Legend Biotech (LEGN) 9 Aug 242024 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Welcome to Legend Biotech's Second Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

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

eventful The been quarter an second has one.

sequential pleased are CARVYKTI to XX.X% We growth report sales. in

from More EMA. FDA importantly, and both expansion we label received approvals

in more live are about joy patients multiple myeloma CARVYKTI than we analysis of benefit demonstrated the helping Lastly, second survival CARTITUDE-X. Nothing longer. most by excited the gives us with

Officer; Huang, me Macomber, and on Executive today's company's Joining Officer. Lori Ying company's the Financial are Chief the Chief call

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

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

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

our which to in earnings our we second last presentation made Slide call, earnings multiple am pleased call. welcome see that us. you earnings and Hello, have on X. progress Since you I can could fronts, join quarter on our

therapies. We coming statistically standard First, meetings in and to clinically medical results top prespecified in months. data forward from demonstrated survival set line analysis, this we important compared CARVYKTI significant major positive second meaningful announced CARTITUDE-X. to the In interim at the overall presenting improvement look

data We like published your a study II data new III to bring from CARTITUDE-X and paper study. we Phase would at Additionally, EHA, Phase ASCO recent Nature. new updated and the and CARTITUDE-X to in attention from provided the

in from you median with of and in conjugate, XX see follow-up data engagers with months. The Mayo study at The OS both initial Slide through efficacy the should provides and insight cell Clinic efficacy, will CAR-T CARVYKTI. XXXX, concluded engagers reviewed a We're ADCs. be PFS found CAR-T of XXXX multiple BCMA the demonstrates antibody were that that period into drug of therapy. evidence on the patients to the clinical directive that CAR-T XXX also by and encouraged myeloma T-cell treated BCMA superior it X, As strong efficacy particularly real-world where feasible, targeting the of CAR-T authors of T

to market of global you regulatory X for approvals you this us added The our and the see as opportunity continue Agency Regulatory United expansive recently multiple Slide approved foundation set Canada we many for As market Products approved to a penetration. Healthcare Health CARVYKTI second-line CARVYKTI on our Medicines know, strong data enables well. CARVYKTI myeloma On building note, and Kingdom's X.

efficiencies. the and translated manufacturing the Slide patients increase the increase XX.X% year-over-year, into CARVYKTI from to on versus you globally to quarter is quarter our $XXX effort performance which quarter million, launch bring was second see will second an trade of increase expansion capacity gains a of as result CARVYKTI for sales Our of more shared in net X. The ongoing a XX% first and quarter-over-quarter,

laser the and Importantly, expand our to market available more reiterating growth the capacity. We supply in are focused and pronounced to and for we to continue making for time. half CARVYKTI second more slots demand, continue the add on growth patient van-to-van expectation we of in as reducing see our year remain we

Turning to Slide XX.

anticipate physical Raritan for up expansion in of half has on of the production and the second of U.S. site CMO, begun capacity track This approval clinical Raritan, frees our Raritan XXXX. CARVYKTI to the new Our of the facility in at We're production production New commercial of in section Novartis, Jersey. complete

commercial for facility expansion. The Obelisc our be continued up production are our approved demand. year. We for later us CARVYKTI track production production with will keep increases that expect to our and in than continue on capacity Ghent, growing patient will XXXX this to We doubled more in capacity Belgium help

now I continue cash we expect Outpatient We treatment believe of authorized our needed us marketing to volume balance for which an XXXX community the of stands the medium when runway line as the and more $X.X profit. In us at XX important mentioned, approximately certified increase XX% efforts bring CARVYKTI hospitals treat production, other U.S. operating a just have total provides treatment our and now and achieve us we now to resources in into centers. financial developments, billion, remains Our begin hospitals to to online setting second gives expand we comprises for as as we an patients. beyond. to

to our on I turning to recently that pleased pipeline share am Slide completed enrollment. we Finally, XX. CARTITUDE-X

therapy. it the newly in you state-of-the-art CARTITUDE-X, with therapies. patients also center this planned advance As initial recall, ground Phase whom might multiple study an If XX,XXX stem of CARTITUDE-X and to based approvals to pleased were randomized new recently research not we diagnosed into on evaluates receive Philadelphia cell as cell next-generation on for transplant share translate is III to would portfolio we broke patients additional annually. I'm that myeloma our

activities top cell research gene growing summary, our the Philadelphia, and the We the opportunity and ahead are innovation in eye therapy. In towards presence future capabilities excited against in our of cell of from transformative we commercial therapies. line U.S. biotechnology substantial attract are investment increase talent us to hub the as of birthplace expand we and expand with manufacturing an earlier executing our

the walk over quarter. Lori? Now I turn to would second to call to through like the Lori financials for you the

Ying, everyone. good morning, you, and Thank

during ongoing million driven approximately quarter, year-over-year, net and the have $XXX second share of increase in made XX% As we sales an generated the we mentioned, market for market total progress capacity expanding Ying by improvements. launches, CARVYKTI with

share we profits China in Janssen. reminder, losses and CARVYKTI ex partner, with a all of As equally our

