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Moderna, Inc. (MRNA)

CIK: 0001682852. SIC: 2836 Biological Products, (No Diagnostic Substances). Latest 10-K as of: 2026-02-20.

SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2836 Biological Products, (No Diagnostic Substances)

SEC company page: https://www.sec.gov/edgar/browse/?CIK=1682852. Latest filing source: 0001682852-26-000033.

Selected Fundamentals

MetricValueUnitFYFiled
Revenue1,944,000,000USD20252026-02-20
Net income-2,822,000,000USD20252026-02-20
Assets12,338,000,000USD20252026-02-20

Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-20. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001682852.json. Derived margins are computed from the extracted annual SEC facts.

Flow metrics use full-year FY periods from 10-K/10-K/A filings; balance-sheet metrics use FY-end instants. Missing metrics are omitted rather than fabricated.

Metric2016201720182019202020212022202320242025
Revenue60,209,00018,471,000,00019,263,000,0006,848,000,0003,236,000,0001,944,000,000
Net income-216,211,000-255,916,000-384,734,000-514,000,000-747,000,00012,202,000,0008,362,000,000-4,714,000,000-3,561,000,000-2,822,000,000
Operating income-223,771,000-269,356,000-413,266,000-546,000,000-763,000,00013,296,000,0009,420,000,000-4,239,000,000-3,945,000,000-3,074,000,000
Diluted EPS-1.55-1.9628.2920.12-12.33-9.28-7.26
Assets1,084,489,0001,962,149,0001,589,422,0007,337,000,00024,669,000,00025,858,000,00018,426,000,00014,142,000,00012,338,000,000
Liabilities459,193,000431,908,000414,612,0004,776,000,00010,524,000,0006,735,000,0004,572,000,0003,241,000,0003,688,000,000
Stockholders' equity-334,810,000-551,365,0001,530,000,0001,175,000,0002,561,000,00014,145,000,00019,123,000,00013,854,000,00010,901,000,0008,650,000,000
Cash and cash equivalents50,080,000134,859,000658,364,000236,000,0002,624,000,0006,848,000,0003,205,000,0002,907,000,0001,927,000,0002,595,000,000
Net margin66.06%43.41%-68.84%-110.04%-145.16%
Operating margin71.98%48.90%-61.90%-121.91%

Financial Charts

Macro Cross-References

Latest 10-K MD&A

Extracted between Item 7 and the next Item 7A/8 heading after HTML sanitization. Confidence: high. Filing date: 2026-02-20. Report date: 2025-12-31.

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes and other financial information appearing elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in “Part I, Item 1A - Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics.

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). We also have a diverse development pipeline of 25 development candidates across our 35 development programs currently in clinical studies.

2025 Business Highlights

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.

Total Revenue and Loss Per Share

For the year ended December 31, 2025, we recognized total revenue of $1.9 billion compared to $3.2 billion and $6.8 billion for the years ended December 31, 2024 and 2023, respectively. Loss per share was $(7.26) for the year ended December 31, 2025, compared to loss per share of $(9.28) and $(12.33) for the years ended December 31, 2024 and 2023, respectively.

Program Developments

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.

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•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.

•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).

Oncology Therapeutics

•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.

Rare Disease Therapeutics

•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.

•Methylmalonic acidemia (MMA) therapeutic: mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.

Other Business Updates

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.

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Financial Operations Overview

Revenue

Net product sales

Net product sales by customer geographic location were as follows for the periods presented (in millions):

Years Ended December 31,

2025

2024

2023

United States

$

1,165 

$

1,726 

$

1,720 

Europe

50 

573 

1,353 

Rest of world

603 

810 

3,598 

Total

$

1,818 

$

3,109 

$

6,671 

Net product sales by product were as follows (in millions):

Years Ended December 31,

2025

2024

2023

COVID (1)

$

1,810 

$

3,084 

$

6,671 

RSV

8 

25 

— 

Total

$

1,818 

$

3,109 

$

6,671 

_______

(1)Includes sales of Spikevax and mNEXSPIKE.

As of December 31, 2025, we have three commercial products, our COVID vaccines, Spikevax and mNEXSPIKE, and our RSV vaccine, mRESVIA. mRESVIA was approved by the FDA in May 2024 for adults aged 60 years and 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 (LRTD) caused by RSV. 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. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns and government rebates, and other related deductions.

The following table summarizes product sales provision for the periods presented (in millions):

Years Ended December 31,

2025

2024

2023

Gross product sales

$

3,304 

$

4,517 

$

8,203 

Product sales provision:

Wholesaler chargebacks, discounts and fees

(1,037)

(1,141)

(976)

Returns, rebates and other fees

(449)

(267)

(556)

Total product sales provision(1)

$

(1,486)

$

(1,408)

$

(1,532)

Net product sales

$

1,818 

$

3,109 

$

6,671 

_______

(1)Includes an adjustment of approximately $216 million in 2024, reflecting a reduction in prior year provision estimates, primarily related to returns and chargebacks for the previous COVID vaccine season. Adjustments recorded in 2025 related to prior year provision estimates were not material.

Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of December 31, 2025, we had deferred revenue of $107 million related to product sales, of which $42 million is expected to be realized in less than one year.

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Other revenue

Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue and stand-ready manufacturing revenue. 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. Licensing and royalty revenue is related to our out-licensing agreement for mRNA COVID related intellectual property in Japan, executed in 2024. Stand-ready manufacturing revenue relates to long-term strategic agreements with certain government entities to maintain manufacturing readiness, while the remaining consideration under these agreements is related to product sales.

The following table summarizes other revenue for the periods presented (in millions):

Years Ended December 31,

2025

2024

2023

Grant revenue

$

22 

$

37 

$

94 

Collaboration revenue

13 

48 

83 

Licensing and royalty revenue

11 

42 

— 

Stand-ready manufacturing revenue

80 

$

— 

$

— 

Total other revenue

$

126 

$

127 

$

177 

Cost of sales

Cost of sales includes raw materials, personnel, facility and other indirect overhead costs associated with manufacturing our commercial products. These costs include production materials, production costs at our manufacturing facilities, third-party manufacturing costs, and final formulation and packaging costs. Cost of sales also includes shipping costs, third-party royalties on net sales of our products, and charges for inventory valuation, excess and obsolete inventory and losses on firm purchase commitments.

Research and development expenses

The nature of our business and primary focus of our activities generate a significant amount of research and development costs.

Research and development expenses represent costs incurred by us for the following:

•cost to develop our platform;

•discovery efforts leading to development candidates;

•preclinical, nonclinical, and clinical development costs for our programs;

•cost to develop our manufacturing technology and infrastructure; and

•digital infrastructure costs related to our drug discovery efforts and clinical trials.

The costs above comprise the following categories:

•personnel-related expenses, including salaries, benefits, and stock-based compensation expense;

•expenses incurred under agreements with third parties, such as consultants, investigative sites, contract research organizations (CROs), that conduct our preclinical studies and clinical trials, and in-licensing arrangements;

•expenses associated with developing manufacturing, modification of formulation or design of a product or process, advancing the design to meet specific functional and economic requirements for manufacture and obtaining materials for preclinical studies, clinical trials and pre-launch inventory from internal and third-party contract manufacturing organizations (CMOs);

•expenses incurred for the procurement of materials, laboratory supplies, and non-capital equipment used in the research and development process;

•upfront fees and milestones paid to third-parties for licenses and technologies that had not reached technological feasibility and did not have an alternative future use; and

•facilities, depreciation, and amortization, and other direct and allocated expenses incurred as a result of research and development activities.

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We use our employee and infrastructure resources for the advancement of our platform, and for discovering and developing programs. Due to the number of ongoing programs and our ability to use resources across several projects, indirect or shared operating costs incurred for our research and development programs are generally not recorded or maintained on a program- or therapeutic area-specific basis.

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, 2025, 2024, and 2023 (in millions):

Years Ended December 31,

2025

2024

2023

Program-specific expenses by therapeutic area:

Infectious disease vaccines

$

652 

$

1,297 

$

1,903 

Oncology

201 

154 

62 

Rare disease therapeutics

43 

82 

67 

Total program-specific expenses by therapeutic area(1)

$

896 

$

1,533 

$

2,032 

Other research and development expenses:

Discovery and platform research

$

356 

$

520 

$

751 

Technical development and manufacturing expenses

792 

1,081 

1,116 

Shared discovery and development expenses

797 

1,145 

789 

Stock-based compensation

291 

264 

157 

Total research and development expenses

$

3,132 

$

4,543 

$

4,845 

__________

(1)Includes a total of 25 development candidates at December 31, 2025, 34 development candidates at December 31, 2024, and 42 development candidates at December 31, 2023. Program-specific expenses are reflected as of the beginning of the period in which the program was internally advanced to development.

The program-specific expenses by therapeutic area summarized in the table above include external development costs, such as fees paid to outside consultants, central laboratories, investigative sites, and CROs in connection with our preclinical studies and clinical trials. We generally do not allocate personnel-related costs, including stock-based compensation, costs associated with our general platform research, technical development, and other shared costs on a program-specific basis. These costs were therefore excluded from the summary of program-specific expenses by therapeutic area.

Discovery and platform research expenses include costs associated with early-stage research activities for preclinical programs and the development of technical advances in mRNA science, delivery science, and manufacturing process design. These costs include external CRO and lab services, personnel-related costs, technology and digital, facilities, and other directly attributable research support costs.

Technology development and manufacturing expenses are primarily related to manufacturing process development and manufacturing costs, including expenses for acquiring and manufacturing pre-launch inventory, mRNA supply for preclinical studies and clinical trials.

Shared discovery and development expenses are research and development costs such as personnel-related costs and other costs, such as the purchase of priority review vouchers. These expenses are not otherwise included in development programs, discovery and platform research, technical development, manufacturing expenses, or stock-based compensation.

Historically, we have made substantial investments in research and development activities, including development of our platform, mRNA technologies, and manufacturing technologies. We expense research and development costs as incurred and cannot reasonably estimate the nature, timing, and estimated costs required to complete the development of the development candidates and investigational medicines we are currently developing or may develop in the future.

Changes in expectations or outcomes of any of the known or unknown risks and uncertainties may materially impact our expected research and development expenditures. Continued research and development is central to the ongoing activities of our business. Investigational medicines in later stages of clinical development, such as our intismeran autogene, norovirus, and flu+COVID combination vaccine candidates, and development of any new COVID vaccines against variants of 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-

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stage clinical trials. In addition, we may incur research and development costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. We expect our research and development costs to be substantial in the near term as our investigational medicines advance through development phases and as we identify and develop additional programs.

There are numerous factors associated with the successful commercialization of any of our investigational medicines, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time due to the early stage of development of many of our investigational medicines. Moreover, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.

Selling, general and administrative expenses

Selling, general and administrative expenses consist primarily of personnel-related costs, including stock-based compensation, for executives, finance, legal, human resources, business development, commercial, marketing, and other administrative and operational functions, professional fees, accounting and legal services, technology and digital and facility-related costs, and expenses associated with obtaining, maintaining, and defending intellectual property (IP). These costs relate to the operation of the business, unrelated to the research and development function, or any individual program.

Prior to 2024, selling, general and administrative expenses increased annually as we expanded our commercial infrastructure to support the global commercialization of our COVID vaccine. These increases were driven by investments in building regulatory, sales, and marketing teams, establishing subsidiaries in multiple countries, and supporting operational growth. In 2025 and 2024, selling, general and administrative expenses decreased significantly year over year by $156 million and $375 million, or 13% and 24%, respectively. This decline reflects our focus on productivity improvements, cost-saving initiatives, and targeted investments that strengthen our overall efficiency.

Interest income

Interest income consists of interest generated from our investments in cash and cash equivalents, money market funds, and high-quality fixed income securities.

Other expense, net

Other expense, net consists of interest expense, gains or losses related to the sale of investments in marketable securities, changes in fair value of investments in equity securities, foreign currency transactions, remeasurements and hedges, and other income and expense unrelated to our core operations. Interest expense is primarily derived from our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, certain contract manufacturing service agreements, and, beginning in November 2025, interest associated with our long-term debt (see Note 10 and Note 11 to the consolidated financial statements).

Critical accounting policies and significant judgments and estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, are reflected in the consolidated financial statements prospectively from the date of change in estimates.

While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policy used in the preparation of our

consolidated financial statements requires the most significant judgments and estimates.

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Net product sales

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. In the third quarter of 2023, we commenced sales of Spikevax to the U.S. commercial market, in addition to continuing sales to foreign governments and organizations, and subsequently expanded our commercial COVID vaccine portfolio with the launch of mNEXSPIKE in the third quarter of 2025. We also commenced sales of our RSV vaccine in the third quarter of 2024. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers.

We recognize net product sales when control of the product transfers to the customer, typically upon delivery. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns, government rebates, and other related deductions. These provisions are recorded based on contractual terms, our estimate of returns for product sold, and other relevant considerations, during the period, using the expected value method or the most likely amount method. Estimates are assessed each period and adjusted as required to revise information or actual experience. See Note 2 to our consolidated financial statements for further discussion and analysis of each significant category of product sales provisions and the accounting policy.

The application of our critical accounting policies necessitates substantial management judgment and estimation, particularly when determining the amount of variable consideration to recognize. The subjectivity of this process is heightened when assessing factors outside our direct control such as the limited historical data, constrained third-party information, and evolving market dynamics. Among all variables, estimating returns presents the most significant judgment due to the broad range of potential outcomes and the current lack of established return trends. While we now have two years of data on our product returns, this remains limited and subject significant variability given current market conditions. We will continue to refine our projections as additional information becomes available. The actual results could differ from our estimates, and such differences could have a material impact to our financial statements.

Recently issued accounting pronouncements

See Note 2 - Summary of Significant Accounting Policies, to the consolidated financial statements, under the caption “Recently Issued Accounting Standards”.

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Results of operations

A discussion regarding our results of operations for the year ended December 31, 2025 compared to 2024 is presented below. A discussion regarding our results of operations for the year ended December 31, 2024 compared to 2023 can be found under Part II -Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (SEC) on February 21, 2025.

The following table summarizes our consolidated statements of operations for the periods presented (in millions):

Years Ended December 31,

Change 2025 vs. 2024

2025

2024

Change

%

Revenue:

Net product sales

$

1,818 

$

3,109 

$

(1,291)

(42)

%

Other revenue

126 

127 

(1)

(1)

%

Total revenue

1,944 

3,236 

(1,292)

(40)

%

Operating expenses:

Cost of sales

868 

1,464 

(596)

(41)

%

Research and development

3,132 

4,543 

(1,411)

(31)

%

Selling, general and administrative

1,018 

1,174 

(156)

(13)

%

Total operating expenses

5,018 

7,181 

(2,163)

(30)

%

Loss from operations

(3,074)

(3,945)

871 

(22)

%

Interest income

314 

425 

(111)

(26)

%

Other expense, net

(8)

(87)

79 

(91)

%

Loss before income taxes

(2,768)

(3,607)

839 

(23)

%

Provision for (benefit from) tax provision

54 

(46)

100 

(217)

%

Net loss

$

(2,822)

$

(3,561)

$

739 

(21)

%

Revenue

Total revenue decreased by $1.3 billion, or 40%, in 2025, primarily driven by a decline in net product sales. Net product sales decreased by $1.3 billion, or 42%, in 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, net product sales declined compared to 2024, driven largely by the completion of advance purchase agreements related to COVID vaccines with government customers that contributed to revenue in the prior year, as well as lower overall demand in these markets. These impacts were partially offset by product sales generated under long-term strategic partnerships with government entities through our in-country manufacturing arrangements. Other revenue was relatively consistent compared to 2024, as lower grant revenue, collaboration revenue, and licensing and royalty revenue were largely offset by higher stand-ready manufacturing revenue.

Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities, as well as continued uptake of mNEXSPIKE in the U.S.

Operating expenses

Cost of sales

Our cost of sales was $868 million, or 48% of our net product sales, in 2025, including third-party royalties of $88 million, inventory write-downs of $291 million, primarily for raw materials and our finished and semi-finished COVID vaccine inventory, and unutilized manufacturing capacity and wind-down costs of $93 million. Our cost of sales was $1.5 billion, or 47% of our net product sales, in 2024, including third-party royalties of $155 million, inventory write-downs of $495 million, unutilized manufacturing capacity and wind down costs of $368 million, and losses on firm purchase commitments and cancellation fees of $60 million. These charges in both 2025 and 2024, other than royalties, were largely driven by customer demand forecast adjustments related to the seasonal nature of the COVID vaccine market, termination of third-party contract manufacturing service agreements, and commitments for

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manufacturing capacity and raw material purchase agreements. Forecasting demand for COVID vaccines requires advance production planning ahead of each season, including production of multiple COVID vaccine products, which resulted in excess inventory and capacity as actual demand differed from forecasted demand. See Note 7 to our consolidated financial statements for further details on inventory related charges and this initiative.

Cost of sales for 2025 decreased by $596 million, or 41%, compared to 2024. As a percentage of net product sales, cost of sales was 48% in 2025 compared to 47% in 2024, remaining relatively consistent year over year. The decrease in cost of sales was primarily driven by reduced inventory write-downs, reduced unutilized manufacturing capacity and wind-down costs, lower losses on purchase commitments, and lower sales volume. In 2024, cost of sales included $238 million of wind-down costs related to the termination of a contract manufacturing agreement, whereas wind-down costs incurred in 2025 were significantly lower. As a result, the cost of sales as a percentage of net product sales remained relatively consistent year over year, as the benefit of a more efficient manufacturing cost structure was largely offset by lower product sales.

In 2026, we anticipate that cost of sales will remain at a relatively consistent level compared to 2025, reflecting continued manufacturing productivity improvements and operational efficiencies. To the extent net product sales increase, cost of sales as a percentage of net product sales may decrease modestly.

Research and development expenses

Research and development expenses decreased by $1.4 billion, or 31%, in 2025. The decrease was primarily attributable to lower clinical trial expenses of $578 million and lower clinical manufacturing expenses of $239 million, reflecting the wind-down of large Phase 3 respiratory programs and the timing of certain clinical trial activities shifting into 2026, partially offset by increased investment in our norovirus vaccine and oncology program. In addition, preclinical research expenses decreased by $107 million due to continued portfolio prioritization across the organization, and consulting and outside service costs declined by $175 million, consistent with the lower level of clinical and manufacturing activities. Separately, the prior-year period included an expense related to the purchase of two priority review vouchers, which did not recur in 2025.

We anticipate a modest reduction in research and development expenses in 2026 compared to 2025, driven by continued portfolio prioritization, disciplined cost management, and a focused approach to pipeline execution. These reductions are expected to be partially offset by certain clinical trial activities shifting into 2026 and additional costs related to post-marketing commitments. We remain committed to advancing our pipeline and late-stage programs, including intismeran autogene and norovirus vaccine programs, while continuing to manage research and development investment levels in line with our long-term objectives.

Selling, general and administrative expenses

Selling, general and administrative expenses decreased by $156 million, or 13%, in 2025. The decrease was mainly due to a $57 million broad-based reduction in consulting and outside services, along with a $59 million reduction in commercial, marketing and distribution costs. These decreases were attributable to continued cost discipline and ongoing efforts to streamline operations.

We expect selling, general and administrative expenses in 2026 to remain at a level relatively consistent with 2025, reflecting an efficient and scalable operating structure. While we will continue to make selective investments to support our key priorities, including our global commercial and regulatory activities, we expect these investments to be largely offset by ongoing efficiency initiatives and disciplined resource allocation.

Interest income

Interest income generated from our investments in marketable securities decreased by $111 million in 2025, mainly due to lower average investment balances.

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Other expense, net

The following table summarizes other expense, net for the periods presented (in millions):

Years Ended December 31,

Change 2025 vs. 2024

2025

2024

Change

%

Loss on investments

$

(5)

$

(56)

$

51 

(91)

%

Interest expense

(10)

(24)

14 

(58)

%

Other income (expense), net

7 

(7)

14 

(200)

%

Total other expense, net

$

(8)

$

(87)

$

79 

(91)

%

Total other expense, net decreased by $79 million, or 91%, in 2025. The decrease was primarily driven by lower equity investment losses and lower interest expense. Interest expense is primarily related to our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, certain contract manufacturing service agreements, and, beginning in November 2025, interest associated with our long-term debt. See Note 10 and Note 11 to our consolidated financial statements for additional information.

Provision for income taxes

Provision for income taxes for 2025 remained immaterial and consistent with 2024 and 2023, reflecting the valuation allowance established on deferred tax assets in 2023, which has been applied consistently since its initial recognition. Provision for income taxes increased by $100 million, or 217%, in 2025, mainly driven by the absence of a discrete tax benefit related to research and development credits that was recognized in 2024, as well as taxable income in certain of our foreign subsidiaries, while we incurred a consolidated pre-tax loss. See Note 14 to our consolidated financial statements for additional details.

Liquidity and capital resources

The following table summarizes our cash, cash equivalents, investments and working capital for each period presented (in millions):

December 31,

2025

2024

Financial assets:

Cash and cash equivalents

$

2,595 

$

1,927 

Investments

3,204 

5,098 

Investments, non-current

2,336 

2,494 

Total

$

8,135 

$

9,519 

Working capital:

Current assets

$

6,544 

$

8,099 

Current liabilities

1,987 

2,206 

Total

$

4,557 

$

5,893 

Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Our investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of December 31, 2025 decreased by $1.4 billion, or 15%, compared to December 31, 2024. For the year ended December 31, 2025, we had a net cash outflow from operations of $1.9 billion, and purchases of property, plant and equipment of $192 million, partially offset by $578 million of net proceeds from our credit facility.

Working capital, defined as current assets less current liabilities, as of December 31, 2025 decreased by $1.3 billion, or 23%, compared to December 31, 2024. This was primarily due to a $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 $174 million decrease in accounts receivable, primarily driven by lower revenue and invoice volumes as well as timing of collections. These decreases were partially offset by a $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 advance payments received.

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Cash flow

The following table summarizes the primary sources and uses of cash for the periods presented (in millions):

Years Ended December 31,

2025

2024

Net cash (used in) provided by:

Operating activities

$

(1,873)

$

(3,004)

Investing activities

1,946 

1,949 

Financing activities

593 

56 

Operating activities

We derive cash flows from operations primarily from cash collected from customer advance payments and accounts receivable related to our product sales, as well as other revenue and funding arrangements. Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. We sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. Certain supply agreements include upfront payments, which are initially recorded as deferred revenue. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers, which typically do not make upfront payments. In addition, we receive customer advance payments related to certain other revenue arrangements. As of December 31, 2025, we had $252 million in deferred revenue related to customer advance payments received or billable.

Net cash used by operating activities in 2025 was $1.9 billion and consisted of net loss of $2.8 billion and non-cash adjustments of $716 million, plus a net change in assets and liabilities of $233 million. Non-cash items primarily included stock-based compensation of $483 million and depreciation and amortization of $215 million. The net change in assets and liabilities was primarily due to a decrease in accounts receivable of $156 million, mainly due to lower invoice volumes and timing of collections, a $153 million decrease in prepaid expenses and other current assets, primarily due to reduced manufacturing and capital spend, and a $41 million decrease in deferred revenue due to revenue recognized from deferred revenue in excess of customer advance payments received. This was partially offset by a decrease in accounts payable and accrued liabilities of $94 million resulting from overall lower operating expenses in the period.

Net cash used by operating activities decreased by $1.1 billion, or 38%, in 2025 compared to 2024. This decrease was primarily driven by a decrease in net loss of $739 million, a change in deferred revenue of $480 million, reflecting less revenue recognized from deferred revenue in excess of customer advance payments received in 2025, and a change in accounts payable and accrued liabilities of $360 million, driven by decreased clinical and manufacturing spend. This was partially offset by a change in accounts receivable of $378 million, driven by lower invoice volumes and timing of collections, and a change in inventory of $117 million, driven by a smaller reduction in inventory write-downs.

Investing activities

Our primary investing activities consist of purchases, sales, and maturities of our investments, capital expenditures for land, building, leasehold improvements, manufacturing, laboratory, computer equipment and software, and business development.

Net cash provided by investing activities in 2025 was $1.9 billion, which primarily included proceeds from maturities of marketable securities of $5.6 billion and proceeds from sales of marketable securities of $2.4 billion, partially offset by purchases of marketable securities of $5.8 billion, and purchases of property, plant and equipment of $192 million.

Net cash flows provided by investing activities were relatively consistent in 2025 compared to 2024, primarily due to a decrease in proceeds from sale of marketable securities of $1.6 billion, which was partially offset by a decrease of $859 million in purchases of property, plant, and equipment, and a $761 million decrease in purchases of marketable securities.

Financing activities

Our primary financing activities consist of issuance of common stock related to our equity plans, repurchases of common stock, borrowings under our credit facility, and finance leases.

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Net cash provided by financing activities in 2025 was $593 million, consisting of $578 million of net proceeds from our credit facility and net proceeds from the issuance of common stock in connection with the exercise of stock options and employee stock purchases under our equity plans of $35 million.

Net cash provided by financing activities increased by $537 million, or 959%, in 2025 compared to 2024, mainly due to the net proceeds from our credit facility.

Operation and funding requirements

Our principal sources of funding as of December 31, 2025 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $2.8 billion, $3.6 billion and $4.7 billion for the years ended December 31, 2025, 2024 and 2023, respectively. In contrast, we generated net income of $8.4 billion and $12.2 billion for the years ended December 31, 2022 and 2021, respectively, following the authorization of our first commercial product in December 2020. From our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. We have retained earnings of $7.2 billion as of December 31, 2025.

We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs. We anticipate maintaining substantial expenses across all areas of our ongoing activities, particularly as we continue research and development of our development candidates and clinical activities for our investigational medicines. This also extends to our manufacturing costs, including our arrangements with our manufacturers and suppliers. Our ongoing work on our intismeran autogene, norovirus, and flu+COVID combination vaccine candidates, development of any new COVID vaccines against variants of SARS-CoV-2, late-stage clinical development, investments in digital capabilities and artificial intelligence technologies, and buildout of global commercial, regulatory, sales and marketing infrastructure and manufacturing facilities will require significant cash outflows in future periods, most of which may not be reimbursed or otherwise paid for by our collaborators or alliances. We may also incur additional costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. In addition, we have substantial facility, lease and purchase obligations. We have also entered into various collaboration and licensing agreements, as well as a research and development funding arrangement with a third party. These arrangements collectively encompass the funding of specific research and development activities, with the distinction that under the research and development funding arrangements, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.

In November 2025, we entered into a Credit Agreement providing for a term loan facility with aggregate commitments of $1.5 billion. As of December 31, 2025, we had drawn $600 million under the initial term loan. The Credit Agreement also provides for $900 million of delayed draw term loan commitments, consisting of $400 million available, subject to applicable conditions, through November 2027 and $500 million available, subject to applicable conditions and specified regulatory approval milestones, through November 2028. Borrowings under the Credit Agreement bear interest at a variable rate based on Term SOFR or a base rate, at our option, plus an applicable margin, with interest payable periodically and the principal amount due in full at maturity in November 2030. The Credit Agreement includes customary affirmative and negative covenants, with which we were in compliance as of December 31, 2025. See Note 11 to our consolidated financial statements for additional information.

We believe that our cash, cash equivalents, and investments as of December 31, 2025, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of the financial statements included in this Annual Report on Form 10-K. We are subject to all the risks related to the development and commercialization of novel medicines, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business. For example, we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend has continued into 2025 as the market transitions to a more competitive and commercially driven environment. We foresee that our commitment to investing in our business for future product launches may lead to continued negative cash flows from operations in upcoming periods. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

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Contractual obligations and commitments

The following table summarizes our contractual obligations as of December 31, 2025, and the effects that such obligations are expected to have on our liquidity and cash flows in future periods (in millions):

Payments Due by Period

Total

Less than 1

year

1 - 3 years

3 - 5 years

More than 5

years

Operating leases

$

1,066 

$

65 

$

159 

$

162 

$

680 

Financing leases

47 

27 

20 

— 

— 

Purchase obligations(1)

1,438 

481 

441 

343 

173 

Long-term debt(2)

900 

62 

130 

708 

— 

Total contractual cash obligations

$

3,451 

$

635 

$

750 

$

1,213 

$

853 

_______

(1)The amounts represent non-cancelable fixed payment obligations related to purchases of raw materials, contract manufacturing services, research and development and other goods or services in the normal course of business. As of December 31, 2025, $5 million of the purchase commitments related to raw materials was recorded as an accrued liability for loss on future firm purchase commitments and is included in the purchase obligations line above.

(2)In November 2025, we entered into the Credit Agreement providing for a senior secured term loan facility with aggregate commitments of $1.5 billion, consisting of a $600 million initial term loan and $900 million of delayed draw term loan commitments. As of December 31, 2025, the $600 million initial term loan was outstanding and matures on November 24, 2030. Borrowings under the Credit Agreement bear interest at a variable rate. Interest amounts preset in the table are based on the applicable interest rate in effect as of December 31, 2025. The principal amount of $600 million is due in full at maturity, and no principal payments are required prior to that date. See Note 11 to the consolidated financial statements for additional details.

We have agreements with certain vendors for various services, including services related to clinical operations and support and contract manufacturing, which we are not contractually able to terminate for convenience. Certain agreements provide for termination rights subject to termination fees or wind down costs. Under such agreements, we are contractually obligated to make certain payments to vendors, mainly to reimburse them for their unrecoverable outlays incurred prior to cancellation. The exact amounts of such obligations are dependent on the timing of termination, and the exact terms of the relevant agreement and cannot be reasonably estimated. At December 31, 2025, we had cancelable open purchase orders of approximately $1.8 billion, reflecting amounts associated with our significant vendor arrangements, under such agreements for our clinical operations and support and contract manufacturing. These amounts represent only our estimate of those items for which we had a contractual commitment to pay at December 31, 2025, assuming we would not cancel these agreements. The actual amounts we pay in the future to the vendors under such agreements may differ from purchase order amounts.

In addition to the above obligations, we enter into a variety of agreements and financial commitments in the normal course of business. The terms generally allow us the option to cancel, reschedule, and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. It is not possible to predict the maximum potential amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.

As of December 31, 2025, we did not have any off-balance sheet arrangements, other than those obligations and commitments disclosed herein, that were material or reasonably likely to become material to our financial condition or results of operations.

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