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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2024
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
Moderna, Inc.
(Exact Name of Registrant as Specified in Its Charter)
| | | | | | | | | | | |
Delaware | | 81-3467528 |
(State or Other Jurisdiction of Incorporation or Organization) | | (IRS Employer Identification No.) |
| | | |
325 Binney Street | | |
Cambridge, | Massachusetts | | 02142 |
(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 class | Trading symbol(s) | Name of each exchange on which registered |
Common stock, par value $0.0001 per share | MRNA | The 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 July 26, 2024, there were 384,396,030 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 vaccine, and our plans and expectations regarding future generations of our COVID-19 vaccine that we may develop, including in response to variants of the SARS-CoV-2 virus, ongoing clinical development, manufacturing and supply, pricing, commercialization, regulatory matters (including authorization or approval for updated vaccines), demand for COVID-19 vaccines, our provisions for product returns, and third-party and governmental arrangements and potential arrangements;
•our expectations regarding the endemic and seasonal commercial market for COVID-19 vaccines and our preparations for and ability to effectively compete in such a market, as well as the impact that the evolving market will have on our financial returns;
•expected sales and delivery of our COVID-19 vaccine in future periods, and expected seasonality for sales;
•stability and storage conditions for our next-generation COVID-19 vaccine (mRNA-1283), and its potential as a component for a commercial combination vaccine;
•our expectations regarding commercialization of our respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345), including anticipated demand, competition and further regulatory approvals for this product;
•financing and funding options we may consider as part of our research and development strategy;
•our ability to successfully contract with third-party suppliers, distributors and manufacturers;
•our ability and the ability of third parties with whom we contract to successfully manufacture, supply and distribute our COVID-19 vaccine and any future 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 our products, including our COVID-19 vaccine, and the impact on our cost of sales, and our anticipated 2024 cost of sales as a percentage of net product sales;
•the scope of protection we are able to establish and maintain for intellectual property rights covering our commercial products, product candidates and technology, including our ability to enter into license agreements, and our expectations regarding pending legal proceedings related to our intellectual property;
•the potential of our individualized neoantigen therapy (INT) program and our plans for the program, including to expand to additional tumor types and plans for regulatory approval of INT;
•the timing of initiation, progress, completion, results and cost of our clinical trials, preclinical studies and research and development programs, as well as those of our collaborators;
•participant enrollment in our clinical trials, including enrollment demographics and timing;
•potential advantages of mRNA as compared to traditional medicine;
•our ability to obtain and maintain regulatory approval of our product candidates;
•the implementation of our business model and strategic plans for our business, products, product candidates and technology;
•potential product launches, including the timing of launches;
•our ability to successfully commercialize our products, if approved;
•the pricing and reimbursement of our medicines, if approved;
•the build out of our manufacturing and commercial operations;
•estimates of our future expenses, revenues and capital requirements;
•our operation and funding requirements, including our forecast of the period of time through which our financial resources will be adequate to support our operations;
•the potential benefits of strategic collaboration agreements and our ability to enter into strategic collaborations or other agreements with collaborators with development, regulatory and commercialization expertise;
•our financial performance;
•our tax provision and related tax liabilities;
•legal and regulatory developments in the United States and foreign countries;
•our ability to produce our products or product candidates 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 and under Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. 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, and our Statements and Perspectives webpage, https://investors.modernatx.com/Statements--Perspectives/default.aspx; as well as our social media channels: Facebook, www.facebook.com/modernatx; X, www.twitter.com/moderna_tx (@moderna_tx); LinkedIn, www.linkedin.com/company/modernatx; Instagram (@moderna_tx); and Threads (@moderna_tx) contain a significant amount of information about us, including financial and other information for investors. We encourage investors to visit these websites and social media channels as information is frequently updated and new information is shared. Information contained on our website, corporate blog and social media channels shall not be deemed incorporated into, or be a part of, this Form 10-Q.
