bluebird bio (BLUE) 9 Aug 212021 Q2 Earnings call transcript

Company Profile

Participants

Nick Leschly	Chief Executive Officer
Elizabeth Pingpank	Direct Investor Relations
Andrew Obenshain	President Severe Genetic Diseases
Philip Gregory	Chief Scientific Officer
William Denise Baird	Chief Financial Officer
Salvesen Richter	Goldman Sachs
Mani Foroohar	SVB
Yaron Werber	Cowen
Difei Yang	Mizuho Securities
Charlie Ang	Morgan Stanley
Dane Leone	Raymond James
Gena Wang	Barclays
Jason Gerberry	Bank of America
Matthew Luchini	BMO Capital
Mark Breidenbach	Oppenheimer
Raju Prasad	William Blair
Luca Issi	RBC

Call transcript

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Operator

Good day and thank you for standing by. Welcome to the Bluebird Bio Second Quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to [Operator instructions]. limit to please question to request your one question only. We is advised that be being today's Please conference recorded.

Liz ahead. would conference first Ms. over I to please Now, like your speaker to for hand the Pingpank, go today,

Elizabeth Pingpank

to Good morning, you announcing updates. Second of thank Investor everyone these business website. updates results associated press found our discuss on Relations today's and the for Quarter The our joining and call release can be section

and that statements our that statements which could description Before XXXX, section to risks A plans, results statement. www.bluebirdbio.com Investor forward-looking elect Company's and factors risk contains the we addition expectations expectations, these change, clinical begin, our Today's Securities Private involve is our me of materially including so, of as if expectations we regarding are the current future, with results. any may projected in Relations of Such our forward-looking statements to risks harbor based to the Safe and even are are the Litigation let review uncertainties our development of projections that update on filings specifically many differ to from cause available Act or do the intentions statements law. by on While required actual except obligation we contained the website, assumptions disclaim under programs. in discussion in Reform financial to of are subject SEC,

with Andrew, opening severe statements is then himself, follows. any after agenda date these and should as updates several an review the You over oncology the I'll genetic members of Nick. not They business. additional turn make will that, news business review by it today. of on joined be as associated will and will separation. disease for representing expectations management the With update Q&A Chip team. on share forward-looking will then our our to rely Nick Today's planned Then remarks

Nick Leschly

Thanks, for morning. joining you, everyone, call thank the Liz. And this

forward people the with has worry "why" my to happy Deep and and stronger a biggest Bluebird and words was to over to focus be commitment DNA X We'll hold the and the I'm and decision companies launch worries share we has press more As separate in Quarter, our incredible made the safety months, Fourth outlined the last with of only prepare you event culture. unique use the the Xseventy. humbling, the potential sharing studies channel morning, strong, that Bluebird we the as to the and gotten we we with Blue excitement the X exciting One say our also Xseventy progress look FDA and forward, clinical on my teams to CALD in as impact the early split we've release placed to turned thing passion one the but as this on the missions. We about Bluebird different going associated inspiring is continue will and on may the that hold. I'll into talk has the force.

few approaching that the In separation progress items respective the will made share next Our note. the few ensure deliver I to is particular X. the the intent day ready we There bottom on of business to with to each top missions. for ourselves to minutes, from optimize we've are

and share U.S. on Andrew adopt innovative curative, Andrew, made not access you CEO, but hear potentially Bluebird will genetic disease ready more. and that reimbursement The focus onetime are the from to business call post-split the to call, our will environment medicines. E.U current our severe hard simply today's right During we support

ALD study. recent for a Next, boy very MDS an of the the our emergence team will in diagnosis share

The the hold. FDA, family. Our hearts abundance the program and a caution, placed of go out out to CALD clinical man of his this on young

external the remains to this with positive. discussed resolution thought on of at the submission Pending we experts, the program all year. the to CALD information have hold, CALD U.S. length the We new leaders. plan pursue and continue for with that a We risk-benefit this investigators, patients believe regulatory

credit now Importantly, does programs, and efforts we that the foundation thal, will strategic resilient and only of including execute separation our sickle on event significantly thal grown therapy planned move. no plans. this Our our our and has confidence X and impact has right lentiviral-based have and gotten broadly BLA the Shifting upon of we not the submissions. and we was that oncology our gene committed believe gears, into reflect our unbelievably field and team, it an as importantly, to are operational months Most stronger sickle,

Our on task X that focused efforts know the key be areas have to to we ahead. important

each and establish for strategy First, the and tune business. vision

all for for down value double over Second, create patients the impact and in create every R&D will time, on an products, capabilities stakeholders. and that way

the in get Third, place execute with leaders, conviction. people, culture to best and

enable we'll Finally, progress the to businesses we've I'm Quarter. healthy highly innovative to beginning launch on be to huge at Balance ready and say Fourth pleased X the runway all companies sheet. a with the of made financial fronts, and

under better but efforts soon. are thousand plans the business birds On teams track coming the with even The progress been X s the tough great milestones. U.S. businesses. The we to ready first several our All leadership expected. sorted to place the go. filing up the SGD is shaping the homes in been to their with and IND next-gen Xseventy forward business while and on made necessary up, product the with culture and BLA uptake in vision call clear in to engine fired place, front, U.S. deep People of has in and ABECMA the oncology SGD have future than tremendous and Andrew's run product making focus CALD front, Filing continues on has move Thal staying have near-term

field. incredibly to more We members Board bench-to-bedside teams and several has with senior add The that executives independently unprecedented are operating team the continue key in soon. to leadership experience joining complicated an

on tuned hear front. stay that So to more news

been right-sized picture, as busy the we The ensuring strong as operational financial we've Lastly, on cash will take-homes. starting are positions. here the have but chip plans, well more, share the

