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Moderna Inc

For the period ended Mar 31, 2024. Filed May 2, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 2, 2024

MRNA$269.00+5.8%Stored close · as of Nov 9, 2026

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Notes to Condensed Consolidated Financial Statements

(Unaudited)

  1. Description of the Business

Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our or the Company) is a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing 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 40 development candidates across our 47 development programs, of which 43 are in clinical studies currently.

  1. Summary of Basis of Presentation and Recent Accounting Standards

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2023 (2023 Form 10-K). Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the Accounting Standard Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). This report should be read in conjunction with the audited consolidated financial statements in our 2023 Form 10-K.

The condensed consolidated financial statements include Moderna, Inc. and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The significant accounting policies used in the preparation of these condensed consolidated financial statements for the three months ended March 31, 2024 are consistent with those described in our 2023 Form 10-K. The only exception pertains to the policy related to research and development funding. We entered into a research and development funding arrangement in the first quarter of 2024. Please refer to Note 5 for further details regarding this policy. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the operating results to be expected for the full fiscal year or future operating periods. We anticipate seasonal fluctuations in demand for our COVID-19 vaccine, with higher sales expected during the fall and winter seasons.

Use of Estimates

We have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes. We base our estimates on historical experience and various relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods that are not readily apparent from other sources. Changes in our estimates are recorded in the financial results of the period in which the new information becomes available. The actual results that we experience may differ materially from our estimates.

Comprehensive Income (Loss)

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

The components of accumulated other comprehensive loss for the three months ended March 31, 2024 were as follows (in millions):

Unrealized Gains on Available-for-Sale Debt SecuritiesPension and Postretirement BenefitsTotal
Accumulated other comprehensive loss, balance at December 31, 2023$(114)$(9)$(123)
Other comprehensive income22—22
Accumulated other comprehensive loss, balance at March 31, 2024$(92)$(9)$(101)

Restricted Cash

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

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

March 31,
20242023
Cash and cash equivalents$2,051$3,441
Restricted cash(1)17—
Restricted cash, non-current(2)320
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows$2,071$3,461

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

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

Recently Issued Accounting Standards 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 condensed 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 statement 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. We are currently assessing the impact that this new accounting standard will have on our consolidated financial statement disclosures.

  1. Net Product Sales

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

Three Months Ended March 31,
20242023
United States$100$1
Europe—576
Rest of world671,251
Total$167$1,828

As of March 31, 2024, 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 international 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 March 31, 2024 and December 31, 2023, we had deferred revenue of $580 million and $613 million, respectively, related to customer deposits for our COVID-19 vaccine. We expect $522 million of our deferred revenue related to customer deposits as of March 31, 2024 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 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 international 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):

Three Months Ended March 31,
20242023
Gross product sales$222$1,828
Product sales provision:
Wholesaler chargebacks, discounts and fees(22)—
Returns and other fees(33)—
Total product sales provision$(55)$—
Net product sales$167$1,828

The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the three months ended March 31, 2024(in millions):

Returns and other fees
Balance at December 31, 2023$(556)
Provision related to sales made in current period(33)
Payments and returns related to sales made in prior periods15
Balance at March 31, 2024$(574)
  1. Other Revenue

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

Three Months Ended March 31,
20242023
Grant revenue$—$24
Collaboration revenue—10
Total other revenue$—$34

Grant revenue and collaboration revenue were immaterial for the three months ended March 31, 2024.

Grant Revenue

In April 2020, we entered into an agreement with the 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. The agreement has been subsequently amended to provide for additional commitments to support various late-stage clinical development efforts of our original COVID-19 vaccine, 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 March 31, 2024, the remaining available funding, net of revenue earned was $101 million.

  1. Collaboration Agreements and Research and Development Funding Arrangement

Merck

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, or INT) with Merck. This agreement was subsequently amended and restated in 2018. Our role in this strategic alliance involves identifying genetic mutations in a particular patient’s tumor cells, synthesizing mRNA for these mutations, encapsulating the mRNA in one of our proprietary lipid nanoparticles (LNPs), and administering a unique mRNA INT to each patient. Each INT is designed to specifically activate the patient’s immune system against her or his own cancer cells.

In September 2022, Merck exercised its option for INT, including mRNA-4157, pursuant to the terms of the agreement and in October 2022 paid us an option exercise fee of $250 million. Following this exercise, the Merck Participation Term commenced. Pursuant to the agreement, we and Merck have agreed to collaborate on further development and commercialization of INT, with costs and any profits or losses to be shared equally on a worldwide basis.