Table of Contents
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PART I. | | Page |
Item 1. | | |
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Item 2. | | |
Item 3. | | |
Item 4. | | |
PART II. | | |
Item 1. | | |
Item 1A. | | |
Item 2. | | |
Item 5. | | |
Item 6. | | |
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Item 1. Financial Statements
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions, except per share data)
| | | | | | | | | | | |
| June 30, | | December 31, |
| 2024 | | 2023 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 2,478 | | | $ | 2,907 | |
Investments | 6,010 | | | 5,697 | |
Accounts receivable, net | 163 | | | 892 | |
Inventory | 399 | | | 202 | |
Prepaid expenses and other current assets | 611 | | | 627 | |
Total current assets | 9,661 | | | 10,325 | |
Investments, non-current | 2,326 | | | 4,677 | |
Property, plant and equipment, net | 2,196 | | | 1,945 | |
Right-of-use assets, operating leases | 775 | | | 713 | |
| | | |
Deferred tax assets | 81 | | | 81 | |
Other non-current assets | 641 | | | 685 | |
Total assets | $ | 15,680 | | | $ | 18,426 | |
Liabilities and Stockholders’ Equity | | | |
Current liabilities: | | | |
Accounts payable | $ | 279 | | | $ | 520 | |
Accrued liabilities | 1,333 | | | 1,798 | |
Deferred revenue | 702 | | | 568 | |
Income taxes payable | 7 | | | 63 | |
Other current liabilities | 42 | | | 66 | |
Total current liabilities | 2,363 | | | 3,015 | |
Deferred revenue, non-current | 95 | | | 83 | |
Operating lease liabilities, non-current | 668 | | | 643 | |
Financing lease liabilities, non-current | 576 | | | 575 | |
Other non-current liabilities | 266 | | | 256 | |
Total liabilities | 3,968 | | | 4,572 | |
Commitments and contingencies (Note 11) | | | |
Stockholders’ equity: | | | |
Preferred stock, par value $0.0001; 162 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued or outstanding at June 30, 2024 and December 31, 2023 | — | | | — | |
Common stock, par value $0.0001; 1,600 shares authorized as of June 30, 2024 and December 31, 2023; 384 and 382 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | — | | | — | |
Additional paid-in capital | 631 | | | 371 | |
Accumulated other comprehensive loss | (71) | | | (123) | |
Retained earnings | 11,152 | | | 13,606 | |
Total stockholders’ equity | 11,712 | | | 13,854 | |
Total liabilities and stockholders’ equity | $ | 15,680 | | | $ | 18,426 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Revenue: | | | | | | | | |
Net product sales | | $ | 184 | | | $ | 293 | | | $ | 351 | | | $ | 2,121 | |
Other revenue | | 57 | | | 51 | | | 57 | | | 85 | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Total revenue | | 241 | | | 344 | | | 408 | | | 2,206 | |
Operating expenses: | | | | | | | | |
Cost of sales | | 115 | | | 731 | | | 211 | | | 1,523 | |
Research and development | | 1,221 | | | 1,148 | | | 2,284 | | | 2,279 | |
Selling, general and administrative | | 268 | | | 332 | | | 542 | | | 637 | |
Total operating expenses | | 1,604 | | | 2,211 | | | 3,037 | | | 4,439 | |
Loss from operations | | (1,363) | | | (1,867) | | | (2,629) | | | (2,233) | |
Interest income | | 111 | | | 104 | | | 231 | | | 213 | |
Other (expense) income, net | | (27) | | | 14 | | | (46) | | | (34) | |
Loss before income taxes | | (1,279) | | | (1,749) | | | (2,444) | | | (2,054) | |
Provision for (benefit from) income taxes | | — | | | (369) | | | 10 | | | (753) | |
Net loss | | $ | (1,279) | | | $ | (1,380) | | | $ | (2,454) | | | $ | (1,301) | |
| | | | | | | | |
Net loss per share: | | | | | | | | |
Basic and diluted | | $ | (3.33) | | | $ | (3.62) | | | $ | (6.41) | | | $ | (3.39) | |
| | | | | | | | |
| | | | | | | | |
Weighted average common shares used in calculation of net loss per share: | | | | | | | | |
Basic and diluted | | 384 | | | 381 | | | 383 | | | 383 | |
| | | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited, in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, | |
| | 2024 | | 2023 | | 2024 | | 2023 | |
Net loss | | $ | (1,279) | | | $ | (1,380) | | | $ | (2,454) | | | $ | (1,301) | | |
Other comprehensive income, net of tax: | | | | | | | | | |
Available-for-sale securities: | | | | | | | | | |
Unrealized gains (losses) on available-for-sale debt securities | | 29 | | | (10) | | | 49 | | | 69 | | |
Less: net realized losses on available-for-sale securities reclassified in net loss | | 1 | | | 14 | | | 3 | | | 30 | | |
Net increase from available-for-sale debt securities | | 30 | | | 4 | | | 52 | | | 99 | | |
Cash flow hedges: | | | | | | | | | |
| | | | | | | | | |
Less: net realized losses on derivative instruments reclassified in net loss | | — | | | — | | | — | | | 8 | | |
Net increase from derivatives designated as hedging instruments | | — | | | — | | | — | | | 8 | | |
| | | | | | | | | |
| | | | | | | | | |
Total other comprehensive income | | 30 | | | 4 | | | 52 | | | 107 | | |
Comprehensive loss | | $ | (1,249) | | | $ | (1,376) | | | $ | (2,402) | | | $ | (1,194) | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited, in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Loss | | Retained Earnings | | Total Stockholders’ Equity |
| Shares | | Amount | | | | |
Balance at March 31, 2024 | 383 | | | $ | — | | | $ | 487 | | | $ | (101) | | | $ | 12,431 | | | $ | 12,817 | |
| | | | | | | | | | | |
Exercise of options to purchase common stock | 1 | | | — | | | 22 | | | — | | | — | | | 22 | |
Issuance of common stock under employee stock purchase plan | — | | | — | | | 10 | | | — | | | — | | | 10 | |
Stock-based compensation | — | | | — | | | 112 | | | — | | | — | | | 112 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 30 | | | — | | | 30 | |
| | | | | | | | | | | |
