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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM10-Q
(Mark One)
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2022
OR
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _ to _
Commission File Number: 001-38753

mrna-20220930_g1.jpg

Moderna, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware81-3467528
(State or Other Jurisdiction of Incorporation or Organization)(IRS Employer Identification No.)
200 Technology Square
Cambridge,Massachusetts02139
(Address of Principal Executive Offices)(Zip Code)
(617) 714-6500
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading symbol(s)Name of each exchange on which registered
Common stock, par value $0.0001 per shareMRNAThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes     No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer o
Non-accelerated filer o
Smaller reporting company
Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes No

As of October 31, 2022, there were 384,180,469 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.



SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (Form 10-Q) contains express or implied forward-looking statements. All statements other than those of historical facts contained in this Form 10-Q are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements in this Form 10-Q include, but are not limited to, statements about:

our activities with respect to our COVID-19 vaccines, and our plans and expectations regarding future generations of our COVID-19 vaccines, including boosters, that we may develop in response to variants of the SARS-CoV-2 virus, ongoing clinical development, manufacturing and supply, pricing, commercialization, regulatory matters (including dosage for vaccines and authorization or approval for boosters), demand for COVID-19 vaccines, and third-party and governmental arrangements and potential arrangements;

timing of product sales of our Omicron-targeting bivalent booster vaccines against COVID-19;

our ability to contract with third-party suppliers, distributors and manufacturers and their ability to perform adequately, particularly with respect to the timely production, release and delivery of our COVID-19 vaccines, including variant-specific booster vaccines;

our ability and the ability of third parties with whom we contract to successfully manufacture our commercial products at scale, as well as drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical and clinical use;
internal and external costs associated with manufacturing for our products, including our COVID-19 vaccines, as well as costs associated with winding down or terminating relationships or agreements with third-party manufacturers or suppliers in connection with the production of our COVID-19 vaccines;

the scope of protection we are able to establish and maintain for intellectual property rights covering our commercial products, investigational medicines and technology;
the initiation, timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work and the period during which the results of the trials will become available;

the direct or indirect impact of COVID-19 or any future large-scale adverse health event, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses, initiation or continuation of treatment for diseases that may be addressed by our development candidates and investigational medicines, or in patient enrollment in clinical trials, potential clinical trials, regulatory review or supply chain disruptions, and other potential impacts to our business, the effectiveness or timeliness of steps taken by us to mitigate the impact of COVID-19, and our ability to execute business continuity plans to address disruptions caused by COVID-19 or any future large-scale adverse health event;

our anticipated next steps for our development candidates and investigational medicines that may be slowed down due to the impact of COVID-19, including our resources being significantly diverted towards our COVID-19 vaccine efforts;

our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop development candidates and investigational medicines, including by applying learnings from one program to our other programs and from one modality to our other modalities;

our ability to obtain and maintain regulatory approval of our investigational medicines;

our ability to commercialize our COVID-19 vaccines and any other products, if approved;

the pricing and reimbursement of our medicines, if approved;

the implementation of our business model, and strategic plans for our business, investigational medicines, and technology;

estimates of our future expenses, revenues and capital requirements;

the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory, and commercialization expertise;




future agreements with third parties in connection with the commercialization of our investigational medicines, if approved;

the size and growth potential of the markets for our investigational medicines, and our ability to serve those markets;

our financial performance;

the rate and degree of market acceptance of our investigational medicines;

our ability to produce our products or investigational medicines with advantages in turnaround times or manufacturing cost; and

developments relating to our competitors and our industry.

Forward-looking statements often contain words such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our operational or financial performance, and involve risks, uncertainties, and other factors that may cause our actual results to differ materially from any future results expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section entitled “Risk Factors” and elsewhere in this Form 10-Q. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual results could differ materially from those expressed or implied by the forward-looking statements.

The forward-looking statements in this Form 10-Q represent our views as of the date of this Form 10-Q. We undertake no obligation to update any forward-looking statements, except as required by applicable securities law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Form 10-Q. However, any further disclosures made on related subjects in our subsequent reports filed with the Securities and Exchange Commission should be consulted.

