【行业研究报告】康方生物-Expect another fruitful year in 2024

20Mar2024
CMBInternationalGlobalMarkets|EquityResearch|CompanyUpdate
Akeso(9926HK)
Expectanotherfruitfulyearin2024
InFY23,AkesorecordedRMB4.53bninrevenue,includingRMB1.63bnfrom
productsalesandRMB2.92bnfromlicenseincomerelevanttoAK112(PD-
1/VEGF).Cadonilimab/AK104(PD-1/CTLA-4)achievedRMB1.36bninsalesin
FY23,surpassingtheCompany’sinitialguidanceofRMB1.2-1.3bn.In2H23,
AK104recordedRMB752mnsales,+24%HoH,evenwiththeimpactof
challengingregulatoryenvironmentinChinain2H23.Akesomaintainedahigh
productGPmarginat91.8%inFY23,comparedto91.5%inFY22.Overallselling
expenses(incl.distributioncost)as%ofproductsalesdecreasedfrom74.5%in
FY22to56.3%inFY23,indicatingtheimprovingoperatingefficiency.TheR&D
expensesdecreased5.2%YoYtoRMB1.25bninFY23.Akesorecorded
RMB2.03bnattributablenetprofitinFY23.Excludingthelicenseincomeand
equityinvestmentloss,theoperatingnetlossshrankby45%YoYtoRMB788mn
inFY23,vsRMB1.43bninFY22.Asofend-2023,Akesohadasufficientcash
balanceofRMB4.90bn.
Near-termdatareadoutofAK112’shead-to-headstudy.TheH2HPh3
studyofAK112monovsKeytrudaforPD-L1+(TPS≥1%)NSCLCwasfully
studyofAK112monovsKeytrudaforPD-L1+(TPS≥1%)NSCLCwasfully
enrolledinAug2023,withtheinterimPFSdatareadoutexpectedin2Q24.
WethinkOStrendofthisstudyisalsoimportantalthoughOSisasecondary
endpointofthestudy.AkesoalsofiledtheNDAofAK112inAug2023for
post-TKIEGFR-mnsq-NSCLC,withtheapprovalexpectedin2H24aligned
withtimingofthedatarelease.TheMRCTHARMONitrialisontrackfor
enrolmentcompletionin2H24asperSummit.ThePh3trialinChina
evaluatingAK112+chemovstislelizumab+chemoin1Lsq-NSCLCis
expectedtocompleteenrolmentin2024/early-2025aswell.Weexpect
AkesotoinitiatemorePh3trialsofAK112toexpandtheindicationsofthe
drug.
FastindicationexpansionprogressofAK104.Besidestheapproved2/3L
CC,AK104isinmultiplePh3trialstoexpanditsindicationcoverage.InNov
2023,thePh3trialofAK104in1LGCmettheOSendpointandasNDAwas
submittedtoCDEinJan2024,withtheapprovalexpectedinend-2024/early-
2025.ThePh3datain1LGCwillbereleasedattheAACRmeetinginApr.
InNov2023,thePh3trialofAK104in1LCCmetthePFSendpointinthe
interimanalysis,withthesNDAsubmissionexpecteduponthematurityofOS
data.AK104hasalsorecentlystartedtwoadditionalPh3trials,for1LHCC
(+lenvatinib+TACE)andpost-PD(L)-1GC(+AK109+chemo).InaPh2study
ofAK104+lenvatinib+TACEinmid-andadvanced-stageHCC(link),theORR
reached85%(CR15%)in60patients.RecallthatKeytruda+lenvatinib
+TACErealizeda47%ORR(10%CR,link).TheresultssupportedAK104’s
newlystartedPh3trialin1LHCC.AkesoalsostartedaPh3trialofAK104+
AK109(VEGFR2mAb)+chemoinpost-PD(L)-1GC.InaPh2trial,thistriple-
comboachievedORRof48%inpost-PD(L)1GCpatients,vs27%ORRof
ramucirumab+chemointheRAINBOW-Asiatrial(link)and42%ORRof
fruquintinib+chemointheFRUTIGAtrial(link)for2LGCpatients.