A Dark Vector Cognition product

Item 8. Financial Statements and Supplementary Data

173K characters. Original on sec.gov · Markdown

Item 8. Financial Statements and Supplementary Data

MODERNA, INC.

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm102
Consolidated Balance Sheets as of December 31, 2023 and 2022104
Consolidated Statements of Operations for the years ended December 31, 2023, 2022, and 2021105
Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, 2023, 2022, and 2021106
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022, and 2021107
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022, and 2021109
Notes to Consolidated Financial Statements110

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Moderna, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Moderna, Inc. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 23, 2024, expressed an unqualified opinion thereon.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Reserves for returns on product revenue
Description of the MatterDuring the year ended December 31, 2023, the Company’s net product revenues for Spikevax were $6.7 billion. As explained in Note 2 of the consolidated financial statements, revenue from product sales includes estimates of variable consideration for which reserves are established, including reserves for product returns. Auditing the Company’s measurement of reserves for product returns under its contracts with wholesalers, distributors and retail customers (collectively, “Customers”) was especially challenging because (1) it involves management assumptions about inventory remaining in the distribution channel as of the balance sheet date that could be subject to return in future periods and projected market demand, and (2) the Company has limited returns history on which to base its assumptions.
How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company’s process to determine reserves for returns on product revenue. For example, we tested controls over management’s review of the completeness and accuracy of the data used in the process and the assumptions about the amount of inventory in the distribution channel that could be subject to return in future periods. To test the Company’s reserves for returns on product revenue, our audit procedures included, among other procedures, testing the accuracy and completeness of the underlying data used in the calculations and evaluating the assumptions used by management to estimate its reserves. To test management’s assumptions, we inspected agreements with significant Customers to validate the rights of return, made inquiries of members of the commercial function regarding any changes to the terms and conditions of commercial contracts. We also examined credit memos issued during and after year end for unusual items or trends not consistent with the Company’s analysis of product returns and performed revenue cutoff testing at period end to assess whether there were unusual trends that should have been considered in the Company analysis of product returns. In addition, we reviewed inventory on hand-reporting from significant Customers at the balance sheet date and subsequent to the balance sheet date and inspected vaccination data from third-party sources through the report date. We also performed sensitivity analyses over the Company’s return rate to assess the effect of changes in assumptions.
Raw Material Inventory Write-downs
Description of the MatterAs of December 31, 2023, the Company had $0.4 billion of inventory. As disclosed in Note 2, inventory is recorded at the lower of cost or net realizable value. The Company periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise unsaleable items. For the year ended December 31, 2023, inventory write-downs were $2.2 billion, which included $903 million in raw material inventory write-downs resulting from the Company’s long-range financial planning process in the third quarter of 2023. Auditing management's estimates for raw material inventory write-downs involved especially subjective auditor judgment because the estimates rely on a number of factors that are affected by market and economic conditions outside the Company’s control. In particular, raw material inventory write-downs are sensitive to significant assumptions, including the expected demand for the Company’s products and the expiration dates of the raw materials.
How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design, and tested the operating effectiveness of internal controls over the Company's raw material inventory write-down process including management’s review of the significant assumptions described above and controls over the completeness and accuracy of the information used to develop the estimates. To test the Company’s raw material inventory write-downs, our audit procedures included, among other procedures, testing the accuracy and completeness of the underlying data used in the calculations and evaluating the assumptions used by management in its estimates. Our testing of the data used in the Company’s estimates included the accuracy of the raw material expiration dates used, materials required in the Company’s products, and any alternate uses. We evaluated the Company’s forecast of future demand, including testing of the significant assumptions within its forecast, and evaluating the consistency of the forecast with that used by management for other purposes. We also performed sensitivity analyses to assess the impact of changes in significant assumptions to the raw material inventory write-downs and evaluated any contrary evidence identified.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2014.

Boston, Massachusetts

February 23, 2024

MODERNA, INC.

CONSOLIDATED BALANCE SHEETS

(In millions, except per share data)

December 31,
20232022
Assets
Current assets:
Cash and cash equivalents$2,907$3,205
Investments5,6976,697
Accounts receivable, net8921,385
Inventory202949
Prepaid expenses and other current assets6271,195
Total current assets10,32513,431
Investments, non-current4,6778,318
Property, plant and equipment, net1,9452,018
Right-of-use assets, operating leases713121
Deferred tax assets81982
Other non-current assets685988
Total assets$18,426$25,858
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable$520$487
Accrued liabilities1,7982,101
Deferred revenue5682,038
Income taxes payable6348
Other current liabilities66249
Total current liabilities3,0154,923
Deferred revenue, non-current83673
Operating lease liabilities, non-current64392
Financing lease liabilities, non-current575912
Other non-current liabilities256135
Total liabilities4,5726,735
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $0.0001; 162 shares authorized as of December 31, 2023 and 2022; no shares issued or outstanding at December 31, 2023 and 2022——
Common stock, par value $0.0001; 1,600 shares authorized as of December 31, 2023 and 2022; 382 and 385 shares issued and outstanding as of December 31, 2023 and 2022, respectively——
Additional paid-in capital3711,173
Accumulated other comprehensive loss(123)(370)
Retained earnings13,60618,320
Total stockholders’ equity13,85419,123
Total liabilities and stockholders’ equity$18,426$25,858

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

MODERNA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In millions, except per share data)

Years Ended December 31,
202320222021
Revenue:
Net product sales$6,671$18,435$17,675
Other revenue177828796
Total revenue6,84819,26318,471
Operating expenses:
Cost of sales4,6935,4162,617
Research and development4,8453,2951,991
Selling, general and administrative1,5491,132567
Total operating expenses11,0879,8435,175
(Loss) income from operations(4,239)9,42013,296
Interest income42120018
Other expense, net(124)(45)(29)
(Loss) income before income taxes(3,942)9,57513,285
Provision for income taxes7721,2131,083
Net (loss) income$(4,714)$8,362$12,202
(Loss) earnings per share:
Basic$(12.33)$21.26$30.31
Diluted$(12.33)$20.12$28.29
Weighted average common shares used in calculation of (loss) earnings per share:
Basic382394403
Diluted382416431

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

MODERNA, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In millions)

Years Ended December 31,
202320222021
Net (loss) income$(4,714)$8,362$12,202
Other comprehensive income (loss), net of tax:
Available-for-sale securities:
Unrealized gains (losses) on available-for-sale debt securities210(348)(42)
Less: net realized losses (gains) on available-for-sale securities reclassified in net (loss) income3826(1)
Net increase (decrease) from available-for-sale debt securities248(322)(43)
Cash flow hedges:
Unrealized gains on derivative instruments—13074
Less: net realized losses (gains) on derivative instruments reclassified in net (loss) income8(154)(58)
Net increase (decrease) from derivatives designated as hedging instruments8(24)16
Pension and postretirement benefit plans:
Pension and postretirement obligation adjustments(9)——
Total other comprehensive income (loss)247(346)(27)
Comprehensive (loss) income$(4,467)$8,016$12,175

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

MODERNA, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(In millions)

Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive (Loss) IncomeRetained Earnings (Accumulated Deficit)Total Stockholders’ Equity
SharesAmount
Balance at December 31, 2020399$—$4,802$3$(2,244)$2,561
Exercise of options to purchase common stock7—112——112
Issuance of common stock under employee stock purchase plan——12——12
Stock-based compensation——142——142
Other comprehensive loss, net of tax———(27)—(27)
Repurchase of common stock(3)—(857)——(857)
Net income————12,20212,202
Balance at December 31, 2021403$—$4,211$(24)$9,958$14,145
Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive LossRetained EarningsTotal Stockholders’ Equity
SharesAmount
Balance at December 31, 2021403$—$4,211$(24)$9,958$14,145
Vesting of restricted common stock1—————
Exercise of options to purchase common stock4—50——50
Issuance of common stock under employee stock purchase plan——15——15
Stock-based compensation——226——226
Other comprehensive loss, net of tax———(346)—(346)
Repurchase of common stock(23)—(3,329)——(3,329)
Net income————8,3628,362
Balance at December 31, 2022385$—$1,173$(370)$18,320$19,123
Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive (Loss) IncomeRetained EarningsTotal Stockholders’ Equity
SharesAmount
Balance at December 31, 2022385$—$1,173$(370)$18,320$19,123
Vesting of restricted common stock1—————
Exercise of options to purchase common stock4—25——25
Issuance of common stock under employee stock purchase plan——21——21
Stock-based compensation——305——305
Other comprehensive income, net of tax———247—247
Repurchase of common stock, including excise tax(8)—(1,153)——(1,153)
Net loss————(4,714)(4,714)
Balance at December 31, 2023382$—$371$(123)$13,606$13,854

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

MODERNA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In millions)