We for to have sources streamlined launch pipelines respective X pandemic the our weeks, million following some Despite the we pulled challenges work each emerging business to years cost launch. cost the expect and and and eliminate of and approximately our us in delivering a months, extra and structure. to not systematically and thoughts runway separation, revenue allow the unlocking ready are efforts is share the financial will SGD some / these XX consistently we X over but we front. excited Bluebird Andrew strong more last which that, by supported also approximately cumulative With XXX reshaped their will In products In business Collectively, with I enabling XX approaching to each over of foundation. further reshaped only past on months now existing separation. expenses, the on and of short, Andrew. in structure it runway. now navigating pass the levers

Andrew Obenshain

within to morning This our provide of the the initiate seeking outside wind-down on that are actively you, of Thank opportunity for and we activities focus significant an the to the business Europe. Nick. strategic plan that alternatives, access we therapies Meanwhile, our orderly to we in U.S. patients will market. U.S. And we announced

innovative are and prepare of small it makes we for Company, European to proud bring wait our cannot teams, value to appropriately yet super the and This, afford payers Bluebird a the While of the its patients out. able successfully commercialization. for Governments support at priced strong regulatory were patient recognized and time, the navigate physician we to unfortunately, gene path this despite it not transformative and Stoner untenable therapies, for in as Sky communities. integral and Europe to innovative us have

are there a Turning need to patients reimbursement. path of in clear number and the significant a to U.S.,

We patients eligible serve devastating of plan characterized the are our by to for have beta-thalassemia, are at to the and clinical believe debilitating know gene need. our deliver and plan there U.S. directing to pain have efforts patients we in our we launch. have and centers excited We The majority is with are additional with where therapies of to market hospitalization. with product And cerebral Through about that frequent extensive disease therapies that a patients. XX,XXX years over treat. adrenoleukodystrophy in cell X time, reach these partnering U.S. these sickle patients that preparation, trials which qualified improvements. treatment and will these our over We we a disease, may to how sickle-cell, deep patients plus the be patients serve patients commercialization understanding

our physicians both infrastructure are building deliver and commercial U.S. ongoing We U.S. access we customer pleased for are patients. payers. patient have engagement to seamless actively a with with experience And our prioritized and

package was our our will to Today our but forward, Moving in patient's LSL a our impact some technologies have treated on the an hope ago one single with And globally Separately, that diagnosed of we have myelodysplastic we have data with tackle months. invest the thalassemia we've therapy lives. LSL that year we for safety address business had to a couple we our milestones in X announce streamlined summarize, future. with to submit decisions, to ahead product and study lineage the patients ALD-XXX update. on in to laser largest important major opportunities next in FDA and focus continue next-generation approval Phase difficult are we track patient improvements make to to of syndrome dysplasia. To approximately

family. in this been this trial It continues likely by his Eli-cel. with mediated are Bluebird He treating of of lentiviral clinical insertion. bio-sponsored to thoughts vector care boy Our physician followed be Lenti-D remains the that his determined and case and has under is a MDS of

on the like update, safety on out have hold, hold hold. this has BLA over XXXX. We do placed the that the impact or turn programs has Philip. rolling an the event front, of to mentioned, believe on abundance clinical some of on safety specifically will Nick anticipating LVV broadly, regulatory FDA with to shared regarding the it LVV in to complete thalassemia. this for studies details stakeholders on that resolution not sickle-cell this we the forward share an continue therapy CALD we Philip of the I'd additional programs in the the program and As gene our information and Pending clinical relevant push LSL caution, to been

Philip Gregory

approximately and authorities to dysplastic has stated, our site of greater sites bone with triggered these monitored of a been of LSL X a treated when diagnosed has their LSL has with given treated patient This X patients Andrew one contribution. and X today, XXX year these ago, study, previously presented patients reported in a are we thrombocytopenia MDS. one which a the regulatory ALD clone insertion is have XX megacarrier As announced X physicians. in with as patient predominant X being has of All XX% clonal with and treating closely X MDS. have marrow, boys by developed with than

can transform leukemia. into While MDS

tumor as the this indicating presently known have blast have Without in did Importantly, exact blast cells Lenti-D heaters cells cannot not MDS. evaluate, the does cells, confirm leukemia. played patient emergence we of not that role LVV to

to with due gene LVV gene this of the Mid-Con Eli-cel and insertion. therapy, the the benefit-risk of stem likely misregulation Indeed, years. by advisors, in and disabilities Lenti-D the investigators, progression, disease with of and believe this with clone, favorable blood several locus and cell of the context devastates in of with results the major decline we neurological and consequences CALD. usually the However, a patient, believe at with our experts The preventing with across X we discussion and in LSL expression allogeneic MDS of this XX% case Nonetheless, external CALD. associated as to locus the we or mark of locus, the this in is and efficacy previously profile -- alive mediated within due neurological Mid-Con well post-treatment. transplant. at presence predominant associated of integration treatment, the patients progressive peripheral death site MDS, in in whom MFTS limitations, mortality studies, our the X-year free remains of are CALD treated of devastating XX as Without of devastating Eli-cel functional morbidity, cell the observed

