Legend Biotech (LEGN) 11 Mar 242023 Q4 Earnings call transcript

Company Profile

Participants

Jessie Yeung	executive
Ying Huang	executive
Lori Macomber	executive
Jessica Fye	analyst
Jonathan Miller	analyst
Ziyi Chen	analyst
Steven Gavel	executive
Leonid Timashev	analyst
Vikram Purohit	analyst
Konstantinos Biliouris	analyst
Ashwani Verma	analyst
Edward Tenthoff	analyst
Justin Zelin	analyst
Mitchell Kapoor	analyst
George Farmer	analyst
Kelsey Goodwin	analyst

Call transcript

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Operator

Good day, and welcome to the Legend Biotech Reports Fourth Quarter Earnings Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to hand the call over to Jessie Yeung, Head of Investor Relations and Public Relations.

You may begin.

Jessie Yeung

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

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

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

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

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

Ying Huang

join happened morning, us Good you a our earnings since lot everyone. call. because today last We're glad could has

the excited patients myeloma therapy, lead to CARVYKTI we're bringing our prospect multiple First, Europe. more in of at

decision of first As and to for a the multiple into CARVYKTI Human Medicinal for expected relapsed lenalidomide-refractory in for received you April. is Use heard, Commission positive CAR-T in the myeloma. The the treatment. therapy lines opinion positive to Committee with opinion CHMP Products earlier is have many a formal setting patients of from expand CARVYKTI receive European second-line

answer PDUFA they will, are this a Friday, of launch we are you expanded As Drug Committee FDA's to XXth. in the United and April the for in date To meet Oncologic on the States the second for of X, scheduled preparing any line, have, keep we CARVYKTI indication course, approval potential the posted. questions of in Advisory this we outstanding the with

activities achievements last turn like since other and I'd Now to our to earnings call.

fourth quarter total resulted million. $XXX of CARVYKTI the sales more XXXX patients net bring for to work globally of to in Our

fourth the versus share $X.X for third the efficiencies. was total our quarter expansion gain CARVYKTI performance quarter and full in of of capacity increase from year, the manufacturing were and CARVYKTI launch result For sales ongoing billion. The a

for Switzerland, fastest provides We CAR-T partner, through vectors of we and have quarters, therapy. us as market We the launched runway of targets, supply been are quarter-over-quarter end growth XXXX the X anticipate order we with Johnson more and X, of well. balance our our a believe have in the serve billion patients $X.X significantly continued now Johnson. financial throughout cash lentiviral XXXX. In meet & our our operated expanded by reactor in through to large We revenue

& in Johnson another the factory addition, has In Netherlands. under Johnson construction

internal capacity also in manufacturing to We continued expand Janssen. partnership our with

for batches at CARVYKTI Our of clinical year. site expected the called in Belgium, of hope in XXXX. in year. in cell Construction processing start first our to to Obelisc the on of We and is manufacturing Lane produced Belgium site, second commercial the half second end Tech progressed production be use the complete January Ghent, the

sites. have patients a announce experience am the to of XX,XXX now increases XX Jersey XXXX. target production with New capacity cell Raritan, excited by facility, of of We since more to our end have increased overseeing doubling the our of to help years capacity CARVYKTI will beginning supplying The meet we federal XXXX. I we at than processing new ensure manufacturing leader capacity our our

Vice Our promoted own Birk Operations. Senior to Manufacturing Vanderweeën Global has Technical and been President,

second one European joined from just The just the has to Ghent Gosen senior and Global our stepped for in us mentioned. I for Our reasons adviser is organization previous has Liz Tech XXXX Head under start aside Ops, and personal that a work Birk now construction. manufacturing serving site full-time of and as came in facilities online us.

Phase to big joining he and he's at increase production our of made and earned certified with trust global to life in second we at a as early results In measures CARVYKTI respect line standard total In hospitals AstraZeneca. Birk has more from of other symptoms data in unveiled to quality online, fourth Society of an American in the and The XX as demand treat Legend, patient treatment already now data clinically we demonstrated deals with study. The care. manufacturing presentation, bring reductions outcomes treatment the enabling health-related of CARVYKTI oral presented and pivotal teams, our growing in compared improvements a meeting III with Hematology patients. quarter, continue us of Janssen, we have Before impact. new to parallel the patient meet served improvement we December. meaningful Teva in the U.S. CARTITUDE-X comes hospitals in and in capacity following showing

are in outpatient Additionally, administered about XX% the now patients of setting.

multiple Turning solid potential to in blood myeloma beyond the and our We're pipeline. also investigating in cell tumors. cancers of therapies the

in take fronts. in conduct closed clinic. After commercial year on patients clinical DLLX-targeted in the started accomplishments XXXX, trial including over and Phase up if the dosing can with To deployed in We LBXXXX [indiscernible] activities. I programs pipeline also Phase further the our development validated The cancer. other manufacturing lung be we several I, and any in have sum Novartis LBXXXX program, used will