TRADEMARKS

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

NOTE REGARDING COMPANY REFERENCES

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

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



Table of Contents

PART I.
Page
Item 1.
Item 2.
Item 3.
Item 4.
PART II.
Item 1.
Item 1A.
Item 2.
Item 6.


Item 1. Financial Statements

MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions, except per share data)
September 30,December 31,
20222021
Assets
Current assets:
Cash and cash equivalents
$3,027 $6,848 
Investments
5,321 3,879 
Accounts receivable
2,695 3,175 
Inventory2,077 1,441 
Prepaid expenses and other current assets
1,177 728 
Total current assets
14,297 16,071 
Investments, non-current
8,655 6,843 
Property and equipment, net
2,019 1,241 
Right-of-use assets, operating leases113 142 
Restricted cash, non-current
14 12 
Deferred tax assets920 326 
Other non-current assets
38 34 
Total assets
$26,056 $24,669 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$330 $302 
Accrued liabilities
1,856 1,472 
Deferred revenue
4,002 6,253 
Income taxes payable66 876 
Other current liabilities
553 225 
Total current liabilities
6,807 9,128 
Deferred revenue, non-current
175 615 
Operating lease liabilities, non-current79 106 
Financing lease liabilities, non-current922 599 
Other non-current liabilities
81 76 
Total liabilities8,064 10,524 
Commitments and contingencies (Note 12)
Stockholders’ equity:
Preferred stock, par value $0.0001; 162 shares authorized as of September 30, 2022 and December 31, 2021; no shares issued or outstanding at September 30, 2022 and December 31, 2021
  
Common stock, par value $0.0001; 1,600 shares authorized as of September 30, 2022 and December 31, 2021; 387 and 403 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
  
Additional paid-in capital
1,488 4,211 
Accumulated other comprehensive loss(351)(24)
Retained earnings16,855 9,958 
Total stockholders’ equity
17,992 14,145 
Total liabilities and stockholders’ equity
$26,056 $24,669 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5

MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(Unaudited, in millions, except per share data)
Three Months Ended September 30,Nine Months Ended September 30,
2022202120222021
Revenue:
Product sales$3,120 $4,810 $13,576 $10,740 
Grant revenue144 140 453 473 
Collaboration revenue100 19 150 47 
Total revenue3,364 4,969 14,179 11,260 
Operating expenses:
Cost of sales1,100 722 3,498 1,665 
Research and development820 521 2,084 1,343 
Selling, general and administrative278 168 757 366 
Total operating expenses2,198 1,411 6,339 3,374 
Income from operations1,166 3,558 7,840 7,886 
Interest income58 4 113 11 
Other expense, net(7)(10)(33)(22)
Income before income taxes1,217 3,552 7,920 7,875 
Provision for income taxes174 219 1,023 541 
Net income$1,043 $3,333 $6,897 $7,334 
Earnings per share:
Basic$2.67 $8.27 $17.41 $18.25 
Diluted $2.53 $7.70 $16.46 $17.00 
Weighted average common shares used in calculation of earnings per share:
Basic390 404 396 402 
Diluted412 434 419 431 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6

MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited, in millions)

Three Months Ended September 30,Nine Months Ended September 30,
2022202120222021
Net income$1,043 $3,333 $6,897 $7,334 
Other comprehensive (loss) income, net of tax:
Available-for-sales securities:
Unrealized losses on available-for-sale debt securities(126)(3)(384)(10)
Less: net realized losses (gains) on available-for-sale securities reclassified in net income 3 (1)18 (2)
Net decrease from available-for-sale debt securities(123)(4)(366)(12)
Cash flow hedges:
Unrealized gains on derivative instruments62 30 133 51 
Less: net realized (gains) on derivative instruments reclassified in net income(50)(11)(94)(11)
Net increase from derivatives designated as hedging instruments12 19 39 40 
Total other comprehensive (loss) income(111)15 (327)28 
Comprehensive income $932 $3,348 $6,570 $7,362 


The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7

MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021
(Unaudited, in millions)

Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive LossRetained EarningsTotal Stockholders’ Equity
SharesAmount
Balance at June 30, 2022392 $ $2,413 $(240)$15,812 $17,985 
Vesting of restricted common stock units1 — — — — — 
Exercise of options to purchase common stock1 — 11 — — 11 
Stock-based compensation— — 70 — — 70 
Other comprehensive loss, net of tax— — — (111)— (111)
Repurchase of common stock(7)— (1,006)— — (1,006)
Net income— — — — 1,043 1,043 
Balance at September 30, 2022387 $ $1,488 $(351)$16,855 $17,992 


Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive IncomeRetained EarningsTotal Stockholders’ Equity
SharesAmount
Balance at June 30, 2021403 $ $4,931 $16 $1,757 $6,704 
Exercise of options to purchase common stock2 — 32 — — 32 
Stock-based compensation— — 40 — — 40 
Other comprehensive income, net of tax— — — 15 — 15 
Net income— — — — 3,333 3,333 
Balance at September 30, 2021405 $ $5,003 $31 $5,090 $10,124 

8






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 stock units1 — — — — — 
Exercise of options to purchase common stock3 — 31 — — 31 
Purchase of common stock under employee stock purchase plan— — 9 — — 9 
Stock-based compensation— — 164 — — 164 
Other comprehensive loss, net of tax— — — (327)— (327)
Repurchase of common stock(20)— (2,927)— — (2,927)
Net income— — — — 6,897 6,897 
Balance at September 30, 2022387 $ $1,488 $(351)$16,855 $17,992 


Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive 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 stock6 — 91 — — 91 
Purchase of common stock under employee stock purchase plan— — 5 — — 5 
Stock-based compensation— — 105 — — 105 
Other comprehensive income, net of tax— — — 28 — 28 
Net income— — — — 7,334 7,334 
Balance at September 30, 2021405 $ $5,003 $31 $5,090 $10,124 


The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
9

MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
Nine Months Ended September 30,
20222021
Operating activities
Net income$6,897 $7,334 
Adjustments to reconcile net income to net cash provided by operating activities:
Stock-based compensation
164 105 
Depreciation and amortization
268 154 
Amortization/accretion of investments
35 33 
Deferred income taxes(473)(89)
Other non-cash items36  
Changes in assets and liabilities:
Accounts receivable
480 (1,751)
Prepaid expenses and other assets
(669)(186)
Inventory(636)(918)
Right-of-use assets, operating leases
29 (25)
Accounts payable
89 26 
Accrued liabilities
354 600 
Deferred revenue
(2,691)4,431 
Income taxes payable(810)565 
Operating lease liabilities
(27)8 
Other liabilities
273 23 
Net cash provided by operating activities3,319 10,310 
Investing activities
Purchases of marketable securities
(8,925)(10,279)
Proceeds from maturities of marketable securities
2,222 1,075 
Proceeds from sales of marketable securities
2,918 1,983 
Purchases of property and equipment
(308)(164)
Investment in convertible notes(35) 
Net cash used in investing activities
(4,128)(7,385)
Financing activities
Proceeds from issuance of common stock through equity plans40 96 
Repurchase of common stock (2,927) 
Changes in financing lease liabilities(123)(96)
Net cash used in financing activities(3,010) 
Net (decrease) increase in cash, cash equivalents and restricted cash(3,819)2,925 
Cash, cash equivalents and restricted cash, beginning of year
6,860 2,636 
Cash, cash equivalents and restricted cash, end of period
$3,041 $5,561 
Non-cash investing and financing activities
Purchases of property and equipment included in accounts payable and accrued liabilities
$80 $66 
Right-of-use assets obtained through finance lease modifications and reassessments$ $364 
Right-of-use assets obtained in exchange for financing lease liabilities$781 $126 

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

10


MODERNA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)

1. Description of the Business

Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our, or the Company) is a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines to improve the lives of patients. 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, autoimmune and cardiovascular diseases, independently and with our strategic collaborators.

