Earnings call transcript Q2 2023

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Operator

Good day and thank you for standing by. Welcome to the 2seventy bio Second Quarter 2023 Earnings Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Jenn Snyder, Head of Corporate Affairs. ahead. go Please

Jenn Snyder

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

Q&A. Scientific Nick line Speaking Steve Officer; Medical Bernstein, are Kairos Officer also Chip the Leschly, Chief on is the the on today Baird, Officer; for Chief Philip Chief call Chief Officer; Gregory, Financial

a will and expectations to which results, financial risks As discussion strategic Xseventy lines expectations bio's statements are others. certain plans, among related today's forward-looking statements our and forward-looking and reminder, include to statements other These current expectations, and condition, statements and future regarding time financial include regarding plans uncertainties. subject our

filings. may recent as results those including of in Actual risks, various representing materially XX-K date. this relied our to as any call Forms our other should and subsequent forward-looking our differ uncertainties not Factors upon of and factors, and SEC be views as the These section most statements of Risk views represent described due other

not undue these statements law, reliance except place are forward-looking or by to obligation we as forward-looking on required to no statements. You and undertake update cautioned any any revise

At to would to turn like Nick? this I Nick time, the call Leschly. over

Nick Leschly

Thanks on second line the everyone for everyone. as to results quarter XXXX our Good we and us afternoon, discuss Thanks business Jenn. joining updates.

And of to these on important the engine been in progress made the our deliver pipeline. XXX, of through mission our time power cell against first people on mission more our innovative an commercial are transformative to second translational to creation Since year the has always cell executing bio cancer with of of half now we've full Abecma of therapy. therapy We prompt, well as our XXXX, into Xseventy living and potential to develop goals. leverage giving dual the

with Abecma, deliver extensive treatment his in at reminding the setting commercial us the that in multiple to who growing hosted a inspiring We options. continue our on families. need better With we meeting, are a to living successfully myeloma patients and It an people recently the of deep number our wife All humbling, was why. and patient having is reflection and myeloma and Abecma of impact of Hands

the the inline impact tactical but time, recognize midst we amount we've At Chip Abecma of can environment, a significant of are hear the competitive performance. long-term commercial broader for say of market dynamics half fully same strategy. the I Abecma comment evolving that time will the to a potential on to belief in the we of not which also the and spent is rapidly Abecma, second in their with expected more BMS only team rationale month-to-month

potential of It a the and sales making is internal by understanding maximize resources the this to grounded therapy we're from to conviction BMS both very long-term of the supported significant therapy to CEO with patients. given in their strong rep Overall, investments well short landscape field. for the important cell and

to in challenges apply pressing most oncology. and side, of some development our the address On the knowledge continue to engine therapeutic we research scientific

potentially layered and solid preclinical patients. the is cell a transformative in using have We for clinical number and programs that approaches thread impact therapy of liquid we're common tumors deliver and to

the in will amendments of June the DARICXX the official past have their XAE the in will is XXX in and it this potential developed notice forward Friday, team Steve Seattle the PLAT-XX cause received the to Seattle hear of potential terms need grad call. since to we FDA more One from and impact Children's for expected the Children's path This later protocol. details investigation, how and such program. was This the hold. concerns root clinical specific program FDA conducted more it provide and the

with innovation eyed programs. That disciplined opportunities to bar, very program allocate also programs multiple we we steps And elsewhere. are be Our and for not a said, pipeline these represent and forward stacked will if about will high terminate patients for clear us clearing make capital a is with cancer. unincreamental and

I results. over more talk our look to Chip? hand for forward it and now more, Chip to your I'll QX Abecma to questions, but about to take

William Baird

solid second in States. delivered Nick, United million everyone quarter joining $XXX.X Thanks, call. to and the the with the of thanks for results revenue Abecma in

record the profit As of a of revenue we which business U.S. for U.S. represents we reminder, with and BMS our business. Coco the are arrangement Abecma XX-XX XX% operating collaboration in a the

which arrangement the turn has been XX%. quarter remain helped collaboration. collaboration revenue For Abecma which had related better expected than it's XX, an margin of driven This million recorded to improving of success our by in manufacturing rates the we is improvement and north $XX.X gross in ending continuing we June by

is Abecma XXX. expected, So collaboration cash the delivering to as flow

As their lower they the XQ revenues third BMS in reported in are quarter earnings, forecasting

X-End

which Has XX%. success in improvement remain been rates, by a of helped north manufacturing continuing

So to is expected, XXX. the Abecma as collaboration delivering flow cash

XQ reported revenues are to forecasting lower their BMS return the earnings, in in fourth growth quarter with the they quarter. As the in third

to our of updated $XXX to guidance Based end original on revenue this, million lower U.S. our XXXX we the Abecma $XXX range. million have for

want we hear this investors important on points forecast. updated three have We to

SXX not original normal for online. and aseptic a was revision successful downward planned facility was driven is This processes. by June. the forecast manufacturing the built into we're maintenance was The scheduled course back maintenance First, manufacturing in and the shutdown of and the

based a to due has line been Second, setting are bolus there fifth is we line in significant incidence patient soon. to with believe original largely but we larger competitive, opportunity PDUFA for for expansion Abecma landscape and a to in plus, market, now addressed December label an the is a the plus downturn dynamic third potential the a becoming a competitive date

and is their commercial and footprint sales are XXXX their the capacity market. beyond on my in efforts across spent increasing with the – for marketing manufacturing intensity day leadership level multiple last the to they week, this Abecma. commercial third, BMS And commercial and the We market. are across address increasing investing team We BMS larger and with the BMS

closely impact continue see our to collaboration, you our expenses can bottom line. the on the Abecma contribution together and the improving with manage from We

our, investments our For We continue of at the year. second structure. overall quarter significantly of we runway XXXX, least committed a $XX.X of a down loss period XXXX, to cost the net million and same million recorded and to pipeline evaluate into net for loss last from actively maintaining we cash remain $XX.X

detail provided this AML morning update provide we've I'll regarding Without, program. on the Steve? to hand our to it additional over Steve some

Steven Bernstein

the fatal Thanks, X the level the occurred In we in serious trial. stated enough that event utmost our PLAT-XX who second the family event. This of pause Good patient us, in the therapies study priority adverse cannot It to June, or everyone. Phase patient the continue thoughts. Chip. dose in in be morning, AML to participates keep and I to first studies treated the patient's we a safety our our every is in receives response in announced our at Grade of

the study with Seattle sponsor, the of of event. cause leading several Children's, mitigate investigation for may which of the has both Since and This to this team that this study protocol provided collaboration our believes changes, the insights investigation and the time regulatory this into and of thorough conducting toxicity PLAT-XX the we root allow a continuation in toxicity pathobiology have study. been partner

of formal as a notice shared, protocol. the collective FDA clinical team afternoon. Friday And is result, we Nick As our received actively hold on amending

determine to we'll but to the to in pass will a it now, next We I'm and collaborate forward address portion, Q&A continue here. back with Children's Nick. FDA path to appropriate any questions Seattle potential happy for steps and the

Nick Leschly

And for company Steve. by remain time. We that a committed patients, it to to There has shareholders. and hard hiding driving no that saying innovation evolving we'll all for the stakeholders. for Thanks, is we appreciate been value hard and everyone's – to and rapidly period delivering close

and on operator, may to and across best dedicated including to now and enable shareholders for are everything stakeholders, deliver the With open we that, day-to-day doing in all to questions. us employees, can line our patients course, strategic of We focused need. execution focus and, you adjust families committed improve hard-working,

Operator

Thank you. comes line the Salveen Sachs. Goldman from first with [Operator Richter question Our of Instructions]

is line now Your open.

Unidentified Analyst

Hi, we revenue the not updated mentioned Can thank Salveen. demographics. about detail but you get for just shutdown, the prescheduled patient for believe on the taking This to little that it is that our Tom [indiscernible] more a was more drivers due behind bit question. guidance. so the you I

that you. Just helpful. be some more would on color Thank

Nick Leschly

Yes. This Nick. is

I can jump that. think into Chip

these had that maintenances the certainly think moving some various in all the confusion marketplace. been know we've parts. you I we come, when And one thing watching

in a what combination why evolve. it right? as to feel for of and that be combination we to surprise? in looking the do the as provide not myeloma. confident are in on along BMS, will elaborate just more marketplace surprise? with marketplace. And of a a then people treatments more lines want Chip, want you we little said or is a the little the of wasn't know? would a on think wasn't think Chip bit evolving that a use that that to with Or other as clear detail the And bit and bit in And I these partnership to So the continues is dynamics saying, what that can was expansion I evolves, But so we make

William Baird

said. was that well No, Yes.

is as think cell date the we back, in capacity, innovative T all. is both capacity field regulatory line is a competitive plus shift getting It's which an is History setting, utilization this a fifth we end approvals a been take therapies, well have a for and coming. huge opportunity. again, moment our never collectively Again, time, T CAR myeloma our year seen has patients. great capacity, as and yet Stepping the in the more that as with of I patients market. overall PDUFA huge to of view what winner towards the the engagers in with going again other increase

to we have and therapies that And so important I Abecma these see well. as play, certainly will think for all roles

Unidentified Analyst

Thank you.

Operator

you. Thank

Our with from next Partners. Leerink question Graybosch of comes Daina line the

line is Your now open.

Daina Graybosch

that for there'll you. patients KarMMa-X? Hi, And you've there I T earlier hesitancy move much referral given in earlier I'd in refer dynamics demand lines BMS say, more that the community you question. expect come and done with work thanks skepticism, the CAR how demand wonder – lines that a would for in been is the lot lot of And to doing and recently. KOL what of market some maybe a into there's Thank the of just myeloma earlier. and docs interviews gives will you confidence their as for We've you demand be some

Nick Leschly

stab. quick Nick. a is This I'll take

you doctors; answers. XXX call can probably get you XXX think I different

and earlier view will gets a more role impactful long having with research the we over of for and collaboration Our T at that the as strong is is it a day, because think a our pretty term. that, sooner strong efficacy. role have you the BMS that end about for very clear It do can in and conviction our there's CAR And dramatic impact. is the about cancer the it be very

to us certainly proven So the as starting data, but be by by well has data through be other we as to the is CAR it Ts. proven think out out that

a in sense, fourth line is have fifth line an be that certainly, going that to line, third have first strong where contribution line, the a and very marketplace. area So in we conviction we'll place very second strong in line,

a certainly especially is alternatives. you if Convenience have no factor,

in take And dynamic. setting, don't is data-driven you to If We our fifth-line availability whatever can't CAR dynamic. driven is if you an that what hold a don't you're get that to think we've available. of a that going the you for going have That are is dynamic So the time, is do? example, T, seen.

we believe, colleagues third we've a we anyone And who J&J further. then as evolve, T. And heard into get as has even the and go I will, as thing out so of as over our especially CAR else time, well line think that you same

have we'll to we're confident. out quarter-by-quarter. again, But play So something pretty that's

Operator

Thank you.

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

is now open. Your line

Yaron Werber

plenty was – list sure the taking that of in couple out now, for in there. because, prioritizing obviously, general match of up make right obviously have I to supply issue the Thanks and in sort thinking the competitive dynamically what's just Great. wait going quarter demand they clinics questions. list One, when a with or the on you're the there's market to

point off-line I you me sounds know little downtick July increase your May? year? out. end to like And just secondly, are grow it going because worked and it your in QX you a the And bit? happen? to explain to of it Or would QX. the capacity mostly is you QX Can be over is at back this to of over fast a going how able is are QX to then back sort that way the But totally of by obviously

Nick Leschly

had Chip, do I know you a want to few comments you just – there.

William Baird

think Thanks, have Yes. right. I you Yaron. Yes, it

The is impacted shutdown. by third June quarter the

the revenue. So again, about, slots as we've become talked July June

a roughly lag there's month So there.

contributes the So sites July down. here. couple factors. We're is and expanding month, the and is BMS growth a We different of that commercial we with late third expectation number to month-to-month do of as which footprint. to a expect a quarter-to-quarter move the return Driven by overall quarter the

setting academic just reps back of think that's referral here community dynamic but as and in as important community at that's We're the the in Daina's an that I the to people important as earlier well the question, earlier at the not talking expanding field, will and in detailing backlog, Fifth-line be treaters, lines to centers, important dynamic number well.

I BMS – top for again, is from for us. priority well. it the over as a time, certainly we down, is This will on this priority So but think a evolve

Nick Leschly

chatted to not boots right? was pretty settling much highlight few active folks or look last It lot sure we very ground, in things That BMS, sites, six much been view the that on quarter and you getting happened on force focus, and this, at the have and what traditional want have that where very this going I access sales, a you've et I'm Chip over has now last dramatic to I a of not people at just effort. still because also the capacity, kind investment kind settling, with certainly the ongoing sure done the Yaron, we there's And cetera, full very a that continued a just over. equivalent said the been phenomenon. And around has of a more is situation share the a been and it around is think and but you're where which a of is across has months, of it's make but is situation growth voice the a this way still settlement. very

We're a and in ourselves evolving this on. quarter we're and the think situation sitting both now the be sort understanding clear well one of more there's right We're there enough I that one certainly very much anyone in has than and that is opportunity is TCEs getting are don't drugs that in we the certainly and no other are are in coming CAR stance. are bank waiver their has that forth better assets myeloma. that And the led in have ramp-up out think of confidence, that and I We've ones, to see shares growth as seen for and BMS again that back of confidence most as that a And again one going happy other us phase certainly just them. to T and lot to early a again. one that

Operator

comes you. Instructions] question Thank Kelsey the of [Operator Our with Goodwin from next line Guggenheim.

is line now Your open.

Kelsey Goodwin

made provide Thanks study. morning. good could some you color my for just toxicity of you. PLAT-XX Abecma. what gears And more Maybe were in taking on analysis off shifting post cause Maybe provide Thank changes question. the root some maybe could protocol on Hey the you color analysis.

Nick Leschly

only get because sure can't into colleague, sort collaboration We're done to some and Kelsey, FDA enrolling. study you now, much honor study the also non-answer. get confident here root cause right that we And We save details of with up want make the and we that have Right Great – – painful back but not we're I'll very the like Steve this said, proposals the analysis. with from patients a sort have the Nick. the is of we in this now question. we to with the my FDA. Steve, of relationship

as at can about as far time. point that's in go So this we

wording its pretty So that there that – specific was that ongoing. was the chose we

FDA SCRI with shared the It's plan. and has a engagement begun. have We

we're so we And a details but date. share subsequent at don't confident,

Operator

Thank you.

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

line Your is now open.

Vikram Purohit

Thanks questions. taking for our good Hi, morning.

from ones quick our two Just side.

First, in size BMS bit rate And could could BMS talk little commercial that discussed from us is to are what And plans then of they'll the what into alluded that that? aside, and put run messages some with to be you forward key scope on commercial pipeline a from increased the putting you've XXXX? of Thanks. increased more the kind secondly, for you a presence scale remind about What standpoint of BMS the that muscle development helped of compete like your you implied Abecma that guidance further? cash Abecma.

Nick Leschly

question. Nick It's again. Hi. Thanks. Good Yes.

sort going and the a to We're is that to there. associated significant, answer. So and the there, not both intention with also provide little you're it it along totally of be probably expansion details is my sites sizable, but the not on going

this more more base that, an So the because exciting that getting the fashion, that but also field rollout, therapy and innovation the still capabilities to in leading and is their across cell important people piece. and something on ground in the is that's boots really sell a on centers rapid on

there, contact is a feel He's on. I very cell been And therapy our relationship. Chris, has incoming entire our lot that So confidence much of the throughout lead CEO been. always behind

CEO. got to very incoming that we're So be opportunity he the pleased to the see

commitment I'm that in sense, the in confident around So that regard.

Abecma experiencing view. in consistent are, the but become a behind in view will and a people only relates and real-world As certainly Not stand to clear of of point of the point view, from efficacy a manufacturing messages we but from the safety point field, are manner. it that far as how what evidence very

lots there's that so in to CAR out continue ample one of the evolve T the of of that for drugs choice to leads it's that us And sort sure there will believe data of space.

certainly exceeds And as if with. in quarter-by-quarter their BMS Celgene that will, but And is plenty of there are player going to their other is of used one a given battle, opportunities as going it is myeloma feel know, we are and is, any out messages there kind the probably space types is to that to experience And now just that. those the expands, that of about in be history. relates you that people you

William Baird

to Do you want address...

Nick Leschly

second the That's question. Sorry.

William Baird

question we utilization into the shots That's and the about, have the ramp From what's contribution second and there. towards. from a we monitor into number XXXX think the the was and And seen but which that just contribution to think drive good and that overall setting between investment I already there. something we've then assume perspective to continue that certainly perspective, the feel we'll as an we we setting. move into line clinical a continues seen margin starts clinical and in that, and third we've closely assumed and cash pickup I flow a from on Abecma, goal of setting, moving

as we in the that XX And to see mean, first proof either move to in incremental human of on. goal elsewhere. I way. capital Our or Nick XX said is we before, an allocate achieve patients concept we

with that again, is that been this prosecute solid place us investment Day, and put across cell a we've collaborations, of a through a programs. tumor the BMS, other our in amount whether we it's to The we whether comms funded of in Abecma actually collaborations have Regeneron, that but it's we've say a slide it pipeline and R&D to of our with the enable just on therapy emphasizing thing number lot to good programs subsidy showed R&D the

Nick Leschly

to I'll question. thing add on backside of last Abecma. the quick one Real Just the

and back is are of go the what the to digesting half time drug is conclusions relates is it a And to because last has that performance Just find word, time. time CAR the that this. the see shown couple of of is to us entertaining this everyone if that happening over The the real it what I years to is based the about hell we find FDA anything this. in to I the on talking manufacturing don't I digesting is future wrong because of we're this a opportunity quick digesting information how but on moment sort field so specialists it as the is know drug think T curious draw at

sites in The that digesting are that all And we're still very this. much space.

We this is no view, out this of of we has is this very patients for relates going quarter strong going The are BMS. very tremendous one nor aspects it So to feel continue And quarter. that play have it never in future thing has it need. about that as will bounciness from potential our of question about to to point know on expand, the in medicine Abecma. to has and the that But by this quarter Abacus and long-term quarter a reflection question of any and strongly of a role a number unfortunately, opportunity the is that. myeloma and been

Vikram Purohit

Got you. it. Thank

Nick Leschly

welcome. You’re

Operator

you. Thank

Our from Graybosch next follow-up Partners. with is Daina a of line Leerink the question

Your now line is open.

Daina Graybosch

Abecma thanks the to question I'm for me. second another ask one. Hi, for going

sorry, asked And in what's the at you look happening moment. Nick, to

those CAR offered. other expanded big And have really that then these sites it the academic fewer BMS different two and And competitive CAR available where are centers Ts where more T competitive You I in options. and wonder both you're the Abecma different have from have of to competitively, sites really learning and options types already don't what have those site. sites they're has

If insights available more and implications gained any the have going as any forward. that thoughts demand the have on that of you competitiveness and you you've

Nick Leschly

are available. gives not confidence, site-by-site frankly, level. gives one good dynamic that in But actually is in that And is going that you're of a And right, that publicly Abecma generically cases, it of people us insight a do, of time. have, They're bit because to in have at into time drug direction so some just going a one and us have there I that's spend experience it's both and lot that BMS. other about Yes, we're available, talking one or one period quite cases, the a the some that move we're speaking, a or for which frankly, with and utilization. does other centers something some following to exactly certainly

few has as where get people end And going out to not both BMS' supply supply were the is use very in to light we want more drive expanded and the right, that that's goes and the from It's greatly on, on not not last partly frequently, But more demand medicines but seeing want catching the dynamic. you because a now we're where turns more months story. of and constrained, much into light demand and basis, because one up. you're that's actually footprint and has to expanded, go

I dynamic. to have So continue that

relates I efficacy a in to the think as and data very the the how it very also have of and being performs can We clear the well Abecma real manufacture. profile in to of probability able on and provider saw in world. dialogue safety expectations clarity the that

agree all. good us And Does Does sort at very you at not that's a know, field. that. relevant. think, as I on out. both support analytics also not tremendous a to sharing as about go that I in we And say that No, far much will so confidence that into necessarily amount a detail It's things, yes prone of would those I we and everything? level to the But of very I have Lots I BMS it that mean detail BMS that. on something And it's the our would certainly Abecma that? on of because know place future won't that. and sort mean competitive of puts play go is think not position. in

to going participate to we're accordingly. continue So

Operator

Thank you.

question of with next comes the John line Genuity. Our Canaccord Newman from

line now Your open. is

John Newman

Hey morning question. taking thank guys. my and Good for you

discussed work you've past in the suspension vector. about the So to transition to ongoing

suspension about giving should capacity the KarMMa-X. online, we you've that more when that I investigated that higher. think think comes rate as vector success actually process Curious or in even you pushing

high always You've those wondering been success very a perhaps but those it's of of both or in one if rate,

William Baird

moving things. vector, a the John, commercial next a for which material early starting manufacturing that Yes, one. that on the is take capacity. is a It of more margin. Suspension What us manufacturing Yes, that I'm a year. It also towards key cost-effective gross certainly does greater suspension way process. for is happy our will approval help has couple to of for

And and so ability of product. focused continue an to to come for scale important that to vector drug what on supply product couple de-risks be is component the factor to suspension there. in chain increasing of is drug years of our terms going we're Ultimately, capacity But that. and

John Newman

you. Great. Thank

Operator

turn I questions call like to at And I'd this to back for show further no time. the over Nick Leschly closing remarks.

Nick Leschly

and thank us, for of more now, out I'll about to call would in elements to more joining joining we're encourage talk of to Yes. this. everyone day. Thank and a the want you But understand you these for to reach And hope I you any detail if has you, for great you questions. for and just everyone thank than happy the everybody, thank any

Operator

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

disconnect. now You may

2seventy bio (TSVT) 14 Aug 232023 Q2 Earnings call transcript