Moderna MRNA Form 10-Q filing Q3 FY2025

TRADEMARKS

This Form 10-Q contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to may appear without the ® or ™ symbols, but such references are not intended to indicate that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our reference to other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

NOTE REGARDING COMPANY REFERENCES

Unless the context otherwise requires, the terms “Moderna,” the “Company,” “we,” “us” and “our” in this Form 10-Q refer to Moderna, Inc. and its consolidated subsidiaries.

ADDITIONAL INFORMATION

Our website, www.modernatx.com, including the Investor Relations section, www.investors.modernatx.com; and corporate blog www.modernatx.com/moderna-blog, and our Statements and Perspectives webpage, https://investors.modernatx.com/Statements--Perspectives/default.aspx; as well as our social media channels: Facebook, www.facebook.com/modernatx; X, www.x.com/moderna_tx (@moderna_tx); LinkedIn, www.linkedin.com/company/modernatx; Instagram (@moderna_tx); and Threads (@moderna_tx) contain a significant amount of information about us, including financial and other information for investors. We encourage investors to visit these websites and social media channels as information is frequently updated and new information is shared. Information contained on our website, corporate blog and social media channels shall not be deemed incorporated into, or be a part of, this Form 10-Q.

Item 1. Financial Statements (Unaudited)

Item 1. Financial Statements

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MODERNA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

1. Description of the Business

Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our or the Company) is 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 four franchises: respiratory virus vaccines, latent and other virus 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®, our original COVID vaccine, mRESVIA®, our vaccine against respiratory syncytial virus (RSV), and mNEXSPIKE®, our new COVID vaccine. Additionally, we have a diverse and extensive development pipeline of 30 development candidates across our 40 development programs, of which 37 are in clinical studies currently.

2. Summary of Basis of Presentation and Recent Accounting Standards

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2024 (2024 Form 10-K). Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). This report should be read in conjunction with the audited consolidated financial statements in our 2024 Form 10-K.

The condensed consolidated financial statements include Moderna, Inc. and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. Except for (1) the revision to the estimated useful lives of certain manufacturing equipment (refer to "Use of Estimates" below), and (2) updates to our approach for estimating the expected term of stock options and the removal of peer company data in determining expected volatility for stock-based compensation (refer to Note 12), the significant accounting policies used in the preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2025 are consistent with those described in our 2024 Form 10-K. The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the operating results to be expected for the full fiscal year or future operating periods. We anticipate seasonal fluctuations in demand for our COVID and RSV vaccines, with higher sales expected during the fall and winter seasons.

Use of Estimates

We have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes. We base our estimates on historical experience and various relevant assumptions 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 at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods that are not readily apparent from other sources. Changes in our estimates are recorded in the financial results of the period in which the new information becomes available. The actual results that we experience may differ materially from our estimates.

Effective January 1, 2025, we revised the estimated useful life of certain manufacturing equipment from five years to a range of five to twelve years. This change followed an assessment completed in connection with the expansion of our internal manufacturing

capabilities and reflects the expected economic utility of the equipment. The change was accounted for prospectively, with carrying values depreciated over their revised remaining useful lives. As a result, depreciation expense and net loss for the three and nine months ended September 30, 2025 decreased by an immaterial amount.

Comprehensive Income (Loss)

Comprehensive income (loss) includes net income (loss) and other comprehensive income/loss for the period. Other comprehensive income/loss consists of unrealized gains/losses on our investments, derivatives designated as hedging instruments, foreign currency translation, and pension and postretirement obligation adjustments. Total comprehensive income (loss) for all periods presented has been disclosed in the condensed consolidated statements of comprehensive income (loss).

The components of accumulated other comprehensive income (loss) for the three and nine months ended September 30, 2025 were as follows (in millions):

Restricted Cash

We include our restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the condensed consolidated statements of cash flows.

The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in millions):

(1) Included in prepaid expenses and other current assets in the condensed consolidated balance sheets.

(2) Included in other non-current assets in the condensed consolidated balance sheets.

Recently Issued Accounting Standards

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Except as noted below, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our condensed consolidated financial statements and disclosures.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. The standard requires entities to disclose federal, state, and foreign income taxes in their rate reconciliation tables and elaborate on reconciling items that exceed a quantitative threshold. Additionally, it requires an annual disclosure of income taxes paid, net of refunds, categorized by jurisdiction based on a quantitative threshold. The ASU is effective on a prospective basis for fiscal years beginning after December 15, 2024. Early adoption is permitted. This ASU will result in the required additional disclosures being included in our consolidated financial statements, once adopted. We plan to adopt this standard in the fourth quarter of 2025 and expect to expand our income tax disclosures in our Annual Report on Form 10-K for the fiscal year ending December 31, 2025.

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. Specifically, entities are expected to provide tabular disclosures for prescribed categories such as inventory purchases, employee compensation, depreciation, and intangible asset amortization for each relevant expense caption. The standard also requires disclosure of total selling expenses and a definition of those expenses in annual filings. Any remaining amounts not quantitatively disclosed are expected to be described qualitatively. This ASU is effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption permitted, and the standard may be applied on a prospective or retrospective basis. We are currently assessing the impact that this new accounting standard will have on our consolidated financial statement disclosures.

In September 2025, the FASB issued ASU No. 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. This ASU makes targeted amendments to the accounting for and disclosure of software costs under ASC 350-40. The amendments modernize the guidance to reflect current software development practices, including nonlinear development approaches, and remove references to “development stages.” Under the ASU, the following two criteria must be met for entities to begin capitalizing software costs: (1) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project, and (2) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the “probable-to-complete recognition threshold”). The ASU clarifies that this threshold would not be met when there is “significant uncertainty associated with the development activities of the software (referred to as ‘significant development uncertainty’).” The new standard is effective for all entities for annual reporting periods beginning after December 15, 2027, and for interim reporting periods within those fiscal years. Early adoption is permitted, and entities may apply the amendments prospectively, retrospectively, or using a modified prospective transition approach. We are currently evaluating the impact that this new accounting standard will have on our consolidated financial statements and disclosures.

3. Net Product Sales

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

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

(1) Includes sales of Spikevax and mNEXSPIKE.