On December 18, 2020, we received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the emergency use of the Moderna COVID-19 Vaccine (also referred to as mRNA-1273 and marketed under the brand name Spikevax®) as a two-dose, 100 µg primary series in individuals 18 years of age or older. In January 2022, we received full commercial approval for Spikevax as a two-dose, 100 µg primary series to prevent COVID-19 in individuals 18 years of age and older in the United States. Spikevax is approved or authorized in individuals 18 years and older in more than 70 countries. In addition, Spikevax is authorized by the FDA and global regulators in more than 50 countries as a two-dose, 100 µg primary series in adolescents aged 12 to 17 years old and as a two-dose, 50 µg primary series in children ages 6 to 11 years old. Additionally, a two-dose, 25 µg primary series of Spikevax is authorized in young children aged 6 months to 5 years old in the United States, Canada, Australia, and other jurisdictions.

The FDA, European Medicines Agency (EMA), Swissmedic and other health agencies around the world have authorized a booster dose of Spikevax at the 50 µg dose level for adults ages 18 years and older. The FDA and other health agencies have also authorized a second booster dose at the 50 µg dose level for adults 50 years and older and adults 18 years of age and older with certain kinds of immunocompromise.

On August 15, 2022, we received the first authorization for our BA.1 Omicron-targeting bivalent COVID-19 booster vaccine (Spikevax Bivalent Original/Omicron, mRNA-1273.214) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, given as a 50 µg booster dose for individuals 18 years of age and older who have received either a primary series or an initial booster of any of the authorized or approved COVID-19 vaccines. The EMA in the European Union provided a similar authorization for mRNA-1273.214 as a booster vaccine for individuals 12 years and older on September 2, 2022. During the third quarter of 2022, we received authorizations for mRNA-1273.214 as a booster vaccine in the United Kingdom, the European Union, Japan, Australia, Canada, and Switzerland.

On August 31, 2022, we received an EUA from the FDA for our BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine (mRNA-1273.222), given as a 50 µg booster dose for individuals 18 years of age and older who have received either a primary series or an initial booster of any of the authorized or approved COVID-19 vaccines. On October 12, 2022, we received an EUA from the FDA for mRNA-1273.222 as a 50 µg booster dose for adolescents 12 to 17 years old and as a 25 µg booster dose for children 6 to 11 years old, each following a completed primary series of any authorized COVID-19 vaccine or a previous booster. The EMA in the European Union, the MHRA in the United Kingdom and other countries worldwide have provided similar authorizations for mRNA-1273.222.

2. Summary of Basis of Presentation and Recent Accounting Standards

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2021 (2021 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 2021 Form 10-K.
11


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 preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2022 are consistent with those described in our 2021 Form 10-K. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the operating results to be expected for the full fiscal year or future operating periods.

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. Significant estimates relied upon in preparing these financial statements include, but are not limited to, critical accounting policies or estimates related to revenue recognition, income taxes, valuation allowance on deferred tax assets, leases, fair value of financial instruments, derivative financial instruments, inventory, firm purchase commitment liabilities, useful lives of property and equipment, research and development expenses, and stock-based compensation. The actual results that we experience may differ materially from our estimates.

Comprehensive Income

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

The components of accumulated other comprehensive loss for the three and nine months ended September 30, 2022 were as follows (in millions): 
Unrealized Loss on Available-for-Sale Debt SecuritiesNet Unrealized Gains on Derivatives Designated As Hedging InstrumentsTotal
Accumulated other comprehensive loss, balance at December 31, 2021$(40)$16 $(24)
Other comprehensive loss(171)11 (160)
Accumulated other comprehensive loss, balance at March 31, 2022(211)27 (184)
Other comprehensive loss(72)16 (56)
Accumulated other comprehensive loss, balance at June 30, 2022(283)43 (240)
Other comprehensive loss(123)12 (111)
Accumulated other comprehensive loss, balance at September 30, 2022$(406)$55 $(351)

Restricted Cash

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

The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in millions):
September 30,
20222021
Cash and cash equivalents $3,027 $5,550 
Restricted cash, non-current 14 11 
Total cash, cash equivalents and restricted cash shown in the condensed consolidated
    statements of cash flows
$3,041 $5,561 

12

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. Unless otherwise discussed, 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.

