AddedRisk Factors
Regulatory and market uncertainty have and may continue to impact our business and the markets for our products.
The 10-K against last year's
286 changes: 52 added, 45 removed, 178 reworded, 11 quiet changes
10-K 0001682852-26-000033 (2026-02-20) vs 10-K 0001682852-25-000022 (2025-02-21)
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The paragraph that changed most in each section
Marked against last year's 10-K:
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Risk Factors 322 words changed in this paragraph; it is 45% similar to last year's version.
Our internal computer systems and infrastructure and those of our strategic collaborators, vendors, contractors, consultants or regulators with whom we share confidential, protected or sensitive data or information, or upon which our business relies, are vulnerable to damage from computer viruses, unauthorized access, misuse, natural disasters, terrorism, cybersecurity threats, war and telecommunication and electrical failures, as well as security compromises or data breaches, which may compromise our systems, infrastructure, data or that of those with whom we share such data or information or upon which our business relies, or lead to data compromise, misuse, misappropriation or leakage. We have experienced, and may experience additional, cyber-attacks on our information technology systems and infrastructure by threat actors of all types (including nation states, criminal enterprises, individual actors or advanced persistent threat groups). In addition, we may experience intrusions on our physical premises by these threat actors. In addition Bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to extracting sensitive engage in illegal activities involving the theft and misuse of personal information, such attacks could include the deployment of harmful malware, ransomware, digital extortion, business email compromises and denial-of-service attacks, social engineering (including phishing attacks) and other means to affect server reliability and threaten the confidentiality, integrity and availability of information, systems or infrastructure. If any such cyber-attack or physical intrusion against us or those with whom we share confidential, protected or sensitive data or information, or upon which our business relies, were to result in a loss of or damage to our data, systems or infrastructure, or interrupt our operations, such as a material disruption of our development programs or our manufacturing operations, or due to a loss of any of our proprietary or confidential information, it would have a material adverse effect on us. For example, the loss of clinical trial data could delay our regulatory approval efforts and increase our costs to recover or reproduce the data. In addition, because we run multiple clinical trials in parallel, any breach or compromise of our computer systems or infrastructure or physical premises may result in a loss of data or compromised data integrity across multiple programs in many stages of development. While we seek to take steps to address cybersecurity risks, our efforts may not wholly mitigate such risks. Further, our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages or claims related to our privacy and data security obligations. Further, although we maintain cyber liability insurance, this insurance may not provide adequate coverage against potential liabilities related to any experienced cybersecurity incident or breach. information
Source: Item 1A, 10-K 0001682852-26-000033 vs Item 1A, 10-K 0001682852-25-000022
Accounting Policies 285 words changed in this paragraph; it is 52% similar to last year's version.
We issue stock-based awards to employees and non-employees, generally in the form of stock options, restricted stock units (RSUs), and performance stock units (PSUs). We account for our stock-based compensation awards in accordance with ASC 718 (Compensation—Stock Compensation). Most of our stock-based awards have been made to employees. We measure compensation cost for equity awards at their grant-date fair value and recognize compensation expense over the requisite service period, which is generally the vesting period, on a straight-line basis. The grant date fair value of stock options is estimated using the Black-Scholes option pricing model, which requires management to make assumptions with respect to the fair value of our common stock on the grant date, including the expected term of the award, the expected volatility of our stock, calculated based on a period of time generally commensurate with the expected term of the award, risk-free interest rates and expected dividend yields of our stock. We estimate the expected term of our stock options granted to employees and non-employees using the simplified method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option. 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. The expected volatility is based on a blended measure, which incorporates the historical stock volatilities of selected guideline companies, historical volatility of our stock price, and implied stock price volatility derived from the price of exchange traded options on our stock. 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. We will continue to apply this process until a sufficient amount of historical information regarding the expected term and historical volatility of our own stock price becomes available, and until we believe that historical experience is relevant to our expectations for current grants. The grant date fair value of RSUs is estimated based on the fair value of our underlying common stock. For performance-based stock awards, we recognize stock-based compensation expense over the requisite service period using the accelerated attribution method when achievement is probable. We classify stock-based compensation expense in our consolidated statements of operations in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified. We made an accounting policy election to recognize forfeitures of stock-based awards as they occur.
Source: Item 8, Note 2 – Summary of Significant Accounting Policies, 10-K 0001682852-26-000033 vs Item 8, Note 2 – Summary of Significant Accounting Policies, 10-K 0001682852-25-000022
MD&A 215 words changed in this paragraph; it is 33% similar to last year's version.
Total revenue decreased by $3.6 $1.3 billion, or 53%, 40%, in 2024, 2025, primarily attributable to driven by a significant reduction decline in net product sales of our COVID vaccine. sales. Net product sales decreased by $3.6 $1.3 billion, or 53%, 42%, in 2024, mainly 2025, largely due to lower sales volumes of our COVID vaccine across all regions. In the U.S., net product sales declined compared to 2024, reflecting a year-over-year decline in overall COVID vaccine demand. This decrease was partially offset by increased market share in the retail channel, supported by the successful launch and performance of mNEXSPIKE during the 2025/2026 respiratory vaccination season. In Europe and the rest of the world. This decline reflects world, net product sales declined compared to 2024, driven largely by the transition to a seasonal commercial market for COVID vaccine, as revenue from these regions was previously generated largely through completion of advance purchase agreements related to COVID vaccines with foreign governments and international organizations during government customers that contributed to revenue in the pandemic. In the United States, prior year, as well as lower overall demand in these markets. These impacts were partially offset by product sales remained generated under long-term strategic partnerships with government entities through our in-country manufacturing arrangements. Other revenue was relatively consistent compared to 2023. However, 2024 sales include an approximately $216 million benefit related to a reversal of prior-year sales provisions. Excluding this adjustment, product sales volume in the United States declined compared to 2023, primarily due to 2024, as lower vaccination rates grant revenue, collaboration revenue, and increased market licensing and royalty revenue were largely offset by higher stand-ready manufacturing revenue.
Source: Item 7, 10-K 0001682852-26-000033 vs Item 7, 10-K 0001682852-25-000022
Legal Proceedings 120 words changed in this paragraph; it is 36% similar to last year's version.
In May 2023, March 2022 and July 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed a third complaint two complaints against us in the U.S. District Court for the District of Delaware asserting three additional that our manufacture and sale of our COVID vaccine infringed certain U.S. patents concerning cationic lipids. 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. In November On August 25, 2023, the District Court entered an order of partial dismissal with respect to two of the patents at issue. Subsequently, in October 2024, the District Court entered a final judgment Final Judgment of non-infringement of all asserted patents in these lawsuits. In the first case, Alnylam appealed and the Federal Circuit decided the appeal in our favor with respect to the third patent at issue. The decision is subject to appeal. in June 2025.
Source: Item 3, 10-K 0001682852-26-000033 vs Item 3, 10-K 0001682852-25-000022
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Sentences and paragraphs of MRNA's Risk Factors and MD&A, 10-K 2026-02-20 against 10-K 2025-02-21. Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier (may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, wouldAddedRisk Factors
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.
AddedRisk Factors
We may experience difficulties executing our near-term strategy and prioritized pipeline.
AddedRisk Factors
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.
AddedRisk Factors
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.
AddedRisk Factors
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.
AddedRisk Factors
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.
AddedRisk Factors
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.
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AddedRisk Factors
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.
AddedRisk Factors
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.
AddedRisk Factors
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.
AddedRisk Factors
•product or facility contamination, including due to ineffective quality control strategies or failures identified through environmental monitoring programs;
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Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or foreign regulators, the regulatory approval, potential market for the subject product candidate, sizes and competition, the costs and complexities of manufacturing and delivering such a product candidate to trial participants, the potential of competing drugs, the existence of uncertainty with respect to our or the proposed collaborator’s ownership of technology, which can exist if there is a challenge to such ownership without regard to technology (regardless of the merits of the challenge, challenge), and industry and market conditions generally.
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Any disruption in our or our contract manufacturers’ these manufacturing capabilities could delay scaling up production capacity for our drug substances or products or shut down facilities, impose additional add costs, cause us to fail to meet certain product volume or delivery timing obligations, or may require us to identify, qualify and establish an alternative manufacturing site, which could adversely affect our business.
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Demand for third-party manufacturing manufacturing, raw materials or testing facilities may grow at a faster rate than their existing available capacity, which could disrupt our ability to find and retain third-party manufacturers capable of producing secure sufficient quantities of such raw materials, components, parts materials and consumables required to manufacture our mRNA product candidates. services.
RewordedRisk Factors
These processing steps may differ between individuals or tissues, potentially leading to variable levels of therapeutic protein, variable activity, immunogenicity or variable distribution to tissues for a therapeutic effect. 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.
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Additionally, many foreign jurisdictions have passed data privacy legislation and others or are considering various proposals for new data privacy and protection laws, and data protection laws. privacy remains an evolving landscape at the domestic and international levels, subject to continued legal challenges.
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In response, we have established ESG goals and adapted the our tracking and reporting of our corporate responsibility program to various evolving ESG frameworks, frameworks; however, these goals reflect our current plans and we have established aspirations and may not be achieved.
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Disruptions at the FDA, CDC and other agencies may also slow delay the time necessary for review or approval of new product candidates to be reviewed candidates, or approved, or for recommendations on use to be developed. the development of usage recommendations.
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Additionally, we faced continued exclusion have been excluded from selling our COVID vaccines in many European markets by due to a pandemic-era competitor competitor’s contract with the European Commission. Commission, which does not lapse until year-end 2026.
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The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may not be unable to compete effectively in the market for existing or new products, treatment methods or technologies.
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We have experienced commercial challenges and are likely to may experience additional challenges in the future.
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If we, our contract manufacturers or other strategic collaborators fail to comply with applicable any post-approval regulatory requirements, a regulator may issue a warning letter asserting that we are in violation of the law, seek an injunction or impose civil or criminal penalties or monetary fines, suspend or withdraw regulatory approval or revoke a license, suspend any ongoing clinical trials, refuse to approve a pending BLA or supplements to a BLA submitted by us, seize or recall products or product candidates, or require field alerts to physicians, pharmacists and hospitals or refuse to allow us to enter into supply contracts.
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If we cannot enter into or maintain such arrangements on favorable terms, or at all, our ability to develop, manufacture and distribute our products would could be adversely affected.
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Such production manufacturing process issues may include:
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Establishing additional or replacement suppliers for any of the components or processes used in our products or product candidates, if required, candidates may not be accomplished quickly, if at all.
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Our existing and any future strategic alliances may pose a number of risks, including:
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We are generally also subject to all of the same risks with respect to protection of IP that we license as we are for IP that we own.
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Our resource allocation decisions, or our contractual commitments to provide resources to our strategic collaborators, may cause us to fail to capitalize on certain other commercial products or profitable market opportunities.
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Likewise, if insurance coverage should become became unavailable to us or become economically impractical, we would be required to operate our business without indemnity from commercial insurance providers.
Quiet changesRisk Factors
These shareholders will have the ability to influence us through their ownership positions.
AddedMD&A
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.
AddedMD&A
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.
AddedMD&A
•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.
AddedMD&A
•mRESVIA: Our RSV vaccine has been approved for adults aged 60 years and older in 40 countries. It is also approved in 31 of those countries for individuals 18 to 59 years of age who are at increased risk for disease.
AddedMD&A
•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.
AddedMD&A
•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.
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•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).
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•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.
AddedMD&A
•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.
AddedMD&A
•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.
AddedMD&A
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.
AddedMD&A
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.
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This was partially offset by a change in prepaid expenses accounts receivable of $378 million, driven by lower invoice volumes and other assets timing of $1.7 billion, mainly due to a decrease in deferred income tax assets in 2023 resulting from the establishment of a valuation allowance and reductions in vendor prepayments, collections, and a change in inventory of $664 $117 million, driven by a smaller reduction in inventory write-downs.
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These decreases were partially offset by a $415 $129 million reduction in accounts payable and accrued liabilities, reflecting an overall reduction in operating expenses, and a $54 million reduction in short-term deferred revenue, mainly resulting from revenue recognized from deferred revenue in excess of customer deposits received, and a $371 million decrease in accrued liabilities, reflecting an overall reduction in spend. advance payments received.
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Investigational medicines in later stages of clinical development, such as our norovirus vaccine, seasonal flu vaccine, intismeran autogene, norovirus, and flu+COVID combination vaccine candidates, and development of any new generations COVID vaccines against variants of COVID vaccines, combination vaccines, CMV vaccine, and our INT program, SARS-CoV-2, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. later-
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Our cost of sales was $1.5 billion, $868 million, or 47% 48% of our net product sales, in 2024, 2025, including third-party royalties of $155 $88 million, inventory write-downs of $495 $291 million, primarily for raw materials and our finished and semi-finished COVID vaccine inventory, and unutilized manufacturing capacity and wind-down costs of $263 million, unutilized manufacturing capacity of $105 million, and losses from non-cancellable raw material purchase commitments of $60 $93 million.
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This decrease was primarily driven by a decrease in net loss of $1.2 billion, $739 million, a change in deferred revenue of $1.6 billion, $480 million, reflecting less revenue recognized from deferred revenue in excess of customer deposits advance payments received in 2024. 2025, and a change in accounts payable and accrued liabilities of $360 million, driven by decreased clinical and manufacturing spend.
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This was primarily due to a $1.6 $1.2 billion decrease in cash, cash equivalents and short-term investments, mainly used to fund our operating activities, a $191 million decrease in prepaid expenses and other current assets driven by reduced manufacturing and capital spend, and a $534 $174 million decrease in accounts receivable, primarily driven by lower revenue and invoice volumes as well as timing of collections.
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For example, we experienced a decline in customer demand for our COVID vaccine in 2023, 2023 and 2024, and this trend has continued into 2024, reflecting 2025 as the market's ongoing transition market transitions to a seasonal commercial pattern in the endemic COVID vaccine market. more competitive and commercially driven environment.
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In the third quarter of 2023, we commenced sales of our latest COVID vaccine Spikevax to the U.S. commercial market, in addition to continuing sales to foreign governments and organizations. organizations, and subsequently expanded our commercial COVID vaccine portfolio with the launch of mNEXSPIKE in the third quarter of 2025.