For the three months ended March 31, 2024 and 2023, we recognized expenses of $76 million and$19 million, respectively, net of Merck's reimbursements, related to the INT collaboration under the Merck Participation Term. Additionally, for the three months ended March 31, 2024 and 2023, the net cost recovery for capital expenditures was$24 million and$6 million, respectively, which was applied to reduce the capitalized cost of the asset.

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

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

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

Given the substantive transfer of financial risk to Blackstone, we account for this arrangement as an obligation to conduct research and development activities. The funding will be recognized as a reduction to the expenses of our mRNA-based influenza program. This reduction will be recognized proportionally as the related costs are incurred, based on an input method. No expense reduction associated with this arrangement was recorded in the first quarter of 2024.

  1. Financial Instruments

Cash and Cash Equivalents and Investments

The following tables summarize our cash and available-for-sale securities by significant investment category as of March 31, 2024 and December 31, 2023 (in millions):

AmortizedCostUnrealizedGainsUnrealizedLossesEstimated Fair ValueCash andCashEquivalentsCurrentMarketableSecuritiesNon-CurrentMarketableSecurities
Cash and cash equivalents$2,051$—$—$2,051$2,051$—$—
Available-for-sale:
Certificates of deposit75——75—75—
U.S. treasury bills1,157——1,157—1,157—
U.S. treasury notes3,8731(56)3,818—2,4451,373
Corporate debt securities4,9012(65)4,838—2,6392,199
Government debt securities226—(4)222—15666
Total$12,283$3$(125)$12,161$2,051$6,472$3,638
AmortizedCostUnrealizedGainsUnrealizedLossesEstimated Fair ValueCash andCashEquivalentsCurrentMarketableSecuritiesNon-CurrentMarketableSecurities
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

The amortized cost and estimated fair value of available-for-sale securities by contractual maturity as of March 31, 2024 and December 31, 2023 were as follows (in millions):

AmortizedCostEstimatedFair Value
Due in one year or less$6,536$6,472
Due after one year through five years3,6963,638
Total$10,232$10,110
AmortizedCostEstimatedFair 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

In accordance with our investment policy, we place investments in investment grade securities with high credit quality issuers, and generally limit the amount of credit exposure to any one issuer. We evaluate securities for impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation. Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and our intent and ability to hold the investment to allow for an anticipated recovery in fair value. Any impairment that is not credit related is recognized in other comprehensive income (loss), net of applicable taxes. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. We didnot recognize any impairment charges related to available-for-sale securities for the three months ended March 31, 2024 and 2023. We didnot record any credit-related allowance to available-for-sale securities as of March 31, 2024 and December 31, 2023.

The following table summarizes the amount of gross unrealized losses and the estimated fair value for our available-for-sale securities in an unrealized loss position by the length of time the securities have been in an unrealized loss position as of March 31, 2024 and December 31, 2023 (in millions):

Less than 12 Months12 Months or MoreTotal
Gross Unrealized LossesEstimated Fair ValueGross Unrealized LossesEstimated Fair ValueGross Unrealized LossesEstimated Fair Value
As of March 31, 2024:
U.S. treasury bills$—$947$—$—$—$947
U.S. treasury notes(7)1,603(49)2,025(56)3,628
Corporate debt securities(4)1,068(62)2,929(66)3,997
Government debt securities—51(3)145(3)196
Total$(11)$3,669$(114)$5,099$(125)$8,768
As of December 31, 2023:
U.S. treasury bills$—$25$—$—$—$25
U.S. treasury notes(3)774(64)2,983(67)3,757
Corporate debt securities(1)562(79)3,518(80)4,080
Government debt securities—8(4)143(4)151
Total$(4)$1,369$(147)$6,644$(151)$8,013

As of March 31, 2024 and December 31, 2023, we held 395 and 392 available-for-sale securities, respectively, out of our total investment portfolio that were in a continuous unrealized loss position. We neither intend to sell these investments, nor do we believe that we are more-likely-than-not to conclude we will have to sell them before recovery of their carrying values. We also believe that we will be able to collect both principal and interest amounts due to us at maturity.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

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

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

The following tables summarize our financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2024 and December 31, 2023 (in millions):

Fair value at March 31, 2024 · Fair Value Measurement Using
Level 1 · Level 2
Assets:
Money market funds$709$709$—
Certificates of deposit75—75
U.S. treasury bills2,158—2,158
U.S. treasury notes3,818—3,818
Corporate debt securities5,072—5,072
Government debt securities222—222
Equity investments(1)5353—
Derivative instruments3—3
Total$12,110$762$11,348
Fair value at December 31, 2023 · Fair Value Measurement Using
Level 1 · Level 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

(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 condensed consolidated statements of operations.

As of March 31, 2024 and December 31, 2023, we did not have non-financial assets or liabilities measured at fair value on a recurring basis and did not have any Level 3 financial assets or financial liabilities.

For the three months ended March 31, 2024 and 2023, we recognized net losses of $13 million and $18 million on equity investments from changes in fair value of the securities.

In addition, as of December 31, 2023, we had $42 million in equity investments without readily determinable fair values, which were recorded within other non-current assets in our condensed consolidated balance sheets and excluded from the fair value measurement tables above. These investments became publicly traded during the first quarter of 2024 and were recorded at their quoted market price in our condensed consolidated balance sheets as of March 31, 2024.

  1. Inventory

Inventory as of March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Raw materials$215$163
Work in progress6015
Finished goods2024
Total inventory$295$202
Inventory, non-current(1)$145$170

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

Inventory write-downs as a result of excess, obsolescence, scrap or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our condensed consolidated statements of operations. For the three months ended March 31, 2024 and 2023, inventory write-downs were $30 million and $148 million, respectively. For the three months ended March 31, 2024, there wereno losses on firm purchase commitments. For the three months ended March 31, 2023, losses on firm purchase commitments were $66 million. 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.

As of March 31, 2024 and December 31, 2023, the accrued liability for losses on firm future purchase commitments in our condensed consolidated balance sheets was $24 million and $79 million, respectively. As of March 31, 2024 and December 31, 2023, we had inventory on hand of $440 million and $372 million, respectively. Our raw materials and work-in-progress inventory have variable shelf lives. We expect that the majority of this inventory will be consumed over the next three years. The shelf life of our COVID-19 vaccine product ranges from nine to twelve months.

  1. Property, Plant and Equipment, Net

Property, plant and equipment, net, as of March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Land and land improvements$32$22
Manufacturing and laboratory equipment355345
Leasehold improvements642522
Furniture, fixtures and other3226
Computer equipment and software7374
Construction in progress865860
Right-of-use assets, financing (Note 10)529529
Total2,5282,378
Less: Accumulated depreciation(465)(433)
Property, plant and equipment, net$2,063$1,945

Depreciation and amortization expense for three months ended March 31, 2024 and 2023 was $35 million and $78 million, respectively.

  1. Other Balance Sheet Components

Accounts Receivable, net

Accounts receivable, net, as of March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Accounts receivable$422$1,584
Less: Wholesalers chargebacks, discounts and fees(285)(692)
Accounts receivable, net$137$892

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets, as of March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Prepaid services$204$182
Down payments and prepayments related to manufacturing and materials123168
Income tax receivable9319
Interest receivable6259
Collaboration receivable5961
Value added tax receivable3650
Other current assets6888
Prepaid expenses and other current assets$645$627

Other Non-Current Assets

Other non-current assets, as of March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Down payments and prepayments, non-current$322$342
Inventory, non-current(1)145170
Equity investments5366
Goodwill5252
Finite-lived intangible asset4344
Other3511
Other non-current assets$650$685

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

Accrued Liabilities

Accrued liabilities, as of March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Provisions related to product sales (Note 3)$574$556
Development operations141140
Clinical trials136175
Other external goods and services135137
Manufacturing112167
Compensation-related95245
Property, plant and equipment9594
Commercial4056
Raw materials3627
Loss on future firm purchase commitments(1)2479
Royalties8122
Accrued liabilities$1,396$1,798

(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 March 31, 2024 and December 31, 2023 consisted of the following (in millions):

March 31,December 31,
20242023
Lease liabilities - operating (Note 10)$25$25
Estimated reimbursements to wholesalers and distributors119—
Other4641
Other current liabilities$190$66

Deferred Revenue

The following table summarizes the activities in deferred revenue for thethree months ended March 31, 2024 (inmillions):

December 31, 2023AdditionsDeductionsMarch 31, 2024
Product sales$613$14$(47)$580
Grant revenue4——4
Collaboration revenue343(4)33
Total deferred revenue$651$17$(51)$617
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.