3. Product Sales

Product sales are primarily associated with our COVID-19 vaccine supply agreements with the U.S. Government, other international governments and Gavi (on behalf of the COVAX Facility).

Product sales by customer geographic location were as follows (in millions):
Three Months Ended September 30,Nine Months Ended September 30,
2022202120222021
United States$985 $1,197 $3,380 $4,648 
Europe1,045 1,688 4,511 3,028 
Rest of world (1)
1,090 1,925 5,685 3,064 
Total $3,120 $4,810 $13,576 $10,740 
_______
(1) Includes product sales recognized under the agreement with Gavi, which facilitates the allocation and distribution of our COVID-19 vaccines around the world, particularly for low- and middle-income countries.

As of September 30, 2022, our COVID-19 vaccine (marketed under the brand name Spikevax) and Omicron-targeting bivalent boosters (mRNA-1273.214 and mRNA-1273.222) were our only commercial products authorized for use.

As of September 30, 2022 and December 31, 2021, we had deferred revenue of $4.1 billion and $6.7 billion, respectively, related to customer deposits. We expect $3.9 billion of our deferred revenue related to customer deposits as of September 30, 2022 to be realized in less than one year. Timing of product manufacturing, delivery, and receipt of marketing approval will determine the period in which product sales are recognized.

4. Grant Revenue

In September 2020, we entered into an agreement with the Defense Advanced Research Projects Agency (DARPA) for an award of up to $56 million to fund development of a mobile manufacturing prototype leveraging our existing manufacturing technology that is capable of rapidly producing therapeutics and vaccines. As of September 30, 2022, the committed funding, net of revenue earned was $5 million. An additional $30 million of funding will be available if DARPA exercises additional contract options.

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 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 vaccine candidate against COVID-19. The agreement was amended in both 2020 and 2021 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 and pharmacovigilance studies. In March 2022, we entered into a further amendment to the BARDA agreement, increasing the amount of potential reimbursements by $308 million, in connection with costs associated with the clinical development for the adolescent and pediatric studies and the Phase 3 pivotal study. The maximum award from BARDA, inclusive of the 2020, 2021 and 2022 amendments, was approximately $1.7 billion. All contract options have been exercised. As of September 30, 2022, the remaining available funding, net of revenue earned was $67 million.

In September 2016, we received from BARDA an award of up to $126 million, subsequently adjusted to $117 million in 2021, to help fund our Zika vaccine program. In September 2022, the performance period of the grant expired, and BARDA was released of the obligation to fund the remaining $36 million of the award.

13

In January 2016, we entered a global health project framework agreement with the Bill and Melinda Gates Foundation (Gates Foundation) to advance mRNA-based development projects for various infectious diseases, including human immunodeficiency virus (HIV). As of September 30, 2022, the available funding, net of revenue earned was $7 million, with up to an additional $80 million available if additional follow-on projects are approved.

The following table summarizes grant revenue for the periods presented (in millions):
Three Months Ended September 30,Nine Months Ended September 30,
2022202120222021
BARDA$141 $128 $442 $454 
Other grant revenue3 12 11 19 
Total grant revenue$144 $140 $453 $473 

5. Collaboration Agreements

We have entered into collaboration agreements with strategic collaborators to accelerate the discovery and advancement of potential mRNA medicines across therapeutic areas. As of September 30, 2022 and December 31, 2021, we had collaboration agreements with AstraZeneca plc (AstraZeneca), Merck & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated and Vertex Pharmaceuticals (Europe) Limited (together, Vertex), and others. Please refer to our 2021 Form 10-K under the heading “Third-Party Strategic Alliances” and Note 5 to our consolidated financial statements for further description of these collaboration agreements.