as is program and placed year. to address complete programs a and disease. the is supports a designed that CALD we the Furthermore, versus control is stem pending allogeneic an the the resolution LSL-BLA we and of types. MFD known was has a severe other its significant other This because XX results not implicated. to knowledge, safety neurodegenerative including therefore expression hold, our treatment at with believe of transplant-related a of and option disease. all for safety of submission available host approximately XX% MNDUX, cell To to of is promoter efficacy broad design. on our are specific expression custom the clinical Based each other tissue therapeutic which believe treatment the this transplant, of event selected in plan rest no survival comparison, the months protein graft of under employs this free debilitating all disease, our genetic CALD high transgene a in cell which viral profile For was isolated information activity, medical the LVV-HSC ALD The the this only program mortality. program therapeutic that

and called for thal which and file plan the track on open, remains foul sickle studies, are our means XXXX. For different our Bluebird, BBXXX a clinical for QX, BLA vector, use to this

let call Andrew. Now, me back over the to turn

Andrew Obenshain

of Thank updates house much the we more look deliver data SGD therapies. sickle of of share about investors. closing, engage therapy We update you, on strong to the show patients at a the call particular these year. forward U.S. in with We our to cell Philip. an side to continues it on end didn't to the in plan the is our potential tremendous the but clinical benefit In in data and gene talk today's discussing in-depth we the to position weeks and coming Important the as Q&A in

our Our continue by to pending focused. the XXXX, is our on by And to path a this QX year. of is regulatory be hold. The of in clinical planned of end CALD - sickle completed the And planned filings TDT cell expected BLA update completed BLA with year. be regulatory the year-end business resolution

to scientific and the patients management hires more and strong forward team now U.S. to management expand disclosed therapies in sharing with through our getting be I'll to working the SGD time detail a coming advancements the to in the of key on weeks, talk our coming with Chip our in a have to about focuses products. We and place in laser over reach on weeks look months. to turn and oncology Xseventy. partnership I And team strategy in the

William Denise Baird

capacity to March with extremely commercial as being launch. aspects we we're pleased partners approval possible. And study gears, clinical encouraged bring well line of [Indiscernable] both with patients start, Quarter resource working every interest expectations the First and continue and been the in the Thanks, KarMMa been was physicians XXth and available how the and year. able quickly I'll the additional excellent significantly in exceeded has to announced to treatment patients. our We've Andrew. key Switching FDA settings. with highlights And among strong highlight get unmet prep, in from myeloma, Recall multiple team of on sites our BMS onboarded up the of this Demand translated need a strong as running. online as the to ABECMA This launch later we've demand. at as tremendous from in results deploying to such particularly quickly unprecedented see into speaks

share suspension do possible, [Indiscernable] treatment. to deal million Resilience the reimbursement our a work a is to for current occurring to ongoing ABECMA strategic to launch, bring piece time. of Xseventy forward base ABECMA future including deal which not our recently to I able to continuing patients been we've in a we as developed announced. this as seen collaboration barrier have $XX wanted infrastructure closing, We from the backgrounds a provides work as for earlier we and the reimbursement get per is in of able therapy On to at plans employee and employees. the increases leverage Third through and have side, of Resilience lines. we expertise Resilience the and at over The look savings lot think external continue many still win-win established retain anticipate needs outcome. the to to coverage both This Bluebird future clinical million skilled We significant Carolina patients ABECMA as will we that studies to approximately to some becomes I clear foundational bio support that true of the and receive all Quarter. will we've be North highly $XXX validation Vecta North cost Financially, Xseventy. the LVV Blue. in Carolina of to year the advancing

We rates. will the preferential facility to have at preferred access

is for than collaboration Resilience manufacturing more Importantly, much the BRT innovation we of to remain an sale Xseventy. about facility. The committed with strategic asset the

collaborating we programs the number of manufacturing future expect be of the will and pace the which will together, development. on pipeline We products of increase

capability more to clinical as product capacities iterate a the in separation. we manufacturing also to in new product invest ability details clinical vital We answer We expect drug designing early that in And development be component for ask trials. internal to oncology. support rapidly that plan believe share and engine to our will approach candidates of the on and

about As of we we plan to planned towards approach end each Quarter look information the in to continue share the the separation business. and Fourth the year,

about these pleased management to also of While the teams investor that plan original the to today, the SGD by sides, Andrew this milestones. plan. the in launch million We approximately streamlined provide balance been and Resilience ABECMA end we Company necessary deeply building ended flexibility IND over of current principle Xseventy will those on clinical we've anticipate that's call. through the highlighted upfront expenses the and short, this significant about to approximately to to payment both equally the time. by In announced achieve about both more upcoming share and summarize parts future our position the plans. position progress forward at the operating cash approximately this and both collaboration. for upcoming internally trajectory from s our made And cash we've the with Xseventy each more but existing the of that financial much On with million launch moving top-tier s plans and strong needs the the the having Bluebird, we're the on cash that, focused organizations expected and the of on sharing future we sufficient the to it $XXX partnership business. financial an cash expect I planned and delving with today, and boards, turn as but closer under increased Nick the back regulatory hires into operations We're Resilience year emerging for milestones continued new in IND on milestones. of anticipates we to excited our from those the of the file remarks. and balance Forward-looking are focused will value-creating cash we of balance side. to starting European sheet wind-down always, important And our to X capital rightsize fund Together Second some will to guidance it and wanted equally we strength. closing million More remain X split, of excited carry $XXX coming with approximately We and will ensure With with businesses having fronts beginning on $XXX separation. head we financially. we've the and Nick what we million with companies of The operations progress $XXX separation. and business A tough We'll months. it we've step both reshaped come all engagement of a from the foundational important strong runway, based start milestones, position been on we're and that XX businesses, back on will means say Quarter we'll we balance respective be to Since lot sheets, key operating and We've for reiterating look current front. the highlighted, the more building made of as investor measures positions. but lot on a taken further months and have as towards expect reduced their weeks XXXX, about sources the value-creating revenue, the at increased time

Nick Leschly

this Thanks, if A Chip, and With well walking you several happy Philip, call, what and to on line can have feel. questions lot and on that, for we have Q&A management members operator questions. us through be we'll the the these any see of Andrew team take as to updates. to so let's go the digest

Operator

first Sachs. Your Instructions] [Operator Richter Salvesen you. from Goldman Thank question comes of

Your line is now open.

Salvesen Richter

questions. taking Sonia for you is thank Hi, Salvesen. our on so much This for

the of it? treated Thank the this likely features design I MDS to it? leverage And you then year from have to question. can patient For you. what one follow-up And earlier understand learnings case LSL, contributed to more are with in have better LVV of

Nick Leschly

question. the Thanks, Sonia, for

that's Philip. think best I fielded probably by

Philip Gregory

would Yes, you for The in sickle The that Essentially, leukemia tumor question. thing. that side peripheral site Lenti-D is or that several as believe like namely mediated will short we of that likely in answer exonerated that the LVV work-up case. prior this LVV case the of and went did cell I gene I do recall, point that us the cells misregulation remind we in analyze to yes. the integration insertion will the same said you point, expression at Yes. to that of don't disease, try we of features blood, is through on event. make call, have this the that thanks and this a

-- the differences programs features distinct. between a are sickle the the But of ALD perspective, vector quite particularly other can There From to. asked the You many that you of point also we program. vector about usage sort are promoter and actually is

vector very high-level the so expression And cells By designed designed between expression cell those erythroid for in types. for the programs. on a important used the ALD the tissue distinction call, said blood towards is and expression two across that's BBXXX the the that only program drive contrast, I broad was red will cells, promoter tissue-specific As all in lineages.

Nick Leschly

a lot. Thanks

question. Next

Salveen Richter

Oh, another one quick sorry. Could I or ask --

Nick Leschly

if one, quick limit yes. Were to to then a trying it's but follow-up,

Salvesen Richter

you Just doing understand a would what the better quick to assays be that? on follow-up -- experiments or

Philip Gregory

to point without can tumor this cells that you. analyze, completed do experiments we've time. At the we this Thank at

Salvesen Richter

Yeah.

Operator

Your from next Foroohar SVB. comes of question Mani

Your now line is open.

Mani Foroohar

We've in developing for diseases. you Thanks for outs, the Europe, of Commercially with taking question. therapies couple a guys. challenges seen come some severe tough for and doing novel complex science pretty

the able any these may be not had program. and trepidation you into overcome in extent [Indiscernable] little in about the or commercial executions reimbursement to what talk signals What a the that disease run -- challenges the situation look for be U.S. U.S. franchise. confidence E.U, in can to and Let's will sickle can rare around bit across reasonably better for where given and investors you've the will realized safety beta the that the

Nick Leschly

real is This your quick, Tom it I'll on over just pass last there. Nick, Andrew to here and bit little a

or the very that engagement. and it's dynamics the said, U.S. the But why community. signaled have think that that certainly sickle it they're reasonable actually to studied extensively there's to broader approach not I Andrew. read-through belief That same versus Thal with a have taking we that pass there. European on certainly the and because to strong the And no regulators have we quite believe

Andrew Obenshain

reminder, in for in payer -- negotiated U.S. and have with. have payers private negotiate that and with the consolidated systems systems different Europe payers has The government country. a U.S. each European the just a single pricing in prices many as than entire governments So parties, general, different are the overall free very and

hand to So Officer different like genetic Commercial comment diseases. Tom Chief to for is it very, to Klima, But systems. more, I'd the very who severe

Nick Leschly

some Tom, just you can just real your don't line you if before There's mute quick? mind. background noise you go. Mani,

Mani Foroohar

Sure.

Tom Klima

the Mani. Thanks Yeah. for question,

these in about with I and three qualified treatment positive working get dialog think with patients. both we're reimbursement. and payers patients for U.S. to one now we've very coverage sure continue our one can to working stakeholders therapies our both and path for of all our feedback our the for years bring Access been centers, is closely make we and number curative one-time to of QTCs, actively over securing that priorities, potentially

Mani Foroohar

guys. Thanks,

Nick Leschly

Man. you, Thank

Operator

Cowen. question Werber comes Next Yaron of from

line is open. Your now

Yaron Werber

August, Good Yes. morning. [Indiscernable] Can bit understand to Off quarter. actually question there is a -- vector a got little here great it's and been production has per there can point, clear said believe to give the month XXX some as I think I many patients the I supply. of rate that's going as run on get about Bristol(ph) confusion from us REBECCA. at point they a I you The is in to the some a step in be sense? but not that question a this launch really is onwards. more rate-limiting

could it sense be you. a So better understand model appropriately? can and so supply the we just us what can give can you we Thank

Nick Leschly

Nick. Ron. Hey is This

it's I think comment. fair a

to -- the this and both because I thing we think of say is the medicine are importance BMS one is as by this the can completely community evidenced focused us uptake. patient on I clearly

drug side of product details product when, we're end the is be meaning the we'll something approval fully Exactly is year equation, if demand more as the and ramp and able to evolution drug to the something of and FDA Chip, working the by that we at we're you of running and are this and that meet working both the capabilities progress forth. and be we Vector. any exact on of haven't with have on much certainly the want We're both on now to where so since so the with optimistic numbers add vector on the made as between that great to and And going BMS house, continue to that actually that? disclosed. sides of we're

William Denise Baird

Nick. No,

the terms you well and focused a and products capacity as increasing setting, date. amongst increasing. certainly quickly pushing of we weekly the and Reminder just vector CMO giving of we third-party at is But focus deliver to the online can think going But drug month-by-month every it. are is we increasing here expectation, was we're the today, the name, and chain for that aspect testing, will There's suspension year, vector that a actually at expect, downstream the release produce, we teams Vector of said. future of as numbers many produced think on I patients and that stop be testing, end monthly number I short in can the to here yet. on at as supply between of today production, the also towards bringing

Nick Leschly

And the you're been question interest in for And that is the One exciting lines?" seem be is answered. the therapy of certainly demand on that was, doesn't type clearly this there later right? part has "What here constraint, to

And so Giovanni over can various (ph) you basis a I tell or Chris folks are BMS, on at completely weekly (ph) engaged. the it's over whether

Yaron Werber

Great.

Nick Leschly

question. Next

Operator

Yang from comes question Securities. Next Difei of Mizuho

Your line is now open.

Difei Yang

taking and question. for Hi. morning thanks my Good

treatment, on So quickly when you do move quick expecting and part. you ABECMA, think earlier should how data? of into lines can a Then CALD see initial question be the we to

your with about pipeline you And if still curious what's thinking adding on choices? the side. with the an is would that that if CALD, additional limit are disease happening Just rare case

Nick Leschly

to second broad CALD maybe so to the a from there lines This in and lines and plan is third continues Andrew, Nick, collaboration line -- can you Everything take question. question, comprehensive the the line with forth. be Earlier earlier I'll to BMS. the and speak and development

as working and with on likely, one data more year next the something continue throughout those them. studies. after, The to this would expect with that year, we that are the and will So emerge is year

will time, of interest very we have in believe as can that a earlier be in also ABECMA broad to that shown we the if that certainly well, over medicine therapy. not this spectrum we still So better, as commitment the and seen work And therapy. lines

that and continue. So investment commitment

for Now just let it me pass question. over the [Indiscernable]

Andrew Obenshain

Yeah absolutely. in is products The there the as CALD, the we are answer the design vivo capability right safely. to positive. is that have remain that We do now now, on in we're focused active do. our to something bring short is into confident know right the we believe including we how do going U.S., risk-benefit research to patients that we LVV Vector and That have X

not for So it future indications. LVV limit using to approach will our

Nick Leschly

future is the will, also also and the you. we allows a I to those that sleeve in invest deploy the And of only which think part to Thank here is not the capital, the you decision those the by you products products improvement invest limiting think also on I focus Good hearing and but question. today. move benefit if of can of taken then question the where benefit U.S.

Operator

Mr. from your Stanley(ph). Next line of is question now comes Harrison Morgan Sir, open. Matthew

Charlie Ang

partner Matthew. one expect a what have marketing a maybe for my is more just be of you find Thank to your another into you that the for wind-down? is from Or is, down you Do can European [Indiscernable] Ang(ph) and winding timeline would Charlie year? taking for we this kind operations like able Thank Then question. This you. saving expect it to

Nick Leschly

the you can implications you of don't the start, take the comment and of financially. details on question Chip the Andrew, the first wind-down, part we Why about timing

Andrew Obenshain

of to year. expect completed end be majority We the the by wind-down the of the

We be will a either operations mount through after the that over in the taken -- the patients year. that, pushed end be will the down. of But by or will pipeline are partner treating be

William Denise Baird

piece a the structure. side, was of terms Europe our In SG&A meaningful cost cost overall of

We period are in some European employees take and time. as by with that through will Europe consultation mandated governments moving a so

of a guidance think precise short giving little I there. we're

largely down. we think it the more will the studies down. winding we'll process I be importantly look regulatory as coming through in be or future whatever, have terms will maintain think the and We think of value to as we I and of get say meaningful longer-term of we there but infrastructure those to savings o will extension submissions assets the

Nick Leschly

partnering think engaging And important to have it of Europe. lean we products part with and that I engage towards us of to set will players a lands, number certainly, your other there with on on is just that was the we that patients, mention there that that over there, now, question on no specific right sickle do we'll side, that. front. because different optimistic are front But not of time. we as product, us are to certainly if The on to will the get Exactly are comments are where including see

Charlie Ang

you. Thank

Nick Leschly

you. Thank

Operator

of Raymond from James. Next Dane question comes Leone

is line open. Your now

Dane Leone

a sure about the you the Thank operations. there Europe. you later, consolidated hope I'm addressed In see you spend a that degree operating models, I less have bit know taking it burn for little for but going the that's in for basis, a script a both not mentioned your an maybe businesses on adjustment is how work that XX of for post with disclosure, current but basis to into for we it, bit months in our a split. runway is post-split, the clarify be can on going the questions. get you of dyssynergia just you cash you versus might But little more to

give businesses, just be what in might additional Thank can I on you in see SG&A think you. we would of rationalization the helpful. us or terms post-split color up any R&D So for

Nick Leschly

Why question. Chip? to that Good pass I right over on don't

William Denise Baird

rationalize until we Yeah. cost are fully No, next the manufacturing effects and decision continuing Europe. Resilience, the thanks. to of between I then in would plant the won't year, be to yes, those realized say this BRT transition and structure

So big oncology ramp, an the those or for At to Xseventy ABECMA time, we the two our continuing important pretty see provides tailwind are the levers. business. which same

for terms the In late-stage it's be products squarely the focus In bringing to Xseventy, focus the going going U.S.. on patients. those the four be on of three And engine. then to particular, is the pipeline in to IND those patients SGD,

there's months as sources in control which revenue emerging also the side alluded SGD on we of a to, commitment that is and of equation, revenue managing which is that our runway. of And of a business cost with As the revenue side existing there's ABECMA, sources to products within XX to largely the are approved but number X see year. these the to to to our years. U.S. the feel think next businesses for we And of as that we a we I can ability continue side. then there say move revenue here about we the in operate levers forward, good More exercise on next strategic

Dane Leone

Thank you

Nick Leschly

Good question. Thank you.

Operator

Gena of Wang from comes question Barclays. Next

Your line open. now is

Gena Wang

including due to wondering the Thank because for LentiGlobin, need differences the reason have question submit sure to questions. [Indiscernable] there not the insulator you show is components. is data also I that other what or make regarding for experiment FDA promoter, versus the the Lenti-D I of X my to MDS you locus element. this three the want kind no Lenti-D the of remove and other the to to taking region [Indiscernable] control backbone just for that you just

Nick Leschly

one pass to I'll think that I over Philip.

Philip Gregory

Gena. Thanks,

there these obviously, between vectors are differences That difficult, retrospect. do in that you are substantial experiments it's to the said, to. So alluding

it may will, enough. want necessary things We right? I a Lenti-D, that much a However, the we there and we and first the specifically think other of make to of So component major that's itself that's that believe here. integration one be that was [Indiscernable] necessary. if choice the is best the in of sufficient, that's is the by clear and you That in into are don't the sort by locus tissue-specific. that's for and is, expression particular we critical that more itself case think said, not choice difference hit broad tissue restricted role versus which a of promoter think that's promoter playing

used CALD component. the a think difference important So and Lenti-D globin difference. between a significant with the MNDUX we from promoter that's that's an that's BBXXX promoter, and But the

Gena Wang

Okay. Thank you.

Nick Leschly

make that we and that we'll But fairly the with go we to towards you, believe around risk-benefit our through on expeditiously, assessment continue to we the appreciate can well updates provide engagement agency people do an we'll as on this more Thank have. and down sure One expect certainly Gena. thing filing. this given that that front, will process that come path program this as

Operator

of of America. Jason comes Your next Bank question Gerberry from

Your line's now open.

Jason Gerberry

questions. my Hey, guys, good morning. Thanks for taking

European for much your key on great Sogensma, Europe Europe back that Thal predicated beta LentiGlobin capture this you really market was one not captured would and in a value. if typically specific to investors Southern drove Wondering Because was of anything just I can pricing pretty which product imagine look the Just Germany. curious with opportunities at least at decision versus the there this of in was wanted a come like that decision. to -- and say to markets LentiGlobin how for good market

these maybe As here, some comes different prognosis of on of drive Thanks. But the a to gets the that value. can played down written into patient. just and Europe one-time for postscript the [Indiscernible] Ultimately, LentiGlobin, wondering, therapy that and availability factors in perhaps, as the decision. alternatives how

Andrew Obenshain

were we one that. countries is take multiple Andrew. Yeah, conversations so enough -- from see gotten be wasn't -- there wasn't not -- overall. sufficient countries to was far country, X Europe. on had achieving Italy, There were one there Then going Italy going it wasn't value those in that we Germany gun were that achieving particularly country. can right? And multiple -- This the across we it to particularly wasn't It I value wasn't particularly recognition smoking

some unmet make the have relieved. need the some not issues. did, are not of some case recognize bag of you care. it a did being really, they they terms the think not of point and costs recognizing a European do I in premium In what were therapy cases provide were the Unfortunately, some comparator other that governments cases, in good In about in in thalassemia, standard willing some to over a so cases not. mixed was something of were duration

the Europe. though move very parse that to to So for levels The was difficult forward that single were not a seeing in price sufficient out one. we result net were us

Nick Leschly

add it's like question, And the one there this. thing element is that I'd that, system situations an broken an is I the think frankly that's to European important of for

from as quite time, get described not myself, ready what But for on Andrew, I a to be basis so the over we value optimistic think time, this it's just of are have just on back and sort in is, medicine question Andrew actually nature. the that. think to Tom that others and and we moment we'll experience this look And able at

together for of that's but And we make a fix European Company. reality with to hope we this So the today. what live something over in point, it's that to the that's we at time system. had But this unfortunate, move

Jason Gerberry

you. Thank

Operator

Next Matthew Capital. question Luchini, BMO comes from of

open. is now Your line

Matthew Luchini

questions. the morning. you good for Thank taking Hi,

the onetime. still shifted point bit. the goal or a the current genetic still severe or And review, for at aiming Europe? that U.S. now reimbursement, value market product the to And just it's that nature the the as strategy fragmented even relative for U.S. the strategy? Is the really your reimbursement. paid the U.S. has does a strategy Company's X On this the little discussion about the nature of approach based consolidated year the in for or Recognizing trying support philosophies get to is

Nick Leschly

why something have to don't Andrew, we question, comment if and Tom, you have why don't Great add. you on that

Tom Klima

Yes a good question. it's sure,

all access we're looking Our priority, main to access. and for patients I at achieve is options different securing said, as

and I to time, we in if the the payment payer we're secure depend tactics it. that willing they how certainly short, to it implement will so that, each on case consider a was over numerous of over to And flexibility and access payer different then think time. and In strategic the going and adopt willingness would offer for payment adopt

Andrew Obenshain

Tom. you, Thank Yes. Good.

-- an that take trying make consideration to we flexible issues. taking the We're right. And that's to right? be think into that's willing around sure those I approach we're payers want, what

Matthew Luchini

on is just there blast can absence sounds recognizing tests the like without said how that the that the of be been it blast possible have Great. cells, Okay. cells done Thanks. quickly, And done.

from blast resolution we hold here? like it of of to cells. on do about think absence path sort has progress needing how stalled So basically the seems Since these

do from here? So go we where

Tom Klima

think wouldn't how I -- don't we that's it. view I

said, I as patients, with XX have treated We eli-cel.

We that data in have extensive durability trial.

set for risk-benefit. I agency data the think sufficient is to the that understand

We said, view data experts insertional with a LSL dataset, [Indiscernible] all to obtained have will that the based better progress event forward in than risk think able should the be the outcome be on that and we based an we much filing I transplant. -- that CALD view, we've As and of physicians. low the is spoken in to, on treating view of our the the application. actually to We

Matthew Luchini

Thank you question. for taking that

Operator

Mark Next open. line question Oppenheimer, now comes from your Breidenbach is about

Mark Breidenbach

guys. morning, taking the for good Hey, Thanks question.

if or can Just CALD previously who syndrome to-date? we've wanted of sickle Thank you. trials non-malignant in year. from distinct at clarify, who evidence patient expansion seen myelodysplastic last EBMT remind clonal one thalassemia non-malignant us And expansion of of any the is to showed you any just cell the clonal the developed evidence

Nick Leschly

pass Rich. that I'll to over

Rich Colvin

other Yeah X or no clonal this that Great. who've you. cell in who previously expansion Thank or -- any had thal had is have of sickle expansion. about non-malignant we patients at been patients talked had There clonal any clonal one Yes, all.

Mark Breidenbach

you. Thank

Operator

Blair. from of Next William Raju question Prasad comes

is now line open. Your

Raju Prasad

and Thanks about production question. us just for how revisit taking to wanted as I we And you it's adherent the is the remind Can just produced Vector currently I being bit process? think pipeline under partnership ABECMA. for as the moving support it an help about but it a know talk little suspension we may maybe meet suspension, was Resilience initially how demand, and cell process to the move Thanks. oncology the sickle forward. then

Nick Leschly

Yes.

is gonna made well. and have production engaged as adherent network. that process, through that time suspension is BMS do Resilience now, be a part time, It an over facility, this of correct. at process commitment the that as they is That is BRT very Nick. This plan the is certainly you're much is So and at we through

Nick Leschly

a other that certainly also that's for clients. of this the better we'll and that make utilize and in. help So we're relationship the it cost be would you on use can also something capacity, is Bluebird, should we bunch breadth participate the likely to overtime, most as with of Resilience, we of on that's and in Resilience they that fronts. facility to, to One And something able expeditiously something context, is which vector would of two front, as moving the as down there, through forth. plan goods expand so That's

I Chip, to add have anything else on if you So that? know, don't

William Denise Baird

No, Nick.

I think you hit that well.

and I the ramp that will part will be Thanks. access that of so long for think preferred there, next-gen, be the continued ABECMA. -term important for on of key both And the structure Great. deal. of suspension side at key access businesses was the an BRT pipeline that

Operator

Issi Next question comes RBC. Luca from of

open. Your now is line

Luca Issi

Toloka. the taking Lisa for is on This Thanks Perfect. question.

expect Thanks. like gene developing Insertion the more given editing we more CALD, with and on evidence platform? pipeline you now oncogenesis have direct Just LVV focus [Indiscernible] suggesting could broadly, therapies technologies caused your some to some mega other see

Nick Leschly

it can I'm but answer. sure This to to provide is I'll make not over kick contextualized that a there, Philip Nick, you connection

Philip Gregory

vector right? Yeah, involved the is field. own but we because this -- Lenti-D we believe programs to think supposed broadly to as see and the I n you've that We -- just this insertion. it [Indiscernible] CALD, more is and applicable, differences between So thal mean, on first I'd between is more we in also not critical, say don't that sickle, part, thing the LVV restricted the broadly of our that's what particular And was have large in as case. think described that's

Philip Gregory

we megaTAL In technology. excited We're terms so gene-editing have that, we're obviously of application the our technology, applying about the of yes, that.

know, hemophilia. we have have IND Novo T-cell in well. around And you vivo we as have We product towards that's with as a collaborations heading --

opportunities technology We for use are using we'll in to that technology and in to continue that future. look other products the

Nick Leschly

Lisa, Question, thank you.

Next.

Operator

from of Michael Schmidt Guggenheim. Next question comes

Your line is now open.

Michael Schmidt

guys. Thanks split. I question. another for business the had taking one regarding Hey, my upcoming

relative and sheet consensuses to Bluebird it the a or cash Legacy Xseventy to from balance to to have between perspective, cash balance current rebuild different be perhaps both what will ABECMA two-year will be ratio guidance. Just three to ramp as this it a split and runway evenly

so thanks So much.

Nick Leschly

It's good question.

on want it? Here, to you in Chip, jump do

William Denise Baird

Yes, happy to.

balance burn businesses don't X runway an years expect the the the of here Again, of The months we Quarter is sides. the house. Again, ed a the would evenly we launch. in an And the revenue to that the look seeing. the million in math, runway of million we're for total And same rate. or between be fairly a ABECMA roughly piece the side on terms both U.S. strong is on the runway $XXX have split with important And amount $XX the we again, X. two businesses. a cash see of equal each very In of between split, XX exact at of of of First approximately demand to yes, portion component as oncology for commercial solve

the of the Xseventy investment for help So that provides pipeline. in aspects support tailwind earlier a and

guidance provide fourth detailed the So our the of as we into and Form with move other public documents filing separation. again, of quarter XX more we'll moment

Nick Leschly

a only capacity year game [Indiscernible] treat is be thing approvals might maximize advancement to the possible timeframe, other the The as be there, and the of both next difficult. anticipate I number, baked thinking same the launch add good this we think how with regard. into right? many runway. able best a I about appropriately can, really Given without that forecast in to sharing and the certainly also to meeting demand that right to we being even think But to as about news to as because there on more as specific do relates year and out are in we expecting thing that demand businesses opposed also That's we as ABECMA, our patients most that's to be it and just interest with

Michael Schmidt

thanks. Greg,

Nick Leschly

Good.

Operator

comes Zhu Yanan Fargo. Your Wells from question next of

Your line is now open.

Yanan Zhu

Lenti-D and a on read the question and have programs. I my case question. thanks Hi, through taking MDS other for to

heard -- also is gene think to I due I locus the[Indiscernible]. might probably I perhap disregulation there think promoter. And seem this to site mention Philip the the that some and vector be at the integration

of to of regulated? the there So program, and And affected what clones more the this integration importantly, disrupt Mid-Con that overall -- could for the locus? gene the is rate that percentage chance locus? what Thanks. is into And alone gene LentiGlobin any or is is at be happened could what clones integration due the

Nick Leschly

regulators regulatory and and whole in situation, this a like second. the we over fairly pass thing and on on the forth, on one was So made the a I on the specifically a will it recently, decision The equation the hold of it that the here to is in say intentional program. an by program, Philip I'll program that's had thal side ALD ALD sickle the so prior just much not is

how moving point So believe we're why with view in regulatory very And all the vectors planning not we us, a actually medical it's is read has other a understand that's no the that's how different. clear. and scientific forward just the and healthy and point-of-view. I but There very and a ecosystem from programs read field. way the is through evolved, that's of we're through the think are -- also nuances of to And

to over I that pass don't it with So as context, why Philip.

Philip Gregory

peripheral important What recognize across after in quite called mecom integration. That's -- said, and the all and -- see or are or why critical it's is is point clone it's that expression In the analyzing, vector CALD that least increase -- Yes, integration the in gene that lentiviral program, common ALD the a we this reached locus. mis XX% what to the the and the so. we an Mecom general, I've X that's question of been so of the which the the our quite we've to a peripheral good tumor as into analyze, criteria as that EDX. means a happens indication. at blood we've boy don't of the they're regulated. therapies is locus independent and the predominant Integrations the reached a has and is this And MECOM gene blood common cells seen a that have gets And proxy misregulation blasts been of design of is

and at the -- that's of we said a dominant don't clone. thal dominant as integration but see we studies case, in and described earlier, a context become in in a the all. Nick have So, those we've And as sickle, clones ALD [Indiscernible]

Yanan Zhu

you. Thank it. Got

Nick Leschly

to that, got launch we'll detail soon Xseventy going sharing Quarter. continue updated by think for with it, lean that With Fourth the speak behind look well thank to anticipate Bluebird of close. the substance more importantly, you we and the certainly in others filings X as we're prepare you 's With And speaking with these as oncology here. is with we as we IND you forward time, your early we We you again. U.S. and companies and as themselves more and these towards I are both excited that, keep the to which very businesses, to

Operator

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

You may disconnect. now

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