Years Ended December 31,
202320222021
Operating activities
Net (loss) income$(4,714)$8,362$12,202
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
Stock-based compensation305226142
Depreciation and amortization621348232
Amortization/accretion of investments(61)3154
Loss on equity investments, net35——
Deferred income taxes828(559)(318)
Other non-cash items728—
Changes in assets and liabilities, net of acquisition of business:
Accounts receivable, net4931,790(1,784)
Prepaid expenses and other assets974(1,699)(489)
Inventory747492(1,394)
Right-of-use assets, operating leases(605)21(58)
Accounts payable13240204
Accrued liabilities(340)612989
Deferred revenue(2,060)(4,157)2,824
Income taxes payable15(828)876
Operating lease liabilities551(14)17
Other liabilities7388123
Net cash (used in) provided by operating activities(3,118)4,98113,620
Investing activities
Purchases of marketable securities(3,760)(11,435)(12,652)
Proceeds from maturities of marketable securities5,5753,1511,338
Proceeds from sales of marketable securities3,2063,5483,105
Purchases of property, plant and equipment(707)(400)(284)
Acquisition of business, net of cash acquired(85)——
Investment in convertible notes and equity securities(23)(40)(30)
Net cash provided by (used in) investing activities4,206(5,176)(8,523)
Financing activities
Proceeds from issuance of common stock through equity plans4665124
Repurchase of common stock, including excise tax(1,153)(3,329)(857)
Changes in financing lease liabilities(270)(184)(140)
Net cash used in financing activities(1,377)(3,448)(873)
Net (decrease) increase in cash, cash equivalents and restricted cash(289)(3,643)4,224
Cash, cash equivalents and restricted cash, beginning of year3,2176,8602,636
Cash, cash equivalents and restricted cash, end of year$2,928$3,217$6,860
Supplemental cash flow information
Cash (received) paid for income taxes$(357)$2,729$480
Cash paid for interest$39$25$14
Non-cash investing and financing activities
Purchases of property, plant and equipment included in accounts payable and accrued liabilities$130$72$111

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

MODERNA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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 therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases, independently and with our strategic collaborators.

Our COVID-19 vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®. Our original vaccine, mRNA-1273, targeted the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated.

We have a diverse and extensive development pipeline of 42 development candidates across our 45 development programs, of which 40 are in clinical studies currently.

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

Our consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (GAAP). 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 Standard Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).

The consolidated financial statements include the Company and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

Other revenue in the consolidated statements of operations comprises grant revenue and collaboration revenue that were previously presented as separate line items in our consolidated statements of operations in our 2022 Form 10-K. The associated prior period amounts in the consolidated financial statements, as well as in the notes thereto, have been reclassified to conform to the current presentation.

Use of Estimates

We have made estimates and judgments affecting the amounts reported in our 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 revenue 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.

Segment Information

We have determined that our chief executive officer is the chief operating decision maker (CODM). The CODM reviews financial information presented on a consolidated basis. Resource allocation decisions are made by the CODM based on consolidated results. There are no segment managers who are held accountable by the CODM for operations, operating results, and planning for levels or components below the consolidated unit level. As such, we have concluded that we operate as one segment.

Revenue Recognition

To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following five steps (the five-step model): (i) identify the contract(s) with our customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as each performance obligation is satisfied.

Net Product Sales

Prior to the third quarter of 2023, we sold our COVID-19 vaccine to the U.S. Government, foreign governments and organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns. Certain of these agreements entitle us to upfront deposits for our COVID-19 vaccine supply, initially recorded as deferred revenue. In the third quarter of 2023, we commenced sales of our latest COVID-19 vaccine to the U.S. commercial market, in addition to continuing sales to international governments and organizations. In the U.S., our COVID-19 vaccine is 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.

We recognize net product sales when control of the product transfers to the customer, typically upon delivery. Payment terms generally range from 30 to 60 days, in line with customary practices in each country. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns, and other related deductions. These provisions are recorded based on contractual terms and our estimate of returns for product sold during the period, using the expected value method or the most likely amount method. We update our estimates quarterly and record necessary adjustments in the period when we identify the adjustments. Product sales, net of provisions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable when the uncertainty associated with the provisions is subsequently resolved. Shipping and handling activities are considered fulfillment activities and not a separate performance obligation. Taxes assessed by governmental authorities that are imposed on and collected from our product sales are excluded from net product sales.

Wholesaler chargebacks, discounts and fees

We contract with retailers, healthcare providers, and group purchasing organizations (GPO) to broaden our customer reach and offer contractual discounts. The chargeback represents the difference between the invoice price billed to the wholesaler and the negotiated price charged to the retailers, healthcare providers and GPO members. For distribution and related services, such as stocking and cold chain storage, we provide compensation to our wholesalers and distributors. We typically offer our customers invoice discounts on product sales for prompt payments and pre-orders. The estimation of these discounts and fees is based on contractual terms and our expectations regarding future customer payment behaviors. Wholesaler fees and invoice discounts are deducted from our gross product sales and accounts receivable at the time such product sales are recognized.

Product returns

We typically offer customers in the U.S. the right to return products, up to a certain limit as stipulated in our contracts. Estimated returns for our COVID-19 vaccine are determined considering available return rates for similar products, estimated levels of inventory in the distribution channel, and projected market demand. The estimated amount for product returns is presented within accrued liabilities on our consolidated balance sheets and is deducted from our gross product sales in the period the related product sales are recognized.

Other fees

Fees payable to third party payers and healthcare providers, along with fees to our direct customers that are settled via cash payments, including certain patient assistance programs, are recorded as accrued liabilities on our consolidated balance sheets.

Determining the amount of variable consideration to recognize necessitates substantial judgment, especially when assessing factors outside our direct control such as lack of pertinent historical data and limited third-party information. Among all variables, estimating returns presents the most significant judgment due to the broad range of potential outcomes and the current lack of return history with our customers. As we receive more historical data on our product returns, we will integrate this information to refine our estimates and enhance the precision of our financial projections. The actual results could differ from our estimates, and such differences could have a material impact to our financial statements.

Other Revenue

Other revenue consists primarily of grant revenue and collaboration revenue.

Grant revenue

We have contracts with government-sponsored and private organizations for research and development related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs as well as a related profit margin. We recognize grant revenue from these contracts as we perform services under these arrangements when the funding is committed. Associated expenses are recognized when incurred as research and development expense. Grant revenue and related expenses are presented gross in the consolidated statements of operations as we have determined we are the primary obligor under the arrangements relative to the research and development services we perform as lead technical expert.

Collaboration Revenue

We have entered into strategic collaborations and other similar arrangements with third parties for research and other licenses, development and commercialization of certain products and product candidates. Such arrangements provide for various types of payments to us, including upfront fees, funding of research and development services and preclinical and clinical material, technical, development, regulatory, and commercial milestone payments, licensing fees, option exercise fees, and royalty and earnout payments on product sales. Such payments are often not commensurate with the timing of revenue recognition and therefore result in deferral of revenue recognition. We recognize revenue based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good or service to the customer.

Cash and Cash Equivalents

We consider all highly liquid investments with an original maturity of 90 days or less from the date of purchase to be cash equivalents.

Restricted Cash

Restricted cash is composed of amounts held on deposit related to our lease arrangements and funds held in an escrow account related to a business acquisition in 2023. The funds are maintained in money market accounts and are recorded at fair value. Restricted cash is classified as either current or non-current based on the terms of the underlying arrangement and is included in either prepaid expenses and other current assets or other non-current assets in our consolidated balance sheets.

Cash, Cash Equivalents and Restricted Cash shown in the Consolidated Statements of Cash Flows

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

December 31,
202320222021
Cash and cash equivalents$2,907$3,205$6,848
Restricted cash(1)17——
Restricted cash, non-current(2)41212
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows$2,928$3,217$6,860

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

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

Investments

We invest our excess cash balances in marketable debt securities. We classify our investments in marketable debt securities as available-for-sale. We report our available-for-sale securities at fair value at each balance sheet date, and include any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders’ equity. Realized gains and losses are determined using the specific-identification method, and are included in other expense, net in our consolidated statements of operations. We classify our available-for-sale securities as current or non-current based on each instrument’s underlying effective maturity date and for which we have the intent and ability to hold the investment for a

period of greater than 12 months. Available-for-sale securities with maturities of less than 12 months are classified as current and are included in investments in the consolidated balance sheets. Available-for-sale securities with maturities greater than 12 months for which we have the intent and ability to hold the investment for greater than 12 months are classified as non-current and are included in investments, non-current in the consolidated balance sheets.

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. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Any impairment that is not credit- related is recognized in other comprehensive income (loss), net of applicable taxes.

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 expense, net, in our consolidated statements of operations. Investments in equity securities without readily determinable fair values are recorded at cost minus impairment, if any, adjusted for changes resulting from observable price changes in orderly transactions for identical or similar securities. Such adjustments are recorded in other expense, net, in our consolidated statements of operations.

Accounts Receivable, net

Accounts receivable, net represent amounts due from customers less wholesalers chargebacks, discounts and fees (please refer to our “Revenue Recognition” policy within Note 2 for product sales provision) and allowance for expected credit losses. Amounts payable to us are recorded as accounts receivable when our right to consideration is unconditional. To estimate the allowance for credit losses, we determine the allowance based on ongoing credit evaluation, historical experience and the aging of such receivables, among other factors. There was no allowance for doubtful accounts at December 31, 2023 or 2022. Additionally, bad debt expenses were immaterial for the years ended December 31, 2023, 2022 and 2021.

Concentrations of Credit Risk

Financial instruments that subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash, marketable debt securities, and accounts receivable, net. Our investment portfolio comprises money market funds and marketable debt securities, including U.S. Treasury securities, debt securities of U.S. government agencies and corporate entities and commercial paper. Our cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in business operations. We invest in a variety of financial instruments and limit the amount of credit exposure with any individual financial institution. Bank accounts in the United States are insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. Our primary operating accounts significantly exceed the FDIC limits.

