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SecondQuarter2022
EarningsTeleconference
July28,2022
Breakthroughsthatchangepatients'lives?
Introduction
ChristopherStevo
SeniorVicePresident,
ChiefInvestorRelationsOfficer
Forward-LookingStatementsandNon-GAAPFinancialInformation
Ourdiscussionsduringthisconferencecallwillincludeforward-lookingstatementsthataresubjecttosubstantialrisksanduncertaintiesthatcouldcauseactualresults
todiffermateriallyfromthoseexpressedorimpliedbysuchstatements.Weincludeforward-lookingstatementsabout,amongothertopics,ouranticipatedoperatingandfinancialperformance,reorganizations,businessplans,strategyandprospects,ourEnvironmental,SocialandGovernance(ESG)prioritiesandgoals,expectationsforourproductpipeline,in-lineproductsandproductcandidates,includinganticipatedregulatorysubmissions,dataread-outs,studystarts,approvals,clinicaltrialresultsandotherdevelopingdata,revenuecontribution,growth,performance,timingofexclusivityandpotentialbenefits,strategicreviews,capitalallocationobjectives,dividendsandsharerepurchases,plansforandprospectsofouracquisitions,dispositionsandotherbusinessdevelopmentactivities,andourabilitytosuccessfullycapitalizeontheseopportunities,manufacturingandproductsupply,oureffortstorespondtoCOVID-19,includingComirnatyandouroralCOVID-19treatment(Paxlovid),ourexpectationsregardingtheimpactofCOVID-19onourbusiness,operationsandfinancialresults,andourEnvironmental,SocialandGovernancestrategy.Amongotherthings,statementsregardingrevenueandearningspersharegrowth;thedevelopmentorcommercialpotentialofourproductpipeline,in-lineproducts,productcandidatesandadditionalindications,includingexpectedclinicaltrialprotocols,thetimingoftheinitiationandprogressofclinicaltrialsanddataread-outsfromtrials;thetimingforthesubmissionofapplicationsforandreceiptofregulatoryapprovals;expectedprofileandlabeling;andexpectedbreakthrough,bestorfirst-in-classorblockbusterstatusofourmedicinesorvaccinesareforward-lookingandareestimatesthataresubjecttochangeandclinicaltrialandregulatorysuccess.Thesestatementsaresubjecttorisks,uncertaintiesandotherfactorsthatmaycauseactualresultstodiffermateriallyfrompastresults,futureplansandprojectedfutureresults.AdditionalinformationregardingtheseandotherfactorscanbefoundinPfizer’sAnnualReportonForm10-KforthefiscalyearendedDecember31,2021anditssubsequentreportsonForm10-Q,includinginthesectionsthereofcaptioned“RiskFactors”and“Forward-LookingInformationandFactorsThatMayAffectFutureResults”,aswellasinoursubsequentreportsonForm8-K,allofwhicharefiledwiththeU.S.SecuritiesandExchangeCommissionandavailableat
and
.PotentialrisksanduncertaintiesalsoincludetheimpactofCOVID-19onoursalesandoperations,includingimpactsonemployees,manufacturing,supplychain,marketing,researchanddevelopmentandclinicaltrials.Theforward-lookingstatementsinthispresentationspeakonlyasoftheoriginaldateofthispresentationandweundertakenoobligationtoupdateorreviseanyofthesestatements.
Also,thediscussionsduringthisconferencecallwillincludecertainfinancialmeasuresthatwerenotpreparedinaccordancewithU.S.generallyacceptedaccounting
principles(GAAP).Additionalinformationregardingnon-U.S.GAAPfinancialmeasurescanbefoundonslides41-43andinourearningsreleasefurnishedwithPfizer’sCurrentReportonForm8-KdatedJuly28,2022.Anynon-U.S.GAAPfinancialmeasurespresentedarenot,andshouldnotbeviewedas,substitutesforfinancialmeasuresrequiredbyU.S.GAAP,havenostandardizedmeaningprescribedbyU.S.GAAPandmaynotbecomparabletothecalculationofsimilarmeasuresofothercompanies.
Today’sdiscussionsandpresentationareintendedfortheinvestorcommunityonly;theyarenotintendedtopromotetheproductsreferencedhereinorotherwise
influencehealthcareprescribingdecisions.
SecondQuarter2022Earnings3
OpeningRemarks
AlbertBourla
ChairmanandChiefExecutiveOfficer
KeyGrowthDrivers
$8.1B*op
U.S.$4.5B,*
Int'l$3.7B,*op
$552M+16%op
Prevnar
Family(2)
$1.4B+18%op
U.S.$906M,+41%Int'l$523M,-7%op
$1.7B+23%op
U.S.$1.1B,+28%Int'l$681M,+16%op
U.S.$296M,+32%Int'l$256M,+3%op
U.S.$1.1B,-47%Int'l$7.8B,+43%op
$8.8B20%op
(3)
Breakthroughsthatchangepatients’lives.
~845MPatients77%Increase
fromprior-yearquarter
reachedworldwideYTD2022withourmedicinesandvaccines(4)
Q22022KeyHighlights
StrongFinancial
Performance
+53%
OperationalRevenueGrowth
+100%
OperationalAdj.
DilutedEPS(1)Growth
SecondQuarter2022Earnings
*Indicatescalculationnotmeaningful
(1)SeeSlides41-43fordefinitions
(2)PresentedfiguresincludesalesofbothPrevnar/Prevenar13and20
(3)PresentedfiguresincludesalesofbothVyndaqelandVyndamax
(4)Patientcountsareestimatesderivedfrommultipledatasources;~182Mpatientsex-Comirnaty
5
COVID-19:WhereDoWeGoFromHere?
COVID-19
likelytoremainaglobalhealthcareconcern
foryearstocome
Pfizer
well-positionedtocontinue
commercialleadershipin
battleagainst
COVID-19
SecondQuarter2022Earnings
Pfizer'sscience
continuestoaddress
highlymutativevirus
6
Comirnaty:ContinuedLeadershipIntheFightAgainstCOVID-19
CumulativeShareofDoses(1)
(2)
(4)
(3)
Morethan
3.6B
dosesshippedto
180countriesand
territoriestodate(5)
SecondQuarter2022Earnings
(1)MarketsharedataincludesonlythosemarketsinwhichPfizeroperatesandthatreportmarketsharedata
(2)Incl.allmarketsinDevelopedMarkets(3)plusEmergingMarkets(Argentina,Chile,Ecuador,HongKong,Nepal,Peru,SouthAfrica,Uruguay)
(3)IncludestheU.S.,EU/EEA,otherInt'lDevelopedmarkets(Japan,SouthKorea,Switzerland,Ukraine)7
(4)StartingdateofJanuary1,2022forthisdatasetisfromQ12022earningspresentation
(5)FromDecember2020
Omicron-AdaptedCOVID-19VaccineCandidatesforFall2022Boosters
SubmitteddatatoEMA(1)
BA.1BivalentOmicron-modified
FDArequests
BA.4/BA.5BivalentOmicron-modified
Becauseofourrobustmanufacturingcapabilities,weareplanningtodeliverbothvariantvaccinesinthefall,pendingregulatoryapprovals
(1)EuropeanMedicinesAgency
SecondQuarter2022Earnings
8
Paxlovid:ExpandingAccessinU.S.
>41K
siteswithPaxlovidsupplyasofJuly
15
(increaseof>7Ksinceearly-May)
SecondQuarter2022Earnings
OnJuly6,FDArevisedEUA
toauthorizestate-licensed
pharmaciststoprescribe
Paxlovidundercertain
conditions
9
U.S.MarketShare(4)(%)
DatafromQ1earnings
PaxlovidisprescribedmorethananyotherCOVID-19oraltherapy
Paxlovid:NearlyFive-FoldGrowthinU.S.UtilizationSinceQ1(1)
U.S.EstimatedUtilization(NPA)(2)vs.Cases(3)
DatafromQ1earnings
HCPsusingmorePaxlovid,asnumberofreportedCOVID-19casesrises
SecondQuarter2022Earnings
(1)SinceweekendingApril22,2022,thelastweekforwhichdatawaspresentedatQ12022earningsupdate
(2)EstimatedPaxlovidpatientsandestimatedutilizationratescalculatedfromwholesalershippingdataarecomparedtoPaxlovidutilizationfromIQVIA'sNationalPrescriptionAudit(NPA)todetermineestimatedNPAmarketcoverageandsubsequentfactoruprate
(3)Reportedcaseshistoricalareweeklycumulativetotalsderivedfrom
CDCCOVIDDataTracker
forFebruary25,2022toJuly15,2022.
(4)BasedondatafromIQVIAXponent(asofweekendingJuly15,2022),relativetomolnupiravirintheretail,long-termcare,andmailorderchannels,whichtogetherrepresent~80%ofPaxlovidutilization.
10
Paxlovid:ExpandingAccessinInternationalDevelopedMarkets
RecentwaveofBA.4/BA.5resultingin
increasedhospitalizations,ICUadmissionsanddeaths(1)
Averagedailydeathsincreasedfrom6/24-7/24
Europe(2):~2x(0.61.15per1Mpeople)
Japan:~3x(0.120.34per1Mpeople)
inusageacrossinternationaldevelopedmarkets
~116%increase(3)
SecondQuarter2022Earnings
(1)BasedondataoverthemonthfromJune24,2022toJuly24,2022from
OurWorldinData
(ICUadmissionsanddeaths)and
ECDCdata
(hospitalizations)
(2)IncludesEUandnon-EUcountries
(3)BasedoninternalestimatescomparingJune24,2022toJuly15,2022
11
Successful
U.S.Launch
Q2U.S.AdultRevenue(1)
337%op
vsprioryear
quarter,to
$431M
97%
Market
Share
Strong
Uptake
Simplicityof1-shot
Prevnar20Adult:Market-LeadingU.S.Performance
RoutineRecommendation
19-64Years
withunderlyingmedicalcondition
(1)Prevnar13andPrevnar20Adultrevenue-Prevnar20representedmorethan3/4oftotalAdultrevenue
12
SecondQuarter2022Earnings
Firstquarterly
uptickinU.S.
revenuessince
Q42020
Ibrance:EncouragingU.S.Trends
Q2U.S.Revenues
Up1%
vsprioryearquarter
despitecontinuedincreaseinproportion
ofpatientsaccessingIbrancethroughour
PatientAssistanceProgram
Q2U.S.TotalVolumeDemand(1)
Up3%
vsprioryearquarter
(1)Totalvolumedispensed
13
SecondQuarter2022Earnings
Net-ZeroStandard(2)
?GoaltoachieveNet-ZeroStandardacrossourvaluechainby2040,tenyearsaheadofanewvoluntaryexternalstandard
ESG:TurningCommitmentintoAction
ClimateChange
EquitableAccessandAffordability
AccordforaHealthierWorld(1)
?AllcurrentandfuturePfizerpatentedmedicinesandvaccinesavailableinU.S.andEUtobeofferedonanot-for-profitbasisto1.2Bpeoplein45lower-incomecountries
?FirstproducthasarrivedinRwanda
(1)See
May25,2022pressrelease
(2)See
June30,2022Pfizerstatement
SecondQuarter2022Earnings
BusinessEthics
SupportforUkraine(3)
?DonatingequivalentofallprofitsfromoursalesinRussiatocausesthatprovidedirecthumanitariansupporttopeopleofUkraine
?Firstdownpaymentof$5Mto8globalandlocalNGOs
?ContinuingtoservepatientswhilehelpingthepeopleofUkraine
(3)See
June22,2022Pfizerstatement
14
MSCIESGRatingUpgrade
Toxic
Product
Safety&Quality
CorporateBehaviour
Rating&
Emissions
Accessto
HumanCapital
Trend
&Waste
HealthCare
Corporate
Governance
PfizerInc.
A
BBB
BBB
July
2022
June
2021
TopQuartile
UpgradeUpgradebytwoormorenotchesDowngradeDowngradebytwoormorenotches
QuartileKey:BottomQuartile
RatingTrendKey:Maintain
SecondQuarter2022Earnings15
ScientificUpdates
MikaelDolsten
ChiefScientificOfficerandPresident,
WorldwideResearch,Developmentand
Medical
CharlotteAllerton
ChiefScientificOfficer,Anti-InfectivesHeadofMedicineDesign
LeadingtheWaytoBreakthroughs
DeepexpertiseandsuccessfultrackrecordinCOVID-19andinfectiousdisease
AnnaliesaAnderson,Ph.D.,FAAM
SeniorVicePresidentandHead,
VaccineResearch&Development
SecondQuarter2022Earnings17
ThePandemicContinuestoEvolve
Newvariantsemerginginshortertimeintervals
GlobalCirculatingStrainsTrend
COVID-19GlobalCases/Deaths
~565M
GlobalCases
~6.4M
GlobalDeaths
GISAIDdataasofJuly22,2022
AsofJuly19,2022:JohnHopkinsUniversityCovid-19
site:
/
18
SecondQuarter2022Earnings
AdvancingOmicronVariant-modifiedVaccineCandidates
Evaluatedsafety&immunogenicityofmono-andbivalentOmicron(BA.1)–modifiedvaccinecandidatesin~1,920participants>55years
BNT162b2
BNT162b2
MonovalentBNT162b2
Omi(BA.1)
BivalentBNT162b2+BNT162b2Omi(BA.1)
or
or
Dose4administeredamedianof6.3months(4.7,12.9)fromDose3
?MonovalentBNT162b2Omi(BA.1),bivalentBNT162b2+BNT162b2Omi(BA.1)alsobeingevaluatedinparticipants18-55yearsofage
?30μgbivalentcandidateselectedfollowingguidancefromregulators
SimplifiedstudyschemefromSubstudyE:evaluatingsafety&immunogenicityofmono-andbivalentOmicron(BA.1)–modifiedvaccinecandidatesin~1,920participants>55yearsat30or60μg,n=320eachPresentedatJune28,2022VaccinesandRelatedBiologicalProductsAdvisoryCommittee.
SecondQuarter2022Earnings19
LOD
AdvancingOmicronVariant-ModifiedVaccineCandidates
Insub-studyevaluatingBA.1-modifiedvaccine
candidatescomparedtowildtypevaccine,
resultsforOmicronBA.1demonstrate:
?GMRconsistentwithsimplesuperiority
criterion
?Seroresponserateexceedsnoninferiority
criterion
with4thdosebooster
?Similarlocalreactionandsystemicevent
?Neutralizationactivitysubstantiallyincreased
profiletowildtypevaccine
BA.4/BA.5responsetoBA.1-modifiedvaccinecandidate
ParticipantsWITHOUTEvidenceofInfectionupto1MonthAfterFirstStudyVaccination
OmicronresponsestoBA.1-
modifiedvaccinecandidates
werehigheroverall
comparedtotheoriginal
vaccine,thoughBA.4/5was
lowerthanBA.1
ResultsfromSubstudyE:evaluatingsafety&immunogenicityofmono-andbivalentOmicron(BA.1)–modifiedvaccinecandidatesin~1,920participants>55years;
FFRNT,fluorescentfocireductionneutralizationtest;LOD,LimitofDetection
PresentedatJune28,2022VaccinesandRelatedBiologicalProductsAdvisoryCommittee
20
SecondQuarter2022Earnings
OmicronBA.4/5MonovalentandBivalentBoostersinMice
SubstantialincreaseinOmicronneutralizationresponsestoallOmicronvariants
BNT162b2OmicronBA.1MonovalentOmicronBA.4/5MonovalentOmicronBA.4/5Bivalent
n=8.Micepreimmunizedwith2dosesofBNT162b2;boostersgivenatday104
pVN=Pseudovirusneutralizationassay;LOD=LimitofDetection;GMT=Geometricmeantiter
PresentedatJune28,2022VaccinesandRelatedBiologicalProductsAdvisoryCommittee
21
SecondQuarter2022Earnings
BivalentBoosterStrategytoAdapttoPaceofVirus
Potentialtoenableamorerapidresponsetochangingvariantlandscape
Variant
Vaccine
Regulatory
Update
Pathway
USACirculatingOmicronStrainsTrend
?OmicronBA.1
?OmicronBA.2
?OmicronBA2.12.1?OmicronBA.4
?OmicronBA.5
?Overallresponsessimilarbetweenhumanclinicalandmousedata
?ExtensiveclinicalexperiencewithvariantmodifiedvaccineswithsamemRNAplatformandmanufacturingmayenablepreclinicalimmunogenicitydataandbivalentCMCpackagetobesufficientforfutureEUAs1
GISAIDdataasofJuly22,2022
(1)Subjecttoregulatoryagreement.
SecondQuarter2022Earnings22
wildtype
SecondQuarter2022Earnings
23
StrategiesAimingtoProvideDurableDiseaseProtectionAgainst
EmergingVariants
Next-generationSARS-CoV-2SpikeAntigen
?Phase1/2studyinitiatedwithbivalentvaccinecandidate(WTandOmicronBA.2)
?Next-generationspikeproteinengineeringaimsto:
?Increaseprefusionstability
?Exposemoreneutralization-sensitiveepitopes
FutureProof-of-ConceptStudyPlannedforClinic2H2022
?Pan-SARS-CoV-2vaccinecandidate
WT=
Hospitalized
HighRisk
ContinuedExpansionofPAXLOVIDClinicalStudies
Immunocompromised
Study
EPIC-HR1
EPIC-IC
EPIC-Hos4
TrialSize
2,246
150
279
Milestone
PDUFADateExpectedQ120232,3
PlannedStudyStart2H20222
PlannedStudyStart2H20222
LongCOVID
Pregnancy
Retreatment
Study
Multiplecollaborativestudiesbeingconsidered
WorkingwithFDAtofinalizeprotocol
NCT05386472
TrialSize
45
Milestone
Ongoing
EPIC=EvaluationofProteaseInhibitionforCOVID-19;HR=HighRisk;IC=Immunocompromised;Hos=Hospitalized
(1)StudyresultspublishedinNEJM2022;386:1397-1408DOI:10.1056.
(2)Anticipatedtiming,underreviewandsubjecttochange.
(3)NDAsubmissionsupportedbydatafromEPIC-HR,EPIC-SR(SR=StandardRisk),andEPIC-PEP(PEP=Post-ExposureProphylaxis)
(4)ICandnon-IChigh-riskhospitalizedpatients
24
SecondQuarter2022Earnings
CurrentFluVaccinesareSuboptimalinAddressingUnmetNeed
mRNAplatformshortenstimelinespotentiallyenablingquickerresponsetofluevolution
3–5M
Severecases/yrglobally1
5-20%USpopulationbecomesinfected
with≥200Khospitalizationsand
upto79Kdeaths/yr2
Elderlyaccountfor
70–85%
ofdeaths3
Upto
$25B
ineconomiclossinU.S.4
Inefficientfluvaccinecycleresultsinsuboptimaleffectiveness
PotentialAdvantagesofmRNAvaccinesforFlu:
?Improvedstrainmatch
?Morerapid,reliablemanufacturingtofacilitateseasonalstrainchanges
?Broaderimmuneresponses(bothantibodies&Tcells)
(1)WorldHealthOrganization:
/mediacentre/factsheets/fs211/en/
;
(2)CentersforDiseaseControlandPrevention:
/flu/about/qa/disease.htm
;
(3)CentersforDiseaseControlandPrevention:
/flu/highrisk/65over.htm
(4)Putrietal,Vaccine.2018Jun22;36(27):3960-3966.doi:10.1016/j.vaccine.2018.05.057
25
SecondQuarter2022Earnings
N2-foldqRNAGMFRsforB/VictoriaandH3N2>QIVatDay7
**
QIVn=44
qRNAn=35
Strain-SpecificCD8+TcellResponses
QuadrivalentmodRNAFluVaccineCandidate:OngoingPhase2Study
FirstevidenceofsubstantialinductionofbothCD4+andCD8+responses
Phase2ExpansionStudyinSubjects65+YearsofAge(n=118)
N2-foldqRNAGMFRsforall4strains>QIVatDay7
Strain-SpecificCD4+TcellResponses
*
*
*
*
QIVn=44qRNAn=35
Phase3studyplanningbasedonencouragingTcellresponsesandseroconversion
modRNA=modifiedRNA;qRNA=quadrivalentmodRNA;QIV=quadrivalentinfluenzavaccine(FluzoneHD);HA1=hemagglutininA;H1N1=InfluenzaASubtype;H3N2=InfluenzaASubtype;BYAM=YamagataB
Subtype;BVIC=VictoriaBSubtype;GMFR=GeometricMeanFoldRise
(*)GMFRaxis:HighestQIVstrain-specificIFNy+CD4orCD8TcellresponsesatDay7;%ResponderRateaxis:HighestresponderrateforQIV
26
SecondQuarter2022Earnings
MeanDailyGlucose
Reduction(mg/dL)
0
PF-07081532:PotentialBest-In-ClassOnce-DailyOralGLP-1Profile
UpcomingEASDPhase1datashowrapid,robustreductioninglucoseandbodyweight1
99mg/dLReductioninMeanDailyGlucoseafter6weeks1
Placebo
PF-07081532
-20
-40
-29
-60
-80
-100
-99
-120
5kgReductioninBodyWeightafter6weeks1
BodyweightReduction(kg)
0
-1
-2
-3
-4
-5
-6
Placebo
PF-07081532
-2
-5
?Similarchangesinbodyweightobservedinparticipantswithnon-diabeticobesity
?SafetyandtolerabilityprofileconsistentwithGLP-1RAclass,furthertitrationoptimizationinplannedPhase2Study
?Threepresentations2acrossoralGLP-1RAfranchiseatEASDAnnualMeeting,September2022
EASD=EuropeanAssociationfortheStudyofDiabetes;T2DM=Type2DiabetesMellitus;GLP-1=Glucagon-likePeptide-1;RA=ReceptorAgonist
ResultsfromCidentifier:NCT04305587,Randomized,double-blind,placebo-controlled,multipleascendingdosePhase1StudyinadultswithT2DMandnon-diabeticobesity
SecondQuarter2022Earnings
(1)Abstract#114,58thAnnualMeeting-Once-DailyOralSmallMoleculeGLP-1RAgonistPF-07081532RobustlyReducesGlucoseandBodyWeightwithin4-6WeeksinAdultswithT2DMandNon-DiabeticAdultswithObesity,Modelledmeanspresented,Meanbaselinedailyglucose212mg/dL,MeanbaselinebodyweightinT2DMparticipants90kg
(2)Abstracts#114,588,589
27
Anti-IFN-β:PotentialtoAddressKeyDriverofAutoimmunity
?IFN-βisoneof~20TypeIinterferonswhichareimportantfornormalimmunefunction
?AdministrationofIFN-βcanleadtoautoimmunityinpeople
?PatientswithdermatomyositisshowelevatedTypeIIFNgenesignatureinblood,skinandmuscle,correlateswithdiseaseactivityinskin
?BlockingIFN-βhaspotentialforbroaderutilizationinotherinflammatoryautoimmunediseasessuchaslupus(~200,000U.S.patients1)
Anti-IFN-βinDermatomyositis(DM)
?DMislife-threateningandchronicallydebilitating
?Manifestationsincludeskinlesionsandprogressivelydebilitatingmuscleweakness,cardiacimpairment,lungandjointmanifestations,increasedriskofmalignancy
?Approximately50,000dermatomyositis(DM)and50,000–55,000polymyositis(PM)U.S.patients
?OpportunitytobefirstapprovedtargetedtherapyforDMandPM2
(1)
/chronicdisease/resources/publications/factsheets/lupus.htm
(2)Subjecttoclinicaltrialsuccess/regulatoryreview
28
SecondQuarter2022Earnings
AmendedStage2
Stage3
Efficacy
SkinPredominantDisease
?Bothdoses(600mgand150mg)metprimaryefficacyendpointasassessedbyCutaneousDermatomyositisDiseaseAreaandSeverityIndex(CDASI-A)
MusclePredominantDisease
?Numericallybetterefficacyscoresacrossallkeymuscleendpoints
Safety
?Generallywelltoleratedwithfavorablesafetyprofileinallstagesofthestudy,nosafetysignalsidentified
?NocasesofHerpesZosterorHerpesSimplex
Anti-IFN-β:UpdatedPhase2DermatomyositisPositiveData
Phase2,PlaceboControlledStudy
Skin
Muscle
Stage3
Stage1
Stage2
AmendedStage2
Stage1
Stage2
Skin
Skin
Skin
Predominant
Predominant
Predominant
Disease
Disease
Disease
Dose
Fixed
Ranging
Sequence
n=9
n=32
n=16
Muscle
Predominant
Disease
n=18
ResultsstrengthengrowingI&Iportfoliowithdiversemechanismstohelpaddressmultipledriversofdiseaseandunmetneed
SecondQuarter2022Earnings29
Efficacy:
?ConfirmedORRwas64%among55patients
?35%ofpatients(19/55)achievedsCRorCR
?54%(7/13)ofpatientswhoreceivedpriorBCMA-directedtherapy(ADCorCAR-T)achievedaresponse
?Forresponders(n=35),theprobabilityofbeingeventfreeat9monthswas77%(95%CI,58-88%)
Safety:
?Manageablesafetyprofile
?Withpre-medicationand1-steppriming,noGrade
3orhigherCRS,incidencewas66.7%dividedequallybetweenGrade1and2
Follow-upPhase1MagnetisMM-1TrialofelranatamabforMM
ASCO1resultsshowconfirmedORRof64%inpatientswithRRMM
DurationofTreatmentandBestOverallResponseforAllPatients
MM=MultipleMyelomia;RRMM=Relapsed/refractorymultiplemyeloma;ASCO=AmericanSocietyofClinicalOncology;ADC=
antibodydrugconjugate;BCMA=B-cellmaturationantigen;CAR-T=chimericantigenreceptorT-celltherapy;CR=completeresponse;MR=minimalresponse;NE=notevaluable;ORR=overallresponserate;PD=progressivedisease;PR=partialresponse;REL=relapse;sCR=stringentcompleteresponse;SD=stabledisease;VGPR=verygoodpartialresponse;CRS=cytokinereleasesyndrome
(1)Abstract#8014,ASCO2022AnnualMeeting:Elranatamab,aBCMA-TargetedT-CellRedirectingImmunotherapy,forPatientswithRelapsedorRefractoryMultipleMyeloma:UpdatedResultsfromMagnetisMM-1
30
SecondQuarter2022Earnings
Follow-upPhase1MagnetisMM-1TrialofelranatamabforMM
ASCO1resultsshowdurableMRDnegativity
DurationofTreatmentandMolecularResponseforCR/sCRPatients
MM=multiplemyeloma;MRD=Minimalresidualdisease;RRMM=Relapsed/refractorymultiplemyeloma;ASCO=AmericanSocietyofClinicalOncology;CR=completeresponse;sCR=stringentcompleteresponse
(1)Abstract#8014,ASCO2022AnnualMeeting:Elranatamab,aBCMA-TargetedT-CellRedirectingImmunotherapy,forPatientswithRelapsedorRefractoryMultipleMyeloma:UpdatedResultsfromMagnetisMM-1
(2)Triple-ClassRefractoryMultipleMyeloma:ClinicalTIdentifier:NCT04649359
(3)Double-ClassExposedMultipleMyeloma;ClinicalTIdentifier:NCT05020236
(4)Newlydiagnosedpost-transplantMultipleMyelomaClinicalTIdentifier:NCT05317416
MRDNegativity:
?100%(13/13)ofevaluableCR/sCRpatients(includingunconfirmed)achievedMRDnegativityatasensitivityof1x10-5
?Molecularresponsesweredurablewith62%(8/13)documentedMRDnegativeat>6months,including2patientsMRDnegativebeyond18months
MagnetisMM-1results,andemergingdata
fromMagnetisMM-32,supportfurther
developmentacrossabroaderprogram
withpotentialregistra
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