: 13, 2026,] there were [removed: 385,815,877] [added: 394,939,424] shares of the registrant’s common stock, par value $0.0001 per share, outstanding.
Portions of the registrant’s Definitive Proxy Statement relating to its [removed: 2025] [added: 2026] Annual Meeting of Stockholders to be filed hereafter are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated.
| Item 1. | | | Business | | | [removed: [6](#i936f1894ad9e4b3c8b6c404bf64d47b3_19)] [added: [6](#i151f4968467f44d985f22077f4372877_19)] | | |
| Item 1A. | | | Risk Factors | | | [removed: [45](#i936f1894ad9e4b3c8b6c404bf64d47b3_73)] [added: [43](#i151f4968467f44d985f22077f4372877_73)] | | |
| Item 1B. | | | Unresolved Staff Comments | | | [removed: [77](#i936f1894ad9e4b3c8b6c404bf64d47b3_82)] [added: [76](#i151f4968467f44d985f22077f4372877_82)] | | |
| Item 1C. | | | Cybersecurity | | | [removed: [77](#i936f1894ad9e4b3c8b6c404bf64d47b3_85)] [added: [77](#i151f4968467f44d985f22077f4372877_85)] | | |
| Item 2. | | | Properties | | | [removed: [78](#i936f1894ad9e4b3c8b6c404bf64d47b3_88)] [added: [78](#i151f4968467f44d985f22077f4372877_88)] | | |
| Item 3. | | | Legal Proceedings | | | [removed: [78](#i936f1894ad9e4b3c8b6c404bf64d47b3_91)] [added: [78](#i151f4968467f44d985f22077f4372877_91)] | | |
| Item 4. | | | Mine Safety Disclosures | | | [removed: [80](#i936f1894ad9e4b3c8b6c404bf64d47b3_94)] [added: [81](#i151f4968467f44d985f22077f4372877_94)] | | |
| Item 5. | | | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | | [removed: [81](#i936f1894ad9e4b3c8b6c404bf64d47b3_100)] [added: [82](#i151f4968467f44d985f22077f4372877_100)] | | |
| Item 6. | | | \[Reserved\] | | | [removed: [82](#i936f1894ad9e4b3c8b6c404bf64d47b3_106)] [added: [83](#i151f4968467f44d985f22077f4372877_106)] | | |
| Item 7. | | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | | [removed: [83](#i936f1894ad9e4b3c8b6c404bf64d47b3_109)] [added: [84](#i151f4968467f44d985f22077f4372877_109)] | | |
| Item 7A. | | | Quantitative and Qualitative Disclosures about Market Risk | | | [removed: [96](#i936f1894ad9e4b3c8b6c404bf64d47b3_121)] [added: [97](#i151f4968467f44d985f22077f4372877_121)] | | |
| Item 8. | | | Financial Statements and Supplementary Data | | | [removed: [97](#i936f1894ad9e4b3c8b6c404bf64d47b3_124)] [added: [99](#i151f4968467f44d985f22077f4372877_124)] | | |
| Item 9. | | | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | | [removed: [137](#i936f1894ad9e4b3c8b6c404bf64d47b3_238)] [added: [141](#i151f4968467f44d985f22077f4372877_238)] | | |
| Item 9A. | | | Controls and Procedures | | | [removed: [137](#i936f1894ad9e4b3c8b6c404bf64d47b3_241)] [added: [141](#i151f4968467f44d985f22077f4372877_241)] | | |
| Item 9B. | | | Other Information | | | [removed: [139](#i936f1894ad9e4b3c8b6c404bf64d47b3_244)] [added: [143](#i151f4968467f44d985f22077f4372877_244)] | | |
| Item 9C. | | | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | | [removed: [139](#i936f1894ad9e4b3c8b6c404bf64d47b3_250)] [added: [143](#i151f4968467f44d985f22077f4372877_247)] | | |
| Item 10. | | | Directors, Executive Officers and Corporate Governance | | | [removed: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_256)] [added: [144](#i151f4968467f44d985f22077f4372877_253)] | | |
| Item 11. | | | Executive Compensation | | | [removed: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_259)] [added: [144](#i151f4968467f44d985f22077f4372877_256)] | | |
| Item 12. | | | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | | [removed: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_262)] [added: [144](#i151f4968467f44d985f22077f4372877_259)] | | |
| Item 13. | | | Certain Relationships and Related Transactions, and Director Independence | | | [removed: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_265)] [added: [144](#i151f4968467f44d985f22077f4372877_262)] | | |
| Item 14. | | | Principal Accountant Fees and Services | | | [removed: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_268)] [added: [144](#i151f4968467f44d985f22077f4372877_265)] | | |
| Item 15. | | | Exhibits, Financial Statement Schedules | | | [removed: [141](#i936f1894ad9e4b3c8b6c404bf64d47b3_274)] [added: [145](#i151f4968467f44d985f22077f4372877_271)] | | |
| Item 16. | | | Form 10-K Summary | | | [removed: [143](#i936f1894ad9e4b3c8b6c404bf64d47b3_277)] [added: [147](#i151f4968467f44d985f22077f4372877_274)] | | |
- We have experienced commercial challenges and [removed: are likely to] [added: may] experience additional challenges in the future;
- The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may [removed: not] [added: be unable to] compete effectively in the market for existing or new products, treatment methods or technologies;
- As we grow as a commercial company and our drug development pipeline [removed: increases and] matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to [removed: operate.][added: operate;]
- Our [removed: individualized neoantigen therapy (INT)] [added: intismeran autogene] product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production;
- We have [removed: entered, and may enter into,] [added: entered into] strategic alliances with third parties for product development and commercialization.