Turning to our revenue.

with agreement agreement potential of collaboration $XXX were the and the quarter $X.XX and the quarter CARVYKTI driven by of license for connection Novartis of June million, $X.XX same XXXX, the other share in of milestones compared period million, As Janssen with total $XX million $XX for and million a with recognition $XX last $XX connection second consisting per cilta-cel, commercialize revenue share develop, you'll of sale $XX revenues loss revenue therapy LBXXXX in year. a XX, ended loss and was CAR-T a million targeting per or of XX, of for million Slide our achieved revenue in to recognized deferred net million DLLX. Net selectively the see loss from loss or on for under to of $XXX revenue manufacture

Collaboration portion to on million for agreement compared the along connection revenue quarter for manufacturing in second of collaboration with XXXX of sales to year. support capacity cost expansion. collaboration period Janssen under was $XX expenses Slide same the These on with million, the cost Legend's of the Moving last expenditures the are XX. to $XX revenue

same and revenue CAR-T develop, to Additionally, quarter to Novartis of therapies development DLLX. Research and are no for These of license selectively and of cost second LBXXXX XXXX, were to the continued in expansion expenses of compared investment million with other is of The and cost months the to in administrative $XX second we primarily for the $XX license for solid clinical our spending last to expansion ended period strong and the $XX including million $X months revenue summarize, million to start-up Salesforce million million quarter research June $XX to X million the year. $XX year. compared was million to the our and to ended other programs. Administrative potential of a due infrastructure for commercialization with $X year. functions in same expenses last sheet. $XX remains XX, ended the second-line to The and the was for for in activities for increase June and The quarter period X preparation. To last the compared XXXX the on costs indication primarily expense second distribution continue compared XXXX, the support with capacity. Selling tumor increased X and June XX, period of CARVYKTI, same manufacturing were the our XXXX, million development June cilta-cel, XX, year-over-year costs of million for increase and $XXX due including maintain due Belgium track, XXXX, XX, to million of manufacture X year-over-year production compared $X or other months targeting XXXX associated commercialize for agreement months balance was XXXX. launch increase of connection for ended costs

closing for Thus, in operating billion and will equivalents, XX, cash investments. capital and sufficient profit. Thank believe into it deposits to our expect back June now achieve to I operating to we begin we pass we we XXXX, to when fund capital have have Ying expenditures of an you. As $X.X remarks.

patients am sum To expansion that reflecting remains our multiple priorities. commitment capacity line. I dedicated pleased second team our share to our myeloma our and our like date, and their to CARVYKTI Lori. serve to X,XXX of we on patients each their dedication also to served launch employees execute the strategic recently our Thanks, families. for to deep we patients to up, commercial thank as in steadfastly would treated I we

about myeloma to like ensure patients. We we it risk, political I has best know position close have team look particularly and this an potential momentum Q&A, we recent we management that our advance help in to business there being assure taking for are as would continue Board Before been election been to our to and up at speculation growth year. you a mission multiple given open our our

And share, the can and I going continue provide on driving this speculate meantime, In your potential the assured, we forward. If ready first not time. your is to Our risks. hypotheticals we when if take our we updates focused call. consider as and to questions. question. of path like keep value at Operator, on assess them on our that, Board focused have active are earnings appreciate for we with the you results. and to we're rest will the would those But we questions shareholder to We're engaged impact on right

Barclays. question Instructions] first the Wang of [Operator Gena from Our comes line from

already we you I major anything cannot also I to on comment I wanted much and don't overhang Ying, can -- stock this know share now potential production? the #X stock. is say know the it to regarding not on much, is color to production a how color do little or know ask second than -- should a level in about is comments. very ask prepare the too do comments, bit rather this the to risk the you address more bit potential Act speculative questions? And more but what Raritan you said process much, in impact July some BIOSECURE country Since regarding you is could you I high fair little Jersey know has comment company but XXX% the Is cannot a clinical Novartis site. site too political I Raritan the to commercial New now, because the a XXXX.

Sure. first. questions. Gena, can thank Maybe your for the second I question address you

So production. Since Novartis right. Plains, in you're Jersey July, clinical has initiated site New Morris

IND first that The coming by CARTITUDE-X, patient and FDA. follows clearance was from the the

shifting the trial the are Plains Novartis we in production now, process right So to of in site more Morris clinical site. patients

However, we have clinical certain the site. trials for do Raritan production in still

commercial Over clinical going go think Novartis in the site the next of that production, production few percentage I trial up should Raritan. months ramping you clinical with Ghent expect the will lower and

stakeholders been of Raritan. And then the have Housepeaker's on say bill ] that [ engaging Washington, have mean, with draft first all, I about committee evaluated also, first can and we office. carefully certain that's D.C., including we and question, So in I your

do at we in any flow, terms of given conduct model be point, this believe operation not also there data business. Legend and is impact direct and IP we our to how the will So how

that, say the bill. the to we're target concerned we're suffice So that of too not BIOSECURE

the Our line next Fye comes JPMorgan. Jessica from question from of

was the is it doesn't this directly should creation? With dynamic I best is outpatient up can it the talk value like across up but that's to and you're does result. stock the company period coming of Can see the you under path be question, are, a as of proportion also just pressure more up? as Gena's potentially make year edges half impacted then say, driving what for Or political the a BIOSECURE, other you did follow increase really about where come Or a what's to look that and wanted recognizing as like the stand-alone in new a now by you XX%, the kind us change? And first shareholder be XXX% in for considering use on outpatient, remind that into just on contentious alternatives? heading the quarter institutions Board, Legend where U.S.? sense at forward Board And the that coming last

I take take Why Steve, it's one, Jessica. don't why the first don't -- I

those coming outpatient, from. do trends to patients where with has outpatient question Your are

you So quarter-over-quarter. asked also

that XX% So last we're trending U.S. significant there's reported so at we as jump the right Actually, a were outpatient to quarter, in opposed XX% up closer outpatient. we XX%, use now to in

where [ that of from, the sites you XX% largely ], see of coming at driving the XX% terms is you to the largely top is U.S. volume we about it that of volume. top the in In look the majority if serve, these hospitals XX% so

or to So board, you key and using, rate academic patient bring see just setting least centers XX to trying board is that to of as spread should at volume I in reps, similar opposed sites CARVYKTI understand the limiter thing new in the to a now. Typically, in large the our is evenly on say, majority the the outpatient a profile for as we've a our right looking on sites throughout just what is seen site it's the registration in setting, outpatient toxicity real-world study. we are they repetitions get

it sure at XX% just that's to now, turn wanted the to make now for We're So over right but spread it's corrected we right out percentage. the how Ying. trending have right I quarter. I'll back

Jess.

been period, has X in as think about for company years. progress I for So we've And a that Legend delivering made company, a patients. tremendous public

from have And recent the both ordering the announced the from data, into milestones. if and we potential also lot in And just what feedback you and production We our the and field. U.S. line enrollment look we also approval numerous in a new at frontline. completed preliminary can Europe of see the there's second the for CARTITUDE-X, book we indication. And another clearly, that entry that's achieved

us. to to believe certainly strategy pipeline we our full And of remain as lot there's that of realize confident growth a we treatment innovative the CARVYKTI and current options. continue ahead potential our in So we of advance long-term also develop

So it's a I or to answer maximize one not create value. think one or shareholder way

this our Board responsibility have mentioned, And I and we of stakeholders. is at other the shareholder as point, with value. fiduciary Although, our investors engaged Obviously, maximizing

this. can about much pretty I that's So what say

question from next the line Our Shi comes from Kelly Jefferies. of

typical therapies, when change on Since second in refractoriness time? performance the and what for use And over baseline see the prior you is regarding received treatment, approval line patient the do status and characteristics how line demand CARVYKTI, second also patients the in early CARVYKTI patient the [indiscernible].

Yes.

terms don't it's cetera. So we're how where is Kelly, use, Steve. et the Why I take the the seeing in of question going, launch

So just remind of launched quarter. we to folks, part the early

really in until you a to see now in starting quarter. the impact revenue from see to didn't pronouncedly late third the more We're start the perspective So quarter. it

of as the the was saw the in that's off CARTITUDE-X lot thing. So first indication performance of A to second CARTITUDE-X. we quarter opposed

XX% indicators, at uptick see, the data quarter. What of leading through that we we're we terms and the the in CARTITUDE-X seeing into portal, some is of about end XX% our seeing some again, average are this right -- are the on portal orders analyzing we between did patient now indication. However, new of of coming measuring to we're our to related through the ordering

-- that's forward. indicator demonstration, what it's a So good big very we moving see of leading hopefully

provide to these to entering did again, that for are purposes, patients. are portal you. scheduling are that want but I These on Now point the not treated patients data

won't these that, will the we'll terms the to of be the inbound month until actual that give what is fact over to this all of indication. CARTITUDE-X able seeing start very, we're of seeing objective our line data towards at coming us in we very patients use. in XX% the are by through the and In channels -- claims that of data, terms evidence least portal we're excited But ordering therapy through see patients, of more exactly end coming see when the

Our of Ash next Verma from comes question the from UBS. line

specific like, to their does benefit an for finding something could XQ CARVYKTI that be is BCMA saw increase on you MNTs And is the comment Galapagos be how in realized that believe one, you Parkinsonism. the this to already? study on make that Galapagos XQ? binder mostly so Can yours? compares more So could camelid-derived first maybe so paused on you that like just CAR-T antibodies price XQ sales additional then that XQ the secondly, dynamics, took, Or the X% And like to also tailwind you compound?

Ash, this is Ying. questions. Thanks for the

MNT this the that happened you the to just coming I [ And watch XX movement launch down sure neurological our been commercial the on BCMA. patients clinic. think the of at So and by went the from the mechanism of obviously, in everyone the It's or one, although the the AR that not what for if second We science with patients, see date. and the reported at from have toxicity, saw X action experiment think first well look elucidated database. In not to you in quarter we program. dramatically CARVYKTI. yes, population CAR-T cases of to it's not data CARVYKTI, from follows cases either, did I'm we And treated coming CARVYKTI we quarter, first FDA just has while same Galapagos ] obviously, increased

safety our here. trials. in the also secondly, in So CARVYKTI very the world the risk really is demonstrated profile working believe about And we in confident and real feel that by mitigation we then clinic well the strategy also

So neurotox here. that's MNT say I and can what about the

question, not reflected in mostly the quarter. the second last second ramp it's XXX% believe reflected, I the quarter, up On the fully was second in although

in So you. Thank continue third to that reap the quarter. we benefit

Markets. Our from from Leonid of comes next Capital question the Timashev RBC line

survival you the of overall obviously, on hit there survival was And mentioned that the advisory endpoint and ask overall to discussion at CARTITUDE-X. committee. want just I some recently you

more you physicians that. just physicians survival of I'm you your there continue about in from see on perhaps the for data? guess, are hearing overall might any label are I earlier this you and to to Did expectation to You what who I going use waiting sense overall sort that lines to guess the this marketing data? CARVYKTI impact and how is of curious importance see were this have a on So strategy?

all ratios I perspective data. what take pretty I'll with right But -- are imagine, actually it's on in as The have, we generally a have our the earlier very board, question that. We're sure to at that. different this you large look of The study be standard excited -- very population lines. tested maybe to this it risk may positive. I'm is has fielded advisory hazard start you to see can speaking, more does data now, Yes, we physicians of the market open mean up and at have that

see. speaking, next yet. an Ying, mean, it. I But don't we'll can we to for out. that We we'll generally answer as So have data take this by you you question. we're enthusiastic very just imagine, once get you read But have the

Yes, teams do JNJ and on expansion. cleaning about of EMA is I'll to and data the which to we the up question, submit have are plans label and on FDA talk we survival other the agencies, part working including the

for So very, is be benefit, meaningful at also clinically the here had we on separation will survival you the meeting major significant and and see at of a hopefully, medical ODAC. And preview very see benefit important. published a soon, data will you a strategically already which which magnitude

through many incurable, As different therapies. given is cycle myeloma patients that you know, still

the very benefit benefit have there, out it's So the survival also of the think will in I a which few meaningful drugs one show a is difficult label. CARVYKTI significant to and on trials. been And clinical survival

to promotion explain going and think the is patients. to even tool benefit late This So when way, by in and line, be very it's a physicians the the the powerful second also the we not we in line.

and differentiation certain to again, competition with rate. CR benefit look care a competition, of compared the we So if also talk huge about factor. that's top survival if PFS might in but at or And you label. think kind the only one things, you of to potentially the obviously, one right, we the upcoming And field, on physicians is be they that considerations

So we global demonstrated really feel strong survival randomized such the about a trial with benefit. good benefit active really, in control

from Evercore comes Jonathan line Our ISI. of next from Miller question the

on the market what already Is second Congrats there, end could on half as between us the all manufacturing progress many Lots of market years? that's diagnosed patients take is to your of expected half setting. second end of lot even all year that guidance you the delta guidance potential for But Obviously, from secondly, even be but news so and more be expansion in of year? And going this coming stuff the patients and to the left end you you you 'XX? to the then X through. went that are here. enormous walk a 'XX through in for a mentioned or What there's done going look manufacturing in to more is if that's newly of covers. here, of than out sufficient manufacturing to ever extensible there cover you

questions. the for you thank Jonathan,

first out the year of I have end end 'XX. to and On between of expect what can one, we this lay the

year, Europe. And we in construction to then we commercial So in also, we're of facility in between have in of time Ghent, now, end commercial production Belgium end by production first our activities by Obelisc. other which And next month our commercial approval we Right first year, called TechLane. the can in September. expecting of then complete called expect facility start should in Belgium by this the this end

production commercial then that, second FDA Plains, expect we start. early XXXX, come we to clinical first have we Belgium in after major Jersey to by then do 'XX, TechLane from here. that, half of sometime approval. And the X the first year after the half, site So start milestones Morris the of to in And half in pending facility the expect next first, in Novartis New also production Ghent,

commercial production expansion TechLane the we expect in XXXX, facility other is start the to of in the the second start First, we 'XX. half upcoming And site in of the to Ghent, second also of expect to Belgium commercial milestone approval production. Raritan gain half FDA

So of this this and year. of is could the between nodes happen year all the end next of cadence different that end

the the in in JNJ, having we ongoing and have first you're very line, our given in second productive discussions line, that, the future where only lot the months launch the opportunities and of terms skeptics launch. I second of is saying line are especially about already also encouraging demand, second in been we Now uptake demand. X know after right, well, how there partner, satisfy can line many a

have the supply. greenfield for We of or we are highest to X tuned. is should the you. engaging with priority being creative alternative the assure And one JNJ and are can future to the construction or in partnership, been other stay our the major we that, of you Thank centers That that partners and Raritan, in and think routes. I today at we includes have hospital notes, of here, and this, brownfield have discuss you all internal terms X we in trying finding second line. for JNJ box out

timing maybe Makes sense. do early you since Where CARs? are just beginning Phase on especially I, to And that single I some those I ask you then And pipeline to targets? When data know the do assets yet. in currently on has relative IND about nobody show expectations for anticipate autoimmune? have the those for can dual of are they pipeline that asked from one question

Thanks, Jonathan. Yes, Guowei. is this

[ U.S. ] and I and IP trials Phase we We have trial. are also multiple having

on initial broad CDXX Phase and of for autoimmune spectrum trial. a targeting Currently, efficacy tested is being XX.X result neurological in expect China I see of Claudin an This trial top targeting safety triple a CAR-T, we which CAR-T IP autoimmune and have in U.S. hematological different we autologous a tumor CDXX, Next CDXX, ] [ year, to in is indications. indication.

The XXXX. we this where clinical first to see year, towards in expect readout we dosed patient QX

As have dual XXXX. some also to we in ] that allogeneic In read data product, multiple are of point targeting. out expect [ you we oncology out indication, those

Thank studies initiating filing, the allogeneic we around IND for U.S. projecting of the filing terms IND-enabling we in product this actively XXXX. are and year, In IND U.S. are you.

from comes Werber Our the next question Yaron TD from Cowen. of line

growth Great. a couple this Maybe questions. just of And nice quarter.

you jump about smaller? but QX, think a sense, have -- commercial? a can much think of you QX like the same right? can you've As to over meaningful And jump or that maybe looks going next over clinical. in of about us how it give then qualification sort meaningful Can QX? for QX Some year, can as still of is of doubling, maybe going ramping Is little QX a supply you capacity, capacity us and obviously said commercial all bit it give that not a is some you of lots be little double you that is to be bit

the questions. thanks Yaron, for

to It's next collect need FDA. can data timing we give process, So I bit for to to a we expect because, experiments, review difficult you can obviously, the on that need and year. next then submit tell around as then, now analyze happen this me exact the first And there's the the you one, we you run FDA ramp-up the data, probably to to end of year little early or imagine.

that have around year. every year growth be end I expect to But in time, this throughout going beginning quarter. year, cannot We that of of specifically it's do XXXX, said of the I general, next QX. sequential we beginning on mentioned, So at like think comment the we

QX. that XX.X% in QX. with growth seen higher expect sequential growth And follow growth have much we again you sequential do from and in up QX hopefully So now

clinical a then capacity, volume the will in of would given that going call say, also that's percentage on on percentage production. And the and percentage. rounds the production nonrevenue-generating of relative stand So our continues right, forward, general, I we higher, where we what the to decline increase as

means into well as commercial detail, if because at overall but double the much we're XXXX. compared roughly I that next commercial look capacity doubling, too go much is will then production looking we So that you at say number year, if capacity, wouldn't production to batch a larger

from Bank. Deutsche next question Shin from the line of Our James comes

post-hoc a as data year, is this unveiled OS of possible have that doubling should gross to When 'XX? expect it will a it my margin capacity, second crossover benefit the in as question, we is CX later analysis? And relates you well

I'll this I'll over -- and answer then question. question, Lori. to your it answer your turn second I'll is answer your to first Ying

have going As the online, see certain nodes, you're in of the in all bringing consistency each do gross different locations, those volume a we're margins. as keep our to margins. you of industry get once ramping in we your as your really level Because with imagine, will are variability can up of be to that But you you're gross to line the in nodes anticipate standards. margins our to on gross

question, James, going survival I'm from not back are able I'm in the survival on to sure the be curve guys meeting March. the [indiscernible] in medical presentation. ODAC from panel But you to a

showed is shape very period, we X between curve, survival survival and very overall, trend that was certain never Not by you the of change. CARVYKTI see Again, after a again not we're every X overall that, as So periods. the this early also really of a so-called curves. the it's will by trial Number consistently in in think the imbalance have the every right? And crossed for see general, guys that over tail, encouraged we I which we're of you after setting. beginning in initial wide only secondly, conduct things. mean flattening single separation overall the very one, there survival curve, I But saw. small did encouraged in when yes, you the

trend. CR run in there's who also very, long patients clearly, that a the very this of in overall terms benefit portion And PFS, is of survival. and a consistent So

for think beat. competition it's hard be I to going to

Our Vikram Purohit from line next from Stanley. the Morgan question comes of

both X, on We CARVYKTI. had

mentioned that you to treat quarter, there last certified patients were think with hospitals CARVYKTI. I XX First,

you data XX. could think by I XXXX. this a where curious this end was of think question of timing secondly, and updates I reported on you sets. morning I had just earlier-line year for then by footprint that go end And also

is the on you from realistic an your completed initial data be when vein, progressing from there? has versus then So think you enrollment, that us enrollment update in ENF data CARTITUDE-X now CARTITUDE-X just and give expectations? cohorts might And expect CARTITUDE-X, could same how to you

Let's take questions. clinical the

Okay.

the it's So I why don't don't I Steve, questions around activation. take take why site --

the right, reported had keep site on forecasting sites. and Again, to patients sites. we sell we something these very year-end, By we is now we're QX, efficient we the be of for that that per right I because in sites, reminding calls, XXX competition around our mind at into. in keep outpatient XX percentage basis XX So the sites in to you're treat setting, are of a throughput is during versus

per So clinical that we please race. going site turn so It's of not questions treat. I'm some releases. that many really of of It's around how a over to mind. much the it the patients keep in site some data

sure. Yes,

are excited CAR-T We So JNJ the about ] survival yes. on and also [ very X survival, benefit.

interim this the We significance statistical consolidated analysis, by they're interim data, bar again, benefit. is survival for [ at also physicians seen our who and physicians, very have already encouraged this Remember, ] hit have with for we the certain analysis. the survival pie first actually prespecified

the So magnitude of clearly, tells benefit. that you the

the we is In you wait our enrollment complete I what point. X fully patient year, in have though expect ahead a to given terms medical last if for you we expectation right planning X the now, the way year we data tell October only our of the at enrollment CAR-T XXXX. But we're in this until of Even will first I that publish enrolled lines, guess CAR-T meeting can of date are tracking of in trial, later seeing to those see any or would not. early to

patients I the also I enrollment. that's a physicians reflection think, and clinical So the helps clearly, That the are seeing. benefit think of

next line BTIG. Justin question of comes from Our from Zelin the

bit, how that a have decreased? has you comment rates relaxed rates, the now out-of-spec can on been threshold on Just

you for question. thank Justin, the

because early second-line you wider very still a it's X, on April FDA So as the back recall, received with we by label. along release

think point see before. expect but we shouldn't who had settle time anytime early see to online release And you that full we second as in can XX start it or cytogenetics a see rate little more the or the a probably launch slightly down sickest back at we OS this expect And to point, to bit high-risk trend I we're to patients So more rate data, time. you therefore, will should to quarter. the a before percentage in come quarterly point. And take was pronounced X be you to the the the than what second very at soon, line, second continue for first shouldn't it it wide compare line second this a a over surprised eventually, of so can quarterly see mutation the that line is that quarter if might OS out-of-spec imagine, is we lower lower in than of because to benefit

comes next H.C. question from of Our from Kapoor Mitchell line the Wainwright.

bit you centers mild to patients Wanted physicians bit they'd line the the of on second-line this color for sickest, a are supply? to Are also of test discussions all It's you medical risk able the of a ask provide earlier want risk mention little patients it at who their demand. of and in cytogenetics transition initially I patients to about that like me just is to the magnitude highest the into, out they in would their who in Or more guess, treating in it queue. little with where highest patients? is at point? can risk to function cytogenetics more on before demand tell like migrating on they And on major the second a with the queue your then treat,

seeing it first Europe. and that was in well is see we're It's before and once goes in was seeing And that the we Yes, last I'll Ying's that Steve. right What is you're this terms are the true the we expect to question high patient characteristics. what filled as these to Why the CARTITUDE-X maybe the of don't we I all was saw take take And question. launch, the their I'm how during the plan right? here. Physicians. what how research riskers for all indications first, seeing launch, CARTITUDE-X out We'll sickest the happen we're again, data of gate pointing point lines actually sell. out earlier on the treated be So sick they gets with of of first the on candidates earlier other receiving high-risk so the in to it lines, trying earlier. In that we to would new bearing question -- the But out under terms in cell-to-cell think launch. be our treating. that see the they data. would indication. also true

So at to the a try academic look looking by sites. you these though, is at that's patients it within they're way academics as The there's dynamic I referring bifurcate our the generally But this. centers, large now. speaking, market, how know, for

lines, for cell. have is work where this risk outpatient the benefit in clinics that's this So point most is probably to these But would have are lot one side against that on equation. And deployed frankly, where them standard the the patients with patients of of quite we our the to this cell the the area different in population, is the now that the the and with our to the educate that we in are referral deployed meet and physicians a greatest identifying earlier currently partner we're who options. to at work these

use the this field. Maybe, this, Mitchell, the terms feedback in is early they how of right? Again, add -- that from feedback I'll

they in second who are harbor line in high-risk that's that focusing population. strategy a only the mutation, on patients XX% yes, So roughly but of not the

There's have not actually harbor what presentation first-line means do they at call but cytogenetic functional they treatment. sure XX the of months right? you portion For progress seen data a we risk, within of mutation, may I'm high patients, our example, which ASCO, the

are patients those another So treatment definitely option. needing

is done still They And the from CAR-T lastly, population like a administration. get and population. there's another relatively to and also would these benefits young folks that's So who then are working. the once

their back daily they can normal that activities. living So to go

those patients likely that CAR-T probably line at X of buckets are second point. this get in a those will the So

probably So if line X that's at you roughly numbers, our -- second if buckets the it's those here. population, look you XX% of add

question of from comes line from Farmer next George Our the Scotiabank.

A couple me. from

expansion, That's our in we about back market the getting model wondering focused looking Ying, we could see, about what numbers on the Number be your pounding of those England if would to of out Journal ADC to that does you you years? was you've seen comments should to number manufacturing looks what you heavily to great results kind think at? there, XX,XXX published that's compares in get potential data in front finally, survival patient overall And how Medicine, costs that on comment I and some Let's like the on were on good out of putting real with FDA early ODAC threw belantamab how are CARVYKTI? And then BCMA follow-up, two, New be had number one. the up pretty the come in that on perspective That would the imbalance activity with this It in line. at your ever get phases helpful in world? that. that physicians that was

X-part your questions. for thanks George, Yes,

the of capital terms first on here. one, So investments in

table It's X dose by we years don't capacity. And to us roughly leave then on a there's next so dose X So from partner, year. point. somewhat it that will to after first to that $X of end with XX,XXX of capacity you to additional say decided Is XX,XXX greenfield brownfield we that, investment, which at with a this on at look JNJ. And models? very capital plans, incremental the little with in our get we if get obviously, we have billion we round. our can going hard in that And But next existing the think to about this be really right? then to depends other want after Or terms market So some a is here. -- the it's about we going investment, ground in scratch? in years it total X choose, the those to break structure or facility, bit it be mode

you that George, or view the terms right, So -- the we to T if who think There channel the unlock is recall. also and then our and be the here even tap that at additional from partner with from are ADC, the of we now think also CAR-T and CAR-T from second see, we and is benefit. option of the in line capacity. And more penetration having And session, a doctors there really benefit of our ASCO, I was with a engagers, given the including in once-and-done KOLs potential a I frontline then data market were consensus considered on ADC. actually also maybe discussion [indiscernible] first discussed cell response durability panel checking couple very in the the recent into and market how thoughtful survival

or are we're today. And think I So on dynamic patient is there from do at is again, coming really just large Clinic. it than will PFS based study engagers than that that's we thinking survival, from the in publication not both but Mayo saw this Clearly, market real-world landscape a the engagers ADC, a Nature the position CAR-T better change and T-cell ADC. and overall better for T-cell

that's think Mayo at study very I a from Clinic. indisputable large result cohort a

] actions. versus CAR-T other I think X that speaks -- methods the the benefit of volume of [

phenomenon that actually guess, before the you the the given the long-term haven't phenomenon in administered, on even you in CARVYKTI similar encountered was So right? in saw questions field maybe prospects in And we that's the some imbalance. too CAR-T last other feel here CAR-T the we clearly, No, on we that in clinic. about experiments many experiments. really the of seen I -- CAR-T some because have data then see question based OS That's benefits PFS, OS. And good the is,

the no, hand, early are that that shrinking of we're issue could van-to-van other short, available or increase encountering there momentum about work But questions so lot imbalance. well. And the On we bridging of as that really physicians of of therapies in a time. address skeptics our lot today, doing an to the also in not a in also terms is

of next Bienkowski line question from Fitzgerald. from the Rick Our comes Cantor

patients immediately could third the clinical for capacities capacity up by immediate quarter? And also expect improved First, it question, like production this about an effect guess an second I'm I the about should wanted I time? just downstream just how thinking I have get XX% on improvement confirm, over goods could free P&L Novartis X% on impact but drug I I'd in rate hoping on the production. my have that to could to was average, effects for But initiation and you out-of-spec comment cost a of out-of-spec of like And thoughts commercial ask to wanted how your you to hear specifically rate quickly if on should on operations. the if sounds

you first a It On in the I'll third gradual about Novartis initiated Rick. month a So it's hockey the up talk curve ticking CAR-T question, can is the and Novartis, yes, batch as typically facility, production but facility, stick. in last first imagine, any not here.

yes, is have, quarter, So dramatic at van-to-van question impact up example, in incremental on producing there's batches right? CARTITUDE-X, third free I data. we the Raritan, you the on commercial the Novartis then that if that time, capacity wouldn't impact XX yes, positive say that. And for But it's I definitely some for impact. that latest does then on So the can third X-batch a so give is direct

look second That the quarter, within PXX X a it's of out it days, you to the XX% or about to [indiscernible] days. XX at deliver were XX was in shipment. if So And then the our to sample median, inspect weeks. than is XX shipped so less

So And to Lori make our we'll van-to-van then in time ask comment. second here. to the of continue terms progress part, I'll

Rick.

drive But an imagine, can that you yes, help the So improvement down the can't definitely give will But help would improvement one the in to that if influences relation of how to COGS. to in drive the I and much cost your there's as sold. our you in an down COGS. goods time, is would of OS, our van-to-van P&L, be direct on improve bring that definitive guidance there

Our line the Raymond McCutcheon of from next question Sean from comes James.

And you for can in separately, of accelerated as back around approval for update additional piggy your of progress thinking intermediate in study? manufacturing an that any off any to your efforts? specific speak Maybe frontline point, MRD last endpoint to the efficiency

is improvement And COGS continue you our those well, down over improve. as different Lori. gross take is in efficiencies efficiencies this that gross as as that see earnings, manufacturing pretty nodes first you're you why additional go on we the turn realize regarding QX you'll your to to continue margins that seeing, saw margins. significant I'll there manufacturing Sean, those question our our saw QX was in our we and

question strong to quarter-over-quarter, you mentioned I we'll want gross you gross take transparent, really see good nodes just to do in on and saw these online we each As for variability the continue our expect continue we to But in additional to before, we margin will frontline? margins and quarters to be capital. do the your as of those. Ying, second in see invest bring product

Yes, sure.

MRD do we registration and down So a as given a to to in and sit with meeting plans the recent ODAC our potential partner recommendation, the using activity talk agency request about endpoint. have

you if in already clinicaltrial.gov, MRD clinical trial will see product on the a look that published activity So you that at in we CARTITUDE-X trial, is the endpoint. co-prime

a agency. Now with CARTITUDE-X the If the MRD endpoint, in agency could that to agrees, the as certainly, we MRD use and in market that a just welcome a XX-month significantly or as to decrease discussed registration time remains entry for would indication. actually activity could first-line that, activity be we

from Our of next Capital Konstantinos the BMO Biliouris from line question comes Markets.

is Konstantinos. This Phil on the ] quarter. on [ for Congrats

So CARVYKTI just the one question from label. us regarding

remove with risk were they if noticed black mentioned that you have labels, secondary that And with was a being warning? chemotherapies. around risk few on the recently that on label only of wonder Marks provide warning lymphomas, incidence updates the in potentially And the in also order may So super given discussion cases FDA helpful. CAR-T box the if the we positive color lower any topic, so such versus any of such Peter you FDA additional revisit that for consequences just magnitude is that can malignancy can

thanks question. the ] Phil, [ for

I a when it think label of some class time updated, last label. was SPM the was

commercial FDA similar, same not CAR-Ts language in the label. very if putting So basically, all X

had at that discussion any with a because we to detailed have agency that well, probably not we might potentially wouldn't expect speculate that. the on about as there's want be that label So if I point any change, this class but

the data trials those and the a think the very the regardless, SPM and guided also everything we as large given benefit clinical continue claim collection observed I believe there's world, we in in over here. clinical real real-world continue to of to be both in we incidence also and believe data small also well. But by benefit will risk that the strong

concern also has treatments. And with field really the I this what SPM as and discussed multiple has and the to physicians events a of myeloma, not He some ] you because, that So the [ more have way cancer this prescribing from associated have I than one treating about big know, this topic in patient worrying physicians with. adverse patient about issue focused too physician for concerned cancer the am just much either out been rather been has we decades recall know of very oh, said, about mean other may later. there the

Goonewardene Asthika of the from Our from Truist. next line question comes

do of I push here. made larger strong going being some target to on have question those and what list progress credit flow? the patient and impact would what process thoughts about ADCs. making year-end your -- your the for to we about to and on centers XXXX, on community have of larger academics, there is these And in XXX I a but have a want Congrats get priority your what you community onboarding by Gilead centers. to of would these ADCs talks centers? What would back the have in some your larger mix community you're mix how want thinking obviously, they in be, targeting the

don't because strategy thanks. Yes, that the that brand. Why Thanks Steve. important an bringing for part this It's for up that's take I of question.

centers. near as our the and into you we're said, today term basically So major academic in deployed

However, partnering offload referring basically constraints we level. are pilots to they today academic community site at running some as centers are the the with capacity that major where of our their well, have centers

So our affiliate. they're very activity we where pilot centers academic are already working some closely with through engaged community their in

the also that's the been that. to commercial for -- is bring to the academic second on to as our part moving start with ongoing, out we that's into ongoing large centers the that been we'll to we which are only So board you're but better early not include broaden today, year. Because continue footprint of those community line, centers, right, and that affiliated

coordinated. that then keeping important very the is -- the us because with always much thing obviously, as us first. So academics patient more it's And safety key it's bring on we they for

conversations and downstream community there initial then So leg we the out our they're with does something and we want finally, had accordance academics. And right earlier with some to that academic point dovetail into is with make better at see because what understand how our around then as well large clinic we've was the hospitals that referring retail in some is the some of of centers. that ultimately And getting that's do sure there strategy providers frontline the in is large out conversation third their role large the the of time role clinic. as that to

we next as we'll something be rolling forthcoming. It's years market our frontline. that in over that's of for out the So launch prepare something couple the

concludes Thank This today's you. participating. call. you conference for Thank

disconnect. You may now