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1、 1Novartis Q1 Results|April 29,2025ContentCompany overviewFinancial reviewConclusionsClick below to navigate through the documentAppendixReferencesInvestor presentationApril 29,2025Q1 2025 Results 2Novartis Q1 Results|April 29,2025ContentCompany overviewFinancial reviewConclusionsClick below to navi

2、gate through the documentAppendixReferencesDisclaimerThis presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995,that can generally be identified by words such as“potential,”“expected,”“will,”“planned,”“pipeline,”“out

3、look,”“confident,or similar expressions,or by express or implied discussions regarding potential new products,potential new indications for existing products,potential product launches,or regarding potential future revenues from any such products;or regarding results of ongoing clinical trials;or re

4、garding potential future,pending or announced transactions;regarding potential future sales or earnings;or by discussions of strategy,plans,expectations or intentions,including discussions regarding our continued investment into new R&D capabilities and manufacturing;or regarding our capital structu

5、re.Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties.Should one or more of these risks or uncertainties materialize,or should underlying assumptions prove in

6、correct,actual results may vary materially from those set forth in the forward-looking statements.You should not place undue reliance on these statements.There can be no guarantee that the investigational or approved products described in this presentation will be submitted or approved for sale or f

7、or any additional indications or labeling in any market,or at any particular time.Nor can there be any guarantee that such products will be commercially successful in the future.Neither can there be any guarantee that the expected benefits or synergies from the transactions described in this present

8、ation will be achieved in the expected timeframe,or at all.In particular,our expectations could be affected by,among other things:uncertainties concerning global healthcare cost containment,including ongoing government,payer and general public pricing and reimbursement pressures and requirements for

9、 increased pricing transparency;uncertainties regarding the success of key products,commercial priorities and strategy;uncertainties in the research and development of new products,including clinical trial results and additional analysis of existing clinical data;our ability to obtain or maintain pr

10、oprietary intellectual property protection,including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products;uncertainties regarding our ability to realize the strategic benefits,operational efficiencies or opportunities expected from our extern

11、al business opportunities;uncertainties in the development or adoption of potentially transformational digital technologies,including artificial intelligence,and business models;uncertainties surrounding the implementation of our new IT projects and systems;uncertainties regarding potential signific

12、ant breaches of information security or disruptions of our information technology systems;uncertainties regarding actual or potential legal proceedings,including regulatory actions or delays or government regulation related to the products and pipeline products described in this presentation;safety,

13、quality,data integrity,or manufacturing issues;our performance on and ability to comply with environmental,social and governance measures and requirements;major macroeconomic and geo-and socio-political developments,including the impact of any potential tariffs on our products or the impact of war i

14、n certain parts of the world;uncertainties regarding future global exchange rates;uncertainties regarding future demand for our products;and other risks and factors referred to in Novartis AGs most recently filed Form 20-F and in subsequent reports filed with,or furnished to,the US Securities and Ex

15、change Commission.Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information,future events or otherwise.All product names appearing in italics are trademarks owned by or lice

16、nsed to Novartis.This presentation includes non-IFRS financial measures,including Constant currencies(cc),core results and free cash flow.An explanation of non-IFRS measures can be found on page 31 of the Novartis First Quarter 2025 Condensed Interim Financial Report.3ContentClick below to navigate

17、through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Vas Narasimhan,M.D.Chief Executive OfficerCompany overview 4ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Re

18、sults|April 29,2025Novartis delivered double-digit sales growth and robust margin expansion in Q1,supporting upgrade to FY 2025 guidance1.Constant currencies(cc)and core results are non-IFRS measures.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Repor

19、t.Unless otherwise noted,all growth rates refer to same period in PY.2.Please see detailed guidance assumptions on slide 22.Innovation highlightsPluvicto FDA approval for pre-taxane mCRPCVanrafia FDA accelerated approval for IgANFabhalta FDA,EC and NMPA approvals for C3G Remibrutinib global submissi

20、ons for CSUOAV101 IT Ph3 STEER study positive readout in SMAFY 2025 guidance upgraded2:Sales expected to grow high single-digit,and core operating income to grow low double-digitCore1 operating incomeUSD bn,%ccQ1 2024Q1 20254.55.6Core margin 42.1%(+400 bps)+27%Sales USD bn,%cc1Q1 2024Q1 202511.813.2

21、+15%5ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025SalesUSD millionGrowth vs.PYUSD millionGrowth vs.PYcc2,261 22%956 56%899 43%1,534 18%257 72%238 76%81 nm371 21%Strong momentum from priority brands co

22、ntinued to drive robust growth,demonstrating our replacement powerConstant currencies(cc)is a non-IFRS measure.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.38232926220810610275

23、61Q1 salesGROWTHStrong growth+32%ccexcl.Entresto+38%cc 6ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Kisqali grew+56%cc,reflecting positioning as CDK4/6 inhibitor of choice across mBC and eBCSee page

24、72 for references(footnotes 1-4).Constant currencies(cc)is a non-IFRS measure.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.GROWTHSales evolutionUSD m,%ccUSEx-USUS:+87%in Q1 Lea

25、ding share in mBC NBRx at 48%2;now tied for TRx leadershipeBC NBRx grew 65%with share reaching 60%2;56%of volume from exclusive populationEx-US:+24%cc in Q1mBC leader in top 10 countries with 46%3 NBRx share and 35%3 TRx shareeBC now approved in EU+9 countries;Germany eBC NBRx share at 67%4Strong gu

26、idelines supportCategory 1 Preferred NCCN Guidelines recommendation in both mBC and eBC Only CDK4/6i with highest ESMO magnitude of benefit score for mBC and eBCUS Total Brand NBRx1313586314370Q1 2025Q1 2024627956+56%7ContentClick below to navigate through the documentFinancial reviewConclusionsAppe

27、ndixReferencesCompany overviewNovartis Q1 Results|April 29,2025Kesimpta grew+43%cc,outpacing both B-cell and MS marketSee page 72 for references(footnotes 1-5).Constant currencies(cc)is a non-IFRS measure.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial

28、Report.Unless otherwise noted,all growth rates refer to same period in PY.OLE:Open-label extension study.GROWTHContinued robust demand growth US:+41%,with TRx growth(+29%vs.PY)outpacing B-cell(+12%)and MS(+3%)markets;highest quarterly NBRx volume since launchEx-US:+45%cc,with leading NBRx share in p

29、atients in 8/10 major markets17-year data at AAN reinforce favorable benefit/risk profile ALITHIOS OLE:9/10 recently diagnosed and treatment naive RMS patients showed delays in disability progression based on 6-month PIRA at year 72,3Convenience of at-home self-administration First and only B-cell t

30、reatment option intentionally designed for self-administration One dose delivers consistent treatment benefits across BMI subgroups4 One minute,once a month,at home or on the go,no pre-medications5 Sales evolutionUSD m,%ccUSEx-US415587222312Q1 2025Q1 2024637899+43%8ContentClick below to navigate thr

31、ough the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Pluvicto grew+21%cc in Q1,laying the foundation for mCRPC pre-taxane launch in USSee page 72 for references(footnote 1).Constant currencies(cc)is a non-IFRS measure.An explanation of non-IF

32、RS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.Market leader in mCRPC post-taxane setting Leading NBRx in VISION 1L setting(40%),closest to PSMAfore populationEncouraging momentum in VISION NBRx(1.9k NB

33、Rx,+9%vs.PQ)Gaining traction in community setting(4k TRx,+11%vs.PY)Ex-US:Continuous growth driven by Europe and expansion into 20+countriesMarch FDA approval in pre-taxane setting based on PSMAforePluvicto more than doubled median rPFS with favorable safety and tolerability vs.daily oral ARPIFinal O

34、S analysis unadjusted for crossover numerically favored Pluvicto with HR 0.91;crossover-adjusted1 HR 0.59NCCN Guidelines already updated to recommend Pluvicto in the PSMAfore settingContinuing to advance Pluvicto LCMPSMAddition readout in mHSPC expected H2 2025;incidence similar to mCRPC populationG

35、ROWTH28128784Q1 2025Q1 202431037129+21%Sales evolutionUSD m,%ccUSEx-US 9ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Confident in growth acceleration with PSMAfore launch in USPre-filled syringeInfusi

36、onPSMAfore population 2x VISION620 sites opened(+5%vs.PQ)Pre-filled syringe national launch enabling broad adoption50%of PSMAfore patients treated by key HCPs who have prescribed in VISIONIncreased promotional spend(doubled FF,DTC)Strong foundation in placeExpect 4-7 weeks lead-time for new patients

37、 to be treatedInitial uptake driven by depth in established accounts with high VISION 1L shareExpanding breadth in community and urology over timeFavorable NCCN Guidelines recommendation supporting access and reimbursement confidenceLaunch dynamicsGROWTH 10ContentClick below to navigate through the

38、documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Leqviogrew+72%cc in Q1,on track to achieve blockbuster status in 2025See page 72 for references(footnotes 1-2).Constant currencies(cc)is a non-IFRS measure.An explanation can be found on page 31 of

39、the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.Novartis obtained global rights to develop,manufacture,and commercialize Leqvio under license/collaboration agreement with Alnylam Pharmaceuticals.GROWTHUS:+72%,outpacing advanced lipid-lowering

40、 market1,2Steady climb in MOTRx,+70%vs.PY(vs.market+37%),with growth across all channelsIncreasing depth in priority systems,+10%vs.PQ and+51%vs.PY Evolved field operating model to support continued growth and customer impactEx-US:+74%cc,with robust growth in all marketsSolid pricing and access secu

41、red in JapanContinued out-of-pocket market expansion in ChinaSignificant runway to expand the market2025 ACC/AHA ACS Guidelines now recommend use of non-statin LLTOnly 2%of secondary prevention patients in US receive aLLT within 12 months of eventSales evolutionUSD m,%ccUSEx-US7477Q1 2024130127Q1 20

42、25151257+72%11ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025GROWTHScemblix market leadership continues globally in 3L+,with early lines launch driving momentum in the USSee page 73 for references(footn

43、otes 1-3).Constant currencies(cc)is a non-IFRS measure.An explanation can be found on page 31 of Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.Consistent leadership in 3L+CMLUS:NBRx share of 54%,3x higher than next competitor1Ex-US:NBRx leaders

44、hip(68%in JP,47%in DE)2 and 47%total share in key markets3Continued momentum in early lines launch in USStrong start driven by clinical profile(including NCCN Guidelines Category 1 Preferred recommendation)and expanded payer coverage(54%of Commercial lives PA to label)Expanding prescriber breadth,+1

45、6%vs.PQStrong uptake in 2L,with NBRx leadership(40%share)1Making inroads in 1L with 10%NBRx share1Early line approvals on track globally Early lines indication approved in 10 countriesRegulatory submission to EMA completed881544884Q1 2024Q1 2025136238+76%Sales evolutionUSD m,%ccUSEx-US 12ContentClic

46、k below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Cosentyxgrew+18%cc,with ongoing launches in HS and IV and expansion in core indicationsSee page 73 for references(footnotes 1-5).Constant currencies(cc)is a non-IFRS

47、measure.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.SpA refers to the Cosentyx indications in psoriatic arthritis(PsA),non-radiographic axial spondyloarthritis(nr-axSpA),and a

48、nkylosing spondylitis(AS).GROWTHUS continued strong growth(+23%)Strong demand growth(+29%)more than offsetting Medicare Part D redesign impact NBRx volume outperforming the market in core indications QoQ(+15%vs.market in PsO,+12%SpA)1 Continued NBRx leadership in HS(53%)1Accelerated adoption in IV(1

49、,900 accounts,+13%QoQ)2Ex-US growth(+12%cc)driven by demandDelivered+15%volume growth,mainly in core indicationsLeading originator biologic in EU3and China4HS reimbursed in key markets5;approved by China NMPA in Q1Confident in continued growthAnticipating two Ph3 readouts in 2025:GCA and PMR66181566

50、5719Q1 2024Q1 20251,3261,534+18%Sales evolutionUSD m,%ccUSEx-US 13ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Entrestodelivered consistent performance,growing+22%cc in Q1See page 73 for references(fo

51、otnotes 1-5).Constant currencies(cc)is a non-IFRS measure.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.US weekly TRx1Total prescriptions(000)Expect continued growth ex-US post

52、US LoEStrong guideline position2(US/EU)Balanced geographic sales3:US 50%,Europe 20%,China 10%,Japan 5%Ex-US:RDP to Nov 20264 in EU,Jun 2030 in Japan,with possible additional protectionUS:For forecasting purposes,we assume Entresto LoE in mid-20255GROWTHSales evolutionUSD m,%ccJuly 2015Mar 2025139489

53、31Q1 2024Q1 20251,8792,2611,0921,169+22%USEx-US 14ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|April 29,2025Renal portfolio continues to expand,with ongoing US Fabhalta launches and Vanrafia FDA accelerated approv

54、al See page 74 for references(footnotes 1-4).5.Use of Vanrafia is contraindicated in patients who are pregnant and patients with hypersensitivity.Serious warnings associated with Vanrafia include embryo-fetal toxicity,hepatotoxicity,fluid retention,and decreased sperm counts.FabhaltaC3GApproved by F

55、DA in March;first patient treated within 5 days2K HCPs REMS certified applicable to IgAN and C3G Approved in EU in Q1,China in AprilIgAN100%volume growth,60%increase in writers vs.PQ190%patients remaining on treatment after 5 months268%commercial PA to label coverage in 5 years-1123456Favors shamFav

56、ors OAV101 IT0Primary and key secondary endpoint2 to 18 yearsINNOVATIONExploratory endpoints5 to 18 yearsNext steps Global regulatory submissions planned in H1 2025 16ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesCompany overviewNovartis Q1 Results|A

57、pril 29,2025Remibrutinib:Long-term data in CSU support differentiated profile of this potential pipeline-in-a-pill;FDA decision expected H2 2025 See page 74 for references(footnotes 1-5).Next steps FDA decision on CSU indication expected H2 2025REMIX studies:Strong efficacy1,2 with oral convenience

58、INNOVATIONAchieving key milestones in CSUNEJM publication of REMIX 24-week resultsCompleted submissions in US with PRV,EU and China Initiated HTH study vs.dupilumab;readout exp.20275Advancing indications beyond CSU CINDU:Ph3 ongoing,targeting 2026 submission HS:Ph3 studies started in Q1 FA:Ph2a/b on

59、going,readout expected H2 2025RMS:Ph3 ongoing,readout expected in 2026 gMG:Ph3 ongoing,readout expected in 2028 Meaningful improvement in symptom control across all measures3 as early as week 1 and sustained to week 52 Favorable safety profile4 up to 52 weeks,including balanced LFTsChange from basel

60、ine in UAS7(mean SE)Remibrutinib 25 mg bidPlacebo Remibrutinib 25 mg bid Week08 12 16 20 24 28 32 36 40 44 48 52-25-20-15-10-504REMIX-1REMIX-2-25-20-15-10-5008 12 16 20 24 28 32 36 40 44 48 524Week 17ContentClick below to navigate through the documentFinancial reviewConclusionsAppendixReferencesComp

61、any overviewNovartis Q1 Results|April 29,2025Key innovation milestones in 20251.Ongoing study shown is sponsored by PTC Therapeutics.Novartis has obtained global rights to develop,manufacture,and commercialize votoplam under License&Collaboration agreement with PTC Therapeutics.2025 selected key eve

62、nts(expected)H1 2025H2 2025Status as of end Q1Regulatory decisionsAtrasentan IgANUSUS approval in April Fabhalta(iptacopan)C3GUS,JPEUUS,EU approvals in Q1,China approval in AprilPluvicto mCRPC,pre-taxane USUS approval in Q1Scemblix 1L CMLJPSubmissionsRemibrutinib CSU US,EU,CNUS,EU and China submissi

63、ons in Q1,China priority review grantedZolgensma SMA ITUS,EUJPPh3 STEER&STRENGH data presented at MDA 2025Scemblix CML 1LEUEU submission in Q1Pluvicto mHSPC USCosentyx GCAUS,EUReadoutsCosentyx GCA Ph3(GCAPTAIN)Cosentyx PMR Ph3(REPLENISH)Ianalumab SjSPh3s(NEPTUNUS-1 and-2)Ianalumab 2L ITPPh3(VAYHIT2)

64、Pluvicto mHSPC Ph3(PSMAddition)Remibrutinib FAPh2 Ianalumab HSPh2Votoplam(PTC518)HD1Ph2Key study startsRemibrutinib HSPh3Ph3 trials RECHARGE-1 and-2 started in Q1Remibrutinib gMGPh3Ph3 trial RELIEVE started in Q1Ac-PSMA-617 PCPh3YTB323 AAVPh2Ph2 trial started in Q1JSB462(AR degrader)PCPh2GIA632(IL-1

65、5 mAb)Ph2QCZ484 rHTNPh2Ph2 trial started in Q1 VHB937(TREM2)ADPh2INNOVATION 18ContentClick below to navigate through the documentCompany overviewConclusionsAppendixReferencesFinancial reviewNovartis Q1 Results|April 29,2025Harry Kirsch Chief Financial OfficerFinancial review and 2025 guidance 19Cont

66、entClick below to navigate through the documentCompany overviewConclusionsAppendixReferencesFinancial reviewNovartis Q1 Results|April 29,2025Q1 net sales increased+15%cc,with strong core1 margin expansion1.Constant currencies(cc),core results and free cash flow are non-IFRS measures.An explanation o

67、f non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.FINANCIAL PROFILEKey figures1USD millionQ12024Q12025Change vs.PY%USD%ccTotal net sales11,829 13,233 1215Core operating income4,537 5,575 2327Core m

68、argin38.4%42.1%+3.7%pts+4.0%ptsOperating income3,373 4,663 3844Net income2,688 3,609 3437Core EPS1.80 2.28 2731EPS1.31 1.83 4042Free cash flow2,038 3,391 66Novartis Q1 Results|April 29,2025 20ContentClick below to navigate through the documentCompany overviewConclusionsAppendixReferencesFinancial re

69、viewNovartis Q1 Results|April 29,2025Free Cash Flow1USD bn,period ratesContinued focus on Free Cash Flow generation1.Free Cash Flow and core results are non-IFRS measures.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all

70、growth rates refer to same period in PY.2.0Q1 20243.4Q1 2025FINANCIAL PROFILE2025 growth driven by higher core operating income+66%21ContentClick below to navigate through the documentCompany overviewConclusionsAppendixReferencesFinancial reviewNovartis Q1 Results|April 29,2025Substantial cash gener

71、ationContinuing our shareholder-friendly capital allocation strategy1.In CHF.2.USD 5.3 billion annual net dividend payment in March,which is the gross dividend of USD 7.8 billion reduced by the USD 2.5 billion Swiss withholding tax that was paid in April 2025,according to its due date.3.As of March

72、31,2025.Investing in the businessReturning capital to shareholdersInvestments in organic businessOngoing investment in R&D and CapEx,e.g.,five-year USD 23bn investment in the USFINANCIAL PROFILEzConsistently growing annual dividend1USD 7.8bn dividend paid in March/April 20252Share buybacksUp-to USD

73、15bn share buyback continuing,with up to USD 2.7bn still to be executed3Value-creating bolt-onsAcquisition of Anthos Therapeutics(closed in April)22ContentClick below to navigate through the documentCompany overviewConclusionsAppendixReferencesFinancial reviewNovartis Q1 Results|April 29,2025Raising

74、 Novartis 2025 full year guidanceExpected,barring unforeseen events;growth vs.PY in cc11.Constant currencies(cc)and core results are non-IFRS measures.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer t

75、o same period in PY.2.Timing of Entresto US generic entry is subject to ongoing patent and regulatory litigation.FINANCIAL PROFILEFY guidance on other financial KPIs Core net financial result:Expenses expected to be around USD 1bn Core tax rate:Expected to be around 16-16.5%Core operating income exp

76、ected to grow low double-digitNet sales expected to grow high single-digitKey assumptions2 We assume Tasigna,Promacta and Entresto US generic entry mid-2025 for forecasting purposes2(from mid-to high single-digit)(from high single to low double-digit)23ContentClick below to navigate through the docu

77、mentCompany overviewConclusionsAppendixReferencesFinancial reviewNovartis Q1 Results|April 29,2025Expected currency impact for Q2 and full year 2025Novartis Q1 Results|April 29,202523FINANCIAL PROFILE 24ContentClick below to navigate through the documentCompany overviewFinancial reviewAppendixRefere

78、ncesConclusionsNovartis Q1 Results|April 29,2025Vas Narasimhan,M.D.Chief Executive OfficerConclusions 25ContentClick below to navigate through the documentCompany overviewFinancial reviewAppendixReferencesConclusionsNovartis Q1 Results|April 29,2025Constant currencies(cc)and core results are non-IFR

79、S measures.An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report.Unless otherwise noted,all growth rates refer to same period in PY.Novartis Q1 Results|April 29,202525Strong start to the year,with double-digit sales growth and robust core margin expans

80、ionUpgraded guidance for FY 2025Significant pipeline progress,including three new product approvalsConfident in achieving our mid-to long-term growth outlookReferences 26ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsInnovation:Pipeline overviewFinancia

81、l performanceInnovation:Clinical trialsAbbreviationsAppendixNovartis Q1 Results|April 29,2025Appendix 27ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation

82、:Clinical trialsAbbreviationsAppendixOur pipeline projects at a glanceIB&GH:In-market Brands and Global Health.Phase I/IIPhase IIIRegistrationTotalOncology239133Solid tumors184123Hematology55010Immunology148123Neuroscience87015Cardiovascular,Renal and Metabolic78015Others(thereof IB&GH)10(9)3(3)2(2)

83、1562354101INNOVATION 28ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trialsAbbreviationsAppendixNovartis pipeline in Phase IOncologyCodeName

84、MechanismIndication(s)Solid tumorsAAA603177Lu-NeoBRadioligand therapy target GRPRBreast cancerGlioblastoma multiformeAAA617PluvictoRadioligand therapy target PSMAMetastatic neuroendocrine prostate cancerAAA802225Ac-PSMA-R2Radioligand therapy target PSMA Prostate cancerAAA817225Ac-PSMA-617 Radioligan

85、d therapy target PSMA Metastatic castration-resistant prostate cancerECI830ECI830CDK2 inhibitorBreast cancerFXX489177Lu-NNS309Radioligand therapySolid tumorsHRO761HRO761Werner inhibitorSolid tumorsIAG933IAG933-MesotheliomaKFA115KFA115Novel immunomodulatory AgentSolid tumorsMGY825MGY825-NSCLCHematolo

86、gyDFV890DFV890NLRP3 inhibitorLow risk myelodysplastic syndromePIT565PIT565-B-cell malignanciesYTB323rapcabtagene autoleucel CD19 CAR-TAdult ALLImmunologyCodeNameMechanismIndication(s)IPX643IPX643-Inflammation-driven diseasesPIT565PIT565-Systemic lupus erythematosusYMI024YMI024-Inflammation-driven di

87、seasesNeuroscienceCodeNameMechanismIndication(s)DFT383DFT383CTNS gene deliveryCystinosisNIO752NIO752Tau antisense oligonucleotideAlzheimers diseaseProgressive supranuclear palsy YTB323rapcabtagene autoleucelCD19 CAR-TRelapsing multiple sclerosisPrimary progressive multiple sclerosisGeneralized Myast

88、henia GravisOthersCodeNameMechanismIndication(s)IB&GHEDI048EDI048CpPI(4)K inhibitorCryptosporidiosisITU512ITU512HbF inducing agent Sickle cell disease 16 lead indicationsLead indicationINNOVATIONCardiovascular,Renal and MetabolicCodeNameMechanismIndication(s)DFV890DFV890NLRP3 inhibitorCardiovascular

89、 risk reduction 29ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trialsAbbreviationsAppendixNovartis pipeline in Phase II1.Phase I/II.Oncolog

90、yCodeNameMechanismIndication(s)Solid tumorsAAA601LutatheraRadioligand therapy target SSTRGEPNET,pediatrics1L ES-SCLCGlioblastomaAAA603177Lu-NeoBRadioligand therapy target GRPR Multiple solid tumorsAAA614AAA614Radioligand therapy target FAPSolid tumorsDZR123tulmimetostatEZH1,EZH2 inhibitorSolid tumor

91、s&lymphomasJSB462luxdegalutamideAndrogen receptor protein degrader Prostate cancerHematologyABL001ScemblixBCR-ABL inhibitorChronic myeloid leukemia,pediatricsYTB323rapcabtagene autoleucelCD19 CAR-T1L high-risk large B-cell lymphomaImmunologyCodeNameMechanismIndication(s)DFV890DFV890NLRP3 inhibitorOs

92、teoarthritisLOU064remibrutinibBTK inhibitorFood allergyMAS825MAS825IL1B,IL18 InhibitorNLRC4-GOF indicationsNGI226NGI226-TendinopathyRHH646RHH646-OsteoarthritisVAY736ianalumabBAFF-R inhibitor,ADCC-mediated B-cell depletorHidradenitis suppurativaSystemic sclerodermaYTB323rapcabtagene autoleucelCD19 CA

93、R-TsrSLE/LNSystemic scleroderma MyositisANCA associated vasculitisNeuroscienceCodeNameMechanismIndication(s)HTT227votoplamHuntingtin ModulatorHuntingtons diseaseVHB937VHB937TREM2 stabilizer and activatorAmyotrophic lateral sclerosisCardiovascular,Renal and MetabolicCodeNameMechanismIndication(s)LNP0

94、23Fabhalta CFB inhibitorLupus nephritisANCA associated vasculitis LTP001LTP001SMURF1 inhibitor Pulmonary arterial hypertension1Idiopathic pulmonary fibrosisQCZ484QCZ484-HypertensionTIN816TIN816ATP modulatorAcute kidney injuryOthersCodeNameMechanismIndication(s)IB&GHEYU688EYU688NS4B inhibitorDengue f

95、everINE963INE963Plasmodium falciparum inhibitor Malaria,uncomplicatedKAE609cipargaminPfATP4 inhibitorMalaria,severeMalaria,uncomplicatedLXE408LXE408Proteasome inhibitorVisceral leishmaniasisPKC412RydaptMulti-targeted kinase inhibitorAcute myeloid leukemia,pediatricsSEG101AdakveoP-selectin inhibitorS

96、ickle cell disease,pediatricsOthersLNP023Fabhalta CFB inhibitoriAMD17 lead indicationsLead indicationINNOVATION 30ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performance

97、Innovation:Clinical trialsAbbreviationsAppendixNovartis pipeline in Phase IIIOncologyCodeNameMechanismIndication(s)Solid tumorsAAA601LutatheraRadioligand therapy target SSTRGastroenteropancreatic neuroendocrine tumorsAAA617PluvictoRadioligand therapy target PSMA Metastatic hormone sensitive prostate

98、 cancer(mHSPC)Oligometastatic prostate cancerBYL719VijoicePI3K-alpha inhibitorLymphatic malformationsHematologyDAK539pelabresibBET inhibitorMyelofibrosisLNP023Fabhalta CFB inhibitorAtypical hemolytic uraemic syndromeVAY736ianalumabBAFF-R inhibitor,ADCC-mediated B-cell depletor1L Immune Thrombocytope

99、nia 2L Immune Thrombocytopenia warm Autoimmune Hemolytic Anemia ImmunologyCodeNameMechanismIndication(s)AIN457CosentyxIL17A inhibitorGiant cell arteritisPolymyalgia rheumaticaLOU064remibrutinibBTK inhibitorChronic spontaneous urticaria,pediatricsChronic inducible urticariaHidradenitis suppurativaVAY

100、736ianalumabBAFF-R inhibitor,ADCC-mediated B-cell depletorSjgrensLupus NephritisSystemic lupus erythematosusCardiovascular,Renal and MetabolicCodeNameMechanismIndication(s)FUB523zigakibartAnti-APRILIgA nephropathyKJX839LeqviosiRNA(regulation of LDL-C)CVRR(secondary prevention)CVRR(primary prevention

101、)Hyperlipidemia,pediatricsLNP023Fabhalta CFB inhibitorC3 glomerulopathy,pediatricsIC-MPGNMAA868abelacimabFXI inhibitorAtrial fibrillationTQJ230pelacarsenASO targeting Lp(a)Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein(a)(CVRR-Lp(a)NeuroscienceCodeNameM

102、echanismIndication(s)BAF312MayzentS1P1,5 receptor modulatorMultiple sclerosis,pediatricsLNP023Fabhalta CFB inhibitorMyasthenia gravisLOU064remibrutinibBTK inhibitorMultiple sclerosisMyasthenia gravisOAV101onasemnogene abeparvovecSMN1 gene replacement therapy SMA IT administrationOMB157KesimptaCD20 A

103、ntagonistMultiple sclerosis,pediatricsMultiple sclerosis,new dosing regimenOthersCodeNameMechanismIndication(s)IB&GHAMG334 AimovigCGRPR antagonistMigraine,pediatricsKLU156Ganaplacide+lumefantrine Non-artemisinin plasmodium falciparum inhibitorMalaria,uncomplicatedQMF149AtecturaLABA+ICSAsthma,pediatr

104、ics6 lead indicationsLead indicationINNOVATION 31ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trialsAbbreviationsAppendixNovartis pipeline

105、in registrationOncologyCodeNameMechanismIndication(s)Solid tumorsAAA6011LutatheraRadioligand therapy target SSTRGastroenteropancreatic neuroendocrine tumors(GEP-NET),1st line in G2/3 tumors INNOVATIONOthersCodeNameMechanismIndication(s)IB&GHCOA566CoartemArtemisinin combination therapyMalaria,uncompl

106、icated(Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixNovartis Q1 Results|April 29,2025IR Clinical StudiesNovartis Q4 Results|January 31,20251Includes selected ongoing or recently concluded global trials ofNovartis development p

107、rograms/products which are in confirmatorydevelopment or marketed(typically Phase 2b or later).For further information on all Novartis clinical trials,please visit:Clinical Trials Update 36ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Resul

108、ts|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixCardiovascular,Renal and MetabolicIR Clinical StudiesNovartis Q4 Res

109、ults|January 31,20251 37ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuros

110、cience Oncology In-market Brands&Global HealthAbbreviationsAppendixatrasentan-ETA receptor antagonistNCT04573478 ALIGN(CHK01-01)IndicationIgA nephropathyPhasePhase 3Patients380Primary Outcome MeasuresChange in proteinuria Time Frame:Up to Week 24 or approximately 6 months Annualized total estimated

111、Glomerular Filtration Rate(eGFR)slope estimated over 24 monthsArms InterventionArm 1 Experimental:Atrasentan,once daily oral administration of 0.75 mg atrasentan for 132 weeksArm 2 Placebo comparator:Placebo once daily oral administration of placebo for 132 weeksTarget PatientsPatients with IgA neph

112、ropathy(IgAN)at risk of progressive loss of renal functionReadout Milestone(s)2023(primary endpoint for US initial submission)2026(24 months)PublicationTBD 38ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConcl

113、usionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixFabhalta-CFB inhibitorFabhalta-CFB inhibitorNCT04578834 APPLAUSE-IgAN(CLNP023A2301)IndicationIgA ne

114、phropathyPhasePhase 3Patients450Primary Outcome MeasuresRatio to baseline in urine protein to creatinine ratio(sampled from 24h urine collection)at 9 months Annualized total estimated Glomerular Filtration Rate(eGFR)slope estimated over 24 monthsArms InterventionArm 1-LNP023 200mg BIDArm 2-Placebo B

115、IDTarget PatientsPrimary IgA Nephropathy patientsReadout Milestone(s)2023(primary endpoint for US initial submission,9 months UPCR)2025(24 months)PublicationTBDNCT05755386 APPARENT(CLNP023B12302)IndicationImmune complex-mediated membranoproliferative glomerulonephritisPhasePhase 3Patients106Primary

116、Outcome MeasuresLog-transformed ratio to baseline in UPCR(sampled from a 24 hour urine collection)Arms InterventionArm 1 experimental:Drug:iptacopan 200 mg b.i.d.(Adults 200mg b.i.d;Adolescents 2x 100mg b.i.d)Arm 2 placebo to iptacopan 200mg b.i.d.(both on top of SoC)Target PatientsPatients(adults a

117、nd adolescents aged 12-17 years)with idiopathic IC-MPGNReadout Milestone(s)2028PublicationVivarelli M,et al.,Kidney International Reports(2023),Iptacopan in idiopathic immune complex-mediated membranoproliferative glomerulonephritis:Protocol of the APPARENT multicenter,randomized Phase III study 39C

118、ontentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market

119、 Brands&Global HealthAbbreviationsAppendixLeqvio-siRNA(regulation of LDL-C)Leqvio-siRNA(regulation of LDL-C)NCT03705234 ORION-4(CKJX839B12301)IndicationHypercholesterolemia inc.Heterozygous Familial Hypercholesterolaemia(HeFH)PhasePhase 3Patients16124Primary Outcome MeasuresA composite of major adve

120、rse cardiovascular events,defined as:Coronary heart disease(CHD)death;Myocardial infarction;Fatal or non-fatal ischaemic stroke;orUrgent coronary revascularization procedureArms InterventionArm 1:every 6 months treatment Inclisiran sodium 300mg(given bysubcutaneous injection on the day of randomizat

121、ion,at 3 months and then every 6-months)for a planned median duration of about 5 yearsArm 2:matching placebo(given bysubcutaneous injection on the day of randomization,at 3 months and then every 6 months)for a planned median duration of about 5 years.Target PatientsPatient population with mean basel

122、ine LDL-C 100mg/dLReadout Milestone(s)2026PublicationTBDNCT05030428 VICTORION-2P(CKJX839B12302)IndicationSecondary prevention of cardiovascular events in patients with elevated levels of LDL-CPhasePhase 3Patients16970Primary Outcome Measures1.Time to First Occurrence of 3P-MACE(3-Point Major Adverse

123、 Cardiovascular Events)Arms InterventionArm 1:Experimental Inclisiran sodium,Subcutaneous injectionArm 2:Placebo Comparator,Placebo Subcutaneous injectionTarget PatientsParticipants with established cardiovascular disease(CVD)Readout Milestone(s)2027PublicationTBD 40ContentClick below to navigate th

124、rough the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviatio

125、nsAppendixLeqvio-siRNA(regulation of LDL-C)Leqvio-siRNA(regulation of LDL-C)NCT04652726 ORION-16(CKJX839C12301)IndicationHyperlipidemia,pediatricsPhasePhase 3Patients141Primary Outcome MeasuresPercentage(%)change in low-density lipoprotein cholesterol(LDL-C)from baseline to Day 330Arms InterventionG

126、roup 1:Inclisiran sodium 300mg on Days 1,90,270,placebo on Day 360,inclisiran sodium 300mg on Days 450 and 630Group 2:Placebo on Days 1,90,270,inclisiran sodium 300mg on Days 360,450 and 630.Target PatientsAdolescents(12 to less than 18 years)with heterozygous familial hypercholesterolemia(HeFH)and

127、elevated low density lipoprotein cholesterol(LDL-C)Readout Milestone(s)2025PublicationPublication Design publication(O-16/-13)in Eur.J.Prev.Cardiol.Vol.29,Feb.2022 Presentation at EAS May-2022 on O-13/-16 study design NCT04659863 ORION-13(CKJX839C12302)IndicationHyperlipidemia,pediatricsPhasePhase 3

128、Patients13Primary Outcome MeasuresPercentage(%)change in low-density lipoprotein cholesterol(LDL-C)from baseline to day 330Arms InterventionGroup 1:Inclisiran sodium 300mg on Days 1,90,270,placebo on Day 360,inclisiran sodium 300mg on Days 450 and 630.Group 2:Placebo on Days 1,90,270,inclisiran sodi

129、um 300mg on Days 360,450 and 630.Target PatientsAdolescents(12 to less than 18 years)with homozygous familial hypercholesterolemia(HoFH)and elevated low density lipoprotein cholesterol(LDL-C)Readout Milestone(s)2025PublicationPublication Design publication(O-16/-13)in Eur.J.Prev.Cardiol.Vol.29,Feb.2

130、022 Presentation at EAS May-2022 on O-13/-16 study design 41ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,R

131、enal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixLeqvio-siRNA(regulation of LDL-C)NCT05739383 VICTORION-1P(CKJX839D12302)IndicationCVRR(Primary prevention)PhasePhase 3Patients14000Primary Outcome MeasuresTime to the first occurrence of 4P-MACE 4-

132、Point-Major Adverse Cardiovascular Events(4P-MACE):composite of cardiovascular death,non-fatal myocardial infarction,non-fatal ischemic stroke,and urgent coronary revascularizationArms InterventionArm 1 Experimental:Inclisiran Sodium 300mg,subcutaneous injection in pre-filled syringeArm 2 PlaceboTar

133、get PatientsHigh-risk primary prevention patientsReadout Milestone(s)2029PublicationTBD 42ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Cl

134、inical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixpelacarsen-Antisense oligonucleotide(ASO)targeting Lp(a)NCT04023552 Lp(a)HORIZON(CTQJ230A12301)IndicationSecondary prevention of cardiovascular events in patients with

135、 elevated levels of lipoprotein(a)PhasePhase 3Patients8323Primary Outcome MeasuresTime to the first occurrence of MACE(cardiovascular death,non-fatal MI,non-fatal stroke and urgent coronary re-vascularization)Arms InterventionTQJ230 80 mg injected monthly subcutaneously or matched placebo Target Pat

136、ientsPatients with a history of Myocardial infarction or Ischemic Stroke,or a clinically significant symptomatic Peripheral Artery Disease,and Lp(a)70 mg/dL Readout Milestone(s)2026(Event driven)PublicationTBD 43ContentClick below to navigate through the documentCompany overviewFinancial reviewConcl

137、usionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixQCZ484NCT06857955(CQCZ484A12201)IndicationHyp

138、ertensionPhasePhase 2Patients380Primary Outcome MeasuresChange from baseline at Month 3 in mean 24hr systolic blood pressure(SBP)by ambulatory blood pressure measurement(ABPM)Arms InterventionPlacebo Comparator:Placebo ControlArm 1:QCZ484 Dose 1 solution for injectionArm 2:QCZ484 Dose 2 solution for

139、 injectionArm 3:QCZ484 Dose 3 solution for injectionArm 4:QCZ484 Dose 4 solution for injectionArm 5:QCZ484 Dose 5 solution for injectionTarget PatientsMild to moderate hypertensive patientsReadout Milestone(s)2027PublicationTBD 44ContentClick below to navigate through the documentCompany overviewFin

140、ancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesConclusionsInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixzigakibart-Anti-APRILNCT058

141、52938 BEYOND(CFUB523A12301)IndicationIgA nephropathyPhasePhase 3Patients292Primary Outcome MeasuresChange in proteinuria Time Frame:40 weeks or approximately 9 months Arms InterventionArm 1 Experimental:BION-1301(Zigakibart)600mg subcutaneous administration every 2 weeks for 104 weeksArm 2 Placebo C

142、omparator:Placebo subcutaneous administration every 2 weeks for 104 weeksTarget PatientsAdults with IgA Nephropathy Readout Milestone(s)2026PublicationWCN Poster April 2024:BEYOND:A Phase 3,Randomized,Double-Blind,Placebo-controlled Trial of Zigakibart in Adults with IgA Nephropathy.Trimarchi H.,et.

143、al.45ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Bran

144、ds&Global HealthAbbreviationsAppendixImmunologyIR Clinical StudiesNovartis Q4 Results|January 31,20251 46ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovatio

145、n:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixCosentyx-IL-17A inhibitorCosentyx-IL-17A inhibitorNCT04930094 GCAPTAIN(CAIN457R12301)IndicationGiant cell arteritisPhasePhase 3Patients349Primary Outcome MeasuresN

146、umber of participants with sustained remissionArms InterventionExperimental:Secukinumab 150 and 300 mgPlacebo Comparator:PlaceboTarget PatientsPatients with Giant Cell Arteritis(GCA)Readout Milestone(s)Primary 2025PublicationTBDNCT05767034 REPLENISH(CAIN457C22301)IndicationPolymyalgia rheumaticaPhas

147、ePhase 3Patients360Primary Outcome MeasuresProportion of participants achieving sustained remission Arms InterventionArm 1 Experimental:Secukinumab 300 mg,randomized in 1:1:1 ratio every 4 weeksArm 2 Experimental:Secukinumab 150 mg,randomized in 1:1:1 ratio every 4 weeksArm 3 Placebo:randomized in 1

148、:1:1 ratio every 4 weeksTarget PatientsAdult patients with PMR who have recently relapsedReadout Milestone(s)2025PublicationTBD 47ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinan

149、cial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorNCT05126277 SIRIUS-LN(CVAY736K12301)IndicationLupus NephritisPhasePhase 3Patients4

150、20Primary Outcome MeasuresFrequency and percentage of participants achieving complete renal response(CRR)Time Frame:week 72 Arms InterventionArm 1:Experimental-ianalumab s.c.q4w in addition to standard of care(SoC)Arm 2:Experiemental-ianalumab s.c.q12w in addition to SoCArm 3:Placebo comparator-Plac

151、ebo s.c.q4w in addition to SoCTarget PatientsPatients with active Lupus Nephritis Readout Milestone(s)Primary 2027PublicationTBD 48ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFina

152、ncial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorNCT05349214 NEPTUNUS-2(CV

153、AY736A2302)IndicationSjgrens syndromePhasePhase 3Patients506Primary Outcome MeasuresChange from baseline in EULAR Sjgren Syndrome Disease Activity Index(ESSDAI)score at Week 48 as compared to placebo Arms InterventionArm 1:Experimental-ianalumab exposure level 1Arm 2:Experimental-ianalumab exposure

154、level 2Arm 3:Placebo comparatorTarget PatientsPatients with active Sjogrens syndrome Readout Milestone(s)Primary 2025PublicationTBDNCT05350072 NEPTUNUS-1(CVAY736A2301)IndicationSjgrens syndromePhasePhase 3Patients276Primary Outcome MeasuresChange from baseline in EULAR Sjgren Syndrome Disease Activi

155、ty Index(ESSDAI)score at Week 48 as compared to placebo Arms InterventionArm 1:Experimental-ianalumabArm 2:Placebo comparatorTarget PatientsPatients with active Sjogrens syndromeReadout Milestone(s)Primary 2025PublicationTBD 49ContentClick below to navigate through the documentCompany overviewFinanc

156、ial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixianalumab-BAFF-R inhibitor,ADCC-mediated

157、B-cell depletorianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorNCT05639114 SIRIUS-SLE 1(CVAY736F12301)IndicationSystemic lupus erythematosusPhasePhase 3Patients406Primary Outcome MeasuresProportion of participants on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index-4(

158、SRI-4)Time Frame:Week 60 Arms InterventionExperimental:Ianalumab s.c.monthlyExperimental:Ianalumab s.c.quarterlyPlacebo Comparator:Placebo s.c.monthlyTarget PatientsPatients with active systemic lupus erythematosus(SLE)Readout Milestone(s)2027PublicationTBDNCT05624749 SIRIUS-SLE 2(CVAY736F12302)Indi

159、cationSystemic lupus erythematosusPhasePhase 3Patients280Primary Outcome MeasuresProportion of participants achieving Systemic Lupus Erythematosus Responder Index-4(SRI-4)Time Frame:Week 60 Arms InterventionExperimental:ianalumab s.c.monthlyPlacebo Comparator:placebo s.c.monthlyTarget PatientsPatien

160、ts with active systemic lupus erythematosus(SLE)Readout Milestone(s)2027PublicationTBD 50ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trial

161、s Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorNCT06470048(CVAY736S12201)IndicationSystemic sclerodermaPhasePhase 2Patients200Primary Outcome Measures3/5 Revised Composit

162、e Response Index in Systemic Sclerosis 25(rCRISS25)response at Week 52Arms InterventionArm 1 Experimental VAY736(Ianalumab)-Treatment Period 1:Ianalumab subcutaneous(s.c.)injection as defined in the protocol-Treatment Period 2:Open-label(OL)Ianalumab subcutaneous(s.c.)injection as defined in the pro

163、tocolArm 2 Placebo Comparator:Placebo-Treatment Period 1:Placebo to Ianalumab subcutaneous(s.c.)injection as defined in the protocol-Treatment Period 2:Open-label(OL)Ianalumab subcutaneous(s.c.)injection as defined in the protocolTarget PatientsPatients with diffuse cutaneous systemic sclerosisReado

164、ut Milestone(s)2028PublicationTBD 51ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuro

165、science Oncology In-market Brands&Global HealthAbbreviationsAppendixremibrutinib-BTK inhibitorNCT05976243(CLOU064M12301)IndicationChronic inducible urticariaPhasePhase 3Patients348Primary Outcome Measures1.Proportion of participants with complete response in Total Fric Score;symptomatic dermographis

166、m Time Frame:Week 12 2.Proportion of participants with complete response in critical temperature threshold;cold urticaria Time Frame:Week 12 3.Proportion of participants with itch numerical rating scale=0;cholinergic urticaria Time Frame:Week 12 Arms InterventionAll arms oral,twice daily:Arm 1 Exper

167、imental Remibrutinib,symptomatic dermographism groupArm 2 Placebo symptomatic dermographism groupArm 3 Experimental Remibrutinib,cold urticaria groupArm 4 Placebo cold urticaria groupArm 5 Experimental Remibrutinib,cholinergic urticaria groupArm 6 Placebo cholinergic urticaria groupTarget PatientsAd

168、ults suffering from CINDU inadequately controlled by H1-antihistaminesReadout Milestone(s)2026PublicationTBD 52ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInn

169、ovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixremibrutinib-BTK inhibitorremibrutinib-BTK inhibitorNCT06840392 RECHARGE2(CLOU064J12302)IndicationHidradenitis suppurativaPhasePhase 3Patients555Primary Outc

170、ome MeasuresProportion of participants with Hidradenitis Suppurativa clinical response 50(HiSCR50)at Week 16Arms InterventionArm 1:Experimental Participants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2Arm 2:Experimental Participants randomized to receive remibrutinib Dos

171、e B during Treatment Period 1 and 2Arm 3:Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2Target PatientsAdult patients With moderate to severe Hidradenitis SuppurativaReadout Milestone(s)2028PublicationTBDNCT06799000 RECHA

172、RGE1(CLOU064J12301)IndicationHidradenitis suppurativaPhasePhase 3Patients555Primary Outcome MeasuresProportion of participants with Hidradenitis Suppurativa clinical response 50(HiSCR50)at Week 16Arms InterventionArm 1:Experimental Participants randomized to receive remibrutinib Dose A during Treatm

173、ent Period 1 and 2Arm 2:Experimental Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2Arm 3:Placebo comparator Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2Target PatientsAdult patie

174、nts With moderate to severe Hidradenitis SuppurativaReadout Milestone(s)2028PublicationTBD 53ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical t

175、rials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixNeuroscienceIR Clinical StudiesNovartis Q4 Results|January 31,20251 54ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1

176、 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixFabhalta-CFB inhibitorNCT123456 APPRAISE(CLNP023Q12301)IndicationGenerali

177、zed Myasthenia GravisPhasePhase 3Patients146 Primary Outcome MeasuresChange from baseline to Month 6in Myasthenia Gravis Activity ofDaily Living(MG-ADL)total scoreArms InterventionParticipants who meet the eligibility criteria will be randomized in a ratioof 1:1,to receive either iptacopan at a dose

178、 of 200 mg orally b.i.d or matching placeboTarget PatientsPatients with generalized MG who anti-AchR-positive and are not adequately responding to 2/3rd line SoC.Readout Milestone(s)2027PublicationTBD 55ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNov

179、artis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixKesimpta-anti-CD20NCT06869785 FILIOS(COMB157Q12301)IndicationMult

180、iple sclerosis new dosing regimenPhasePhase 3Patients180Primary Outcome MeasuresOfatumumab plasma pharmacokinetics-area under the curve,up to 12 weeksArms InterventionArm 1:Active Comparator Ofatumumab dose 1,Approved dosageArm 2:Experimental Ofatumumab dose 2,New dosageTarget PatientsPatients with

181、relapsing multiple sclerosisReadout Milestone(s)2028PublicationTBD 56ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Ren

182、al and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixMayzent-S1P1,5 receptor modulatorNCT04926818 NEOS(CBAF312D2301)IndicationMultiple sclerosis,pediatricsPhasePhase 3Patients120Primary Outcome MeasuresAnnualized relapse rate(ARR)in target pediatric pa

183、rticipants Arms InterventionArm 1:Experimental ofatumumab-20 mg injection/placeboArm 2:Experimental siponimod-0.5 mg,1 mg or 2 mg/placeboArm 3:Active Comparator fingolimod-0.5 mg or 0.25 mg/placeboTarget PatientsChildren/adolescent patients aged 10-17 years old with Multiple Sclerosis(MS).The target

184、ed enrollment is 120 participants with multiple sclerosis which will include at least 5 participants with body weight(BW)40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms.There is a minimum 6 month follow up period for all participants(core and ex

185、tension).Total duration of the study could be up to 7 years.Readout Milestone(s)2027PublicationTBD 57ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Cl

186、inical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixremibrutinib-BTK inhibitorremibrutinib-BTK inhibitorNCT05147220 REMODEL-1(CLOU064C12301)IndicationMultiple sclerosisPhasePhase 3Patients800Primary Outcome MeasuresAnnu

187、alized relapse rate(ARR)of confirmed relapses Core Part.ARR is the average number of confirmed MS relapses in a yearArms InterventionArm 1:Experimental;Remibrutinib-Core(Remibrutinib tablet and matching placebo of teriflunomide capsule)Arm 2:Active Comparator;Teriflunomide-Core(Teriflunomide capsule

188、 and matching placebo remibrutinib tablet)Arm 3:Experimental;Remibrutinib-Extension(Participants on remibrutinib in Core will continue on remibrutinib tablet)Arm 4:Experimental;Remibrutinib-Extension(on teriflunomide in Core)(Participants on teriflunomide in Core will switch to remibrutinib tablet)T

189、arget PatientsPatients with relapsing Multiple SclerosisReadout Milestone(s)Estimated primary completion 2026PublicationTBDNCT05156281 REMODEL-2(CLOU064C12302)IndicationMultiple sclerosisPhasePhase 3Patients800Primary Outcome MeasuresAnnualized relapse rate(ARR)of confirmed relapses Arms Interventio

190、nArm 1:Experimental;Remibrutinib CoreRemibrutinib tablet and matching placebo of teriflunomide capsuleArm 2:Active Comparator;Teriflunomide CoreTeriflunomide capsule and matching placebo remibrutinib tabletArm 3:Experimental:Remibrutinib ExtensionParticipants on remibrutinib in Core will continue on

191、 remibrutinib tabletArm 4:Experimental:Remibrutinib-Extension(on teriflunomide in Core)Participants on teriflunomide in Core will switch to remibrutinib tabletTarget PatientsPatients with relapsing Multiple SclerosisReadout Milestone(s)Estimated primary completion 2026PublicationTBD 58ContentClick b

192、elow to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbb

193、reviationsAppendixremibrutinib-BTK inhibitorNCT06744920 RELIEVE(CLOU064O12301)IndicationMyasthenia Gravis PhasePhase 3Patients180Primary Outcome MeasuresChange from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living(MG-ADL)total scoreArms InterventionArm 1 experimental:remibrutinib ta

194、blet taken orally Arm 2 placebo comparator:placebo tablet taken orally Target PatientsPatients with generalized Myasthenia Gravis Readout Milestone(s)2028PublicationTBD 59ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025Re

195、ferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixOncologyIR Clinical StudiesNovartis Q4 Results|January 31,20251 60ContentClick below to navigate

196、through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendi

197、xianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorianalumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorNCT05653349 VAYHIT1(CVAY736I12301)Indication1L Immune ThrombocytopeniaPhasePhase 3Patients225Primary Outcome MeasuresTime from randomization to treatment failure(TTF)Arms InterventionArm

198、1:Experimental:Ianalumab Lower dose administered intravenously with corticosteroids oral or parentally(if clinically justified)Arm 2:Ianalumab Higher dose administered intravenously with corticosteroids oral or parentally(if clinically justified)Arm 3:Placebo Comparator administered intravenously wi

199、th corticosteroids oral or parentally(if clinically justified)Target PatientsAdult patients with primary ITPReadout Milestone(s)2026PublicationTBDNCT05653219 VAYHIT2(CVAY736Q12301)Indication2L Immune ThrombocytopeniaPhasePhase 3Patients150Primary Outcome MeasuresTime from randomization to treatment

200、failure(TTF)Arms InterventionArm 1:Experimental:eltrombopag and ianalumab lower doseArm 2:Experimental:eltrombopag and ianalumab higher doseArm 3:eltrombopag and placeboTarget PatientsPrimary ITP patients who failed steroidsReadout Milestone(s)2025PublicationTBD 61ContentClick below to navigate thro

201、ugh the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixian

202、alumab-BAFF-R inhibitor,ADCC-mediated B-cell depletorNCT05648968 VAYHIA(CVAY736O12301)IndicationWarm autoimmune hemolytic anemiaPhasePhase 3Patients90Primary Outcome MeasuresBinary variable indicating whether a patient achieves a durable response Durable response:hemoglobin level 10 g/dL and 2 g/dL

203、increase from baseline,for a period of at least eight consecutive weeks between W9 and W25,in the absence of rescue medication or prohibited treatmentArms InterventionArm 1:experimental Ianalumab low dose(intravenously)Arm 2:experimental Ianalumab high dose(intravenously)Arm 3:placebo Comparator(int

204、ravenously)Target PatientsPreviously treated patients with warm Autoimmune Hemolytic AnemiaReadout Milestone(s)2026PublicationTBD 62ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFin

205、ancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixiptacopan-CFB inhibitorNCT04889430 APPELHUS(CLNP023F12301)IndicationAtypical haemolytic uraemic syndromePhasePhase 3Patients75Primary Ou

206、tcome MeasuresPercentage of participants with complete TMA response without the use of PE/PI and anti-C5 antibodyArms InterventionSingle arm open-label with 50 adult patients receiving 200mg oral twice daily doses of iptacopanTarget PatientsAdult patients with aHUS who are treatment naive to complem

207、ent inhibitor therapy(including anti-C5 antibody)Readout Milestone(s)2028PublicationTBD 63ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical tria

208、ls Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixLutathera-Radioligand therapy target SSTRNCT06784752 NETTER-3(CAAA601A62301)IndicationGastroenteropancreatic neuroendocrine tumorsPhasePhase 3Patients240Primary Outcome MeasuresP

209、rogression Free Survival(PFS)centrally assessed by Blinded Independent Review Committee(BIRC)Arms InterventionArm 1:Experimental:177LuLu-DOTA-TATE+Octreotide LARParticipants in this arm will receive 177LuLu-DOTA-TATE plus Octreotide long-acting release(LAR).Arm 2:Active Comparator:Octreotide LARPart

210、icipants in this arm will receive Octreotide LAR only.Target PatientsPatients newly diagnosed with Grade 1 and Grade 2(Ki-67 Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixPluvicto-Radioligand therapy target PSMANCT04720157 PSMA

211、ddition(CAAA617C12301)IndicationMetastatic hormone sensitive prostate cancerPhasePhase 3Patients1126Primary Outcome MeasuresRadiographic Progression Free Survival(rPFS)Arms InterventionArm 1:177Lu-PSMA-617 Participant will receive 7.4 GBq(+/-10%)177Lu-PSMA-617,once every 6 weeks for a planned 6 cycl

212、es,in addition to the Standard of Care(SOC);ARDT+ADT is considered as SOC and treatment will be administered per the physicians orderArm 2:For participants randomized to Standard of Care arm,ARDT+ADT is considered as SOC and treatment will be administered per the physicians orderTarget PatientsPatie

213、nts with metastatic Hormone Sensitive Prostate Cancer(mHSPC)Readout Milestone(s)Primary Analysis:2025(event driven)PublicationTBD 65ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFin

214、ancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixVijoice-PI3KiNCT05948943 EPIK-L1(CBYL719P12201)IndicationLymphatic MalformationPhasePhase 2/3Patients230Primary Outcome MeasuresStage 2:

215、Radiological response rate at Week 24 of Stage 2(adult and pediatric(6-17 years of age)participants)Time Frame:Baseline,Week 24 Arms InterventionArm 1:Experimental.Adult participants,alpelisib dose 1(Stage 1)Arm 2:Experimental.Adult participants,alpelisib dose 2(Stage 1)Arm 3:Experimental.Pediatric

216、participants(6-17 years of age),alpelisib dose 2(Stage 1)Arm 4:Experimental.Pediatric participants(6-17 years of age),alpelisib dose 3(Stage 1)Arm 5:Experimental.Adult participants,alpelisib(Stage 2)Arm 6:Placebo comparator.Adult participants,placebo(Stage 2)Arm 7:Experimental.Pediatric participants

217、(6-17 years of age),alpelisib(Stage 2)Arm 8:Placebo Comparator.Pediatric participants(6-17 years of age),placebo(Stage 2)Arm 9:Experimental.Pediatric participants(2-5 years of age),alpelisib(Stage 2)Target PatientsPediatric and adult patients with lymphatic malformations associated with a PIK3CA mut

218、ationReadout Milestone(s)2030PublicationTBD 66ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immuno

219、logy Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixIn-market Brands&Global HealthIR Clinical StudiesNovartis Q4 Results|January 31,20251 67ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025Referen

220、cesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixcipargamin-PfATP4 inhibitorNCT04675931 KARISMA(CKAE609B12201)IndicationMalaria severePhasePhase 2Patie

221、nts252Primary Outcome MeasuresPercentage of participants achieving at least 90%reduction in Plasmodium falciparum(P.falciparum)at 12 hours Time Frame:Day 1(12 Hours)Arms InterventionAge descending treatment evaluating IV KAE609 doses versus active comparator,IV Artesunate.Follow on therapy for all a

222、rms:Coartem,Standard of careTarget PatientsPatients with Malaria,severeReadout Milestone(s)2025PublicationTBD 68ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|April 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceIn

223、novation:Clinical trials Cardiovascular,Renal and Metabolic Immunology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixganaplacide/lumefantrine-Non-artemisinin plasmodium falciparum inhibitorNCT05842954 KALUMA(CKLU156A12301)IndicationMalaria,uncomplicated PhasePhase 3Patient

224、s1500Primary Outcome MeasuresPCR-corrected adequate clinical and parasitological response(ACPR)at day 29Arms InterventionArm 1 experimental:KLU156 oral;400/480 mg(ganaplacide/lumefantrine)is the fixed dose combination for patients with a bodyweight 35kg.Patients Cardiovascular,Renal and Metabolic Im

225、munology Neuroscience Oncology In-market Brands&Global HealthAbbreviationsAppendixRydapt-Multi-targeted kinase inhibitorNCT03591510(CPKC412A2218)IndicationAcute myeloid leukemia,pediatricsPhasePhase 2Patients20Primary Outcome MeasuresOccurrence of dose limiting toxicitiesSafety and TolerabilityArms

226、InterventionChemotherapy followed by MidostaurinTarget PatientsNewly diagnosed pediatric patients with FLT3 mutated acute myeloid leukemia(AML)Readout Milestone(s)2026PublicationTBD 70ContentClick below to navigate through the documentCompany overviewFinancial reviewConclusionsNovartis Q1 Results|Ap

227、ril 29,2025ReferencesInnovation:Pipeline overviewFinancial performanceInnovation:Clinical trialsAbbreviationsAppendixAbbreviationsAbbreviationFull FormAAVAdeno-Associated VirusACCAmerican College of CardiologyACS Acute Coronary SyndromeADAlzheimers Disease AHAAmerican Heart AssociationaLLT Advanced

228、Lipid Lowering Therapy AS Ankylosing Spondylitis C3G Complement 3 Glomerulopathy CIndUChronic Inducible UrticariaCML Chronic Myeloid LeukemiaCSU Chronic Spontaneous Urticaria DTCDirect to ConsumereBC Early Breast Cancer FAFood AllergyFFField ForceGCAGiant Cell ArteritisGEP-NETGastroenteropancreatic

229、Neuroendocrine Tumors gMGGeneralized Myasthenia GravisHbHemoglobinHCPHealth Care ProviderHD Huntingtons DiseaseHF Heart FailureHFMSEHammersmith Functional Motor Scale ExpandedHRHazard RatioHS Hidradenitis Suppurativa HTN Hypertension IB&GHIn-market Brands and Global HealthIgAN Immunoglobin A Nephrop

230、athy ITPImmune ThrombocytopeniaIV Intravenous LFTLiver Function TestLoE Loss of Exclusivity AbbreviationFull FormmBC Metastatic Breast CancermCRPC Metastatic Castration-Resistant Prostate Cancer mHSPC Metastatic Hormone-Sensitive Prostate CancerMOTRxUnits Normalized to Month-on-Therapy MSMultiple Sc

231、lerosisNBRx New to Brand Prescription NCCNNational Comprehensive Cancer NetworkNEJMThe New England Journal of Medicinenr-axSpANon-Radiographic Axial SpondyloarthritisNSCLC Non-Small Cell Lung Cancer OLEOpen Label ExtensionOSOverall SurvivalPAPrior AuthorizationPCProstate CancerPIRAProgression Indepe

232、ndent of Relapse ActivityPMAPolymyalgia ArteriticaPMRPolymyalgia RheumaticaPNH Paroxysmal Nocturnal HemoglobinuriaPRVPriority Review VoucherPsA Psoriatic Arthritis PSMAProstate-Specific Membrane AntigenPsO Psoriasis RDP Regulatory Data ProtectionREMS Risk Evaluation and Mitigation StrategyrHTNResist

233、ant HypertensionRMSRelapsing Multiple SclerosisrPFSRadiographic Progression-Free SurvivalRULMRevised Upper Limb ModuleSMA Spinal Muscular AtrophySjSSjgrens SyndromeSpASpondyloarthritisTRx Total PrescriptionsUAS7Weekly Urticaria Activity Score 71ContentClick below to navigate through the documentComp

234、any overviewFinancial reviewConclusionsAppendixReferencesNovartis Q1 Results|April 29,2025References 1/3Kesimpta(slide 7 references)1The 8 markets include Germany,Japan,China,Australia,Canada,France,Italy,and UK.2Pardo et al.Continuous Ofatumumab Treatment Up to 7 Years Shows a Consistent Safety Pro

235、file and Delays Disability Progression in People With Relapsing Multiple Sclerosis(P7.016 AAN 2025).3Limitations include a potential for attrition bias and the open-label nature of the extension study.4Coyle et al.B-Cell Depletion and EfficacyOutcomes of Ofatumumab Are Consistent Across Different Bo

236、dy Mass Index Categories:Insights From ASCLEPIOS I and II Trials(P09.002 AAN 2024).5As per stability technical specification data,when the patient is ready to inject,it typically takes less than 1 minute a month to administer.Once-monthly dosing begins after the initial dosing period,which consists

237、of 20 mg subcutaneous doses at weeks 0,1,and 2.Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.Patient must take pen out of the refrigerator 15-30 minutes before self-administering.Kisqali(slide 6 references)1IQVIA Market Sizing Monthly Re

238、port,February 2025;Data lag:2 months.2Of CDK4/6 market,US rolling 3 months ending February 2025,IQVIA Breast Cancer Market Sizing report.3Ex-US data ending December 2024 based on country specific IQVIA or local PMR data.4Monthly NBRx.BEST International-New to Brand(Dynamic Patients),Feb 2025.Pluvict

239、o(slide 8 references)1With the inverse probability of censoring weighting(IPCW)method.Leqvio(slide 10 references)1Includes PCSK9 monoclonal antibodies and bempedoic acid.2Depth:complete Q1 25 data;MOTRx Q1 QTD ending 3/28.72ContentClick below to navigate through the documentCompany overviewFinancial

240、 reviewConclusionsAppendixReferencesNovartis Q1 Results|April 29,2025References 2/3Scemblix(slide 11 references)1Source:US January rolling 3-months US IQVIA CML market sizing report(April 2025).2-3 Source and Q1 Patient Share Projection Assumptions:For Q125 International Patient share calculation co

241、nsidered individual markets patient shares as follows,EU4:IQVIA OD until Feb25(Preliminary data),Germany:LRx until Jan25 and Japan:MDV until Q424 and assumed same shares for Q125 as in Q424.Entresto(slide 13 references)1IQVIA National Prescription Audit.2Approved indications differ by geography.Exam

242、ples include“indicated to reduce the risk of cardiovascular death and hospitalization for HF in adult patients with CHF.Benefits are most clearly evident in patients with LVEF below normal”(US),HFrEF(EU),HFrEF and HTN(China)and CHF and HTN(JP).HTN is not an approved indication in the US and EU.3Base

243、d on 2024 sales.4Extension of regulatory data protection to November 2026 in EU based on approval of pediatric indication.5Timing of Entresto US generic entry is subject to ongoing IP and regulatory litigation.Cosentyx(slide 12 references)1IQVIA National Source of Business(NSOB)data.NBRx volume has

244、been adjusted by excluding the volume of Cordavis Humira since Mar 8,2024.2IV formulation indication:PsA,AS,nr-axSpA.Source:IQVIA mastered 867 data.3Refers to EU5.Indications:Pso,PsA,axSpA.Source:DE:IQVIA LRx;FR:IQVIA Ltd;UK:IQVIA Analyzer,Stethos;IT:Stethos,Elma(September 2024);ES:IQVIA,Amber Marke

245、t Research(June 2024 data extrapolated to September).4Hospital value share.Market definition includes all approved immunology brands with at least one indication overlapping with Cosentyx Source:IQVIA China Immunology Market Value Share(November 2024).5US,DE,UK,FR,ES,AU.73ContentClick below to navig

246、ate through the documentCompany overviewFinancial reviewConclusionsAppendixReferencesNovartis Q1 Results|April 29,2025References 3/3Fabhalta(slide 14 references)1Based on Novartis internal data as of March 2025.2UBC;data through March 21,2025.Vanrafia(slide 14 references)3Vanrafia prescribing inform

247、ation.April 2025.4Heerspink HJL,Jardine M,Kohan DE,et al.Atrasentan in Patients with IgA Nephropathy.N Engl J Med.2025;392(6):544-554.doi:10.1056/NEJMoa2409415.Remibrutinib(slide 16 references)1Originally 24-week data was presented at the American College of Allergy,Asthma,and Immunology(ACAAI)2023

248、with 52-week data presented at European Academy of Allergy and Clinical Immunology(EAACI)2024.2Full analysis set;data from the REMIX-1 and REMIX-2 studies presented at EAACI 2024.3Weekly Urticaria Activity Score(UAS7)comprised of the Weekly Itch Severity Score(ISS7)and the Weekly Hives Severity Score(HSS7).4Full analysis set;data from the REMIX-1 and REMIX-2 studies presented at European Academy of Dermatology and Venereology(EADV)2024.5Anticipating approval of remibrutinib in CSU H2 2025.