Earnings call transcript Q2 2023

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Operator

Good morning and thank you for standing by. Welcome to the Legend Biotech Reports Second Quarter 2023 Financial Results. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

to Investor conference Relations like Yeung, to now of Head and would turn over the Jessie I Public Relations. ahead. go Please

Jessie Yeung

Good call today Head Yeung, review our Relations Thank is XXXX Relations to for This performance. quarter you conference Public Biotech. at of our joining second and Legend morning. Investor Jessie

call today's are CEO; on Huang, me our Lori and Joining Ying Macomber, Legend's CFO.

we will for call open Q&A. the remarks, up prepared the Following

Europe for joining and Officer, Q&A We have the Gavel, of US Commercial Chief and Guowei Steve Development the Head session. Scientific Fang,

During we are be cause you be of encourage Investors forward-looking subject SEC are differ or making to results and statements read found in may under company to the forward-looking expressed materially discussed actual our today's filings, that implied greater will which call These in our section can statements website. here from those we risks which and our within. to uncertainties detail

the will you Ying. turn and I call Thank over to now

Ying Huang

us morning, today. Good for everyone. Thank you joining

very of quarterly basis We our with a on had to the you latest with corporate first today's sharing excited we're a starting call. be have and developments year busy half

past milestones for the have of to number accomplish the six critical years incredibly teams our months, a worked Over have stage company for decisive hard come. growth set for that our to

as foremost, reported by XXth. our have and you First seen, July may partner J&J on

sales $XXX $XXX in sales Our a in the the million of first million quarter total second XXXX, approved of CARVYKTI to therapy of amounting first generated XXXX. in half

increase daily capacity. to a anticipated, for was made quickly by the lot performance and able continued in which our ramp improvements strong strong our demand slot meaningful product a more quarter in our manufacturing driven were continued up than exceeded processes. expectations, our we We and The in

launch very the efficiency increase ongoing who of by second in treatments accessible XXXX. available CARVYKTI progress and eligible and pleased improve commercial in are capacity remain our investments to our to patients the to and committed for making made We're through half

continue that needs. including our portfolio in find the patients populations. and development clinical novel relentless program CARVYKTI to and investigates additional our demonstrate of success unmet pursuit patient pipeline, for We therapies company of results with our in strength the CARTITUDE These

the of from year, Phase study in investigating III three prior June, treatment. new This in lenalidomide-refractory one Society Oncology presented Clinical American we patients to meeting our CARVYKTI at relapsed of and lines data with CARTITUDE-X

to and European this reduced In study, risk the standard-of-care that The Hematology death the of CARVYKTI were published New data presented XXXX progression compared at by Association Congress Medicine disease of Journal the or in later also XX% regimens. England month.

CARTITUDE-X a Based Agency the the as US after on first variation for indication myeloma earlier CARVYKTI II partner Biologics Medicines multiple and Food Administration treatment as submitted data, supplemental European to relapse. application License the Application a our in for lines to use Drug the of expand to Janssen and Type early

to patients see We're We of the their lives provide the are encouraged treatment myeloma plus and by earlier excited plus crux its journey regulatory in from by potential submitted results options two study. to four have of for new applications landscape and ongoing CARVYKTI lives. expansion to CARTITUDE-X as the treatment the

the closely forward we around to working We regulatory world the expand authorities as to seek look indication. with

access April expand to centers quarter additional clinical to we efforts novel part three-year treatment of this capacity XX added and manufacture our contract doses a efforts ongoing improve of efficiencies, part and with to while of As this as therapy. our in Novartis manufacturing capacity, expanding additional to signed CARVYKTI

addition success tumors. In we're advancing solid also CARVYKTI, therapies our our with to of for pipeline

for in patient small-cell our we lung in therapy orphan were to site a Administration for LBXXXX Drug DLL-X, US investigational branded This open which recruitment. able to drug trial quarter, the US and Food prepare cancer and targeting designation the