We are also subject to credit risk from our accounts receivable, net related to our net product sales and strategic alliances. We sell our products primarily to wholesalers and distributors and other governments and organizations. We do not require collateral or other security to support accounts receivable. To date, we have not experienced material losses with respect to the collection of our accounts receivable.

Significant Customers

Our accounts receivable, net are generally unsecured and are from customers in different countries. We generated revenue from product sales to wholesalers and distributors and other governments and organizations, and to a lesser extent, grants made by government-sponsored and private organizations, and collaboration revenue from our strategic alliances.

A significant portion of our revenue to date has been generated from the following entities that accounted for more than 10% of total revenue and accounts receivable for the periods presented:

Percentage of Revenue Years Ended December 31,Percentage of Accounts Receivable December 31,
20232022202120232022
FFF Enterprises***39%*
European Commission*28%32%*29%
U.S. Government (excluding BARDA)*23%29%**
Takeda Pharmaceutical Company*10%***
Ministry of Health, Labor, and Welfare of Japan21%***30%
UK Health Security Agency***35%11%

________

** - Represents an amount of less than 10%*

Fair Value Measurements

Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities, which are required to be recorded at fair value, we consider the principal or most advantageous market in which we would transact and the market-based risk measurements or assumptions that market participants would use in pricing the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. ASC 820 (Fair Value Measurement) establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from our independent sources. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. 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).

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

Our cash equivalents and marketable debt securities are reported at fair value determined using Level 1 and Level 2 inputs (Note 6). The fair value of our foreign currency forward contracts is calculated using Level 2 inputs, which include currency spot rates, forward rates, interest rate curve and credit or non-performance risk. We do not have any non-financial assets or liabilities that should be recognized or disclosed at fair value on a recurring basis at December 31, 2023 and 2022.

Inventory

Inventory is recorded at the lower of cost or net realizable value, with cost determined using first-in, first-out and average cost methods for different components of inventory. We periodically review the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise unsaleable items. If unsaleable items are observed and there are no alternate uses for the inventory, we will record a write-down to net realizable value in the period that the decline in value is first recognized through a charge to cost of sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. We also assess whether we have any excess firm, non-cancelable, purchase commitment liabilities, resulting from our supply agreements with third-party vendors, on a quarterly basis. The determination of net realizable value and firm purchase commitment liabilities requires judgment, including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions, potential product obsolescence, expiration and utilization of raw materials under firm purchase commitments and contractual minimums, among others. We hold raw materials beyond our one year forecasted production plan, which were classified as non-current and included in other non-current assets in our consolidated balance sheets.

Pre-launch Inventory

Costs relating to raw materials and production of inventory in preparation for product launch prior to regulatory approval are capitalized when future commercialization is considered probable, the future economic benefit is expected to be realized, and we believe that material uncertainties related to the ultimate regulatory approval have been significantly reduced. For pre-launch inventory that is capitalized, we consider a number of factors based on the information available at the time, including the product candidate’s current status in the drug development and regulatory approval process, results from the related clinical trials, results from meetings with relevant regulatory agencies prior to the filing of regulatory applications, potential impediments to the approval process such as product safety or efficacy, historical experience, viability of commercialization and market trends. As of December 31, 2023, we did not have any capitalized pre-launch inventory on our consolidated balance sheets.

Property, Plant and Equipment

Property, plant and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful lives of property, plant and equipment are described below:

Estimated Useful Life
Land and land improvementsNot depreciated
Manufacturing and laboratory equipment5 years
Leasehold improvementsLesser of estimated useful life of improvement or remaining life of related lease
Computer equipment and software3 to 5 years
Furniture and fixtures5 years
Right-of-use asset, financingLease term

Construction in progress includes direct costs related to the construction of various property, plant and equipment, including leasehold improvements, and is stated at original cost. Once the asset is placed into service, these capitalized costs will be allocated to certain property, plant and equipment categories and will be depreciated over the estimated useful life of the underlying assets.

Acquisitions

We account for acquisitions either as business combinations or asset acquisitions, based on whether the set of assets acquired meets the definition of a business. When an acquisition is determined to be a business combination, we apply the acquisition method of accounting. This method requires that the assets acquired and liabilities assumed be recorded at their fair values as of the acquisition date on our consolidated balance sheets. Any excess of the consideration transferred over the fair value of the net identifiable assets acquired is recognized as goodwill. The process of determining the fair value of assets and liabilities involves significant estimates and assumptions. During the measurement period, which may extend up to one year from the acquisition date, we may record adjustments to these fair values. Any such adjustments are recorded with a corresponding change to goodwill. Transaction costs incurred in connection with business combinations are expensed as incurred.

On January 31, 2023, we completed a business combination by acquiring all outstanding shares of OriCiro Genomics K.K. for a cash consideration of $86 million. As a result of this acquisition, we recognized $52 million in goodwill and an intangible asset related to acquired technology valued at $48 million, which are included within other non-current assets in our consolidated balance sheets. This acquisition provided us with tools for cell-free synthesis and amplification of plasmid DNA, a key building block in mRNA

manufacturing. OriCiro’s technology strategically complements our manufacturing process and further accelerates our research and development efforts.

Goodwill and Intangible Assets

Goodwill represents the excess of purchase price over the fair value of net assets acquired and is carried at cost. Goodwill is tested at least annually for impairment by assessing qualitative factors in determining whether it is more likely than not that the fair value of net assets is below their carrying amounts. To date, an impairment of goodwill has not been recorded.

The fair value of acquired intangible assets is determined by applying the income-based approach, which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. To estimate the expected cash flows attributable to an intangible asset, it requires the use of Level 3 fair value measurements and inputs. Finite-lived intangible assets are amortized on a straight-line basis over their estimated useful lives.

Impairment of Long-Lived Assets, including Intangibles and Lease Right-of-Use Assets

We evaluate our long-lived assets, which consist of property, plant and equipment, intangibles and right-of-use assets to determine if facts and circumstances indicate that the carrying amount of assets may not be recoverable. If such facts and circumstances exist, we assess the recoverability of the long-lived assets by comparing the projected future undiscounted net cash flows associated with the related asset or group of assets over their remaining lives against their respective carrying amounts. If such review indicates that such cash flows are not expected to be sufficient to recover the recorded value of the assets, the assets are written down to their estimated fair values based on the expected discounted future cash flows attributable to the assets or based on appraisals. Impairment expenses for the years ended December 31, 2023, 2022 and 2021 were immaterial.

Leases

Leases are classified at their commencement date, which is defined as the date on which the lessor makes the underlying asset available for use by the lessee, as either operating or finance leases based on the economic substance of the agreement. We recognize lease right-of-use assets and related liabilities in our consolidated balance sheets for both operating and finance leases. Lease liabilities are measured at the lease commencement date as the present value of the future lease payments using the interest rate implicit in the lease. If the rate implicit is not readily determinable, we will utilize our incremental borrowing rate as of the lease commencement date. Lease right-of-use assets are measured as the lease liability plus initial direct costs and prepaid lease payments less lease incentives. The lease term is the non-cancelable period of the lease and includes options to extend or terminate the lease when it is reasonably certain that an option will be exercised.

We recognize operating lease cost in operating expenses in our consolidated statements of operations, inclusive of rent escalation provisions and rent holidays, on a straight-line basis over the respective lease term. For our finance leases, we recognize depreciation expense associated with the leased asset acquired and recognize interest expense related to the portion of the financing in our consolidated statements of operations.

We do not separate non-lease components from lease components for all classes of underlying assets. We do not recognize right-of-use assets and lease liabilities for leases with a lease term of 12 months or less. Instead, these lease payments are recognized in the statements of operations on a straight-line basis over the lease term.

Collaboration Arrangements

We analyze our collaboration arrangements to assess whether they are within the scope of ASC 808 (Collaborative Arrangements) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, we assess whether aspects of the arrangement between us and our collaboration partner are within the scope of other accounting literature. If we conclude that some or all aspects of the arrangement represent a transaction with a customer, we account for those aspects of the arrangement within the scope of ASC 606 (Revenue from Contracts with Customers). Please refer to our "Revenue Recognition" policy within Note 2 for additional discussion of revenue recognition under these types of arrangements. If we conclude that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, we recognize our allocation of the shared costs incurred with respect to the jointly conducted activities as a component of the related expense in the period incurred. Additionally, for any payments related to capital expenditures that are partially reimbursed by a collaboration partner, to the extent the underlying capital costs qualify for capitalization, any reimbursements received will offset the capitalized cost of the asset.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, overhead costs, contract services, and other outside costs. The value of goods and services received from contract research organizations and contract manufacturing organizations in the reporting period are estimated based on the level of services performed, and progress in the period in cases when we have not received an invoice from the supplier. Research and development costs also include costs and shared cost associated with third-party collaboration arrangements, including upfront fees and milestones paid to third-parties in connection with technologies that had not reached technological feasibility and did not have an alternative future use.

Assets that are acquired or constructed for research and development activities and that have alternative future uses, in research and development projects or otherwise, are capitalized and depreciated over their useful lives. However, the costs of equipment or facilities that are acquired or constructed and intangibles that are purchased from others for a particular research and development project, and that have no alternative future uses and therefore no separate economic values, are considered research and development costs and expensed when incurred.

Advertising Costs

Costs associated with advertising are expensed as incurred and are included in selling, general and administrative expense in the consolidated statements of operations. Advertising expenses were $204 million in 2023, $121 million in 2022, and immaterial in 2021.

Stock-Based Compensation

We issue stock-based awards to employees and non-employees, generally in the form of stock options, restricted stock units (RSUs), and performance stock units (PSUs). We account for our stock-based compensation awards in accordance with ASC 718 (Compensation—Stock Compensation). Most of our stock-based awards have been made to employees. We measure compensation cost for equity awards at their grant-date fair value and recognize compensation expense over the requisite service period, which is generally the vesting period, on a straight-line basis. The grant date fair value of stock options is estimated using the Black-Scholes option pricing model, which requires management to make assumptions with respect to the fair value of our common stock on the grant date, including the expected term of the award, the expected volatility of our stock, calculated based on a period of time generally commensurate with the expected term of the award, risk-free interest rates and expected dividend yields of our stock. We estimate the expected term of our stock options granted to employees and non-employees using the simplified method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option. We utilize this method as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term, and because significant changes in our business over the past few years have rendered historical experience less relevant. The expected volatility is based on a blended average of average historical stock volatilities of selected guideline companies over the expected term of the stock options, historical volatility of our stock price, and implied stock price volatility derived from the price of exchange traded options on our stock. Given the transformative changes in our business, we believe that a blended volatility rate is more indicative of future volatility than our historical volatility alone. We will continue to apply this process until a sufficient amount of historical information regarding the expected term and historical volatility of our own stock price becomes available, and until we believe that historical experience is relevant to our expectations for current grants. The grant date fair value of RSUs is estimated based on the fair value of our underlying common stock. For performance-based stock awards, we recognize stock-based compensation expense over the requisite service period using the accelerated attribution method when achievement is probable. We classify stock-based compensation expense in our consolidated statements of operations in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified. We made an accounting policy election to recognize forfeitures of stock-based awards as they occur.

Income Taxes

We account for income taxes based on an asset and liability approach. We recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities. These differences are measured using the enacted statutory tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided when the expected realization of deferred tax assets does not meet a “more likely than not” criterion. 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. We make estimates and judgments about our future taxable income that are based on assumptions that are consistent with our plans and estimates. Should the actual amounts differ from our estimates, the amount of our valuation allowance could be materially impacted. Changes in these estimates may result in significant increases or decreases to our tax provision in a period in which such estimates are changed, which in turn would affect net income or loss. We recognize tax benefits from uncertain tax positions if we believe the position is more likely than not to be sustained on examination by the taxing authorities based on the technical merits of the position. We make adjustments

to these tax reserves when facts and circumstances change, such as the closing of a tax audit or the refinement of an estimate. The provision for income taxes includes the effects of any reserves for uncertain tax positions, as well as the related net interest and penalties.

Earnings (Loss) per Share

We calculate diluted net earnings (loss) per share attributable to common stockholders by dividing net earnings (loss) by the weighted average number of common shares outstanding after giving consideration to the dilutive effect of restricted common stock and stock options that are outstanding during the period. For periods in which we have generated a net loss, the basic and diluted net loss per share attributable to common stockholders are the same, as the inclusion of the potentially dilutive securities would be anti-dilutive.

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 and losses on our investments and derivatives designated as hedging instruments. Total comprehensive income (loss) for all periods presented has been disclosed in the consolidated statements of comprehensive income (loss).

The components of accumulated other comprehensive loss for the years ended December 31, 2023 and 2022 were as follows (in millions):

Unrealized (Loss) Gain on Available-for-Sale SecuritiesNet Unrealized Gain (Loss) on Derivatives Designated As Hedging InstrumentsPension and Postretirement BenefitsTotal
Accumulated other comprehensive loss, balance at December 31, 2021$(40)$16$—$(24)
Other comprehensive loss(322)(24)—(346)
Accumulated other comprehensive loss, balance at December 31, 2022(362)(8)—(370)
Other comprehensive income (loss)2488(9)247
Accumulated other comprehensive loss, balance at December 31, 2023$(114)$—$(9)$(123)

Share Repurchases

Shares of our common stock repurchased pursuant to our repurchase programs are retired. The purchase price of such repurchased shares of common stock is recorded as a reduction to additional paid-in-capital. If the balance in additional paid-in-capital is exhausted, the excess is recorded as a reduction to retained earnings.

Recently Issued Accounting Standards Not Yet Adopted

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 consolidated financial statements and disclosures.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU broadens the disclosure requirements by requiring disclosures of significant segment expenses that are regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss. The standard also requires entities to disclose, on an interim and annual basis, the amount and description, including the nature and type, of the other segment items. Additionally, entities are required to disclose the title and position of the individual identified as the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources. These enhanced disclosure obligations apply to entities that operate with one reportable segment as well. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. Early adoption is permitted. We are currently assessing the impact that this new accounting standard will have on our 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 annual periods 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.

3. Net Product Sales

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

Years Ended December 31,
202320222021
United States$1,720$4,405$5,393
Europe1,3536,7326,834
Rest of world3,5987,2985,448
Total$6,671$18,435$17,675

As of December 31, 2023, 2022 and 2021, our COVID-19 vaccine was our only commercial product authorized for use.

Prior to the third quarter of 2023, we sold our COVID-19 vaccine to the U.S. Government, foreign governments and organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns. Certain of these agreements entitle us to upfront deposits for our COVID-19 vaccine supply, initially recorded as deferred revenue.

As of December 31, 2023 and 2022, we had deferred revenue of $613 million and $2.6 billion, respectively, related to customer deposits. We expect $554 million of our deferred revenue related to customer deposits as of December 31, 2023 to be realized in less than one year. Timing of product delivery and manufacturing, and receipt of marketing approval for the applicable COVID-19 vaccine will determine the period in which net product sales are recognized.

In the third quarter of 2023, we commenced sales of our latest COVID-19 vaccine to the U.S. commercial market, in addition to continuing sales to foreign governments and organizations. In the U.S., our COVID-19 vaccine is 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.

Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns, and other related deductions.

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

Years Ended December 31,
202320222021
Gross product sales$8,203$18,435$17,675
Product sales provision:
Wholesaler chargebacks, discounts and fees(976)——
Returns and other fees(556)——
Total product sales provision$(1,532)$—$—
Net product sales$6,671$18,435$17,675

The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the year ended December 31, 2023 (in millions):

Returns and other fees
Balance at December 31, 2022$—
Provision related to sales made in current period(556)
Balance at December 31, 2023$(556)

4. Other Revenue

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

Years Ended December 31,
202320222021
Grant revenue$94$388$735
Collaboration revenue8344061
Total other revenue$177$828$796

Grant Revenue

In April 2020, we entered into an agreement with Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for 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 mRNA-1273, our original vaccine candidate against COVID-19. The agreement has been subsequently amended to provide for additional commitments to support various late-stage clinical development efforts of mRNA-1273, 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. As of December 31, 2023, the remaining available funding, net of revenue earned was $97 million.

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

Years Ended December 31,
202320222021
BARDA$88$372$713
Other grant revenue61622
Total grant revenue$94$388$735

Collaboration Revenue

We have entered into collaboration agreements with strategic collaborators to accelerate the discovery and advancement of potential mRNA medicines across therapeutic areas. As of December 31, 2023, 2022 and 2021, we had collaboration agreements with Merck & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated and Vertex Pharmaceuticals (Europe) Limited (together, Vertex), AstraZeneca plc (AstraZeneca) and others. Please refer to Note 5 to for further description of these collaboration agreements.

The following table summarizes our total consolidated net revenue from our strategic collaborators for the periods presented (in millions):

Years Ended December 31,
Collaboration Revenue by Strategic Collaborator:202320222021
Vertex$82$48$26
Merck—30923
AstraZeneca—807
Other135
Total collaboration revenue$83$440$61

5. Collaboration Agreements

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 individualized neoantigen therapy (INT)) with Merck, to develop and commercialize INTs for individual patients using our mRNA and formulation technology. This agreement was subsequently amended and restated in 2018 (INT Agreement). 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.

Pursuant to the INT Agreement, we received an upfront payment of $200 million from Merck and we were responsible for designing and researching INTs, providing manufacturing capacity and manufacturing INTs and conducting Phase 1 and Phase 2 clinical trials for INTs, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, all in accordance with an agreed upon development plan and budget. We concluded that the collaboration arrangement was governed by the revenue recognition standard ASC 606.

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. Pursuant to the agreement, we and Merck have agreed to collaborate on further development and commercialization of INT, with costs and any profits or losses to be shared equally on a worldwide basis. We concluded that the collaboration arrangement under the Merck Participation Term is within the scope of ASC 808. For the years ended December 31, 2023 and 2022, we recognized expense of $184 million and $6 million, net of Merck's reimbursements, related to the INT collaboration under the Merck Participation Term. Additionally, the net cost recovery for capital expenditures during the same periods were $102 million and $3 million, respectively, which were applied to reduce the capitalized cost of the asset.

