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1、 1 Moderna Reports First Quarter 2025 Financial Results and Provides Business Updates Reports first quarter revenues of$0.1 billion,GAAP net loss of$(1.0)billion and GAAP EPS of$(2.52)Reiterates 2025 expected revenue range of$1.5 to$2.5 billion and 2025 year-end cash balance of approximately$6 billi

2、on Announces reduction of$1.4 to$1.7 billion in estimated GAAP operating costs by 2027 Advancing up to 10 products toward approval,including multiple oncology candidates CAMBRIDGE,MA/ACCESSWIRE/May 1,2025/Moderna,Inc.(NASDAQ:MRNA)today reported financial results and provided business updates for the

3、 first quarter of 2025.In the first quarter,we continued to execute with financial discipline,significantly reducing our operating expenses,and further prioritized our investments in oncology,said Stphane Bancel,Chief Executive Officer of Moderna.“Looking ahead,we are reiterating our 2025 financial

4、framework and announcing a cost structure that is expected to reduce our annual operating expenses by approximately$1.5 billion by 2027.With several Phase 3 readouts approaching and continued momentum toward 10 product approvals,we remain confident in Modernas long-term outlook.Recent progress inclu

5、des:Commercial Updates COVID-19:The Company reported$84 million in Spikevax sales in the first quarter of 2025,which includes$29 million of U.S.sales and$55 million of international sales.As previously reported,Moderna entered into a tender opportunity in January to compete for COVID vaccine busines

6、s in the EU.RSV:The Company reported$2 million in mRESVIA sales in the first quarter of 2025.Modernas RSV vaccine for adults aged 60 years and older has been recently approved in Australia,Switzerland,Taiwan and the UK.First Quarter 2025 Financial Results Revenue:Total revenue for the first quarter

7、of 2025 was$108 million,compared to$167 million in the first quarter of 2024.The decline was primarily driven by lower net product sales,which totaled$86 million in the quarter.The reduction in product sales reflects lower vaccination rates compared to the same period last year and the continued nor

8、malization of COVID into a seasonal commercial market,with demand expected to be concentrated in the second half of the year.Cost of Sales:Cost of sales for the first quarter of 2025 was$90 million,which included third-party royalties of$5 million,inventory write-downs of$42 million,unutilized manuf

9、acturing capacity and wind-down costs of$21 million,and losses on firm purchase commitments of$10 million.Compared to the same period in 2024,cost of sales decreased by$6 million,or 6%,reflecting lower sales volume and the seasonal nature of the Companys COVID vaccine business,with limited product s

10、ales in both periods.Despite the overall decrease in cost of sales,cost of sales as a percentage of net product sales 2 increased to 104%,compared to 58%in the first quarter of 2024,reflecting the impact of lower net product sales.Research and Development Expenses:Research and development expenses f

11、or the first quarter of 2025 decreased by 19%to$856 million,compared to the first quarter in 2024.The decrease was primarily driven by lower clinical development costs across respiratory programs due to timing of trial activities and program wind-downs.This reduction was partially offset by increase

12、d investment in Modernas individualized neoantigen therapy(mRNA-4157),which has been assigned the generic name intismeran autogene,and norovirus programs.Selling,General and Administrative Expenses:Selling,general and administrative expenses for the first quarter of 2025 decreased by 23%to$212 milli

13、on,compared to the first quarter in 2024.The decline was primarily driven by broad-based reductions across digital,facility,marketing,personnel-related expenses,and external consulting and service costs,as the Company continues to streamline operations and prioritize cost management.Income Taxes:The

14、 Company recognized an income tax provision of$7 million for the first quarter of 2025,compared to$10 million in the same period last year.In both periods,the income tax provision was not material,as the Company continues to maintain a global valuation allowance against most of its deferred tax asse

15、ts.Net Loss:Net loss was$(1.0)billion for the first quarter of 2025,compared to$(1.2)billion for the first quarter of 2024.Loss Per Share:Loss per share was$(2.52)for the first quarter of 2025,compared to$(3.07)for the first quarter of 2024.Cash Position:Cash,cash equivalents and investments as of M

