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1、UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,DC 20549FORM10-Q(Mark One)QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the quarterly period ended March 31,2025OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF
2、1934For the transition period from _ to _Commission File Number:001-38753Moderna,Inc.(Exact Name of Registrant as Specified in Its Charter)Delaware81-3467528(State or Other Jurisdiction of Incorporation orOrganization)(IRS EmployerIdentification No.)325 Binney StreetCambridge,Massachusetts02142(Addr
3、ess of Principal Executive Offices)(Zip Code)(617)714-6500(Registrants 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 registeredCommon stock,par value$0.0001 per shareMRNAThe Nasdaq Sto
4、ck Market LLCIndicate 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
5、 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 thischapter)during the preceding 12 months(or for such shorter pe
6、riod 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.Seethe definitions of“large accelerated filer”,“acceler
7、ated filer”,“smaller reporting company”,and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filerAccelerated filer oNon-accelerated filer oSmaller reporting companyEmerging growth companyIf an emerging growth company,indicate by check mark if the registrant has elected no
8、t to use the extended transition period for complying with any new or revised financialaccounting 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 April 25,2025,there wer
9、e 386,741,820 shares of the registrants common stock,par value$0.0001 per share,outstanding.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Quarterly Report on Form 10-Q(Form 10-Q)contains express or implied forward-looking statements.All statements other than those of historical factscontaine
10、d in this Form 10-Q are based on our managements 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 ability to drive use of Spikevax and mRESVIA and to increase market share
11、;our ability to execute on our prioritized research and development portfolio;our ability to deliver cost efficiency across our business;our expectations regarding the size and durability of the commercial COVID and RSV vaccines markets and our ability to effectively compete in suchmarkets,as well a
12、s the impact that evolving markets will have on our financial returns;expected sales and delivery of our vaccine products in future periods,and expected seasonality for sales;anticipated near-term regulatory actions with respect to product candidates in our respiratory virus vaccines portfolio,inclu
13、ding potential approvals;our ability to obtain and maintain regulatory approval of our product candidates across our portfolio;our ability to successfully launch and commercialize our products and the timing of launches;the potential of our oncology portfolio and our ability to expand to additional
14、tumor types;our ability and the ability of third parties with whom we contract to successfully manufacture,supply and distribute our COVID or RSV vaccines and anyfuture commercial products at scale,as well as drug substances,delivery vehicles,development candidates,and investigational medicines for
15、preclinicaland clinical use;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;internal and external costs associated with manufacturing our products,including o
16、ur COVID or RSV vaccines,and the impact on our cost of sales,andour anticipated 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,including those covering our commercial products,productcandidates and tec
17、hnology,and our expectations regarding pending legal proceedings related to our intellectual property;the timing of initiation,progress,completion,results and cost of our clinical trials,preclinical studies and research and development programs,as well asthose of our collaborators;participant enroll
18、ment in our clinical trials,including enrollment demographics and timing;potential advantages of mRNA as compared to traditional medicine;the implementation of our business model and strategic plans for our business,products,product candidates and technology;the pricing and reimbursement of our prod
19、ucts,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 ourop
20、erations;the potential benefits of strategic collaboration agreements and our ability to enter into strategic collaborations or other agreements with collaborators withdevelopment,regulatory and commercialization expertise;our financial performance;our tax positions and related tax liabilities;legal
21、 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;anddevelopments relating to our competitors and our industry.Forward-looking statements often contain words such
22、 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 statementscontain these words.Although we believe that the expect
23、ations reflected in these forward-looking statements are reasonable,these statements relate to futureevents or our operational or financial performance,and involve risks,uncertainties,and other factors that may cause our actual results to differ materially fromany future results expressed or implied
24、 by these forward-looking statements.Accordingly,you should not place undue reliance on these forward-lookingstatements.Factors that may cause actual results to differ materially from current expectations include,among other things,those listed under the sectionentitled“Risk Factors”and elsewhere in
25、 this Form 10-Q and under Part I,Item 1A.“Risk Factors”in our Annual Report on Form 10-K for the fiscal yearended December 31,2024.If one or more of these risks or uncertainties occur,or if our underlying assumptions prove to be incorrect,actual results could differmaterially from those expressed or
26、 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
27、forward-looking statements as representing ourviews 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 withthe Securities and Exchange Commission should be consulted.TRADEMARKSThis Form 10-Q contains refere
28、nces to our trademarks and to trademarks belonging to other entities.Solely for convenience,trademarks and trade namesreferred to may appear without the or symbols,but such references are not intended to indicate that their respective owners will not assert,to the fullestextent under applicable law,
29、their rights thereto.We do not intend our reference to other companies trade names or trademarks to imply a relationship with,orendorsement or sponsorship of us by,any other companies.NOTE REGARDING COMPANY REFERENCESUnless the context otherwise requires,the terms“Moderna,”the“Company,”“we,”“us”and“
30、our”in this Form 10-Q refer to Moderna,Inc.and itsconsolidated subsidiaries.ADDITIONAL INFORMATIONOur website,including the Investor Relations section,;and corporate our Statements and Perspectives webpage,https:/ as our social media channels:Facebook, Threads(moderna_tx)contain a significant amount
31、 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 frequentlyupdated and new information is shared.Information contained on our website,corporate blog and social media channels sh
32、all not be deemed incorporated into,or be a part of,this Form 10-Q.Table of ContentsPART I.PageItem 1.Financial Statements(Unaudited)5Condensed Consolidated Balance Sheets as of March 31,2025 and December 31,20245Condensed Consolidated Statements of Operations for the three months ended March 31,202
33、5 and 20246Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31,2025 and 20247Condensed Consolidated Statements of Stockholders Equity for the three months ended March 31,2025 and 20248Condensed Consolidated Statements of Cash Flows for the three months ended M
34、arch 31,2025 and 20249Notes to Condensed Consolidated Financial Statements10Item 2.Managements Discussion and Analysis of Financial Condition and Results of Operations27Item 3.Quantitative and Qualitative Disclosures about Market Risk35Item 4.Controls and Procedures35PART II.Item 1.Legal Proceedings
35、36Item 1A.Risk Factors37Item 2.Unregistered Sales of Equity Securities and Use of Proceeds37Item 5.Other Information37Item 6.Exhibits37SIGNATURES38Table of ContentsItem 1.Financial StatementsMODERNA,INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited,in millions,except per share data)March 31,Decemb
36、er 31,20252024AssetsCurrent assets:Cash and cash equivalents$1,623$1,927 Investments4,352 5,098 Accounts receivable,net78 358 Inventory128 117 Prepaid expenses and other current assets585 599 Total current assets6,766 8,099 Investments,non-current2,418 2,494 Property,plant and equipment,net2,212 2,1
37、96 Right-of-use assets,operating leases752 759 Other non-current assets556 594 Total assets$12,704$14,142 Liabilities and Stockholders EquityCurrent liabilities:Accounts payable$226$405 Accrued liabilities1,001 1,427 Deferred revenue125 153 Other current liabilities252 221 Total current liabilities1
38、,604 2,206 Deferred revenue,non-current58 58 Operating lease liabilities,non-current667 671 Financing lease liabilities,non-current35 39 Other non-current liabilities274 267 Total liabilities2,638 3,241 Commitments and contingencies(Note 11)Stockholders equity:Preferred stock,par value$0.0001;162 sh
39、ares authorized as of March 31,2025 and December 31,2024;noshares issued or outstanding at March 31,2025 and December 31,2024 Common stock,par value$0.0001;1,600 shares authorized as of March 31,2025 and December 31,2024;387and 386 shares issued and outstanding as of March 31,2025 and December 31,20
40、24,respectively Additional paid-in capital982 866 Accumulated other comprehensive income(loss)10(10)Retained earnings9,074 10,045 Total stockholders equity10,066 10,901 Total liabilities and stockholders equity$12,704$14,142 The accompanying notes are an integral part of these unaudited condensed co
41、nsolidated financial statements.5Table of ContentsMODERNA,INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited,in millions,except per share data)Three Months Ended March 31,20252024Revenue:Net product sales$86$167 Other revenue22 Total revenue108 167 Operating expenses:Cost of sales90 96 Re
42、search and development856 1,063 Selling,general and administrative212 274 Total operating expenses1,158 1,433 Loss from operations(1,050)(1,266)Interest income90 120 Other expense,net(4)(19)Loss before income taxes(964)(1,165)Provision for income taxes7 10 Net loss$(971)$(1,175)Net loss per shareBas
43、ic and diluted$(2.52)$(3.07)Weighted average common shares used in calculation of net loss per shareBasic and diluted386 382 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.6Table of ContentsMODERNA,INC.CONDENSED CONSOLIDATED STATEMENTS OF C
44、OMPREHENSIVE LOSS(Unaudited,in millions)Three Months Ended March 31,20252024Net loss$(971)$(1,175)Other comprehensive income,net of tax:Available-for-sale securities:Unrealized gains on available-for-sale securities16 20 Less:net realized(gains)losses on available-for-sale securities reclassified in
45、 net loss(1)2 Net increase from available-for-sale securities15 22 Pension and postretirement obligation adjustments2 Gains on foreign currency translation3 Total other comprehensive income20 22 Comprehensive loss$(951)$(1,153)The accompanying notes are an integral part of these unaudited condensed
46、consolidated financial statements.7Table of ContentsMODERNA,INC.CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY(Unaudited,in millions)Common StockAdditionalPaid-InCapitalAccumulatedOtherComprehensiveIncome(Loss)RetainedEarningsTotalStockholdersEquitySharesAmountBalance at December 31,202438
47、6$866$(10)$10,045$10,901 Vesting of restricted common stock units1 Exercise of options to purchase common stock 2 2 Tax payments related to net share settlements on equity awards (1)(1)Stock-based compensation 115 115 Other comprehensive income,net of tax 20 20 Net loss (971)(971)Balance at March 31
48、,2025387$982$10$9,074$10,066 Common StockAdditionalPaid-InCapitalAccumulatedOtherComprehensiveLossRetainedEarningsTotalStockholdersEquitySharesAmountBalance at December 31,2023382$371$(123)$13,606$13,854 Exercise of options to purchase common stock1 15 15 Stock-based compensation 101 101 Other compr
