行业报告RigelPharmaceuticals2023年第一季度报告1684136094_市.docx

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1、May2,2023/二一、rge1Rige1ReportsFirstQuarter2023Financia1Resu1tsandProvidesBusinessUpdate Firstquarter2023Tota1Revenueof$26.1mi11ionwhichinc1udesTAVA1ISSEnetproductsa1esof$22.3mi11ionandREZ1IDHIAnetproductsa1esof$1.5mi11ion G1oba1expansionofTAVA1ISSEinITPwithJapanese1aunchbypartnerKissei Conferenceca11

2、andwebcastschedu1edtodayat4:30p.m.EasternTimeSOUTHSANFRANCISCO,Ca1if.,May2,2023/PRNewswire/-Rige1Pharmaceutica1s,Inc.(Nasdaq:RIG1)todayreportedfinancia1resu1tsforthefirstquarterendedMarch31,2023,inc1udingsa1esofTAVA1ISSE(fostamatinibdisodiumhexahydrate)tab1etsforthetreatmentofadu1tswithchronicimmune

3、thrombocytopenia(ITP)whohavehadaninsufficientresponsetoaprevioustreatmentandsa1esofREZ1IDHIA(O1utasidenib)capsu1esforthetreatmentofadu1tpatientswithre1apsedorrefractory(RR)acutemye1oid1eukemia(AM1)withasusceptib1eisocitratedehydrogenase-1(IDH1)mutationasdetectedbyanFDA-approvedtest.,Wearethri11edwit

4、hourstrongfirstquarternetproductsa1esperformance,a47%increasefromQ12023.Thisref1ectsourabi1itytoadvanceour1aunchofREZ1IDHIAinm1DH1R/RAM1whi1edrivingcontinuedgrowthinTAVA1ISSEITPsa1es,saidRau1Rodriguez,RigespresidentandCEO.Tortheremainderof2023,wehaveestab1ishedastrongfoundationforourhemato1ogy-onco1

5、ogybusinesstosuccessfu11yde1ivergrowthinbothTAVA1ISSEandREZ1IDHIA,andtoadvanceourdeve1opmentprograms.11BUSineSSUPdate Inthefirstquarterof2023,atota1of2,281bott1esofTAVA1ISSEwereso1dintheU.S.,2,256ofwhichwereshippeddirect1ytopatientsandc1inics,representingthehighestnumberofbott1esshippedtopatientsand

6、c1inicsinaquartersince1aunch. Duringthefirstfu11quarterof1aunch,atota1of113bott1esofREZ1IDHIAwereso1dintheU.S.,109ofwhichwereshippeddirect1ytopatientsandc1inics. REZ1IDHIAwasaddedbytheNationa1ComprehensiveCancerNetwork(NCCN)tothe1atestNCCNC1inica1PracticeGuide1inesinOnco1ogy(NCCNGuide1ines)forAM1inJ

7、anuary2023.REZ1IDHIAisinc1udedasarecommendedtargetedtherapyforadu1tpatientswithR/RAM1withIDH1mutation. Rige1announcedapeer-reviewedpub1icationofdatainB1oodAdvancesinFebruary2023,whichsummarizedc1inica1resu1tsfromthePhase2registrationtria1ofREZ1IDHIAinpatientsWithm1DH1R/RAM1.Thepub1isheddatademonstra

8、tethatREZ1IDHIAinduceddurab1eremissionsandtransfusionindependencewithawe11-characterizedsafetyprofi1e. InApri1,RigespartnerKisseiannouncedthe1aunchofTAVA1ISSEinJapanforthetreatmentofchronicITP. Rige1continuestoadvancetheopen-1abe1,Phase1bc1inica1tria1ofR289,aninvestigationa1,potent,andse1ectiveIRAK1

9、/4inhibitor,inpatientswith1ower-riskmye1oiddysp1asticsyndrome(1R-MDS)whoarerefractory/resistanttopriortherapies.Rige1hascomp1etedenro11mentofthefirstcohortofthetria1andenro11mentofthesecondcohortisunderway. R552,aninvestigationa1,potent,andse1ectiveRIPK1inhibitor,isbeingadvancedbyRigespartnerE1i1i11

10、y(1i11y).Theinitia1Phase2atria1inapproximate1y100patientswithmoderate1ytosevere1yactiverheumatoidarthritis(RA)isanticipatedtobegininthesecondquarterof2023andwi11invo1veg1oba1recruitment.ThePhase2atria1ana1ysisisexpectedbytheendof2024.FinanCia1UPdateForthefirstquarterof2023,Rige1reportedanet1ossof$13

11、.5mi11ion,or$0.08perbasicanddi1utedshare,comparedtoanet1ossof$27.4mi11ion,or$0.16perbasicanddi1utedshare,forthesameperiodof2023.Forthefirstquarterof2023,tota1revenueswere$26.1mi11ion,consistingof$22.3mi11ioninTAVA1ISSEnetproductsa1es,$1,5mi11ioninREZ1IDHIAnetproductsa1es,and$2.3mi11ionincontractreve

12、nuesfromco11aborations.TAVA1ISSEnetproductsa1esof$22.3mi11ionincreasedby38%from$16.2mi11ionforthesameperiodof2023.Contractrevenuesfromco11aborationsforthefirstquarterof2023consistedprimari1yofrevenuefromGrifo1sS.A.,with$1.6mi11ionre1atedtothede1iveryofdrugsupp1iesandaroya1tyof$0.7mi11ion.Forthefirst

13、quarterof2023,tota1costsandexpenseswere$38.8mi11ion,comparedto$43.0mi11ionforthesameperiodof2023.Thedecreaseincostsandexpenseswasprimari1yduetodecreasedresearchanddeve1opmentcostsre1atedtothePhase3c1inica1tria1ofIostamatinibforwAIHA,thePhase3c1inica1tria1offostamatinibinhigh-riskhospita1izedpatients

14、withCOVID-19,andtheIRAK1/4inhibitorprogram.AsofMarch31,2023,Rige1hadcash,cashequiva1entsandshort-terminvestmentsof$58.7mi11ion,comparedto$58.2mi11ionasofDecember31,2023.InMarch2023,Rige1accessedanadditiona1$20.0mi11ionterm1oanthroughitscreditfaci1itywithMidCapFinancia1Trust.COnferenCeCa11andWebCaStW

15、ithS1ideSTOdaVat4:30PmEaSternTimeRige1W川ho1da1iveconferenceca11andwebcasttodayat4:30pmEasternTime(1:30pmPacificTime).Participantscanaccessthe1iveconferenceca11bydia1ing(877)407-3088(domestic)or(201)389-0927(internationa1).Theconferenceca11wi11a1sobewebcast1iveandcanbeaccessedfromtheInvestorRe1ations

16、sectionofthecompanyswebsiteatThewebcastwi11bearchivedandavai1ab1eforrep1ayaftertheca11viatheRige1website.AbOUt1TPInpatientswithITP(immunethrombocytopenia),theimmunesystemattacksanddestroysthebodysownb1oodp1ate1ets,whichp1ayanactivero1einb1oodc1ottingandhea1ing.CommonsymptomsofITPareexcessivebruisingandb1eeding.Peop1esufferingwithchronicITPmay1ivewithanincreasedriskofsevereb1eedingeventsthatcanresu1tinseriousmedica1c