16、arch 31,2025,were$8.4 billion,compared to$9.5 billion as of December 31,2024.The decrease during the quarter was primarily driven by the operating loss for this quarter.2025 Financial Framework Expectations for full year 2025 remain consistent with prior expectations.Revenue:The Company reiterates 2

17、025 expected revenue of$1.5 to$2.5 billion.Moderna expects revenue of approximately$0.2 billion in the first half of the year,reflecting the seasonality of its respiratory business.Cost of Sales:Cost of sales for 2025 is expected to be approximately$1.2 billion.Research and Development Expenses:Full

18、-year 2025 research and development expenses are anticipated to be approximately$4.1 billion.Selling,General and Administrative Expenses:Selling,general and administrative expenses for 2025 are projected to be approximately$1.1 billion.Income Taxes:The Company continues to expect its full-year tax e

19、xpense to be negligible.Capital Expenditures:Capital expenditures for 2025 are expected to be approximately$0.4 billion.3 Cash and Investments:Year-end cash and investments for 2025 are projected to be approximately$6 billion.2026 and 2027 Financial Updates Moderna is expanding its cost efficiency a

20、nd prioritization programs and expects estimated GAAP operating costs of$5.4 to$5.7 billion in 2026,a reduction from the Companys previous estimate of$5.9 billion.The Company is announcing a new 2027 GAAP operating cost estimate of$4.7 to$5.0 billion,resulting in a reduction of$1.4 to$1.7 billion in

21、 estimated operating costs by 2027,compared to its 2025 estimate.Recent Progress and Upcoming Late-Stage Pipeline Milestones The Company continues to advance its research and development portfolio.Recently,Moderna updated its prioritized pipeline by adding its Phase 2 oncology candidate,checkpoint(m

22、RNA-4359)therapy,and deprioritizing its flu/COVID combination vaccine(mRNA-1083)for adults aged 18-49.Respiratory vaccines:Next-generation COVID-19 vaccine:Moderna shared pivotal safety,immunogenicity and relative vaccine efficacy data for its next-generation COVID-19 vaccine(mRNA-1283)at the Adviso

23、ry Committee on Immunization Practices meeting in April 2025.The Company filed for regulatory approval of mRNA-1283 with the 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.Respiratory syncytial virus(RSV)vaccine:The Co

24、mpany recently shared positive Phase 3 data for its RSV vaccine(mRNA-1345)in high-risk adults aged 18-59 at the ESCMID 2025 Global Congress.Moderna filed for regulatory approval of mRNA-1345 for high-risk adults with the FDA using a priority review voucher in 2024.The FDA has assigned a PDUFA goal d

25、ate of June 12,2025.Seasonal flu+COVID vaccine:Moderna shared positive Phase 3 immunogenicity data for its flu/COVID combination vaccine(mRNA-1083)for adults aged 50 years and older at its 2024 R&D Day event.The Company submitted mRNA-1083 for regulatory approval in older adults in 2024.Based on FDA

26、 feedback confirming the need for Phase 3 flu efficacy data,Moderna expects an extended review timeline and is now targeting approval in 2026.Seasonal flu vaccine:Moderna has shared positive Phase 3 immunogenicity and safety data for its seasonal flu vaccine(mRNA-1010).The Phase 3 vaccine efficacy s

27、tudy(P304)exceeded its case accrual target in the first season and Moderna anticipates an interim data readout in summer 2025.Latent and other vaccines:Cytomegalovirus(CMV)vaccine:The Company recently shared 36-month durability data from a Phase 2 extension trial of its CMV vaccine candidate(mRNA-16

28、47)at the ESCMID 2025 Global Congress.The pivotal Phase 3 study of mRNA-1647 is fully enrolled and accruing cases,4 evaluating its efficacy,safety and immunogenicity in the prevention of primary infection in women of childbearing age.The Data Safety Monitoring Board(DSMB)met to review the initial st

29、udy data in 2024 and informed the Company that the criterion for early efficacy was not met.The DSMB recommended that the study continue as planned.The Company remains blinded and anticipates efficacy data from the study in 2025.Norovirus vaccine:The two-season Phase 3 study evaluating the efficacy,

30、safety and immunogenicity of Modernas trivalent vaccine against norovirus(mRNA-1403)is fully enrolled in the Northern Hemisphere and enrolling in the Southern Hemisphere.The FDA clinical hold following a single adverse event report of a case of Guillain-Barr syndrome has been lifted.The timing of th

31、e Phase 3 readout will be dependent on case accruals.Oncology therapeutics:Intismeran autogene:Moderna continues to demonstrate the potential clinical benefit of mRNA-4157.In collaboration with Merck,the Phase 3 clinical trial for adjuvant melanoma is fully enrolled.Two Phase 3 studies for non-small

32、 cell lung cancer(NSCLC)are enrolling.A randomized Phase 2 study for high-risk muscle invasive bladder cancer is enrolling,and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled.Moderna and Merck have launched a new Phase 2 study for patients with high-risk non-muscle inv

33、asive bladder cancer.Checkpoint adaptive immune modulation therapy(AIM-T):Moderna is expanding the number of oncology development candidates in its prioritized pipeline with the addition of Checkpoint AIM-T(mRNA-4359).The Phase 1/2 study is ongoing and a Phase 2 study,which includes first-line melan

34、oma and first-line metastatic NSCLC patients,is enrolling.Rare disease therapeutics:Propionic acidemia(PA)therapeutic:In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA,Modernas investigational therapeutic(mRNA-3927)has been generally well-tolera

35、ted to date with no events meeting protocol-defined dose-limiting toxicity criteria.Early results suggest potential decreases in annualized metabolic decompensation event(MDE)frequency compared to pre-treatment,and the majority of patients have elected to continue on the open label extension study.T

36、he Companys PA program is in a registrational study.Methylmalonic acidemia(MMA)therapeutic:Modernas investigational therapeutic for MMA(mRNA-3705)has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics(START)pilot program.The FDA and Moderna have agreed o

37、n the pivotal study design.The Company expects to start a registrational study in 2025.Company Updates&Accolades Moderna has been named to LinkedIns list of Top Companies in the U.S.for the second consecutive year.Moderna debuted on Fortunes annual list of Americas Most Innovative Companies.5 Key 20

38、25 Investor and Analyst Event Dates Analyst Day:November 20 Investor Call and Webcast Information Moderna will host a live conference call and webcast at 8:00 a.m.ET on May 1,2025.To access the live conference call via telephone,please register at the link below.Once registered,dial-in numbers and a

39、 unique pin number will be provided.A live webcast of the call will also be available under Events and Presentations in the Investors section of the Moderna website.Telephone:https:/register-conf.media- Webcast:https:/ The archived webcast will be available on Modernas website approximately two hour

40、s after the conference call and will be available for one year following the call.About Moderna Moderna is a leader in the creation of the field of mRNA medicine.Through the advancement of mRNA technology,Moderna is reimagining how medicines are made and transforming how we treat and prevent disease

41、 for everyone.By working at the intersection of science,technology and health for more than a decade,the company has developed medicines at unprecedented speed and efficiency,including one of the earliest and most effective COVID vaccines.Modernas mRNA platform has enabled the development of therape

42、utics and vaccines for infectious diseases,immuno-oncology,rare diseases and autoimmune diseases.With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health,Moderna strives to deliver the greatest possible impact to people throug

43、h mRNA medicines.For more information about Moderna,please visit and connect with us on X(formerly Twitter),Facebook,Instagram,YouTube and LinkedIn.6 MODERNA,INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited,in millions,except per share data)Three Months Ended March 31,2025 2024 Revenue

44、:Net product sales$86$167 Other revenue1 22 Total revenue 108 167 Operating expenses:Cost of sales 90 96 Research and development 856 1,063 Selling,general and administrative 212 274 Total operating expenses 1,158 1,433 Loss from operations (1,050)(1,266)Interest income 90 120 Other expense,net (4)(

45、19)Loss before income taxes (964)(1,165)Provision for income taxes 7 10 Net loss$(971)$(1,175)Loss per share:Basic and diluted$(2.52)$(3.07)Weighted average common shares used in calculation of loss per share:Basic and diluted 386 382 _ 1Includes grant,collaboration,licensing and royalty,and other m

46、iscellaneous revenue.7 MODERNA,INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited,in millions)March 31,December 31,2025 2024 Assets Current assets:Cash and cash equivalents$1,623$1,927 Investments 4,352 5,098 Accounts receivable,net 78 358 Inventory 128 117 Prepaid expenses and other current asset

47、s 585 599 Total current assets 6,766 8,099 Investments,non-current 2,418 2,494 Property,plant and equipment,net 2,212 2,196 Right-of-use assets,operating leases 752 759 Other non-current assets 556 594 Total assets$12,704$14,142 Liabilities and Stockholders Equity Current liabilities:Accounts payabl

48、e$226$405 Accrued liabilities 1,001 1,427 Deferred revenue 125 153 Other current liabilities 252 221 Total current liabilities 1,604 2,206 Deferred revenue,non-current 58 58 Operating lease liabilities,non-current 667 671 Financing lease liabilities,non-current 35 39 Other non-current liabilities 27

49、4 267 Total liabilities 2,638 3,241 Stockholders equity:Additional paid-in capital 982 866 Accumulated other comprehensive income(loss)10 (10)Retained earnings 9,074 10,045 Total stockholders equity 10,066 10,901 Total liabilities and stockholders equity$12,704$14,142 8 MODERNA,INC.CONDENSED CONSOLI

50、DATED STATEMENTS OF CASH FLOWS (Unaudited,in millions)Three Months Ended March 31,2025 2024 Operating activities Net loss$(971)$(1,175)Adjustments to reconcile net loss to net cash used in operating activities:Stock-based compensation 115 101 Depreciation and amortization 39 36 Amortization/accretio

51、n of investments (19)(27)Loss on equity investments,net 8 13 Other non-cash items 2 3 Changes in assets and liabilities:Accounts receivable,net 280 755 Prepaid expenses and other assets 46 3 Inventory (8)(93)Right-of-use assets,operating leases 9 16 Accounts payable (156)(303)Accrued liabilities (38

52、1)(398)Deferred revenue (29)(33)Operating lease liabilities (5)(6)Other liabilities 33 119 Net cash used in operating activities (1,037)(989)Investing activities Purchases of marketable securities (1,764)(2,544)Proceeds from maturities of marketable securities 1,933 1,573 Proceeds from sales of mark

53、etable securities 688 1,285 Purchases of property,plant and equipment (117)(196)Purchase of intangible asset (10)Net cash provided by investing activities 730 118 Financing activities Proceeds from issuance of common stock through equity plans 3 15 Tax payments related to net share settlements on eq

54、uity awards (1)Changes in financing lease liabilities 2 (1)Net cash provided by financing activities 4 14 Net decrease in cash,cash equivalents and restricted cash (303)(857)Cash,cash equivalents and restricted cash,beginning of year 1,929 2,928 Cash,cash equivalents and restricted cash,end of perio

55、d$1,626$2,071 9 Spikevax and mRESVIA are registered trademarks of Moderna.Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,as amended,including statements regarding:Modernas 2025 financial fra

56、mework,including its expected revenue range and ending cash balance;Modernas advancement of up to 10 product approvals;Modernas anticipated cost reductions by 2027;and anticipated milestones for Modernas pipeline programs.In some cases,forward-looking statements can be identified by terminology such

57、 as will,may,should,could,expects,intends,plans,aims,anticipates,believes,estimates,predicts,potential,continue,or the negative of these terms or other comparable terminology,although not all forward-looking statements contain these words.The forward-looking statements in this press release are neit

58、her promises nor guarantees,and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks,uncertainties,and other factors,many of which are beyond Modernas control and which could cause actual results to differ materially from those expresse

59、d or implied by these forward-looking statements.These risks,uncertainties,and other factors include,among others,those risks and uncertainties described under the heading Risk Factors in Modernas Annual Report on Form 10-K for the fiscal year ended December 31,2024,filed with the U.S.Securities and

60、 Exchange Commission(SEC),and in subsequent filings made by Moderna with the SEC,which are available on the SECs website at www.sec.gov.Except as required by law,Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release

61、in the event of new information,future developments or otherwise.These forward-looking statements are based on Modernas current expectations and speak only as of the date of this press release.#Moderna Contacts Media:Chris Ridley Head of Global Media Relations+1 617-800-3651 Chris.R Investors:Lavina Talukdar Senior Vice President&Head of Investor Relations+1 617-209-5834 Lavina.T SOURCE:Moderna,Inc.