Net loss | — | | | — | | | — | | | — | | | (1,279) | | | (1,279) | |
Balance at June 30, 2024 | 384 | | | $ | — | | | $ | 631 | | | $ | (71) | | | $ | 11,152 | | | $ | 11,712 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Loss | | Retained Earnings | | Total Stockholders’ Equity |
| Shares | | Amount | | | | |
Balance at March 31, 2023 | 384 | | | $ | — | | | $ | 731 | | | $ | (267) | | | $ | 18,399 | | | $ | 18,863 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Exercise of options to purchase common stock | 1 | | | — | | | 4 | | | — | | | — | | | 4 | |
Issuance of common stock under employee stock purchase plan | — | | | — | | | 12 | | | — | | | — | | | 12 | |
Stock-based compensation | — | | | — | | | 74 | | | — | | | — | | | 74 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 4 | | | — | | | 4 | |
Repurchase of common stock | (4) | | | — | | | (628) | | | — | | | — | | | (628) | |
Net loss | — | | | — | | | — | | | — | | | (1,380) | | | (1,380) | |
Balance at June 30, 2023 | 381 | | | $ | — | | | $ | 193 | | | $ | (263) | | | $ | 17,019 | | | $ | 16,949 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Loss | | Retained Earnings | | Total Stockholders’ Equity |
| Shares | | Amount | | | | |
Balance at December 31, 2023 | 382 | | | $ | — | | | $ | 371 | | | $ | (123) | | | $ | 13,606 | | | $ | 13,854 | |
Vesting of restricted common stock | 1 | | | — | | | — | | | — | | | — | | | — | |
Exercise of options to purchase common stock | 1 | | | — | | | 37 | | | — | | | — | | | 37 | |
Issuance of common stock under employee stock purchase plan | — | | | — | | | 10 | | | — | | | — | | | 10 | |
Stock-based compensation | — | | | — | | | 213 | | | — | | | — | | | 213 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 52 | | | — | | | 52 | |
| | | | | | | | | | | |
Net loss | — | | | — | | | — | | | — | | | (2,454) | | | (2,454) | |
Balance at June 30, 2024 | 384 | | | $ | — | | | $ | 631 | | | $ | (71) | | | $ | 11,152 | | | $ | 11,712 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Loss | | Retained Earnings | | Total Stockholders’ Equity |
| Shares | | Amount | | | | |
Balance at December 31, 2022 | 385 | | | $ | — | | | $ | 1,173 | | | $ | (370) | | | $ | 18,320 | | | $ | 19,123 | |
| | | | | | | | | | | |
Vesting of restricted common stock | 1 | | | — | | | — | | | — | | | — | | | — | |
Exercise of options to purchase common stock | 3 | | | — | | | 13 | | | — | | | — | | | 13 | |
Issuance of common stock under employee stock purchase plan | — | | | — | | | 12 | | | — | | | — | | | 12 | |
Stock-based compensation | — | | | — | | | 149 | | | — | | | — | | | 149 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 107 | | | — | | | 107 | |
Repurchase of common stock | (8) | | | — | | | (1,154) | | | — | | | — | | | (1,154) | |
Net loss | — | | | — | | | — | | | — | | | (1,301) | | | (1,301) | |
Balance at June 30, 2023 | 381 | | | $ | — | | | $ | 193 | | | $ | (263) | | | $ | 17,019 | | | $ | 16,949 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2024 | | 2023 |
Operating activities | | | |
Net loss | $ | (2,454) | | | $ | (1,301) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Stock-based compensation | 213 | | | 149 | |
Depreciation and amortization | 77 | | | 170 | |
Amortization/accretion of investments | (55) | | | (29) | |
Loss (gain) on equity investments, net | 35 | | | (17) | |
Deferred income taxes | — | | | (530) | |
| | | |
Other non-cash items | 7 | | | (12) | |
Changes in assets and liabilities, net of acquisition of business: | | | |
Accounts receivable, net | 729 | | | 1,153 | |
Prepaid expenses and other assets | 3 | | | (142) | |
Inventory | (197) | | | 234 | |
Right-of-use assets, operating leases | (62) | | | (9) | |
Accounts payable | (199) | | | (187) | |
Accrued liabilities | (464) | | | (633) | |
Deferred revenue | 146 | | | (979) | |
Income taxes payable | (56) | | | (1) | |
Operating lease liabilities | 25 | | | 12 | |
Other liabilities | (11) | | | (18) | |
Net cash used in operating activities | (2,263) | | | (2,140) | |
Investing activities | | | |
Purchases of marketable securities | (3,390) | | | (1,281) | |
Proceeds from maturities of marketable securities | 3,536 | | | 3,264 | |
Proceeds from sales of marketable securities | 1,999 | | | 2,427 | |
Purchases of property, plant and equipment | (378) | | | (347) | |
Acquisition of business, net of cash acquired | — | | | (85) | |
Investment in convertible notes and equity securities | — | | | (23) | |
Net cash provided by investing activities | 1,767 | | | 3,955 | |
Financing activities | | | |
| | | |
Proceeds from issuance of common stock through equity plans | 47 | | | 25 | |
| | | |
Repurchase of common stock, including excise tax | — | | | (1,154) | |
Changes in financing lease liabilities | 1 | | | (81) | |
Net cash provided by (used in) financing activities | 48 | | | (1,210) | |
Net (decrease) increase in cash, cash equivalents and restricted cash | (448) | | | 605 | |
Cash, cash equivalents and restricted cash, beginning of year | 2,928 | | | 3,217 | |
Cash, cash equivalents and restricted cash, end of period | $ | 2,480 | | | $ | 3,822 | |
Non-cash investing and financing activities | | | |
Purchases of property and equipment included in accounts payable and accrued liabilities | $ | 86 | | | $ | 105 | |
Right-of-use assets obtained through finance lease modifications and reassessments | $ | — | | | $ | 50 | |
| | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
MODERNA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Description of the Business
Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our or the Company) is a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing 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.