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

Lori Macomber

Thank and morning, Ying, you, everyone. good

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

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

the revenue for share same XX, $XX.X loss revenue. Total for share the our a loss net $XXX.X were the of $X.XX sale of million CARVYKTI. consisting of December of a for compared million period per Net was loss almost collaboration a million, from fourth to quarter $X.XX revenues quarter entirely the ended to or year. $XXX.X last of or Turning XXXX, loss per

year or December net ended for the For a per ended loss $X.XX share XX, $XXX.X XXXX. the million of $X.XX of loss to or December a compared million of was $XXX.X year per XX, loss net a XXXX, share loss

Legend to December compared in XXXX, and for expenses. $XX.X cilta-cel, to on same X million Janssen The increase $XX.X primarily continuous expenses for for million months to continuing portion Biotech's last XXXX months of research building summarize, the strong December the $XX.X development quarter information clinical fourth costs was million XX, other expansion. Research due ended research due to spending the the of $XX.X continuous was compared $XX.X CARVYKTI. To increase cost global expansion primarily and in along same $X.X the XXXX, support compared patient last revenue year. and compared an associated compared expense of with track, for sheet. are last to the with million Agreement, of for for of The months to quarter and collaboration $XX.X connection year. to $XXX.X on Moving last revenue period year-over-year the Legend's with for technology to administrative the trials III ended maintain X expenses to sales cost including due period and and the development million The of pipeline increase X investment for XX, to $XX same in These XXXX, million and million is to manufacturing for ended facilitate due growth commercialization capacity items. Administrative functions XXXX infrastructure. Selling cilta-cel million the year-over-year we increase the for same $X expenditures months year. in business activities XXXX, fourth to period million were million $XX.X year. a under for ended the development December million XX, to distribution continue our for collaboration period X XX, was balance remains activities enrollment December higher of were Phase Collaboration of

billion of and equivalents, XX, cash As we $X.X investments. deposits and had December in

as I Additionally, Ying Novartis capital new we early license DLLX. with in end to closing with enter through our $XXX believe expenditures back upfront to CAR-T you. now year, pass of fund therapies we we global in and agreement certain Thus, XXXX. Thank for operating connection for sufficient it we have January payment the our million received remarks. the capital targeting

Ying Huang

impressive we'd thank you, like questions. more CARVYKTI fastest year be to to therapy The our the for of to for launched and that, achievements your global XXXX, I was even provide an to poised X,XXX great first more patients success Legend. in commitment the around each dedication of take has the ready CAR-T for teams with we're Lori. and question. up us proven Legend. And to to therapy. their XXXX for we're Operator, employees Thank world. set want our have

Operator

Jessica from Fye Our Instructions] [Operator question with first JPMorgan. comes

Jessica Fye

you know for, and put think, out year-end I I the appreciate doses. Question XX,XXX prepared on and 'XX color I remarks. target there the supply,

way target XXXX think about could grant You year? going year-end not, to have the I share? to you're you. for if guess, this right FDA you to And step-ups example, manufacturing the a Thank the ask the, what's

Ying Huang

is this Jess, the manufacturing. Thank question about for Ying. you

XXXX. We one. we goal combined to beginning did year the in provide supply mention exit that is per take last when I'll doses of year our global So of a that XX,XXX

same. from for That approval FDA. achieve This Jersey Beyond on we increases is last our are plan New X if FDA. Raritan, just year, guidance for any that, increases planning successfully the I applied year, capacity in for scale our look that, capacity site X and that approvals XXXX tell is providing you FDA manufacturing request you to we we not we additional plan up. But at did both we're in can

XXXX. cadence same the that's So last year. for the That's plan as

Operator

Jonathan with next Miller from question Evercore Our comes ISI.

Jonathan Miller

us pipeline investors if to? familiar And ask I'd many a into targets, give about separately, what to to looking choices like any familiar new be have are you And go [indiscernible], and folks, plans get for to can to can specifying or little about autoimmune are space beyond of your whether not CAR? so you to both your like you're likely bit do places forward even the that be these targets your DLLX color they'll peers? then look of early

Unknown Executive

Thanks, Jonathan. This is Yes. [indiscernible] the question.

I of targets thinking [indiscernible]. are the target about internal through where some on some So pipeline. our are towards provide front, we pipeline high-level can probably heading our

have We a few priorities.

currently target try are research platform diverse where The space, with target net targeting we is to approach. treatment. development, under known you well and multiple post of as the who myeloma [indiscernible] patients especially see are CARVYKTI some -- First novel fairly a for really build as franchise,

on this is space, as with an area Second see the priority critical. indication. differentiated autoimmune we this think is In emerging the great opportunities. disease approach We have really focusing I

setting. and at space, those value the we on to also patient, the primary focusing the the -- focus [indiscernible] bring point, type really -- approach some this patient internal approach, bring but to to focusing of treatment differentiation on Our allogeneic programs and the can

some where also space, in disease focusing the key pathology. some on We investment solid associated are have of disease tumor hurdles just with we state,

the commonly example, from tumor duration the of associated current with For [indiscernible] which solid major indication, is the limitation [indiscernible]. disease

investing are we tumor to able on and how there, of target extend and, effect the innovation TFS, benefit key by So being solid to technological retreatment. standard the cytotoxicity the [indiscernible] to therefore, generate the address

a So will be that's level question. just high the you probably Thank for sum.

Jonathan Miller

if is in of lot any a guiding to in burn fair may. revenue one million by not 'XX, follow-up, like a quarter. way think guidance not you're corresponding for that spend. $XXX about to increases then in like rate And at you're looks Is improvement noticed as end improvement at of runway about a or I It here it? I a offset your seems burn

Lori Macomber

correct. That's

do If stands conservative from pipeline BCMA for our It's will [indiscernible] upon and the it of program. really way our advances. to bridge as -- how profitability through the cash the XXXX. today, the take pipeline believe a our end dependent we're we with comfortable be you being But look, going balance,

Operator

comes Our with next Sachs. Ziyi from question Goldman Chen

Ziyi Chen

OS you the meeting [indiscernible] was more ASH And who ODAC benefit in And could cutoff a ASH showed data bit very also upcoming a to for XXXX about Group for the share the OS those so share compared with data Trade day the on which strong for group. to for committee? shared potentially the Friday,

trying as group which to about so So to European on ASH discuss more launches. understand important countries will Trade thoughts like previous your Group communication the we're be the initial per with well, also your regulators. they including would And

preliminary that? launch updates and incremental strategy the any on So any on

Ying Huang

is This I'll ODAC. around question take Ying. first your

on I overall point, this X FDA we of at So were FDA we March that ODAC EMA and the survival. submitted tell the the to cuts because focus you, upcoming the by XX also data will can overall survival be on told

last of XXXX. cut was the So in and of year, the analysis BLA as X, with the data pre-specified first on submitted the November data you in cut first that mentioned, June part was interim

data And then put we October FDA survival That with a recently, on submitted from of on safety of year, year. update April another with part the XX And then CARTITUDE-X. X we from day of XXXX. cut XXX to of submitted a January CARTITUDE of December latest update survival as of we the in last data most in the X, data last cut was

So we provided are survival different overall as those discussed that X to Friday analysis FDA those X ODAC data on are be the cuts well. by the will and

to here. We you all-cost of plan ITT agency analysis on all was treat survival intention most not to analysis, mortality on the the the of of is benefit terms of and I provided [indiscernible]. submit data In versus the that is which conservative basis data our to can scenario basis tell [indiscernible], that the do the the ITT on survival

question hope the that then European recent the ask colleague, your about I opinion? to I'll Steve CHMP ODAC. comment most And launch answers So on my given

Steven Gavel

A Ying. to of with of Thanks, listeners the our that planning States Yes. responsible couple for launch United partner exception CARVYKTI's things the and remind outside is the China. just

Ying as he think maybe, don't mentioned, far I goes, mention. did Europe As as and

We Austria, through on around know negotiations year. The Germany in December well are CARTITUDE-X intention and is with new data. our our partners I in as currently this partner. in Austria last CARVYKTI as our of and active -- board currently came

this don't is launch of environment to have pretty and of the So agencies partners. because a our now know right guiding, planning, terms with guide fluid terms I the in in Europe yet anything in we country

So can't in this at unfortunately, point you I guide time.

Operator

Our next from Yaron Cowen. question TD Werber comes with

Unknown Analyst

to to can has we you And produces seen effects. on you irreversible ask CARVYKTI CAR-Ts. have Jenna that wanted is parkinsonism, than This about for spoke CARVYKTI which other What parkinsonism. I more of Yaron. think kind [indiscernible] do pretty also,

to think don't show CAR-T's is you this this? earlier setting, line that do So using going competing if deter especially

Ying Huang

I'll Well, and both take also trials on Jenna, that's look this the all, Ying. AER's this of on you if is not is database, CARVYKTI. phenomenon parkinsonism first clinical unique data, of parkinsonism. your at the from question in FDA

was also Yescarta, ABECMA. In taking and are reported who from fact, on Kymriah patients it

year, And we so database about as far, of last FDA patients. cases the end could from see the in of U.S. reported X

out kind couple a to of parkinsonism, So why you that's seeing the say there. fact. With number. I the are That's would regard actually delayed there's this of hypotheses

into patient For has years be the leaky of as because if of the therapy brain it had the such could T-cell or CNS trafficking example, when the in the pre-existing neurology a patient already situations after blood-brain barrier neuropathy. or

that could hypothesis. one of be So the

point, show cause think at parkinsonism. is root clinical don't evidence to there's this of any the I Although which solid

the Regarding lines. your question earlier on in parkinsonism

And going that following was X reported that case from reported were was down from we the at we CARTITUDE-X. CARTITUDE-X reported the to parkinsonism As X% to ASCO. we grade in about mitigation cases given implemented X risk about CARTITUDE-X, ASCO, strategy we X.X% at show incidence able in of the the

you believe potentially that the mitigation population because we look patient entirely the risk Thank that you. manageable think of and at the earlier here. if also So phenomenon because is line baseline patient we of difference,

Operator

next question Our with Kelly from Jefferies. Shi comes

Unknown Analyst

should and you in do on to record treatment? Japan? be countries in feedback multiple we is provide on Also have is Dave the J&J have color couple you guidance? to other from first on the you U.S. progress. the versus how received And does Kelly revenue This Congrats CARVYKTI any available on for Shi. Any sales, other One EU for are responsible a agents outside position now, of expect on they when sales questions. expect mentioned BCMA will as I physician although when

Unknown Executive

around take don't last the Why I question sales.

being as for the far that And and because Europe. the next EU comment mentioned So Austria ongoing, I we're -- in as matter. be negotiations country we what includes Japan unfortunately, on that Japan, that may in can't Germany. in up And already the

other I do against as are mentioned in selection ABECMA. his your think obviously, in the of now in in line I and patient within plus of mean, What with share Ying fifth here we're the where XX% sites we're Europe in about right opening remarks, setting seeing, type. we U.S. market an competing terms had the CARVYKTI in running States, basically question to

of that preference in So terms categories, And it's speaks risk I think volumes in risk positions. of or in terms all high be standard risk. whether

CARVYKTI physician or at think market bispecific the to may product not if sure seeing a think therapy we're of of uses where where other around that bispecific therapy, I space, doing is available market erosion uptick -- [indiscernible]. the in in terms opposed when you potentially as a I see wants in the used when to bridge you're some has CAR-T it ABECMA a for that erosion, CAR-T bispecific you're some be a front in research with seeing seeing to you're least is occurring use

Ying Huang

I'll your question. first take

I think the label update. was it on

all the want CARTITUDE-X our little AML we FDA is So bit label line X-year clarification MDS, myeloma. follow-up provide late on with update. I did I'll included a late label and update this. in includes aware on of that into That year, And of multiple official a answer respects. also Number one that an an to minimum in you're last provide also so that, receive

of XX cases. total from patients the XX we saw X at look you if So patients CARTITUDE-X, with

rate roughly of back you look it's in XX%. at If started XXXX. this was recall, But cumulative AML/MDS, the trial

roughly the essentially, X cumulative XX%. So rate is last years, AML/MDS of in the

from treated from been drug protease class, of ASH one insurance were year IMiD antibody. one from Now at patients means then and over CDXX drug exposed, drug one which have including who inhibitor patients there's a paper that X,XXX with looked triple in triple was classes, claim last database published these December which

any from population, that without AML the on developing X% don't and background MDS. higher if that So believe background update actually And year. Therefore, the of we even look already you MDS rate. is AML got or you is roughly at data we at if look rate treatment, label CARTITUDE-X, each the the than patient

saw And Now T-cell guys all this class regarding receive the update believes as brands one, FDA. you communication CAR-T a the will effect. is of from the a lymphoma. second X on label therapies public All FDA from

XX,XXX exact get similar language now, the the than also and is is the to update. Suffice trial the So we with in over risk clinical treated a patients And label who cases and near right the get future. denominated and FDA about everyone were same patients. 'XX will we'll we with language. rare those update of from It think in are reported the label J&J discussion that say different the given or FDA small some and

question have also CARVYKTI think about they about a other versus therapies. how physicians You on feedback novel from

prescription saw And been CARVYKTI the then XX% behavior you touch have on line. We with [indiscernible]. again, results seen survival how that. from helped care that late And as not or we in has We in provides to changed such you or the dexamethasone. with will CARVYKTI progression patients in also, see T-cell a of believe this our [indiscernible] label those risk Friday PFS change. well. of reduction if AML/MDS look CARTITUDE-X based nearly standard DPD that's as in point, at at to compared saw years best-in-class lymphoma continue any physicians and if And efficacy, physicians And efficacy have X on either you

positioned best-in-class injection the CARVYKTI. physicians with still So as point, efficacy think convenience. I one-time is at how That this view it's

Operator

comes question next Capital Our Timashev Markets. Leonid RBC with from

Leonid Timashev

Is how less to is you if to thinking greater the the they of potentially splitting given be for the with guess, regards of on I you coming any ask I succeed, committee being you? think Or to do for drug to a ODAC. I on same drive I awareness. CAR-T there do implications what helpful, with going there you're be them mean? can wanted you're depending to going the market that's brush competitive risk competitor present? out they painted And setbacks less competition? broadly are positive about be that space think sharing any And also the going that with, specifically, guess, the guess

Ying Huang

for Thanks, Leo, the question.

if ODAC, think it's though registered different roster federal the actually I of it's So look same you you at panels. but the see publication, even will X

the application morning competition will from indication for roster then and of afternoon, will from application. discuss On the KOLs application the experts ODAC line ODAC same us CARVYKTI. March of the second in on the XX, discuss the third-line And in

panel each I it panel. [indiscernible] believe by So class. and CAR-T on the discussed on debated and its merit. is separate think And a It's will a necessarily be not application I also a

can't but in comment or data, our application on endpoints also the I benefit and we firmly provides So that survival here. overall CARVYKTI of competition believe PFS overwhelming

general, late-line failed say has these been as can have we protease what inhibitor look did point, patients directed treated CDXX in new therapy and you classes, myeloma all besides have a a class agents. for who -- of a BCMA clearly, that's if choice class have CAR-T provided the antibody. At So also about the that major option and this. And much who multiple at IMiD, not patients a also in including treated an really

So the believe in place a there treatment for we firmly myeloma BCMA-directed very here. CAR-T multiple is of important that

Operator

Morgan from with Our comes next question Vikram Stanley. Purohit

Vikram Purohit

on had and on commercialization. the one We pipeline one two,

study, we your from administered in you thoughts then in to that CARTITUDE-X think midterm near latest were cohorts the the do use what CARVYKTI do for could can commercialization, pipeline, you on significantly what outpatient of a if that move in greater think high number the that's the up think mentioned you are E&F. data and in that patients the XX% go outpatient term? you were kind of curious just timing on setting. around So And for on the setting near How facilitates

Ying Huang

second. take cohort colleague CARTITUDE-X my on answer and on question Steve E&F I'll first then question probably the So the will

patients. cohort roughly and patients So of E&F, enrolled reminder, in multiple myeloma a as E&F, cohort we total on CARTITUDE-X a these are XX diagnosed newly

And data this the at timing you providing probably not data guidance. report at know, any report of point, But earliest can end think as towards we will major always year. conferences. we're the we I medical when Vikram, this be So

what timing Steve? E&F. So that's can about say for cohort we

Steven Gavel

stand Yes, important especially Ying. into outpatient larger metric, lines much we earlier with the Thanks, as patient metric populations. is an

to use question that just mentioned, of United in things number driving increase. I the mean volume what's around causing about States. One, are there's itself. I the So the a outpatient as

the Our hospitals. need they into recognizing options at CAR-T that all patients sites than to look fact are admitting other their other these

In terms I of are we said, what today, assuming? are XX you at like share thereabout. mean, roughly a we

think we double could I easily that.

issue the have largely rate sites limit outpatient the beginning. metric They into us get think be of XX%. I much around our the rates with uses sites product doubling of higher ability very would in outpatient been with that our market. We're to clear since the very or or on have

As the consistent new XXX that get just come it's to global on I a ensure perspective, and setting to pushing if that the have this of patient to board, reps, year, hoping with from we're they're quite around label. frankly, safety seeing sites need to in what

it So product right the the a of to it's allowing drug this physicians then in place get really that getting hands to also of for outpatient with put now they comfortable use into them infrastructure put to necessary just use. and need matter and

Operator

comes Kostas Markets. question BMO Capital Biliouris from with next Our

Konstantinos Biliouris

Congrats questions of A from on couple the progress. us.

you the great slots CARTITUDE-X events the although under arms I'm to if briefing more between year-end one there slots you CARVYKTI thinking the XX,XXX was standard arm, could that be even the any on Is that had double care. I explain can is of recall or XXXX, slots on first were again. data. XX,XXX by you which second wondering this year, that the wondering showed is we supply? And can how are of produce enough saturation difference, guiding speculations there the So last really question should is the this is this of there standard if see beyond care there front. during any potentially in phase, update If is future correctly, than the recall I'm I the around XXXX. any both arm that you characteristic not

Ying Huang

I'll take your question.

we So the that first line of XX,XXX that see the to XX,XXX and slots one J&J end significant do because there the and capacity second be on is Obviously, approved partner, by will regarding the plans beyond. have our demand drug once beyond in extend we a quite XXXX.

program I would specific you guidance certain now, CapEx $X future we are get with can after a which incremental tell year. XXXX. on cannot So actually say we we the But any provide investments, think given can larger the in conducting roughly billion to we near I number

there do round Now what of of of CapEx. course, current is we a this can with limit

we next the our thinking about step. partner are -- So already and

potentially obviously, approvals this In It need fact, not? be physicians. a round or decision XXXX, made based assessment could market in CapEx the year and all of on on, conduct the whether another we to also depends regulatory from feedback

arm that, from look fact, EMA key to therapy of the months on exhaustively in events arms exactly partner are receiving imbalance guys when patients bridging subgroup the Care our clinical and question your So here. the our same, Standard assure look the have and analysis in a [indiscernible]. We data. that also CARTITUDE-X to of question. Kostas, a competitive we characteristics. also we do baseline on have tuned was tried you both landscape [indiscernible] when CapEx the On or surveys all that committee CARVYKTI the did I data of first latest conducted at you And on stay at in in initial of that CARTITUDE-X the on and can question February can physicians from second PFS time regulators based meeting of the to and the because couple was time plan And either

imbalance that of can in you for dose we I will difference found then in after thing of the on was And some the couple only you and guys the tell that a [indiscernible] So difference density regimens, Care that analysis, the some including book. a on dose see exhaustive dose there's slight [indiscernible]. Standard briefing

think I I Wednesday. be published believe on that will

that's So only have we seen. difference could the

it's CARTITUDE-X, that after and in see months. the data CHMP enrollment CARVYKTI that's patients to label difficult post-hoc at myeloma said of protease couple second-line first treatment could for of is for out. But That's the from is And we [indiscernible] account treatment. receive from analysis, you an includes that did look and the recommended does patient you dose a also for document, Unfortunately, That has we label we as why Kostas, of the only you also to after at the thing find the in inhibitor difference all recommendation, the Revlimid. much right? If imbalance that. clean got pretty Now intensity multiple clean conclude the Europe. received looking and exactly IMiD X criteria of refracted are that's line that also very a

hopefully Thank you a hint. that you. So gives

Operator

question next comes UBS. Our with from Verma Ash

Ashwani Verma

in to Would pricing doses the more are secondly, of So is at of align towards that need pools. And doses exiting you'll comment different run? you slot a is? expecting with XX% roughly long to on contribute? trend European can in So XX,XXX get months price XXXX, our Does expansion the dynamic Or math, XX,XXX where it get Europe any you play there? of the U.S. your annual then the every to that's much one. terms there thinking X then and to to by how belt those

Unknown Executive

to Yes. questions first manufacturing Maybe I'll talk some the had. last question turn the and Yes. then I'll take to Ying of you

shortly guidance pricing the coming pricing, going European of terms to Germany out to see you're related In dose. some

of month, the into that early possibly April. see going part the to by expect the end of We

tuned talk the Ying, want you to question? about manufacturing that. on So stay

Ying Huang

Yes.

plan Ash, to number to me by talk let of So how get end XXXX. that we about XX,XXX

last the in I notes, already of that's X so to we're got well, as actually year planning continue mentioned of that. earlier right? J&J do first capacity and year. have of are year like that that, In increases this we'll in But similar call, all, So side. And we of expansion internal something beyond we X the this XXXX and physical in Raritan the part Raritan, we doing

this is So done physical essentially, this in year after construction XXXX.

area the effective We are side. in manufacturing doubling our of Raritan

equipment, year, training suites will of the months into spend the the because staff current year the is increase all the that the on then physical and the also So GMP figure get done XXXX this in standard. construction installing validated we'll capacity once

let's the in of right? And part important X the talk an Raritan notes other increase, about that's So then Belgium.

is released. that one Obelisc, commercial end is called building to clinical batch That by for this of demand a first year. plan to the European January. started our And site production which stand-alone production is in bring So

So towards done this commercial Tech the have end then of foot of will physical this another construction by facility at year, called is much the Lane, XXX,XXX square year. we'll larger roughly be by which Ghent. note design. The end And

next early will is production Lane to again, into that year. in that plan clinical production Lane the our half So facility XXXX, mode. Tech to And Tech second enter bring of facility commercial

So those can how those strategies, nodes. to are XX,XXX. the get we that cornerstone And are X important very internal

you last clinical It that, beyond agreement year. with Now IND potentially Novartis supply. year. know, was guys first now, all X-way Novartis executed for this file of a we're expecting X-year we half Right to for

trial Now that for pending the material Novartis to produce start clinical approval will us. FDA IND, the of

strategy our of pillar important XX,XXX. an also to is strategy that CMO to get external that So

on Europe. But revenue combined especially the could revenue you XX-XX, usually allocation it's split. I look capacity at by all is right XX%. XXXX, of split, we demand, from that enough to the once now, shy in slightly the this so really much to revenue satisfy we this capacity. And allocate have only European capacity Europe, the just and last, demand and if the it's U.S. generate then European it's some to roughly whatever prior by think, future, to asked maybe of ex-U.S., revenue we're the for U.S. annual you at comment Ash, both favoring too way we then from CARVYKTI about Obviously, because point all get end So early because $XX,XXX to there's for of us track CAR-T

be the So we should think dynamic CAR-T myeloma. same that for BCMA

Operator

Our next question comes Piper from Tenthoff Sandler. with Edward

Edward Tenthoff

And I appreciate today. update Congrats progress. color the the and on the all good

to you thoughts by Any the Is going from be that the use be kind CARVYKTI earlier So up prioritizing do think you appreciated. CARTITUDE-X. line of allocating assuming with line to as CARVYKTI? really you evidenced utilization. my on they're has see expansion? physicians superior sites, it second Do color move your that how kind How plus to that would on results question do saw really will patients of envision label early

Steven Gavel

that since just we I specific to don't Why question. that Yes. have some data take readout

it's look actually and the all across consistent That's if it. re back pretty showing, versus of been last population step represent data and high released after we how And you just the that's is lines year's by do of about we assume when recently. this of you population, our they if total, research And consistent. and therapy. What we at ran it segmented So risk. myeloma fairly data and standard ran XX% that some ASCO we right that risk high-risk

risk CARVYKTI and have that for in with going to or forward change, they the and -- is even with also that therapy terms is, physician of population in positive [indiscernible] second line. And in this then the was based we're seeing, patients bit So which results shared them data, for seeing population, our a a moving XX% moving quickly line high-risk CAR-T change we're that very well. upon as of earlier was within second physicians over group CARTITUDE-X Ying said sure, a standard risk with yes, see plus standard XX%

quite that's exciting. So

standard standard through trained launch, our staff fully to CARTITUDE-X pretty most partners was last much just up Now -- here opposed which so of of this in front those and for be information, that today is said, as especially from to us. are dynamic quickly fresh [indiscernible] already sizable referral patients and you outpatient our that fairly in maybe our is know, partner those where referral the does group, that's risk that our population the pushing to new most now. go. They'll risk quarter. I data, guess within I CAR-T setting the refer is patients are a had site. the represents patients real a eligible quite ready like the the to tidbit that our But of dynamic, the hospitals that this plus readout were We patient first in as launch

the outpatient say, our this the active to from I added the wrinkle in clinics engagement hospital. really would terms of only, that's into So second line referral plus indication is

Operator

next comes Justin with Our from BTIG. Zelin question

Justin Zelin

the on Congrats progress.

on I you're the on the update that widening FDA's the you out-of-spec the out-of-spec and to Ying, could of recent seeing an rate wanted if give most us confidence window So with submission. your ask

Ying Huang

Justin, thanks for the question.

can X or I last I mentioned, range. So it's rate so, say like in months X teens out what that quarters in has spec is or the think the we the been stable, quite

a spec point, be spec we leg release we trend in to then this hope we'll next another FDA hope approval, and the are at wider the we rate. a very And would pending of seeing up So OS. the get have reduction out significant stable

Now regarding approval. FDA the

of data on our supplemental in as clinical submit So in you based release to asking [indiscernible] did know, June received us data. last widen the CARTITUDE-X from FDA the the Justin, year we it we spec

a this we we provided confident what the analysis call of release to be interaction on sensitivity outcome. At by correlating agency. So should clinical wealth I receive spec with with detailed we the comment wider are we spec able that point, still the the don't but the

what then receive to has wait when we'll approval, guys the the we let have action agency You're see kind the and FDA you taken. to know going regulatory of

Operator

Wainwright. with Our next Mitchell question H.C. Kapoor from comes

Mitchell Kapoor

have I X.

setting? new sales the earlier in patients with their begin assuming the the the have to that would expect of do move lines, to put line force line you strategy on ask moving patients lines? is first you a physician the ask lines setting, Or earlier patients one lines? And contextualize would in undoubtedly into you potentially otherwise us earlier to knowing opportunity initially later treated earlier help can on moving messaging, of true into them approval then the of second setting, kind been new you'll accounts, later who CARVYKTI of expansion of the treat and the strategy first kind in on then is The to in earlier line additional

Steven Gavel

that Yes, That's a this one. for is question. Steve. good Thanks

will -- mode we in launch CARTITUDE-X. with So obviously, we'll be be

So Obviously, second the in of that new the all indication, patients eligibility the we the will be messaging it line hard. meet nature criteria. plus

from dominating be really CARTITUDE-X messaging will and we message perspective, our second-line So here a plus. on really

these could may you who modeling. are -- are numbers numbers help help population, your patients a that As -- math, give the of at treated with This eligible. your that far patients the least some are folks actually patient as and may population, I eligibility but you meet necessarily that global eligible some not criteria, the here these

[indiscernible] XX,XXX opportunity that globally same frontline the number, this a patient setting, about XX,XXX around XX,XXX. is So in tripling CARTITUDE-X, global there's the about number. We XX,XXX. a to to foresee of moving

some will lines. as go in So incremental into hopefully, we terms of perspective you give that impact earlier

Operator

Farmer George Our with from next question Scotiabank. comes

George Farmer

myeloma share use place? for to versus ABECMA. You maybe in you second Are multiple XX% mentioned in that think what's first comment And market decision you the on question, And still even I guys in you profitability guiding CARVYKTI then for physicians Can that can of do driving missed improve? ABECMA this. XXXX?

Steven Gavel

I you was had the ABECMA use. This mechanical again. you We repeat related first question? Could that hearing. -- ABECMA think is a Steve on added and difficulty question little to

George Farmer

Yes.

XX% you And guys And over upon in to even do to with do XXXX. think, decision the like guys market CARVYKTI? share, said use you had that you message wondering that? and had can right? ABECMA, a second you then still Is communicating? So And that improve driving just what's like are you profitability question

Steven Gavel

Sure. one. the I'll first take

me we were some they WiFi Sorry Can your here. having all problems, got guys, you end? on okay hear right guys

George Farmer

Yes.

Steven Gavel

good. Okay,

Okay.

the and are to going bother you I think with, using question do again, ABECMA use first ABECMA. had to once why

think is just, satisfy now is can't yet. patients this large quite I speaking frankly, here, in number what's we this setting second there's the still line and a happening of research that

simple. It's and CAR-T therapy thankfully, -- available. it's you're quite another that therefore, that ABECMA setting. seeing there's in used So

centers. we -- commercial thing map, think territories don't other so United identical the and have The marrying States, We're in in we or all to to about, not speak.

going obviously, that get ABECMA centers in happen to the ABECMA very doesn't CAR-T in So but they're town, is, where they're some only frequently.

us. that ABECMA bit some you of you terms talk might different see footprint the in the where area commercial a do being about want process? to Lori, is use other than just So

Lori Macomber

Sure.

uptake penetration that the to is And continuing and into about to the about be going of of other talked kind profitability our with is costs our our really, of pipeline lines earlier, is revenues I on the therapy for managing then and our drive bridging down. critical in advancement. We've What's profitability component the consistent there BCMA still So earlier program. is to XXXX. talked

XXXX, are we perspective. profitable an overall from break by So we projecting can or company that be even

Operator

comes from Barclays. Our next Gena Wang question with

Unknown Analyst

dialed apologize I already those late, Sorry, questions so if I in been asked.

to regarding So XX,XXX capacity think your first what this And reach would second week. doses? later would can regarding the that I take then end question how in for to XXXX, is that And take? reach question -- ODAC, you long you the past, mentioned XX,XXX of is by doses? And XX,XXX

you FDA? maybe as data discussion regarding like the So to expect the such submit you And can do kind you some neurotox? profile if of what share the toxicity

Ying Huang

This is questions. Ying. I'll take your

take to will I couple It it. at goes So on some take commented point, we rather will that probably investment round capital I one, that. not years to get of to any partner, and would XX,XXX around incremental there. But our put this the previously details numbers think share another I and first investment, it this between of beyond extensive have and potentially J&J, that can with very the go us think current we

to yes, with suffice this our and potentially current go external from [indiscernible] on say beyond round side. of that, partners help also CapEx XX,XXX Just we'll

provides CARTITUDE-X one which they're right? from second of the So the really terms the overall ODAC focus some on. PFA you the of in -- the verbal from ODAC So the of very discussed survival CARVYKTI you have population this regarding seen the the what also patient focusing writing that's benefit that then question -- that communication PFS that's the question. And answer tell in for of it's the clear of in in And context here valued I be curve, the your in can and the focus ODAC, will early first in study. imbalance,

point survival survival talk some I any risk overall the it's they FDA. including sure meeting, I'm benefit CRS, based the X-hour primary the And probably about the the at this from like the issue the ODAC in on neurotox always But -- is mentioned, touch the And SPM not second you. Thank will focus or Now that also issue session. what focus heard is again, of malignancies. benefit. events, upon neurotox, we a adverse ODAC

Operator

question next Kelsey from Goodwin Our with comes Guggenheim.

Kelsey Goodwin

how I first sales in fourth and half fully on 'XX 'XX about given of secondly, saw? think kind quarter that should likely AdCom. guess, back the the quarter sales we the step And the not up of recognized the given we First, being then

CARTITUDE-X? given in for is rationale for both day any are not remind crossover the a same might hang main way? the that, and And the So on obviously a Could in FDA allowing you crossover that up you us focus. do think be

Lori Macomber

we know half for of anticipate want So crossover? in with growth to quarter-over-quarter setting. I we're but into about quarter-over-quarter you, with if the pronounced tell growth, I talk not giving Ying, growth do guidance, you more can second the second line the launch specific the don't year anticipated

Ying Huang

Sure.

question, for thank So Kelsey. you the

some not [indiscernible]. is the which did we know, difference between CARTITUDE-X provide who allow the Care to Standard means did not the there progressed And of on the patients we As over crossover, to study, X you trials. cross in

available X patient commercially And available CAR-T the also, clinical the get of the any the available However, trials. can on and once also progresses commercially Care, can therapies they they bispecifics. into therapy, including Standard actually enroll commercially

you, tell patients briefing on receive. But what yes, those will a see after did So can you patients are progression. out, will when of details Wednesday receive some come the subsequent therapies who therapies CAR-T those I there

that's the So fact.

the about brief with though the before the crossover design. to -- CARTITUDE-X other also allow as including of regulators product But and global very both had the enrolling patients, communication -- a on EMA hand, started actually didn't we the FDA we talk we crossover. not allowing even Now

think will big this here point, at focus a I So of ODAC. at don't debate that be

Operator

you That's Thank today. the have questions participation. we all for for your

a have Everyone, great disconnect. now may You day.

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