2024年生物制药行业回顾-2024

2024

Review

TheLong&

WindingRoad

Evaluate.

anorstellacompany

Clickhereorpressenterfortheaccessibilityoptimisedversion

Foreword

Foreword

B

iopharmaexpertsknewthat2024wasunlikelytobetheyearthatpharma

cameroaringbackina

blazeofmega-mergers,highprofileIPOsandeye-wateringprivate

investmentrounds.Andlooking

backontheyear,atleastwecansaywedidnÕtgetourhopesuptoo

much,despitewhatlookedlikeapromisingstart.

Butwas2024adampsquib?Orwasitasmuchaswecouldreasonablyexpectafterthepainof2023?Inthisround-upwelookatthedealmakinglandscapeofthepast

12months,seekoutthehighsandlows,andconsider

whatitmeansfortheyear

ahead

.

LetÕsstartatthebottomandworkourwayup:

M&A

.Abusyfirstquartersparked

hopesofareturntosomedynamic

dealmaking,butthosehopesweresoondashed.Therestoftheyearslithered

downhillwithever-reducingdealvalues

andwasnÕtevenrescuedbyaQ4surgeasweÕdseenfortheprevioustwoyears.Thebestthatcanbesaidofyearendisthat

dealvolumeincreased.

Inslightlybetternews,the

IPOwindow

creakedopenalittlefurther.Total

flotationshit38Ðupfrom2023and2022,thoughwellbelowtheCovid-inspired

peakthatnearlyblewthewindowoffitshinges.Thereisnoshortageofprivate

biotechslookingtolaunchIPOsin2025,buttheyneedthefragilemarketsto

stabilizeandtheglobaleconomytosettlebeforetheytaketheplunge.

Ontothebetternews:

venturecapital

fundraisingforbiopharmacompanieshadastrongyearend,boostingtheyearÕstotaltoover$28bnandbeating2023and

2022.Therewereevensomemega-

roundsfortheindustrytogetexcited

about,includinga$400mseriesAroundforKailera,acompanyfocusedonÐyouguesseditÐobesity.Backwithabump,thenthough,aswelookatafarfrom

vintageyearforbiotechintermsof

stock

performance

.

Finally,welookatthedynamicsofsomeofthe

drugsthathitthemarketin2024

.

Recentthemesremainapparentwithbiglaunchesaroundmetabolicdiseaseand

neurologicalconditionsinthetop12list.WhatÕsmostinteresting,though,isthe

factthathalfofthosetoplaunchesdonotsitwithBigPharmabutinsteadwithsmallorfirst-time-to-marketfirms.

IspharmaÕsglasshalffullorhalfempty?Graba(full)cupofcoffeeandletÕsfindoutÉ

Formoretimely,data-driveninsightsintothepharmamarket,checkout

Scrip

and

InVivo

.

Evaluate.

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M&AValuesContinuedToDecline

DuringQ42024

Evaluatedatashowthatthe

biopharmaindustrymade$9.5bnofacquisitionsduringthefourthquarter,athirdconsecutive

quarterofdecline,althoughdealvolumeroseto33fromQ3’s29.

M&AValuesContinuedToDeclineDuringQ42024

Evaluatedatashowthatthebiopharmaindustrymade$9.5bnofacquisitionsduringthefourthquarter,athirdconsecutivequarterofdecline,althoughdealvolumeroseto33fromQ3’s29.

Although2024gotofftoapromising

startwithabusyfirstquarter,thefourthquartermarkedthethirdconsecutive

quarterofdecliningbiopharmamerger-

and-acquisitionvaluation.Evaluate

reportedthattherewere33M&Adeals

duringQ4,upfrom29inthethirdquarter,butwithatotalvaluationofslightlymorethan$9.5bn,downsubstantiallyfrom

nearly$52.3bninQ42023.

Industrywatcherswere

readywiththeir

explanations

ofwhyM&Aactivityhad

crateredthroughout2024whenpositiveconditionsappearedinplaceforsuch

activity–whilepotentialbuyershadbothcashandneedtoaddpipelineassetstooffsetcomingrevenuelossesdueto

patentexpirations,macroeconomic

uncertainty,especiallyinthefinancial

markets,andtheloomingpresidential

electionhelddownactivityasdeep-

pocketedplayersawaitedabetter

environmentforplacinghigher-pricedbets.

BiopharmaM&Aisexpectedtoreboundin2025andtheyeargotofftoahotstart

whenJohnson&Johnsonagreedtobuy

Intra-Cellularfor$14.6bnon13January,

nearlytriplingthepricetagofthelargesttakeoutrecordedduring2024,Vertex’s

$4.9bnpurchaseofAlpineImmuneinApril.

Thebiopharmasectordidnoteven

approachapurchaseofthatsizeduring

Q4,asH.Lundbeck’s$2.6bnacquisitionof

LongboardPharmaceuticalsendedupthehighest-valueddealannouncedinthefinalthreemonthsof2024.Itwasoneofjustthreeacquisitionsvaluedat$1bnorhigherduringQ4.

The

firstquarterof2024

provedanoutlier,astheindustrymade54M&Atransactionswithatotalvaluationofnearly$37bn.Thatvaluationnearlyequaledtheslightlyless

than$40bninacquisitionsrecordedoverthefinalninemonthsof2024,butNovoHoldings’$16.5bnacquisitionofCatalent

–amanufacturing-drivendealexpectedtobenefitNovoNordiskbyaddressingits

supplyissuesforsemaglutide-containingproductssuchasOzempicandWegovy–skewedtheQ1dollartotal.Thetransactionwasbiopharmaceutical-adjacent,butnotstrictlyapure-playbiopharmadeal.

Thebiopharmasectordidnot

approachtheQ1dealvolumeorvaluationtotalsduringtheremainderof2024,

althougharelativelyhealthy38takeoutsvaluedatslightlymorethan$20bnwere

recorded

duringthesecondquarter

.

InQ3,

acleardecline

inM&Aactivitywasevident

–whiletherewere29M&Atransactions,totalvalueonlyreached$10.5bn.

BiopharmaM&Aisexpectedtoreboundin2025.

Thefourthquarterof

2024reversedatrend

seeninthepriortwo

years,whenM&Aactivitysurgedduringthefinal

threemonthsoftheyear.

Thefourthquarterof2024reverseda

trendseeninthepriortwoyears,when

M&Aactivitysurgedduringthefinalthreemonthsoftheyear.InQ42023,the

biopharmasectormade49M&Adeals

valuedatmorethan$52bn,highlightedbyapairof$10bn-plustakeouts,andin2022,thefinalquarter’stotalsof48acquisitionsvaluedatmorethan$37bnmadeforthe

busiestquarterofthatyear.

Lundbeck’sInterestInEpilepsyLeadsQ4M&A

Denmark-headquarteredLundbeckmadethelargestdealofthefourthquarter,

agreeingtopay$2.6bnon14OctobertoacquireLaJolla,CA-basedLongboard,

mainlytogetitshandsonbexicaserin,anext-generation5-HT2Creceptoragonistthatisbeingstudiedinseizure

disorderssuchasDravetsyndrome(DS),Lennox-Gastautsyndrome(LGS)and

otherdevelopmentalandepilepticencephalopathies(DEEs).

LastSeptember,thecandidateenteredaPhaseIIIstudyinDravetsyndrome,an

indicationithasbreakthroughtherapy

designationforfromtheUSFoodand

DrugAdministration.Accordingto

EvaluatePharma,thedrugisontracktolaunchinlate2028,withapeakrevenueprojectionof$850min2030.Lundbeckclosedthedealon2December,paying$60pershareforthebiotech,a70%

premiumtoLongboard’s10-dayaveragesharepricebeforethedealwas

announced.

Thequarter’ssecond-largestdeal

wasAbbVie’s$1.4bnbuyoutofAliada

Therapeuticson28October,bringingtheNorthChicagofirmALIA-1758,aPhaseI

bispecificantibodycandidatefor

Alzheimer’sdiseasethattargets

pyroglutamateamyloidbeta(3pE-Aβ),thesametargetasLilly’sKisunla(donanemab),butwithpotentiallybettertargetingand

otheradvantages.Thetransactionclosedon11December.

AbbViealsomadethefifth-largest

acquisitionofQ4,paying$200mon13

DecembertoacquireWisconsin-

headquarteredNimbleTherapeutics,a

2019spinoutfromRoche,witha

specializedtechnologytochemically

synthesizescaffoldednaturaland

modifiedmacrocyclicpeptidomimetics–fromalibraryofphotoprotectedamino

acids–formultipletherapeuticareas.Thedeal,whichincludesthepotentialof

earnoutstoNimbleshareholders,broughtAbbViethebiotech’splatform

technologyaswellasitsleadcandidate,anoralpeptideIL23Rinhibitorin

preclinicaldevelopmentforpsoriasis.

Rocheaddedtoitscancerpipelineon26Novemberbypaying$1bnupfront,withupto$500minearnoutspossible,forcelltherapyspecialistPoseida.Thetwo

companieshadbeenpartneredsince

2019ondevelopingoff-the-shelfchimericantigenreceptorT-cell(CAR-T)therapies,withaninitialfocusonmultiplemyeloma.Stillnotclosed,thedealwasstructuredsothatshareholdersintheSanDiego

biotechget$9pershareupfrontand

potentialtorealizeupto$4pershareinmilestonepayments.

Germany’sBioNTechagreedon13

NovembertoacquireBiotheus,a

developerofbispecificantibodies,for$800mupfrontplusupto$150minearnouts.BioNTechhadlicensedtheChinesefirm’sBNT327(alsoPM8002),oneofthemostadvancedPD-(L)1x

VEGF-Abispecificcandidates,inJuly2023.

BNT327itselfisyettoenterPhaseIII,butBioNTechsaidduringaQ3investor

presentationthatitplannedtoinitiatea

PhaseII/IIINSCLCtrialinnon-smallcell

lungcancerandaPhaseIIItrialinsmall

celllungcancerbytheendof2024,withaPhaseIIIstudyintriple-negativebreast

cancerplannedforthefollowingyear.

Evaluate.

anorstellacompany

ModestFinalQuarter

CompletesShaky

BiotechIPOComebackFor2024

SepternaisthebestperformerofnewlylaunchedfirmsfromQ4,

withmoreinitialpublicofferingsfueledbypotentialinterestratecutshopedforin2025.

ModestFinalQuarterCompletesShakyBiotechIPOComebackFor2024

SepternaisthebestperformerofnewlylaunchedfirmsfromQ4,withmoreinitialpublicofferingsfueledbypotentialinterestratecutshopedforin2025.

BiotechIPOsstagedamoderaterecoveryin2024butamutedendtotheyear

showedhowfragilethemarketremainsforcompanieslookingtolaunch.

Fullyeardatashows26companies

debutedonUSexchangeslastyear,

higherthanthe21achievedin2023and22in2022,whenapandemic-fueled

boominbiotechflotationsabruptly

ended.Howeverthemarketisnosurefireroutefornewbiotechslookingto

acceleratetheirbusinessplansandthefinalquarterof2024sawjustfour

companiescompleteanIPO,raisingatotalof$670m.

Lukewarminvestorsentimentforthe

wholesectorisunderminingperformanceforpost-IPObiotechs,withmany

launchedinthelastfewyearstradingwellbelowtheirlaunchvalues.Thisappliestothemostrecentadditions,withthreeof

thefourlaunchedinthefinalquarter–

UpstreamBio,JupiterNeurosciencesandCAMP4Therapeutics–currentlytradingata50%discounttotheirlaunchprices.(seetable).

StandingoutfromthiscohortisSepterna,whichraisedthemostcapital($331m)anditsshareprice($19.30on23January)is

only9%lowerthanitslateOctoberlaunchprice.TheSouthSanFrancisco,CA-basedcompanyisdevelopingnextgeneration

oralsmallmoleculeGPCRtherapiesanditsleadcandidateisSEP-786,aPTH

receptoragonistforhypoparathyroidism.

Thereisaconsiderablebacklogofprivate

biotechcompanies

lookingtolaunchIPOs.

CurrentlyinaPhaseIstudy,thecompanyisexpectingtoshareinitialresultsby

mid-2025.

ResearchbyanalystsatJefferiesshowsthereisaconsiderablebacklogofprivatebiotechcompanieslookingtolaunch

IPOs,withmanyawaitingmorefavorablemacro-economicandbiotechmarket

conditions.

InterestRatesAndTrumpAdministration

ChiefamongthemacrofactorsistheUSinterestrate,andtheFederalReservehasindicatedthatitmaycontinuetocuttheratein2025,aslongasinflationremainsundercontrolanddownfromits2022

peak.

InDecember,theUScentralbanklowered

itspolicyratetoa4.25%-4.50%range,

withexpectationsoftwofurtherratecutsthisyear,withthefirstpotentiallyarrivinginMarch.

ThenewTrumpadministrationhas

promisedabroadandwide-rangingsetofpolicychanges,theimpactofwhich

remainshardtoread.Thesewillinclude

macro-economicpoliciessuchastariffsoncertainimportsandatthesectorlevel,effortstoshakeupregulation,includingthelikelyappointmentofpharmaindustryskepticRobertF.KennedyJnratthe

DepartmentofHealthandHumanServices.

Lacklusterinterestinsmall-to-mediumbiotechwasdemonstratedbytheoverallflatperformanceofthesector-specificXBIexchangein2024,whichshowed

Thereissomeoptimismaboutabouncebackinthebiotechsectorin2025.

virtuallynogrowthoverthe12months.

Thiswasincontrasttoacontinuingboomintechcompanystocks,whichhelped

raisetheDowJonesby16%lastyear.

Nevertheless,thereissomeoptimism

aboutabouncebackinthebiotechsectorin2025,withthehopedforinterestratecutspotentiallycombiningwithhigher

M&Aactivitytostimulatethesector.

OntheIPOfront,fourcompanieshave

alreadydeclaredtheirintentiontofloatinearly2025:cysticfibrosis-focusedSionna,autoimmuneandinflammatoryconditionscompanyOdyssey,precisionmedicines

firmMazeTherapeuticsandobesityspecialistsMetsera.

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Biopharma

VC

FundraisingReached

HighestTotalSince2021

EvaluatePharmadatafromthefourthquarterof2024show

anotherperiodofventurecapitalfundraisingthatbeateach

quarterof2023,as$100m-plusmega-roundssurged.

WithQ4DataIn,BiopharmaVCFundraisingReachedHighestTotalSince2021

EvaluatePharmadatafromthefourthquarterof2024showanotherperiodofventurecapitalfundraisingthatbeateachquarterof2023,as$100m-plusmega-roundssurged.

Venturecapitalfundraisingby

biopharmaceuticalcompaniesroseto

$7.11bninthefourthquarterof2024,afterfallingto$6.46bninQ3from$7.95bnin

Q2,accordingtodatafromEvaluate.Buttheyearhasshownasignificantrebound.BytheendofQ3,the2024fundraising

totalalreadyexceededthefull-year2023totalof$19.61bn,andwiththeQ4datainhand,venturefundraisinglastyeartotaled$28.05bn,alsobeatingthe$27.27bn

raisedbydrugdevelopersin2022.

Eachquarterof2024exceededeachofthequartersin2023.

Eachquarterof2024exceededeachof

thequartersin2023,drivenbyasurgeinVCmega-roundsof$100mormore.

Evaluate’sdatashowthatVCfinancingsinthe$100m-pluscategorytotaled

$3.79bn-$5.25bnduringeachofthefourquartersof2024,butthequarterlymega-roundtotalsexceededthoselevelsduringonlyfourquartersbetweenQ12020andQ42023.Thelastquarterof2024

includedfinancingsfortwocompaniesthatraised$400mormoreinventure

capital–TreelineBiosciencesandKaileraTherapeutics.

(SeetablealongsideforQ4’stopfiveVCfinancings.)

Meanwhile,the$1.32bninventureroundsof$50morlessandthe$1.79bninVC

roundsof$50m-$100minQ4ofthisyearwerethebiggestquarterlytotalsforthe

twocategoriesin2024.However,the

quarterlytotalforVCfinancingsof$50morlessexceededtheQ42024levelduring12oftheprior19quarters,whileseven

quartersexceededtheQ42024totalforfinancingsof$50m-$100m.

Theshiftofventurecapitaltolarger

financings,usuallyforlater-stage

companies,isareflectionofthecurrent

capitalmarketsenvironmentinwhich

investorsarelesslikelytoinvestinriskieropportunities,suchasearly-stagedrug

development,whileinterestratesarehigh.VCandpublicmarketinvestorsare

favoringcompanieswithclinical-stage

drugcandidatesintherapeuticareassuchasobesityandcardiovasculardiseases,

neuroscience,targetedoncologyandimmunology.

Ifmergersandacquisitionscontinue

at

thepaceandscaleseenearlierinJanuary

–withJohnson&JohnsonbuyingIntra-

CellularTherapiesfor$14.6bn,GSKpayingupto$1.15bnforIDRxandEliLilly

committingupto$2.5bnforScorpion

Therapeutics–thatmayboostinvestorconfidenceinbiopharmaopportunities.Evenstart-upscouldbenefitfromsimilarbusinessdevelopmentactivity,since

IDRx’sandScorpion’sleadprogramswereinearlyclinicaldevelopment,andBig

Pharmacompaniescontinuetoseek

VCandpublicmarketinvestorsarefavoring

companieswithclinical-stagedrugcandidatesintherapeuticareassuchasobesityand

cardiovasculardiseases,neuroscience,targetedoncologyandimmunology.

partnershipsatthepreclinicalstage.

ThetopfiveVCfinancingsinQ4of2024reflectthetherapeuticareasofgreatestinteresttobothBigPharmabuyersandinvestors–

obesity

,targetedcancer

therapiesandneuropsychiatry.

TreelineBioscienceshasbeenquietto

dateaboutitstargetedcancerdrug

pipeline,butthecompanydisclosedinaFormDfiledwiththeUSSecuritiesand

ExchangeCommission(SEC)inOctoberthatitraised$421.8m,whichfollowedtwopriorFormDfilingswiththeSECthat

exceeded$200meachin2021and2022.

KaileraburstontothesceneatthestartofQ4witha$400mseriesAroundtofunditspipelineofobesitymedicines,includingfourdrugslicensedfromHengrui–the

GLP-1/GIPdualagonistHRS9531

(KAI-9531),theoralGLP-1agonist

KAI-7535,anoraltabletformulationofKAI-9531andthepreclinicalGLP-1/GIP/glucagonreceptoragonistKAI-4729.

KaileraandHengruireportedpositivePhaseIIdataforKAI-9531earlierthismonth.

TheteambehindKarunaTherapeutics–thedeveloperofthenewlyapproved

schizophreniadrugCobenfy(xanomelineandtrospiumchloride),whichBristol

MyersSquibbacquiredfor$14bn–

launchedSeaportTherapeuticswith

$225minseriesAfundinginOctober.

Seaportwilluseitsinitialfundingto

initiateaPhaseIIbclinicaltrialforlead

drugcandidateSPT-300inmajor

depressivedisorderandbeginclinical

developmentofSPT-320forgeneralizedanxietydisorder.

Metseraraised$215minseriesB

financinginNovemberafteritclosed

a$290mseriesAroundinApril,bringingits2024venturecapitalhaulto$505m.

TheproceedswillfundaPhaseIItrialof

theonce-monthlyinjectableGLP-1

receptoragonistMET-097ithatthe

companyinitiatedlatelastyearaswellasongoingPhaseItrialsofMET-233i,anultra

long-actinginjectableamylinanalog,andMET-002,anoralGLP-1receptoragonist.

Inthetargetedcancerdrugspace,AlentisTherapeuticsraised$181.4min

Novembertofunditspipelineof

Claudin-1positive(CLDN1+)antibodiesandantibody-drugconjugates.TheSwissfirm’sseriesDroundalsowillsupportitsCLDN1+ADCprogramforfibrotic

diseases.

Formoreonwhat2025willholdforpharma,checkoutour

2025PreviewReport

.

Evaluate.

anorstellacompany

Mid-Cap

Biopharma’sBiggest

WinnersAndLosersOf

2024

SummitTherapeuticshitthe

stockmarketheightsin2024,alongwithahandfulofbiotechwithnoveltherapiesand

platforms,whileModernawasdraggeddownbyshrinking

COVID-19vaccinesales.

Mid-CapBiopharma’sBiggestWinnersAndLosersOf2024

SummitTherapeuticshitthestockmarketheightsin2024,alongwithahandfulofbiotechwithnoveltherapiesandplatforms,whileModernawasdraggeddownbyshrinkingCOVID-19vaccinesales.

Lastyearwasfarfromvintageforthe

biotechsectorintermsofstock

performance:theS&PBiotechnology

SelectIndustryIndexrosebyonly3%in2024,andlaggedfarbehindthe25%

achievedbytheS&P500andbigtechfirms,whichhitrecordhighs.

Nevertheless,therewereafewstarperformers–andnotjustonUS

Lastyearwasfarfromvintageforthebiotechsectorintermsofstockperformance.

exchanges.EvaluatePharmahascompiledatop10ofthebest-performingstocks

acrossmid-capcompanies,aswellasthetenfirmsthatsawtheirstocksinkthe

mostoverthe12-monthperiod.

ClaimingtheprizeofbiggestsharepriceincreasewasSummitTherapeutics,whichsawitsmarketcapgrowsixfold.ItsstockwentthroughtheroofinSeptemberwhenitspartnerAkesounveileddatafromtheHARMONi-2trialofitsdualPD-1/VEGF

inhibitor,ivonescimab,infirst-linenon-small-celllungcancer(NSCLC).

Ivonescimabbecamethefirstdrugtoachieveclearprogression-free

survivalsuperioritytoMerck&Co’santi-PD1,Keytruda(pembrolizumab),inthissetting.

SummitmustnowreplicatethesuccessofthisChina-basedPhaseIIIstudywithaglobal/USone,andinvestorsare

convincedthatitsmanagementteam–whichpreviouslyworkedtogetheratviaPharmacyclicstobringBTKinhibitor

ibrutinibtomarketwithJ&Janda$21bnbuyoutbyAbbVie–canachievesuccessagain.

ItisnotablethatAkeso,listedontheHongKongexchangeandholdingthe

Claimingtheprizeofbiggestshareprice

increasewasSummitTherapeutics.

Chinarights,didnotenjoythesame

magnitudeofuplift,itssharesrisingby

onlyaround50%overtheyear,

underliningtheimportanceoftheUS

marketandUSinvestorsinfuelingbiotechstocks.

InsecondplaceisJanux,whichsawits

sharestakeoffwithhighlypromisingdata

fromitsinprostatecancertreatment,JANX007.

WhiletherearemanycompanieslookingtodevelopT-cellengagerantibodydrugs,Janux’sdrugcouldbebest-in-classfor

safetyandefficacy,basedonits“masking”technologywhichblocksactivityagainsthealthytissue.

ThecompanyisnowmovingJANX007intoPhaseIbexpansiontrials,with

updatesexpectedin2025.

CanBayerStopTheRot?

Onceaformidablebigpharmaplayer,

Bayerhasbeendraggeddownby

strategicmisstepsandevaporating

investorconfidence.EffortsbyCEOBillAndersontohackawayatdeadwoodatthecompanyhavenotyetinspired

renewedconfidenceinthefirm,andits

sharesdeclinedbyawhopping25%inNovemberafterthecompanywarnedaboutfutureearnings.

ManagementwillhopethattheexpectedUSapprovalofelinzanetantforvasomotorsymptoms(hotflashes)associatedwith

menopauseandmarketexpansionforitsprostatecancerdrug,Nubeqa

(darolutamide),willbegintoturnthingsaroundin2025.

TheoutlookisperhapsevengloomierforModerna,whichwontheunenviableprizeofthebeingthecompanywiththe

steepestsharepricedeclinelastyear.

Unfortunately,thattrendhas

only

continuedin2025

,withitssharelosingafurther20%sofar,afteranalystsat

MorganStanleysaidthefirm’sCOVID-19vaccinesrevenueswouldshrinkagainthisyear.

WhiletherearemanycompanieslookingtodevelopT-cellengagerantibodydrugs,Janux’sdrugcouldbebest-in-classforsafetyandefficacy.

Beingoneitherthefastest-growingorfastest

decliningstocklistsmakesacompanyapotentialtargetforabuyout.

Othercompaniesonthelistwereless

victimsoffundamentalproblemswiththepipeline,andmoretheexcitablenatureofinvestorswhenabuyoutcouldbeinthemaking.

LegendBiotechsawitssharepricerisesteeplyinthesummerwhenrumorsofapotentialacquisitionbyitspartnerJ&Jemerged.However,whennooffer

materialized,theexcitementturnedtodisappointment,andLegendendedup42%downattheendof2024.

Beingoneitherthefastest-growingor

fastestdecliningstocklistsmakesa

companyapotentialtargetforabuyout–thoughoncontrastingvaluations–and

analystsexpectbigpharmatobemoreactiveinthisfieldthisyearthanlast.

Evaluate.

anorstellacompany

OnlyHalfOf2024,s

Biggest

Launches

BelongToBigPharma

JustahandfulofBigPharma

approvalsof2024aretippedtobemulti-billiondollar

blockbusters.Eventhoughitisstillearlydaysforthesedrugs,thepullofM&Aislooking

increasinglystrongforbig

pharmaasmoresmallerfirmsgoitalone.

OnlyHalfOf2024’sBiggestLaunchesBelongToBigPharma

JustahandfulofBigPharmaapprovalsof2024aretippedtobemulti-billiondollarblockbusters.Eventhoughitisstill

earlydaysforthesedrugs,thepullofM&Aislookingincreasinglystrongforbigpharmaasmoresmallerfirmsgoitalone.

Ahealthytotalof61noveldrugswere

approvedintheUSinthecourseof2024,butjustahandfuloftheselookcertaintogeneratethemulti-billiondollarsalesthatbigpharmaincreasinglyneeds.

AnewEvaluatePharmaanalysisofthe

top-12mostvaluabledruglaunchesfromlastyearshowsthatjustfourareexpectedtoearnover$3bnayearby2030,andjustoneofthese–Merck&Co’spulmonary

arterialhypertensiontherapy,Winrevair

(sotatercept)–ispredictedtoexceedthe$6bnmark.

MostalarminglyforBigPharma

companies,onlyhalfofthetop-12belong

tothem,theothersixbeingdevelopedandlaunchedbysmallorfirst-time-to-marketbiopharmafirms.

Onedrugthathadbeentippedfor

approvalin2024wasDaiichiSankyoandAstraZeneca’sTROP-2targeting

antibody

drugconjugate

,datopotamabderuxtecan(Dato-DXd),innon-smallcelllungcancer(NSCLC).However,feedbackfromtheUSandEUregulatorsaboutitsPhaseIIIdatainnon-squamousNSCLCsawthe

companieswithdrawtheirfilingsininNovemberandDecemberrespectively.

Thepartnershavealreadyre-submittedittotheUSFoodandDrugAdministration

Whetherornot2024willultimatelybeavintageyearfordrugapprovalsisnotyetclear.

forthesmallerindicationofpreviously

treatedadvancedEGFR-mutatedNSCLC.AnFDAdecisionisexpectedlaterthis

year,butDato-DXd’speaksalesforecastsinlungcancerwillnowbeadjusteddownfrom$5bnby2030estimates.

StillTimeForForecastUpgrades

Whetherornot2024willultimatelybeavintageyearfordrugapprovalsisnotyetclear,however,assomeofthemost

successfuldrugsonlyemergeassuchafteryearsonthemarket.

Anumberoffactorsoftenmakeayear’scropofdrugsappearlesspromisingthantheywillultimatelyprovetobe.Analystsoftentakeaconservativeapproachto

forecastingsalesfiveyearsafterlaunchor

peakrevenuesanddonotinitiallyincludeadditionalindicationsthatcanbump

drugsupintothe$5bnandaboveblockbustercategory.

Thismayapplyparticularlytooneofthelisteddrugs,AkesoandSummit’sdual

PD-1/VEGFinhibitorivonescimab,whichlastyearbecamethefirstdrugto

outperformMerck&Co’s

Keytruda(pembrolizumab)inapivotaltrialinnon-smallcelllungcancer(NSCLC).

ItisincludedonthelistdespitenothavingnotyetgainedUSFoodandDrug

Administrationclearance,asitgaineditsfirstglobalapprovalinChinain2024(inEGFR-mutant,non-squamousandinPD-L1positiveNSCLC).Consensusestimatesof2030salesremainlow,fornow,at

$2.2bn,althoughsomeanalystsaremoreupbeat.AnAugustinvestornotefromH.C.Wainwrightpredicted$7bninsalesin

NSCLCaloneby2027,withpotential

additionalapprovalsintriple-negativebreastcancerandcolorectalcancer

potentiallyaddinganother$5bn-6bnby2029.

Nevertheless,replicatingtheoutsized

successofcurrentpipelines-in-a-productblo