In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA® (mRNA-1345), our mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.
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.
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, 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 and six months ended June 30, 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 and six months ended June 30, 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 and recently approved RSV vaccines, with higher sales expected during the fall and winter seasons.
Use of Estimates
We have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes. We base our estimates on historical experience and various relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods that are not readily apparent from other sources. Changes in our estimates are recorded in the financial results of the period in which the new information becomes available. The actual results that we experience may differ materially from our estimates.
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 loss.
The components of accumulated other comprehensive loss for the three and six months ended June 30, 2024 were as follows (in millions):
| | | | | | | | | | | | | | | | | | | |
| Unrealized Gains on Available-for-Sale Debt Securities | | | | Pension and Postretirement Benefits | | Total |
Accumulated other comprehensive loss, balance at December 31, 2023 | $ | (114) | | | | | $ | (9) | | | $ | (123) | |
Other comprehensive income | 22 | | | | | — | | | 22 | |
Accumulated other comprehensive loss, balance at March 31, 2024 | (92) | | | | | (9) | | | (101) | |
Other comprehensive income | 30 | | | | | — | | | 30 | |
Accumulated other comprehensive loss, balance at June 30, 2024 | $ | (62) | | | | | $ | (9) | | | $ | (71) | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
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):
| | | | | | | | | | | | | | |
| | June 30, |
| | 2024 | | 2023 |
Cash and cash equivalents | | $ | 2,478 | | | $ | 3,801 | |
| | | | |
Restricted cash, non-current(1) | | 2 | | | 21 | |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | | $ | 2,480 | | | $ | 3,822 | |
_______
(1)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.
3. Net Product Sales
Net product sales by customer geographic location were as follows (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
United States | | $ | 162 | | | $ | 2 | | | $ | 262 | | | $ | 3 | |
Europe | | — | | | 60 | | | — | | | 636 | |
Rest of world | | 22 | | | 231 | | | 89 | | | 1,482 | |
Total | | $ | 184 | | | $ | 293 | | | $ | 351 | | | $ | 2,121 | |
As of June 30, 2024, we have two commercial products authorized for use, our COVID-19 vaccine and our RSV vaccine. The RSV vaccine was approved by the FDA in May 2024 for adults aged 60 years and older. As of June 30, 2024, we had not commenced sales of our RSV vaccine.
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 June 30, 2024 and December 31, 2023, we had deferred revenue of $740 million and $613 million, respectively, related to customer deposits for our COVID-19 vaccine. We expect $645 million of our deferred revenue related to customer deposits as of June 30, 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 June 30, | | Six Months Ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Gross product sales | | $ | 191 | | | $ | 293 | | | $ | 413 | | | $ | 2,121 | |
Product sales provision: | | | | | | | | |
Wholesaler chargebacks, discounts and fees | | 22 | | | — | | | — | | | — | |
Returns and other fees | | (29) | | | — | | | (62) | | | — | |
Total product sales provision | | $ | (7) | | | $ | — | | | $ | (62) | | | $ | — | |
Net product sales | | $ | 184 | | | $ | 293 | | | $ | 351 | | | $ | 2,121 | |
The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the six months ended June 30, 2024 (in millions):
| | | | | | | | |
| | Returns and other fees |
Balance at December 31, 2023 | | $ | (556) | |
Provision related to sales made in 2024 | | (62) | |
| | |
Payments and returns related to sales made in current period | | 13 | |
Payments and returns related to sales made in prior year | | 51 | |
Balance at June 30, 2024 | | $ | (554) | |
4. Other Revenue
The following table summarizes other revenue for the periods presented (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Grant revenue | | $ | 20 | | | $ | 28 | | | $ | 20 | | | $ | 52 | |
Collaboration revenue | | 7 | | | 23 | | | 7 | | | 33 | |
Licensing and royalty revenue | | 30 | | | — | | | 30 | | | — | |
Total other revenue | | $ | 57 | | | $ | 51 | | | $ | 57 | | | $ | 85 | |
Grant Revenue
In April 2020, we entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), for an award of up to $483 million to accelerate development of 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 June 30, 2024, the remaining available funding, net of revenue earned was $77 million.