As of September 30, 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 RSV disease. 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 vaccines, Spikevax and mNEXSPIKE, to the commercial market as well as to foreign governments and international organizations. We launched commercial sales of our RSV vaccine, mRESVIA, in the third quarter of 2024. In the U.S., our COVID and RSV vaccines are sold to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Wholesalers and distributors typically do not make upfront payments to us. 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):

The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the nine months ended September 30, 2025 (in millions):

Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2025 and December 31, 2024, we had deferred revenue of $144 million and $188 million, respectively, related to product sales. We expect $79 million of our deferred revenue related to product sales as of September 30, 2025 to be realized in less than one year. Timing of product delivery and manufacturing, and receipt of marketing approval for our seasonal vaccines will determine the period in which product sales are recognized.

4. Other Revenue

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

Grant Revenue

In April 2020, we entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), for an award of up to $483 million to accelerate development of our original COVID vaccine, mRNA-1273. The agreement has been subsequently amended to provide for additional commitments to support various late-stage clinical development efforts of our original COVID vaccine, including a 30,000 participant Phase 3 study, pediatric clinical trials, adolescent clinical trials and pharmacovigilance studies. The maximum award from BARDA, inclusive of all amendments, was approximately $1.8 billion. All contract options have been exercised. The BARDA contract concluded on June 15, 2025, upon completion of all contractual deliverables. We accrued and recognized revenue through that date for eligible costs incurred in accordance with the agreement. As of September 30, 2025, the remaining available funding, net of revenue earned, was approximately $62 million. While this funding remains available, we do not expect to recognize material additional revenue, as the contract has concluded and all obligations have been fulfilled. Final billing and closeout activities are ongoing and may result in immaterial adjustments to the recognized revenue amount.

In June 2024, we were awarded up to $176 million through the Rapid Response Partnership Vehicle (RRPV), funded by BARDA, to accelerate the development of mRNA-based pandemic influenza vaccines. The project award was intended to support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus. This subtype of the influenza virus causes a highly infectious and severe disease in birds known as avian influenza and poses a risk of spillover into the human population. The agreement also included additional options to prepare for and accelerate responses to future public health threats. In January 2025, we were awarded up to $590 million through the RRPV, funded by BARDA, to support the continued late-stage development and licensure of mRNA-based pre-pandemic influenza vaccines, including expanded clinical studies for up to five additional subtypes of pandemic influenza. This funding built on the scope of the June 2024 funding related to the H5 influenza virus and expanded the program to cover additional influenza subtypes. In May 2025, we received notice from HHS that the award for late-stage development and the right to purchase pre-pandemic influenza vaccines would be terminated. Revenue recognized related to this agreement was immaterial as of September 30, 2025.

Licensing and Royalty Revenue

In April 2024, we entered a non-exclusive out-licensing agreement with a pharmaceutical company based in Japan for mRNA COVID-related intellectual property for the territory of Japan. Under the terms of the agreement, we received an upfront payment of $50 million, which included a $20 million prepayment creditable against future royalties. Additionally, we are entitled to receive low double-digit royalties on the net sales of the company’s COVID product. Upon execution of the agreement, we recognized $30 million of the upfront payment as other revenue in our condensed consolidated statements of operations. The remaining $20 million was recorded as deferred revenue in our condensed consolidated balance sheets and recognized as royalty revenue as the underlying sales occurred. In accordance with the terms of the agreement, the $20 million was fully recognized by the end of the first quarter of 2025.

Other Revenue

We have entered into long-term strategic agreements with certain 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.

5. Collaboration Agreements and Research and Development Funding Arrangement

Merck – Personalized mRNA Cancer Vaccines (Individualized Neoantigen Therapy)

In June 2016, we entered into a Collaboration and License Agreement for the development and commercialization of personalized mRNA cancer vaccines (also known as INT) with Merck & Co., Inc. (Merck). This agreement was subsequently amended and restated in 2018. Our role in this strategic alliance involves identifying genetic mutations in a particular patient’s tumor cells, synthesizing mRNA for these mutations, encapsulating the mRNA in one of our proprietary lipid nanoparticles (LNPs), and administering a unique mRNA INT to each patient. Each INT is designed to specifically activate the patient’s immune system against her or his own cancer cells. INT has recently been assigned the generic name intismeran autogene.

In September 2022, Merck exercised its option for INT, including mRNA-4157, pursuant to the terms of the agreement and in October 2022 paid us an option exercise fee of $250 million. Following this exercise, the Merck Participation Term commenced. Pursuant to the agreement, we and Merck have agreed to collaborate on development and potential commercialization of INT, with costs and any profits or losses generally shared equally on a worldwide basis, subject to certain exceptions as outlined in the agreement. We concluded that the collaboration arrangement under the Merck Participation Term is within the scope of ASC 808. For the three and nine months ended September 30, 2025, we recognized expenses, net of Merck's reimbursements, of $101 million and $304 million, respectively, related to the INT collaboration under the Merck Participation Term. For the three and nine months ended September 30, 2024 these expenses were $109 million and $280 million, respectively.

Additionally, for the three and nine months ended September 30, 2025, the net cost recovery for capital expenditures was $1 million and $19 million, respectively. For the three and nine months ended September 30, 2024, this amount was $25 million and $82 million, respectively. These amounts were applied to reduce the capitalized cost of the assets.

We have other collaborative and licensing arrangements that we do not consider to be individually significant to our business at this time. Pursuant to these agreements, we may be required to make upfront payments and payments upon achievement of various development, regulatory and commercial milestones, which in the aggregate could be significant. Future milestone payments, if any, will be reflected in our consolidated financial statements when the corresponding events have occurred. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized.

Development and Commercialization Funding Arrangement with Blackstone Life Sciences (Blackstone)

In March 2024, we entered into a development and commercialization funding arrangement with Blackstone, under which Blackstone has committed to providing up to $750 million in funding to us. This funding supports the development of our investigational mRNA-based influenza vaccine. Contingent upon regulatory approval in the U.S. and only if the approval is dependent on data from the funded activities, Blackstone will be entitled to receive low single-digit percentage royalties and up to $750 million in sales milestone payments. These payments are based on net sales of our future influenza and combination vaccines, with sales milestone payments contingent upon achieving specified cumulative net sales targets.

Given the substantive transfer of financial risk to Blackstone, we account for this arrangement as an obligation to conduct research and development activities. The funding is recognized as a reduction to the expenses of our mRNA-based influenza program. This reduction is recognized proportionally as the related costs are incurred, based on an input method. For the three and nine months ended September 30, 2025, we recorded research and development expense reductions of $25 million and $274 million, respectively. For the three and nine months ended September 30, 2024, we recorded research and development expense reductions of $30 million and $35 million, respectively.

6. Financial Instruments

Cash and Cash Equivalents and Investments

The following tables summarize our cash, cash equivalents, and available-for-sale securities by significant investment category as of September 30, 2025 and December 31, 2024 (in millions):

The amortized cost and estimated fair value of available-for-sale securities by contractual maturity as of September 30, 2025 and December 31, 2024 were as follows (in millions):

In accordance with our investment policy, we place investments in investment grade securities with high credit quality issuers, and generally limit the amount of credit exposure to any one issuer. We evaluate securities for impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation.

Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and our intent and ability to hold the investment to allow for an anticipated recovery in fair value. Any impairment that is not credit related is recognized in other comprehensive loss, net of applicable taxes. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. We did not recognize any impairment charges related to available-for-sale securities for the three and nine months ended September 30, 2025 and 2024. We did not record any credit-related allowance for available-for-sale securities as of September 30, 2025 and December 31, 2024.

The following table summarizes the amount of gross unrealized losses and the estimated fair value for our available-for-sale securities in an unrealized loss position by the length of time the securities have been in an unrealized loss position as of September 30, 2025 and December 31, 2024 (in millions):

As of September 30, 2025 and December 31, 2024, we held 103 and 252 available-for-sale securities, respectively, out of our total investment portfolio that were in a continuous unrealized loss position. We neither intend to sell these investments, nor do we believe that we are more-likely-than-not to conclude we will have to sell them before recovery of their carrying values. We also believe that we will be able to collect both principal and interest amounts due to us at maturity.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used to value the assets and liabilities:

• Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
• Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or
• Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

The following tables summarize our financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024 (in millions):

(1) Investments in publicly traded equity securities with readily determinable fair values are recorded at quoted market prices for identical securities, with changes in fair value recorded in other income (expense), net, in our condensed consolidated statements of operations.

As of September 30, 2025 and December 31, 2024, we did not have non-financial assets or liabilities measured at fair value on a recurring basis and did not have any Level 3 financial assets or financial liabilities.

For the three and nine months ended September 30, 2025, we recognized a net gain of $3 million and a net loss of $5 million, respectively, on equity investments from changes in fair value of the securities. For the three and nine months ended September 30, 2024, we recognized net losses of $8 million and $43 million, respectively, on equity investments from changes in fair value of the securities.

7. Inventory

Inventory as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

(1) Consisted of raw materials with an anticipated consumption beyond one year. Inventory, non-current is included in other non-current assets in the condensed consolidated balance sheets.

Inventory write-downs as a result of excess, obsolescence, scrap or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our condensed consolidated statements of operations. For the three and nine months ended September 30, 2025, inventory write-downs were $67 million and $147 million, respectively. For the three and nine months ended September 30, 2024, inventory write-downs were $214 million and $302 million, respectively. For the three and nine months ended September 30, 2025, losses on firm purchase commitments were $7 million and $24 million, respectively. For both the three and nine months ended September 30, 2024, losses on firm purchase commitments were $21 million. Inventory write-downs were mainly related to inventory in excess of expected demand and shelf-life expiration. Losses on firm purchase commitments were primarily related to excess raw material purchase commitments that will expire before the anticipated consumption of those raw materials. As of September 30, 2025 and December 31, 2024, the accrued liability for losses on firm future purchase commitments in our condensed consolidated balance sheets was $12 million and $60 million, respectively.

In May 2025, the FDA approved mNEXSPIKE, our new COVID vaccine, and we began to capitalize mNEXSPIKE inventory. As of September 30, 2025 and December 31, 2024, we had inventory on hand of $447 million and $267 million, respectively, inclusive of inventory for our COVID and RSV vaccines. Our raw materials and work-in-progress inventory have variable shelf lives. We expect that the majority of this inventory will be consumed over the next three years. The shelf life of Spikevax, our original COVID vaccine, is nine to twelve months. mNEXSPIKE has a shelf life of twelve months. The shelf life of mRESVIA, our RSV vaccine, is eighteen months.

8. Property, Plant and Equipment, Net

Property, plant and equipment, net, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

Depreciation and amortization expense related to property, plant and equipment for the three and nine months ended September 30, 2025 was $51 million and $145 million, respectively. Depreciation and amortization expense related to property, plant and equipment for the three and nine months ended September 30, 2024 was $51 million and $126 million, respectively.

9. Other Balance Sheet Components

Accounts Receivable, net

Accounts receivable, net, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

Other Non-Current Assets

Other non-current assets, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

(1) Consisted of raw materials with an anticipated consumption beyond one year.

Accrued Liabilities

Accrued liabilities, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

(1) Related to losses that are expected to arise from firm, non-cancellable, commitments for future raw material purchases (Note 7).

Other Current Liabilities

Other current liabilities, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

Other Non-Current Liabilities

Other non-current liabilities, as of September 30, 2025 and December 31, 2024 consisted of the following (in millions):

Deferred Revenue

The following table summarizes the activities in deferred revenue for the nine months ended September 30, 2025 (in millions):

10. Leases

We have entered into various long-term, non-cancelable lease arrangements for our facilities and equipment, expiring at various times through 2039. Certain of these arrangements have free rent periods or escalating rent payment provisions. We recognize lease costs under such arrangements on a straight-line basis over the life of the lease. We lease various parcels of land, office, lab, and manufacturing spaces across the globe for our business operations.

We have two main campuses in Massachusetts, our Moderna Science Center (MSC), located in Cambridge, which serves as our headquarters, and our Moderna Technology Center (MTC), located in Norwood. The MSC, comprising approximately 462,000 square feet, includes our principal executive office and additional office and laboratory spaces. The MSC lease commenced in the third quarter of 2023 and has a term of 15 years, with options for two additional seven-year extensions. The MTC is a multiple-building campus spanning approximately 722,000 square feet. It includes laboratory and office space that directly supports our manufacturing operations as well as our commercial and clinical activities. The MTC was previously subject to long-term lease arrangements, and we completed the acquisition of the campus, including the underlying land and buildings, in December 2024.

Operating and financing lease right-of-use assets and lease liabilities as of September 30, 2025 and December 31, 2024 were as follows (in millions):

(1) These assets are real estate related assets, which include land, office, manufacturing, and laboratory spaces.

(2) Net of accumulated amortization.

(3) These assets are related to contract manufacturing service agreements.

(4) Included in property, plant and equipment in the condensed consolidated balance sheets, net of accumulated depreciation.

(5) Included in other current liabilities in the condensed consolidated balance sheets.

Future minimum lease payments under our non-cancelable lease agreements as of September 30, 2025, were as follows (in millions):

11. Commitments and Contingencies

Legal Proceedings

We are a party to various legal proceedings and claims. Accruals are recognized for legal matters when a loss is both probable and reasonably estimable. As of September 30, 2025, no material contingent liabilities have been recognized. If a material loss is reasonably possible and we can estimate the amount or range of the loss, we disclose such information. Unless otherwise noted, either the outcome of these matters is not expected to be material, or the potential loss cannot be reasonably estimated.

From time to time, we may be a party to litigation, arbitration, or other legal proceedings in the course of our business. The outcome of such matters is inherently uncertain and often involves significant judgment in assessing risk and estimating potential exposure. While we do not currently expect any pending proceedings to have a material adverse effect on our financial position, results of operations, or cash flows, there can be no assurance that future developments will not have a material impact.

The following summarizes our significant legal proceedings and matters outstanding as of September 30, 2025.

We have brought patent-infringement actions against Pfizer Inc. (Pfizer), BioNTech SE (BioNTech) and related entities in the U.S., Germany, the Netherlands, the UK, Ireland and Belgium concerning our mRNA platform technology and disease-specific vaccine designs. Pfizer and BioNTech have commenced actions or asserted defenses seeking to revoke our patents in these jurisdictions.

Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) have brought patent-infringement actions against us in the U.S. District Court for the District of Delaware, as well as in Canada, Japan, Switzerland and the Unified Patent Court (UPC) asserting patents concerning lipid nanoparticles.

GlaxoSmithKline Biologicals SA (GSK) has filed two complaints against us in the U.S. District Court for the District of Delaware asserting certain patents owned by GSK. GSK has also filed two patent-infringement lawsuits against us in the UPC concerning liposomes and modified liposomes for RNA delivery.

Northwestern University has filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents concerning lipid nanoparticle technology.

We are subject to shareholder class action and shareholder derivative litigation pending in the U.S. District Court for the District of Massachusetts related to statements about our RSV vaccine (mRNA-1345).

Indemnification Obligations

As permitted under Delaware law, we indemnify our officers, directors, and employees for certain events, occurrences while the officer, or director is, or was, serving at our request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime.

We have standard indemnification arrangements in our leases for laboratory and office space that require us to indemnify the landlord against any liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or non-performance under our leases.

We enter into indemnification provisions under our agreements with counterparties in the ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, we generally indemnify and hold harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited.

Through the three and nine months ended September 30, 2025 and the year ended December 31, 2024, we had not experienced any material losses related to these indemnification obligations, and no material claims were outstanding. We do not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.

Purchase Commitments and Purchase Orders

We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services. As of September 30, 2025, we had $522 million of non-cancelable purchase commitments related to raw materials and manufacturing agreements, which are expected to be paid through 2029. As of September 30, 2025, we had $1.2 billion of non-cancelable purchase commitments related to research and development and other goods and services which are expected to be paid through 2032. These amounts represent our minimum contractual obligations, including termination fees.

In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors. 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. As of September 30, 2025, we had cancelable open purchase orders of $1.8 billion in total under such agreements for our significant 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 as of September 30, 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 the purchase order amounts.

Licenses to Patented Technology

We have patent license agreements with Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), an Institute of the National Institutes of Health (NIH). Under these agreements, we are required to pay royalties and certain milestone payments. For further information on our licensing and royalty payments, please refer to our 2024 Form 10-K under the heading “Business—Intellectual Property—In-licensed intellectual property” and Note 11 to our consolidated financial statements contained therein.

In January 2025, we entered into a non-exclusive patent license agreement with NIAID to license certain patent rights related to the development of mRNA-based vaccines for the prevention or treatment of respiratory syncytial virus (RSV) infection. Upon execution of the agreement, we made a total payment of $10 million, which was capitalized as an intangible asset and is amortized to cost of sales on a straight-line basis over the estimated useful life of the licensed patents. In addition, we are obligated to pay low single-digit royalties on future net sales of licensed products.

For the three and nine months ended September 30, 2025, we recognized $43 million and $54 million, respectively, of royalty expenses associated with our product sales. For the three and nine months ended September 30, 2024, we recognized $92 million and $110 million, respectively, of royalty expenses associated with our product sales. These royalty expenses were recorded to cost of sales in our condensed consolidated statements of operations.

Additionally, we have other in-license agreements with third parties which require us to make future development, regulatory and commercial milestone payments and sales-based royalties for specified products associated with the agreements. The achievement of these milestones have not yet occurred as of September 30, 2025.

12. Stock-Based Compensation and Share Repurchase Programs

Stock-Based Compensation

The following table presents the components and classification of stock-based compensation expense for the three and nine months ended September 30, 2025 and 2024 as follows (in millions):

As of September 30, 2025, there was $770 million of total unrecognized compensation cost related to unvested stock-based compensation with respect to options, RSUs and PSUs granted. That cost is expected to be recognized over a weighted-average period of 2.1 years as of September 30, 2025.

Effective in the first quarter of 2025, we revised the assumptions used in the Black-Scholes option pricing model for estimating the grant date fair value of stock options. The expected term is estimated using a methodology that combines historical settlement data with a hypothetical settlement pattern for outstanding options, based on estimated time to arrive at-the-money and adjusted for employee departure rates. We also revised our approach for estimating expected volatility by removing peer company data and using a blended measure of our own historical and implied volatility. These updates reflect the increased availability of company-specific data and did not have a material impact on stock-based compensation and our financial statements.

Share Repurchase Programs

As of September 30, 2025, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock (the 2022 Repurchase Programs) remains outstanding, with no expiration date. There were no shares repurchased during the three and nine months ended September 30, 2025 or 2024.

13. Income Taxes

The following table summarizes our income tax expense for the periods presented (in millions, except for percentages):

The effective tax rate for the three and nine months ended September 30, 2025 was higher than the statutory rate, primarily due to our global valuation allowance, which limits our ability to recognize tax benefits from the loss. The higher effective tax rate was also impacted by certain of our foreign subsidiaries that have taxable income, while we incurred a net loss before income taxes in other jurisdictions. The effective tax rate for the three and nine months ended September 30, 2025 continue to reflect the maintenance of global valuation allowance. The effective tax rate for the third quarter of 2024 was comparatively higher due to a small amount of pre-tax income in that period, while the rate for the nine-month period in 2024 remained low and consistent with the current year. For additional details regarding our deferred tax assets and the policies governing our valuation allowance, please refer to Note 13 to our consolidated financial statements in our 2024 Form 10-K.

We periodically reassess the need for valuation allowances on our deferred tax assets, considering both positive and negative evidence to evaluate whether it is more likely than not that all or a portion of such assets will not be realized. Significant management judgment is required in assessing the realizability of our deferred tax assets. In the event that actual results differ from our estimates, we adjust our estimates in future periods and we may need to modify our valuation allowance, which could materially impact our financial position and results of operations.

We file U.S. federal income tax returns and income tax returns in various state, local and foreign jurisdictions. As of September 30, 2025, we are under audit in various U.S., and foreign jurisdictions; however, no adjustments to our tax positions have been proposed at this time.

14. Loss per Share

The computation of basic earnings (loss) per share (EPS) is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and potential dilutive common shares during the period as determined by using the treasury stock method.

Basic and diluted EPS for the three and nine months ended September 30, 2025 and 2024 were calculated as follows (in millions, except per share data):

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

2. 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 unaudited financial information and related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financial information in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the Securities and Exchange Commission (the SEC) on February 21, 2025 (the 2024 Form 10-K).

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 four franchises: respiratory virus vaccines, latent and other virus 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®, our original COVID vaccine, mRESVIA®, our vaccine against respiratory syncytial virus (RSV), and mNEXSPIKE®, our new COVID vaccine. Additionally, we have a diverse and extensive development pipeline of 30 development candidates across 40 development programs, of which 37 are in clinical studies currently.

Business Highlights

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 new 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 Canada and we have filed and are targeting 2026 approvals in Australia, the EU, Japan and Taiwan.

mRESVIA

mRESVIA, our vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV, 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.

Moderna's International mRNA Manufacturing Facilities

In 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 partnership with government and industry.

Net Product Sales and Net Loss Per Share

For the third quarter of 2025, we recognized net product sales of $973 million, compared to $1.8 billion for the third quarter of 2024. Net loss per share was $(0.51) for the third quarter of 2025, compared to net income per share of $0.03 for the third quarter of 2024.

Recent Program Developments

Respiratory Virus Vaccines

• COVID: In September 2025, we announced positive preliminary immunogenicity data from ongoing Phase 4 clinical trials evaluating the 2025-2026 formulas of our COVID vaccines, Spikevax and mNEXSPIKE. The 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2, generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across individuals 12 through 64 years of age with at least one underlying condition that increases their risk for severe outcomes from COVID, and all adults 65 years of age and older. The 2025–2026 formula of mNEXSPIKE, which also targets the LP.8.1 variant, generated greater than a 16-fold increase in LP.8.1-neutralizing antibodies across the same age groups. The safety profiles for both vaccines were consistent with previous studies, with no new safety concerns identified.
• Seasonal flu vaccine: In October 2025, we presented Phase 3 efficacy and safety data for our seasonal flu vaccine (mRNA-1010) at IDWeek 2025, and Phase 3 relative vaccine efficacy in a high-risk subset of patients at The European Scientific Working Group on Influenza (ESWI) Conference. We expect to complete submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe by January 2026.
• Seasonal flu + COVID vaccine: We presented Phase 3 immunogenicity subanalyses for our flu+COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at the ESWI Conference. We expect to refile with Health Canada in 2025 and are awaiting further guidance from the FDA on refiling. Currently, our mRNA-1083 filing is under review with the European Medicines Agency (EMA).

Latent and Other Virus Vaccines

• Norovirus vaccine: Our ongoing Phase 3 safety and efficacy study of our trivalent vaccine candidate against norovirus (mRNA-1403) has not accrued sufficient cases and will enroll a second Northern Hemisphere season (2025-2026) for additional case accruals. The timing of the Phase 3 readout will continue to be dependent on case accruals.
• Cytomegalovirus (CMV) vaccine: In October 2025, we announced topline results from the Phase 3 pivotal trial evaluating the efficacy of mRNA-1647, our investigational CMV vaccine. The study did not meet its primary efficacy endpoint of preventing CMV infection in seronegative female participants of childbearing age (16 to 40 years of age). We will discontinue our congenital CMV clinical development program. The Phase 3 trial was a randomized, observer-blind, placebo-controlled study. The study included approximately 7,500 women 16 to 40 years of age from approximately 300 sites across 13 countries, representing the largest trial assessing the efficacy of a CMV vaccine to-date. Vaccine efficacy against primary CMV infection in healthy women was well below our target, ranging from 6% to 23%, depending on the case definition used.

We plan to continue to evaluate mRNA-1647 in an ongoing Phase 2 trial of bone marrow transplant patients.

Oncology Therapeutics

• Intismeran autogene (INT): We continue to make progress on advancing mRNA-4157 in the clinic. In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two non-small cell lung cancer (NSCLC) Phase 3 studies for individuals with and without prior neoadjuvant treatment are enrolling. Separate randomized Phase 2 studies for high-risk muscle invasive and high-risk non-muscle invasive bladder cancer are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma is also enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Further, we and Merck have launched a new Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC.
• Checkpoint adaptive immune modulation therapy (AIM-T). The Phase 1/2 study of mRNA-4359, our investigational mRNA-based therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells, is ongoing. Phase 1b data for mRNA-4359 was recently presented at the 2025 European Society for Medical Oncology (ESMO) Congress. The Phase 2 portion of the study, which includes cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, is enrolling patients.

Rare Diseases

• Propionic acidemia (PA) therapeutic: We recently presented final results from the Part 1 dose-escalation cohorts of our ongoing Phase 1/2 study and cumulative data from ongoing participants in the extension study of our investigational therapeutic for PA (mRNA-3927) at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025. In the study, which is designed to evaluate safety and pharmacology in trial participants with PA, mRNA-3927 has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Previously presented 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. mRNA-3927 is in a registrational study and target enrollment has been reached.
• Methylmalonic acidemia (MMA) therapeutic: We recently shared interim data from the Phase 1/2 study of our investigational therapeutic for MMA (mRNA-3705) at ICIEM 2025. mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. We and the FDA have agreed on the pivotal study design. We expect to start a registrational study in 2026.
• Glycogen storage disease type 1a (GSD1a): In October 2025, we decided to discontinue our Phase 1 study of mRNA-3745, our rare disease therapeutic targeting GSD1a, in order to evaluate how advancements in our mRNA platform technology can best be applied to this program.

Our Pipeline

The following chart shows our current pipeline of 40 development programs across our several modalities.

Abbreviations: CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; HR MIUC, high-risk muscle-invasive urothelial carcinoma; HR MIBC, high-risk muscle invasive bladder cancer; HR NMIBC, high-risk non-muscle invasive bladder cancer; HSV, herpes simplex virus; IM, infectious mononucleosis; NSCLC, non-small cell lung cancer; pCR, pathological complete response; RCC, renal cell carcinoma; RSV, respiratory syncytial virus; VZV, varicella-zoster virus.

Results of operations

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

Revenue

Net product sales

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

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

As of September 30, 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 RSV disease. 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 vaccines, Spikevax and mNEXSPIKE, to the commercial market as well as to foreign governments and international organizations. We launched commercial sales of our RSV vaccine, mRESVIA, 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. 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):

Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2025, we had deferred revenue of $144 million related to product sales, of which $79 million is expected to be realized in less than one year.

Other revenue

Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and other miscellaneous revenue.

For the three and nine months ended September 30, 2025, total revenue decreased by $846 million, or 45%, and $1.0 billion, or 44%, respectively, compared to the same periods in 2024, driven by a decline in net product sales. Net product sales decreased by $847 million, or 47%, for the three-month period and $999 million, or 46%, for the nine-month period, primarily due to lower COVID vaccine sales in both the U.S. and international markets. The decrease was more pronounced in the U.S., reflecting lower overall COVID vaccination rates compared to the prior year, and the absence of an approximately $140 million positive adjustment related to sales provision estimates that was recorded in the third quarter of 2024. Outside the U.S., net product sales also declined, mainly due to the completion of certain advance purchase agreements with government customers and the timing of deliveries between the third and fourth quarters of 2025. Other revenue was relatively flat compared to the prior year for both periods, as lower royalty and collaboration revenue were largely offset by higher revenue related to our stand-ready obligation to maintain manufacturing readiness.

We expect demand for our COVID and RSV vaccines to follow a seasonal pattern aligned with fall and winter vaccination campaigns in both hemispheres. As COVID has transitioned to a seasonal respiratory vaccine, we anticipate a decline in net product sales for the full year 2025 compared to 2024, primarily due to lower expected vaccination rates and a more competitive commercial market environment. Although we commenced sales of our RSV vaccine in the third quarter of 2024, product sales from our RSV vaccine are not expected to present a significant portion of total product sales in 2025.

Operating expenses

Cost of sales

Cost of sales for the three months ended September 30, 2025 was $207 million, which included third-party royalties of $43 million, and inventory write-downs of $67 million. Cost of sales for the nine months ended September 30, 2025 was $416 million, which included third-party royalties of $54 million, inventory write-downs of $147 million, primarily related to our finished and semi-finished COVID vaccine inventory and certain raw materials, unutilized manufacturing capacity and wind-down costs of $50 million, and losses on firm purchase commitments of $24 million. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges. These charges in 2025, other than royalties, were largely driven by proactive production decisions to maintain supply flexibility and commitments related to manufacturing capacity.

Cost of sales for the three and nine months ended September 30, 2025 decreased by $307 million and $309 million, or 60% and 43%, respectively, compared to the same periods in 2024. Cost of sales as a percentage of net product sales was 21% and 35% for the three and nine months ended September 30, 2025, respectively, compared to 28% and 33% for the corresponding periods in 2024. The decrease for the three-month period was primarily driven by lower inventory write-downs and reduced unutilized manufacturing capacity, while the increase for the nine-month period reflected the impact of lower net product sales.

We expect full year 2025 cost of sales to be lower compared to 2024, primarily driven by a reduction in period charges, particularly lower wind-down costs related to contract manufacturing organization contracts and inventory write-downs, along with lower anticipated sales volume. We expect this decrease will be partially offset by costs associated with internal manufacturing sites commencing operations in 2025. However, cost of sales as a percentage of net product sales is expected to vary widely due to continued uncertainty around demand and increased market competition. This variability is primarily driven by the fixed nature of a significant portion of our manufacturing costs, which cannot be quickly adjusted in response to changes in sales volume. As part of our long-term strategy, we continue to invest in internal manufacturing capabilities to improve cost control and support potential future product launches.

Research and development expenses

Research and development expenses decreased by $336 million, or 30%, for the three months ended September 30, 2025, compared to the same period in 2024. Clinical trial expenses declined by $117 million, driven by lower activity in the RSV, COVID, and seasonal flu programs as a result of trial wind-downs and higher research and development funding from Blackstone for the seasonal flu program, partially offset by increased investment in our norovirus program. Clinical manufacturing costs decreased by $44 million, reflecting lower production-related spending due to reduced activity levels. Preclinical research expenses decreased by $22 million due to investment reprioritization, and consulting and outside service costs declined by $17 million, consistent with the lower level of clinical and manufacturing activities. The prior-year period also included an expense related to the purchase of a priority review voucher.

For the nine months ended September 30, 2025, research and development expenses decreased by $1.1 billion, or 31%, compared to the same period in 2024. Clinical trial spending declined by $403 million, primarily due to reduced activity in the RSV, COVID, and flu+COVID combination vaccine programs, consistent with trial wind-downs and the timing of trial activities, partially offset by increased investment in our norovirus program. Clinical manufacturing costs were $196 million lower, driven by reduced production-related spending due to reduced activity levels. Additionally, both clinical trial and clinical manufacturing expenses included a $62 million benefit from the Blackstone research and development funding related to the seasonal flu program in the second quarter of 2025, reflecting revisions to prior period estimates. Consulting and outside service costs declined by $110 million, and preclinical research expenses decreased by $96 million, both driven by reduced program activities and investment reprioritization. Separately, the prior-year period included an expense related to the purchase of two priority review vouchers.

We continue to anticipate a reduction in research and development expenses in 2025 compared to 2024, driven by disciplined cost management, portfolio prioritization, and a focused approach to pipeline execution. While we remain committed to advancing our pipeline and late-stage programs, including our intismeran autogene, norovirus, seasonal flu and combination vaccine programs, we are also implementing operational efficiencies across the organization, including meaningful resourcing adjustments to align with the current stage of our pipeline and to support long-term sustainability.

Selling, general and administrative expenses

Selling, general and administrative expenses decreased by $13 million, or 5%, for the three months ended September 30, 2025, compared to the same period in 2024. The decrease primarily reflected reductions in consulting and outside services across multiple functions, as well as digital and facility-related costs.

For the nine months ended September 30, 2025, selling, general and administrative expenses decreased by $113 million, or 14%, compared to the same period in 2024. The decrease was mainly driven by a $42 million broad-based reduction in consulting and outside services, lower digital and facility-related costs of $21 million, a $21 million decrease in legal expenses, and a $20 million decrease in personnel-related expenses due to lower headcount. The decreases in both periods largely reflects continued cost discipline and ongoing efforts to streamline operations.

We continue to anticipate a reduction in selling, general and administrative expenses in 2025 compared to 2024. This reflects our ongoing commitment to operating efficiency as we expand our global commercial, regulatory, sales and marketing infrastructure, while continuing to invest in digital capabilities and leverage artificial intelligence technologies. In parallel, we are making organizational refinements to better align resources with the evolving needs of the business and support long-term scalability.

Interest income

For the three months ended September 30, 2025, interest income decreased by $30 million, or 29%, compared to the same period in 2024. For the nine months ended September 30, 2025, interest income decreased by $90 million, or 27%, compared to the same period in 2024. The decreases were primarily due to lower average investment balances.

Other income (expense), net

The following tables summarize other income (expense), net for the periods presented (in millions):

For the three and nine months ended September 30, 2025, total other income, net, was immaterial and $4 million, respectively, compared to total other expense, net, of $12 million and $58 million for the same periods in 2024. The improvement was largely driven by lower equity investment losses and a reduction in interest expense. Interest expense is primarily related to our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, and certain contract manufacturing service agreements. Please refer to Note 10 to our condensed consolidated financial statements for additional information.

Income taxes

Provision for income taxes for the three and nine months ended September 30, 2025, remained immaterial and consistent with the same periods in 2024. The effective tax rates for both periods in 2025 continue to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits from the losses. Please refer to Note 13 to our condensed consolidated financial statements for additional details.

Liquidity and capital resources

The following table summarizes our cash, cash equivalents, investments and working capital as of September 30, 2025 and December 31, 2024 (in millions):

Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of September 30, 2025 decreased by $2.9 billion, or 30%, compared to December 31, 2024. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $2.8 billion and purchases of property and equipment of $153 million during the nine months ended September 30, 2025.

Working capital, defined as current assets less current liabilities, decreased by $1.0 billion, or 17%, as of September 30, 2025, compared to December 31, 2024. This was primarily driven by a decrease in cash, cash equivalents and current investments of $2.5 billion to fund operations, partially offset by an increase in accounts receivable of $688 million, mainly due to timing of collections, a decrease in accrued liabilities and accounts payable of $387 million, driven by lower spend during the period, and an increase in inventory of $215 million, driven by manufacturing of our COVID vaccines.

As of September 30, 2025, we did not have any off-balance sheet arrangements, other than those obligations and commitments disclosed herein.

Cash flow

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

Operating activities

We derive cash flows from operations primarily from cash collected from accounts receivable and customer deposits related to our product sales and other revenue, as well as certain government-sponsored and private organizations, strategic alliances and funding arrangements. Our operating cash flows are significantly affected by our use of cash for operating expenses and working capital to support the business.

We sell our vaccines to the commercial market as well as to foreign governments and international organizations. In the U.S., our vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Wholesalers and distributors typically do not make upfront payments to us. Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2025, we had $144 million in deferred revenue related to product sales.

Net cash used in operating activities for the nine months ended September 30, 2025 was $2.8 billion and consisted of net loss of $2.0 billion, non-cash adjustments of $519 million and a net change in assets and liabilities of $1.3 billion. Non-cash items primarily included stock-based compensation of $370 million, and depreciation and amortization of $148 million. The net change in assets and liabilities was mainly due to an increase in accounts receivable of $703 million, driven by timing of collections, a decrease in accrued liabilities and accounts payable of $310 million and other liabilities of $137 million, driven by overall lower spend in the period, and an increase in inventory of $213 million, driven by increased manufacturing of our COVID vaccines, partially offset by an increase in deferred revenue of $108 million due to upfront payments received in excess of revenue recognized.

Net cash used in operating activities decreased by $1.0 billion, or 27%, during the nine months ended September 30, 2025, compared to the same period in 2024, primarily attributable to a decrease in net loss of $445 million, a change in deferred revenue of $285 million driven by collections of upfront payment in excess of revenue recognized, and a change in accrued liabilities and accounts payable of $208 million driven by continued decrease in spend.

Investing activities

Our primary investing activities consist of purchases, sales, and maturities of our investments, capital expenditures for facilities, manufacturing and laboratory equipment, and computer equipment and software, as well as business development activities.

Net cash provided by investing activities for the nine months ended September 30, 2025 was $2.0 billion, driven primarily by proceeds from maturities and sales of marketable securities of $6.4 billion, partially offset by purchases of marketable securities of $4.2 billion, and purchases of property and equipment of $153 million.

Net investing cash flows decreased by $494 million, or 20%, during the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $1.3 billion, partially offset by a decrease in purchases of marketable securities of $420 million, and a decrease in purchases of plant, property and equipment of $376 million.

Financing activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was $12 million, primarily related to proceeds from issuance of common stock through equity plans.

Net cash provided by financing activities decreased by $47 million, or 80%, during the nine months ended September 30, 2025, compared to the same period in 2024, mainly due to a decrease in proceeds from issuance of common stock through equity plans of $36 million.

Operation and funding requirements

Our principal sources of funding as of September 30, 2025 consisted of cash and cash equivalents, investments, and cash we may generate from operations. From our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. Following authorization of our first commercial product in December 2020, we generated significant net income in both 2022 and 2021. We also incurred a net loss of $2.0 billion for the nine months ended September 30, 2025 and net losses of $3.6 billion and $4.7 billion for the years 2024 and 2023, respectively. We have retained earnings of $8.0 billion as of September 30, 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 advancing research and development for our investigational medicines. This also extends to our manufacturing costs, including our arrangements with our supply and manufacturing partners. 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 will not be reimbursed or otherwise paid for by our partners or collaborators. 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 (refer to Note 10 and Note 11 to our condensed consolidated financial statements). We have 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 arrangement, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.

We believe that our cash, cash equivalents, and investments as of September 30, 2025, together with cash expected to be generated from product sales, 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 these financial statements included in this Form 10-Q. 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.

Critical accounting policies and significant judgments and estimates

There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the three months ended September 30, 2025 compared to those disclosed in our 2024 Form 10-K.

Contractual Obligations

As of September 30, 2025, other than disclosed within Note 10 and Note 11 to our condensed consolidated financial statements, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2024 Form 10-K.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Our market risks, and the way we manage them, are summarized in Part II, Item 7A., “Quantitative and Qualitative Disclosures About Market Risk” of our 2024 Form 10-K. There have been no material changes to our market risk or to our management of such risks for the three and nine months ended September 30, 2025.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

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 September 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 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.

Changes in Internal Control over Financial Reporting

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) during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by the collusion of two or more people or by a management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II

Item 1. Legal Proceedings

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described in our 2024 Form 10-K under the heading “Legal Proceedings.” Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2024 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.

Proceedings Related to Patents Owned by Alnylam

As more fully described in our 2024 Form 10-K, Alnylam Pharmaceuticals, Inc. (Alnylam) brought two proceedings against Moderna in the U.S. District Court for the District of Delaware asserting that the manufacture and sale of our COVID vaccine infringes certain U.S. patents concerning cationic lipids. The Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits. In the first case, Alnylam appealed and the Federal Circuit Court of Appeals decided the appeal in our favor on June 4, 2025. Following the Federal Circuit decision, Moderna and Alnylam entered into an agreement on September 15, 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 Moderna.

Item 1A. Risk Factors

Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our 2024 Form 10-K. There have been no material changes from the risk factors previously disclosed in the 2024 Form 10-K.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Issuer Purchases of Equity Securities

On August 1, 2022, our Board of Directors authorized a share repurchase program for our common stock of up to $3.0 billion, with no expiration date. During the three months ended September 30, 2025, there were no shares repurchased. As of September 30, 2025, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remains outstanding, with no expiration date.

For details about our share repurchase programs, please refer to Note 12 to our consolidated financial statements, as set forth in our 2024 Form 10-K.

Item 5. Other Information

During the three months ended September 30, 2025, the following directors and officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) of the Company took the following actions regarding trading arrangements with respect to our securities:

Stéphane Bancel, our Chief Executive Officer, has three different stock option awards that will reach their ten-year expiration in 2026, including 688,073 options that will expire on February 23, 2026, 558,394 options that will expire on August 10, 2026, and another 193,321 options that also expire on August 10, 2026 (the Expiring Options). Mr. Bancel intends to contribute all of the after-tax proceeds from the exercise and sale of the Expiring Options to charitable causes. On September 3, 2025, Mr. Bancel adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Bancel 10b5-1 Plan). Between December 17, 2025 and August 10, 2026, the Bancel 10b5-1 Plan provides for the potential exercise of vested stock options and the associated sale of the Expiring Options, which represent up to 1,439,788 shares of the Company’s common stock. The Bancel 10b5-1 Plan expires on August 10, 2026, or upon the earlier completion of all authorized transactions under the Bancel 10b5-1 Plan.

On September 5, 2025, Abbas Hussain, one of our directors, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Hussain 10b5-1 Plan). Between December 9, 2025 and April 30, 2026, the Hussain 10b5-1 Plan provides for the sale of up to 6,186 shares of the Company’s common stock to satisfy tax obligations in connection with the vesting of equity awards. The Hussain 10b5-1 Plan expires on April 30, 2026, or upon the earlier completion of all authorized transactions under the Hussain 10b5-1 Plan.

On September 9, 2025, Shannon Klinger, our Chief Legal Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Klinger 10b5-1 Plan). Between March 2, 2026 and September 4, 2026, the Klinger 10b5-1 Plan provides for the potential exercise of vested stock options and the associated sale of up to 20,827 shares of the Company’s common stock. The Klinger 10b5-1 Plan expires on September 4, 2026, or upon the earlier completion of all authorized transactions under the Klinger 10b5-1 Plan.

Item 6. Exhibits

The Exhibits listed below are filed or incorporated by reference as part of this Form 10-Q.

Exhibit No. Exhibit Index

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 2002 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 2002 32.1+ Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS* XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document 101.SCH* XBRL Taxonomy Extension Schema Document 101.CAL* XBRL Taxonomy Extension Calculation Document 101.DEF* XBRL Taxonomy Extension Definition Linkbase Document 101.LAB* XBRL Taxonomy Extension Label Linkbase Document 101.PRE* XBRL Taxonomy Extension Presentation Link Document 104* Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101.)

* Filed herewith

• The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.