TSVT - Earnings call 2 2022 | 2seventy bio, Inc.

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Operator

Hello, and welcome to 2seventy bio's Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the prepared remarks, there will be a question-and-answer session. Please be advised that this call is being recorded. I would now like to turn the call over to Jenn Snyder, Head of Corporate Affairs.

You may begin.

Jenn Snyder

operator. you, Thank bio update Xseventy results. press providing release This addition issued to business in financial second a morning, a quarter XXXX The website found section press be Investors release Media & in of Xseventybio.com. at the company's the can

On officer; Baird, the Bernstein, Medical Chief kairos Steve Chip Officer. and call Nick Officer; chief are Chief today Leschly, Financial

statements of As Xseventy to and include other plans views as and forward-looking are as factors, future risks subject not of our bio's any differ materially certain our results described forward-looking others. Actual various SEC statements due today's date. upon and forms represent call regarding expectations, statements will this These may financial views among including conditions, forward-looking other be include time to expectations representing discussion XX-Q, reminder, XX-K expectations plans, most current a relied filings. statements our as and recent to Factors uncertainties. risks These lines other related and in strategic and should results, and our which uncertainties financial section of statements those the and regarding subsequent Risk our

not cautioned forward-looking and we any Nick Nick? would I as the over undue to reliance turn call statements, revise law, to on to undertake Leschly. statements. At required these by update obligation time, this place except no or are forward-looking You any like to

Nick Leschly

update for launch Xseventy you, the everyone. passed Thank us the milestones for quarter an XXX-day since company. of on morning, XXXX Jenn, and Last the good second joining our results. week, Thanks

the sure clinical and for for a the a half be house. your the side financial After of get study. more great Chip year. Steve announced fantastic over it partner, company few Then highlights, to questions. We're I'll our I'll the and start we'll to the KarMMa-X first about this hand on with morning a recent that, on spend So BMS this off news to minutes of talking bit to including the

team Xseventy we as several is across tracks. build gelling Our

commercial with Our is growing business for ABECMA. significant demand

as stated, we clinical Regeneron opened when ability both Yancopoulos that Perhaps cell enough. to good, many achieve. Holy multiple across from in continues treat of Existing not B-NHL good design Zooming as and been our and immune in ABECMA is to George to yet Regeneron. good you're partners are progress solid We and the integrate the not unprecedented standards mission Grail. previously pipeline side, able patients revenues technologies novel stage are immunotherapies collaboration in continue exciting. capacity and to as towards XXXX and emerging publicly a can on anticipated modalities the and tracking enough. is programs for committed that integrating The with also system, therapy end product we with. tumors our of but layering as next-gen Xseventy's firmly the clinical are have modalities, the of statement door as high but with This agree powerful. AML We're to to trail also programs we out, sales. And said recently our both solutions improvements, is which set clear Xseventy the well to we've we're on

costs. the operating model took financial the of reduce our On this and part we the year reshape front, overhead to time during earlier our

growing needs opportunity in ABECMA We outlined BMS to top line evolve recently including earnings call, to of meet growth. the that continue the their exciting

ramp-up investment increased quarter, in the higher-than-anticipated cost costs. On an we saw ABECMA and vector this activities side,

You term impacted will from more near hear has Chip on our detail how this guidance.

gears. runway in confident our remain Importantly, XXXX. Shifting we into

the by prior line significant news lines KarMMa-X, recommendation the regarding was receiving and X study in studying After patients patients today share news of and it improvement the our ABECMA potential for along excited It's is study, certainly extremely to myeloma. with X the performing quarter. analysis our I'll updates a called on with Phase hand excitement and that, are conviction Steve, hard great our to endpoint exciting Monitoring Medical We earlier progression-free met Data of III over Board, over Safety demonstrating term. primary unblinded Officer, statistically its BMS, news study this give more of the the both this interim a survival. has our Steve? preplanned a with for increases of humble. With long to And to the exciting Chief to overstate bit It clinical of ABECMA and therapy.

Steven Bernstein

exciting morning, everybody. Nick. you, incredibly Yes. It an indeed. is Good day Thank

this the refractory been from KarMMa-X, a to evaluate guidance to schedule versus III trial. randomized, of results positive on data and study to earlier issued these at original the line prespecified ahead are future We, with predictable with we the have of data have in and standard patients could So refractory announcing demonstrated mean terms line open-label Bristol-Myers BMS been superiority Indeed, and press compared primary clinical for along a ABECMA exposed BCMA-directed first which in Squibb, expand triple CAR-T these met of our morning, study and in results this data a authorities. regimens had multiple discuss regimen makes paths with patients. The updates from pivotal present analysis controlled demonstrate in these Phase survival what results shared medical global, a a would findings inhibitor the XXXX, compared treat the to so-called trial. randomized were their top is expect X the in these timing relapsed ABECMA additional and IMiD prior of so that daratumamab must KarMMa potential a to interim came and of study lines have patients and progression-free of the multicenter, meeting pleased Xseventy endpoint to that outcome They of therapy who proteasome that regimens. This in and health profile consistent release last the Nick well-established myeloma to safety of combination to and previously exposed, in was to X therapy. standard

in presented ABECMA The Annual for at by Therapy the data June set profile data would ABECMA data criteria Myeloma ASCO additional including XXXX reinforcing presented consistent and patients seen KarMMa, the pivotal the Consortium with what overwhelming for was eligibility the were have setting in of academic despite date commercial also ABECMA. institutions. Multiple of the the patients largest the that the met efficacy We Cell to of fact the in safety treated of study Meeting, such KarMMa majority not

multiple XXXX, that share earlier our in development will for to expect data high-risk inform plans. our KarMMa-X further we forward, Looking proof-of-concept early-stage line study in myeloma

In of I/II on Seattle Phase oncology a is proof-of-concept to drug ramp-up looking that's addition, a exciting forward Xseventy patients on from trial of by as cell XXXX, PLAT-XX, in our and into manufacturing B a presented move of Phase and more. this we overarching very young of at relapsed/refractory updates exhaustive with adult ASCO non-Hodgkin's poster study progress studies a in internal and bbTXXX significant a relapsed/refractory CRC-XXX, moving study presented for efforts needed and rapidly lymphoma, years pediatric poster I throughput SC-DARIC-XX we the portfolio Children's into in progress of by in trial strategy therapies, quite AML drive privilege of many to our ongoing our translational the Therapeutics. Overall, time clinic, a in sharing efficient stages, supported

turn Chip deeper the I'll results. Now on dive over second call the Chip? to a quarter for

William Baird

and Steve, Thanks, morning, everyone. good

ABECMA quarter. quarter, revenue, second U.S. up the in to the During million generated prior $XX commercial XX% compared

the to ABECMA losses reminder, related we and and all U.S. manufacturing development, the equally ABECMA profits in shared a of As for BMS with commercialization

continue revenue share to strong guidance cost track U.S. million We the loss for for of and demand very our $X.X there. with ABECMA, the end includes achieve of high the trajectory remain gross second between with U.S. on $XXX ABECMA associated the and ABECMA profit, we're see pleased of in growth of XXXX share of which $XXX We commercialization million million. We less reported our of quarter, to collaboration

therapy been demand investments earlier manufacturing making for growing play ABECMA the our across increase an significant the the important to belief and chain. for potential and in Given we've lines, supply strong role this capacity to

costs, In future. That said, affect $XXX target, and their This costs in we were BMS than experienced believe increasing in to our addition we supporting million target to cash manufacturing we vector as investments, manufacturing higher costs continue Between for vector million. partnering the invest are closely continuing to to capacity not sufficient are the capacity. vector lower and and and spend revenue increasing XXXX for anticipated. net have are we that higher achieve XXXX capacity we have efforts our the manufacturing manufacturing does in our capacity we $XXX vector to investments that to increase guidance to

our important Nick closing the based XXXX on sufficient into forecast to plan. now business. I'd to runway turn like achieve for Nick? current continue cash across is to back to This We runway our operating milestones remarks. call

Nick Leschly

Thank you, you, Chip, Steve. and thank

As past few concept us been company, about is you our all who've the what mission a closing, every very it quarter. such past be few just and dedication drives productive at powerful. day can see, but and as and focus excited rewarding it's our months, very years. In of here if simple, team a grateful It's the to not over Much pretty time. the I'll demonstrated I'm to has that Xseventy, tremendous say

designed the coming Kyle, to cancer in for mission. With therapies questions. treatment time that, do months focused and what more serve the updates new we advance continue ready we more We we was to landscape sharing people is forward to the we're Given look Xseventy disrupt all are by operator, as on. this what developing that

Operator

comes Salveen first Sachs. of question the [Operator from Your Instructions] Goldman from line Richter

Elizabeth Webster

on This Salveen. for is Elizabeth

powering analysis. and the if for follow-up of wondering that. CRC to the then on kind about comment vector comment staff provide. could stringent you then Just a criteria on supply prespecified any that XXXX or And how you was at think could interim to the there's on And how if

Nick Leschly

continuing can up you. to pass Steve. script, I'll -- later as we over and crunched here it just you will here, be be, medical Thank a as imagine is the heads Elizabeth, said meeting. now, at right data we're obviously communicate the to in But

pass to share will over it up, can, it heads limited. I'll pretty what but be Steve he to So Steve? just

Steven Bernstein

positive the Nick, analysis. interim for a analysis the superiority It was our result. unblind and your This that it we prespecified Yes, a sure. and was recommended DSMB Thanks, was thanks and for study, question.

response of terms rates, all significant. can this endpoint overall that's But response was and of was secondary rate share. I the that that met could time, share statistically at In I

Nick Leschly

who want don't the question, on one? that Chip, supply do you And we vector -- take to

William Baird

continued Thanks, good to. make that It's throughout our Sure. year Yes, we in of question. terms our weekly capacity terms step-ups product Nick. of patients to in we've provide a this can

well. as step-ups, regulators plans with work and 'XX the to have make make year continue step-ups to We this to additional and later in we

So picture of the that to outlook should share in as more year. get we have and this quarter-to-quarter continues of that we the to 'XX is terms closer month-to-month, our improve, end for to

Operator

next Your SVB comes from Instructions] of Daina Graybosch from the line question [Operator Securities.

Daina Graybosch

then couple early interim sort spent, help ABECMA? that of you triggered And Can on the on us then in A far manufacturing $XXX how sort much million clinical is that previous spend of to for as if down Can of down the ABECMA net being then that supporting is on the particular, and on get? And you follow-ups since of you secondary were secondary? the -- cash what events up $XXX the break what your ones. you you how us said, much hierarchy design said to triggered primary help you KarMMa-X, the will, scale costs, for how just the programs understand -- in and expect the OR remind statistical program, can and secondary this able discovery you were you Chip? million, on and on this is

Nick Leschly

can that that OR, top here, were but and not of questions. again the PFS line, design far the is the as which the charge, what some data was you dancing So first Steve, significant. of driven we've question off given to statistics down I'll But through we're both maybe pass go so

sharing be comments, few you this and Steve? I'm So has that's a point. zoom over to But Chip. we'll if we'll sure Steve at go extent of the the then data out,

Steven Bernstein

as endpoint follow-up as driven. endpoint mentioned, sure questions interim the response rate. the overall not and analysis that improved. And statistics say which Overall remains a significantly we we were and Yes, for mentioned, rate PFS if were was for secondary primary Daina the was is ongoing. and both there endpoints the the that... were can Nick survival key primary was survival key response any overall the endpoint other, secondary The PFS, that I'm

Daina Graybosch

specifically what the about the If trigger analysis? you could was talk PFS prespecified to do

Steven Bernstein

that sure not honestly be I'm really Yes. could truthful. into very I how to get much

Nick Leschly

right? preplanned, But preplanned. it was It's

Steven Bernstein

it preplanned of analysis. right? an So it events, was was preplanned terms Yes, in event-driven

Nick Leschly

the And net? Great. you Chip, off breakdown little cover of the to a of want bit do

William Baird

Yes.

So is with out. Daina, give ide-cel From feel XX-Q it's disclosure programs meter remains how a for good you question. an can biggest that even our a our the across And the investment perspective, clinical program. development the KarMMa is research in largest studies scale a better there other investments and Regeneron there. stage and manufacturing with next stage various up. in also collaborations The programs, DARIC-XX is XXX earlier investments and balance partners

scale side, comment, mentioned, in invested BMS scaling as there. to terms of on together with we've increasing the capacity. both I continuing manufacturing can supply drug just the product then On I work And and that vector on side

Nick Leschly

there. just might I thing one And add

team in bit on script we as just ABECMA, and spun that And it technology and referring we for making the we on that's sure believing make we on. referenced approach good good level to ongoing. it's We're as of progress did, continue also something both One purpose the not we that's there. we working right? of have. Chip that feel is what the that across the for where but purpose which That we've things very was certainly have that's little about and I have, was, we been his pretty the in to we're a fit But the future much still company, the business, in that we that,

in investment ABECMA. as X with call do there. and well for in certainly the But increase Horizon certainly the here the and as that bigger aggressive research ongoing side we pretty what driver, has burn So to is burn

Operator

question, So for Werber comes from Yaron the it line from next your of Cowen.

Yaron Werber

data. you fourth mean, another really terms wanted probe expect you did Congrats Or of to to say to line, PFS could you getting IMiD have the can triple you're if can't triplet have just here. therapies I mean, and thinking DARZALEX data again? lot, second -- know think comp is some respect ORR. to but patients be the of again get little typically a exposed. bit. or When on with can, they obviously prior what sort I about a It PI? And do I are you you and you I it's another doublet in

bit to for et on that with is of Chip, at So you to But see kind study what Because for a it a the manageable clinical X small range getting question spend they X OpEx. sustainability? sort profitability some brackets lot supply, and of big obviously essentially to more us give only ongoing. can the spending of are now is and like were now I we're beginning point? And it's and you toward predictable. the have and where then you We study little cetera. getting a variable depending going And secondly, be on for clinical collaboration Bristol on know sounds

Nick Leschly

Hi, Excellent is Nick. questions Yaron, that. on this

Steve over those thereon. think of me understand to the important questions because kick expectations kind an set we So I make that are of sure triplet the to let and

don't So jump cover you Steve, off Chip that, to on why after. we'll

Steven Bernstein

sure. No, Yes, question. an is excellent that

So reply make and that points let me X regard. in

combination which The investigators therapies of the is point care of and it to had randomization that it's combination could was potential have before randomized would use regimen and the they arm in were likelihood they arm, approved therapy benefit. chose the of choice patients first increases X so not a if standard the that the that that that

triple important their is line And have last are of patients data been days look progressed XX they you patients the to, exposed. daratumamab, your extremely an you question. literature would means be poor. In as outcome failed lot which of within status studies, of last performance you I on have are these that both that they there's Because therapy. who but were to second, were if totality terms in the think across what the of suggests And of refractory the that databases response line overall and therapy, an exposed, and of if their one, expected, your not large your question, alluded awful of triple the

in rate some was ideas performance study seen who built upon very status this failed that. poor our look study that had But were and of this patients daratumamab. we really a we in and what we So improvement clinically what might had had really what like encouraged significant ABECMA the response believe is statistically over poor significant

Nick Leschly

Yaron. questions. Thanks, Good

jail. Sorry, him we to let Chip over Chip? forgot here, of to out skip

William Baird

for Nick. Thanks that,

to in the good noncommercial in that think those -- investment we about path that So on terms predict predictable more OpEx right, the how spend, the are side, the studies -- clinical you existing to -- of got continues. Yes, for range. question. that, related a would the We you're studies glide

Although develop. plans that think today's data for on I I myeloma. And this given queue half of think impact from more quarter's are in patients on give is therapy. in of trade-off short BMS path that I you're increasing to second with is making us treatment us And thinking ramps think monthly in an to results all the in today, I those continue to that about on these And hear think quote investments of together this of the from and throughout ABECMA. the going can, of terms as long-term conviction the us terms we in sustainability, is to today that ABECMA seeing investments capacity. would in but But getting as is refer to what who of make you increased you'll patients I those side. those profitability, press we year future -- to And in release, then hearing this in that the we're our think, investment quarterly have role the profitability, wait the term to priority path we manufacturing and the justified the

longer But investments is in an the term, and picture we into it's short potential. we're So attractive, we as maximize and ABECMA making beyond, that business. head think to the attractive commercial right term, 'XX the

Nick Leschly

couple Yaron, as but plan. were have I of for back and is around zoom market I you right, there out, CAR-T And of a lot a myeloma about questions talked Chip. think -- this Thanks, opportunity you the times,

interest relative and right? I think for there et vicleucel ABECMA been where to The fit et is room sort that's both, does dispelled, of there's there. is Then cetera, cetera.

also just our quite in ample And with we think now that of sort thinking that I I service these lines, have big patients market clear are is about and desperate for health. becoming excitement. we here growing is earlier who room saying as opinion, opportunity there an conviction to unfortunately start think

feel high think bouncy are BMS regard. So than -- get you every degree much very level here, I confidence certainly into as in I'm like we're cell a they're it's paying of side right, XX 'XX you're frankly, better that they pretty we a and regard. be lot the turn and this BMS. was with execution excited. that ago, still very partner months And right possibly less along that committed we a on that space to in imagine attention, -- therapy But pleased can with And more now the But able X, as still far taken, little a as we've getting to absolutely off. bouncy it bouncy

that helps. So hopefully, Yaron,

Operator

next your from it the question, comes from Stanley. for Harrison line of So Matthew Morgan

Unknown Analyst

] This for Tang is [ Matthew.

X KarMMa-X interim maybe on question analysis. So the just follow-up

like planned is -- analysis. can just whether a comment because on I'm So you this interim mentioned you wondering

have and on like wondering my interim -- many is for out in then So question the analysis whether And whether XXX second I'm DARIC-XX PFS? the you the just total planned programs. how come can you

you So this that data have programs you these X a mentioned year. will readout for later

can could these discuss programs? data year like So you for we of this what kind X for safety get

Nick Leschly

XXX the to Steve. want do the of statistical you the And pass I think level specifics question? on take Yes. outlined then I'll I don't But high DARIC that? plan to and we've here. comment can off it Steve,

Steven Bernstein

was mean this our interim I first Yes. superiority. this analysis for the was --

Unknown Analyst

Yes.

just will other whether on like So mean, the will interim analysis be PFS only additional right? then whether sorry. and OS, any you -- wondering like internal just have or I'm one analysis I you have on analysis this

Steven Bernstein

Well, for later a presenting meeting data we're this on of following at year. planning and we're all OS, the hopefully

I'm though, we So you just right? be primary met point, getting end clear, to if our right,

Unknown Analyst

Yes.

Nick Leschly

Yes.

something So a the point to that's bit. you -- because that's early. we're key what we right? was this certainly the because anticipating expect length excited met, was just it full study, about met are the we're of not So Primary end And excited that. see that's

the seeing be year getting both lot we next said and next On year And impact depends you're to this looking safety goes, something consistently substantive XXX question? obviously sort it go on the first But like visibility at, timing enrollment of is into of of et right, half the of very looking depends dosing into how good start cetera. that at you half safety, the beyond year at the in end that we've how beginning of of as of to is then hopefully towards this when of But how much But data. and on and get the of going right, it the seeing that next. first that, and goes programs. Operator, of more sort sort expectations has. this next the and rough beginning how I we're we're a DARIC-XX, should start end those and these think this of patients

Operator

no are to this back closing would to time. questions like for conference There the turn now further remarks. Nick Leschly I at

Nick Leschly

happy with have day. with they'd into, Get everybody, in please things to we're you, follow I appreciate to the or this. on to up. the group, guys investor more here. and and want more up turnaround Thank the than Just you thank a touch has jump additional any and to with directly. call dig follow like time for great quick us anyone questions our us everybody, effort apologies making on If and

Operator

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

now may disconnect. You

2seventy bio (TSVT) 10 Aug 222022 Q2 Earnings call transcript