In June 2024, we were awarded up to $176 million through the Rapid Response Partnership Vehicle (RRPV), funded by BARDA, to accelerate the development of mRNA-based pandemic influenza vaccines. The project award will support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus. This subtype of the influenza virus causes a highly infectious and severe disease in birds known as avian influenza and poses a risk of spillover into the human population. The agreement also includes additional options to prepare for and accelerate responses to future public health threats. We had not recognized any revenue under this agreement as of June 30, 2024.
Licensing and Royalty Revenue
In April 2024, we entered a non-exclusive out-licensing agreement with a pharmaceutical company based in Japan for mRNA COVID-19-related intellectual property for the territory of Japan. Under the terms of the agreement, we received an upfront payment of $50 million, which included a $20 million prepayment creditable against future royalties. Additionally, we are entitled to receive low double-digit royalties on the net sales of the company’s COVID-19 product.
Upon execution of the agreement, we recognized $30 million of the upfront payment as other revenue in our condensed consolidated statements of operations. The remaining $20 million was recorded as deferred revenue in our condensed consolidated balance sheets. Royalty revenue will be recognized when the underlying sales occur.
5. 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 and six months ended June 30, 2024, we recognized expenses, net of Merck's reimbursements, of $95 million and $171 million, respectively, related to the INT collaboration under the Merck Participation Term. For the three and six months ended June 30, 2023, these expenses were $50 million and $69 million, respectively.
Additionally, for the three and six months ended June 30, 2024, the net cost recovery for capital expenditures was $33 million and $57 million, respectively. For the three and six months ended June 30, 2023, the net cost recovery for capital expenditures was $12 million and $18 million, respectively. These amounts were applied to reduce the capitalized cost of the assets.
We have other collaborative and licensing arrangements that we do not consider to be individually significant to our business at this time. Pursuant to these agreements, we may be required to make upfront payments and payments upon achievement of various development, regulatory and commercial milestones, which in the aggregate could be significant. Future milestone payments, if any, will be reflected in our consolidated financial statements when the corresponding events have occurred. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized.
Development and Commercialization Funding Arrangement with Blackstone Life Sciences (Blackstone)
In March 2024, we entered into a development and commercialization funding arrangement with Blackstone, under which Blackstone has committed to providing up to $750 million in funding to us. This funding supports the development of our investigational mRNA-based influenza vaccine. Contingent upon regulatory approval in the U.S. and only if the approval is dependent on data from the funded activities, Blackstone will be entitled to receive low single-digit percentage royalties and up to $750 million in sales milestone payments. These payments are based on net sales of our future influenza and combination vaccines, with sales milestone payments contingent upon achieving specified cumulative net sales targets.
Given the substantive transfer of financial risk to Blackstone, we account for this arrangement as an obligation to conduct research and development activities. The funding is recognized as a reduction to the expenses of our mRNA-based influenza program. This reduction is recognized proportionally as the related costs are incurred, based on an input method. We recorded immaterial research and development expense reductions for the three and six months ended June 30, 2024.
6. Financial Instruments
Cash and Cash Equivalents and Investments
The following tables summarize our cash, cash equivalents, and available-for-sale securities by significant investment category as of June 30, 2024 and December 31, 2023 (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | June 30, 2024 |
| | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Estimated Fair Value | | Cash and Cash Equivalents | | Current Marketable Securities | | Non- Current Marketable Securities |
Cash and cash equivalents | | $ | 2,478 | | | $ | — | | | $ | — | | | $ | 2,478 | | | $ | 2,478 | | | $ | — | | | $ | — | |
Available-for-sale: | | | | | | | | | | | | | | |
Certificates of deposit | | 29 | | | — | | | — | | | 29 | | | — | | | 29 | | | — | |
U.S. treasury bills | | 588 | | | — | | | — | | | 588 | | | — | | | 588 | | | — | |
U.S. treasury notes | | 3,593 | | | — | | | (45) | | | 3,548 | | | — | | | 2,642 | | | 906 | |
Corporate debt securities | | 4,023 | | | 1 | | | (47) | | | 3,977 | | | — | | | 2,594 | | | 1,383 | |
Government debt securities | | 196 | | | — | | | (2) | | | 194 | | | — | | | 157 | | | 37 | |
Total | | $ | 10,907 | | | $ | 1 | | | $ | (94) | | | $ | 10,814 | | | $ | 2,478 | | | $ | 6,010 | | | $ | 2,326 | |
| | | | | | | | | | | | | | |
| | December 31, 2023 |
| | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Estimated Fair Value | | Cash and Cash Equivalents | | Current Marketable Securities | | Non- Current Marketable Securities |
Cash and cash equivalents | | $ | 2,907 | | | $ | — | | | $ | — | | | $ | 2,907 | | | $ | 2,907 | | | $ | — | | | $ | — | |
Available-for-sale: | | | | | | | | | | | | | | |
Certificates of deposit | | 27 | | | — | | | — | | | 27 | | | — | | | 27 | | | — | |
U.S. treasury bills | | 807 | | | — | | | — | | | 807 | | | — | | | 807 | | | — | |
U.S. treasury notes | | 4,407 | | | 3 | | | (67) | | | 4,343 | | | — | | | 2,664 | | | 1,679 | |
Corporate debt securities | | 5,067 | | | 3 | | | (81) | | | 4,989 | | | — | | | 2,082 | | | 2,907 | |
Government debt securities | | 211 | | | — | | | (3) | | | 208 | | | — | | | 117 | | | 91 | |
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 June 30, 2024 and December 31, 2023 were as follows (in millions):
| | | | | | | | | | | | | | |
| | June 30, 2024 |
| | Amortized Cost | | Estimated Fair Value |
Due in one year or less | | $ | 6,067 | | | $ | 6,010 | |
Due after one year through five years | | 2,362 | | | 2,326 | |
Total | | $ | 8,429 | | | $ | 8,336 | |
| | | | | | | | | | | | | | |
| | December 31, 2023 |
| | Amortized Cost | | Estimated Fair Value |
Due in one year or less | | $ | 5,751 | | | $ | 5,697 | |
Due after one year through five years | | 4,768 | | | 4,677 | |
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 did not recognize any impairment charges related to available-for-sale securities for the three and six months ended June 30, 2024 and 2023. We did not record any credit-related allowance for available-for-sale securities as of June 30, 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 June 30, 2024 and December 31, 2023 (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Less than 12 Months | | 12 Months or More | | Total |
| | Gross Unrealized Losses | | Estimated Fair Value | | Gross Unrealized Losses | | Estimated Fair Value | | Gross Unrealized Losses | | Estimated Fair Value |
As of June 30, 2024: | | | | | | | | | | | | |
| | | | | | | | | | | | |
U.S. treasury bills | | $ | — | | | $ | 1,282 | | | $ | — | | | $ | — | | | $ | — | | | $ | 1,282 | |
U.S. treasury notes | | (5) | | | 1,175 | | | (38) | | | 2,164 | | | (43) | | | 3,339 | |
Corporate debt securities | | (4) | | | 945 | | | (45) | | | 2,523 | | | (49) | | | 3,468 | |
Government debt securities | | — | | | 52 | | | (2) | | | 116 | | | (2) | | | 168 | |
Total | | $ | (9) | | | $ | 3,454 | | | $ | (85) | | | $ | 4,803 | | | $ | (94) | | | $ | 8,257 | |
| | | | | | | | | | | | |
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 June 30, 2024 and December 31, 2023, we held 341 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 June 30, 2024 and December 31, 2023 (in millions):
| | | | | | | | | | | | | | | | | | | | |
| | Fair value at June 30, 2024 | | Fair Value Measurement Using |
| | | Level 1 | | Level 2 |
Assets: | | | | | | |
Money market funds | | $ | 647 | | | $ | 647 | | | $ | — | |
Certificates of deposit | | 29 | | | — | | | 29 | |
U.S. treasury bills | | 1,972 | | | — | | | 1,972 | |
U.S. treasury notes | | 3,548 | | | — | | | 3,548 | |
Corporate debt securities | | 4,286 | | | — | | | 4,286 | |
Government debt securities | | 194 | | | — | | | 194 | |
Equity investments(1) | | 31 | | | 31 | | | — | |
Derivative instruments | | 2 | | | — | | | 2 | |
Total | | $ | 10,709 | | | $ | 678 | | | $ | 10,031 | |
Liabilities: | | | | | | |
Derivative instruments | | $ | 2 | | | $ | — | | | $ | 2 | |
| | | | | | | | | | | | | | | | | | | | |
| | Fair value at December 31, 2023 | | Fair Value Measurement Using |
| | | Level 1 | | Level 2 |
Assets: | | | | | | |
Money market funds | | $ | 1,572 | | | $ | 1,572 | | | $ | — | |
Certificates of deposit | | 27 | | | — | | | 27 | |
U.S. treasury bills | | 1,246 | | | — | | | 1,246 | |
U.S. treasury notes | | 4,343 | | | — | | | 4,343 | |
Corporate debt securities | | 5,480 | | | — | | | 5,480 | |
Government debt securities | | 208 | | | — | | | 208 | |
| | | | | | |
Equity Investments(1) | | 24 | | | 24 | | | — | |
Derivative instruments | | 4 | | | — | | | 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 income (expense), net, in our condensed consolidated statements of operations.
