艾昆玮-转折点：临床试验结果如何影响生物制药估值（英）.pdf

WhitePaperInflectionPoint:HowClinicalTrialResultsImpactBiopharmaValuationsUnderstandingthedriversofvaluecreationtonavigateanoptimaldevelopmentpathMARKUSGORES,VicePresident,EMEAThoughtLeadership,IQVIAWILLIAMHARRIES,SeniorConsultant,EMEAThoughtLeadership,IQVIAFRANCESCOCAPUZZI,SeniorConsultant,EMEAIntegratedResearch,IQVIATableofcontentsDisclaimerTheanalyses,theirinterpretation,andrelatedinformationcontainedhereinaremadeandprovidedsubjecttotheassumptions,methodologies,caveats,andvariablesdescribedinthisreportandarebasedonthirdpartysourcesanddatareasonablybelievedtobereliable.Nowarrantyismadeastothecompletenessoraccuracyofsuchthirdpartysourcesordata.Noinvestmentadviceisgiven.Introduction2Methodology:briefoverview3Theasymmetryofmarketresponse3Driversofvaluationimpact:therapyareas,trialdesigns,companysize6Considerationsformanagementteams11Closingthoughts13Appendix:additionalmethodologydetails14References16Abouttheauthors18iqvia.com|2Developingnoveltherapiestoaddressunmetpatientneedisthelifebloodofthebiopharmaceuticalindustry.Itisalsoacapital-intensiveandhigh-stakesendeavour,requiringanestimated$3.1billiontobringanewtherapytomarket,1withacompositesuccessrateof11%fromphase1throughregulatorysubmission.2Clinicaltrialreadouts,therefore,representmajorinflectionpointsinthisjourney,asmomentsoftruth,thatresolveuncertaintyaroundanasset’sfutureprospects,includingitsultimatepotentialforrevenuegeneration.Consequently,companyvaluationsrespondtoclinicaltrialresults—positiveandnegative—asinvestorsre-calibratetheirexpectationsbasedonthenewinformationbecomingavailable.3-6Inthiswhitepaper,wewillsystematicallyinvestigatehowclinicaltrialoutcomesimpactcompanyvaluationsandexploretheunderlyingdrivers,suchashowtrialresultscomparetoinvestors’priorexpectations,developmentphaseatreadout,therapyareaortrialdesign.Wefocusonemergingbiopharmacompanies(EBPs),inparticularthosewith3|InflectionPoint:HowClinicalTrialResultsImpactBiopharmaValuationsMethodology:briefoverviewIQVIAperformedaneventstudyanalysisthatquantifiedthesharepricereactiontoclinicaloutcomesformorethan2,600trialsfrom2017to2023.Ouranalysisdefinestheeventdateastheprimaryendpointreporteddate,i.e.,theearliestdateofpublicreportofresultsthataddressestheprimaryendpointsofthetrial.Positiveandnegativeoutcomesattheprimaryendpointreporteddatewereallocatedbasedonthecompany-reportedclinicaldefinition.Arobuststatisticalmodelwasdevelopedtoanalysethechangeinsponsorcompanysharepriceattheprimaryendpointreporteddate.Thechangewascalculatedastheaverageattheclosepricesoftwodayspriorandonedaypriortotheprimaryendpointreporteddateversustheaverageattheclosepricesonthedayoftheeventandthedayafter.Sponsorcompaniesandtherapeuticareas(TAs)wereallocatedbasedonIQVIAofficialclassifications.Furthermethodologicaldetailsaredocumentedinthe appendix.TheasymmetryofmarketresponseAmainfocusofouranalysiswasunderstandingthemarketresponsetopositiveandnegativeclinicalresultsfordifferenttrialphasesalongtheclinicaldevelopmentpath.Weobservedanintriguingasymmetryinthestati