Legend Biotech (LEGN) 20 Nov 232023 Q3 Earnings call transcript

Company Profile

Participants

Jessie Yeung	executive
Ying Huang	executive
Lori Macomber	executive
Huidong Wang	analyst
Steven Gavel	executive
Guowei Fang	executive
Dingding Shi	analyst
Vikram Purohit	analyst
Leonid Timashev	analyst
Yaron Werber	analyst
Ashwani Verma	analyst
Konstantinos Biliouris	analyst
Justin Zelin	analyst
Mitchell Kapoor	analyst
Kelsey Goodwin	analyst
Samantha Corwin	analyst

Call transcript

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Operator

Good day, ladies and gentlemen. Thank you for standing by. Welcome to Legend Biotech Reports Third Quarter 2023 Financial Results Conference Call. [Operator Instructions]. Please note that today's conference may be recorded. the of to Relations. Investor hand Jessie speaker now Head Yeung, Relations will conference your over host, I and Public

may begin. You

Jessie Yeung

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

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

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

Chief Scientific and will and joined be Guowei Fang, Development U.S. We Head Gavel, the Commercial Europe. Officer; of by Steve for

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

Ying Huang

third thank Good discuss today to accomplishments financial Biotech. and joining corporate us and you of for Legend morning, quarter

We are over our last therapies made and we pleased progress advance serious innovative on to that disease with pipeline of focused addressing patients face. have portfolio are quarter the the intractable the and

commercialize which we other that and DLLX. Novartis, the global Novartis grants we selectively manufacture LBXXXX with announced therapies, week, agreement is and Last to have exclusive entered an potential licensing into targeting rights CAR-T develop,

lung cell patients extensive treatment adult investigational an with therapy receptor autologous cell for small is chimeric the T LBXXXX antigen stage of cancer.

eligible in receive $XXX will on as receive as milestone up sales. tiered million this to agreement, and upfront an part billion we payment of net well ROEs payments $X.XX of to are As

for ongoing performs We and large Phase look and in be drive dose costs by recommended cell therapy transaction, safety evaluate or will for neuroendocrine with the the and will We're to carcinoma, the direct to patients revenue cell the I our excited cancer priorities. patients cilta-cel to in our and this for with CARVYKTI, II efficacy determine reimbursed this study. forward clinic. trial, Phase how clinical small and we which development seeing continues also lung

worked far are We for third in bringing are treatment tirelessly bring sales net patients to million CARVYKTI to $XXX this have total to reflected our eligible efforts total XXXX year. the million sales who so and in $XXX for of net quarter,

you CARVYKTI well was quarter expanding the commercial market the driven [indiscernible] which in Our of U.S., with contributed to ex XX% quarter-over-quarter. goal growth journey steadfast remain sharing accessible XXX%. CARVYKTI share of worldwide, highlights quarter-over-quarter patients to of as ongoing we available third our in that and launches, we make improvements In market capacity We and by growth Germany, as forward performance look experienced to and to today. U.S.

met for Janssen. CARVYKTI demand with progressively have We strong in collaboration

ramp-up. by Netherlands supply and is scaled First, Switzerland XXXX. growing of complement in supply, Janssen factor LV online should which has in front in-house has in is the construction our often another [indiscernible] is and factories to it manufacturing LV at the the factory in support its any because an be expansion crucial CAR-T LV rate-limiting production important under and

that we're production from Second, still with CDMO side our our on year. increase and expansion track next [indiscernible] preplanned supporting capacity our at is

facility this use will the chain The medicinal product part CARVYKTI clear. Ghent approved important hurdle facilities manufacturing Medicines from investigation to of our license state-of-the-art local in by important for in has at year. dossier an the Ghent supply end begin clinical is of be Belgium. This Federal once a was first received of will Ghent an of network. Agency cilta-cel by Health the manufacturing And Products authorities Third, and for the

committed to more this bring therapy. We're important eligible patients CARVYKTI for who are to

patient. Our X with cilta-cel, the Janssen. trials our ongoing as X Of evaluating as development program manufacturing Ghent continue for the III well ramp-up its activation while facilities of first patients. CARTITUDE-X, frontline clinical began our us new [indiscernible] the patients to commercial enable our Phase are of X will we in study supports delivery ongoing onboarding clinical The commercial and enrolled U.S. ramp

roughly CARVYKTI we making In addition centers in capacity including access to are select to the across treatment European enhancements, expanding with work XX and U.S. countries, certified Germany.

bring hard need. onetime efficacious working to to are multiple Our treatment patients teams this in on fronts

cilta-cel. than to We more pleased since we people that with share began X,XXX trials have treated are in XXXX,

also of be tumors. solid to is deployed our in The cell both other validated is in can used will robust, be transaction develop other in as primarily from in LGXXXX programs potential ] hematologic the Our assets pipeline exploring and Novartis cell allogeneic The our therapies. also funds and therapies such promising the [ used [indiscernible] we're pipeline clinic. malignancies pipeline with

our innovation explore excited in about to progression. their and are continue pipeline We

to to want turn I it Now Lori.

Lori Macomber

Ying, you, everyone. Thank morning, good and

As $XXX total quarter, generated our year-over-year over in Ying quarter, the increase. XXX% driven ongoing market by sales, mentioned, market pleased share with performance That also represents approximately million CARVYKTI which are increase improvements. the an we of this previous and product capacity performance launches, very XX% expanding commercial of

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

outlined plan cilta-cel. million sale milestone quarter and CARVYKTI for the $XX.X global under will deposits expenditures for for revenue $XX revenues time were investments Starting collaboration in of as $X.X the of million third the our and development Starting a fund revenue. of of Janssen and XXXX. equivalents, the into billion, this Total million, from achievement the consisting cash license Agreement in operating quarter $XX.X in with and planned revenue during with the cash capital short-term

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

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

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

clinical of quarter same X Research and compared third for the the XXXX, development months million The expenses million the ended $X.X for for September compared to last million were $XXX.X XXXX decrease period year. XX, to $XX.X [indiscernible] Janssen CAR-T transfer of due the Pharmaceuticals and X Corporation. XX, product agreement timing to expenses the manufacturing connection in service Novartis months for with and ended was with XXXX, incurred master September technology

for for the facilitate period XXXX, September business of months X growth expenses last $XX.X functions million in technology to of Biotech's continuous and XX, global Administrative $X.X compared building administrative The year-over-year million increase expansion primarily continued Legend to $XX.X same investment ended is due the were year. infrastructure. to million information

for the due the XX, associated expense million the distribution $XX.X to million ended CARVYKTI. months was compared million for of year. $XX.X and with XXXX, costs September commercialization same $X of year-over-year to X The last Selling increase period

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

to you. of fund remarks. it which and leaves capital September will Ying Biotech and equivalents, back for XX, investments, $X.X Legend in I XXXX. deposits will now and expenditures As billion pass we Thank closing operating cash had into

Ying Huang

to we remarkable be the closing the for XXXX look quarter. Lori. to Thank you, year another in forward Legend continues out year Biotech, strong and fourth

our have of and capabilities strides in lowering enhancing made spec out We considerable rate. our manufacturing

therapy company cell integrated fully a tumors. be solid and malignancies focused to proud We're both hematologic, on

open we as we encouraged responsibly. to Looking our long-term forward, we'll today. capacity value Biotech, continue continue and We'll the call work our up We'll these expeditiously questions. manufacturing At our deliver to to pipeline. shareholders to to patients to Legend CARVYKTI us joining deliver for you invest developments. for in expand Thank are by also strive and now

Operator

first is Our Barclays. from coming the question line Wang Instructions] with of Gena [Operator

Huidong Wang

Also the quarter. congrats on great

the maybe require have that an based morning, is we think PDUFA they are with So the interaction you what And regarding on far? a got and outcome? also I pushed news, [indiscernible] FDA this I maybe One questions. so news, And out. the X saw is ADCOM your will anticipating

landscape. is regarding And competitive question second the

of related update at staying a setting? see ASH? competitive. the is other some the profile, What thoughts your question regarding And will the In is terms we outpatient commercial efficacy strategy in

Ying Huang

the for thanks questions. Gena,

first our the for take be will regarding I'll first, competition. which ODAC X the that So outcome by FDA is hosted

the the agency I So to trend typically, a so that standard benefit. emphasis survival. the an that on significant on benefit, CAR-T overall benefit in plays can encouraging our with tell clearly, survival far filing, demonstrate an have you PFS the interactions given our OS And is you overall with agent FDA

August AdCom X advisory on tell So not that we for filing FDA anything further, can we without advised That August. I of or by to you CARTITUDE-X the supplement. that to agency, planning disclosing received hold was this an as discuss were when was committee acceptance

say last at seeing overall tell [indiscernible]. FDA overall also and the since I for the on the I'm additional submit about we the survival pleased data, And we X-month remain update Secondly, as from trend presented that you stronger very survival our the did profile we to [indiscernible] confident part of of when very a CARVYKTI. to safety that's what was would update, again, so-called are data

of in but with dosed patients last CARVYKTI, that CAR-T started we any after stand not which X,XXX been includes patients dosed also China. program, I'm competition, into by already setting dose various and in efficacy behind commercial also ASH the we in on year [indiscernible] the Secondly, who since and and data, the than and and more program were to approval FDA patients safety comment competitive

we to in are of every see response we So have very setting durable deep, tested happy very so multiple the consistent, myeloma, very, far.

the ask Steve? my Steve comment. to With colleague, I'll strategy, commercial

Steven Gavel

Thanks, Thanks, Yes. Gena. Ying.

question maybe bringing I how what's that. claims of at in exit. an that's around obviously, doubling from share We is board the on year you our is also supply our I give area. your getting update CARTITUDE-X predicated next were perspective, constant do next would to as measuring our holding and exit sites consistent XX% with we in had share lines think inpatient particular right terms on versus even in data a could earlier forecasting I really that outpatient launch It's about on maybe market. to now, just We're to enter outpatient. We up. happening and But hope year, into assume

Operator

with next line our of coming question Chase. from Jessica the And Fire JPM

Unknown Analyst

wave of Novartis next you interested the licensing, be? might talk is the what about can heels the of targets Legend On pursuing in

Guowei Fang

Jessica. is Thanks, This Guowei.

in [indiscernible] franchise solid the at have pipeline, same on front. as targets In we as broad the into to internal pocket the also continue both time space, our well momentum indications. our focus extensive we in building So the cancer tumor expand

have as we profile on in in investments and expand In platforms, to collect several our years, is are in compound [indiscernible] past deep primarily and to platform we focused well. and alergenetic setting, [indiscernible] response blood have platform communicate clinical offer the space, we indication. platform Currently, allogeneic is the cancer several different the waiting tested on the

Operator

Shi And Kelly line question coming with the Jefferies. our next from

Dingding Shi

progress. follow-up. holidays Q-over-Q you demand a QX, in CARVYKTI as seasonality and Congrats on estimate mainline the think increase settings the experienced how manufacturing great Legend the the and capacity How we growth considering great of also, have do [indiscernible] of the and launch. into also And also from J&J impact a the should about level

Lori Macomber

I'm Thank it just you and you. Lori. turn Kelly, then to over I'll this overview give quarter-over-quarter, Steve. to going is

are as QX, doing we've As talked about into you a we step before, up. look going out

comparability We have we're we've that XXXX will in additional XXXX. getting for of gotten until launch. QX, to support as the these capacity and But up our we second-line QX nodes be really as some indicated of see signaled And impact runs before, of reminder, won't running help also we've for some that a you manufacturing as doing approved. that

QX, that, over you're those with we're it because to giving of activities. but guidance, to quarter-over-quarter And going growth both at So that, Steve, specific I'll see look turn not if you. not of you significant with

Steven Gavel

Steve. it's Kelly, Yes.

to [indiscernible] think with launch. the tech I do

to market see been we're that seeing we're to that market therapies seeing you has a I the cilta-cel. it been is share what from in demand terms going market of So in you're think that's the with line coming [indiscernible], where robust erosion, still CAR-T in running in from I And if we've seen you our data erosion continue market that bispecifics, in out share [indiscernible] terms of We're later see search. research see in latest of see coming settings. where

Dingding Shi

And enrollment frontline the even regarding on majority near CARTITUDE-X U.S. in do pace share And Terrific. also to the Could to initiation we expect compared the you come population. enrollment of -- trial CARTITUDE-X from should transplant-eligible trial? in the consider the start term? Europe, actually patient impact you enrollment

Steven Gavel

Kelly. Thanks,

patient enrolled announce last the pleased very Spain. month has first to in we're that So been

percentage officially have going soon. in to also and this can will promise are U.S. representative off certain the to a you the that to U.S. have submit we enroll CARTITUDE-X in So of a U.S.-based because we to sure overall. patients very initiation later point, enrollment of to the tell the we have agency kicked we we population that make At I initiate patient data the

Although CARTITUDE-X. majority enrolled of be probably ex the for patients will U.S.

Operator

Vikram next our from Purohit And Stanley. line coming question from Morgan the

Vikram Purohit

X. had We

line the by us were ramp in First, for CARVYKTI you through CARTITUDE-X to obtain based like use you latest in on the for to earlier April. just the your thinking assuming onwards. label expect on what walk data approval expanded look you XXXX next Could

to back of topic then competition. And secondly, the

this that for [indiscernible] if I And [indiscernible]? at point response commercial wanted So includes any expansion efforts impact you've a and J&J to Bristol-Myers feel [indiscernible] [indiscernible] and CARVYKTI noticed broaden and to Bristol-Myers from increase have the in marketing site behind out the push your mentioned bigger to those competitive that to making spend, they're in if therapy. see promotional you need from efforts.

Steven Gavel

Steve. It's

So let take them. me try to

manufacturing I delivering to sites spend. also We'll expansion we I had is expansion increasing. around this our part the will do in right XX site site second your think, predicated on sites. with capacity promotional continue question expand over our exit to We'll see time. year, think of

are we the be end [indiscernible]. about by of year next between exiting to targeting So at

answers hopefully that around expansion. your question site So

are in treat. to terms created just remember, of they And continue I the sites as not patients more site as of is this I state there, that All equal numbers than expansion. these

our within we to is demand ensure those accommodate the Our continue that to site philosophy increase expansion can sites.

can question do second with had I CARTITUDE-X to help your the think Yes. or [indiscernible] someone ramp.

So thanks.

ramp perspective, in initially a second population also CARTITUDE-X the the in filled assume planning of in plus. terms release continue forecast we ASCO, in and we're of we're in especially the research we to also CARTITUDE-X standard the demand ramp-up, high-risk quick risk population. how So we post we line the were seeing very data, once some In that the high

our much So patients. beyond than CARTITUDE-X the we as But again, excited, very generally were speaking, can you we see launching it thinking group. we're imagine, in broader for initially high-risk

Operator

Capital line question next Markets. Leonid our from And of from RBC coming the Timashev

Leonid Timashev

hearing in Congrats little just on Do quarter. a capacity actually I there's stick BCMA the expect lift to continuing something is space whole to I as actually CAR-T and launch with you're competition and that CARVYKTI? CDXX-directed capacity. constraints the wanted as discussion for was a bit. CAR-Ts this that competing you're the We've been continue? guess, for infusion you dynamic or to seeing any beds been

Steven Gavel

It's Steve. take I'll that again.

a that's very, think I very point. good

why you're cilta-cel. hospital this to that's for So sites a it's so percentage is important, seeing moving large of outpatient now why

it's inpatient point, the continue We you therapies were into how we to CAR-T cannot launch. mortality. it to as your reason market outpatient single to treat the that very just your And valid to so capacity to leading yes, a why a monitor increase point. was to was that knew moving So point continuing

stated So patients earlier, see X you the I outpatient the significantly now as continue you about treated grow over right? to we out that is running address how market to So that continuing setting, way, of essence, and in to time. X capacity moving at XX in see and ways, monitor being

solving first piece of issue. that the of that's So that

that sites way to And we'll is resolve do and you themselves, as well. second continue that increasing then the by

a combination of moving different So of number a parts. it's

indication. in more market And to our pull more the volume also moving -- we'll enough continue sites is setting. your So to we'll patients we see of and ensure accommodate, the to to or volume that for to enough then have sites [indiscernible] outpatient through the point, add patient have how the the

Ying Huang

I want Maybe this add is Leonid, that. And Ying. to

look every United setting in X,XXX at the it's performed transplants, the the year performed are market. transplants of myeloma, about If of in States that you that's number

least multiple we're approaching point, this So we for myeloma, at in not of that limit think yet. terms at

our Thank market, X,XXX number know, As supply look the that we're at you. you you nowhere right, yet. into if near

Operator

And Cowen. with from Werber Yaron question our of TD next line coming the

Yaron Werber

have Great. X. I just

capacity is The looks it sense how us a now? Belgium now, in to basis, give Or what that for that give has on slots And first a know of you authorities. and And in little that secondly, a plant you're hearing of facility bit the much and of we're one, you're approval many sense, a don't wait then but how limitation Europe? centralized if is a any reaffirm a can in approved enhance just us in later up to that slots can like now need little Is you it not and do of Europe, EMA? on sort Europe? bottleneck you in local [indiscernible] of on, differently have you're you're not can you local to I different to that the done [indiscernible] there it? going become got sort foreseeing bit the as more And of potentially noting capacity. ramping I might investigation

Steven Gavel

Steve been question them apheresis onboard collaboratively by sites the a with question. [indiscernible] as having crack of I is conversations know at really again. to certify Why work The This we've take a site. and varies we our don't number them. I

by really be looks what forecasting them, CARTITUDE-X importantly, But now. the addressed being they pretty launch, they are it question volume for by CARTITUDE-X. what obviously, upfront is but whether have because doing obviously sites good the like for is So our apheresis idea, the more a

different number the now, I capacity. number So in [XX in capacity roughly ensure of we to guiding was sites, capacity a to do to number this ways, earlier earlier the in that gave take And these addressing that as the want like to of question? second is that question keep marketplace this a questions terms pull I to ] response Ying, indication of through. enough said, you are aggregate I around of mentioning, this XXX number of I terms right in has

Ying Huang

question facility. the European the take I'll about

the issued receive month production sorry, which part specifically FAG, in by So for is sufficient counter GMP about certificate us the in a local did question FDA. FDA on is in clinical start -- to of we the U.S. Belgium. And Belgium. And your that U.S. then the next

now, is production certain clinical seek in start producing So commercial year year or plan And of planning our we're clinical right about [indiscernible] end Belgium facility to start to our approval regulatory in for mid correct. by then this next trials. for XXXX, to

to Initially, European we're market. planning supply only the

point, not capacity have back then approval. and that case do FDA this the where plan use we at FDA we come approval. in need we could the So ask future, the Ghent excess from will facilities, to we In

you're demand. the So patients, the still, producing now, European we're and commercial that you facilities clinical production help near also materials the the as But our need both does demand future, FDA. trial New very U.S. only only trial our Ghent right, we're designating commercial for in in right we Jersey [indiscernible] in commercial of CARVYKTI our facility. U.S. right from clinical because, by know, and supply But for case now, would approval the

Jersey get, hope up free trials that slots our European facility. the can answers [indiscernible], question. I market some to clinical from and we that your also of more divert whenever will demand New So from

Operator

from And the Lin our Heisel Sachs. line from next coming of question Goldman

Unknown Analyst

questions quick on the financials. Two

starting should expenses in How CARTITUDE-X are X enrolling well spending see as CARTITUDE-X R&D enroll quarter. R&D is flat we the now we and first for The remained fourth to margin improvement quarter and it decreased And is the you for still gross color seems with XXXX? profit second near that share in in and margin quarter-over-quarter. question term? can And gross us any potential on the slightly the profit over

Lori Macomber

front This I pipeline. the been think as see pretty well mean quarter-over-quarter. activities CARVYKTI in have the spend, R&D the lines itself is a program to Lori. our In you'll as I our regards consistent investment for with consistent

we to consistent XXXX, So continual expect going we spend see our historic. into continue with

the second repeat you can question? sorry, I'm

Unknown Analyst

sure. Yes,

gross do see profit a The second margin. When increase about profit expect question the to on further is the we margin?

Lori Macomber

a So from have perspective. been improvements seeing a perspective, gross from margin product we

in we reminder, margins, related OpEx a well for have product the As to gross gross as the as there investments. facility margin

improvement margin manufacturing, we margin to why in you hard because to talked So so expenses gross gross capacity line. it's about, as see that's for with expand to in we've hitting our the have continue we continual continue that

made guidance margins a as on increased have specific don't volumes those process we but some perspective, percentages. from we've as our give product actual But are our improvements, improving and also

Operator

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

Unknown Analyst

CARVICTY? about that through maybe bit tumors to I'm ask I for DLLX more walk And about us levels you broadly? expectations solid broadly. more DLLX talk And solid I Can for dosing how actually your to dose [indiscernible] going the follow-up. relates in the Phase a little versus tumors a have

Steven Gavel

for is Jonathan, Hi, Steve. thanks question. the This

X.X look will disclosure until test million body weight body kilogram from to on So kilogram X doses, weight. million our per clinicaltrials.gov, at we're X million if up per to ranging you cells X see different you that planning

is foresee bit a hematologic this because the And is that little a weight-based dosing dose we need solid this a may tumor, in So than cancers. you bigger and plan.

such the prior is T at bit probably indication, a our starting look if cells. multiple given that dose you dose-ranging we of hematology amount a finding larger this little higher for trials need as So myeloma

TGFBeta the expansion namely ] [ to into armor other setting. put armor the dominant on But the hand, negative penetration we tumor did and an help

DLLX is I. we're for So Phase the dose that and looking at

Unknown Analyst

should we some have there an period of for ramp And be to you will us get how spec Or approved. change on immediately on of approval? that recertification that impact when on expect -- out rate that? big it the spec sort out of happen then Can label. or does a rate And assuming remind will

Steven Gavel

Sure.

randomized the Phase so-called to back significant data we to widen our the sBLA of trial controlled the population, sensitivity beyond trying part So the a release on the clinical ask outcomes, release III and line such second provide based the submitted to to of agency the from filing in clinical analysis survival. we PFS the back correlate as with amount [indiscernible] because FDA,

So then back. we receive confident able rate we the the And a to to hope decrease wider be is our at additional that we if auto eventually, agency we are it based on our wider a spec do that such XX can that partner J&J from from data, respect and very should release where by of That X expectation points today. is course. receive percentage

We have to wait April But hits. until we see the the is label hope. and PDUFA back release also date that the our the FDA next approved when

And of second say, little the let's a to receive to the line in we today, because we is back wide a a if label second question, part time market, going then to start take bit your it start uptake. out to the see more we once do roll and release of and

You will will gradually manufacturing see the that take lower OS process. in place

Unknown Analyst

that a to take said Just time you're you going to is [indiscernible]? benefit say clarify you see only see second because when come also apply Is benefits there, to what the out-of-spec to line in you just little patients? out-of-spec not manufacturing plus that it going that to through,

Steven Gavel

of uniform a the that release get a us. don't because sets the we which the agency before. in you're answer to indication X what an possible market. wait would have CDXX but the question, raised indication, and CAR-Ts Unfortunately, you of and I'm it's back I also X second from release good You Jonathan. both we'll have [indiscernible] happened possible us very see backs, give aware first to gives decide sure the that It's to

question. the wait says. what I at the see actually but to know have don't So it's point, very this FDA We'll answer, and good a

Operator

of next question line Ash our from UBS. And coming from Verma the

Ashwani Verma

I have X.

is with partnership your see program are And where more CARTITUDE-X I with the could to you wanted [indiscernible] eventually of Novartis, could to that tomorrow? and late this study you lower then Second the something that to that at the the just breaker use ASH for abstracts Is on F, ASCO one, just wanted [indiscernible]. Or next see E to just get idea. an the So cohort allow we further year?

Guowei Fang

by the development Internally, process a to manufacturing the in move is into we for are future. unique cell applied charger developing LBXXXX. So manufacturing this platform, also and and going we for Novartis, other tea platform process, local it's internal manufacturing are therapy developed product only

Ying Huang

the this Ash, of I'll Ying. which Cohort question, E with to your second CARTITUDE-X part F. is do and has take the

you both can is I quality tell patient Cohort we not cohort. long. the for because, E as point, release have at moment at setting, PFS and newly the frontline know, enrollment But you this to that So data the we're completed in typically to this in diagnosed F relatively going

So we be follow-up. believe present longer data with we a it will more when informative

Eand stay should you future. tuned the Cohort So when we in present F

Operator

from Our BMO Konstantinos Biliouris Markets. next question coming Capital from

Konstantinos Biliouris

completed, CARTITUDE-X comment quarter. Hello, congrats in the manufacturing everyone, we and this any the the these [indiscernible]. that you from the tier trials. commercial than expect CARTITUDE-X, Can on us or is the the increase larger from given One X CARTITUDE-X with slightly enrollment support are and on impact somewhat independent clinical should and question now on from whether on the clinical is ongoing slots Novartis

Steven Gavel

for Kostas, you, Thank questions. your

U.S. CARTITUDE-X now very And representative have CARTITUDE-X to on in we're would much of patients complete U.S. at because track call, overall a the very looking population this year. enrollment patient CARTITUDE-X. ex in mentioned this to we're of on enrolled as previously like in CARTITUDE-X, we the in I So the potentially end over-enrolling U.S.

by we're But this point, I year. for the we're CARTITUDE-X quarter tell end of pleased going probably down by can the status. we're year. into said, at much enrollment for first pretty ex I next that U.S. you extend Like portion quarter the to with X about very U.S. of So this the enrollment

like is we'd the we and to want U.S. do U.S. up have this everything but that patients also the demand percentage of going given plan, fact given So trial. the to according higher from patients in a over-enroll to in

we patient row. last years a just CARTITUDE-X, in take couple On started of our Spain, will while it us first and probably month a about in

next online production. utilize to plan we that's So of from month regarding capacity CDMO demand additional production our satisfy will to that also production, for our now. CARTITUDE-X. CARTITUDE-X the is could our to We current likely coming Ghent facility use start That

Operator

coming our line Justin with And of Zelin from next BTIG. the question

Justin Zelin

Congrats strong the on quarter.

So can have internally just you you strategy. continue to in look just been for to partnerships how pipeline could future? CARVYKTI Will give them for seek today, And and the us forward? an out-of-spec Or bring on assets on the your you update rate second, them develop trending. pipeline things

Ying Huang

pleased so. last the months about or out-spec talk I'll Justin, very X rate where in question. have the trending We're So things been

out-of-spec rate also from below has the rate. very the does Thanks been now, the Jersey team range. team Our in the label out-of-spec stand And and And J&J in much right XX% the Legend hard on stabilizing. to New it's been facility. work and it decreasing consistently teens

tried reasons very our various by OS have to work product streams. OS hard our looking manufacturing for refine and on improving various We at also

So where are. that's we

I competition don't think very at we're out-of-spec the rate from different much this point.

after we're think the to this second like especially do go line I So approved expect continue mentioned, And down, encouraging seeing FDA we a I very to indication. trend.

our the pipeline, to colleague, I'm Guowei. refer On [indiscernible] going question, the that to

Guowei Fang

question. the Thanks for

the to open internal as seeking In development collaboration we both are terms development out of pipeline well as strategy, partnership.

individual differentiated therapy is accelerate to the of each to time bring [indiscernible]. value development potentially maximize we Our development for so patients that transformative the and line can pipeline goal assets and

a and ourself LBXXXX, for see this In particular we between unique synergy case Novartis.

has sequence and particularly unique overcome and to its design, lung cancer. product the cell armous environment, mechanism tumor of unique which is immune the unique disease in suppression unique process, manufacturing a immune for a whereas Novartis important market infiltration facilitate cell have construct small a We

the grows value you faster manufacture and that As profile. add would product to disease process know fast very

this synergy. in see the we So case,

the to find to the value by asset asset, And we time, ourselves. and can value try the where then if future, will we develop additional and possible. in continue by asset, it's synergy the have realize At we same

in also will [indiscernible]. We do it

Operator

the Wainwright. line next And coming of our Kapoor question from Mitchell H. C. from

Mitchell Kapoor

constraints. we if where a little more to bit give sense a of demand. quantitative I you of in ask just kind wanted are of terms supply the about And meeting could

terms just in able quantitative of about there Could of we're lot understand talk think can't a -- the you you you I where was trend? if point, at supply think about be demand I met. there And help at could a was exceeding of kind number, XX% to X today? just give us being

Ying Huang

question. the to answer going And one. for thanks Mitch, this I'm

you reported look the was you million if last we you exactly last U.S. coming number in quarter, million served the $XXX of the patients of and give revenue which guesstimate cannot $XXX So percentage at sort demand. commercial quarter. the I setting the of can from

seeing we year, month. from tell in are can much in I the the our number of I patients in waiting satisfying, really backlog pretty always queue you queue. the of but the in beginning every We we're you until the terms track now, exactly tell patients essentially And January of backlog starting the from can same

any seeing difference at to not very robust we're So working point. and supply. hard demand in for we're initiate product of this reliable terms And this

So expand we supply. going to to our are continue

receive the did we increase on our our from colleagues call, of capacity As you the FDA in just approval the recently. second heard

So year ramp next Jersey then from increases up that New well. approval. we're in our as planning continuing facility we're additional capacity And given to

die CAR-T If are you to patients, look receiving we market of patients about think therapy. at XX,XXX addressable patients and X,XXX U.S., the for number are around from multiple unfortunately, probably myeloma X,XXX in the so-called every the year, within eligible

this point, still being nowhere think we to our supply, this at demand given near we're So the point. or for CARVYKTI supply able at

Mitchell Kapoor

sales is approved? kind us with Okay. can [indiscernible] us like else looking messaging help it preparation you for you're preparing about how into understand could launch earlier mainly you And just Is moving just the force? what tell for of changes Or the what lines?

Steven Gavel

that Steve. take It's one. I'll Matt, Yes,

right? these a lines So different, population So line from moving you're reliant were be will later type of second-line it's population, different the largely a launch many of that -- this largely major was referral. from a In very academic patients bit earlier centers. you're no, the largely on the where our

that working our with partner U.S. models how has of to to referral appropriately the very is of the what reach through X is our made So working an that centers. in closely clinic outpatient team been cilta-cel appropriate ensure to terms

So it's different. bit a

largely outpatient space. they in You'll at expansion see behalf largely our because play FDA in on that Janssen increase partner of some

I opposed Legend you'll question. around for see answers increase built that some hope U.S. but has our been as legend From footprint commercial outpatient. the as to we increase largely perspective, your setting inpatient sites, the

Operator

coming line And from our next [indiscernible]. question the of

Unknown Analyst

at I margin the the on currently on just Well, results. quarters. follow-up gross a past X Congrats have over the XX%, XX%

So you mentioned about expanding capacity.

our coming So spend have as what gross multiple facility, margin and rate. improving online given the we on an are on the both well as other driver external margin internal

And what even be parts term should the we of profile margin actually? So maybe the in longer well. as the key thinking are how

Lori Macomber

margin, there's X gross we the gross the on in as margin. components again, just talked So about,

to perspective, it's out. your you So from model little it bit look at when a hard you for quarter-over-quarter,

margin mentioned As perspective. in see from before, product we improvement a gross I the continue to

Your are at down process going up, we've that's of based out as have the upon gone plant. to also your gross go improvements we've made margins our volumes improve also spec

a we get going the gross report of of progression the we seeing margins that perspective. improvement So report in capitalized. because the it we product to from number you're to cannot have expansion, side expense facilities that steady are the continually noise the externally be under But

And going [indiscernible]. in on as know, we have expansion you

CMOs. expansion on and also with we We in Belgium, expansion going have have going our on

continue you're going of capital So of through facilities related XXXX. lot those investments a end expense to see to the to

it's to noise. So going create

to with upon are those be quarters capital are others, where of Some just projects. we going higher depending some than

any and disclose I I to you -- numbers can't you if go give something more up talk there's can't to try a can perspective. product any more a bit if question set granular want we detail, call and specific, always submit and from granular a over numbers But but little with

Operator

the with from of coming line question next Kelsey our Guggenheim. Goodwin And

Kelsey Goodwin

kind quick we base updated items? you about questions capital I line Congrats in expenses failure what view the maybe those maybe guess, of up think longer-term guess, do that, of spec then on for for on gross no do venture, building me. of these first, And are for the the you on COGS longer-term included profitability longer should yes, guess any kind of how joint about I kind have out these some And I in assumption on CARVYKTI of COGS? we rate in quarter. X manufacturing following kind the past of for margin. think should once ones how on

Lori Macomber

Kelsey.

still the consistent messaging before. with profitability, is what signaled So we

we're For have looking there. and always perspective, of breakeven put to the from by And striving a BCMA program, profitability in by And end profitability a to for happens we we're business perspective. do development, a company I we've disclaimer will XXXX. XXXX. know pipeline our what been with from we based But upon now, what is depend what signaling. It the of development look trajectory upon the what that

use for at actual COGS, the longer-term I for that through say the going in as continue you're a earlier, would see to could the all on be We're proxy purposes, standard been for I into guidance any end would XXXX. COGS our going your 'XX in your of to good From It way industry. noise COGS. line, modeling mentioned you not probably a what's modeling. the you giving

Kelsey Goodwin

hitting end what then XX,XXX maybe extent on And that is the doses commercial guess, XXXX? follow-up Okay. year? reliant just that by by is quick on the of much I Great. the X How breakeven profitability. profitability that to

Ying Huang

modeling. typical you of you antibodies. at can what look somewhat monoclonal hope really is cost But a understand modality, I cannot general that higher CAR-T the probably we than is for if I goods as internal disclose our the COGS that Kelsey, of say goods cost the

SG&A lower. of the it in be selling will terms distribution much and However, costs,

from look we that in sales financials, if year. marketing, last CARVYKTI it's actually tell this we can you almost quadrupling right? While and sales year, slightly for than lower our year spend our versus quarterly You at last spent what

[indiscernible]. of profitability hint we how a gives that So think about CARVYKTI the

Operator

Blair. from line Corwin question Sami William of And our coming with next the

Samantha Corwin

Given on then will that we enrolling do you you from now, trial? revenue should plan CARVYKTI on CARTITUDE-X that guidance over XXXX. data any when of for providing delay And expect plan beginning

Ying Huang

for the Sami. question, Thanks

much the just patients to close on U.S. are which question, this patients majority any I next plan. mentioned, CARTITUDE-X, we're all And year. sure expect U.S. quarter because like that enrollment exactly So first our by of according for trial. is a have don't pretty this the of no, we of the delay the track the That's U.S. percentage only ex end we make to in enrolling in to over we then on representative

So of readout not at do CARTITUDE-X. expect delay we this in terms any of point,

not the has guidance specific partner [indiscernible] guidance. And then product of XXXX providing on year product guidance, we're because not for our of really giving policy J&J the

for you guidance not will the we with to provide a unfortunately, CARVYKTI in sales. So be position

Operator

Thank Ladies And this questions today's we you may participation, call. queue. this and at have now your no in time, concludes the for conference disconnect. gentlemen, you all further and

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