As of June 30, 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 and six months ended June 30, 2024, we recognized net losses of $22 million and $35 million, respectively, on equity investments from changes in fair value of the securities. For the three and six months ended June 30, 2023, we recognized net gains of $36 million and $17 million, respectively, 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 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 June 30, 2024.
7. Inventory
Inventory as of June 30, 2024 and December 31, 2023 consisted of the following (in millions):
| | | | | | | | | | | | | | | | |
| | June 30, | | December 31, | | |
| | 2024 | | 2023 | | |
Raw materials | | $ | 199 | | | $ | 163 | | | |
Work in progress | | 166 | | | 15 | | | |
Finished goods | | 34 | | | 24 | | | |
Total inventory | | $ | 399 | | | $ | 202 | | | |
| | | | | | |
Inventory, non-current(1) | | $ | 161 | | | $ | 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 and six months ended June 30, 2024, inventory write-downs were $14 million and $44 million, respectively. For the three and six months ended June 30, 2023, inventory write-downs were $464 million and $612 million, respectively. For the three and six months ended June 30, 2024, there were no losses on firm purchase commitments. For the three and six months ended June 30, 2023, losses on firm purchase commitments were $75 million and $141 million, respectively. 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 June 30, 2024 and December 31, 2023, the accrued liability for losses on firm future purchase commitments in our condensed consolidated balance sheets was $1 million and $79 million, respectively.
In May 2024, the FDA approved our RSV vaccine for adults aged 60 years and older, and we began to capitalize RSV vaccine inventory. As of June 30, 2024 and December 31, 2023, we had inventory on hand of $560 million and $372 million, respectively, inclusive of inventory for our COVID-19 and RSV vaccines. Our raw materials and work-in-progress inventory have variable shelf lives. We expect that the majority of this inventory will be consumed over the next three years. The shelf life of our COVID-19 vaccine product ranges from nine to twelve months. The shelf life of our RSV vaccine is 18 months.
Pre-launch Inventory
Consistent with guidance from regulators, we have updated our COVID-19 vaccine to target the KP.2 and JN.1 strains of the SARS-CoV-2 virus, and are prepared to meet the anticipated 2024-2025 season demand. We anticipate supplying our vaccine targeting the KP.2 strain to the U.S. and Canadian markets, consistent with guidance from U.S. and Canadian regulators, respectively. Our vaccine targeting the JN.1 strain will be available to support other markets where regulators are targeting JN.1, subject to regulatory approvals. We have submitted data to regulators worldwide to support registration and supply of the Spikevax 2024-2025 formula in time for the upcoming vaccination season, which will commence in the third quarter.
We commenced manufacturing and capitalizing pre-launch inventory costs related to both KP.2 and JN.1 strains in the first half of 2024, prior to regulatory approval. As of June 30, 2024, we had capitalized pre-launch COVID-19 vaccine inventory of $165 million in our condensed consolidated balance sheets.
8. Property, Plant and Equipment, Net
Property, plant and equipment, net, as of June 30, 2024 and December 31, 2023 consisted of the following (in millions):
| | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
Land and land improvements | | $ | 22 | | | $ | 22 | |
Manufacturing and laboratory equipment | | 355 | | | 345 | |
Leasehold improvements | | 664 | | | 522 | |
Furniture, fixtures and other | | 33 | | | 26 | |
Computer equipment and software | | 136 | | | 74 | |
| | | | |
Construction in progress | | 961 | | | 860 | |
Right-of-use assets, financing (Note 10) | | 529 | | | 529 | |
Total | | 2,700 | | | 2,378 | |
Less: Accumulated depreciation | | (504) | | | (433) | |
Property, plant and equipment, net | | $ | 2,196 | | | $ | 1,945 | |
| | | | |
Depreciation and amortization expense for three and six months ended June 30, 2024 was $40 million and $75 million, respectively. Depreciation and amortization expense for the three and six months ended June 30, 2023 was $90 million and $168 million, respectively.
9. Other Balance Sheet Components
Accounts Receivable, net
Accounts receivable, net, as of June 30, 2024 and December 31, 2023 consisted of the following (in millions):
| | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
Accounts receivable | | $ | 492 | | | $ | 1,584 | |
Less: Wholesalers chargebacks, discounts and fees | | (329) | | | (692) | |
| | | | |
| | | | |
Accounts receivable, net | | $ | 163 | | | $ | 892 | |
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets, as of June 30, 2024 and December 31, 2023 consisted of the following (in millions):
| | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
| | | | |
Prepaid services | | $ | 184 | | | $ | 182 | |
Down payments and prepayments related to manufacturing and materials | | 111 | | | 168 | |
Income tax receivable | | 105 | | | 19 | |
Collaboration receivable | | 73 | | | 61 | |
Interest receivable | | 56 | | | 59 | |
| | | | |
Value added tax receivable | | 26 | | | 50 | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
Prepaid income tax | | 25 | | | — | |
Other current assets | | 31 | | | 88 | |
Prepaid expenses and other current assets | | $ | 611 | | | $ | 627 | |
| | | | |
Other Non-Current Assets
Other non-current assets, as of June 30, 2024 and December 31, 2023 consisted of the following (in millions): | | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
Down payments and prepayments, non-current | | $ | 321 | | | $ | 342 | |
Inventory, non-current(1) | | 161 | | | 170 | |
Goodwill | | 52 | | | 52 | |
Finite-lived intangible asset | | 42 | | | 44 | |
| | | | |
Equity investments | | 31 | | | 66 | |
Other | | 34 | | | 11 | |
Other non-current assets | | $ | 641 | | | $ | 685 | |
_______
(1)Consisted of raw materials with an anticipated consumption beyond one year.
Accrued Liabilities
Accrued liabilities, as of June 30, 2024 and December 31, 2023 consisted of the following (in millions):
| | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
Provisions related to product sales (Note 3) | | $ | 554 | | | $ | 556 | |
Compensation-related | | 187 | | | 245 | |
Manufacturing | | 119 | | | 167 | |
Other external goods and services | | 109 | | | 137 | |
Clinical trials | | 96 | | | 175 | |
Property, plant and equipment | | 93 | | | 94 | |
Development operations | | 90 | | | 140 | |
Raw materials | | 42 | | | 27 | |
Commercial | | 32 | | | 56 | |
Royalties | | 10 | | | 122 | |
Loss on future firm purchase commitments(1) | | 1 | | | 79 | |
| | | | |
Accrued liabilities | | $ | 1,333 | | | $ | 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 June 30, 2024 and December 31, 2023 consisted of the following (in millions):
| | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
| | | | |
Lease liabilities - operating (Note 10) | | $ | 25 | | | $ | 25 | |
| | | | |
| | | | |
Other | | 17 | | | 41 | |
Other current liabilities | | $ | 42 | | | $ | 66 | |
Deferred Revenue
The following table summarizes the activities in deferred revenue for the six months ended June 30, 2024 (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | December 31, 2023 | | Additions | | Deductions | | June 30, 2024 |
Product sales | | $ | 613 | | | $ | 196 | | | $ | (69) | | | $ | 740 | |
Grant revenue | | 4 | | | — | | | — | | | 4 | |
Collaboration revenue | | 34 | | | 6 | | | (7) | | | 33 | |
Licensing and royalty revenue | | — | | | 20 | | | — | | | 20 | |
Total deferred revenue | | $ | 651 | | | $ | 222 | | | $ | (76) | | | $ | 797 | |
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 costs under such arrangements on a straight-line basis over the life of the lease. We have two main campuses in Massachusetts, our Cambridge campus and our Moderna Technology Center (MTC), an industrial technology center located in Norwood. We also lease various parcels of land, and office and lab spaces across the globe for our business operations.
Cambridge Campus
Our Cambridge campus consists of multiple leased properties, including office and research laboratory spaces totaling approximately 667,000 square feet, including the Moderna Science Center.
Moderna Science Center
In September 2021, we entered into a lease agreement for a building in Cambridge, Massachusetts, comprising approximately 462,000 square feet. This facility, which includes our principal executive offices along with additional office and laboratory spaces, is referred to as the Moderna Science Center (MSC). After 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 condensed 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 by early 2025. All our Cambridge leases are classified as operating leases.
Moderna Technology Center
Our Moderna Technology Center is composed 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.
Operating and financing lease right-of-use assets and lease liabilities as of June 30, 2024 and December 31, 2023 were as follows (in millions):
| | | | | | | | | | | | | | |
| | June 30, | | December 31, |
| | 2024 | | 2023 |
Assets: | | | | |
Right-of-use assets, operating, net(1) (2) | | $ | 775 | | | $ | 713 | |
Right-of-use assets, financing, net(3) (4) | | 430 | | | 436 | |
Total | | $ | 1,205 | | | $ | 1,149 | |
| | | | |
Liabilities: | | | | |
Current: | | | | |
Operating lease liabilities(5) | | $ | 25 | | | $ | 25 | |
| | | | |
Total current lease liabilities | | 25 | | | 25 | |
Non-current: | | | | |
Operating lease liabilities, non-current | | 668 | | | 643 | |
Financing lease liabilities, non-current | | 576 | | | 575 | |
Total non-current lease liabilities | | 1,244 | | | 1,218 | |
Total | | $ | 1,269 | | | $ | 1,243 | |
_______
(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.
(4)Included in property, plant and equipment in the condensed consolidated balance sheets, net of accumulated depreciation.
(5)Included in other current liabilities in the condensed consolidated balance sheets.
Future minimum lease payments under our non-cancelable lease agreements as of June 30, 2024, were as follows (in millions):
| | | | | | | | | | | | | | | |
Fiscal Year | Operating Leases | | Financing Leases(1) |
2024 | (remainder of the year) | $ | |