Moderna, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
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Sep 30, 2025 · Filed Nov 6, 2025
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Notes to Condensed Consolidated Financial Statements
(Unaudited)
- 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.
- 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 offive totwelve 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):
| Unrealized Gains on Available-for-Sale Debt Securities | Pension and Postretirement Obligation Adjustments | Gains (Losses) on Foreign Currency Translation | Total | |
|---|---|---|---|---|
| Accumulated other comprehensive loss, balance at December 31, 2024 | $10 | $(12) | $(8) | $(10) |
| Other comprehensive income | 15 | 2 | 3 | 20 |
| Accumulated other comprehensive income, balance at March 31, 2025 | 25 | (10) | (5) | 10 |
| Other comprehensive income | 5 | (1) | 9 | 13 |
| Accumulated other comprehensive income, balance at June 30, 2025 | 30 | (11) | 4 | 23 |
| Other comprehensive income | 5 | 2 | (3) | 4 |
| Accumulated other comprehensive income, balance at September 30, 2025 | $35 | $(9) | $1 | $27 |
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):
| September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash and cash equivalents | $1,132 | $1,644 |
| Restricted cash(1) | 1 | — |
| Restricted cash, non-current(2) | 1 | 3 |
| Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $1,134 | $1,647 |
(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.
- Net Product Sales
Net product sales by customer geographic location were as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| United States | $782 | $1,215 | $901 | $1,477 |
| Europe | 16 | 281 | 16 | 281 |
| Rest of world | 175 | 324 | 255 | 413 |
| Total | $973 | $1,820 | $1,172 | $2,171 |
Net product sales by product type were as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| COVID(1) | $971 | $1,810 | $1,168 | $2,161 |
| RSV | 2 | 10 | 4 | 10 |
| Total | $973 | $1,820 | $1,172 | $2,171 |
(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):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Gross product sales | $1,971 | $2,964 | $2,251 | $3,377 |
| Product sales provision: | ||||
| Wholesaler chargebacks, discounts and fees | (762) | (1,053) | (846) | (1,053) |
| Returns, rebates and other fees | (236) | (91) | (233) | (153) |
| Total product sales provision | $(998) | $(1,144) | $(1,079) | $(1,206) |
| Net product sales | $973 | $1,820 | $1,172 | $2,171 |
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):
| Returns and other fees | |
|---|---|
| Balance at December 31, 2024 | $(370) |
| Provision related to sales made in current period | (199) |
| Provision related to sales made in prior periods | (34) |
| Payments and returns related to sales made in current period | 14 |
| Payments and returns related to sales made in prior year | 163 |
| Balance at September 30, 2025 | $(426) |
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.
- Other Revenue
The following table summarizes other revenue for the periods presented (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Grant revenue | $14 | $7 | $20 | $27 |
| Collaboration revenue (Note 5) | 7 | 28 | 12 | 35 |
| Licensing and royalty revenue | 2 | 7 | 13 | 37 |
| Other revenue | 20 | — | 49 | — |
| Total other revenue | $43 | $42 | $94 | $99 |
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.
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