49、ehensive income,net of tax 22 22 Net loss (1,175)(1,175)Balance at March 31,2024383$487$(101)$12,431$12,817 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.8Table of ContentsMODERNA,INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudit
50、ed,in millions)Three Months Ended March 31,20252024Operating activitiesNet loss$(971)$(1,175)Adjustments to reconcile net loss to net cash used in operating activities:Stock-based compensation115 101 Depreciation and amortization39 36 Amortization/accretion of investments(19)(27)Loss on equity inves
51、tments,net8 13 Other non-cash items2 3 Changes in assets and liabilities:Accounts receivable,net280 755 Prepaid expenses and other assets46 3 Inventory(8)(93)Right-of-use assets,operating leases9 16 Accounts payable(156)(303)Accrued liabilities(381)(398)Deferred revenue(29)(33)Operating lease liabil
52、ities(5)(6)Other liabilities33 119 Net cash used in operating activities(1,037)(989)Investing activitiesPurchases of marketable securities(1,764)(2,544)Proceeds from maturities of marketable securities1,933 1,573 Proceeds from sales of marketable securities688 1,285 Purchases of property,plant and e
53、quipment(117)(196)Purchase of intangible asset(10)Net cash provided by investing activities730 118 Financing activitiesProceeds from issuance of common stock through equity plans3 15 Tax payments related to net share settlements on equity awards(1)Changes in financing lease liabilities2(1)Net cash p
54、rovided by financing activities4 14 Net decrease in cash,cash equivalents and restricted cash(303)(857)Cash,cash equivalents and restricted cash,beginning of year1,929 2,928 Cash,cash equivalents and restricted cash,end of period$1,626$2,071 Non-cash investing and financing activitiesPurchases of pr
55、operty and equipment included in accounts payable and accrued liabilities$50$91 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.9Table of ContentsMODERNA,INC.NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(Unaudited)1.Description of the
56、 BusinessModerna,Inc.(collectively,with its consolidated subsidiaries,any of Moderna,we,us,our or the Company)is a biotechnology company advancing a newclass of medicines made of messenger RNA(mRNA).mRNA medicines are designed to direct the bodys cells to produce intracellular,membrane or secretedpr
57、oteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases.Our platform builds on continuous advances inbasic and applied mRNA science,delivery technology and manufacturing,providing us the capability to pursue in parallel a robust pipeline of new
58、development candidates.We are developing medicines across four franchises:respiratory virus vaccines,latent and other virus vaccines,oncology therapeuticsand rare disease therapeutics.Our approved COVID vaccine(mRNA-1273)is our first commercial product and is marketed under the name Spikevax.mRNA-12
59、73 was first developed totarget 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 provideprotection as the virus evolves and regulatory guidance is updated.In May 2024,the U.S.Food and Drug Administration(FDA)approv
60、ed mRESVIA(mRNA-1345),our mRNA respiratory syncytial virus(RSV)vaccine,to protect adults aged 60 years and older from lower respiratory tract disease caused byRSV infection.This marks our second approved product developed using our mRNA platform.We have a diverse and extensive development pipeline o
61、f 31 development candidates across our 41 development programs,of which 38 are in clinical studiescurrently.2.Summary of Basis of Presentation and Recent Accounting StandardsBasis of Presentation and Principles of ConsolidationThe accompanying unaudited condensed consolidated financial statements th
62、at accompany these notes have been prepared in accordance with U.S.generallyaccepted 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 Repo
63、rt on Form 10-K for the year ended December 31,2024(2024 Form 10-K).Anyreference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found inthe Accounting Standards Codification(ASC)and Accounting Standards Up
64、date(ASU)of the Financial Accounting Standards Board(FASB).This reportshould be read in conjunction with the audited consolidated financial statements in our 2024 Form 10-K.The condensed consolidated financial statements include Moderna,Inc.and its subsidiaries.All intercompany transactions and bala
65、nces have been eliminatedin consolidation.Except for(1)the revision to the estimated useful lives of certain manufacturing equipment(refer to Use of Estimates below),and(2)updates to our approach for estimating the expected term of stock options and the removal of peer company data in determining ex
66、pected volatility for stock-based compensation(refer to Note 12),the significant accounting policies used in the preparation of these condensed consolidated financial statements for thethree months ended March 31,2025 are consistent with those described in our 2024 Form 10-K.The results of operation
67、s for the three months ended March 31,2025 are not necessarily indicative of the operating results to be expected for the full fiscal year or future operating periods.We anticipate seasonal fluctuationsin demand for our COVID and RSV vaccines,with higher sales expected during the fall and winter sea
68、sons.Use of EstimatesWe have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes.Webase our estimates on historical experience and various relevant assumptions that we believe to be reasonable under the circumstanc
69、es,the results of whichform the basis for making judgments about the carrying values of assets and liabilities at the date of the financial statements and the reported amounts ofrevenues and expenses during the reporting periods that are not readily apparent from other sources.Changes in our estimat
70、es are recorded in the financialresults of the period in which the new information becomes available.The actual results that we experience may differ materially from our estimates.10Table of ContentsEffective January 1,2025,we revised the estimated useful life of certain manufacturing equipment from
71、 five years to a range of five to twelve years.Thischange followed an assessment completed in connection with the expansion of our internal manufacturing capabilities and reflects the expected economicutility of the equipment.The change was accounted for prospectively,with carrying values depreciate
72、d over their revised remaining useful lives.As a result,depreciation expense and net loss for the three months ended March 31,2025 decreased by an immaterial amount.Comprehensive Income(Loss)Comprehensive income(loss)includes net income(loss)and other comprehensive income/loss for the period.Other c
73、omprehensive income/loss consists ofunrealized gains/losses on our investments,derivatives designated as hedging instruments,foreign currency translation,and pension and postretirementobligation adjustments.Total comprehensive income(loss)for all periods presented has been disclosed in the condensed
74、 consolidated statements ofcomprehensive loss.The components of accumulated other comprehensive income(loss)for the three months ended March 31,2025 were as follows(in millions):Unrealized Gains onAvailable-for-Sale DebtSecuritiesPension andPostretirementObligationAdjustmentsLosses on ForeignCurrenc
75、y TranslationTotalAccumulated other comprehensive loss,balance at December 31,2024$10$(12)$(8)$(10)Other comprehensive income15 2 3 20 Accumulated other comprehensive income,balance at March 31,2025$25$(10)$(5)$10 Restricted CashWe include our restricted cash balance in the cash,cash equivalents and
76、 restricted cash reconciliation of operating,investing and financing activities in thecondensed 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 ofthe sa
77、me such amounts shown in the condensed consolidated statements of cash flows(in millions):March 31,20252024Cash and cash equivalents$1,623$2,051 Restricted cash1 17 Restricted cash,non-current2 3 Total cash,cash equivalents and restricted cash shown in the condensed consolidated statements of cash f
78、lows$1,626$2,071 _Included in prepaid expenses and other current assets in the condensed consolidated balance sheets.Included in other non-current assets in the condensed consolidated balance sheets.Recently Issued Accounting StandardsFrom time to time,new accounting pronouncements are issued by the
79、 FASB or other standard setting bodies and adopted by us as of the specified effectivedate.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 condensedconsolidated financial statements and disclosures.(1)(2)
80、(1)(2)11Table of ContentsIn December 2023,the FASB issued ASU No.2023-09,Income Taxes(Topic 740):Improvements to Income Tax Disclosures.This ASU requiresdisaggregated information about a reporting entitys effective tax rate reconciliation as well as additional information on income taxes paid.The st
81、andardrequires entities to disclose federal,state,and foreign income taxes in their rate reconciliation tables and elaborate on reconciling items that exceed aquantitative threshold.Additionally,it requires an annual disclosure of income taxes paid,net of refunds,categorized by jurisdiction based on
82、 a quantitativethreshold.The ASU is effective on a prospective basis for fiscal years beginning after December 15,2024.Early adoption is permitted.This ASU will result inthe required additional disclosures being included in our consolidated financial statements,once adopted.We are currently assessin
83、g the impact that this newaccounting standard will have on our consolidated financial statement disclosures.In November 2024,the FASB issued ASU 2024-03,Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures(Subtopic220-40):Disaggregation of Income Statement Expenses.This
84、 ASU requires entities to disclose,on an annual and interim basis,disaggregated information inthe footnotes related to certain expense categories included in income statement line items.Specifically,entities are expected to provide tabular disclosures forprescribed categories such as inventory purch
85、ases,employee compensation,depreciation,and intangible asset amortization for each relevant expense caption.The standard also requires disclosure of total selling expenses and a definition of those expenses in annual filings.Any remaining amounts not quantitativelydisclosed are expected to be descri
86、bed qualitatively.This ASU is effective for fiscal years beginning after December 15,2026 and interim periods beginningafter December 15,2027.Early adoption permitted,and the standard may be applied on a prospective or retrospective basis.We are currently assessing theimpact that this new accounting
87、 standard will have on our consolidated financial statement disclosures.3.Net Product SalesNet product sales by customer geographic location were as follows(in millions):Three Months Ended March 31,20252024United States$31$100 Europe Rest of world55 67 Total$86$167 Net product sales by product were
88、as follows(in millions):Three Months Ended March 31,20252024COVID$84$167 RSV2 Total$86$167 As of March 31,2025,we have two commercial products authorized for use,our COVID vaccine(mRNA-1273)and our RSV vaccine(mRNA-1345).TheRSV vaccine was approved by the FDA in May 2024 for adults aged 60 years and
89、 older.We sell our COVID vaccine to the commercial market as well as to foreign governments and international organizations.We launched commercial sales of ourRSV vaccine in the third quarter of 2024.In the U.S.,our COVID and RSV vaccines are sold to wholesalers and distributors,and to a lesser exte
90、nt,directly toretailers and healthcare providers.Wholesalers and distributors typically do not make upfront payments to us.Net product sales are recognized net of estimatedwholesaler chargebacks,invoice discounts for prompt payments and pre-orders,provisions for sales returns and government rebates,
91、and other relateddeductions.12Table of ContentsThe following table summarizes product sales provision for the periods presented(in millions):Three Months Ended March 31,20252024Gross product sales$105$222 Product sales provision:Wholesaler chargebacks,discounts and fees(22)(22)Returns,rebates and ot
92、her fees3(33)Total product sales provision$(19)$(55)Net product sales$86$167 The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the three months ended March 31,2025(inmillions):Returns and other feesBalance at December 31,2024$(370)Pr
93、ovision related to sales made in current period(8)Provision related to sales made in prior periods11 Payments and returns related to sales made in current period Payments and returns related to sales made in prior year30 Balance at March 31,2025$(337)Prior to the launch of our commercial market sale
94、s,we sold our COVID vaccine primarily to the U.S.Government,foreign governments and internationalorganizations.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 upfr
95、ont deposits for our COVID vaccine supply,initially recorded as deferred revenue.As of March 31,2025 and December 31,2024,we had deferred revenue of$154 million and$188 million,respectively,related to customer deposits for ourCOVID vaccine.We expect$96 million of our deferred revenue related to cust
96、omer deposits as of March 31,2025 to be realized in less than one year.Timingof product delivery and manufacturing,and receipt of marketing approval for the applicable COVID vaccine will determine the period in which product salesare recognized.4.Other RevenueThe following table summarizes other rev
97、enue for the periods presented(in millions):Three Months Ended March 31,20252024Grant revenue$1$Collaboration revenue(Note 5)1 Licensing and royalty revenue8 Other revenue12 Total other revenue$22$Grant RevenueIn April 2020,we entered into an agreement with the Biomedical Advanced Research and Devel
98、opment Authority(BARDA),a division of the Administrationfor Strategic Preparedness and Response(ASPR)within the U.S.Department of Health and Human Services(HHS),for an award of up to$483 million toaccelerate development of our original COVID vaccine,mRNA-1273.The agreement has been subsequently amen
99、ded to provide for additional commitmentsto support various late-stage clinical development efforts of our original COVID vaccine,including a 30,000 participant Phase 3 study,pediatric clinical trials,adolescent clinical trials13Table of Contentsand pharmacovigilance studies.The maximum award from B
100、ARDA,inclusive of all amendments,was approximately$1.8 billion.All contract options havebeen exercised.As of March 31,2025,the remaining available funding,net of revenue earned was$63 million.In June 2024,we were awarded up to$176 million through the Rapid Response Partnership Vehicle(RRPV),funded b
101、y BARDA,to accelerate thedevelopment of mRNA-based pandemic influenza vaccines.The project award will support the late-stage development of an mRNA-based vaccine to enablethe licensure of a pre-pandemic vaccine against the H5 influenza virus.This subtype of the influenza virus causes a highly infect
102、ious and severe disease inbirds known as avian influenza and poses a risk of spillover into the human population.The agreement also includes additional options to prepare for andaccelerate responses to future public health threats.In January 2025,we were awarded up to$590 million through the RRPV,fu
103、nded by BARDA,to supportthe continued late-stage development and licensure of mRNA-based pre-pandemic influenza vaccines,including expanded clinical studies for up to fiveadditional subtypes of pandemic influenza.This funding builds on the scope of the June 2024 funding related to the H5 influenza v
104、irus and expands theprogram to cover additional influenza subtypes.Revenue recognized related to this agreement was immaterial as of March 31,2025.Licensing and Royalty RevenueIn April 2024,we entered a non-exclusive out-licensing agreement with a pharmaceutical company based in Japan for mRNA COVID
105、-related intellectualproperty for the territory of Japan.Under the terms of the agreement,we received an upfront payment of$50 million,which included a$20 million prepaymentcreditable against future royalties.Additionally,we are entitled to receive low double-digit royalties on the net sales of the
106、companys COVID product.Uponexecution of the agreement,we recognized$30 million of the upfront payment as other revenue in our condensed consolidated statements of operations.Theremaining$20 million was recorded as deferred revenue in our condensed consolidated balance sheets and recognized as royalt
107、y revenue as the underlyingsales occurred.As of March 31,2025,the full$20 million has been amortized and recognized pursuant to the terms of the agreement.Other RevenueWe have entered into long-term strategic agreements with certain government entities to establish domestic mRNA manufacturing capabi
108、lities and supportpandemic readiness.Under these agreements,we are required to build and maintain manufacturing facilities and to supply vaccines in accordance withminimum spend commitments or annual demand forecasts established by the respective governments.A portion of the total consideration unde
109、r eachagreement is allocated to a stand-ready obligation to maintain manufacturing readiness and is recognized as other revenue on a straight-line basis over thecontractual period.The remaining consideration is related to our obligation to supply vaccines and will be recognized as product sales when
110、 control of thevaccines transfers upon delivery.5.Collaboration Agreements and Research and Development Funding ArrangementMerck Personalized mRNA Cancer Vaccines(Individualized Neoantigen Therapy)In June 2016,we entered into a Collaboration and License Agreement for the development and commercializ
111、ation of personalized mRNA cancer vaccines(alsoknown as INT)with Merck.This agreement was subsequently amended and restated in 2018.Our role in this strategic alliance involves identifying geneticmutations in a particular patients tumor cells,synthesizing mRNA for these mutations,encapsulating the m
112、RNA 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 patients immune system against her or hisown cancer cells.INT has recently been assigned the generic name intismeran autogene.In September 202
113、2,Merck exercised its option for INT,including mRNA-4157,pursuant to the terms of the agreement and in October 2022 paid us an optionexercise fee of$250 million.Following this exercise,the Merck Participation Term commenced.Pursuant to the agreement,we and Merck have agreed tocollaborate on developm
114、ent and potential commercialization of INT,with costs and any profits or losses generally shared equally on a worldwide basis,subjectto certain exceptions as outlined in the agreement.We concluded that the collaboration arrangement under the Merck Participation Term is within the scope ofASC 808.For
115、 the three months ended March 31,2025 and 2024,we recognized expenses,net of Mercks reimbursements,of$104 million and$76 million,respectively,related to the INT collaboration under the Merck Participation Term.Additionally,for the three months ended March 31,2025 and 2024,the netcost recovery for ca
116、pital expenditures was$12 million and$24 million,respectively.These amounts were applied to reduce the capitalized cost of the assets.14Table of ContentsWe have other collaborative and licensing arrangements that we do not consider to be individually significant to our business at this time.Pursuant
117、 to theseagreements,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 theco
118、rresponding events have occurred.In addition,we may be required to pay significant royalties on future sales if products related to these arrangements arecommercialized.Development and Commercialization Funding Arrangement with Blackstone Life Sciences(Blackstone)In March 2024,we entered into a deve
119、lopment and commercialization funding arrangement with Blackstone,under which Blackstone has committed toproviding up to$750 million in funding to us.This funding supports the development of our investigational mRNA-based influenza vaccine.Contingent uponregulatory approval in the U.S.and only if th
120、e approval is dependent on data from the funded activities,Blackstone will be entitled to receive low single-digitpercentage royalties and up to$750 million in sales milestone payments.These payments are based on net sales of our future influenza and combinationvaccines,with sales milestone payments
121、 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
122、influenza program.This reduction is recognized proportionally as the relatedcosts are incurred,based on an input method.For the three months ended March 31,2025,we recorded a research and development expense reduction of$90 million.No such expense reduction was recorded during the three months ended
123、 March 31,2024.As of March 31,2025,no research and developmentfunding liability remained related to the advance funding received from Blackstone.The liability was$58 million as of December 31,2024.15Table of Contents6.Financial InstrumentsCash and Cash Equivalents and InvestmentsThe following tables
124、 summarize our cash,cash equivalents,and available-for-sale securities by significant investment category as of March 31,2025 andDecember 31,2024(in millions):March 31,2025AmortizedCostUnrealizedGainsUnrealizedLossesEstimatedFair ValueCash andCashEquivalentsCurrentMarketableSecuritiesNon-CurrentMark
125、etableSecuritiesCash and cash equivalents$1,623$1,623$1,623$Available-for-sale:Certificates of deposit102 102 97 5 U.S.treasury bills731 731 731 U.S.treasury notes2,874 4(8)2,870 1,712 1,158 Corporate debt securities2,976 4(5)2,975 1,732 1,243 Government debt securities92 92 80 12 Total$8,398$8$(13)
126、$8,393$1,623$4,352$2,418 December 31,2024AmortizedCostUnrealizedGainsUnrealizedLossesEstimatedFair ValueCash andCashEquivalentsCurrentMarketableSecuritiesNon-CurrentMarketableSecuritiesCash and cash equivalents$1,927$1,927$1,927$Available-for-sale:Certificates of deposit52 52 52 U.S.treasury bills78
127、6 786 786 U.S.treasury notes3,048 3(15)3,036 1,958 1,078 Corporate debt securities3,590 3(13)3,580 2,172 1,408 Government debt securities138 138 130 8 Total$9,541$6$(28)$9,519$1,927$5,098$2,494 The amortized cost and estimated fair value of available-for-sale securities by contractual maturity as of
128、 March 31,2025 and December 31,2024 were asfollows(in millions):March 31,2025AmortizedCostEstimatedFair ValueDue in one year or less$4,352$4,352 Due after one year through five years2,423 2,418 Total$6,775$6,770 December 31,2024AmortizedCostEstimatedFair ValueDue in one year or less$5,106$5,098 Due
129、after one year through five years2,508 2,494 Total$7,614$7,592 In accordance with our investment policy,we place investments in investment grade securities with high credit quality issuers,and generally limit the amountof credit exposure to any one issuer.We evaluate securities for impairment at the
130、 end of each reporting period.Impairment is evaluated considering numerousfactors,and their relative significance varies depending on the situation.16Table of ContentsFactors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-cre
131、dit-related factors,thefinancial 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.Anyimpairment that is not credit related is recognized in other comprehensive loss,net of applicable taxes.A credit-re
132、lated impairment is recognized as anallowance on the balance sheet with a corresponding adjustment to earnings.We did not recognize any impairment charges related to available-for-salesecurities for the three months ended March 31,2025 and 2024.We did not record any credit-related allowance for avai
133、lable-for-sale securities as of March 31,2025 and December 31,2024.The following table summarizes the amount of gross unrealized losses and the estimated fair value for our available-for-sale securities in an unrealized lossposition by the length of time the securities have been in an unrealized los
134、s position as of March 31,2025 and December 31,2024(in millions):Less than 12 Months12 Months or MoreTotalGrossUnrealizedLossesEstimated FairValueGrossUnrealizedLossesEstimated FairValueGrossUnrealizedLossesEstimated FairValueAs of March 31,2025:U.S.treasury bills$708$708 U.S.treasury notes(1)397(7)
135、613(8)1,010 Corporate debt securities(1)652(4)735(5)1,387 Government debt securities 12 8 20 Total$(2)$1,769$(11)$1,356$(13)$3,125 As of December 31,2024:U.S.treasury bills$101$101 U.S.treasury notes(2)729(13)960(15)1,689 Corporate debt securities(4)843(9)1,646(13)2,489 Government debt securities 37
136、 37 Total$(6)$1,673$(22)$2,643$(28)$4,316 As of March 31,2025 and December 31,2024,we held 180 and 252 available-for-sale securities,respectively,out of our total investment portfolio that were ina continuous unrealized loss position.We neither intend to sell these investments,nor do we believe that
137、 we are more-likely-than-not to conclude we will haveto 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 BasisThe following fair va
138、lue hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used to value the assets andliabilities:Level 1:Unadjusted quoted prices in active markets that are accessible at the measurement date for identical,unrestricted assets or liabilities;Leve
139、l 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;orLevel 3:Prices or valuation techniques that require inputs that
140、 are both significant to the fair value measurement and unobservable(i.e.,supported bylittle or no market activity).17Table of ContentsThe following tables summarize our financial assets and liabilities measured at fair value on a recurring basis as of March 31,2025 and December 31,2024(inmillions):
141、Fair value at March 31,2025Fair Value Measurement UsingLevel 1Level 2Assets:Money market funds$558$558$Certificates of deposit102 102 U.S.treasury bills1,174 1,174 U.S.treasury notes2,870 2,870 Corporate debt securities3,367 3,367 Government debt securities92 92 Equity investments6 6 Derivative inst
142、ruments2 2 Total$8,171$564$7,607 There were no financial liabilities measured at fair value as of March 31,2025.Fair value at December31,2024Fair Value Measurement UsingLevel 1Level 2Assets:Money market funds$1,195$1,195$Certificates of deposit52 52 U.S.treasury bills1,016 1,016 U.S.treasury notes3,
143、036 3,036 Corporate debt securities3,763 3,763 Government debt securities138 138 Equity Investments14 14 Derivative instruments10 10 Total$9,224$1,209$8,015 Liabilities:Derivative instruments$2$2 _Investments in publicly traded equity securities with readily determinable fair values are recorded at
144、quoted market prices for identical securities,withchanges in fair value recorded in other expense,net,in our condensed consolidated statements of operations.As of March 31,2025 and December 31,2024,we did not have non-financial assets or liabilities measured at fair value on a recurring basis and di
145、d not haveany Level 3 financial assets or financial liabilities.For the three months ended March 31,2025 and 2024,we recognized net losses of$8 million and$13 million,respectively,on equity investments fromchanges in fair value of the securities.(1)(1)(1)18Table of Contents7.InventoryInventory as of
146、 March 31,2025 and December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Raw materials$75$63 Work in progress39 26 Finished goods14 28 Total inventory$128$117 Inventory,non-current$134$150 _Consisted of raw materials with an anticipated consumption beyond one year.Inv
147、entory,non-current is included in other non-current assets in the condensedconsolidated 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 ofcost of sales in our condensed consolidated sta
148、tements of operations.For the three months ended March 31,2025 and 2024,inventory write-downs were$42 million and$30 million,respectively.For the three months ended March 31,2025,losses on firm purchase commitments were$10 million.For the threemonths ended March 31,2024,there were no losses on firm
149、purchase commitments.Inventory write-downs were mainly related to inventory in excess ofexpected demand and shelf-life expiration.Losses on firm purchase commitments were primarily related to excess raw material purchase commitments thatwill expire before the anticipated consumption of those raw mat
150、erials.As of March 31,2025 and December 31,2024,the accrued liability for losses on firmfuture purchase commitments in our condensed consolidated balance sheets was$20 million and$60 million,respectively.As of March 31,2025 and December 31,2024,we had inventory on hand of$262 million and$267 million
151、,respectively,inclusive of inventory for ourCOVID and RSV vaccines.Our raw materials and work-in-progress inventory have variable shelf lives.We expect that the majority of this inventory will beconsumed over the next three years.The shelf life of our COVID vaccine product ranges from nine to twelve
152、 months.The shelf life of our RSV vaccine iseighteen months.8.Property,Plant and Equipment,NetProperty,plant and equipment,net,as of March 31,2025 and December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Land and land improvements$59$59 Building and building improvem
153、ents759 743 Manufacturing and laboratory equipment361 344 Leasehold improvements208 207 Furniture,fixtures and other31 31 Computer equipment and software150 150 Construction in progress1,078 1,057 Right-of-use assets,financing(Note 10)132 132 Total2,778 2,723 Less:Accumulated depreciation(566)(527)P
154、roperty,plant and equipment,net$2,212$2,196 Depreciation and amortization expense for the three months ended March 31,2025 and 2024 was$38 million and$35 million,respectively.(1)(1)19Table of Contents9.Other Balance Sheet ComponentsAccounts Receivable,netAccounts receivable,net,as of March 31,2025 a
155、nd December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Accounts receivable$249$698 Less:Wholesalers chargebacks,discounts and fees(171)(340)Accounts receivable,net$78$358 Prepaid Expenses and Other Current AssetsPrepaid expenses and other current assets,as of March
156、31,2025 and December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Prepaid services$171$173 Down payments and prepayments related to manufacturing and materials84 106 Income tax receivable72 72 Interest receivable53 59 Value added tax receivable45 45 Prepaid income tax
157、33 28 Research and development funding receivable(Note 5)32 Collaboration receivable26 58 Other current assets69 58 Prepaid expenses and other current assets$585$599 Other Non-Current AssetsOther non-current assets,as of March 31,2025 and December 31,2024 consisted of the following(in millions):Marc
158、h 31,December 31,20252024Inventory,non-current$134$150 Down payments and prepayments,non-current119 139 Income tax receivable,non-current99 97 Deferred tax assets81 81 Goodwill52 52 Finite-lived intangible asset49 40 Equity investments6 14 Other16 21 Other non-current assets$556$594 _Consisted of ra
159、w materials with an anticipated consumption beyond one year.(1)(1)20Table of ContentsAccrued LiabilitiesAccrued liabilities,as of March 31,2025 and December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Provisions related to product sales(Note 3)$337$370 Manufacturing1
160、28 109 Compensation-related120 312 Development operations120 120 Clinical trials88 94 Other external goods and services82 131 Property,plant and equipment49 99 Raw materials28 41 Commercial24 45 Loss on future firm purchase commitments20 60 Royalties5 46 Accrued liabilities$1,001$1,427 _Related to l
161、osses that are expected to arise from firm,non-cancellable,commitments for future raw material purchases(Note 7).Other Current LiabilitiesOther current liabilities,as of March 31,2025 and December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Estimated reimbursements t
162、o wholesalers and distributors$179$103 Research and development funding liability(Note 5)58 Lease liabilities-financing(Note 10)28 23 Lease liabilities-operating(Note 10)15 14 Other30 23 Other current liabilities$252$221 Other Non-Current LiabilitiesOther non-current liabilities,as of March 31,2025
163、and December 31,2024 consisted of the following(in millions):March 31,December 31,20252024Tax liabilities$234$231 Other40 36 Other non-current liabilities$274$267(1)(1)21Table of ContentsDeferred RevenueThe following table summarizes the activities in deferred revenue for the three months ended Marc
164、h 31,2025(in millions):December 31,2024AdditionsDeductionsMarch 31,2025Net product sales$188$(34)$154 Other revenue23 14(8)29 Total deferred revenue$211$14$(42)$183 10.LeasesWe have entered into various long-term,non-cancelable lease arrangements for our facilities and equipment,expiring at various
165、times through 2039.Certain ofthese arrangements have free rent periods or escalating rent payment provisions.We recognize lease costs under such arrangements on a straight-line basis overthe life of the lease.We lease various parcels of land,office,lab,and manufacturing spaces across the globe for o
166、ur business operations.We have two main campuses in Massachusetts,our Moderna Science Center(MSC),located in Cambridge,which serves as our headquarters,and our ModernaTechnology Center(MTC),located in Norwood.The MSC,comprising approximately 462,000 square feet,includes our principal executive offic
167、e andadditional office and laboratory spaces.The MSC lease commenced in the third quarter of 2023 and has a term of 15 years,with options for two additionalseven-year extensions.The MTC is a multiple-building campus spanning approximately 722,000 square feet.It includes laboratory and office space t
168、hatdirectly supports our manufacturing operations as well as our commercial and clinical activities.The MTC was previously subject to long-term leasearrangements,and we completed the acquisition of the campus,including the underlying land and buildings,in December 2024.Operating and financing lease
169、right-of-use assets and lease liabilities as of March 31,2025 and December 31,2024 were as follows(in millions):March 31,December 31,20252024Assets:Right-of-use assets,operating,net$752$759 Right-of-use assets,financing,net59 65 Total$811$824 Liabilities:Current:Operating lease liabilities$15$14 Fin
170、ancing lease liabilities28 23 Total current lease liabilities43 37 Non-current:Operating lease liabilities,non-current667 671 Financing lease liabilities,non-current35 39 Total non-current lease liabilities702 710 Total$745$747 _These assets are real estate related assets,which include land,office,m
171、anufacturing,and laboratory spaces.Net of accumulated amortization.These assets are related to contract manufacturing service agreements.Included in property,plant and equipment in the condensed consolidated balance sheets,net of accumulated depreciation.Included in other current liabilities in the
172、condensed consolidated balance sheets.(1)(2)(3)(4)(5)(5)(1)(2)(3)(4)(5)22Table of ContentsFuture minimum lease payments under our non-cancelable lease agreements as of March 31,2025,were as follows(in millions):Fiscal YearOperating LeasesFinancing Leases2025(remainder of the year)$47$25 202672 24 20
173、2777 18 202880 202982 Thereafter757 Total minimum lease payments1,115 67 Less amounts representing interest or imputed interest(433)(4)Present value of lease liabilities$682$63 11.Commitments and ContingenciesLegal ProceedingsWe are involved in various claims and legal proceedings of a nature consid
174、ered ordinary course in our business.The outcome of any such proceedings,regardless of the merits,is inherently uncertain;therefore,assessing the likelihood of loss and any estimated damages is difficult and subject to considerablejudgment.We are not currently a party to any legal proceedings for wh
175、ich a material loss is probable,or for which a loss is reasonably estimable at this time.Indemnification ObligationsAs permitted under Delaware law,we indemnify our officers,directors,and employees for certain events,occurrences while the officer,or director is,or was,serving at our request in such