Vertex – Strategic Alliance in Cystic Fibrosis

2016 Strategic Alliance in Cystic Fibrosis

In July 2016, we entered into a Strategic Collaboration and License Agreement (Vertex Agreement), with Vertex Pharmaceuticals Incorporated, and Vertex Pharmaceuticals (Europe) Limited, together, Vertex. The Vertex Agreement, which was amended in July 2019 (2019 Vertex Amendment), is aimed at the discovery and development of potential mRNA medicines for the treatment of cystic fibrosis (CF) by enabling cells in the lungs of people with CF to produce functional cystic fibrosis transmembrane conductance regulator (CFTR) proteins. Pursuant to the Vertex Agreement, we lead discovery efforts during an initial research period, leveraging our platform technology and mRNA delivery expertise along with Vertex’s scientific experience in CF biology and the functional understanding of CFTR. Vertex is responsible for conducting development and commercialization activities for candidates and products that arise from the strategic alliance, including the costs associated with such activities. Subject to customary “back-up” supply rights granted to Vertex, we exclusively manufacture (or have manufactured) mRNA for preclinical, clinical and commercialization purposes. This collaboration arrangement is accounted for under ASC 606 and currently ongoing.

2020 Strategic Alliance in Cystic Fibrosis

In September 2020, we entered into a Strategic Collaboration and License Agreement with Vertex (Vertex 2020 Agreement). The Vertex 2020 Agreement was aimed at the discovery and development of potential medicines to treat CF by delivering gene-editing therapies to lung cells to facilitate production of functional CFTR proteins. The three-year research period of the Vertex 2020 Agreement was initially focus on the identification and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs. Following the initial three-year period, Vertex was responsible for conducting development and commercialization activities for candidates and products that arise from the strategic alliance, including the costs associated with such activities. Vertex was also obligated to pay us for research services in connection with our performance of certain activities in accordance with a jointly agreed research plan. This collaboration was concluded and terminated in the fourth quarter of 2023 in accordance with the terms of the Vertex 2020 Agreement.

AstraZeneca – Strategic Alliances in Cardiovascular and Oncology

We entered into collaboration agreements with AstraZeneca in 2013 and 2016, aimed at developing mRNA medicines for treatments in cardiovascular, cardiometabolic diseases, and cancer. These agreements provided AstraZeneca with exclusive development and commercialization rights for specific programs, including the VEGF-A product AZD8601 and an immuno-oncology program for IL-12, with upfront payments to us totaling $240 million.

In the third quarter of 2022, AstraZeneca terminated our collaborations with them, including the development of VEGF-A and IL-12 programs, for which termination became effective on November 21, 2022. All rights to these two programs reverted to us. As a result of the termination, we recognized the remaining deferred revenue of $76 million as collaboration revenue in the period.

Immatics – Strategic Multi-Platform Collaboration to Develop Oncology Therapeutics

In September 2023, we entered into a strategic research and development collaboration agreement with Immatics, a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies. We will lead the clinical development and commercialization of cancer vaccines and TCER® therapeutics resulting from the collaboration. Immatics will be responsible for conducting the preclinical studies and a potential Phase 1 clinical trial investigating IMA203 TCR-T in combination with the PRAME mRNA vaccine to further enhance IMA203 T cell responses. Each party will retain full ownership of its investigational PRAME compound, and the parties will fund the clinical study on a cost sharing basis.

Upon effectiveness of the agreement in October 2023, we made an upfront payment of $120 million to Immatics. The payment was recognized as research and development expense in the same period. Immatics will also receive research funding and is eligible to receive development, regulatory, and commercial milestone payments. Immatics is also eligible to receive tiered royalties on global net sales of TCER® products and certain vaccine products that are commercialized under the agreement. Under the agreement, Immatics has an option to enter into a global profit and loss share arrangement for the most advanced TCER®.

In addition to the collaborative arrangements mentioned above, 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 become probable. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized.

6. Financial Instruments and Fair Value Measurements

Cash and Cash Equivalents and Investments

The following tables summarize our cash and available-for-sale securities by significant investment category at December 31, 2023 and 2022 (in millions):

December 31, 2023
Amortized CostUnrealized GainsUnrealized LossesFair ValueCash and Cash EquivalentsCurrent Marketable SecuritiesNon- Current Marketable Securities
Cash and cash equivalents$2,907$—$—$2,907$2,907$—$—
Available-for-sale:
Certificates of deposit27——27—27—
U.S. treasury bills807——807—807—
U.S. treasury notes4,4073(67)4,343—2,6641,679
Corporate debt securities5,0673(81)4,989—2,0822,907
Government debt securities211—(3)208—11791
Total$13,426$6$(151)$13,281$2,907$5,697$4,677
December 31, 2022
Amortized CostUnrealized GainsUnrealized LossesFair ValueCash and Cash EquivalentsCurrent Marketable SecuritiesNon- Current Marketable Securities
Cash and cash equivalents$3,205$—$—$3,205$3,205$—$—
Available-for-sale:
Certificates of deposit188——188—188—
U.S. treasury bills767——767—767—
U.S. treasury notes7,781—(229)7,552—4,1823,370
Corporate debt securities6,595—(226)6,369—1,5604,809
Government debt securities148—(9)139——139
Total$18,684$—$(464)$18,220$3,205$6,697$8,318

The amortized cost and estimated fair value of available-for-sale securities, by contractual maturity at December 31, 2023 and 2022 were as follows (in millions):

December 31, 2023
Amortized CostEstimated Fair Value
Due in one year or less$5,751$5,697
Due after one year through five years4,7684,677
Total$10,519$10,374
December 31, 2022
Amortized CostEstimated Fair Value
Due in one year or less$6,792$6,697
Due after one year through five years8,6878,318
Total$15,479$15,015

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. We did not record any impairment charges related to our available-for-sale securities during the years ended December 31, 2023, 2022, and 2021. We did not recognize any credit-related allowance to available-for-sale securities as of December 31, 2023 and 2022.

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 length of time the securities have been in an unrealized loss position at December 31, 2023 and 2022 (in millions):

Less than 12 Months12 Months or MoreTotal
Gross Unrealized LossesEstimated Fair ValueGross Unrealized LossesEstimated Fair ValueGross Unrealized LossesEstimated Fair Value
As of December 31, 2023:
U.S. treasury bills$—$25$—$—$—$25
U.S. treasury notes(3)774(64)2,983(67)3,757
Corporate debt securities(1)562(79)3,518(80)4,080
Government debt securities—8(4)143(4)151
Total$(4)$1,369$(147)$6,644$(151)$8,013
As of December 31, 2022:
U.S. treasury securities$—$128$—$—$—$128
U.S. treasury notes(101)3,956(128)3,541(229)7,497
Corporate debt securities(138)3,505(88)1,890(226)5,395
Government debt securities(2)46(7)93(9)139
Total$(241)$7,635$(223)$5,524$(464)$13,159

At December 31, 2023 and 2022, we held 392 and 582 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 conclude that we are more-likely-than-not that 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 tables summarize our financial assets measured at fair value on a recurring basis as of December 31, 2023 and 2022 (in millions):

Fair value at December 31, 2023Fair Value Measurement Using
Level 1Level 2
Assets:
Money market funds$1,572$1,572$—
Certificates of deposit27—27
U.S. treasury bills1,246—1,246
U.S. treasury notes4,343—4,343
Corporate debt securities5,480—5,480
Government debt securities208—208
Equity investments(1)2424—
Derivative instruments4—4
Total$12,904$1,596$11,308
Liabilities:
Derivative instruments$9$—$9
Fair value at December 31, 2022Fair Value Measurement Using
Level 1Level 2
Assets:
Money market funds$1,079$1,079$—
Certificates of deposit188—188
U.S. treasury bills767—767
U.S. treasury notes7,552—7,552
Corporate debt securities6,369—6,369
Government debt securities139—139
Derivative instruments6—6
Total$16,100$1,079$15,021
Liabilities:
Derivative instruments$32$—$32

(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 expense net, in our consolidated statements of operations.

As of December 31, 2023 and 2022, we did not have non-financial assets or liabilities measured at fair value on a recurring basis.

For the year ended December 31, 2023, we recognized net losses of $35 million on equity investments from changes in fair value of the securities. We did not have equity investments in publicly traded securities with readily determinable fair values during 2022 and 2021.

In addition, as of December 31, 2023 and 2022, we had $42 million, at each balance sheet date, in equity investments without readily determinable fair values, which are recorded within other non-current assets in our consolidated balance sheets and excluded from the fair value measurement tables above.

7. Inventory

Inventory, as of December 31, 2023 and 2022 consisted of the following (in millions):

December 31,
20232022
Raw materials$163$575
Work in progress15205
Finished goods24169
Total inventory$202$949
Inventory, non-current(1)$170$910

(1)Consisted of raw materials with an anticipated consumption beyond one year. Inventory, non-current is included in other non-current assets in the 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 consolidated statements of operations. For the years ended December 31, 2023 and 2022, inventory write-downs were $2.2 billion and $1.3 billion, respectively. Inventory write-downs were immaterial for the year ended December 31, 2021. For the years ended December 31, 2023 and 2022, losses on firm purchase commitments were $141 million and $617 million, respectively. There were no such charges in 2021. Inventory write-downs were mainly related to obsolete inventory due to shelf-life expiration and inventory in excess of expected demand. 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. These charges in 2023 were primarily driven by a continued shift in product demand to the latest variant-targeted COVID-19 vaccine and a decline in customer demand as the COVID-19 vaccine market continues to transition to an endemic seasonal market in 2023.

In the third quarter of 2023, we completed our long-range financial planning process, incorporating revised forecasts of vaccination rates. This resulted in the reassessment of future demand for our COVID-19 vaccine, leading to a strategic initiative to resize our manufacturing cost structure. This initiative, launched in the same quarter, involved reassessing our inventory levels and renegotiating with our suppliers to reduce our purchase commitments related to raw materials which were not expected to be consumed before expiration. This initiative resulted in a raw materials write-down of $903 million, included in the total inventory write-down amount for the quarter.

As of December 31, 2023 and December 31, 2022, the accrued liability for losses on firm future purchase commitments in our consolidated balance sheets was $79 million and $268 million, respectively. As of December 31, 2023 and December 31, 2022, we had inventory on hand of $372 million and $1.9 billion, respectively. Our raw materials and work-in-progress inventory had variable shelf lives. We expect that the majority of this inventory will be consumed over the next three years. The shelf life of our COVID-19 vaccine product ranges from nine to twelve months.

8. Property, Plant and Equipment, Net

Property, plant and equipment, net as of December 31, 2023 and 2022 consisted of the following (in millions):

December 31,
20232022
Land and land improvements$22$11
Manufacturing and laboratory equipment345284
Leasehold improvements522460
Furniture and fixtures2621
Computer equipment and software7438
Construction in progress860281
Right-of-use assets, financing (Note 10)5291,581
Total2,3782,676
Less: Accumulated depreciation(433)(658)
Property, plant and equipment, net$1,945$2,018

Depreciation and amortization expense for the years ended December 31, 2023, 2022, and 2021 was $617 million, $348 million, and $232 million, respectively.

9. Other Balance Sheet Components

Accounts Receivable, Net

Accounts receivable, net, as of December 31, 2023 and December 31, 2022 consisted of the following (in millions):

December 31,
20232022
Accounts receivable$1,584$1,385
Less: Wholesalers chargebacks, discounts and fees(692)—
Accounts receivable, net$892$1,385

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets, as of December 31, 2023 and 2022 consisted of the following (in millions):

December 31,
20232022
Prepaid services$182$216
Down payments to manufacturing vendors100229
Down payments for materials and supplies68219
Collaboration receivable6111
Interest receivable5961
Value added tax receivable50140
Income tax receivable1910
Tenant improvement allowance receivable—42
Prepaid income taxes—187
Convertible note receivable—36
Other current assets8844
Prepaid expenses and other current assets$627$1,195

Other Non-Current Assets

Other non-current assets, as of December 31, 2023 and 2022 consisted of the following (in millions):

December 31,
20232022
Down payments and prepayments, non-current$342$—
Inventory, non-current(1)170910
Equity investments6642
Goodwill52—
Finite-lived intangible asset44—
Restricted cash412
Other724
Other non-current assets$685$988

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

Accrued Liabilities

Accrued liabilities, as of December 31, 2023 and 2022 consisted of the following (in millions):

December 31,
20232022
Provisions related to product sales (Note 3)$556$—
Compensation-related245190
Clinical trials175319
Manufacturing167400
Development operations14088
Other external goods and services137264
Royalties122203
Property, plant and equipment945
Loss on future firm purchase commitments(1)79268
Commercial5648
Raw materials27316
Accrued liabilities$1,798$2,101

(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 December 31, 2023 and 2022 consisted of the following (in millions):

December 31,
20232022
Lease liabilities - financing (Note 10)$—$161
Lease liabilities - operating (Note 10)2535
Other4153
Other current liabilities$66$249

Deferred Revenue

The following table summarizes the activities in deferred revenue during the year ended December 31, 2023 (in millions):

December 31, 2022AdditionsDeductionsDecember 31, 2023
Net product sales$2,626$515$(2,528)$613
Grant revenue42(2)4
Collaboration revenue8131(78)34
Total deferred revenue$2,711$548$(2,608)$651

10. Leases

We have entered into various long-term non-cancelable lease arrangements for our facilities and equipment expiring at various times through 2042. Certain of these arrangements have free rent periods or escalating rent payment provisions. We recognize lease cost under such arrangements on a straight-line basis over the life of the leases. We have two main campuses in Massachusetts, our Cambridge campus and our Moderna Technology Center (MTC), located in Norwood. We also lease various parcels of land, office and lab spaces across the globe for our business operations.

Cambridge Campus

We occupy a multi-building campus at Technology Square in Cambridge, Massachusetts with a mix of offices and research laboratory space totaling approximately 292,000 square feet.

In September 2021, we entered into a lease agreement for a building space, approximately 462,000 square feet, in Cambridge, Massachusetts. This space is designated to be the Moderna Science Center (MSC), housing a blend of office space and laboratories. Following an approximately two-year building project, the lease term is 15 years, with options for two additional seven-year extensions. During the third quarter of 2023, we commenced the lease and recognized the related right-of-use asset and lease liability on our consolidated balance sheets. Following the commencement of the MSC lease, we amended the expiration dates of our existing leases at Technology Square in the fourth quarter of 2023. Originally scheduled to expire ranging from 2024 to 2029, these leases have been adjusted to conclude in early 2025. All our Cambridge leases are classified as operating leases.

Moderna Technology Center

We have an industrial technology center in Norwood, Massachusetts, our Moderna Technology Center (MTC), comprised of three buildings, MTC South, MTC North, and MTC East, totaling approximately 686,000 square feet. Our MTC leases expire in 2042 and we have the option to extend the term for three extension periods of five years each. All of our MTC leases are classified as finance leases.

Embedded Leases

We have entered into multiple contract manufacturing service agreements with third parties which contain embedded leases within the scope of ASC 842. In the third quarter of 2023, as part of our strategic initiative to optimize our manufacturing footprint, we amended a contract manufacturing service agreement, resulting in decreases of $262 million in each of the right-of-use assets and lease liabilities. Additionally, it resulted in accelerated depreciation of the right-of-use assets of $323 million for the year ended December 31, 2023. As of December 31, 2023, we had no remaining right-of-use assets or lease liabilities due to embedded leases. As of December 31, 2022, we had right-of-use assets of $639 million and lease liabilities of $440 million related to embedded leases. All of our embedded leases were classified as finance leases.

Operating and financing lease right-of-use assets and lease liabilities as of December 31, 2023 and 2022 were as follows (in millions):

December 31,
20232022
Assets:
Right-of-use assets, operating, net(1) (2)$713$121
Right-of-use assets, financing, net(3) (4)4361,150
Total$1,149$1,271
Liabilities:
Current:
Operating lease liabilities(5)$25$35
Financing lease liabilities(5)—161
Total current lease liabilities25196
Non-current:
Operating lease liabilities, non-current64392
Financing lease liabilities, non-current575912
Total non-current lease liabilities1,2181,004
Total$1,243$1,200

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

(2) Net of accumulated amortization.

(3) These assets are real estate assets related to the MTC leases as well as assets related to contract manufacturing service agreements.

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

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

The components of the lease costs were as follows for the periods presented (in millions):

Years ended December 31,
202320222021
Operating lease costs$88$48$24
Financing lease costs:
Amortization of right-of-use assets, financing leases500280189
Interest expense for financing lease liabilities382917
Total financing lease costs$538$309$206
Short term lease costs$2$—$49
Variable lease costs$113$165$100

Supplemental cash flow information relating to our leases was as follows for the periods presented (in millions):

December 31,
202320222021
Cash paid for amounts included in measurement of lease liabilities:
Operating cash flows used in operating leases$(93)$(57)$(19)
Operating cash flows used in financing leases(39)(25)(14)
Financing cash flows used in financing leases(292)(184)(140)
Operating lease non-cash items:
Changes in right-of-use assets related to lease modifications and reassessments$67$—$(7)
Right-of-use assets obtained in exchange for operating lease liabilities7142072
Finance lease non-cash items:
Changes in right-of-use assets related to lease modifications and reassessments$213$—$674
Right-of-use assets obtained in exchange for financing lease liabilities—777126
Changes in financing lease liabilities343

Weighted average remaining lease terms and discount rates as of December 31, 2023 and 2022 were as follows:

December 31,
20232022
Remaining lease term:
Operating leases14 years6 years
Finance leases33 years22 years
Discount rate:
Operating leases7.5%7.5%
Finance leases4.2%3.6%

Future minimum lease payments under non-cancelable lease agreements as of December 31, 2023, were as follows (in millions):

Fiscal YearOperating LeasesFinancing Leases**(1)**
2024$72$20
20256722
20266722
20277023
20287223
Thereafter7851,074
Total minimum lease payments1,1331,184
Less amounts representing interest(465)(609)
Present value of lease liabilities$668$575

(1) Include certain optional lease term extensions, predominantly related to the MTC leases, which represent a total of $668 million of undiscounted future lease payments.

11. Commitments and Contingencies

Legal Proceedings

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business. 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. We are not currently a party to any legal proceedings for which a material loss is probable, or for which a loss is reasonably estimable at this time.