- We may seek to establish additional strategic alliances and, if we are unable to [removed: establish them] [added: do so] on commercially reasonable terms, we may have to alter our development and commercialization plans.
- We incurred net losses in [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and expect to incur additional losses in the future; we have a limited history of recognizing revenue from product sales and may [removed: note] [added: not] achieve long-term sustainable profitability;
- We may encounter difficulties in managing [added: changes to] the [removed: development] [added: size, structure] and [removed: expansion] [added: scope] of our company;
- our ability to [removed: delivery] [added: deliver] cost efficiency across our [removed: business;][added: business and to achieve targeted cash breakeven;]
- our expectations regarding the size and durability of the [removed: commercial COVID and RSV vaccines markets] [added: respiratory vaccine market] and future demand for and sales of our products;
- our ability to produce our products or product candidates with advantages in turnaround times [removed: or] [added: and] manufacturing cost;
| Signatures | | | | | | [148](#i151f4968467f44d985f22077f4372877_277) | | |
- Regulatory and market uncertainty have and may continue to impact our business and the markets for our products;
- We may experience difficulties executing our near-term strategy and prioritized pipeline;
- We are subject to the risks of doing business outside of the United States;
- our ability to drive sales growth through geographic expansion and new product launches;
- our expectations regarding revenue growth in 2026;
- the buildout of our global manufacturing and commercial operations, and our ability to leverage our global manufacturing network;
| Signatures | | | | | | [144](#i936f1894ad9e4b3c8b6c404bf64d47b3_280) | | |
- 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;
- We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts;
- We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus;
We rely on third-party service providers, all of whom have inherent risks in their operations;
- our ability to drive use of Spikevax and mRESVIA and to increase market share;
- our focus on ten product approvals over the next three years;
- our ability to continue to develop effective variant-specific versions of our COVID vaccine;
- the buildout of our manufacturing and commercial operations, including our expectations regarding the completion and licensing of manufacturing facilities in Australia, Canada and the United Kingdom;
Item 1C. Cybersecurity
1 rewritten, 0 added, 0 removed, 22 unchanged
Recognizing the threat of security breaches and cyberattacks globally, we have developed a cybersecurity program, overseen by our Chief [added: Technology and] Information Security Officer (CISO), that is designed to protect patient trust, defend the Moderna brand, and reduce the risk and impact of cyber-attacks.
Item 2. Properties
5 rewritten, 11 added, 6 removed, 9 unchanged
The MSC accommodates a combination of scientific and office spaces, including our principal executive [removed: offices.][added: offices, and is the location of our corporate headquarters and platform, drug discovery, and clinical development activities.]
The MTC campus is approximately 722,000 square feet [removed: which] [added: and] includes lab and office space, directly supporting our manufacturing capabilities and commercial and clinical activities.
This facility [removed: is undergoing] [added: underwent] enhancements, including the addition of 60,000 square feet to the existing structure.
[removed: Upon completion, the] [added: The] facility [removed: will have] [added: includes] state-of-the-art mRNA manufacturing areas, including a full manufacturing clean room, quality control laboratories, and a just-in-time satellite warehouse.
In September 2024, we completed [added: construction of] our [added: mRNA] manufacturing facility in Laval, Quebec, Canada, which [added: we own, and the facility] received a Drug Establishment License [removed: (DEL)] from Health [removed: Canada.][added: Canada authorizing the production of mRNA vaccine drug substance.]
The Marlborough facility became operational in August 2025 and is intended to support our intismeran autogene program.
The facility encompasses approximately 100,000 square feet of manufacturing space and has the capacity to produce up to 100 million doses annually.
In 2025, the facility began manufacturing drug substance for our Spikevax, supporting domestic mRNA vaccine production for Canada.
In December 2025, Health Canada approved the addition of the Laval drug substance site for mRESVIA production, representing the second product approval for the Canadian supply chain.
We own a large-scale mRNA manufacturing facility, the Moderna Technology Centre – Melbourne (MTC-M), located in Clayton, Victoria, Australia, within Monash University’s Technology Precinct.
The facility encompasses approximately 130,000 square feet of manufacturing space and is designed to support end-to-end mRNA vaccine manufacturing, with the capacity to produce up to 100 million doses annually.
In August 2025, the facility received full Good Manufacturing Practice (GMP) licensing, authorizing the manufacture of mRNA vaccine drug substance and finished drug product in compliance with applicable regulatory standards.
We own the Moderna Innovation and Technology Centre (MITC), a manufacturing and research facility located at the Harwell Science and Innovation Campus in Oxfordshire, United Kingdom.
The facility, which officially opened in September 2025, encompasses approximately 100,000 square feet and is designed to support mRNA vaccine manufacturing and related research activities.
The MITC has the capacity to produce up to 100 million doses annually and up to approximately 250 million doses in the event of a pandemic.
The facility is intended to produce British-made mRNA respiratory vaccines to support the National Health Service (NHS) seasonal vaccination programs and also supports research into the application of mRNA technology in additional disease areas.
As of December 31, 2024, we have substantially exited our leased spaces at Technology Square in Cambridge, Massachusetts, completing the consolidation of our Cambridge operations into the MSC.
The MSC campus is the location of our corporate headquarters, platform, drug discovery and clinical development.
We expect the facility to be operational in 2025.
This new site is strategically intended to support our INT program.
This certification enables the facility to produce drug substance and positions it to manufacture mRNA vaccines, including COVID, RSV, and seasonal influenza, contingent on Health Canada’s approval, starting in 2025.
The site strengthens our global manufacturing capabilities and supports the Government of Canada’s pandemic readiness and vaccine supply objectives.
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
6 rewritten, 1 added, 0 removed, 20 unchanged
The following graph illustrates a comparison for the five years ended December 31, [removed: 2024] [added: 2025] of the cumulative total return for our common stock, the Nasdaq Biotechnology Index, and the Standard & Poor’s 500 Stock Index (the S&P 500) each of which assumes an initial investment of $100 and reinvestment of all dividends.
[removed: ][added: ]
We had approximately [removed: 63] [added: 62] stockholders of record as of February [removed: 14, 2025.][added: 13, 2026.]
During the three months ended December 31, [removed: 2024,] [added: 2025,] there were no shares repurchased.
As of December 31, [removed: 2024,] [added: 2025,] $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remained outstanding, with no expiration date.
[removed: Refer to [Note 12](#i936f1894ad9e4b3c8b6c404bf64d47b3_199)] [added: See [Note](#i151f4968467f44d985f22077f4372877_199) [13](#i151f4968467f44d985f22077f4372877_199)] to consolidated financial statements for information regarding our share repurchase programs.
In addition, our Credit Agreement with lenders led by Ares Capital Corporation includes covenants that, subject to certain exceptions, restrict our ability and the ability of our subsidiaries to pay dividends or distributions.
Item 8. Financial Statements and Supplementary Data
492 rewritten, 237 added, 118 removed, 815 unchanged
| [Report of Independent Registered Public Accounting [removed: Firm](#i936f1894ad9e4b3c8b6c404bf64d47b3_127)] [added: Firm](#i151f4968467f44d985f22077f4372877_127)] | | | | | | [removed: [98](#i936f1894ad9e4b3c8b6c404bf64d47b3_127)] [added: [100](#i151f4968467f44d985f22077f4372877_127)] | | |
| [Consolidated Balance Sheets as of December 31, [removed: 2024 and 2023](#i936f1894ad9e4b3c8b6c404bf64d47b3_130)] [added: 202](#i151f4968467f44d985f22077f4372877_130)[5](#i151f4968467f44d985f22077f4372877_130) [and 20](#i151f4968467f44d985f22077f4372877_130)[24](#i151f4968467f44d985f22077f4372877_130)] | | | | | | [removed: [100](#i936f1894ad9e4b3c8b6c404bf64d47b3_130)] [added: [102](#i151f4968467f44d985f22077f4372877_130)] | | |
| [Consolidated Statements of Operations for the years ended December 31, [removed: 2024, 2023,] [added: 202](#i151f4968467f44d985f22077f4372877_133)[5](#i151f4968467f44d985f22077f4372877_133)[, 202](#i151f4968467f44d985f22077f4372877_133)[4](#i151f4968467f44d985f22077f4372877_133)[,] and [removed: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_133)] [added: 20](#i151f4968467f44d985f22077f4372877_133)[23](#i151f4968467f44d985f22077f4372877_133)] | | | | | | [removed: [101](#i936f1894ad9e4b3c8b6c404bf64d47b3_133)] [added: [103](#i151f4968467f44d985f22077f4372877_133)] | | |
| [Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, [removed: 2024, 2023,] [added: 202](#i151f4968467f44d985f22077f4372877_136)[5](#i151f4968467f44d985f22077f4372877_136)[, 202](#i151f4968467f44d985f22077f4372877_136)[4](#i151f4968467f44d985f22077f4372877_136)[,] and [removed: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_136)] [added: 2](#i151f4968467f44d985f22077f4372877_136)[023](#i151f4968467f44d985f22077f4372877_136)] | | | | | | [removed: [102](#i936f1894ad9e4b3c8b6c404bf64d47b3_136)] [added: [104](#i151f4968467f44d985f22077f4372877_136)] | | |
| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [removed: 2024, 2023,] [added: 202](#i151f4968467f44d985f22077f4372877_139)[5](#i151f4968467f44d985f22077f4372877_139)[, 202](#i151f4968467f44d985f22077f4372877_139)[4](#i151f4968467f44d985f22077f4372877_139)[,] and [removed: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_139)] [added: 20](#i151f4968467f44d985f22077f4372877_139)[23](#i151f4968467f44d985f22077f4372877_139)] | | | | | | [removed: [103](#i936f1894ad9e4b3c8b6c404bf64d47b3_139)] [added: [105](#i151f4968467f44d985f22077f4372877_139)] | | |
| [Consolidated Statements of Cash Flows for the years ended December 31, [removed: 2024, 2023,] [added: 202](#i151f4968467f44d985f22077f4372877_142)[5](#i151f4968467f44d985f22077f4372877_142)[, 202](#i151f4968467f44d985f22077f4372877_142)[4](#i151f4968467f44d985f22077f4372877_142)[,] and [removed: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_142)] [added: 20](#i151f4968467f44d985f22077f4372877_142)[23](#i151f4968467f44d985f22077f4372877_142)] | | | | | | [removed: [105](#i936f1894ad9e4b3c8b6c404bf64d47b3_142)] [added: [107](#i151f4968467f44d985f22077f4372877_142)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i936f1894ad9e4b3c8b6c404bf64d47b3_145)] [added: Statements](#i151f4968467f44d985f22077f4372877_145)] | | | | | | [removed: [106](#i936f1894ad9e4b3c8b6c404bf64d47b3_145)] [added: [108](#i151f4968467f44d985f22077f4372877_145)] | | |
We have audited the accompanying consolidated balance sheets of Moderna, Inc. (the Company) as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in Internal [removed: Control-Integrated] [added: Control—Integrated] Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 21, 2025,] [added: 20, 2026] expressed an unqualified opinion thereon.
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, [removed: subjective,] [added: subjective] or complex judgments.
The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or [removed: disclosure] [added: disclosures] to which it relates.
| *Description of the Matter* | | | | | | During the year ended December 31, [removed: 2024,] [added: 2025,] the Company’s net product sales were [removed: $3.1] [added: $1.8] billion. As explained in Note 2 of the consolidated financial statements, revenue from product sales includes estimates of variable consideration for which provisions are established, including provisions for product sales returns. Auditing the Company’s measurement of provisions for [added: returns on] product sales [removed: returns] under its contracts with [removed: wholesalers, distributors and retail] customers [removed: (collectively, “Customers”)] was especially challenging because (1) [removed: it involves management] [added: the estimate relies on management’s] assumptions [removed: about] [added: regarding] inventory remaining in the distribution channel as of the balance sheet date that [removed: could] [added: may] be subject to return in future [removed: periods and] [added: periods, as well as] projected market demand, and (2) the Company has limited [added: historical] returns [removed: history] on which to base its assumptions. | | |
| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company’s process to determine provisions for returns on product sales. For example, we tested controls over management’s review of the completeness and accuracy of the data used in the process and the assumptions about the amount of inventory in the distribution channel that could be subject to return in future periods. To test the Company’s provisions for returns on product sales, our audit procedures included, among other procedures, testing the accuracy and completeness of the underlying data used in the calculations and evaluating the assumptions [removed: used] [added: applied] by management [removed: to estimate its] [added: in estimating the] provisions. To test management’s assumptions, we inspected agreements with significant [removed: Customers] [added: customers] to validate the rights of return, made inquiries of members of the commercial function regarding any changes to the terms and conditions of commercial contracts, and assessed the historical accuracy of management’s [removed: estimate.] [added: estimates.] We also examined credit memos issued during and after year end [removed: for] [added: to identify any] unusual items or trends [removed: not consistent] [added: inconsistent] with the Company’s analysis of product returns and performed revenue cutoff testing at period end to [removed: assess] [added: evaluate] whether [removed: there were] [added: any] unusual trends [removed: that] should have been considered in the [removed: Company] [added: Company’s] analysis of product returns. In addition, we reviewed inventory on hand-reporting from significant [removed: Customers at] [added: customers around] the balance sheet date and subsequent to the balance sheet date and inspected vaccination data from third-party sources [removed: through] [added: after] the [removed: report] [added: balance sheet] date. We also performed sensitivity analyses [removed: over] [added: on] the Company’s return rate to assess the [removed: effect] [added: impact] of changes in assumptions. | | |
| | | | [added: | | | | | |] 2024 | | | | | | 2023 | | |
| Cash and cash equivalents | | | [added: | | |] $ | [added: 2,595 | | | | | $ |] 1,927 | | | | | $ | 2,907 | |
| Investments | | | [removed: 5,098] [added: 3,204] | | | | | | [removed: 5,697] [added: 5,098] | | |
| Accounts receivable, net | | | [removed: 358] [added: 184] | | | | | | [removed: 892] [added: 358] | | |
| Inventory | | | [removed: 117] [added: 153] | | | | | | [removed: 202] [added: 117] | | |
| Prepaid expenses and other current assets | | | [removed: 599] [added: 408] | | | | | | [removed: 627] [added: 599] | | |
| Total current assets | | | [removed: 8,099] [added: 6,544] | | | | | | [removed: 10,325] [added: 8,099] | | |
| Investments, non-current | | | [removed: 2,494] [added: 2,336] | | | | | | [removed: 4,677] [added: 2,494] | | |
| Property, plant and equipment, net | | | [removed: 2,196] [added: 2,134] | | | | | | [removed: 1,945] [added: 2,196] | | |
| Right-of-use assets, operating leases | | | [removed: 759] [added: 719] | | | | | | [removed: 713] [added: 759] | | |
| Other non-current assets | | | [removed: 594] [added: 605] | | | | | | [removed: 766] [added: 594] | | |
| Total assets | | | $ | [removed: 14,142] [added: 12,338] | | | | | $ | [removed: 18,426] [added: 14,142] | |
| Accounts payable | | | $ | [removed: 405] [added: 317] | | | | | $ | [removed: 520] [added: 405] | |
| Accrued liabilities | | | [removed: 1,427] [added: 1,386] | | | | | | [removed: 1,798] [added: 1,427] | | |
| Deferred revenue | | | [removed: 153] [added: 99] | | | | | | [removed: 568] [added: 153] | | |
| Other current liabilities | | | [removed: 221] [added: 185] | | | | | | [removed: 129] [added: 221] | | |
| Total current liabilities | | | [removed: 2,206] [added: 1,987] | | | | | | [removed: 3,015] [added: 2,206] | | |
| Deferred revenue, non-current | | | [removed: 58] [added: 153] | | | | | | [removed: 83] [added: 58] | | |
| Operating lease liabilities, non-current | | | [removed: 671] [added: 653] | | | | | | [removed: 643] [added: 671] | | |
| Financing lease liabilities, non-current | | | [removed: 39] [added: 20] | | | | | | [removed: 575] [added: 39] | | |
| Other non-current liabilities | | | [removed: 267] [added: 285] | | | | | | [removed: 256] [added: 267] | | |
| Total liabilities | | | [removed: 3,241] [added: 3,688] | | | | | | [removed: 4,572] [added: 3,241] | | |
| Commitments and contingencies [removed: ([Note 11](#i936f1894ad9e4b3c8b6c404bf64d47b3_193))] [added: ([Note](#i151f4968467f44d985f22077f4372877_193) [12](#i151f4968467f44d985f22077f4372877_193))] | | | | | | | | | | | |
| Preferred stock, $0.0001; 162 shares authorized as of December 31, [removed: 2024] [added: 2025] and [removed: 2023;] [added: 2024;] no shares issued or outstanding at December 31, [removed: 2024] [added: 2025] and [removed: 2023] [added: 2024] | | | — | | | | | | — | | |
| Common stock, par value $0.0001; 1,600 shares authorized as of December 31, [removed: 2024] [added: 2025] and [removed: 2023; 386] [added: 2024; 394] and [removed: 382] [added: 386] shares issued and outstanding as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] respectively | | | — | | | | | | — | | |
| Additional paid-in capital | | | [removed: 866] [added: 1,382] | | | | | | [removed: 371] [added: 866] | | |
February 20, 2026
| Long-term debt | | | 590 | | | | | | — | | |
| Net loss | | | $ | (2,822) | | | | | $ | (3,561) | | | | | $ | (4,714) | |
| Balance at December 31, 2024 | | | | | | | | | | | | | | | | | | | | | 386 | | | | | | $ | — | | | | | $ | 866 | | | | | $ | (10) | | | | | $ | 10,045 | | | | | $ | 10,901 | |
| Tax payments related to net share settlements on equity awards | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | (2) | | | | | | — | | | | | | — | | | | | | (2) | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Net loss | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (2,822) | | | | | | (2,822) | | |
| Balance at December 31, 2025 | | | | | | | | | | | | | | | | | | | | | 394 | | | | | | $ | — | | | | | $ | 1,382 | | | | | $ | 45 | | | | | $ | 7,223 | | | | | $ | 8,650 | |
| Net loss | | | $ | (2,822) | | | | | $ | (3,561) | | | | | $ | (4,714) | |
| Purchase of intangible asset | | | (10) | | | | | | — | | | | | | — | | |
| Proceeds from credit facility | | | 600 | | | | | | — | | | | | | — | | |
| Payment of credit facility issuance costs | | | (22) | | | | | | — | | | | | | — | | |
| Tax payments related to net share settlements on equity awards | | | (2) | | | | | | — | | | | | | (1,153) | | |
| Effect of changes in exchange rates on cash and cash equivalents | | | 2 | | | | | | — | | | | | | — | | |
Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale.
We currently have three commercial products—Spikevax® and mNEXSPIKE®, our COVID vaccines, and mRESVIA®, our vaccine against respiratory syncytial virus (RSV).
While we now have two years of data on our product returns, this remains limited and subject to significant variability given current market conditions.
*Stand-Ready Manufacturing Revenue*
We have entered into long-term strategic agreements with government entities to establish domestic mRNA manufacturing capabilities and support pandemic readiness.
Under these agreements, we are required to build and maintain manufacturing facilities and to supply vaccines in accordance with minimum spend commitments or annual demand forecasts established by the respective governments.
A portion of the total consideration under each agreement is allocated to a stand-ready obligation to maintain manufacturing readiness and is recognized as other revenue on a straight-line basis over the contractual period.
The remaining consideration is related to our obligation to supply vaccines and will be recognized as product sales when control of the vaccines transfers upon delivery.
| Public Works and Government Services Canada | | | 13 | | % | | | | * | | | | | | * | | | | | | 33 | | % | | | | * | | | | | | | | |
| Cardinal Health | | | 11 | | % | | | | * | | | | | | * | | | | | | * | | | | | | * | | | | | | | | |
| Mexico Medistik | | | * | | | | | | * | | | | | | * | | | | | | 29 | | % | | | | * | | | | | | | | |
| Boryung Biopharma Korea | | | * | | | | | | * | | | | | | * | | | | | | 17 | | % | | | | * | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Limited-life land improvements | | | | | | Determined on a project-by-project basis | | |
Finite-lived intangible assets primarily consist of acquired intellectual property and regulatory approval and commercial sales milestone payments.
During 2025, we used historical exercise data in estimating the expected term of stock options, utilizing a methodology that combines historical settlement data with a hypothetical settlement pattern for outstanding options, based on estimated time to arrival at-the-money and adjusted for employee departure rates.
The change in methodology used during 2025 did not have a material impact on stock-based compensation and our financial statements.
However, during the fourth quarter of 2025, in connection with our stock option exchange program (see [Note 13](#i151f4968467f44d985f22077f4372877_199)), which resulted in changes to our stock option population, we determined that we no longer have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term, as such data is no longer indicative of future exercise patterns.
Accordingly, beginning in 2026, we will estimate the expected term of stock options using the simplified method.
evidence to evaluate whether it is more likely than not that all or a portion of such assets will not be realized.
We adopted this ASU prospectively in the fourth quarter of 2025, and the required disclosures are included in [Note 14](#i151f4968467f44d985f22077f4372877_205), Income Taxes.
In November 2024, the FASB issued ASU 2024-03, *Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses*.
This ASU requires entities to disclose, on an annual and interim basis, disaggregated information in the footnotes related to certain expense categories included in income statement line items.
| | | | | | | | | |
February 21, 2025
| Diluted | | | $ | (9.28) | | | | | $ | (12.33) | | | | | $ | 20.12 | |
| Diluted | | | 384 | | | | | | 382 | | | | | | 416 | | |
| Balance at December 31, 2021 | | | | | | | | | | | | | | | | | | | | | 403 | | | | | | $ | — | | | | | $ | 4,211 | | | | | $ | (24) | | | | | $ | 9,958 | | | | | $ | 14,145 | |
| Repurchase of common stock | | | | | | | | | | | | | | | | | | | | | (23) | | | | | | — | | | | | | (3,329) | | | | | | — | | | | | | — | | | | | | (3,329) | | |
| Net income | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,362 | | | | | | 8,362 | | |
| Balance at December 31, 2022 | | | | | | | | | | | | | | | | | | | | | 385 | | | | | | $ | — | | | | | $ | 1,173 | | | | | $ | (370) | | | | | $ | 18,320 | | | | | $ | 19,123 | |
| Repurchase of common stock, including excise tax | | | — | | | | | | (1,153) | | | | | | (3,329) | | |
Our COVID vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®.
Our original vaccine, mRNA-1273, targeted the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated.
In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA® (mRNA-1345), our mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.
Deferred tax assets, previously presented as a separate line item in our 2023 Form 10-K, are presented within other non-current assets in the consolidated balance sheets.
Income taxes payable, previously presented as a separate line item in our 2023 Form 10-K, is presented within other current liabilities in the consolidated balance sheets.
The associated prior period amounts in the consolidated financial statements, as well as in the notes thereto, have been reclassified to conform to the current presentation.
date.
Prior to the third quarter of 2023, we sold our COVID vaccine to the U.S. Government, foreign governments and organizations.
The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns.
Certain of these agreements entitle us to upfront deposits for our COVID vaccine supply, initially recorded as deferred revenue.
In the third quarter of 2023, we commenced sales of our COVID vaccine to the U.S. commercial market, in addition to continuing sales to international governments and organizations.
We also commenced sales of our RSV vaccine in the third quarter of 2024.
Wholesalers and distributors typically do not make upfront payments to us.
While we now have one year of data on our product returns, this remains insufficient to establish reliable patterns.
Restricted cash is composed of amounts held on deposit related to our lease arrangements.
The funds are maintained in money market accounts and are recorded at fair value.
Restricted cash is classified as either current or non-current based on the terms of the underlying arrangement and is included in either prepaid expenses and other current assets or other non-current assets in our consolidated balance sheets.
| Restricted cash, non-current(2) | | | | | | 1 | | | | | | 4 | | | | | | 12 | | |
Bank accounts in the United
States are insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000.
Our primary operating accounts significantly exceed the FDIC limits.
| European Commission | | | * | | | | | | * | | | | | | 28 | | % | | | | * | | | | | | * | | | | | | | | |
| U.S. Government (excluding BARDA) | | | * | | | | | | * | | | | | | 23 | | % | | | | * | | | | | | * | | | | | | | | |
| Takeda Pharmaceutical Company | | | * | | | | | | * | | | | | | 10 | | % | | | | * | | | | | | * | | | | | | | | |
The fair value of acquired intangible assets is determined by applying the income-based approach, which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life.
To estimate the expected cash flows attributable to an intangible asset, it requires the use of Level 3 fair value measurements and inputs.
We utilize this method as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term, and because significant changes in our business over the past few years have rendered historical experience less relevant.
We believe that this blended volatility rate is more indicative of future volatility than relying solely on our historical volatility alone, given the transformative changes in our business.
in turn would affect net income or loss.
In November 2023, the FASB issued ASU No. 2023-07, *Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.* This ASU broadens the disclosure requirements by requiring disclosures of significant segment expenses that are regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss.
An excerpt. Shown here: 40 of 492 rewritten, 40 of 237 added and 40 of 118 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2025 filing and the FY2024 filing.
Item 9A. Controls and Procedures
9 rewritten, 1 added, 1 removed, 36 unchanged
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, [removed: 2024.][added: 2025.]
Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2024,] [added: 2025,] our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management assessed our internal control over financial reporting as of December 31, [removed: 2024.][added: 2025.]
Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2024.][added: 2025.]
The effectiveness of our internal control over financial reporting as of December 31, [removed: 2024] [added: 2025] has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report included in this Annual Report on Form 10-K.
During the three months ended December 31, [removed: 2024,] [added: 2025,] there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act), which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We have audited Moderna, Inc.’s internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
In our opinion, Moderna, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] and the related notes and our report dated February [removed: 21, 2025] [added: 20, 2026] expressed an unqualified opinion thereon.
February 20, 2026
February 21, 2025
Item 9B. Other Information
3 rewritten, 9 added, 1 removed, 1 unchanged
On November [removed: 8, 2024, Stephane Bancel, our Chief Executive Officer, terminated] [added: 28, 2025, Mr. Bancel adopted] a trading arrangement that [removed: was] [added: is] intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Bancel 10b5-1 Plan).
The [removed: Bancel 10b5-1 Plan] [added: plan] provided for the potential sale of up to [removed: 150,000] [added: 1,439,788] shares of common stock.
No shares of common stock were sold under the [removed: Bancel 10b5-1 Plan] [added: plan] prior to its termination.
On November 23, 2025, Stéphane Bancel, our Chief Executive Officer, terminated a trading arrangement that was intended to satisfy the affirmative defense of Rule 10b5-1(c), which had been entered into on September 3, 2025, and was scheduled to commence as early as December 17, 2025, with a termination date of August 10, 2026.
Mr. Bancel has two different stock option awards that will reach their ten-year expiration on August 10, 2026, including an option to purchase 558,394 shares and another option to purchase 193,321 shares (the Bancel Expiring Options).
Mr. Bancel intends to contribute all of the after-tax proceeds from the exercise and sale of the Bancel Expiring Options to charitable causes.
Between May 13,2026 and August 10, 2026, the Bancel 10b5-1 Plan provides for the potential exercise of vested stock options and the associated sale of the Bancel Expiring Options, which represent up to 751,715 shares of the Company’s common stock in the aggregate.
The Bancel 10b5-1 Plan expires on August 10, 2026, or upon the earlier completion of all authorized transactions under the plan.
Stephen Hoge, our President, has two different stock option awards that will reach their ten-year expiration on August 10, 2026, including an option to purchase 223,357 shares and another option to purchase 96,660 shares (the Hoge Expiring Options).
On November 13, 2025, Dr. Hoge adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Hoge 10b5-1 Plan).
Between February 23, 2026 and August 10, 2026, the Hoge 10b5-1 Plan provides for the potential exercise of vested stock options and the associated sale of the Hoge Expiring Options, which represent up to 320,017 shares of the Company’s common stock in the aggregate.
The Hoge 10b5-1 Plan expires on August 10, 2026, or upon the earlier completion of all authorized transactions under the plan.
The Bancel 10b5-1 Plan was entered into on June 10, 2024, and was scheduled to commence as early as September 25, 2024, with a termination date of February 27, 2025.
Item 10. Directors, Executive Officers and Corporate Governance
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2025] [added: 2026] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
Item 11. Executive Compensation
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2025] [added: 2026] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2025] [added: 2026] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
Item 13. Certain Relationships and Related Transactions, and Director Independence
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2025] [added: 2026] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
Item 14. Principal Accounting Fees and Services
1 rewritten, 0 added, 0 removed, 2 unchanged
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2025] [added: 2026] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
Item 15. Exhibits, Financial Statement Schedules
24 rewritten, 3 added, 0 removed, 48 unchanged
| 3.2 | | | | | | [Second Amended and Restated By-laws of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000031/exhibit325820248-k.htm) [(2)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000031/exhibit325820248-k.htm)] [added: Registrant. (2)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000031/exhibit325820248-k.htm)] | | |
| [removed: 4.2*] [added: 4.2] | | | | | | [Description of Capital [removed: Stock.](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit4212312024.htm)] [added: Stoc](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit4212312025.htm)[k. (9)](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit4212312025.htm)] | | |
| 10.2# | | | | | | [2018 Stock Option and Incentive [removed: Plan](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex102.htm)[.] [added: Plan.] (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex102.htm) | | |
| [removed: 10.7#] [added: 10.8#] | | | | | | [Amended and Restated Executive Severance Plan and Form of Participation Letter, as amended on February 23, 2023. [removed: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[7](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)] [added: (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)] | | |
| [removed: 10.8#] [added: 10.9#] | | | | | | [Letter Agreement by and between the Company and Stéphane Bancel, dated as of June 13, 2018, as amended by Amendment No. 1 dated as of November 4, 2018. (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm) | | |
| [removed: 10.9#] [added: 10.10#] | | | | | | [Letter Agreement by and between the Company and Stephen Hoge, dated as of October 17, 2017. (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1016.htm) | | |
| [removed: 10.10#] [added: 10.11#] | | | | | | [Employment Letter Agreement between ModernaTX, Inc. and Shannon Klinger, dated as of March 4, 2021. (5)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm) | | |
| [removed: 10.11#] [added: 10.12#] | | | | | | [Offer Letter by and between ModernaTX, Inc. and James Mock, dated as of August 15, 2022. [removed: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)[6](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)] [added: (6)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)] | | |
| [removed: 10.12#] [added: 10.13#] | | | | | | [Senior Executive Cash Incentive Bonus Plan. (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1017.htm) | | |
| [removed: 10.13#] [added: 10.14#] | | | | | | [Amended and Restated Non-Employee Director Compensation Policy, effective October 1, 2022. [removed: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)[6](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)] [added: (6)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)] | | |
| [removed: 10.14#] [added: 10.15#] | | | | | | [Form of Indemnification Agreement between the Registrant and each of its officers. (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1019.htm) | | |
| [removed: 10.15#] [added: 10.16#*] | | | | | | [2018 Employee Stock Purchase [removed: Plan.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000060/exhibit1019302024.htm) (4)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit1016esppplan.htm)] | | |
| [removed: 10.16#] [added: 10.17#] | | | | | | [Form of Employee Restricted Stock Unit Award Agreement. (8)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1022formofemployeer.htm) | | |
| [removed: 10.17#] [added: 10.18#] | | | | | | [Form of Employee Non-Qualified Stock Option Agreement. (8)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1023formofemployeen.htm) | | |
| [removed: 10.18#] [added: 10.19#] | | | | | | [Form of Non-Employee Director Restricted Stock Unit Award Agreement. (5)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm) | | |
| [removed: 10.19#] [added: 10.20#] | | | | | | [Form of Non-Employee Director Non-Qualified Stock Option Agreement. (5)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm) | | |
| [removed: 10.20#] [added: 10.21#] | | | | | | [Form of Performance-Based Restricted Stock Unit Award Agreement under the 2018 Stock Option and Incentive Plan. (3)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm) | | |
| [removed: 19*] [added: 19] | | | | | | [Moderna, Inc. Insider [removed: Trading Policy](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit19insidertradingpol.htm)] [added: Trading](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit19insidertradingpol.htm) [Policy. (9)](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit19insidertradingpol.htm)] | | |
| 21.1* | | | | | | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit211subsidiaries2024.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit211subsidiaries1231.htm)] | | |
| 23.1* | | | | | | [Consent of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit23112312024.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit23112312025.htm)] | | |
| 31.1* | | | | | | [Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit31112312024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit31112312025.htm)] | | |
| 31.2* | | | | | | [Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit31212312024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit31212312025.htm)] | | |
| 32.1+ | | | | | | [Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit32112312024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit32112312025.htm)] | | |
| 32.2+ | | | | | | [Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit32212312024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/exhibit32212312025.htm)] | | |
| 10.7 | | | | | | [Credit and Guaranty Agreement, dated as of No](https://www.sec.gov/Archives/edgar/data/1682852/000162828025053816/moderna-creditandguarantya.htm)[vember 19, 2025, by and among Moderna, certain subsidiary guarantors, Ares Capital Corporation and the lenders](https://www.sec.gov/Archives/edgar/data/1682852/000162828025053816/moderna-creditandguarantya.htm)[.](https://www.sec.gov/Archives/edgar/data/1682852/000162828025053816/moderna-creditandguarantya.htm) [(](https://www.sec.gov/Archives/edgar/data/1682852/000162828025053816/moderna-creditandguarantya.htm)[10](https://www.sec.gov/Archives/edgar/data/1682852/000162828025053816/moderna-creditandguarantya.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000162828025053816/moderna-creditandguarantya.htm) | | |
| (9) | | | Incorporated by reference to the Annual Report on Form 10-K (File No. 001-38753) filed with the Securities and Exchange Commission on February 21, 2025. | | |
| (10) | | | Incorporated by reference to the Current Report on Form 8-K (File No. 001-38753) filed with the Securities and Exchange Commission on November 24, 2025. | | |
Item 16. Form 10-K Summary
10 rewritten, 1 added, 1 removed, 41 unchanged
| /s/ Stéphane Bancel | | | | | | Chief Executive Officer and Director *(Principal Executive Officer)* | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ James M. Mock | | | | | | Chief Financial Officer *(Principal Financial Officer and Principal Accounting Officer)* | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Noubar B. Afeyan, Ph.D. | | | | | | Chairman and Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Sandra Horning, M.D. | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Abbas Hussain | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Elizabeth Nabel, M.D. | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Francois Nader, M.D. | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ David M. Rubenstein | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Paul Sagan | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| /s/ Elizabeth Tallett | | | | | | Director | | | | | | February [removed: 21, 2025] [added: 20, 2026] | | |
| February 20, 2026 | | | | | | | | | | | |
| February 21, 2025 | | | | | | | | | | | |