176、capacity.The term of the indemnification is for the officers or directors lifetime.We have standard indemnification arrangements in our leases for laboratory and office space that require us to indemnify the landlord against any liability forinjury,loss,accident,or damage from any claims,actions,pro
177、ceedings,or costs resulting from certain acts,breaches,violations,or non-performance under ourleases.We enter into indemnification provisions under our agreements with counterparties in the ordinary course of business,typically with business partners,contractors,clinical sites and customers.Under th
178、ese provisions,we generally indemnify and hold harmless the indemnified party for losses suffered orincurred by the indemnified party as a result of our activities.These indemnification provisions generally survive termination of the underlying agreement.Themaximum potential amount of future payment
179、s we could be required to make under these indemnification provisions is unlimited.Through the three months ended March 31,2025 and the year ended December 31,2024,we had not experienced any material losses related to theseindemnification obligations,and no material claims were outstanding.We do not
180、 expect significant claims related to these indemnification obligations and,consequently,concluded that the fair value of these obligations is negligible,and no related reserves were established.Purchase Commitments and Purchase OrdersWe enter into agreements in the normal course of business with ve
181、ndors and contract manufacturing organizations for raw materials and manufacturing servicesand with vendors for preclinical research studies,clinical trials and other goods or services.As of March 31,2025,we had$454 million of non-cancelablepurchase commitments related to raw materials and manufactu
182、ring agreements,which are expected to be paid through 2027.As of March 31,2025,we had$191 million of non-cancelable purchase commitments related to research and development and other goods and services which are expected to be paidthrough 2028.These amounts represent our minimum contractual obligati
183、ons,including termination fees.23Table of ContentsIn addition to purchase commitments,we have agreements with third parties for various goods and services,including services related to clinical operationsand support and contract manufacturing,for which we are not contractually able to terminate for
184、convenience and avoid any and all future obligations to thevendors.Certain agreements provide for termination rights subject to termination fees or wind-down costs.Under such agreements,we are contractuallyobligated to make certain payments to vendors,mainly,to reimburse them for their unrecoverable
185、 outlays incurred prior to cancellation.As of March 31,2025,we had cancelable open purchase orders of$2.6 billion in total under such agreements for our significant clinical operations and support and contractmanufacturing.These amounts represent only our estimate of those items for which we had a c
186、ontractual commitment to pay as of March 31,2025,assumingwe would not cancel these agreements.The actual amounts we pay in the future to the vendors under such agreements may differ from the purchase orderamounts.Licenses to Patented TechnologyWe have patent license agreements with Cellscript,LLC an
187、d its affiliate,mRNA RiboTherapeutics,Inc.,and the National Institute of Allergy and InfectiousDiseases(NIAID),an Institute of the National Institutes of Health(NIH).Under these agreements,we are required to pay royalties and certain milestonepayments.For further information on our licensing and roy
188、alty payments,please refer to our 2024 Form 10-K under the heading“BusinessIntellectualPropertyIn-licensed intellectual property”and Note 11 to our consolidated financial statements contained therein.In January 2025,we entered into a non-exclusive patent license agreement with NIAID to license certa
189、in patent rights related to the development of mRNA-based vaccines for the prevention or treatment of respiratory syncytial virus(RSV)infection.Upon execution of the agreement,we made a total payment of$10 million,which was capitalized as an intangible asset and is amortized to cost of sales on a st
190、raight-line basis over the estimated useful life of the licensedpatents.In addition,we are obligated to pay low single-digit royalties on future net sales of licensed products.For the three months ended March 31,2025 and 2024,we recognized$5 million and$8 million,respectively,of royalty expenses ass
191、ociated with our productsales.These royalty expenses were recorded to cost of sales in our condensed consolidated statements of operations.Additionally,we have other in-license agreements with third parties which require us to make future development,regulatory and commercial milestonepayments and s
192、ales-based royalties for specified products associated with the agreements.The achievement of these milestones have not yet occurred as ofMarch 31,2025.12.Stock-Based Compensation and Share Repurchase ProgramsStock-Based CompensationThe following table presents the components and classification of s
193、tock-based compensation expense for the three months ended March 31,2025 and 2024 asfollows(in millions):Three Months Ended March 31,20252024Options$39$40 Restricted Stock Units(RSUs)71 55 Performance Stock Units(PSUs)1 3 Employee Stock Purchase Plan(ESPP)4 3 Total$115$101 Cost of sales$7$7 Research
194、 and development69 60 Selling,general and administrative39 34 Total$115$101 As of March 31,2025,there was$1.1 billion of total unrecognized compensation cost related to unvested stock-based compensation with respect to options,RSUs and PSUs granted.That cost is expected to be recognized over a weigh
195、ted-average period of 2.3 years as of March 31,2025.24Table of ContentsEffective in the first quarter of 2025,we revised the assumptions used in the Black-Scholes option pricing model for estimating the grant date fair value ofstock options.The expected term is estimated using a methodology that com
196、bines historical settlement data with a hypothetical settlement pattern foroutstanding options,based on estimated time to arrive at-the-money and adjusted for employee departure rates.We also revised our approach for estimatingexpected volatility by removing peer company data and using a blended mea
197、sure of our own historical and implied volatility.These updates reflect theincreased availability of company-specific data and did not have a material impact on stock-based compensation and our financial statements.Share Repurchase ProgramsAs of March 31,2025,$1.7 billion of our Board of Directors a
198、uthorization for repurchases of our common stock(the 2022 Repurchase Programs)remainsoutstanding,with no expiration date.During the three months ended March 31,2025,there were no shares repurchased.13.Income TaxesThe following table summarizes our income tax expense for the periods presented(in mill
199、ions,except for percentages):Three Months Ended March 31,20252024Loss before income taxes$(964)$(1,165)Provision for income taxes$7$10 Effective tax rate(0.7)%(0.9)%The effective tax rate for the three months ended March 31,2025 was higher than the statutory rate,primarily due to our global valuatio
200、n allowance,whichlimits our ability to recognize tax benefits from the loss.The higher effective tax rate was also impacted by certain of our foreign subsidiaries that have taxableincome,while we incurred a net loss before income taxes in other jurisdictions.The effective tax rate for the three mont
201、hs ended March 31,2025 wasconsistent with the same period in 2024,primarily due to the continued maintenance of global valuation allowance.For additional details regarding ourdeferred tax assets and the policies governing our valuation allowance,please refer to Note 13 to our consolidated financial
202、statements in our 2024 Form 10-K.We periodically reassess the need for valuation allowances on our deferred tax assets,considering both positive and negative evidence to evaluate whether it ismore likely than not that all or a portion of such assets will not be realized.Significant management judgme
203、nt is required in assessing the realizability of ourdeferred tax assets.In the event that actual results differ from our estimates,we adjust our estimates in future periods and we may need to modify our valuationallowance,which could materially impact our financial position and results of operations
204、.We file U.S.federal income tax returns and income tax returns in various state,local and foreign jurisdictions.As of March 31,2025,we are under audit invarious state and foreign jurisdictions;however,no adjustments to our tax positions have been proposed at this time.25Table of Contents14.Loss per
205、ShareThe computation of basic loss per share(EPS)is based on the weighted-average number of our common shares outstanding.The computation of diluted EPS isbased on the weighted-average number of our common shares outstanding and potential dilutive common shares during the period as determined by usi
206、ng thetreasury stock method.Basic and diluted EPS for the three months ended March 31,2025 and 2024 were calculated as follows(in millions,except per share data):Three Months Ended March 31,20252024Numerator:Net loss$(971)$(1,175)Denominator:Basic and diluted weighted-average common shares outstandi
207、ng386 382 Basic and diluted EPS$(2.52)$(3.07)Common stock equivalents excluded from the EPS computation above because their inclusion would have been anti-dilutive49 35 26Table of Contents2.MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the follow
208、ing discussion and analysis of our financial condition and results of operations together with our unaudited financial informationand related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financial information in our Annual Reporton Form 10-K
209、for the fiscal year ended December 31,2024,which was filed with the Securities and Exchange Commission(the SEC)on February 21,2025(the 2024 Form 10-K).OverviewWe are a biotechnology company advancing a new class of medicines made of messenger RNA(mRNA).mRNA medicines are designed to direct the bodys
210、cells to produce intracellular,membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum ofdiseases.Our platform builds on continuous advances in basic and applied mRNA science,delivery technology and manufacturing,providing us the cap
211、abilityto pursue in parallel a robust pipeline of new development candidates.We are developing medicines across four franchises:respiratory virus vaccines,latentand other virus vaccines,oncology therapeutics and rare disease therapeutics.Since our founding in 2010,we have transformed from a research
212、-stage company advancing programs in the field of mRNA to a commercial enterprise with adiverse clinical portfolio of vaccines and therapeutics across several modalities,a broad intellectual property portfolio and integrated manufacturingcapabilities that allow for rapid clinical and commercial prod
213、uction at scale.We have a diverse and extensive development pipeline of 31 developmentcandidates across our 41 development programs,of which 38 are in clinical studies currently.Our approved COVID vaccine(mRNA-1273)is our first commercial product and is marketed under the name Spikevax.mRNA-1273 was
214、 first developed totarget 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 provideprotection as the virus evolves and regulatory guidance is updated.In May 2024,the U.S.Food and Drug Administration(FDA)granted appr
215、oval formRESVIA (mRNA-1345),our mRNA vaccine against respiratory syncytial virus(RSV),to protect adults aged 60 and older from lower respiratory tractdisease caused by RSV infection.This marks our second approved product developed using our mRNA platform.Business HighlightsRSVmRESVIA has received re
216、gulatory approvals in the U.S.and European Union for use in adults aged 60 years and older and is commercially available.In thefirst quarter of 2025,additional approvals were granted in Australia,the United Kingdom,Switzerland and Taiwan,further expanding potential access tomRESVIA for older adults.
