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转折点：临床试验结果如何影响生物制药估值（英）

医药生物2024-06-12MARKUS GORES、WILLIAM HARRIES、FRANCESCO CAPUZZIIQVIA胡***

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Inflection Point: How Clinical Trial Results Impact Biopharma Valuations

Introduction

Clinical trials are pivotal in the biopharmaceutical industry, serving as critical inflection points that significantly influence company valuations. The process of developing novel therapies is capital-intensive and fraught with high stakes, with the average cost reaching $3.1 billion per therapy. Success rates from phase 1 through regulatory submission stand at 11%. Clinical trial outcomes, particularly the readouts at the primary endpoint, directly affect investor perceptions and, consequently, company valuations.

Methodology Overview

IQVIA conducted an event study analysis focusing on over 2,600 clinical trials from 2017 to 2023. The study defined the event date as the primary endpoint reported date and quantified the share price reactions post-clinical outcomes. A robust statistical model was employed to analyze changes in sponsor company share prices around the primary endpoint reported date, comparing pre-event and post-event prices.

The Asymmetry of Market Response

IQVIA’s analysis revealed a striking asymmetry in the market's response to positive versus negative clinical trial results. Negative clinical results caused a larger relative market reaction than positive ones. Specifically:

Negative news had impacts 2.3, 1.3, and 2.0 times higher than positive news for clinical trial phases 1, 2, and 3, respectively.
Phase 2 readouts showed the most favorable risk-reward profile.

Valuation Impact Drivers

The study highlighted several factors driving the impact of clinical trial outcomes on biopharma valuations, including:

Therapy Areas: Different disease areas can significantly affect valuation responses.
Trial Designs: The structure and execution of trials play a crucial role in how outcomes are perceived.
Company Size: Smaller companies, especially those with a market capitalization below $1 billion, are more sensitive to clinical trial results due to the concentration of value in their pipelines.

Practical Implications for Management Teams

Understanding these drivers allows management teams to make informed strategic decisions. Key considerations include:

Optimal Timing for Partnerships: Knowing when to seek collaborations can mitigate risks and maximize value.
Exit Strategies via M&A: Timing is crucial in deciding whether to pursue an exit through mergers and acquisitions.

Conclusion

Clinical trial outcomes represent significant inflection points in the biopharmaceutical development journey. The asymmetric market response, particularly the greater impact of negative outcomes, underscores the importance of managing expectations and mitigating risks. Understanding the drivers of valuation impact can guide biopharma companies in navigating optimal development paths, balancing value maximization against incremental clinical risk.

WhitePaper InflectionPoint:HowClinicalTrialResultsImpactBiopharmaValuations Understandingthedriversofvaluecreationtonavigateanoptimaldevelopmentpath MARKUSGORES,VicePresident,EMEAThoughtLeadership,IQVIA WILLIAMHARRIES,SeniorConsultant,EMEAThoughtLeadership,IQVIA FRANCESCOCAPUZZI,SeniorConsultant,EMEAIntegratedResearch,IQVIA Tableofcontents Introduction2 Methodology:briefoverview3 Theasymmetryofmarketresponse3 Driversofvaluationimpact:therapyareas,trialdesigns,companysize6 Considerationsformanagementteams11 Closingthoughts13 Appendix:additionalmethodologydetails14 References16 Abouttheauthors18 Disclaimer Theanalyses,theirinterpretation,andrelatedinformationcontainedhereinaremadeandprovidedsubjecttotheassumptions,methodologies,caveats,andvariablesdescribedinthisreportandarebasedonthirdpartysourcesanddatareasonablybelievedtobereliable.Nowarrantyismadeastothecompletenessoraccuracyofsuchthirdpartysourcesordata.Noinvestmentadviceisgiven. Introduction Developingnoveltherapiestoaddressunmetpatientneedisthelifebloodofthebiopharmaceuticalindustry.Itisalsoacapital-intensiveandhigh-stakesendeavour,requiringanestimated$3.1billiontobringanewtherapytomarket,1withacompositesuccessrateof11%fromphase1throughregulatorysubmission.2 Clinicaltrialreadouts,therefore,representmajorinflectionpointsinthisjourney,asmomentsoftruth,thatresolveuncertaintyaroundanasset’sfutureprospects,includingitsultimatepotentialforrevenuegeneration.Consequently,companyvaluationsrespondtoclinicaltrialresults—positiveandnegative —asinvestorsre-calibratetheirexpectationsbasedonthenewinformationbecomingavailable.3-6 Inthiswhitepaper,wewillsystematicallyinvestigatehowclinicaltrialoutcomesimpactcompanyvaluationsandexploretheunderlyingdrivers,suchashowtrialresultscomparetoinvestors’priorexpectations,developmentphaseatreadout,therapyareaortrialdesign.Wefocusonemergingbiopharmacompanies(EBPs),inparticularthosewith<$1billionmarket capitalisation,becausetheirvaluationsarehighlyresponsivetotrialresults,asmostoftheirvalueisconcentratedintheirpipelinewhichoftencomprisesjustasingleasset.Unsurprisingly,wefoundthatEBPvaluationsaremuchmoresensitivetoclinicaltrialreadouts,byuptotwoordersofmagnitude,comparedtobigpharmacompanies. Furthermore,wewillelaborateonthepracticalimplicationsofunderstandingthosedriversofvalueinflection.Forexample,howsuchinsightmayinformstrategicdecisionsandhelpmanagementteamsnavigateacompany’soptimalpaththatbalancesvalueupsidevs.incrementalclinicalrisk,suchastheoptimaltimingforexploringpartnershipsorwhentopursueanexitviatheM&Aroute. iqvia.com|2 Methodology:briefoverview IQVIAperformedaneventstudyanalysisthatquantifiedthesharepricereactiontoclinicaloutcomesformorethan2,600trialsfrom2017to2023. Ouranalysisdefinestheeventdateastheprimaryendpointreporteddate,i.e.,theearliestdateofpublicreportofresultsthataddressestheprimaryendpointsofthetrial.Positiveandnegativeoutcomesattheprimaryendpointreporteddatewereallocatedbasedonthecompany-reportedclinicaldefinition. Arobuststatisticalmodelwasdevelopedtoanalysethechangeinsponsorcompanysharepriceattheprimaryendpointreporteddate.Thechangewascalculatedastheaverageattheclosepricesoftwodayspriorandonedaypriortotheprimaryendpointreporteddateversustheaverageattheclosepricesonthedayoftheeventandthedayafter. Sponsorcompaniesandtherapeuticareas(TAs)wereallocatedbasedonIQVIAofficialclassifications. Furthermethodologicaldetailsaredocumentedintheappendix. Theasymmetryofmarketresponse Amainfocusofouranalysiswasunderstandingthemarketresponsetopositiveandnegativeclinicalresultsfordifferenttrialphasesalongtheclinicaldevelopmentpath. Weobservedanintriguingasymmetryinthestatisticallysignificantimpactofpositivevs.negativeclinicaltrialreadoutsoncompanyvaluations,withnegativetrialresultsconsistentlycausingalargerrelativemarketreactionthanpositiveresults.Thispatternholdstrueforalltrialphases. Specifically,wefoundthattheimpactofnegativenewswas2.3,1.3and2.0timeshighervs.positivenewsforclinicaltrialphases1,2and3,respectively,implying amostfavourablerisk-rewardprofileforphase2readouts(seeFigure1). Thisconsistentasymmetryobservedacrossalltrialphasessuggeststhatinvestorsgiveinnovatorsthebenefitofthedoubt,onthebasisofrisk-adjustedexpectations.Consequently,anyvalueupliftfollowing Figure1:Theasymmetryofmarketresponse Trialresults ImpactofclinicaltrialresultsonEBPvaluations,bytrialphase (%changeinshareprice;allresultsarestatisticallysignificantatthe95%confidencelevel) Phase1Phase2Phase3 NEGATIVEPOSITIVE 12%11% 3% -7% -16% -22% Risk/reward profile* 2.3 1.3 2.0 Basedonreadoutsofover1,500EBP-sponsoredclinicaltrials *Ratioofabsolutenegativeimpact/positiveimpactSource:IQVIAEMEAThoughtLeadershipanalysis positiveclinicalnewsfromananticipatedeventislesspronouncedasitconfirmspriorassumptionsthatarealreadysomewhatreflectedinacompany’sshareprice. Conversely,negativetrialresultsdefypriorexpectationsandthusdestroysignificantvalue.Takenbysurprise,investorsfundamentallyrevisetheirexpectations,includingreducingpeaksalesandpossiblyloweringassumed

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