The following table summarizes our total consolidated revenue from our strategic collaborators for the periods presented (in millions):
Three Months Ended September 30,Nine Months Ended September 30,
Collaboration Revenue by Strategic Collaborator:2022202120222021
AstraZeneca$76 $3 $80 $7 
Merck20 7 35 11 
Vertex4 5 33 23 
Other 4 2 6 
Total collaboration revenue$100 $19 $150 $47 

The following table presents changes in the balances of our receivables and contract liabilities related to our strategic collaboration agreements during the nine months ended September 30, 2022 (in millions):
December 31, 2021AdditionsDeductionsSeptember 30, 2022
Contract Assets:
Accounts receivable$9 $287 $(18)$278 
Contract Liabilities:
Deferred revenue$204 $8 $(135)$77 
14


As of September 30, 2022, the aggregated amount of the transaction price allocated to performance obligations under our collaboration agreements that are unsatisfied or partially unsatisfied was $99 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 will become effective on November 21, 2022. All rights to these two programs will revert to us. As a result of the termination, we recognized the remaining deferred revenue of $76 million as collaboration revenue during the three months ended September 30, 2022.

In September 2022, Merck exercised its option to jointly develop and commercialize PCV mRNA-4157 pursuant to the terms of the PCV Collaboration and License Agreement, as amended and restated (the PCV/SAV Agreement). We concluded that the contractual provisions in the existing arrangement are not sufficiently definitive to identify the rights and obligations of the parties during the Merck Participation Term (as defined in the PCV/SAV Agreement). As such, we recorded a receivable of $250 million and other current liabilities of $250 million on our condensed consolidated financial statements related to Merck's participation election as of September 30, 2022. After receipt of the participation election payment, we and Merck will agree on a joint development plan and budget, and we will reassess the accounting treatment for the participation election payment and the collaboration arrangement at such time.

In addition to the collaboration agreements 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.

15

6. Financial Instruments

Cash and Cash Equivalents and Investments

The following tables summarize our cash and available-for-sale securities by significant investment category at September 30, 2022 and December 31, 2021 (in millions):
September 30, 2022
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated Fair ValueCash and
Cash
Equivalents
Current
Marketable
Securities
Non-
Current
Marketable
Securities
Cash and cash equivalents$3,027 $ $ $3,027 $3,027 $ $ 
Available-for-sale:
Certificates of deposit208   208  208  
U.S. treasury bills220  (2)218  218  
U.S. treasury notes7,826  (268)7,558  3,765 3,793 
Corporate debt securities6,124  (270)5,854  1,130 4,724 
Government debt securities147  (9)138   138 
Total$17,552 $ $(549)$17,003 $3,027 $5,321 $8,655 
December 31, 2021
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated Fair ValueCash and
Cash
Equivalents
Current
Marketable
Securities
Non-
Current
Marketable
Securities
Cash and cash equivalents$6,848 $ $ $6,848 $6,848 $ $ 
Available-for-sale:
Certificates of deposit80   80  80  
U.S. treasury bills479   479  479  
U.S. treasury notes6,595  (31)6,564  1,984 4,580 
Corporate debt securities3,508  (20)3,488  1,323 2,165 
Government debt securities112  (1)111  13 98 
Total$17,622 $ $(52)$17,570 $6,848 $3,879 $6,843 

The amortized cost and estimated fair value of available-for-sale securities by contractual maturity at September 30, 2022 and December 31, 2021 were as follows (in millions):
September 30, 2022
Amortized
Cost
Estimated
Fair Value
Due in one year or less$5,417 $5,321 
Due after one year through five years9,108 8,655 
Total$14,525 $13,976 

December 31, 2021
Amortized
Cost
Estimated
Fair Value
Due in one year or less$3,882 $3,879 
Due after one year through five years6,892 6,843 
Total$10,774 $10,722 

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.
16

Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and our intent and ability to hold the investment to allow for an anticipated recovery in fair value. Any impairment that is not credit related is recognized in other comprehensive loss, net of applicable taxes. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. We did not recognize any impairment charges related to available-for-sale securities for the three and nine months ended September 30, 2022 and 2021. We did not record any credit-related allowance to available-for-sale securities as of September 30, 2022 and December 31, 2021.

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 at September 30, 2022 and December 31, 2021 (in millions):
Less than 12 Months12 Months or MoreTotal
Gross Unrealized LossesEstimated Fair ValueGross Unrealized LossesEstimated Fair ValueGross Unrealized LossesEstimated Fair Value
As of September 30, 2022: