BLUE - Earnings call transcript Q1 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the bluebird bio First Quarter 2020 Earnings Conference Call. At this time, all participants lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to Ingrid Goldberg. you. Thank ahead. go Please

Ingrid Goldberg

The today’s highlights will update. good bluebird we Chip. This management plan today’s bio our the Nick, to and call members be by Investor with from of our conference Ingrid call Relations discuss business and earnings at and quarterly complete opening joined revised morning, you, today from and team. is several bluebird everyone. Goldberg, call I’m Thank welcome sickle from cell Dave, will remarks from operating a disease format of regulatory update the to

to We will then questions. turn your

Before I variety Act risks expectations that are factors. begin, the actual our uncertainties a to materially are XXXX. I statements Securities and includes assumptions from and expressed those Private statements remind current of due everyone discussion under would today and to results on to forward-looking that subject may Such like Reform differ Litigation of forward-looking today based

in available Additional filings at information concerning our our the section www.bluebirdbio.com. SEC on the website with of these risk Investors factors is contained and

law. change, in as while statements As statements update even forward-looking update not future, our obligation we elect do if expectations to reminder, we undertake by forward-looking may required any a the to except

You as should representing on subsequent statements to our forward-looking of as not rely these expectations today. date any

will the that, call turn now With I over to Nick.

Nick Leschly

Ingrid. you, Thank

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seen on positivity, of impact best with and The to amazing. the is folks Inside of and the in operations focus ways inspirational stepping all remain resume. we’ve lining passion truly pandemic and can as is silver outside continue vigilant The until the leadership. and human the not sorts yet intend to just known company, up we very normal we bluebird on fully we navigate

operational With the vision excited revised tremendous that has advancing as plan, to but the the more operating all to our developing bluebird’s further of solidifying in our a in progress execute. many development fundamentals patients programs. strength progress show key I’m fronts, significant for across been and The context, not only also

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the the XXXX. in FDA reviewed approval on approval in second latest the at to On have of with to file with path the alignment front, disease cell sickle we LentiGlobin cell meeting accelerated for happy EHA share for we’re mid-June. the the half reached general to plans disease in share upcoming data sickle that an FDA We with plan

ZYNTEGLO of Europe, cell. and milestones, LentiGlobin Overall, LentiGlobin deliver major several for ramp commercial in the to in filings Lenti-D US sickle track US now XXXX CALD, of in approval on thalassemia is including ide-cel, and and launch

as for promised call, optimized to relationship flexibility. to add on our best resources made Second, we serve pandemic. monetize update to unknowns the ex-US front on to we March plans and reflect have by the operational and and COVID-XX ide-cel the to BMS with our $XXX the Notably, XX million our our progress significant rights changes operational on our have brought

new million In reflect tuned our the entire our have $XXX realities addition, plan with help of over operating mid-XXXX. bluebird from flock, plan we removing to the through

will Chip into promise core more pipeline four the our late-stage XXXX, share while extends as intact. revised runway and keeping detail, plan in programs Finally, our

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our on transformative balanced our BLUE into a more we focused mature bluebird short, they charge, patients are desperately the over the way the and coming fundamentals delivering products deserve. as company fully bright now MOJO delivering, so integrated deliver with biotech we Our years, hope. shining as of even more is In recoat and is one operating plan promise sound our to

to Chip that, for the on Dave go over details to With I’ll Dave? it details. we’ll some and operational program hand plan for then

David M. Davidson

for provide clinical disease the approach Nick, data everyone. we as Thanks, last like at a some context update presented to with of the LentiGlobin year. and high regulatory as you I refresher in sickle June, that ASH for cell remind and of good point would morning, EHA we this To

represent of manifestation progressive quintessential lives completely derail These stroke, patients are endpoints sickle meaningful organ clinical damage for and may sickle increased patients irreversible leading most crises and crises the well disease. cell cell of the the clinicians. hospitalization, as with clinically painful and life-threatening morbidity crises, Vaso-occlusive often to as and mortality. These disease

study data least six study each in C, HGB-XXX ASH On had months of patients vaso-occlusive from from syndrome the bar who frequency in at this follow-up. and Group a patient figure the chest capturing acute crises represents

the follow-up period is all we event. of The communicate left potential the LentiGlobin remarkably the after data infusion, a and the with gene of therapy. reduction On shows transformative the an diamond truly too representing pretreatment figure XX% in These LentiGlobin period side time see each frequent crises. red right

effect with The a development program. the revise for that of the positive FDA enabled and magnitude us impressive accelerate has has Type to the B treatment recently meeting allowed and productive path this

an Nick results As update we providing mentioned, at plan EHA. of the study HGB-XXX on

development approval the Phase Phase to prior and HGB-XXX our HGB-XXX support the slide, X study. consisted study of Next plan X/X

endpoint. globin primary to was a of which establish goal with events, the occurrence as and initial key endpoint outcomes HGB-XXX the was vaso-occlusive between response Our secondary captured hemoglobin-based correlation the

interim for results was on observing globin support based HGB-XXX. favorable accelerated This intended to in approach response approval

for discussion shown our HGB-XXX has new FDA the a a resolution in is agreement of BLA, of patients basis alignment be study. data, path the complete updated endpoint the HGB-XXX the of have the severe this slide. clinically the primary which on to On events, recent In with study we FDA, outcome to most reflects provided achievable the which meaningful vaso-occlusive on with this

patients a Group study. based C will seek The of With the the response key accelerated shift of secondary to this planning change, in endpoint. subset are we globin to being endpoint approval on HGB-XXX

for number of anticipate are infusion. submission, filing follow-up support months additional patients that we While already patients demonstrate have of the XX to necessary at we our C the with to after not in sufficient will we treated Group least that efficacy be specifying

subsequently initial on with the resolution follow-up. submitted data approval, an serve of complete of be severe For as intermediate supporting events vaso-occlusive to confirmed purpose the will endpoint an clinical longer accelerated

have BLA XXXX. clinical in second of data outlined, we US able half anticipate being Given the submit to we our package the

X will allow study lentiviral will addition move with we with to parallel, will This to the forward additional vector. patients with to in sickle pediatric continue suspension which study experience serve study. Phase evaluate HGB-XXX in treating the EU In us gaining post-approval confirmatory a disease and patients cell as

and build for in regulatory additional two potentially a geographic full to us enabling label and the together that engage serve will studies comprehensive enable as will dataset future These dialogues, basis approval. expansion clinical

but relapsed/refractory across partnership myeloma. Squibb late-stage to for mentioned, progress Nick as US not for programs. only sickle disease, submitted meaningful multiple We have with Next made slide, in cell ide-cel clinical we Bristol-Myers patients with recently BLA in our

As we important we more amended discuss detail. collaboration, prepare in commercialize, progress that to Chip our have will

also are the ASCO presenting year’s part from looking to We KarMMa study virtual meeting. pivotal data forward of this as

in patients the study Despite as but to for from with highlighted with have transfusions, bbXXXXX as our bluebird’s additional COVID-XX. has risk slowed countries. patients EU myeloma X/X COVID-XX, ZYNTEGLO by of access Phase enrollment for TDT treatment in consenting in has pleased for made multiple CRB-XXX external being and progress to with we in Europe gaining Our frequent for active, Germany, been relapsed/refractory tethered which reimbursement of patients remains challenges blood preparing the and due well partners the our and global in

finally, on at anticipate regulatory US track and updated later HGB-XXX We look for the pivotal EU forward the year studies. year. this And in CALD in pleased data are year, for at to medical for clinical we Lenti-D meeting this providing for and next ongoing Lenti-D and that our planned remains a EHA providing filings updates HGB-XXX we

I’ll And to over the turn with that, Chip. call

William Denise Baird

with and months our Despite the everyone. been operating pleased of The macro Dave. to and time of change the revised Thanks, call. capital on outlook. the business and financial the pandemic fundamentals plan markets updated Good outline dramatic remain these last morning, strong. profound two guidance to environment, the have a COVID economic changes impact unprecedented our today’s I’m to

realized we we vision to so, deliver find on And to streamlined XXXX the needed way that a capital-efficient and a way. in

towards a transformative seeking commitment financial sustainability. forward are our to balance continue patient to that the we moves and products, we prove impact of with operational to As out us cutting-edge innovation plan our

components this business and and core second, non-dilutive by and plan Our the secure the fourth, most continue promising rate; at in by extend scale the commercial runway. funding grow the more balanced and platform are and innovate four a advancing number pipeline to one, third, in fourfold: to goals patients sustainable the setting technologies; of XXXX; deliver financial

we top Nick, of heard at were the against from you goals. all successful As these

This recap revised was market; financial BMS. and support the can than a to to the the milestones that ide-cel manufacturing; slide to for to we set there continue strategic and are paying collaboration: over vector broader BMS royalties program, go $XXX good revised simply and rights the our States. on manufacturing will a and ide-cel terms responsibilities bluebird and for more time bluebird. BMS of in to bluebird exchange for for will to with million To X, on Moving future United BMS the the vector patients bbXXXXX ex-US good manufacture outside bluebird of transition deeper US and is to collaboration takeaways good are transaction related

We’ve non-dilutive revised secured are at are in in of shared both number we investing We critical And with we alignment and very have to for for the sides deliver patients. geographies. operational the have with the BMS importantly, reasons: a company a aggressively ide-cel time. First, most for and US commitment $XXX funding million collaboration ex-US to pleased

excited from ASCO share KarMMa are you Nick, this to the dataset the later heard As month. at we upcoming full conference

XX, slide I’ll operating to details the our of on Moving plan. revised highlight

non-negotiables had launch Europe side programs. core and XXXX. in in approval here, It in you what be and four funded and US to starts the the page, left-hand resourced On the we’re the the commercial And with see our plan. of of by regulatory terms seeking

secure a our to four vector supply and pending without from the to on, manufacturing core commercial and both cost are a the is suspension launch critical perspective. making Moving perspective transition the chain we This doesn’t and here seeking capacity for manufacturing. of happen lentiviral goods

of that the the and two the Research is reduced and we’re ways in suspension and in that critical promising conditioning, toxicity years. and assets, keeping apheresis clinic supports to not four the one of our of blue know. be all operating and and bluebird the culture, cryopreserved like investment to least, there And but core four, last revised support next part continued through of most potential expansion programs two people this certainly plan, plan the people important come preclinical LVV, technologies prioritizing core a could

prior page, you includes: more footprint side On and This and the fixed savings in see which time studies, prioritize deferred facilities, drive actions through to which label-expanding the of side, line where is our we’re we right-hand facility to the being; cost can timing most of with on overhead; the the the notably process reduce plan. a build-out forecast; delayed and sickle research versus stroke have able commercial study SG&A was of programs. preclinical and our for on finally been pause in and prioritization HGB-XXX taking

where long-term of well-positioned answer turn wanted value all it this for and revised today. to the XXXX, financial back Nick. With innovative we In are to clear the we us have we to questions our sustainability, plan, to create I’ll while any we’re be that cash are Q&A, in operating runway got I our conclusion, but business into for stakeholders. to that Happy now, balancing side committed

Nick Leschly

path a that won’t and It’s our cutting as it’s programs, for our first Chip. back, to preserving four towards say, the R&D doing call business forward optimizing a digest, what Thanks, without grow progress but With so and Soul. lot we launching important bone, we we exciting feel

these work launches as this for amount programs XX prepare board. you regulatory to for team up completion four across set to a by our a XX ourselves the In making busy can months our on across and core the submissions slide, see of updates, tremendous by of punctuated we’ve

So, now Q&A. like with open that, to for up I’d

to many going as We’re you as we will be that possible, later. get people get you, one do ask yourself to to to to but and question, to try we Ingrid, up operator? we able with limit if follow you don’t

Operator

Cory JPMorgan. Instructions] Kamov with question comes [Cory Kasimov] line Your the of first [Operator from (sic)

Cory Kasimov

path and the just Good all point. I’m is sickle morning, the Hey. about what curious, agreement question today. color for and I ask taking mean the for this I cell to guys. guess Thanks the wanted general term [indiscernible] at

like there be to sounds guidance, aspects on ironed have need reference of it waiting or in you but just further still lot it terms out So, other manufacturing is a that the details, to are in be just lot. a into go point? Phase and so included, in might at going that’s filing, can this the what confirm of the interim is HGB-XXX you all X study that looks confirmatory not Thanks to

Nick Leschly

Yeah.

Thanks Cory. the over, this. the that on question kick I’ll and So, for support

end clear, on the that we just with we word is be are to sort doesn’t I’d at and it something with agency, legal day, change say, a it certainly basis categorized is that caveat, we general the and HGB-XXX, the is right? this, Just the the of the that have that more sort we of on of – But is it path have of pursuing you believe not HGB-XXX. consistent agreements mentioned

time guidance, have we it’s always sort should every history, agreement of back think we look our of if on general don’t over-read comment this with. you general. sort I word you So, That’s in something the regulatory

it question? thoughts of on Dave, backend the you leave I’d additional of the specifics on do that. But, some any Cory’s So, have at

Dave Davidson

XXXX. are other have Cory on Yeah. clinical ready nuance is to the that address well we have and timelines engagements asked The that, coming CMC mentioned, CMC what the up packages to we alignment only we as both aligned expect on to planned and that we’re and the ensure to for

Cory Kasimov

Okay. Thanks, guys.