217、We continue to pursue regulatory submissions in additional markets worldwide.European Union TenderIn January 2025,we were awarded a multi-year tender agreement to compete to supply our mRNA COVID vaccine to 17 participating countries in theEuropean Union,as well as Norway and North Macedonia.The agr
218、eement allows participating countries to access vaccine supply over a period of up to fouryears and supports diversity of supply,including multiple product formats such as prefilled syringes.Purchases under the agreement are subject to futurecountry-level orders.Net Product Sales and Net Loss Per Sh
219、areFor the first quarter of 2025,we recognized net product sales of$86 million from sales of our COVID and RSV vaccines,compared to$167 million for thefirst quarter of 2024.Loss per share was$(2.52)for the first quarter of 2025,compared to$(3.07)for the first quarter of 2024.Recent Program Developme
220、ntsRespiratory Virus VaccinesNext-generation COVID vaccine:We shared pivotal safety,immunogenicity and relative vaccine efficacy data for our next-generation COVID vaccine(mRNA-1283)at the Advisory Committee on Immunization Practices meeting in April 2025.We filed for regulatory approval of mRNA-128
221、3 withthe FDA using a priority review voucher in 2024.The FDA has assigned a Prescription Drug User Fee Act(PDUFA)goal date of May 31,2025.27Table of ContentsRSV vaccine:We recently shared positive Phase 3 data for our RSV vaccine(mRNA-1345)in high-risk adults aged 18 to 59 at the ESCMID 2025Global
222、Congress.We filed for regulatory approval of mRNA-1345 for high-risk adults with the FDA using a priority review voucher in 2024.TheFDA has assigned a PDUFA goal date of June 12,2025.Seasonal flu+COVID vaccine:We shared positive Phase 3 immunogenicity data for our flu+COVID combination vaccine(mRNA-
223、1083)for adultsaged 50 years and older at our 2024 R&D Day event.We submitted mRNA-1083 for regulatory approval in older adults in 2024.Based on FDAfeedback confirming the need for Phase 3 flu efficacy data,we expect an extended review timeline and are now targeting approval in 2026.Recently,we upda
224、ted our prioritized research and development portfolio,resulting in the deprioritization of mRNA-1083 for adults aged 18 to 49.Seasonal flu vaccine:We have shared positive Phase 3 immunogenicity and safety data for our seasonal flu vaccine(mRNA-1010).We are conductinga two-season Phase 3 efficacy st
225、udy(P304),which exceeded its case accrual target in the first season.We anticipate an interim data readout in summer2025.Due to our strategic prioritization efforts,we have paused development of our mRNA-1011/1012 and mRNA-1020/1030 programs.Latent and Other Virus VaccinesCytomegalovirus(CMV)vaccine
226、:The pivotal Phase 3 study of our CMV vaccine candidate(mRNA-1647)is fully enrolled and accruing cases,evaluating its efficacy,safety and immunogenicity in the prevention of primary infection in women of childbearing age.The Data Safety MonitoringBoard(DSMB)met in December 2024 to review the initial
227、 study data and informed us that the criterion for early efficacy was not met.The DSMBrecommended that the study continue as planned.We remain blinded and anticipate final efficacy data from the study in 2025.Norovirus vaccine:The two-season Phase 3 study evaluating the efficacy,safety and immunogen
228、icity of our trivalent vaccine candidate againstnorovirus(mRNA-1403)is fully enrolled in the Northern Hemisphere and enrolling in the Southern Hemisphere.The FDA clinical hold following asingle adverse event report of a case of Guillain-Barr syndrome has been lifted.The timing of the Phase 3 readout
229、 will be dependent on case accruals.Oncology TherapeuticsIndividualized Neoantigen Therapy(INT):We continue to demonstrate the potential clinical benefit of INT(mRNA-4157).In collaboration withMerck,the Phase 3 clinical trial for adjuvant melanoma is fully enrolled.Two Phase 3 studies for non-small
230、cell lung cancer(NSCLC)are enrolling.Arandomized Phase 2 study for high-risk muscle invasive bladder cancer is enrolling,and a randomized Phase 2 study for adjuvant renal cell carcinomais enrolling.We and Merck have launched a new Phase 2 study for patients with high-risk non-muscle invasive bladder
231、 cancer.Checkpoint adaptive immune modulation therapy(AIM-T).We have expanded the number of oncology development candidates in our prioritizedpipeline with the addition of Checkpoint AIM-T(mRNA-4359).The Phase 1/2 study is ongoing and a Phase 2 study,which includes first-linemelanoma and first-line
232、metastatic NSCLC patients,is enrolling.Rare DiseasesPropionic acidemia(PA)therapeutic:In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA,ourinvestigational therapeutic(mRNA-3927)has been generally well-tolerated to date with no events meeting pro
233、tocol-defined dose-limiting toxicitycriteria.Early results suggest potential decreases in annualized metabolic decompensation event(MDE)frequency compared to pre-treatment,and themajority of patients have elected to continue on the open label extension study.mRNA-3927 is in a registrational study.Me
234、thylmalonic acidemia(MMA)therapeutic:Our investigational therapeutic for MMA(mRNA-3705)has been selected by the FDA for the Supportfor Clinical Trials Advancing Rare Disease Therapeutics(START)pilot program.We and the FDA have agreed on the pivotal study design.We expectto start a registrational stu
235、dy in 2025.Phenylketonuria(PKU):We have discontinued development of our preclinical PKU candidate(mRNA-3210)due to our strategic prioritizationefforts.28Table of ContentsOur PipelineThe following chart shows our current pipeline of 41 development programs across our several modalities.Abbreviations:
236、BARDA,Biomedical Advanced Research and Development Authority;CMV,cytomegalovirus;EBV,Epstein-Barr virus;HIV,human immunodeficiency virus;hMPV,humanmetapneumovirus;HR MIUC,high-risk muscle-invasive urothelial carcinoma;HR NMIBC,high-risk non-muscle invasive bladder cancer;HSV,herpes simplex virus;IAV
237、I,International AIDSVaccine Initiative;ILCM,Institute for Life Changing Medicines;IM,infectious mononucleosis;NIH,National Institutes of Health;NSCLC,non-small cell lung cancer;RCC,renal cell carcinoma;RSV,respiratory syncytial virus;VZV,varicella-zoster virus.29Table of ContentsResults of operation
238、sThe following table summarizes our condensed consolidated statements of operations for the periods presented(in millions):Three Months Ended March 31,Change 2025 vs.202420252024$%Revenue:Net product sales$86$167$(81)(49)%Other revenue22 22 100%Total revenue108 167(59)(35)%Operating expenses:Cost of
239、 sales90 96(6)(6)%Research and development856 1,063(207)(19)%Selling,general and administrative212 274(62)(23)%Total operating expenses1,158 1,433(275)(19)%Loss from operations(1,050)(1,266)216(17)%Interest income90 120(30)(25)%Other expense,net(4)(19)15(79)%Loss before income taxes(964)(1,165)201(1
240、7)%Provision for income taxes7 10(3)(30)%Net loss$(971)$(1,175)$204(17)%RevenueNet product salesNet product sales by customer geographic location were as follows(in millions):Three Months Ended March 31,20252024United States$31$100 Europe Rest of world55 67 Total$86$167 Net product sales by product
241、were as follows(in millions):Three Months Ended March 31,20252024COVID$84$167 RSV2 Total$86$167 As of March 31,2025,we have two commercial products authorized for use,our COVID vaccine and our RSV vaccine.The RSV vaccine was approved by theFDA in May 2024 for adults aged 60 years and older.We sell o
242、ur COVID vaccine to commercial market as well as to foreign governments and international organizations.We launched commercial sales of ourRSV vaccine in the third quarter of 2024.In the U.S.,our COVID and RSV vaccines are sold primarily to wholesalers and distributors,and to a lesser extent,directl
243、y to retailers and healthcare providers.Net product sales are recognized net of estimated wholesaler chargebacks,invoice discounts for prompt paymentsand pre-orders,provisions for sales returns and government rebates,and other related deductions.30Table of ContentsThe following table summarizes prod
244、uct sales provision for the periods presented(in millions):Three Months Ended March 31,20252024Gross product sales$105$222 Product sales provision:Wholesaler chargebacks,discounts and fees(22)(22)Returns,rebates and other fees3(33)Total product sales provision$(19)$(55)Net product sales$86$167 Prior
245、 to the third quarter of 2023,we sold our COVID vaccine to the U.S.Government,foreign governments and international organizations.The agreementsand related amendments with these entities generally do not include variable consideration,such as discounts,rebates or returns.Certain of these agreementse
246、ntitle us to upfront deposits for our COVID vaccine supply,initially recorded as deferred revenue.As of March 31,2025,we had deferred revenue of$154 million associated with customer deposits received or billable under supply agreements,of which$96 million is expected to be realized in less than oney
247、ear.Other revenueOther revenue comprises grant revenue,collaboration revenue,licensing and royalty revenue,and other miscellaneous revenue.For the three months ended March 31,2025,total revenue decreased by$59 million,or 35%,compared to the same period in 2024,mainly due to lower netproduct sales of
248、 our COVID vaccine.Net product sales for the three months ended March 31,2025 decreased by$81 million,or 49%,compared to the same period in 2024,primarily due to lowersales in the U.S.market,driven by a reduced vaccination rate.International sales also declined,but to a lesser extent.We expect deman
249、d for our COVID and RSV vaccines to follow a seasonal pattern aligned with fall and winter vaccination campaigns in both hemispheres.AsCOVID has transitioned to a seasonal respiratory vaccine,we anticipate a decline in net product sales for the full year 2025 compared to 2024,primarily due tolower e
250、xpected vaccination rates and increased competition.Although we commenced sales of our RSV vaccine in the third quarter of 2024,product sales fromour RSV vaccine are not expected to present a significant portion of total product sales in 2025.Other revenue increased by$22 million,or 100%,for the thr
251、ee months ended March 31,2025,compared to the same period in 2024.The increase for the threeand three months ended was mainly due to an increase in licensing and royalty and other revenue.Operating expensesCost of salesCost of sales for the three months ended March 31,2025 was$90 million,which inclu
252、ded third-party royalties of$5 million,inventory write-downs of$42 million,primarily related to our finished and semi-finished COVID vaccine inventory and certain raw materials,unutilized manufacturing capacity andwind-down costs of$21 million,and losses on firm purchase commitments of$10 million.Pl
253、ease refer to Note 7 to our condensed consolidated financialstatements for inventory related charges.These charges in 2025,other than royalties,were largely driven by customer demand forecast adjustments andcommitments related to manufacturing capacity.Cost of sales for the three months ended March