US first our of one patient We track. our progress trial in look program Claudin we anticipate to soon. recently in programs, We tumor two quarter these opened the across targeting programs dosing the forward the reporting the and solid in future. clinical this Another cancer solid on sites also gastric of on progressing for XX.X LBXXXX tumor in is second both

equally finally, positions financial promising XXXX. our And our outlook us execute is to and through plans

able exercise warrant, a data, deposits On and the our strong $XXX investments CARTITUDE-X registered cash, bringing quarter placements, through at cash in $X.X direct heels million the in approximately our offering, of quarter-end. the of were we a to proceeds gross private equivalents, to billion raise and

CARVYKTI this the and quarter, II CARVYKTI we of FDA achieved development of of million $XX for Janssen the and a and part milestone collaboration with and Further, programs, acceptance $XX CARTITUDE application for US received the acceptance another clinical our million of Type sBLA CARTITUDE-X. the for payment as milestone the

key continue additional reach additional We see from to and as revenue data we milestones. CARVYKTI regulatory

pivotal myeloma. and PhaseIb/II. and treatment, or CARTITUDE-X ASCO year the to has made six, our which myeloma. relapsed and years Meetings presented data continues show to a was therapy safety or relapsed refractory of responses multiple refractory slide, adult Turning multiple pre-treated analysis the that sustained EHA option with demonstrate after These CARVYKTI heavily with next patients leading study data the in a slide patients both this that for from efficacy showed at deep final Annual durable

follow-up belief is from data longest the bolster year our that the presented. five these CAR-T At encouraging and addition, follow-up, are paradigm-shifting LEGEND-X therapy. CARVYKTI is data or follow-up any BCMA-targeted by therapy. were five-year a It cilta-cel In cell

Moving seven. slide on to

Food a for the line one with includes Administration proteasome to relapsed lenalidomide-refractory and As I recently submission The who US expansion including CARVYKTI. of received treatment the have biologics myeloma immunomodulatory the earlier, of of application multiple label mentioned application we inhibitor least Drug therapy, announced expand to for the agent. supplemental adult patients at and license and the prior

approval. FDA hope Xth, April filing a filing, XXXX. has FDA date to to two therapy now the sBLA multiple assigned four PDUFA this CARVYKTI accepted myeloma lines into of this With we of move subject to in setting and prior

In for not is to plan we're enrollment quarter enrollment in we intended which in to of Phase fourth CARTITUDE-X by ongoing of XXXX. our complete end III Furthermore, transplant of trial the CARTITUDE-X study whom planning the newly-diagnosed this initiate of year. evaluates cilta-cel clinic, first-line patients

to and was sequential eight. driven with quarter-over-quarter slide, CARVYKTI sales Next and out-of-spec of rate. $XXX We're higher continuous second in that million market high-demand physicians from availability by slide $XXX penetration report pleased patients, The XXXX, the lower US in EU. net and of consisting of in in US quarter primarily the XX% $X growth million million slot

June active As of treatment the US number was of XX, sites XX.

our pipeline continues ongoing last In our our in for our second proprietary trial see we quarter. clinical to second site advance our in team US. in the the will you nine, the slide One quarter, opened trial program clinical R&D DLL-X US, first

In China. addition, IIT patients I Phase programs being of a enrolled number dosed are in of number and a in

our now over to Lori go our will call turn to the I over financial more quarter CFO, second Macomber in detail. performance

Lori Macomber

Ying, good and Thank everyone. morning, you,

Ying over sequential sales, XXX% As the $XXX performance quarter, growth our CARVYKTI very quarter we representing million XX% in with this growth product and of of the XXXX. commercial second total a which are pleased mentioned, generated approximately

outlined total ex-China we reminder, million in quarter losses $XX.X second consisting with equally revenues achievement were million revenue, the and the revenue for Plan Development the all as As of for Starting of a sales CARVYKTI the with million from in revenue share Agreement for in-license milestone during quarter, our of the and $XX.X of the partner cilta-cel. Global Janssen in Janssen. a CARVYKTI collaboration profits under $XX.X

million a $X.XX loss or million per or the ended share XXth, XXXX, June period for of year. net three months share $XXX.X per was loss for Net of the same compared last $XXX.X the to loss $X.XX loss

or $X.XX compared to XXth, $XXX.X For per June six ended million a the six XXXX, of a the per net a of loss net share XXth, loss share months XXXX. months was June or $XXX.X loss ended for $X.XX loss million of

expenses Agreement XXXX Research under along revenue $XX.X for collaboration XXXX revenue for Moving for onto Collaboration $XX.X the were in expenditures to capacity expansion. compared the to million with last cost-of-sales connection last was same-period second quarter second million $XX.X manufacturing the portion year. for Legend's million are cost period the expenses. of $XX.X quarter year. Janssen million support These the collaboration same compared and to development with the of

$XX programs. pipeline higher programs for and enrollment patient III cilta-cel clinical increase our Phase for year-over-year of for development to other million activities is due increases The in R&D

our functions the to financial same related for fees three compared million, of XXth, months expenses administrative ended last period non-reoccurring of continued of along building XXXX company's $X.X and financial Administrative the increase were further $XX.X is and the global statements. IT historical its with for for restatement June $XX.X primarily in The investment million infrastructure the legal build-out million year-over-year year. to

XXXX, expenses was in XXth, CARVYKTI. months Selling primarily decrease last for $XX.X year-over-year expenses launch for three million and The year US the the incurred same first ended the to last June to period due distribution of compared non-reoccurring to of launch support half year. $XX.X is the million

our To balance spending we up, continue a remains track strong sheet. to on maintain wrap and

we extending XXXX. cash $X.X runway in deposits XXth, had June our billion cash equivalents, of As investments, and and through

now closing I you. back will Thank pass for remarks. it Ying to

Ying Huang

the Thanks, year this thus performance encouraged very in closing, Lori. we're far. by In

execute, programs. continuing while to supply to making to tremendous bring continue teams clinical to patients more progress Our our CARVYKTI

runways fund We now have across operations XXXX. balance plans to We our all business. range areas throughout carry out long cash to the a healthy cash of have sufficient

capacity, across which do manufacturing frontline centers ex-US, we studies our invest Activating by facilities ramp X with treatment continuing progressing more will the ahead, in up. the priorities Looking studies. include our to FDA US and and increasing and to our CARTITUDE-X working in

our to the steadfast advancing of remain least, full pipeline potential programs. We commitment CARVYKTI. in not but Last our capturing

reliable availability working Our are tirelessly this teams product globe the to and consistent continue momentum. with enable to across

thank effort. to than globe across like to this dedication for would XXXX take members I their the and more team opportunity the Legend

facilities I by a Obelisk operational this Ghent, our be close Before for production Belgium clinical the of we XXXX. earnings will picture in anticipate close end today, of is which

call We your will for open the up questions. Thank now you.

Operator

[Operator comes question Kelly Instructions] The Jefferies. with Shi from first

is line Your open.

Kelly Shi

is questions. is and products? project when line CARVYKTI to accordingly this I'm you. specification approval progress on line. lines first fourth taking Congrats early the limit, for expecting My Thank expect earlier And from rate for thank higher you should regarding the gets improve rate. out-of-spec second out-of-spec question my we curious, Legend

Ying Huang

for Kelly. Thanks Hey, the question.

about Ying. is I'm answer out-of-spec. questions this going your So to

the not in very and work we're close First higher done last after than to labor out-of-spec current our six the have trending we down the very of rate competition today and rate happy is months, rate. really XX all report to much out-of-spec to that continuously all, our

lot effort spec our the through happy, made CARTITUDE-X answer from analysis over FDA progress our correlated we're convince agency, Thanks your the in submit spec secondly have operations provides widen the comprehensive pending a We that then a application. teams. from Legend there. widening our package of to a we get received June And to in about So the to that data label. approval, question on sBLA filed the believe the to do we we so when FDA wider agency the the CARTITUDE-X we approval to we if when did spec

down months expect current meaningful be from here. We another rate rate the out-of-spec should out-of-spec

Kelly Shi

much Thank and you have I -- also very

Ying Huang

have lot So made perhaps a we --

Kelly Shi

Sorry. Go ahead.

Operator

next comes standby question. Please The Stanley. Flynn the from question for Terence next with Morgan

open. is line Your

Terence Flynn

always for half so increase Great. the of there obviously still maybe a slots much second two about it the second comment the myeloma. until at ASH can then Thanks you steady event was should relates me. wondering more for year. in the cadence to is an taking just I my of state all expect big we the if one And Conference XXXX? questions If in or

if you a Thank you. submitting. of plan preview wondering guys might any that data give on us you Just could potential

Operator

one Standby please. for Please moment standby.

Lori Macomber

Hi, Terence.

for question. you this So Thank the Lori. is

you're ramp but to QX, know, up So for see you the that see realize quarter. we capacity the step got from going the QX. -- the of we that as didn't half cadence a a We full year, second for will you in

in So you ramp. and will we'll in QX step-up see a continue of QX somewhat that then with

Ying. over Regarding the turn question, that to ASH I'll

Ying Huang

Hey, Terence. the for questions. Thanks

made data the disclosure submitted But we think J&J presentation given really not ASCO was the policy, with EHA. and at initial consistent CARTITUDE-X I on comment do So abstracts.

some from coming than analysis published. the probably subgroup tuned stay Thank are more Other expect that you. until ASH should abstracts You CARTITDE-X.

Operator

comes question Please with next Barclays. Gena standby for The Wang the next question. from

line open. is Your

Gena Wang

taking Thank you for my questions.

balance -- question trial between the first -- regarding the between manufacturing clinical balance commercial versus the is The patient. enrollment the

review at would half sure the you manufacturing to the and regarding active since sets another not limitation XXXX, standard confirm is be 'XX, move slot year-end Novartis this a wanted second in also an a or we'll current make just have site you AdCom. by announced each quickly do to the Belgian US, site. expect initially XXXX. CARTITUDE-X Xth, sites So want And Belgian question regarding And a still April of site do you active sites for would the by and you just to PDUFA, then

Operator

standby. Please

Ying Huang

Thanks Gena. I'll I'll question. first third ask for answer to answer morning, and Good Steve the the question. and the second the then

first year. yes, your do CARTITUDE-X facility expect And enrollment we're start of we first up stage timing on question, to the Ghent of this end of our come for by to our facility. basically Belgium, Ghent, So our online for fully online the coming around planning

standard this So CARTITUDE-X the track can't under from comment PDUFA on review. to at on terms your is third start point, dates, for And I Novartis question say, Xth, that at Ghent can Steve? we in April is I yes, of tech on suffice this will clinical activities. XXXX, confirm production on date facility. transfer PDUFA and everything but then related our point

Steve Gavel

Yes, Yes. to with do question sites. the allocation so had for Thanks.

you're correct. So

here continue And on launched foreseeable the an we So be allocated an model to in for future. in allocated model US. we the

we what have to improvements. our recently did However, do significant out-of-spec continue as

We concept a US. also added into the pool

that sites that have, our then into they patient obviously, demand. We go of can level have additional slots providing

now, we specific open an as within So of allocated we in as approach some bit sites the all US. for being where US, sites hybrid have a right a the well pool have

Operator

Raffat Please the from comes standby next question. Evercore. question for next The Umer with

Your line open. is

Umer Raffat

may on front. for or going the first, be governance and Ying, front Hi, happening? just happening GenScript guys. what's changes can dynamics Board understand remind and us taking not with what the Thanks and we question. may can what's you on If Board my

the a) Secondly, I I year This us, XXXX between in a failure learn we about know And you your patient program. much. when or or the was CAR-T you DLL-X seven did back right you versus months the to have get in first a was cleared last it recruited? DLL-X at lag CAR-T what took Thank also Phase IND eight remind what from filed your is fall now. actually very Can Amgen?

Operator

standby. Please

Ying Huang

Hi, questions. Umer. This Thanks for Ying. the is

So the I'll first about answer board.

we you our GenScript. this members. appointed board board by XX% and is know, shareholder ownership the consistent actually have As has And with three a GenScript equity ten-member held

I representative think three board Board very and shareholder a from the independent we is company and six the because good our do those, mix from have one members, sizable GenScript. productive of of

a doing as between the in CARTITUDE and is six of programs terms well pretty mix terms and very is in advancing the a members. Directors. in the fronts. the board large of think I as So as shareholder of board both the of dynamics, guidance well Board pipeline, can on under And independent that it's good you our CARVYKTI company tell, terms And of

your So second that's question. what first was the question, And Umer?

Umer Raffat

around the question CAR-T was second My DLL-X project?

Guowei Fang

Fang. Guowei Amgen's second to is, is comment can the the This Yeah, regard with on DLL-X I CAR-T question therapy. targeted that

one And in DLL-X trial. clinical CAR-T them As different we product has two that of autologous Amgen therapy. know target was

product. the Based substantial stopping tested autologous tried is bispecific. patients decision CAR-T could benefits provide DLL-X in product patients. autologous to antibody. DLL-X They cohorts. two gave CDX their on actually targeted portfolio patient. their based CAR-T second response. dose the very is the on Further, patient CAR-T the that targeted on durable several solely think in One about We prioritization. focus development DLL-X one Amgen's talk We on I'll therapy They've Second a communication, CDX the in bispecific decided to

cell therapy need, highly perspective, ideal disease an blood successful targeted -- know to the in in autologous a is target damage. aspect cell we is And is this that specific for with disease solid a the this biomarker perspective, of of in as some is target a unmet medical from from for First, similar highly very this CAR-T very indications, neuroendocrine DLL-X tumor cancer. also

All each of that targeting specific them biomarker.

design of different Amgen's quite product the DLL-X is Our from product.

of terms overall of First, unique CAR binder, the in a we structure. in terms cost architecture of have design

the a side are being R&D and unique we forward. our is we program armor -- activities two program be currently created by R&D moving Secondly, And and actively this adding have mechanism.

Ying Huang

want US is clinical this in noticed maybe IND Umer, to probably that first-ever the fact moved the and into without conducting a Ying, is have And, DLL-X this, the study China. first-in-human add we you I program

believe in the IND do very Thank from think we to at data promising you. why competitive from DLL-X into Phase Amgen That's the that validated recently. So study shows data bring I And clinically somewhat this risk. decided actually II that's target. we

Operator

the next The next question comes with for from stand Please by Yaron question. Werber Cowen.

Your open. is line

Yaron Werber

well. taking morning, good my for thanks questions as Hi, and

like? had your it's up Can CAR-T a a when any it in your of So, both more actually looking like supply? competitors coming you just sequencing-wise? have some it was little seeing about your to and capacity And what how seeing out-of-spec talk you we're looks you. seeing impact as and they that market? on overall is you seen exactly demand little you what from they're backlog the your extra demand to for Have your now going and bit capacity. are Are And TALVEY demand? QX demand-driven TECVAYLI Thank you position, Ying, J&J from still bit than ramped is you

Operator

Please by. stand

Ying Huang

Yaron, answer this ask Steve? Steve the I'll colleague thanks my for question. to question.

Steve Gavel

release Hi, especially thanks, just we've has this imagine And in Ying. can out for you done cilta-cel. ASCO coming research We've CAR-X seen increase as lot the of Yaron. space. but of data. nothing Yes, demand with done Yes, opposite, market the of a

and has and or should we're backlog bispecific it's in there plus, demand when market. say reduction our the should But to we not at front, risk on we any population. lines in mentioned, of your of, have the a sure, later-line especially this a near in queue, lines has we meet are in launched, in fact been all entry lessening population high the of the terms that question, line there of But the I particular out in of in terms of driven opposite into demand seen launch seeing mostly, these term since earlier So just our very in largely inability these get the indication for to sure been the of late for second that's treatment, seeing, terms unfortunately just you we like the that especially treatment strong, gate. in been in demand

Ying Huang

maybe And frequently. of that confirm I starting very this to I Operations, year. add to January can I that want talked Head Technical our Yaron from of

change We not meaningful in in for backlog backlog, our to process. seen any have of at terms all our manufacturing the operation

Steve Gavel

I I bispecifics, I a me knowing just so second question was think didn't. Yes, that. that around didn't there on -- let address

the what's a it happening question and think So had market also Janssen. I I related in to think to do bispecifics the was question with

the So reaction CAR-T what a get to as Again, clearly to very bispecifics we're therapies. the to constraints our is that we're working it's seeing manufacturing around bridge under. in

used is and reimburse for have options, in importantly for i.e., once different bridge maybe a therapy number commercial insurers a I a cilta-cel. bispecific bispecific is situation, approved. patients good So a key you've very sure, of to bispecific able point continue for prior good think recently this patients for therapy bridging is US also that to the these if to this is or a CAR-T CAR-T cilta-cel situation most the and seen Again, this to very to that whatever from obviously is in a be a bispecific being

that again used. this to efficacy speaks the overwhelming even a with for when that therapy is we're So BCMA seeing prior program,

Operator

Timashev RBC comes next next for question. with standby the question Capital. Please Leonid from The

Your open. is line

Leonid Timashev

slowly back potential line. it them Congrats for fourth on how review going the second priority be the line hearing line and line Hi, and of loss to on given they launch about and starting launch fourth more the the or or in move line progress fourth I able of line to you backlog expect and my the to And launch ground going might Thanks. the to thanks the data you second are are any then and CARVYKTI second the readiness create becomes as fourth the jump require to what about guess when thinking to in second guess third potentially to well. for physicians would related I impacts to will taking that, straight timing up are this the which guys. indication, available a using you guess strength supply? I to question.

Steve Gavel

Steve. Hey, Why the Leo. I answer question. Yeah. right. me, it's go and your don't Excuse It's ahead right question,

models the of is our seeing in high what what the are -- regardless in risk I in very therapy, made earlier and I the we're showing the this response is population, what mentioned just line particular right. and showing So quick adoption of research

anywhere XX% I'm and working in models, particular, is sure between deemed line -- particular second line of XX% you're your in risk. population noticed at be setting, So second that probably to to in the we high between

we're the much presented, Our go is that later you And population as of research very is you our therapy, cilta-cel. use aggressive for how very well, more on we telling US is physicians us see that's that clearly lines the of in data as based this population the of in a that a modeling cilta-cel. treatable

said, high see we risk this very board high you So that's but the And in will population we across like the you have see are this you'll particular approval. use use for from in how our perspective, product. once modeling

Operator

from next next question standby Capital. question. The BMO Kostas Biliouris Please with for the comes

Your line open. is

Kostas Biliouris

and us. Congrats taking questions. the for questions thanks on our from of progress A couple

quarter The for similar ABECMA XXXX, of which sales generated sales, second Lori, of one your first the the XXXX. US in was in quarter first to

a which that, recently Given at a Can of timeline would their second sites your in was at you XXX you. of to quarter maintenance maintenance Thank and all? need BMS the the wondering has and you is this XXXX. your discuss Bio ABECMA you profitable question likely that will type profitability? And one the I first at product need also revenues. frequently how announced impacted manufacturing site if was of manufacturing

Lori Macomber

question of our So profitability. sales regarding the Hi, Kostas. you How are doing? and

gross as know, know, volumes been our is frontline and have of continuing particularly we're steadily manufacturing bulk the our significant standpoint Overall capacity. trial ramping collaboration we've As profitability, increasing our improving. in been as studies make into from up investments you a clinical margin you to

So while on see in QX for a standpoint, be the as it But overall making before gross we're program a will strides margin the side. profitability significant saw from we program. still you

Regarding the question, repeat second can I'm sorry question. you the second

Kostas Biliouris

second to maintenance. the do question The has with

So XXX some maintenance revenues perform Bio of BMS if per all? whether their and your and maintenance will frequently down at quarter Thank The sites, manufacturing at this of also sites CARVYKTI one at slowed need impacted. production you to at the and and ABECMA manufacturing ABECMA, point I was you. would wondering that, for need you how

Ying Huang

this Ying. is This question on maintenance. the you from of Kostas. Hey, I'll take part

as are every know, this kind FDA of required manufacture you for So to year maintenance. aseptic you GMP any by do

all. going However, and the to teams facility we'll we're very from a shutdown in not Janssen do all smart our from at different we which Legend operation suites. a the approach New to have take is, rotation Instead, Jersey, decided

So, wouldn't yes, every revenues do going see much quarter-over-quarter six aseptic run. it really called so the months, so decrease we have to affect to the here. that But you're simulation will

a obviously we're to rest year. Thank for confirm. facility So of conduct the all we say, just of this But planning and not margin aseptic processes we the you. suffice required to the are planning for shutdown will the

Kostas Biliouris

Thank helpful. you. Very

Operator

Zelin from comes Justin Please the next The BTIG. standby with for question. question next

Your open. line is

Justin Zelin

outpatient approval question. could the get will you slots patients Steve, you. the just Maybe for if also for prioritized, prioritized And whether you earlier on line in assuming or therapy will how make understand for impact taking an Maybe may whether so be the just high could of risk and Thank progress on Congrats slots. comment you here Hi. lines administration. us thanks help the be the here.

Steve Gavel

Yeah. in prioritizations. slot priorities terms a Hey, of slot or Justin. Yeah,

just things kind in So a maybe but happen, we how how allocate of at terms site. to of happens what rewind and the things couple of

amounts into. allocating we'll increasing to And increases call to all actually we So higher sites we pool make capacity will you I this our be as as as open as well allocations. for get what mentioned

of that of at of terms type, criteria patients cilta-cel is not sites have now be driven in that know our slot, the end. that terms and basically the In in other terms at types therapies, are so and the in I of site driven will gets these of different -- terms allocation at patient using be site. of sites the who what each what getting will who level

terms In on I for right. question, think of, I outpatient, question get a that thanks

So and larger who've for times, larger this of an you that us get for therapy. those quite as we important know more for some been that's dynamic following indications

the XX% clinic treated So what we're have increase patients seeing about interesting, the hospitals. and use, quarter this an XX% time in are of the outpatient we've our being an a these for is bit in outpatient claims cilta-cel in of that of that the we've within seen quarter-over-quarter first quite seen we've analyzed shown about

we a to quarter, jump quite XX%. second the a bit for seeing up of Now are now

what's you're number down. is seeing keeping is for therapy, less this of also you're for patients time, outpatient our which really from being So dynamic also to and used competitor But exciting have might of CAR-T a the seeing inpatient move marketplace, competitor cost XX% is reasons, for the than the you in happening actually question follow-up the with outpatient setting. our especially

starting more more again you're in we everyone, sure, most for see importantly, the benefits patient. believe play operational market that's believe now and this and So the we flexibility with importantly cilta-cel to we out have

Justin Zelin

questions. the for taking Excellent. Thanks

Operator

The comes with Mitchell Wainwright. Kapoor stand next next question. question the Please H.C. from for by

Your line is open.

Mitchell Kapoor

Thanks for the everyone. taking Hi, questions.

on virtually we the wanted be could issue next just expect could the not secondly, for I to anymore. you XX just this timelines, XX out-of-spec and you. Thank then to months. an comment Firstly catalysts when comment broadly on rate And if you earlier the pipeline the could

Ying Huang

Hi, for your Mitchell. This Thank you is Ying. question.

in right. industry to two example, a then is XXs Novartis workstream, XXs, There's originally Novartis, one paper but demand in that the improvement the public out and one after quote the rate high I'll which was out-of-spec, X%. on now about years or So reduce describes in there able to about to OS Kymriah of was probably that the

So also the done to Legend hard really meaningful this and own experience can our the in very also and and do. obviously, we significant year work to from see able to the also from were teens. last And Janssen the now lot be and we teams work OS in our our beginning of work a of optimize the reduction in continue stream can and we there's a launch

that a As the can get of previously the a we part wider to from call, I data. the release this data back mentioned of have agency the as submitted agency we do sBLA we expect in on CARTITUDE-X lot and

So very the a to single-digit, in rate. middle we that out-of-spec to happens, that And goal rate. to reduce low is eventually our meaningful out-of-spec single-digit when reduction expect low

expectation, date planning XX end So too. terms CARVYKTI. question we're what increasing of the Xth, is towards by the that's working that's XXXX. FDA this number PDUFA depending in of to another approved of our part your capacity, the And year to to April terms supply get on continue approval facilities line for and that'll your by only priority second work then X the the of in our months, indication launch to second next we of On FDA we we're our of increasing our plan obviously, first one

Raritan, meaningfully year our stage of working Belgium from end online in will expansion we're in And with coming So know, up will also opening the facility in And Raritan you Kent. Kent. capacity we're CMO third-party Greenfield work then of large doing our our next expand been facility as expect first to network. we and By be we've 'XX. from increase

in to we to into capacity So We're by come that the And next of at XX,XXX have doses of said a annual or point achieve previously of all this also XXXX. funds. track much crystallize aspire end effort will on an the goal very capacity given in our up years. more with progress we this higher much couple construction that the and other

us probably next important that's the what's really in priorities months. catalyst So X or most XX for to

Mitchell Kapoor

you. Thank

Operator

standby next Sami Please Blair. The Corwin William question. from the comes next question with for

open. is line Your

Brooke Schuster

Thank Brooke my taking Hi. This Sami. for you on for question. Schuster is

saw you inpatient on setting. any the any you community security challenges academic in could color if We in outpatient if are or reimbursement And wondering like provide comparison versus reimbursement. versus to

Steve Gavel

answer Brooke. all to-date, the second cilta-cel quite -- positive. reimbursement a lead really as plus open from very again. indications Steve access of no. The -- are enjoyed line perspective. we Hi, short as reimbursement It's indication, The into has is And

As because of modeling of you when a -- of fact, like cost potentially we've cost long-term it value a at that the cilta-cel the look matter done insurers value drug in terms reduction. love has containment capture potential

our reimbursement the not now very us. been right a we important continue problems really future. any to that no it's area, monitor obviously, one foresee has date, So we'll in don't problem for But to

Brooke Schuster

Thank you.

Operator

for standby Please next with comes Goodwin Kelsey the The question next question. Guggenheim. from

Your line is open.

Kelsey Goodwin

my what on just question, communication morning can to to up? apheresis speed of provide And more I the color you on that from XX building was from last be the guess in guess then And question. Good community? you that thanks and maybe first infusion cilta-cel much. what in guys. I for days, taking done setting? maybe I saw and are referrals terms Hey, seeing time you're Thanks mix median CARTITUDE-X so seeing the could what commercial separately, off

Steve Gavel

time receipts CAR-T around today Sure. the seeing that We're think question most is average, market take you referenced. cycle I'll fairly therapies. with weeks what from is seeing in four to time to between you're on which consistent five the release cycle I anywhere the commercial

I refer might think second Ying. there's question, a over I to

Ying Huang

the Hi, question on CARTITUDE-X. Kelsey. Thanks for

look trial in are for large if end-to-end. were other cycle about confirm that. median believe, So, international outside and US. regions Number the two in was enrolled behind is days of one terms time There Europe XX% that yes, majority, CARTITUDE-X time you at I can the least that from XX to the of at opened the CARTITUDE-X, the sites, I XX% we drivers

of And that. if behind right, therapy outbreak. PVD is So and recall, the supply of the was conducted COVID if obviously, look to you outbreak. clear Difficulty]. at this during because all during That's the major unfortunately customs significantly we care, secondly, either which contribute disrupted or and the COVID chain the time, there's cycle you that the protocol severely had the of then peak to the actually driver requirement [Technical That also was standard really bridging

is commercialization typical, quarter. time Today end CARTITUDE-X. next we a shorter in we you. Thank end And spec for -- samples. reason Steve, can we that another So in from But days improvement make reason time normal confirm about release report we that's end-to-end to that to the the really receipt on can the see XX to you hope the XX cycle continue in to our and we the that a time during just right. than why higher US, the as heard from

Operator

you I and this conference show no thank at participating. today's time. further concludes for This questions call

You may now disconnect.

Legend Biotech (LEGN) 15 Aug 232023 Q2 Earnings call transcript