Operator

comes Goldman question next Salveen Richter Your of from with Sachs. line the

Salveen Richter

Good us with Could can a receiving where And with $XXX product? bbXXXX, you manufactured morning. to just for Group opportunity your the C taking follow-up regard ex-US how the the ex-US the comment view rights stand million on for commercial-grade on patients you question. quickly just Cory’s, correlates Thanks. here? with tell Thanks of you my

Nick Leschly

wasn’t you I worked like questions to Cory, it how your so a in as question. back reference two there, Salveen, technically

On BMS, that does we discussion head the us. details value – of for been comment there, the pretty on with actually part comfortable actually it Joanne can represent first sort quite at and we’re that significant more of who’s so are

best all that project the We’re sort the you the ex-US we you quite is of all of you think pleased. this work can, the fair you had. we the Obviously, the do value of do pie that and recognizing and math piece but

But, or on would we’ll details Joanne, care more whichever? on Joanne. any start that comment Maybe to you Chip, with

Joanne Smith-Farrell

Sure. I’m I Thanks. for sure to not question. the add. Thanks a have lot

think I the resources. overall to commitment well the deal a split sensible as patients we reflects and think being of the ide-cel to as

value a as involvement perspective so passive an fully there. think think As we financials had as in we we responsibilities very well with territories, very from made you a a aligning the operations But and ex-US full Nick just financial operational got we’re perspective, said, both as from value, pleased. know, we’re We sense. overall, the always the perspective, the

Nick Leschly

Salveen, you, I thank repeat can Joanne. sickle manufacturing, question related cell actually that? second And to forgotten I your apologize. commercial-grade you just

Salveen Richter

Yes.

Dave Davidson

Yeah. I is heard This it. Dave.

Dave Davidson

at the adherent? well the have of So, will in clinic vector suspension time filing, lentiviral the with both experience as as we Salveen,

Nick Leschly

you go. There

Nick Leschly

That worked, Salveen?

Salveen Richter

That’s great. Thanks.

Nick Leschly

you questions. Thank Great. for the

Operator

comes Your SVB Leerink. next line Foroohar Mani the from with question of

Mani Foroohar

about then $XXX in that XXXX, on a guys. Hey, Just bit mid-XXXX plan, that? think should for after months my upgrade purposes. month the of [indiscernible] from Chip. question. OpEx now late-XXXX, operating about or think you predominantly quick about in about million When to modeling the to way mid-XXXX, I’ll XX as reduced savings with taking the $XXX of little right for the we tempo next clarity million to early-XXXX, adjusted the is be and about think $XXX of Thanks million it the and

Nick Leschly

good Chip? question. Mani,

Chip Baird

in the savings Yeah, for thanks, earlier to it periods. that’s think Mani. – I important achieve us Yeah, was

of that loaded. I and mid-XXXX that’s in think was a It back-end it. were way general to between important it’s think that to And or fairly a linear the so, this if all think that XXXX good uniform way, balance apportion year, I about not you

Mani Foroohar

question Great. I will a at second That’s helpful. all. not do

Nick Leschly

Mani. Thank Okay. you,

Operator

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

Yaron Werber

Great. Thanks for taking my five questions.

Nick Leschly

Yaron. Go for it,

We’re you after the hanging first. on up

Yaron Werber

Perfect.

So, been that’s postponed indefinitely. HGB-XXX, the patients, my question stroke study about high is which is of risk really now sort HGB-XXX,

HGB-XXX give these cutting an sub-segment. that to And Just cost there a they’re maybe if bit of – even some us that the due sense, has is and a it of a the in? or thinking is little patients that’s is HGB-XXX that why not, important study

you. understand Thank to why been postponed. trying just So, that’s

Nick Leschly

a That’s into you’re and it. I on good Dave? to Dave think question. will get it,

Dave Davidson

question. very Yeah. That’s a perceptive

a So, combination. it’s actually

more we gain HGB-XXX we’ll potentially we you and HGB-XXX that As accelerate from relatively design. able data will, to believe from was if conservative HGB-XXX, do the be – design, a

side, On flip trial. saving it is that defer to also us funding the

So, it able in ready when trial we launch redesign be it’s to a a in sense again. win-win that that to way, the to expect we’re

Nick Leschly

us. if Appreciate four Yaron. And give you you, Thank email call or just questions more me it. means, all please have a by

Operator

comes of next Your line Harrison Stanley. from question with the Matthew Morgan

Nick Leschly

Hi, Matt.

Matthew Harrison

question we Bristol product. challenges Hello, Thank everyone. is that the on T taking facing recently saw [indiscernible] Matthew. you with anti-BCMA, regarding is my for bbXXXX, [indiscernible] This some CAR for is and question. My

any was read-across wondering bbXXXX. for there whether potential I So, is Thank you.