254、31,2025 decreased by$6 million,or 6%,compared to the same period in 2024,primarily due to lower salesvolume.The decrease also reflects the seasonal nature of our COVID vaccine business,with limited product sales in both periods.Despite the overall decreasein cost of sales,cost of sales as a percenta
255、ge of net product sales for the three months ended March 31,2025 increased to 104%,compared to 58%for the sameperiod in 2024,reflecting the impact of lower net product sales.31Table of ContentsWe expect full year 2025 cost of sales to be lower compared to 2024,reflecting lower anticipated production
256、 and inventory-related charges.However,cost ofsales as a percentage of net product sales is expected to vary widely due to continued uncertainty around demand and increased market competition.Thisvariability is primarily driven by the fixed nature of a significant portion of our manufacturing costs,
257、which cannot be quickly adjusted in response to changesin sales volume.As part of our long-term strategy,we are continuing to invest in internal manufacturing capabilities to improve cost control and supportpotential future product launches.Research and development expensesResearch and development e
258、xpenses decreased by$207 million,or 19%,for the three months ended March 31,2025,compared to the same period in 2024.The reduction was primarily driven by a$134 million decrease in clinical trial and manufacturing expenses,reflecting lower spend across our RSV,seasonalflu,COVID,and combination vacci
259、ne programs due to timing of trial activities and program wind-downs.This reduction was partially offset by increasedinvestment in our INT and norovirus programs.Consulting and outside services expenses declined by$42 million as a result of cost management initiatives,while pre-clinical research exp
260、enses decreased by$35 million due to investment reprioritization.We anticipate a reduction in research and development expenses in 2025 compared to 2024,driven by disciplined cost management and a focused approach topipeline execution.While we continue to advance our pipeline,we are maintaining inve
261、stments in late-stage programs,including our INT,norovirus,CMV,andcombination vaccine programs.Selling,general and administrative expensesSelling,general and administrative expenses decreased by$62 million,or 23%,for the three months ended March 31,2025,compared to the same period in2024.The decline
262、 was primarily driven by broad-based reductions across digital,facility,marketing,personnel-related expenses,and external consulting andservice costs,as we continue to streamline operations and prioritize cost management.We anticipate a modest reduction in selling,general and administrative expenses
263、 in 2025 compared to 2024.This reflects our ongoing commitment toefficiency as we expand our global commercial,regulatory,sales and marketing infrastructure,while continuing to invest in digital capabilities and leverageartificial intelligence technologies.These efforts align with our strategic focu
264、s on advancing our program development and enhancing our overall businessprocesses.Interest incomeFor the three months ended March 31,2025,interest income decreased by$30 million,or 25%,compared to the same period in 2024.The decrease in thethree-month period was primarily due to lower average inves
265、tment balances.Other expense,netThe following tables summarize other expense,net for the periods presented(in millions):Three Months Ended March 31,Change 2025 vs.202420252024$%Loss on investments$(7)$(15)$8(53)%Interest expense(1)(6)5(83)%Other income,net4 2 2 100%Total other expense,net$(4)$(19)$1
266、5(79)%For the three months ended March 31,2025,total other expense,net decreased by$15 million,or 79%,compared to the same period in 2024.The decrease wasprimarily driven by lower interest expense and reduced losses on equity investments.Interest expense is primarily related to our finance leases re
267、lated to ourModerna Technology Center prior to its acquisition in December 2024,and certain contract manufacturing service agreements.Please refer to Note 10 to ourcondensed consolidated financial statements for additional information.Income taxesProvision for income taxes decreased by$3 million,or
268、30%,for the three months ended March 31,2025,compared to the same period in 2024,primarily dueto the continued maintenance of our global valuation allowance,which limits our ability to recognize tax benefits from the loss.The effective tax rate remainedconsistent with the prior year and continues to
269、 be immaterial.Please refer to Note 13 to our condensed consolidated financial statements for additional details.32Table of ContentsLiquidity and capital resourcesThe following table summarizes our cash,cash equivalents,investments and working capital as of March 31,2025 and December 31,2024(in mill
270、ions):March 31,December 31,20252024Financial assets:Cash and cash equivalents$1,623$1,927 Investments4,352 5,098 Investments,non-current2,418 2,494 Total$8,393$9,519 Working capital:Current assets$6,766$8,099 Current liabilities1,604 2,206 Total$5,162$5,893 Our cash,cash equivalents and investments
271、are invested in accordance with our investment policy,primarily with a view to liquidity and capital preservation.Investments,consisting primarily of government and corporate debt securities,are stated at fair value.Cash,cash equivalents and investments as of March 31,2025 decreased by$1.1 billion,o
272、r 12%,compared to December 31,2024.The decrease in cash,cash equivalents and investments was primarily due to a netcash outflow from operating activities of$1.0 billion and purchases of property and equipment of$117 million during the three months ended March 31,2025.Working capital,defined as curre
273、nt assets less current liabilities,as of March 31,2025 decreased by$731 million,or 12%,compared to December 31,2024.This was primarily driven by a decrease in cash,cash equivalents and current investments of$1.1 billion to fund operations,and a decrease in accountsreceivable of$280 million,mainly du
274、e to timing of collections,partially offset by a decrease in accrued liabilities and accounts payable of$605 million,drivenby lower spend during the period.As of March 31,2025,we did not have any off-balance sheet arrangements,other than those obligations and commitments disclosed herein.Cash flowTh
275、e following table summarizes the primary sources and uses of cash for each period presented(in millions):Three Months Ended March 31,20252024Net cash(used in)provided by:Operating activities$(1,037)$(989)Investing activities730 118 Financing activities4 14 Net decrease in cash,cash equivalents and r
276、estricted cash$(303)$(857)Operating activitiesWe derive cash flows from operations primarily from cash collected from customer deposits and accounts receivable related to our product sales and otherrevenue,as well as certain government-sponsored and private organizations,strategic alliances and fund
277、ing arrangements.Our operating cash flows aresignificantly affected by our use of cash for operating expenses and working capital to support the business.Beginning in the third quarter of 2020,we entered into supply agreements with the U.S.Government,foreign governments and international organizatio
278、ns forthe supply of our COVID vaccine and received upfront deposits.In the third quarter of 2023,we commenced sales of our COVID vaccine to the U.S.commercial market,in addition to continuing sales to foreign governments and international organizations.In the U.S.,our COVID vaccine is sold primarily
279、 towholesalers and distributors,and to a lesser extent,directly to retailers and healthcare providers.We also commenced sales of our RSV vaccine in the thirdquarter of 2024.Wholesalers and distributors typically do not make upfront payments to us.As of March 31,2025,we had$154 million in deferred re
280、venuerelated to customer deposits received or billable.33Table of ContentsNet cash used in operating activities for the three months ended March 31,2025 was$1.0 billion and consisted of net loss of$1.0 billion,non-cash adjustmentsof$145 million and a net change in assets and liabilities of$211 milli
281、on.Non-cash items primarily included stock-based compensation of$115 million,anddepreciation and amortization of$39 million.The net change in assets and liabilities was mainly due to a decrease in accrued liabilities and accounts payable of$537 million,driven by overall lower spend in the period,par
282、tially offset by a decrease in accounts receivable of$280 million,driven by timing of collections.Net cash used in operating activities increased by$48 million,or 5%,during the three months ended March 31,2025,compared to the same period in 2024,primarily attributable to a change in accounts receiva
283、ble of$475 million,driven by declined product sales,partially offset by a decrease in net loss of$204million,and a change in accrued liabilities and accounts payable of$164 million,primarily driven by lower spend in the period.Investing activitiesOur primary investing activities consist of purchases
284、,sales,and maturities of our investments,capital expenditures for land,building,leasehold improvements,manufacturing,laboratory,computer equipment and software,and business development.Net cash provided by investing activities for the three months ended March 31,2025 was$730 million,driven primarily
285、 by proceeds from maturities and salesof marketable securities of$2.6 billion,partially offset by purchases of marketable securities of$1.8 billion,and purchases of property and equipment of$117million.Net investing cash flows increased by$612 million,or 519%,during the three months ended March 31,2
286、025,compared to the same period in 2024,primarilydue to a decrease in purchases of marketable securities of$780 million.Financing activitiesNet cash provided by financing activities for the three months ended March 31,2025 was$4 million,primarily related to proceeds from issuance of commonstock thro
287、ugh equity plans.Financing cash flows remained immaterial and were consistent with the same period in 2024.Operation and funding requirementsOur principal sources of funding as of March 31,2025 consisted of cash and cash equivalents,investments,and cash we may generate from operations.Fromour incept
288、ion to the end of 2020,we incurred significant losses from operations due to our significant research and development expenses.Followingauthorization of our first commercial product in December 2020,we generated significant net income in both 2022 and 2021.We also incurred a net loss of$1.0 billion
289、for the three months ended March 31,2025 and net losses of$3.6 billion and$4.7 billion for 2024 and 2023,respectively.We have retainedearnings of$9.1 billion as of March 31,2025.We have significant future capital requirements including expected operating expenses to conduct research and development
290、activities,operate ourorganization,and meet capital expenditure needs.We anticipate maintaining substantial expenses across all areas of our ongoing activities,particularly as wecontinue research and development of our development candidates and clinical activities for our investigational medicines.
291、This also extends to ourmanufacturing costs,including our arrangements with our supply and manufacturing partners.Our ongoing work on our INT,norovirus,flu+COVIDcombination,CMV,RSV,and next-generation COVID vaccine candidates,development of any new COVID vaccines against variants of SARS-CoV-2,late-
292、stage clinical development,investments in digital capabilities and artificial intelligence technologies,and buildout of global commercial,regulatory,sales andmarketing infrastructure and manufacturing facilities will require significant cash outflows in future periods,most of which will not be reimb
293、ursed or otherwisepaid for by our partners or collaborators.In addition,we have substantial facility,lease and purchase obligations(refer to Note 10 and Note 11 to ourcondensed consolidated financial statements).We have entered into various collaboration and licensing agreements,as well as a researc
294、h and developmentfunding arrangement with a third party.These arrangements collectively encompass the funding of specific research and development activities,with thedistinction that under the research and development funding arrangement,we receive funding.However,for all these arrangements,we may b
295、e obligated tomake potential future milestone and royalty payments.34Table of ContentsWe believe that our cash,cash equivalents,and investments as of March 31,2025,together with cash expected to be generated from product sales,will besufficient to enable us to fund our projected operations and capit
296、al expenditures through at least the next 12 months from the issuance of these financialstatements included in this Form 10-Q.We are subject to all the risks related to the development and commercialization of novel medicines,and we mayencounter unforeseen expenses,difficulties,complications,delays,
297、and other unknown factors,which may adversely affect our business.For example,weexperienced a decline in customer demand for our COVID vaccine in 2023 and 2024,and this trend has continued into 2025,reflecting the markets ongoingtransition to a seasonal commercial pattern in the endemic COVID vaccin
298、e market.We foresee that our commitment to investing in our business for futureproduct launches may lead to continued negative cash flows from operations in upcoming periods.Our forecast of the period of time through which ourfinancial resources will be adequate to support our operations is a forwar
299、d-looking statement and involves risks and uncertainties,and actual results could varyas a result of a number of factors.We have based this estimate on assumptions that may prove to be wrong,and we could utilize our available capital resourcessooner than we currently expect.Critical accounting polic
300、ies and significant judgments and estimatesThere have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statementsduring the three months ended March 31,2025 compared to those disclosed in our 2024 Form 10-K.Contract
301、ual ObligationsAs of March 31,2025,other than disclosed within Note 10 and Note 11 to our condensed consolidated financial statements,there have been no materialchanges to our contractual obligations and commitments from those described under“Managements Discussion and Analysis of Financial Conditio
302、n andResults of Operations”included in our 2024 Form 10-K.Item 3.Quantitative and Qualitative Disclosures about Market RiskOur market risks,and the way we manage them,are summarized in Part II,Item 7A.,“Quantitative and Qualitative Disclosures About Market Risk”of our2024 Form 10-K.There have been n
303、o material changes to our market risk or to our management of such risks for the three months ended March 31,2025.Item 4.Controls and ProceduresDisclosure Controls and ProceduresOur management,with the participation of our Chief Executive Officer and our Chief Financial Officer,evaluated the effecti
304、veness of our disclosure controlsand procedures as of March 31,2025.The term“disclosure controls and procedures,”as defined in Rules 13a-15(e)and 15d-15(e)under the Exchange Actmeans controls and other procedures of a company that are designed to ensure that information required to be disclosed by a
305、 company in the reports that it filesor submits under the Exchange Act is recorded,processed,summarized and reported,within the time periods specified in the SECs rules and forms.Disclosurecontrols and procedures include,without limitation,controls and procedures designed to ensure that information
306、required to be disclosed by a company in thereports that it files or submits under the Exchange Act is accumulated and communicated to the companys management,including its principal executive andprincipal financial officers,as appropriate to allow timely decisions regarding required disclosure.Mana
307、gement recognizes that any controls and procedures,nomatter how well designed and operated,can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgmentin evaluating the cost-benefit relationship of possible controls and procedures.Based on the e
308、valuation of our disclosure controls and procedures as of March31,2025,our Chief Executive Officer and Chief Financial Officer concluded that,as of such date,our disclosure controls and procedures were effective at thereasonable assurance level.Changes in Internal Control over Financial ReportingThe
309、re were no changes in our internal control over financial reporting(as defined in Rules 13a-15(f)and 15d-15(f)under the Exchange Act)during the threemonths ended March 31,2025 that have materially affected,or are reasonably likely to materially affect,our internal control over financial reporting.35
310、Table of ContentsInherent Limitations on Effectiveness of ControlsOur management,including our Chief Executive Officer and Chief Financial Officer,believes that our disclosure controls and procedures and internal controlover financial reporting are designed to provide reasonable assurance of achievi
311、ng their objectives and are effective at the reasonable assurance level.However,our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.A control system,no matter how well-conceived and operated
312、,can provide only reasonable,not absolute,assurance that the objectives of the control system aremet.Further,the design of a control system must reflect the fact that there are resource constraints,and the benefits of controls must be considered relative totheir costs.Because of the inherent limitat
313、ions in all control systems,no evaluation of controls can provide absolute assurance that all control issues andinstances of fraud,if any,have been detected.These inherent limitations include the realities that judgments in decision making can be faulty,and thatbreakdowns can occur because of a simp
314、le error or mistake.Additionally,controls can be circumvented by the individual acts of some persons,by the collusionof two or more people or by a management override of the controls.The design of any system of controls also is based in part upon certain assumptions aboutthe likelihood of future eve
315、nts,and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;over time,controls may become inadequate because of changes in conditions,or the degree of compliance with policies or procedures may deteriorate.Becauseof the inherent
316、limitations in a cost-effective control system,misstatements due to error or fraud may occur and not be detected.PART IIItem 1.Legal ProceedingsWe are involved in various claims and legal proceedings of a nature considered ordinary course in our business,including those described in our 2024 Form10-
317、K under the heading“Legal Proceedings.”Most of the issues raised by these claims are highly complex and subject to substantial uncertainties.For adescription of risks relating to these and other legal proceedings we face,see Part I,Item 1A.,“Risk Factors,”of our 2024 Form 10-K,including the discussi
318、onunder the headings entitled“Risks related to our intellectual property”and“Risks related to the manufacturing of our commercial products and productcandidates.”The outcome of any such proceedings,regardless of the merits,is inherently uncertain;therefore,assessing the likelihood of loss and anyest
319、imated damages is difficult and subject to considerable judgment.Pfizer/BioNTech Patent LitigationAs more fully described in our 2024 Form 10-K,we have initiated patent infringement proceedings against Pfizer Inc.(Pfizer)and BioNTech SE(and affiliatedentities,together BioNTech)in the U.S.and Europe.
320、The U.S.litigation has been stayed pending the outcome of two Inter Partes Proceedings(IPRs)before theU.S.Patent and Trademark Offices Patent Trial and Appeal Board(PTAB)regarding the validity of two of the three asserted Moderna patents in the lawsuit.InMarch 2025,the PTAB found all challenged clai
321、ms unpatentable in those two patents.The decision is subject to appeal.Also in March 2025,the Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech violated one of our European patents related to our COVIDvaccine technology and that they owe us damages related to the sale of their COVI
322、D vaccine.Pfizer and BioNTech have appealed this decision.The court hasnot ruled on the amount of damages to be paid,which will depend on further legal proceedings.Proceedings Related to Patents Owned by ArbutusIn March 2025,Arbutus Biopharma Corporation(Arbutus)and Genevant Sciences GmbH(Genevant)f
323、iled five international lawsuits asserting that ourmanufacture and sale of Spikevax and/or mRESVIA infringes certain patents concerning lipid nanoparticles.The companies filed lawsuits in the CanadianFederal Court,Tokyo District Court in Japan and Swiss Federal Patent Court,and submitted two lawsuit
324、s to the Unified Patent Court(UPC).The two UPCactions seek relief in all UPC member states and in ten additional European Patent Convention contracting states.Each proceeding identifies Spikevax andmRESVIA as accused products except for the Canadian proceeding,which only identifies Spikevax.The comp
325、laints seek monetary relief and injunctive relief.Proceedings Related to Patents Owned by GSKAs more fully described in our 2024 Form 10-K,GlaxoSmithKline Biologicals SA(GSK)has filed two complaints against us in the U.S.District Court for theDistrict of Delaware,asserting that either Spikevax or mR
326、ESVIA infringe certain patents owned by GSK.Trial dates have been set for both cases,with the trialrelated to Spikevax to begin July 19,2027,and the trial related to mRESVIA to begin August 23,2027.36Table of ContentsItem 1A.Risk FactorsInformation regarding risk and uncertainties related to our bus
327、iness appears in Part I,Item 1A.“Risk Factors”of our 2024 Form 10-K.There have been nomaterial changes from the risk factors previously disclosed in the 2024 Form 10-K.Item 2.Unregistered Sales of Equity Securities and Use of ProceedsIssuer Purchases of Equity SecuritiesOn August 1,2022,our Board of
328、 Directors authorized a share repurchase program for our common stock of up to$3.0 billion,with no expiration date.Duringthe three months ended March 31,2025,there were no shares repurchased.As of March 31,2025,$1.7 billion of our Board of Directors authorization forrepurchases of our common stock r
329、emains outstanding,with no expiration date.For details about our share repurchase programs,please refer to Note 12 to our consolidated financial statements,as set forth in our 2024 Form 10-K.Item 5.Other InformationOn March 13,2025,Abbas Hussain,one of our directors,adopted a trading arrangement tha
330、t is intended to satisfy the affirmative defense of Rule 10b5-1(c)(the Hussain 10b5-1 Plan).The Hussain 10b5-1 Plan provides for the sale on June 11,2025 of up to 313 shares of the Companys common stock to satisfy taxobligations in connection with the vesting of equity awards.The Hussain 10b5-1 Plan
331、 expires on June 30,2025,or upon the earlier completion of all authorizedtransactions under the Hussain 10b5-1 Plan.Item 6.ExhibitsThe Exhibits listed below are filed or incorporated by reference as part of this Form 10-Q.Exhibit No.Exhibit Index31.1*Certification of Principal Executive Officer purs
332、uant to Rule 13a-14(a)and Rule 15d-14(a)of the Securities Exchange Act of 1934,asadopted pursuant to Section 302 of the Sarbanes-Oxley Act of 200231.2*Certification of Principal Financial Officer pursuant to Rule 13a-14(a)and Rule 15d-14(a)of the Securities Exchange Act of 1934,asadopted pursuant to
333、 Section 302 of the Sarbanes-Oxley Act of 200232.1+Certification pursuant to 18 U.S.C.Section 1350,as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002101.INS*XBRL Instance Document-The instance document does not appear in the Interactive Data File because its XBRL tags are embedded withinthe Inline XBRL document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy