【行业研究报告】百济神州-Strong sales continued in 2Q22

8Aug2022
CMBInternationalGlobalMarkets|EquityResearch|CompanyUpdate
BeiGene(BGNEUS)
Strongsalescontinuedin2Q22
BeiGenemaintainedstrongsalesgrowthmomentumin2Q22,withtheproduct
revenuereachingUS$304.5mn(+120YoY,+16%QoQ),mainlydrivenbyfast
salesramp-upofzanubrutinib(BTK)andtislelizumab(PD-1).Salesof
zanubrutinibincreased203%YoYor23%QoQtoUS$128.7mnin2Q22,largely
drivenbythestrongsalesintheUS.Tislelizumabcontinuedtobreakitsrecord,
withthesalesin2Q22reachingUS$104.9mn(+40%YoY,+20%QoQ).BeiGene
continuedtooptimizeitscostefficiency,withtheSG&Aexpensesaspercentage
ofproductsalessignificantlydecreasedto109%in2Q22,comparedwith168%
in1Q21and156%in2021.Webelievethetrendwillcontinuethankstothefast
growingproductsalesandeconomiesofscale.Asof2Q22,BeiGenehas
sufficientcashbalanceofUS$6.7bn,providingastrongsupportforthe
Company’sR&Dactivitiesandglobalexpansion.
Zanubrutinibtoexpanditslabelsintheoverseasmarket.Zanubrutinib
demonstrateditssuperiorityversusibrutinibinr/rCLL/SLLinitsglobalhead-
demonstrateditssuperiorityversusibrutinibinr/rCLL/SLLinitsglobalhead-
to-headPh3ALPINEtrial,withanORRbyIRCof80.4%vs72.9%
(p=0.0264).FDAhasextendedthePDUFAdateofzanubrutinib’ssNDAfor
CLLtoJan2023toallowmoretimetoreviewtheadditionaldata.Withthe
approvaloftheCLLindication,webelievetheglobalsalesofzanubrutinib
willfurtheracceleratein2023andbeyond.BeiGeneplanstoreleasethefinal
resultsoftheALPINEtrial,includingPFSdatain2H22E.IfthePFSresults
arepositive,zanubrutinibwillbefurtherprovedtobetheglobalbest-in-class
BTKinhibitor,whichwillenablezanubrutinibtogainmoremarketsharein
theglobalBTKinhibitormarket.
Tislelizumabisbecomingoneofthebest-sellingPD-1antibodiesin
China.TislelizumabhasbeenapprovedinChinafornineindicationswith
largeindicationssuchas1Lnsq-/sq-NSCLCand2LHCCcurrentlycovered
byNRDL.WeexpecttislelizumabtoexpanditsNRDLcoveragelatethisyear
viasimplifiedrenewalprocedureswithasmallpricecuttoaddfouradditional
indications(1LNPC,2LESCC,2LNSCLC,MSI-H/dMMRsolidtumors).The
sNDAof1LGCindicationiscurrentlyunderreviewbyCDE,withapproval
expectedin1H23.Inaddition,theBLAof2LESCCintheUSwasdeferred
becauseofFDA’sinabilitytoconducton-siteinspectionsduetoCOVID-19
relatedtravelrestrictions.BeiGeneandNovartisplantofileBLAsfor1LGC,
1LHCC,1LESCC,andlocalizedESCCintheUSnextyear.TheBLAsare
allsupportedbyPh3MRCTswithpatientsenrolledfromtheUS,including
NCT03777657(1LGC),NCT03783442(1LESCC)andNCT03412773(1L
HCC).BeiGeneplanstoreleaseresultsofthePh3trialoftislelizumabvs
sorafenibin1LHCCin3Q22E.
MaintainBUY.Thecommercialassetszanubrutinibandtislelizumabwill
maintainthestrongsalesmomentumdrivenbylabelexpansionand
BeiGene’sstrongcommercialcapabilities.Thecoreclinical-stageassets
ociperlimab(TIGIT)andBGB-11417(Bcl-2)willreleaseadditionalPh1data
andinitiatenewpivotaltrialsin2H22E.WerevisedourDCF-basedTPfrom
US$248.52toUS$252.55(WACC:9.20%,terminalgrowthrate:3.0%).