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 December 31, 2023 and 2022, we had not experienced any significant 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 (CMOs) for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services. As of December 31, 2023, we had $1.8 billion of non-cancelable purchase commitments related to raw materials and manufacturing agreements, which are expected to be paid through 2029. As of December 31, 2023, $79 million of the purchase commitments related to raw materials was recorded as an accrued liability for loss on future firm purchase commitments. As of December 31, 2023, we had $261 million of non-cancelable purchase commitments related to clinical services and other goods and services which are expected to be paid through 2039. These amounts represent our minimum contractual obligations, including termination fees.

In addition to purchase commitments, we have agreements with third parties for various 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. At December 31, 2023, we had cancelable open purchase orders of $3.0 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 at December 31, 2023, 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

In 2017, we entered into sublicense agreements with Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc. to sublicense certain patent rights. Pursuant to each agreement, we are required to pay certain license fees, annual maintenance fees, minimum royalties on future net sales and milestone payments contingent on achievement of certain development, regulatory and commercial milestones for specified products, on a product-by-product basis. Commercial milestone payments and royalties based on annual net sales of licensed products for therapeutic and prophylactic products are accounted for as additional expense of the related net product sales in the period in which the corresponding sales occur.

In December 2022, we entered into a non-exclusive patent license agreement with the National Institute of Allergy and Infectious Diseases (NIAID), an Institute or Center of the National Institutes of Health (NIH) to license certain patent rights concerning

stabilizing prefusion coronavirus spike proteins and the resulting stabilized proteins for use in COVID-19 vaccine products. Pursuant to the agreement, we have agreed to pay low single-digit royalties on future net sales, a minimum annual royalty payment, and certain contingent development, regulatory and commercial milestone payments on a licensed product-by-licensed product basis. In addition, in December 2022, we made a catch-up royalty payment of $400 million to NIAID, which was recorded to cost of sales in our consolidated statements of operations.

In 2023, 2022, and 2021 we recognized $301 million, $1.1 billion, and $641 million, respectively, of royalties and commercial milestone payments associated with our net product sales, which was recorded to cost of sales in our 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 for specified products associated with the agreements. The achievement of these milestones have not yet occurred as of December 31, 2023.

12. Stock-Based Compensation and Share Repurchase Programs

Equity Plans

In connection with our initial public offering (IPO), we adopted the 2018 Stock Option and Incentive Plan (the 2018 Equity Plan) in November 2018. The 2018 Equity Plan became effective on the date immediately prior to the effective date of the IPO and replaced our 2016 Stock Option and Incentive Plan (the 2016 Equity Plan). The 2018 Equity Plan provides flexibility to our compensation committee to use various equity-based incentive awards as compensation tools to motivate our workforce. The shares of common stock underlying any awards that are forfeited, canceled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by us prior to vesting, satisfied without any issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2018 Equity Plan and the 2016 Equity Plan will be added back to the shares of common stock available for issuance under the 2018 Equity Plan.

The Board of Directors may grant to employees, nonemployee directors, consultants and independent advisors equity-based awards during their period of service, generally in the form of stock options, restricted stock units, and performance stock units. The terms and conditions of stock-based awards are defined at the sole discretion of our Board of Directors. We issue service-based awards, vesting over a defined period of service, and performance-based awards, vesting upon achievement of defined conditions. Service based awards generally vest over a four-year period, with the first 25% of such awards vesting following twelve months of continued employment or service. The remaining awards vest in twelve quarterly installments over the following twelve quarters. Stock options granted under the 2018 Equity Plan and the 2016 Equity Plan expire ten years from the date of grant and the exercise price must be at least equal to the fair market value of common stock on the grant date.

As of December 31, 2023, we had a total of 47 million shares reserved for future issuance under our Equity Plans, of which 31 million shares were reserved for equity awards previously granted, and 16 million shares were available for future grants under the 2018 Equity Plan. No additional awards will be granted under the 2016 Equity Plan as it was replaced by the 2018 Equity Plan.

Options

We have granted options generally through the 2018 Equity Plan and 2016 Equity Plan. The following table summarizes our option activity during the year ended December 31, 2023:

Number of Options (in millions)Weighted Average Exercise Price per ShareWeighted- Average Remaining Contractual TermAggregate Intrinsic Value**(1)** (in millions)
Outstanding at December 31, 202224.93$42.235.7 years$3,478
Granted4.36113.03
Exercised(3.11)8.13
Canceled/forfeited(0.68)130.23
Outstanding at December 31, 202325.5056.145.6 years1,437
Exercisable at December 31, 202318.9833.344.5 years1,378
Expected to vest at December 31, 20236.52122.508.9 years59

(1)Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of common stock for those options in the money as of December 31, 2023.

The total intrinsic value of options exercised was $413 million, $714 million, and $1.6 billion for the years ended December 31, 2023, 2022, and 2021, respectively. The aggregate intrinsic value represents the difference between the exercise price and the selling price received by option holders upon the exercise of stock options during the period. The excess tax benefits realized from tax deductions from option exercises were $84 million, $144 million, and $325 million during the years ended December 31, 2023, 2022, and 2021 respectively. The total consideration recorded as a result of stock option exercises was approximately $25 million, $50 million, and $112 million for the years ended December 31, 2023, 2022, and 2021.

Restricted Common Stock Units (RSUs) and Performance Stock Units (PSUs)

We have granted RSUs and PSUs generally through the 2018 Equity Plan. The following table summarizes our RSU and PSU activity during the year ended December 31, 2023:

Number of Units (in millions)Weighted Average Grant Date Fair Value per Unit
Outstanding, non-vested at December 31, 20222.90$132.25
Issued3.71107.23
Vested(1.01)98.68
Canceled/forfeited(0.42)130.01
Outstanding, non-vested at December 31, 20235.18121.02

The total grant date fair value of RSUs and PSUs vested during the years ended December 31, 2023, 2022, and 2021, was $99 million, $55 million, and $18 million, respectively. The total intrinsic value of RSUs and PSUs vested during the years ended December 31, 2023, 2022, and 2021, was $120 million, $125 million and $141 million, respectively.

During 2023, 2022 and 2021, we granted an immaterial amount of PSUs, respectively, primarily to certain senior executives with vesting that is contingent upon the achievement of specified preestablished goals over the performance period, generally three years. The actual number of common shares ultimately issued is calculated by multiplying the number of PSUs by a payout percentage ranging from 0% to 200%. The estimated fair value of PSUs is based on the grant date fair value.

Valuation and Stock-Based Compensation Expense

Stock-based compensation for options granted under our Equity Plans is determined using the Black-Scholes option pricing model. The weighted-average assumptions used to estimate the fair value of options granted for the years ended December 31, 2023, 2022, and 2021 were as follows:

Weighted Average
Years Ended December 31,
202320222021
Options:
Risk-free interest rate4.13%2.46%0.84%
Expected term6.07 years6.13 years6.10 years
Expected volatility48%50%46%
Expected dividends—%—%—%
Weighted average fair value per share$57.87$76.02$91.84

Stock-Based Compensation Expense

The following table presents the components and classification of stock-based compensation expense for the years ended December 31, 2023, 2022, and 2021 (in millions):

Years Ended December 31,
202320222021
Options$136$123$96
RSUs and PSUs1619742
Employee stock purchase plan864
Total$305$226$142
Cost of sales$37$45$22
Research and development1579368
Selling, general and administrative1118852
Total$305$226$142

For the years ended December 31, 2023, 2022, and 2021, we recognized stock-based compensation expense of $17 million, $18 million, and $16 million, respectively, related to performance-based awards, including awards with vesting or commencement contingent upon our IPO. Stock-based compensation expenses related to non-employee awards were immaterial for the years ended December 31, 2023, 2022, and 2021.

As of December 31, 2023, there were $835 million of total unrecognized compensation cost related to non-vested stock-based compensation with respect to options, RSUs and PSUs granted. That cost is expected to be recognized over a weighted-average period of 2.6 years at December 31, 2023.

Share Repurchase Programs

On August 2, 2021, our Board of Directors authorized a Share Repurchase Program (2021 Repurchase Program) of our common stock, with an expiration date no later than August 2, 2023. Pursuant to the 2021 Repurchase Program, we were authorized to repurchase up to $1.0 billion of our outstanding common stock. By the end of January 2022, we had repurchased the entire $1.0 billion of common stock that was authorized under the 2021 Repurchase Program. On February 22, 2022, our Board of Directors authorized an additional share repurchase program of our common stock, with no expiration date, for up to $3.0 billion. On August 1, 2022, our Board of Directors authorized an increase of $3.0 billion under the repurchase program for our common stock, with no expiration date (collectively with the February 22, 2022 authorization, the 2022 Repurchase Programs).

As of December 31, 2023, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remains outstanding (the 2022 Repurchase Programs), with no expiration date. The timing and actual number of shares repurchased under the 2022 Repurchase Programs will depend on a variety of factors, including price, general business and market conditions, and other investment opportunities, and shares may be repurchased through open market purchases through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended.

The following table summarizes activity related to our share repurchase programs (in millions, except per share data):

Years Ended December 31,
202320222021
Number of shares repurchased8233
Average price per share(1)$143.26$142.83$245.76
Aggregate purchase price$1,153$3,329$857
Remaining authorization at end of period$1,667$2,814$143

(1)Average price paid per share includes related expenses and excise tax, applicable beginning January 1, 2023.

13. Income Taxes

(Loss) income before income taxes for the years ended December 31, 2023, 2022, and 2021 consisted of the following (in millions):

Years Ended December 31,
202320222021
United States$(4,056)$9,433$13,108
Foreign114142177
(Loss) income before income taxes$(3,942)$9,575$13,285

The provision for income taxes for the years ended December 31, 2023, 2022, and 2021 consisted of the following components (in millions):

Years Ended December 31,
202320222021
Current:
Federal$(225)$1,687$1,304
State724735
Foreign245740
Total current$(129)$1,791$1,379
Deferred:
Federal$888$(569)$(288)
State8(7)(6)
Foreign5(2)(2)
Total deferred901(578)(296)
Total provision for income taxes$772$1,213$1,083

The reconciliation of the federal statutory income tax rate to our effective tax rate for the years ended December 31, 2023, 2022, and 2021 was as follows:

Years Ended December 31,
202320222021
Federal statutory tax rate21.0%21.0%21.0%
Change in valuation allowance(52.6)%—%(5.4)%
Foreign-derived intangible income0.2%(7.4)%(4.8)%
Stock-based compensation windfall2.4%(1.6)%(2.6)%
Federal research and development credits4.6%(0.5)%(0.7)%
State taxes, net of federal benefits5.7%0.4%0.5%
Non-deductible items(0.4)%—%—%
Other(0.5)%0.8%0.1%
Effective tax rate(19.6)%12.7%8.1%

Our effective tax rate for the year ended December 31, 2023 was (19.6)% and was higher than the federal statutory tax rate, primarily due to an increase in valuation allowance against deferred tax assets. The effective tax rates for the year ended December 31, 2023 also include tax benefits from research and development credits and stock-based compensation. Our effective tax rate for the year ended December 31, 2022 was lower than the federal statutory tax rate, primarily due to the tax benefit of the foreign-derived intangible income deduction (FDII) and excess tax benefit related to stock-based compensation. Our effective tax rate for the year ended December 31, 2021 was lower than the federal statutory tax rate, primarily due to the tax benefits related to the release of the valuation allowance on most of our deferred tax assets, FDII and stock-based compensation.

As of January 1, 2022, pursuant to the Tax Cuts and Jobs Act of 2017 (“TCJA”), research and development costs in the current period are required to be amortized over five or fifteen years, depending on where the research is conducted. The new capitalization requirement significantly increased our deferred tax assets and cash tax liabilities, but also decreased our effective tax rate by increasing the foreign-derived intangible income deduction.

The President signed into law the Inflation Reduction Act (the “IRA”) on August 16, 2022. The Act includes a new 15% corporate minimum tax and a 1% excise tax on the value of corporate stock repurchases, net of new share issuances, after December 31, 2022. We do not expect these provisions to have a material impact on our consolidated financial position; however, we will continue to evaluate their impact as further information becomes available.

Deferred income taxes reflect the tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes, tax credit carryforwards and the tax effect of net operating loss carryforwards. Significant components of our deferred tax assets and tax liabilities as of December 31, 2023 and 2022 were as follows (in millions):

December 31,
20232022
Deferred tax assets:
Net operating loss carryforwards$90$59
Stock-based compensation11168
Capitalized licenses, research and development and start-up costs1,449704
Tax credit carryforwards14097
Operating lease liabilities15426
Financing lease liabilities139135
Other comprehensive income34106
Inventory reserve and capitalization25086
Wholesaler chargebacks, discounts and fees92—
Returns and other fees129—
Other9085
Total deferred tax assets2,6781,366
Less: valuation allowance(2,224)(155)
Net deferred tax assets$454$1,211
Deferred tax liabilities:
Right-of-use assets, financing$(106)$(117)
Right-of-use assets, operating(160)(26)
Property, plant and equipment(107)(85)
Other(15)(1)
Total deferred tax liabilities(388)(229)
Net deferred tax (liabilities) assets$66$982

The table below summarizes changes in the valuation allowance for deferred tax assets for the periods presented (in millions):

Years Ended December 31,
202320222021
Valuation allowance at beginning of the period$155$149$823
Decreases recorded as benefit to income tax provision—(12)(722)
Increases to valuation allowance2,0691848
Valuation allowance at December 31$2,224$155$149

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. During 2023, following the completion of our long-range financial planning process, we reassessed the evidence and concluded that a valuation allowance was necessary due to the preponderance of negative evidence, including:

  • A pre-tax loss for the full year 2023, serving as a significant source of objectively verifiable negative evidence in accordance with ASC 740 (Income Taxes).

  • A projected three-year cumulative loss resulting from our long-range financial planning process. This projection is due to a significant decrease in expected sales of our COVID-19 vaccine as we transition to a seasonal market. Additionally, we anticipate substantial research and development expenses for our on-going Phase 3 clinical trials and to advance our product candidates into later-stage development. These factors contribute additional negative evidence with respect to the realizability of our deferred tax assets. The projections are based upon revenue from our currently approved drug product, which we believe can be reasonably estimated. In contrast, future taxable income projections from our investigational medicines are deemed inherently subjective and not objectively verifiable; they are insufficient to override negative evidence, and therefore, they are not assigned any weight in our valuation allowance analysis assessment.

Our evaluation also included whether there were other sources of taxable income that would allow us to realize our deferred tax assets, such as taxable income in carryback years, available tax planning strategies and the future reversals of taxable temporary differences. After assessing these strategies and all evidence, we determined it was more likely than not that we will not realize all of our deferred tax assets and therefore increased the valuation allowance by $2.1 billion during 2023.

In the first quarter of 2021, we reassessed the valuation allowance noting the increase in positive evidence, including significant revenue growth, expectations regarding future profitability, and successful supply chain and manufacturing capabilities to meet global product demand. After assessing both the positive evidence and negative evidence, we determined it was more likely than not that we would realize the majority of our deferred tax assets, and we released the valuation allowance on the majority of our deferred tax assets, accordingly. The release of the valuation allowance was based on the then-prevailing positive outlook, which has since shifted significantly by 2023 due to the factors outlined above, leading to the reinstatement of a full valuation allowance.

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.

At December 31, 2023, we had $1.6 billion of state net operating loss carryforwards, which begin to expire in 2030. At December 31, 2023, we also had state research and development tax credit carryforwards of $178 million, the majority of which will begin to expire in 2030.

We recognize, in our financial statements, the effect of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. A reconciliation of the beginning and ending amounts of unrecognized tax benefits during the years ended December 31, 2023, 2022, and 2021 were as follows (in millions):

Years Ended December 31,
202320222021
Unrecognized tax benefits at beginning of the period$128$68$—
Decrease due to prior positions:
Tax positions for prior years—(1)—
Expiration of statutes———
Settlements with tax authorities(27)——
Increase due to current year tax positions:
Additions based on tax positions for current year445754
Additions based on tax positions for prior years86414
Unrecognized tax benefits at end of the period$231$128$68

As of December 31, 2023, we had $231 million of net unrecognized tax benefits, which would affect our tax rate if recognized. Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business. We do not anticipate a material change to our unrecognized tax benefits over the next twelve months that would have an adverse effect on our consolidated operating results. We recognize interest and penalties, if applicable, related to uncertain tax positions as a component of income tax expense.

We file U.S. federal income tax returns and income tax returns in various state, local and foreign jurisdictions. All tax years since our date of incorporation remain open to examination by the major taxing jurisdictions, as carryforward attributes generated in past years may be adjusted upon examination by the Internal Revenue Service or the state authorities. There are no open tax examinations at this time.

14. (Loss) Earnings 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 outstanding during the period as determined by using the treasury stock method.

Basic and diluted EPS for the years ended December 31, 2023, 2022 and 2021 were calculated as follows (in millions, except per share data):

Years Ended December 31,
202320222021
Numerator:
Net (loss) income$(4,714)$8,362$12,202
Denominator:
Basic weighted-average common shares outstanding382394403
Effect of dilutive securities—2228
Diluted weighted-average common shares outstanding382416431
Basic EPS$(12.33)$21.26$30.31
Diluted EPS$(12.33)$20.12$28.29

The following common stock equivalents, presented based on amounts outstanding as of December 31, 2023, 2022 and 2021, were excluded from the calculation of diluted net (loss) income per share attributable to common stockholders for the periods indicated because their inclusion would have been anti-dilutive (in millions):

December 31,
202320222021
Options2631
RSUs and PSUs5——
Total3131

15. Geographic Information

Geographic Revenue

We operate in one reporting segment that primarily focuses on the discovery, development and commercialization of mRNA medicines. Our chief executive officer manages our operations and evaluates our financial performance on a consolidated basis. Most of our principal operations, other than manufacturing, and our decision-making functions are located at our corporate headquarters in the United States.

Total revenue by geographic area of our customers and collaboration partners was as follows (in millions):

Years Ended December 31,
202320222021
United States$1,895$5,150$6,177
Europe1,3556,8156,846
Rest of world3,5987,2985,448
Total$6,848$19,263$18,471

Our property, plant and equipment, including financing right-of-use assets, by geographic area was as follows (in millions):

December 31,
20232022
United States$1,560$1,267
Europe126714
Rest of world25937
Total$1,945$2,018

Previous: Item 7A. Quantitative and Qualitative Disclosures about Market Risk · Next: Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure