《再生元制藥Regeneron（REGN）2025年第一季度財務與經營業績報告「NASDAQ」（英文版）（11頁）.pdf》由會員分享，可在線閱讀，更多相關《再生元制藥Regeneron（REGN）2025年第一季度財務與經營業績報告「NASDAQ」（英文版）（11頁）.pdf（11頁珍藏版）》請在三個皮匠報告上搜索。

1、Regeneron Reports First Quarter 2025 Financial and Operating ResultsApril 29,2025 at 6:30 AM EDTFirst quarter 2025 revenues of$3.0 billion;GAAP diluted EPS of$7.27 and non-GAAP diluted EPS(a)of$8.22First quarter 2025 Dupixent global net sales(recorded by Sanofi)increased 19%to$3.67 billion versus fi

2、rst quarter 2024First quarter 2025 EYLEA HD U.S.net sales increased 54%to$307 million versus first quarter 2024;total EYLEA HDand EYLEA U.S.net sales decreased 26%to$1.04 billion Dupixent approved for chronic spontaneous urticaria(CSU)in U.S.;approved for chronic obstructive pulmonary disease(COPD)i

3、n JapanFDA accepted for priority review EYLEA HD sBLA for both retinal vein occlusion(RVO)and for monthly dosing inapproved indications;update provided on FDA review of EYLEA HD pre-filled syringe submissionLynozyfic(linvoseltamab)approved in EU for relapsed/refractory multiple myelomaRegulatory app

4、lications submitted for Libtayo in adjuvant cutaneous squamous cell carcinoma(CSCC)in U.S.and EUAnnounced ongoing and planned investments in New York and North Carolina infrastructure and manufacturing expectedto total more than$7 billionTARRYTOWN,N.Y.,April 29,2025(GLOBE NEWSWIRE)-Regeneron Pharmac

5、euticals,Inc.(NASDAQ:REGN)todayannounced financial results for the first quarter of 2025 and provided a business update.Regeneron has one of the most exciting pipelines in the industry,with unmatched diversity,scientific distinction,and potential tohelp millions of patients,said Leonard S.Schleifer,

6、M.D.,Ph.D.,Board co-Chair,President and Chief Executive Officerof Regeneron.We are laser focused on fulfilling the promise of this pipeline by advancing our clinical programs,and expectseveral important data readouts this year.We are also working to ensure our four blockbuster medicines reach even m

7、ore patientswho could benefit,with year-to-date progress including regulatory approvals for Dupixent in CSU in the U.S.and COPD in Japan.Financial Highlights($in millions,except per share data)Q1 2025 Q1 2024%ChangeTotal revenues$3,029$3,145(4%)GAAP net income$809$722 12%GAAP net income per share-di

8、luted$7.27$6.27 16%Non-GAAP net income(a)$928$1,116(17%)Non-GAAP net income per share-diluted(a)$8.22$9.55(14%)We have made meaningful progress across our pipeline so far in 2025,including four regulatory approvals,nine regulatorysubmissions,and are poised to report pivotal or proof-of-concept data

9、across programs in immunology,oncology,hematology,internal medicine,and rare diseases later this year,said Christopher Fenimore,Executive Vice President,Finance and ChiefFinancial Officer of Regeneron.We continue to deploy capital with the goal of maximizing long-term shareholder value,with afocus o

10、n internal investment in our research,development,and commercial capabilities,along with returning capital directly to ourshareholders through opportunistic share repurchases and our dividend program,which we initiated earlier this year.Business HighlightsKey Pipeline ProgressRegeneron has approxima

11、tely 45 product candidates in clinical development,including a number of marketed products for which itis investigating additional indications.Updates from the clinical pipeline include:Dupixent(dupilumab)In April 2025,the U.S.Food and Drug Administration(FDA)approved Dupixent for the treatment of a

12、dults and adolescentsaged 12 years and older with CSU who remain symptomatic despite antihistamine treatment.In March 2025,Japans Ministry of Health,Labour and Welfare(MHLW)approved Dupixent for the treatment of patientswith COPD.The Company and Sanofi presented positive results from the pivotal Pha

13、se 2/3 trial in adults with moderate-to-severebullous pemphigoid at the 2025 American Academy of Dermatology(AAD)Annual Meeting.In February 2025,the FDAaccepted for priority review the supplemental Biologics License Application(sBLA)for Dupixent in bullous pemphigoid,witha target action date of June

14、 20,2025.A regulatory application has also been submitted in the European Union(EU).EYLEA HD(aflibercept)8 mgIn April 2025,the FDA accepted for priority review an sBLA for both the treatment of macular edema following RVO,andbroadening the dosing schedule to include every 4-week(monthly)dosing acros

15、s approved indications.The FDA targetaction date is August 19,2025,following the use of a priority review voucher.The FDA issued a Complete Response Letter(CRL)for the EYLEA HD pre-filled syringe on April 23,2025.The Companyheld several teleconferences with the FDA to better understand the contents

16、of the CRL,and believes the key outstandingissue relates to a question posed by the FDA to a third-party component supplier.This component supplier hasexpeditiously responded to FDA requests for information.The CRL did not identify any issues with the safety or efficacy ofEYLEA HD,the usability of t

17、he device,proposed labelling,or pre-approval inspection findings.In April 2025,the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals.The FDA indicatedthat the submitted data did not support extended dosing intervals greater than every 16 weeks.The Company is evaluatin

18、gthe FDA s decision.The Company presented positive results from the Phase 3 QUASAR trial for the treatment of patients with macular edemafollowing RVO,including those with central,branch,and hemiretinal vein occlusions,at the Angiogenesis,Exudation,andDegeneration(Angiogenesis)2025 annual meeting.Th

19、e Company announced positive three-year(156-week)results from an extension study of the Phase 3 PULSAR trial inpatients with wet age-related macular degeneration(wAMD).Similar to the three-year results for the pivotal PHOTON trialin diabetic macular edema(DME),the longer-term wAMD data demonstrated

20、the vast majority of patients who entered theextension study sustained the visual gains and anatomic improvements achieved by the end of the second year,while alsoachieving substantially longer treatment intervals.The results were presented at the Angiogenesis 2025 annual meeting.Oncology ProgramsTh

21、e Company submitted an sBLA to the FDA and a regulatory application in the EU for Libtayo(cemiplimab)in adjuvantCSCC based upon data from a Phase 3 trial which demonstrated that adjuvant treatment with Libtayo was the first andonly immunotherapy that led to a statistically significant and clinically

22、 meaningful improvement in the primary endpoint ofdisease-free survival(DFS)in patients with high-risk CSCC after surgery.The FDA accepted for review the resubmission of the BLA for odronextamab,a bispecific antibody targeting CD20 andCD3,in relapsed/refractory(R/R)follicular lymphoma,with a target

23、action date of July 30,2025.The FDA accepted for review the resubmission of the BLA for linvoseltamab,a bispecific antibody targeting BCMA andCD3,in R/R multiple myeloma,with a target action date of July 10,2025.The European Commission(EC)granted conditional marketing approval of Lynozyfic(linvoselt

24、amab)to treat adults withR/R multiple myeloma.The indication is specific to those who have received at least three prior therapies including aproteasome inhibitor,an immunomodulatory agent,and an anti-CD38 monoclonal antibody,and have demonstrateddisease progression on the last therapy.Enrollment wa

25、s completed in a Phase 3 confirmatory trial(LINKER-MM3)for linvoseltamab in R/R multiple myeloma.Other ProgramsThe Company presented updated data from the Phase 1/2 trial of DB-OTO,an AAV-based gene therapy,in children withprofound genetic hearing loss due to variants of the otoferlin(OTOF)gene at t

26、he Association for Research inOtolaryngologys(ARO)48th Annual MidWinter Meeting.The data showed that 11 out of 12 children treated demonstrateda notable response,with improved hearing at various decibel hearing levels.This included updated results from the firstchild dosed,who received treatment at

27、10 months of age and at 48 weeks post-treatment showed continued near-normallevels of hearing,as well as formal speech perception improvements between 48-and 72-weeks post-treatment.A Phase 3 study for itepekimab,an antibody to IL-33,in chronic rhinosinusitis with nasal polyposis(CRSwNP)wasinitiated

28、.A Phase 2 study for REGN5381,an agonist antibody to NPR1,in uncontrolled hypertension was initiated.A Phase 2 study for REGN7544,an antagonist antibody to NPR1,in sepsis-induced hypotension was initiated.The FDA granted Orphan Drug designation for mibavademab,an agonist antibody to leptin receptor(

29、LEPR),in generalizedlipodystrophy;a Phase 3 study is ongoing.Corporate UpdatesThe Company reached resolution of its patent infringement litigation related to Biocons EYLEA(aflibercept)Injection 2 mgbiosimilar product.The settlement precludes Biocon from launching its biosimilar product in the United

30、 States until thesecond half of 2026.All intellectual property-related litigation with Biocon in the United States has been dismissed.The Company announced a 10-year agreement with FUJIFILM Diosynth Biotechnologies(Fujifilm)to manufacture andsupply Regenerons commercial bulk drug product at Fujifilm

31、s North Carolina campus.The agreement is anticipated tonearly double the Companys large-scale manufacturing capacity in the United States.First Quarter 2025 Financial ResultsRevenues($in millions)Q1 2025 Q1 2024%ChangeNet product sales:EYLEA HD-U.S.$307$200 54%EYLEA-U.S.736 1,202(39%)Total EYLEA HD

32、and EYLEA-U.S.1,043 1,402(26%)Libtayo-U.S.192 159 21%Libtayo-ROW*93 105(11%)Total Libtayo-Global 285 264 8%Praluent-U.S.57 70(19%)Evkeeza-U.S.31 24 29%Inmazeb-ROW 1(100%)Total net product sales 1,416 1,761(20%)Collaboration revenue:Sanofi 1,183 910 30%Bayer 344 356(3%)Other 4 1*Other revenue 82 117(

33、30%)Total revenues$3,029$3,145(4%)*Percentage not meaningful*Rest of world(ROW)Net product sales of EYLEA HD increased in the first quarter of 2025,compared to the first quarter of 2024,primarily due tohigher sales volumes.Net product sales of EYLEA in the first quarter of 2025,compared to the first

34、 quarter of 2024,were negatively impacted by(i)lower volume as a result of continued competitive pressures(as described below),loss in market share to compoundedbevacizumab due to patient affordability constraints,and the continued transition of patients to EYLEA HD,and(ii)a lower netselling price.I

35、n addition,total EYLEA and EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at theend of the first quarter of 2025 compared to the end of the fourth quarter of 2024.Total EYLEA and EYLEA HD net product salesdecreased 30%on a sequential basis;however,physician

36、unit demand decreased sequentially by 11%.EYLEA net product sales have been,and are likely to continue to be,negatively impacted by increased competition from otheranti-VEGF products,including biosimilars,as well as the transition of patients from EYLEA to EYLEA HD.In addition,ifindependent not-for-

37、profit patient assistance funds that provide copay assistance are unable to support eligible patients,this willlikely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.Sanofi collaboration revenue increased in the first quarter o

38、f 2025,compared to the first quarter of 2024,due to an increase in theCompanys share of profits from the commercialization of antibodies,which were$1.018 billion and$804 million in the first quarterof 2025 and 2024,respectively.The change in the Companys share of profits from commercialization of an

39、tibodies was driven byhigher profits associated with an increase in Dupixent sales.Refer to Table 4 for a summary of collaboration revenue.Operating Expenses GAAP%Change Non-GAAP(a)%Change($in millions)Q1 2025 Q1 2024 Q1 2025 Q1 2024 Research and development(R&D)$1,327$1,248 6%$1,186$1,122 6%Acquire

40、d in-process research anddevelopment(IPR&D)$12$7 71%*n/aSelling,general,and administrative(SG&A)$633$689(8%)$537$584(8%)Cost of goods sold(COGS)$266$240 11%$217$196 11%Gross margin on net product sales(c)81%86%85%89%Cost of collaboration and contractmanufacturing(COCM)$199$193 3%*n/aOther operating

41、expense(income),net$15(100%)*$%*GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded GAAP and non-GAAP R&D expenses increased in the first quarter of 2025,compared to the first quarter of 2024,drivenby the advancement of the Companys clinical pipeline and higher per

42、sonnel-related costs.GAAP and non-GAAP gross margin on net product sales was adversely impacted by higher inventory write-offs andreserves in the first quarter of 2025 compared to the first quarter of 2024.Other Financial InformationGAAP other income(expense),net included the recognition of net unre

43、alized gains on equity securities of$140 million in the firstquarter of 2025,compared to$196 million of net unrealized losses in the first quarter of 2024.In the first quarter of 2025,the Companys GAAP effective tax rate(ETR)was 10.6%,compared to(3.0%)in the first quarter of2024.The GAAP ETR increas

44、ed in the first quarter of 2025,compared to the first quarter of 2024,due to lower tax benefits fromless stock option exercises.In the first quarter of 2025,the non-GAAP ETR was 11.6%,compared to 6.1%in the first quarter of2024.A reconciliation of the Companys GAAP to non-GAAP results is included in

45、 Table 3 of this press release.Capital AllocationIn February 2025,the Companys board of directors authorized a new share repurchase program to repurchase up to anadditional$3.0 billion of the Companys common stock.During the first quarter of 2025,the Company repurchased shares of itscommon stock and

46、 recorded the cost of the shares,or$1.052 billion,as Treasury Stock.As of March 31,2025,an aggregateof$3.874 billion remained available for share repurchases under the Companys share repurchase programs.In April 2025,the Companys board of directors declared a cash dividend of$0.88 per share on the C

47、ompanys common stockand Class A stock,payable on June 6,2025 to shareholders of record as of May 20,2025.2025 Financial Guidance(b)The Companys full year 2025 financial guidance consists of the following components:2025 Guidance Prior UpdatedGAAP R&D$5.560$5.795 billion UnchangedNon-GAAP R&D(a)$5.00

48、0$5.200 billion UnchangedGAAP SG&A$2.910$3.095 billion UnchangedNon-GAAP SG&A(a)$2.550$2.700 billion UnchangedGAAP gross margin on net product sales 84%85%83%84%Non-GAAP gross margin on net product sales(a)87%88%86%87%COCM(d)*$1.000$1.150 billion UnchangedCapital expenditures*$850$975 million$850$95

49、0 millionGAAP effective tax rate 9%11%UnchangedNon-GAAP effective tax rate(a)11%13%Unchanged *GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below:Projecte

50、d Range($in millions)Low HighGAAP R&D$5,560$5,795 Stock-based compensation expense 560 590 Acquisition and integration costs 5 Non-GAAP R&D$5,000$5,200 GAAP SG&A$2,910$3,095 Stock-based compensation expense 360 390 Acquisition and integration costs 5 Non-GAAP SG&A$2,550$2,700 GAAP gross margin on ne

51、t product sales 83%84%Intangible asset amortization expense 2%2%Stock-based compensation expense 1%1%Non-GAAP gross margin on net product sales 86%87%GAAP ETR 9%11%Income tax effect of GAAP to non-GAAP reconciling items 2%2%Non-GAAP ETR 11%13%(a)This press release uses non-GAAP R&D,non-GAAP SG&A,non

52、-GAAP COGS,non-GAAP gross margin on net productsales,non-GAAP other operating(income)expense,net,non-GAAP other income(expense),net,non-GAAP ETR,non-GAAPnet income,non-GAAP net income per share,and free cash flow,which are financial measures that are not calculated inaccordance with U.S.Generally Ac

53、cepted Accounting Principles(GAAP).These non-GAAP financial measures are computedby excluding certain non-cash and/or other items from the related GAAP financial measure.The Company also includes anon-GAAP adjustment for the estimated income tax effect of reconciling items.A reconciliation of the Co

54、mpanys GAAP tonon-GAAP results is included in Table 3 of this press release.The Company makes such adjustments for items the Company does not view as useful in evaluating its operatingperformance.For example,adjustments may be made for items that fluctuate from period to period based on factors that

55、 arenot within the Companys control(such as the Companys stock price on the dates share-based grants are issued or changesin the fair value of the Companys investments in equity securities)or items that are not associated with normal,recurringoperations(such as acquisition and integration costs).Man

56、agement uses these non-GAAP measures for planning,budgeting,forecasting,assessing historical performance,and making financial and operational decisions,and also provides forecasts toinvestors on this basis.With respect to free cash flow,the Company believes that this non-GAAP measure provides a furt

57、hermeasure of the Companys ability to generate cash flows from its operations.Additionally,the non-GAAP measures presentedare intended to provide investors with an enhanced understanding of the financial performance of the Companys corebusiness operations.However,there are limitations in the use of

58、these and other non-GAAP financial measures as theyexclude certain expenses that are recurring in nature.Furthermore,the Companys non-GAAP financial measures may not becomparable with non-GAAP information provided by other companies.Any non-GAAP financial measure presented by theCompany should be co

59、nsidered supplemental to,and not a substitute for,measures of financial performance prepared inaccordance with GAAP.(b)The Companys 2025 financial guidance does not assume the completion of any business development transactions notcompleted as of the date of this press release.(c)Gross margin on net

60、 product sales represents gross profit expressed as a percentage of total net product sales recorded bythe Company.Gross profit is calculated as net product sales less cost of goods sold.(d)Corresponding reimbursements from collaborators and others for manufacturing product is recorded within revenu

61、es.Conference Call InformationRegeneron will host a conference call and simultaneous webcast to discuss its first quarter 2025 financial and operating resultson Tuesday,April 29,2025,at 8:30 AM Eastern Time.Participants may access the conference call live via webcast,or register inadvance and partic

62、ipate via telephone,on the Investors and Media page of Regenerons website at .Uponregistration,all telephone participants will receive a confirmation email detailing how to join the conference call,including thedial-in number along with a unique passcode and registrant ID that can be used to access

63、the call.A replay of the conference calland webcast will be archived on the Companys website for at least 30 days.About RegeneronRegeneron is a leading biotechnology company that invents,develops,and commercializes life-transforming medicines for peoplewith serious diseases.Founded and led by physic

64、ian-scientists,Regenerons unique ability to repeatedly and consistently translatescience into medicine has led to numerous approved treatments and product candidates in development,most of which werehomegrown in Regenerons laboratories.Regenerons medicines and pipeline are designed to help patients

65、with eye diseases,allergic and inflammatory diseases,cancer,cardiovascular and metabolic diseases,neurological diseases,hematologic conditions,infectious diseases,and rare diseases.Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technolo

66、gies,such as VelociSuite,which produces optimized fully human antibodies and new classes of bispecific antibodies.Regeneron isshaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Centerand pioneering geneticmedicine platforms,enabling Regeneron to identify inn

67、ovative targets and complementary approaches to potentially treat or curediseases.For more information,please visit or follow Regeneron on LinkedIn,Instagram,Facebook,or X.Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and

68、 uncertainties relating to future events and the futureperformance of Regeneron Pharmaceuticals,Inc.(Regeneron or the Company),and actual events or results may differmaterially from these forward-looking statements.Words such as anticipate,expect,intend,plan,believe,seek,estimate,variations of such

69、words,and similar expressions are intended to identify such forward-looking statements,althoughnot all forward-looking statements contain these identifying words.These statements concern,and these risks and uncertaintiesinclude,among others,competing drugs and product candidates that may be superior

70、 to,or more cost effective than,productsmarketed or otherwise commercialized by Regeneron and/or its collaborators or licensees(collectively,Regenerons Products)and product candidates being developed by Regeneron and/or its collaborators or licensees(collectively,Regenerons ProductCandidates)(includ

71、ing biosimilar versions of Regenerons Products);uncertainty of the utilization,market acceptance,andcommercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies(whether conductedby Regeneron or others and whether mandated or voluntary)or recommendations and g

72、uidelines from governmental authoritiesand other third parties or other factors beyond Regenerons control on the commercial success of Regenerons Productsand Regenerons Product Candidates;the nature,timing,and possible success and therapeutic applications of RegeneronsProducts and Regenerons Product

73、 Candidates and research and clinical programs now underway or planned,including withoutlimitation EYLEA HD(aflibercept)Injection 8 mg,EYLEA(aflibercept)Injection,Dupixent(dupilumab),Libtayo(cemiplimab),Praluent(alirocumab),Kevzara(sarilumab),Evkeeza(evinacumab),Veopoz(pozelimab),Ordspono(odronextam

74、ab),Lynozyfic(linvoseltamab),itepekimab,fianlimab,garetosmab,Regenerons other oncology programs(including its costimulatorybispecific portfolio),REGN5713-5715,nexiguran ziclumeran(nex-z,NTLA-2001),REGN1908-1909,mibavademab,Regeneronsand its collaborators earlier-stage programs,and the use of human g

75、enetics in Regenerons research programs;the likelihood andtiming of achieving any of the anticipated milestones described in this press release;safety issues resulting from theadministration of Regenerons Products and Regenerons Product Candidates in patients,including serious complications or sidee

76、ffects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials;the likelihood,timing,and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indicationsfor Regenerons Products,including those listed above

77、 and/or otherwise discussed in this press release;the extent to which theresults from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in otherstudies and/or lead to advancement of product candidates to clinical trials,therapeutic applications,o

78、r regulatory approval;ongoing regulatory obligations and oversight impacting Regenerons Products,research and clinical programs,and business,including those relating to patient privacy;determinations by regulatory and administrative governmental authorities which maydelay or restrict Regenerons abil

79、ity to continue to develop or commercialize Regenerons Products and Regenerons ProductCandidates;the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates andrisks associated with tariffs and other trade restrictions;the ability of Regenerons colla

80、borators,suppliers,or other third parties(asapplicable)to perform manufacturing,filling,finishing,packaging,labeling,distribution,and other steps related to RegeneronsProducts and Regenerons Product Candidates;the availability and extent of reimbursement or copay assistance for RegeneronsProducts fr

81、om third-party payors and other third parties,including private payor healthcare and insurance programs,healthmaintenance organizations,pharmacy benefit management companies,and government programs such as Medicare andMedicaid;coverage and reimbursement determinations by such payors and other third

82、parties and new policies and proceduresadopted by such payors and other third parties;changes in laws,regulations,and policies affecting the healthcare industry;unanticipated expenses;the costs of developing,producing,and selling products;the ability of Regeneron to meet any of itsfinancial projecti

83、ons or guidance and changes to the assumptions underlying those projections or guidance,including GAAP andnon-GAAP R&D,GAAP and non-GAAP SG&A,GAAP and non-GAAP gross margin on net product sales,COCM,capitalexpenditures,and GAAP and non-GAAP ETR;the potential for any license or collaboration agreemen

84、t,including Regeneronsagreements with Sanofi and Bayer(or their respective affiliated companies,as applicable),to be cancelled or terminated;theimpact of public health outbreaks,epidemics,or pandemics on Regenerons business;and risks associated with litigation andother proceedings and government inv

85、estigations relating to the Company and/or its operations(including the pending civilproceedings initiated or joined by the U.S.Department of Justice and the U.S.Attorneys Office for the District of Massachusetts),risks associated with intellectual property of other parties and pending or future lit

86、igation relating thereto(including withoutlimitation the patent litigation and other related proceedings relating to EYLEA),the ultimate outcome of any such proceedings andinvestigations,and the impact any of the foregoing may have on Regenerons business,prospects,operating results,and financialcond

87、ition.A more complete description of these and other material risks can be found in Regenerons filings with the U.S.Securities and Exchange Commission,including its Form 10-K for the fiscal year ended December 31,2024 and its Form 10-Q forthe quarterly period ended March 31,2025.Any forward-looking

88、statements are made based on managements current beliefs andjudgment,and the reader is cautioned not to rely on any forward-looking statements made by Regeneron.Regeneron does notundertake any obligation to update(publicly or otherwise)any forward-looking statement,including without limitation any f

89、inancialprojection or guidance,whether as a result of new information,future events,or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about theCompany,including information that may be deemed material to investors.Financial

90、 and other information about Regeneron isroutinely posted and is accessible on Regenerons media and investor relations website(https:/)and itsLinkedIn page(https:/ Financial MeasuresThis press release and/or the financial results attached to this press release include amounts that are considered non

91、-GAAPfinancial measures under SEC rules.As required,Regeneron has provided reconciliations of such non-GAAP financial measures.Contact Information:Ryan Crowe Christina ChanInvestor Relations Corporate Affairs914-847-8790 914-847- TABLE 1REGENERON PHARMACEUTICALS,INC.CONDENSED CONSOLIDATED BALANCE SH

92、EETS(Unaudited)(In millions)March 31,December 31,2025 2024Assets:Cash and marketable securities$17,625.7$17,912.6Accounts receivable,net 5,561.0 6,211.9Inventories 3,192.4 3,087.3Property,plant,and equipment,net 4,694.2 4,599.7Intangible assets,net 1,167.0 1,148.6Deferred tax assets 3,442.9 3,314.1O

93、ther assets 1,862.0 1,485.2Total assets$37,545.2$37,759.4 Liabilities and stockholders equity:Accounts payable,accrued expenses,and other liabilities$4,621.7$4,888.0Finance lease liabilities 720.0 720.0Deferred revenue 831.1 813.4Long-term debt 1,984.8 1,984.4Stockholders equity 29,387.6 29,353.6Tot

94、al liabilities and stockholders equity$37,545.2$37,759.4 TABLE 2REGENERON PHARMACEUTICALS,INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited)(In millions,except per share data)Three Months Ended March 31,2025 2024 Revenues:Net product sales$1,415.6$1,761.3 Collaboration revenue 1,531.2 1,

95、266.8 Other revenue 81.9 116.9 3,028.7 3,145.0 Expenses:Research and development 1,327.4 1,248.4 Acquired in-process research and development 12.3 7.1 Selling,general,and administrative 633.0 689.0 Cost of goods sold 265.5 240.4 Cost of collaboration and contract manufacturing 198.8 193.4 Other oper

96、ating expense(income),net 15.3 2,437.0 2,393.6 Income from operations 591.7 751.4 Other income(expense):Other income(expense),net 322.0 (34.6)Interest expense (8.7)(16.1)313.3 (50.7)Income before income taxes 905.0 700.7 Income tax expense(benefit)96.3 (21.3)Net income$808.7$722.0 Net income per sha

97、re-basic$7.58$6.70 Net income per share-diluted$7.27$6.27 Weighted average shares outstanding-basic 106.7 107.8 Weighted average shares outstanding-diluted 111.2 115.1 TABLE 3REGENERON PHARMACEUTICALS,INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION(Unaudited)(In millions,except per shar

98、e data)Three Months Ended March 31,2025 2024 GAAP R&D$1,327.4$1,248.4 Stock-based compensation expense 141.0 123.0 Acquisition and integration costs 3.8 Non-GAAP R&D$1,186.4$1,121.6 GAAP SG&A$633.0$689.0 Stock-based compensation expense 95.2 86.2 Acquisition and integration costs 0.8 18.8 Non-GAAP S

99、G&A$537.0$584.0 GAAP COGS$265.5$240.4 Stock-based compensation expense 19.5 20.9 Acquisition and integration costs 0.4 Intangible asset amortization expense 28.7 23.2 Non-GAAP COGS$217.3$195.9 GAAP other operating expense(income),net$15.3 Change in fair value of contingent consideration 15.3 Non-GAA

100、P other operating expense(income),net$GAAP other income(expense),net$313.3$(50.7)(Gains)losses on investments,net (139.9)196.1 Non-GAAP other income(expense),net$173.4$145.4 GAAP net income$808.7$722.0 Total of GAAP to non-GAAP reconciling items above 145.3 487.7 Income tax effect of GAAP to non-GAA

101、P reconciling items (25.6)(93.8)Non-GAAP net income$928.4$1,115.9 Non-GAAP net income per share-basic$8.70$10.35 Non-GAAP net income per share-diluted$8.22$9.55 Shares used in calculating:Non-GAAP net income per share-basic 106.7 107.8 Non-GAAP net income per share-diluted 113.0 116.8 RECONCILIATION

102、 OF GAAP TO NON-GAAP FINANCIAL INFORMATION(Unaudited)(continued)Three Months Ended March 31,2025 2024 Effective tax rate reconciliation:GAAP ETR 10.6%(3.0%)Income tax effect of GAAP to non-GAAP reconciling items 1.0%9.1%Non-GAAP ETR 11.6%6.1%Gross margin on net product sales reconciliation:GAAP gros

103、s margin on net product sales 81%86%Intangible asset amortization expense 2%2%Stock-based compensation expense 2%1%Non-GAAP gross margin on net product sales 85%89%Free cash flow reconciliation:Net cash provided by operating activities$1,045.1$1,512.5 Capital expenditures (229.3)(133.9)Free cash flo

104、w$815.8$1,378.6 TABLE 4REGENERON PHARMACEUTICALS,INC.COLLABORATION REVENUE(Unaudited)(In millions)Three Months Ended March 31,2025 2024Sanofi collaboration revenue:Regenerons share of profits in connection with commercialization of antibodies$1,018.2$804.0Reimbursement for manufacturing of commercia

105、l supplies 165.0 105.8Total Sanofi collaboration revenue 1,183.2 909.8 Bayer collaboration revenue:Regenerons share of profits in connection with commercialization of EYLEA 8 mg andEYLEA outside the United States 317.3 333.9Reimbursement for manufacturing of commercial supplies 26.6 22.1Total Bayer

106、collaboration revenue 343.9 356.0 Other collaboration revenue 4.1 1.0 Total collaboration revenue$1,531.2$1,266.8 TABLE 5REGENERON PHARMACEUTICALS,INC.NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS(Unaudited)(In millions)Three Months Ended March 31,2025 2024%Change U.S.ROW Total U.S.ROW Total(To

107、talSales)EYLEA HD(a)$306.8$146.4$453.2$200.0$15.2$215.2 111%EYLEA(a)$736.0$711.4$1,447.4$1,201.6$834.2$2,035.8(29%)Total EYLEA HD and EYLEA$1,042.8$857.8$1,900.6$1,401.6$849.4$2,251.0(16%)Dupixent(b)$2,629.4$1,036.2$3,665.6$2,218.0$858.8$3,076.8 19%Libtayo(c)$192.5$92.6$285.1$159.2$104.7$263.9 8%Pra

108、luent(d)$56.8$136.5$193.3$70.0$131.3$201.3(4%)Kevzara(b)$72.8$43.6$116.4$50.0$44.1$94.1 24%Other products(e)$31.1$23.5$54.6$25.3$18.9$44.2 24%Note:The table above includes net product sales of Regeneron-discovered products.Such net product sales are recorded bythe Company or others,as further descri

109、bed in the footnotes below.(a)The Company records net product sales of EYLEA HD and EYLEA in the United States,and Bayer records net productsales outside the United States.The Company records its share of profits in connection with sales outside the UnitedStates within Collaboration revenue.(b)Sanof

110、i records global net product sales of Dupixent and Kevzara,and the Company records its share of profits inconnection with global sales of such products within Collaboration revenue(c)The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales(d)The Company records

111、 net product sales of Praluent in the United States.Sanofi records net product sales of Praluentoutside the United States and pays the Company a royalty on such sales,which is recorded within Other revenue.(e)Included in this line item are products which are sold by the Company and others.Refer to First Quarter 2025 FinancialResults section above for a complete listing of net product sales recorded by the Company.Not included in this line item arenet product sales of ARCALYST,which are recorded by Kiniksa.Source:Regeneron Pharmaceuticals,Inc.