LEGN - Earnings call transcript Q4 2020 | Legend Biotech Corporation

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Legend Biotech Reports Fourth Quarter 2020 Financial Results. At this time, all participant lines are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference to your speaker today, Jessie Yeung. ma'am. ahead, go Please,

Jessie Yeung

Corporate I Biotech's is year fourth This Head conference everyone. Legend Relations Welcome Biotech. XXXX and to call. of Yeung, Jessie Legend quarter is and hope morning, Investor safe for everyone healthy. earnings Finance Good and full

today's Ying me Officer Executive Financial Huang, and on Joining Legend Biotech. Chief Chief for call is

of certain website. actual accessible from As presentation, company's vary the prospectus being identifies the underline made is or note details, this filed any through those update Legend Investor Biotech presentation statements. may June assumptions usual, of specifically the review includes or from just materially materialize, Biotech in incorrect, X, cautionary results may as before in forward-looking differ should risks to We we get actual factors company's regarding any the Relations materially today's one the to that encourage today's projected, more obligation should those disclaims with section via statements. presentation. such well statements prove Please review these the webcast, Legend described more which cause statement this into forward-looking as available the that uncertainties to you or on results SEC

Moving today's to agenda.

Q&A remarks XXXX before would data I We call Then will call opening we quick Ying. conference turn ASH session. the be to end starting financial followed a results. the with a by to of with now we will the review today's like do

Ying Huang

and Welcome our quarter results morning, XXXX earnings everyone. good and call. Jessie, to you, Thank fourth

hope everyone would like I healthy. thank is and safe I and everyone before start, So to

we what the do call Legend, is here we we and serve today's why here begin do me to by at it reminding patients. what Let do

of to for with be this effort. part patients Our to team diseases. innovative extremely am to Legend tirelessly debilitating a team living proud and this I Biotech therapies bring works at grateful

and ASH recent continued investigation At from a J&J Phase CARTITUDE-X very collaboration show we of rate. overall cilta-cel XXXX quarter exciting X response partner achieved of data Xb the the therapy. critical and XXXX, fourth of Legend Phase The to conference, study Within results milestones. CAR-T shared our high BCMA-targeted combined and

of patients achieved a Specifically, response. XX%

relapsed patients XX.X of median to for the Also XXXX, response we in XX% myeloma. complete Application rolling cilta-cel. cilta-cel FDA safety that This study on at and submission BLA from License importantly, based a efficacy evaluated treatment Phase the is in Phase X a follow-up achieved or stringent of pivotal multiple results months. and/or More the refractory initiated submission of patients with of the Biologics Xb, of U.S. December CARTITUDE-X

LBXXXX, We cleared the is also application for targeting announced investigational for the U.S. FDA autologous treatment Biotech's of which IND CAR-T lymphoma. T-cell the Legend CDX

cutaneous lymphoma in also T-cell medical for that peripheral first-in-human Given experience of treatment the with remains initiate even these patients substantial T-cell this and study with United With portion lymphoma Phase X to clearance, high a we're current unmet need IND States. planning patients. there for relapse, LBXXXX options, a a

evaluation the treatment days. for our relapsed means for Committee achieved partner assessment assessment, or the process The for Medicine the of usually EMA, instead the of collaboration accelerated of Agency cilta-cel. in Janssen, accepted takes Europe this for Use this XXX evaluation evaluation Products from request which for CHMP by accelerated also Medicinal assessment refractory days XXX we Lastly, and designation Human in European the myeloma for

XXXX. over XXXX financial let's to fourth also from the and Now turn results quarter

share our CARTITUDE higher driven were mostly a program number trials, a was about well outpatients as $X.XX the as in Loss $XXX standards Our higher also and for compared loss to number $X.XX, share XXXX results a of XXXX. of program was under well IFRS million. accounting clinical in loss as per as to by per these And This XXXX. in XXXX $XXX million team loss net in of CARTIFAN for larger compared China. clinical

targeting controlled X trial trial lymphoma. the X This conducting loss and of Beside non-Hodgkin's with loss for per as was CARTIFAN-X. cell to includes share the Phase CDXX, also allo U.S., ongoing In $X.XX In the Besides XXXX. In robust to in comparison, continuing T-cell million field of In loss a terms program. the $X.XX, and dual $XX the compared the XXXX, dual XXXX program compares for trials. X CAR-T, see, conducting the quarter-over-quarter XXXX. you the of a Phase we're leukemia for cohort CARTITUDE-X the CARTITUDE-X acute share BCMA that globally next-generation we're studies push in we quarter in to QX China, Phase auto studies, targeting our fourth program, the or fourth the A X BCMA can CDX pivotal the which Phase the therapies. quarter in IP two of in of CLL-X first-in-human for CAR-T Phase active next slide, and quarter Phase million auto continue CDXX lymphoma conducting X allogeneic Loss China. X also was CDXX randomized pipeline of active $XX conduct we're five the about we're CARTITUDE-X of CAR-T forward targeting per fourth studies. to net

lymphoma. one CDXX non-Hodgkin allogeneic CAR-T for is targeting first The a

is the second gastric CAR-T Claudin cancer auto solid The for we're gamma a targeting conducting pancreatic one targeting field, treatment and T-cell tumor BCMA cancer. myeloma. of for XX.X, study a delta for In program

ovarian targeting auto In addition, for Phase X a we recently a started for study cancer. mesothelin CAR-T

take to presented some conference. was the at Now data that moment recently study clinical CARTITUDE-X ASH I'd from the the XXXX of to highlight like a

see to you show specifically the a can rate, achieved this a response. the continues out enrolled from data high response patients XX slide, overall very As of XX

reached a recommended profile Phase has This dose, cilta-cel achieved More importantly, complete XX.X safety progression-free per a yet. X.XX been at data patients million weight. also median the and which follow-up the not of the demonstrated X XX% months response stringent for The median body of is those study cells with cut. survival kilogram manageable

medium pre-treated, six. Given that of these therapy We patients really life prior the are believe were was results fact, excellent. these in heavily

we rest half and the XXXX, look file potentially like MA with into the company. first collaboration XXXX the cilta-cel. I Application XXXX, for In would of the Pharmaceuticals target discuss working with near-term to to also we're As of Janssen into for partner our the EMA

for the year. States, important As United end BLA cilta-cel the we're half for by second cilta-cel. CDE accepted recently in application to previously I Janssen for in request discussion market a for FDA EMA is mentioned, assessment just approval We're with marketing most also accelerated on which the file XXXX. planning from pending of the China, In cilta-cel, of this the targeting

X for LBXXXX first-in-human United in T-cell Lastly, States. we're initiate planning Phase the for lymphoma to study the the

the of Our Japan Welfare in collaboration is working approval file approval this Labor XXXX, We're for cilta-cel Union. half CDE expecting partner in China. Janssen EMA year. also cilta-cel in of the also European Ministry for Health, to the we're In NDA and of to the second an expecting cilta-cel

announce present at in Janssen CARTITUDE-X X XXXX. Legend update CARTITUDE-X In the Biotech data major for terms to studies updated of the cilta-cel, I'm Phase and that from intend collaboration conferences with pleased medical data in to

publish anticipates XXXX. data along Biotech from Phase with first-in-human studies Legend-X the the X to Janssen Legend addition, In in

X the Phase study patient patients in as of global next three-year completed we XXXX, Phase can XXXX. in a of X a we study. In XX Phase total X As a you enrolled clinical see, every And has cilta-cel a In this comprehensive the program myeloma. slide, initiated the patients follow-up required CARTITUDE-X. as November study multiple have reminder, for development with of called

the format, to studies first-line to as at can a CARTITUDE-X. recent and XXXX. data the fallout. major expanded Legend myeloma. the patients We multiple Q&A? we intend Phase The present please also in long-term from operator, We [ph] anticipate study CARTITUDE-X or to also X in enrolling multi-cohort CARTITUDE-X called With is And cohort, myeloma Phase that mentioned, diagnosed newly X conference also you open publish with most I cohort-e paper then,

Operator

from come [Operator course. first Morgan will Of of Our Stanley. Matthew question from line Harrison the Instructions]

open. is Your line

Matthew Harrison

maybe Great. approved questions. the by at I the for for Ying, said, is of assuming an you're your comment, submission and end able taking two plan I you the in Good where are progress believe you you the I the U.S. assessment. And line? just rolling now? of Can to BLA assume, are the morning. time Thanks accelerated guys guess you to XXXX. me. meet have that

sometime submit -- this be you in this broadly prepare we And haven't the expectations just that, So on you're And if year? what, about planning maybe you you're on of, for before, you to work just could Thanks. that could that China. given could commercial opportunity sort talked second, comment then would to great. around comment doing but your maybe later

Ying Huang

for Thank question. the you Matthew

BLA first in me the United the let question So your address States. about

be cilta-cel by both did say we So, to year. this approved the J&J by Legend that FDA end and of expect

So we're a a FDA. completed, been there And breakthrough a FDA our acceptance as, six-month definition expecting by period, period. review given following typically, ask package the priority has to a you which review, there's after BLA know, for two-month is

after So the the months total BLA package. eight we is complete

and the drug if of be Therefore, math, by stated that end do expect BLA we approved you we to should to that by J&J package the Legend have expect XXXX. So, end means, broadly of speaking, the completed be April.

But any we provide what exactly of by And when can providing BLA the this tell XXXX is not we're here. you submission is any to we're cilta-cel expect and clarity the that, we track that stand be So by completely launched end expectation this year. of completed. we approved or today on in terms on guidance again,

the we'll -- that's ahead. And for time-line. Go So a as submission what BLA about yeah. reminder say

Matthew Harrison

I I the question, that? quick was before you a just second to ask answer say, can on follow-up going Sorry,

Ying Huang

Sure.

Matthew Harrison

-- when acceptance submission, FDA? you you when or will announced announce from only complete you the the You have

Ying Huang

here exactly disclosure are BLA is. the the But hear Legend that, J&J thing and say can and say J&J I not from today, about actually I discussing from Unfortunately, am submission you hear liberty tuned. at will BLA tell is the also about partners you will our plan that something Probably So only and this. this. Suffice acceptance. Legend the the to stay to what around

commercial your in if look you current at of commercial guess no therapy in China, China, yet. there's potential address market question the I in landscape to So, second Matthew, CAR-T terms

so been process, two CDE it's If the now, namely reviewed submitted. two Fosun and you Fosun candidates by Kite Pharma far And is which JV at Kite from product, from still product being Yescarta look right CDE. or has

to been application The submitted that review is to and The rights process. the is which Juno Wuxi/Juno, Pharmaceutical. in other the from Wuxi between is has the one a JV sell And CDE. product again,

commercial insurance it's therapy there CAR-T in for the Chinese So, the plans on reimbursement commercial also yet from the or no example comment is given and China. that to market, in from coverage pricing care health difficult

we you bigger a who look compared of and [ph] the it's beyond or similar in States. foci number myeloma at number if to or what However, have sheer patients, suffer actually from the myeloma,

As FDA us pending actually larger. myeloma for patients the believe you know year unfortunately size is in about States XX,XXX in the And the minimal and patient die that's of China from market multiple addressable the every the approval. we population

market don't to come out-of-pocket phase, think there's the self-pay with Because would we the now In be there's this opinion China most is in is national plan since this. for the That national product a first commercial assess However, our drug likely that. just to no coverage patients market mechanism. ceiling no going right immediately through launch the health for in have that's coverage. benchmark the And cost. already any to CAR-T approved from we for paid been yet, drug

Matthew Harrison

Thanks very much. Great.

Ying Huang

you. Thank

Operator

Instructions] Jefferies. of next Biren [Operator from Amin question from line the Our will come

begin. may You

Biren Amin

should in guys. data be talk Hi, for about would Ying CARTITUDE-X, cohorts guys I there have because five think we you're which this provide are Thanks believe year. data you the you that to just about there's I could trial my any Yeah. some color four taking or Can on So, questions. you going helpful? maybe in cohorts expect investigating?

Ying Huang

Biren for your Thanks question. Sure.

so program the know, patient you five enrolling opened global look the CARTITUDE-X at A because for as population, have a So, which first. Cohort you cohorts trial. is far, we're And we if opened already we the

A, lines three one Cohort to therapy XX I to Revlimid. So, the XX enroll treated prior refractory who are were to to just in with planning want remind that and of to you also patients, we

CARTITUDE-X. this population patient we're Phase randomized testing called X the in So, essentially is same trial the global

a is here. this However, single-arm study X Phase

will likely do to present which can data any it as patient That So, or present CARTITUDE-X publish start in we population trial, from the with you most imagine, data if plan is most the in Cohort we A. will likely XXXX.

Biren Amin

when your got CDXX more Great. we some CDXX, maybe expect CLL programs, it Can talk on is year, about CDX, X Should of CDXX, just this X could it you've the then, Phase maybe some you year? Phase the allogeneic. and And studies? of from likely programs, next several or data we expect

Ying Huang

to answer question. Happy Absolutely. that

studies screening So ethical open Biren, some on we’re sites getting we're depending patients patients. Phase In now. X we actually different in programs, we're indications. stage. do have China in through And for dosing ongoing programs, In we're six active new also In the which by various programs, some committee already some approvals. program,

we're So, guidance. given the the official not providing enrollment, any pace of

we some Phase of would data of have second think patients in from of I this for us to report And should number towards we that be the earliest in is X the these year, should programs, reasonable data have However, able end possible time terms any data. hand. to a be half

Biren Amin

And readout the in the IND these would coincide US with programs? data here filing for these

Ying Huang

Biren. necessarily, Not

on IND we're in gastric for China cancer For example, auto for conducting and IIT this a same the gastric patients. in X also XX.X the we're program Phase for already now, working an at time, cancer targeting same cancer. Claudin study Right CAR-T pancreatic

have clinical lab, much given belief And decision but, Claudin move for to our gastric and scientific as have program yet don't move given cancer. we observed also, our a forward. XX.X we forward, have targeting in pancreatic decision for the data made a preclinical for we rationale that data Although, treatment the a we in made have to

actively IND application actually the an preparing in this that later for year. program for we're US So,

Biren Amin

Great, thank you.

Ying Huang

you. Thank

Operator

actually remarks. the queue. the closing I'm turn questions showing Thank like I'd over to And any you. not for further in to call any Ying

Ying Huang

I to interest Again, everyone for you dialing thank and Legend I standby. thank will And your want Jessie Biotech. in be Okay, in, very great. for just and much

productive any us further questions, XXXX. means. a feel forward any you thank again, through year contact look you to to much, If very we have very free And and in

Operator

this gentlemen, for Thank and call. concludes you today's conference Ladies participating.

You may now disconnect.

Legend Biotech (LEGN) 18 Mar 212020 Q4 Earnings call transcript