Nick Leschly

continued Yeah. to bbXXXX Good best we’re From take on not in. any think committed I the perspective, that and speak filing have certainly remain that. question. we BMS I’ll anticipating read-through we the of because success and of that’s that to sort our to

think speak you that, BMS. more course, predict specifics future I around any or can’t it’s concerns of with the we best but So,

straightforward, Joanne, anything but... I there? it’s pretty additional think to add

Joanne Smith-Farrell

I No, don’t. No.

Nick Leschly

Okay.

Operator

the from Biren Amin comes of question next Jefferies. with line Your

Biren Amin

FDA? the gating Yeah. with this hope you finalize relates my to of manufacturing plan are as I it to FDA Hi, the guess filing? would the on questions. taking guys. for What when aspect Thanks regarding And items

Nick Leschly

referencing – sickle be to cell? referencing You’re you’re just clear,

Biren Amin

correct. That’s

Nick Leschly

Yeah.

you clinical and in So, with which right confident equation good we’ve about then learned lot details, is obviously talk through piece, of we’re piece thal. critical heard right, the Dave now the as alignment we’re a manufacturing the quite and the – we now, –

underway the discussion we is think making the agency, and appropriate as various the all across forward that’s also, and of underway. it have So, types sure that about all we be we’re transitions, you well will applications. And always that’s well bringing that products if then ongoing our will, an with as

we’ve that’s not and impact So, the an we’re outlined. anticipating that that comfortable to with why going have timeframe that’s we’re

have anything Dave, to do that? want you additionally you to add

Dave Davidson

we’ve the ready Only package said to, BLA to that leverage we doing is as highlight, cell that for in disease prepare release TDT that can there overlap testing we’re be before, to CMC alluded so, and for the Nick as well. to sickle work the as

Nick Leschly

add it it I’d as as thing relates think that other in press sickle. to with only it Hitachi a we a have manufacturing in the from also relationship you forward-looking And release established them I there, Yeah. relates to saw

to that a sickle. So, and we’re make continue be excited partnership behalf we can deliver able sure in setting to of build on on commercial

Biren Amin

Awesome. Thank you.

Nick Leschly

You’re welcome.

Operator

Dane line with the question Raymond next Your of James. comes from Leone

Dane Leone

have the our Hi. VOC? a the and on when point the or to approval? sickle interpreted last the be “lock” XX they before clarify these you Thank much respective actually And for I between and follow-up for regulatory XX-some-odd the a and update – how of of that you you analysis? the endpoint database by out for wanted FDA for Can long what on a for be you the just would update. is couple So, how do patients taking to maybe need redesign the months regulatory are of of for follow-up their – hurdle to rate lay that looking questions, VOCs relative filing. patient congrats some own just aspects cell baselines will required would how XX

Nick Leschly

best the on and the Thanks jump question that here, for one. to Dave’s clearly

So, Dave?

Dave Davidson

one, actually to Nick. answer that was I hoping you

Nick Leschly

I can.

Dave Davidson

But...

Nick Leschly

can try. I

Dave Davidson

Yeah. Yeah.

rates suggested you your right, we events. be So, comparing as will in question, intra-patients’ of

rates presented baseline that can patient rates from we each the format a then similar and EHA, into forward as go we you for look the expect event we slide compare we’ll that as ASH on So, data saw that to and you treatment. post-LentiGlobin at

within beyond. transplants month-XX months of following As the of and I after X to suggested, XX that really months out we’ll period of with and be minimum follow-up LentiGlobin, on a looking focusing treatment for

peri-transplants like of and have we the treatment washed more really period we’re true peak is LentiGlobin or interventions been level. most and cetera, et where have by year of post-treatment patients effect which nearing out transfusions, the a blood all follow-up the month-X So, seeing

that compared baseline. the So, we’ll interval at follow-up to be looking

doesn’t suggests, And that worked elimination just as looking the that. the complete for criterion with has every severe a in mean study which which to patient endpoint the single for out of complete events, elimination. vaso-occlusive success we’ve There’s agency have

And terms for question of on you’ll status timing get update then in that of study. the of an to into completion get follow-up of of dataset, the EHA, patient the level specific but et cetera, at don’t we granularity, the see of the

Operator

Your next Mark Oppenheimer. from Breidenbach of question comes the with line

Mark Breidenbach

guys, for question. the wondering Hey, wouldn’t regard taking the to confirmatory demonstrates HGB-XXX taking C? HGB-XXX good question. What I’m necessary thanks a why be that a as and is for of study? post-approval adding out HGB-XXX clear benefit is morning, with getting guess Thanks Group VOCs, if clinical eliminating I and we

Nick Leschly

to you, Dave. Over

Dave Davidson

sure. Yeah,

serving is a role of trial. the it So, confirmatory classic post-approval

an seek additional on We of basis HGB-XXX. to data we And trial. accelerated approval, convert to additional patients provide will approval are in a full and data the going the HGB-XXX from approval follow-up on accelerated to that the interim

as will serve pivotal confirmatory it a role So, the trial.

Operator

Chen comes the next question Bernstein. Vincent of with Your from line

Vincent Chen

approval? the to mentioned up complete some Great, give was evaluated to VOEs of severe US question. follow very a the need much [ph] you the on little on think could more More patients and how endpoint the SCD patients, and in you the us meet primary thank percentage should this taking elimination we filing, about percentage you for criteria color of of for

Dave Davidson

that presenting you’ll of that forward, on at terms we’re provide milestones achieving granularity more population. time. so forward have rates the I the not perhaps and I will All able to be study can to far we we provide is look will EHA we’ll data be success success sense criteria, the a what able is should additional be for this to say that not And agency you of our at move but granularity. for this as in

Nick Leschly

ongoing Yeah. together see the and as zoom sort course of evolve. thing And, the the is data to if been add of we’ve Vincent, discussions it notch, I’d only see they agency out that right, having one with we you

the opening And see pretty And as so, really go as can now said Dave that more. the an we I the you both powerful his seeing, – need as can this learn and certainly think displays endpoint, of of to go what’s the in we agency in Dave shifting type and been we the fact and right? in said we what have the here, his belief in unprecedented data. we’ve have actually general comments certainly and as endpoints confidence to about we’re message, is are sort – data and big to notch, that’s speaks the details the take-home the if very can then we it’s say, the certainly maybe agency, of kind zoom getting that with our – out excited fact And your agreement this the it is you a was we I’d a the But question. it we’re of deal exact and, this

Operator

of with question Matthew Luchini BMO the next from comes line Your Markets. Capital

Matthew Luchini

Thanks congrats for progress. on taking morning. Hi. question Good the sickle cell the and

Nick Leschly

Thank you.

Matthew Luchini

– wanted to just this little morning we’ve to what if for light FDA, a could you made you’ve from now should some learned you could of bit provide progress the side? sense European in sickle given color on thinking know how just of cell opportunity I the if get about with the we wanted be US

Nick Leschly

Yeah.

at high Let a me jump level here. just in

have engage the when we that, European to it. authorities then I we we’ve more on now in we’ll well, will and the finalize – as details share with think we be at what continue as there, US, done to point, engage and obviously the and able well this requirements are

get cell to community important very a is certainly population. Europe for sickle to the

our build Right the continue first So, execute US and happy sure come as also back it’s step to. Europe. have with in only full something data now, all to they agency, and that can to we’re to and also agency we make now get then we’re going we launch a the with deeply access is, the we upon we’ll hope dialogue continue we’re plan and in the with, but have Europe to not committed can in thal what a

lot not a that an not So, yet, just of because but a we’re Matthew, of that’s detail sort prepared that’s to share there, discussion. ongoing

Matthew Luchini

Fair enough. Thank you.

Nick Leschly

you. Thank question. Yeah. Good important. It’s

Operator

America. question Bank next from the of Gerberry line Your with comes of Jason

Jason Gerberry

Hello. Good questions. for my Thanks morning. taking

you beta-thal are queued expectation? about I expect those talk it’s the up mainly for Europe commercial therapy. maybe being half you’d at front, On patients Germany that the first presume can where your all second

what’s on and can color any just Just you. of with the going color Thank terms any Group. in if centers provide with AIFA reimbursement there Italian transplant you wondering process on the

Nick Leschly

to Yeah. ask Commercial us, here, excited say coming France that very the speaking advance And groups, a all certainly think and who how and meaning the investigators able emerging version of on quite positive with Italy sure Germany, this and through manner, both in runs been and really this and of qualified Alison bit but the actually centers we’re with and the the make are broadly I countries, a just sort had in treatment really despite a execution on have are delay. in [ph] crisis for making also it’s progress COVID the a front, payers is ball to we recognizing UK comment is various in I’ll bluebirds there engaged. to continue and and and advocacy of I’ll in that. about And the

comment the over like defer she’d question. I’ll on if specifically, more Alison to But to

Alison Finger

question. the for thanks and Nick, thanks, Yeah,

have during our physicians You’re selection to to on with year first are process. engage later they able and are patients anticipate they who are Germany continued COVID patient engage we right, us we and this where where to understand with the in

I’m We’ve markets. with to say engagements market even the continue reimbursement to as also in to open to up. Italy the in that happy that starts And those continue authorities been able engage

to So, markets we look reimbursement in forward through in Germany to Germany continuing in outside our progress of to year. Europe this addition

Nick Leschly

pretty always strong that And, even I’d on. and a that, we’re parts is at this as add lay Alison and good a focused the we’re the way reimbursement XXXX [ph] on to and anchor what team sophisticated I’d game-changing Jason, again, driven. XXXX But – foundation an certainly plus treatment we’ve is thank new point really progress of and approach about, put the making say, that’s making is that looking the we’re pricing sure this – laying is you, only thing that foundation because and said paradigm, – to and it’s about, taking, COVID, is this that a that – and this exclamation is

so, And of sickle say, a products. build to to story and kind move-the-needle opposed unlikely subsequent let’s as then solid foundation build and which thal it’s to to be, our for revenue a

Jason Gerberry

together? many how it lines investors be any [ph] to are your you any or providing foundation reservations metrics along of terms Would in around guys coming a how other ASCO, there that updates supplier is just of at the just sense give

Nick Leschly

we haven’t provided At that detail. this point,

get then visibility most figure closer As we still get we share the going, telling we’ll get out and progress, [ph] we as it’s into what’s we’re way something this, into. to some sort out the get more that’s and insightful continuing to

sense that of lot detail. doesn’t no, not though, that a I’m anyone whole sure at So, lot. to make of in going point, get to a tell it’s kind this

you’d Alison, But, that? on anything add

Alison Finger

Nick. add, to Nothing No.

Nick Leschly

you, Thank Okay. Thank Jason. you.

Jason Gerberry

you. Thank

Operator

of question next Schmidt line comes the from Michael with Your Guggenheim.

Michael Schmidt

what guys. I a Hey, had Thanks LentiGlobin. for taking you understand help my products terms questions. suspension us for of might maybe in year just of on in do sickle just per how cell manufacturing is in capacity courses terms XXXX Could you the capacity, this until manufacturing and a per without or evolve launch your with year process? think potential for current follow-up

Nick Leschly

Yeah, Michael, good question.

feel commit hard the the that. go – if regulatory into for wouldn’t manufacturing. is we to of we we’re the to the patient product we What out thing are we we on gotten that only mention that combination details of forms that quite try timeline haven’t manufacturing do also if That didn’t a right? and to not really really, that. not would drug of population, be were a but deliver vector, to bluebird, We demand, can could actually for for Remember, the the say various confident we

population going confident are see that a who that’s in we’re ramp well. So, we to as the broad hard sickle partners relationship, ramp the make get wanted out and quite range Europe there as and partly in and we US in committed also what pushing have the and in Hitachi in pretty the to the sure you

also So, as that’s made making drug US but the treatment on not as product only clearly support centers capability in the suspension, the and well virus can on get right, there, sure in the to we infrastructure Europe.

So, we timeline that be of didn’t doesn’t the it. we if would you’re feel a infrastructure range give about you numbers talking not a for regulatory timeline up had exact the that execution there, quite we but signing behind or honestly,

Operator

the Alexander Piper next with of Your from comes Sandler. line question Duncan

Alex Duncan

ASCO, also Hi, will question. data taking late-stage good you At and thanks patients. in morning real-world for myeloma present our

the of you. us real-world understand data you is [ph] population it So, update, to the is how materiality it package would reviewing for part compares of and BLA FDA Thank data the KarMMa enrolled help the whether ide-cel? this

Nick Leschly

Dave, you would comment? like to

Dave Davidson

group certainly at offer attempts Well, KarMMa wouldn’t it’s be treatment that. populations. know, It artificial to data really that poor. comparable is patients and to insightful an prognosis few quite because, a sense, for very as based what I I the beyond can control their on It be looked late-stage relapsed/refractory match much in options say, and context will is have should these go provide we

that help you reinforced to KarMMa think for at and, will context again, expect data will provide I the see So, interpreting ASCO. that

Nick Leschly

few just disease gravity one transformative, see further This that and data the you for a also, the is and population at Alex, be here a just ertainly in [ph] And today, of right you’re will right? Yeah. if the that’s things you you talking shared they’re the that here facing. update been can of top-line look the patient the it’s about data we’re from getting days,

is to evidence significant have real-world and for physicians need say armamentarium patients change don’t of their the honestly and that families. that help these the You that patients sort a don’t these really

remain in us that’s for you think here that. what see words, and in better also the lack I collaboration with So, on BMS, double-down super-excited of we

dramatic in a we’re really bbXXXX to its have population. believe So, ability and and committed deeply impact on the myeloma

Operator

comes the with from Gena Wang of question next Your Barclays. line

Gena Wang

BMS I than about sale million. US the my wanted for taking lower we million, $XXX think $XXX opportunity royalty much you be will about Thank the should calculation, the our on that Is based ask as questions. to benchmark, well? peak the

Nick Leschly

I Gena. sure question, understand your XXX% Not

unless, You’re you Joanne, saying you and it can – sorry, got you answer. you repeat can

Gena Wang

Sure. Sure.

opportunity. on in think maybe based as of to the on sales similar benchmark peak basically, analysis based DCF and that the our [ph] So, wondering for like a ex-US the $XXX million be million, just would $XXX analysis, we sale is translate should roughly US the peak

Nick Leschly

obviously I to agree Joanne don’t your that and, model, with don’t I of – we the – guys you I’m know details I’m but math. or it, speak but Chip, – can not would sure

Chip Baird

Yeah.

Chip... [indiscernible] I think

Joanne Smith-Farrell

Yeah.

Chip Baird

Maybe just trying jump in... to

Nick Leschly

[indiscernible]...

Chip Baird

a gross Yeah. couple stepping that things There [ph] also on. we’re now but on voted of It’s back a royalty, a is going behalf from. royalty there’s

[indiscernible] you not of a milestones million There it’s like yet, [indiscernible]. like for top T States, we non-dilutive feel [indiscernible] around in as the So, and an have but largest so as remains royalties, And what simple not it’s not well still within value that. the I again, a certainly commercial the then, The adjust at value United because we in [indiscernible] feel world. $XXX XX/XX to are for form. we’re there so is sides both as think, as space it, Joanne CAR said, is opportunity

one? to that anything on add Joanne,

Joanne Smith-Farrell

said. No. was No, I think that well

Operator

next question comes the Burnett of from Your Ben line with Stifel.

Ben Burnett

Good you. Hi. Thank morning.

here. little pediatric sickle LentiGlobin, come accelerated or approval on as of discussion with part clarity just these a you and bit Do pediatric Just patients would patients HGB-XXX label of anticipate cell the study? any later Thank having the you. follow-up following of

Dave Davidson

question. Great Yeah.

the So, down trial a has the age in HGB-XXX pediatric protocol. enrollment study population included the has XX HGB-XXX and younger to

HGB-XXX we’ll is with in additional one younger advantages experience So, pediatrics. that the of as even I the gain that’s statements, mentioned the introductory study of running

Operator

line Your of comes the next with Evercore. Josh Schimmer from question

Josh Schimmer

for thanks the Hey, question. taking

For the the everything I’m that going your it’s a some a for be guess amendment? of [indiscernible] for the follow-up is year XX given over the gating surprised to assume supplement LentiGlobin, [ph] submitted sickle now, Thanks. a across take that follow-up can as timeline to know little filing months of filing US I step we patients an

Nick Leschly

gets So, the and We do Dave recognize to everyone we’re to still need of of the and you the that you that, follow-up and excited, data adds look data speak need to with timing, longevity the to with of amount magnitude patients that need certain a the can you that right? this but that quite pleased number certainly to see execution, a but but bit. through at timing, the Josh. actually has we

add additional question? you’d to anything like to Dave, But, Josh’s

Dave Davidson

mean, correct. I No. you’re

patients we of results of follow-up C provide HGB-XXX full and minimum follow-up So, a with the be is to longer And Cohort months we’ll to want would submission. initial to as see well subsequently from filing enable of data plan subset a XX HGB-XXX able the on the of enable on that to the and patients the approval. data confirmation the to seen then, conversion

Nick Leschly

at that, complexity as and were look plan, on far this think you how to brings, given the about despite quite and us on and HGB-XXX right, aggressively in other we look of relates at enrollment the going this, some look that way the it Yeah. some at the along timing the And, you of given to of you already to those the world original right, that some also Josh, as liberates the really time changes pandemic now frames there right HGB-XXX. move

the from strategy between outcome. data agency’s a – think and willingness I is the and tremendously and the this, the perspective, actually we collegiality on least our showing that So, a at tremendous believe it’s the positive

Operator

comes Prasad line Raju next from Your question William of Blair. the with

Raju Prasad

question. taking for the Thanks

with aligns suspension can any COG us would around filings And give kind be great? On the versus how with help transfer your process, how [ph] benefits, the agencies? just you would or [ph] COGS that as current of a as of sense color the suspension manufacturing far regulatory adherent Thanks. the

Nick Leschly

high be in at that will, ready doing the live, patients et suspension HGB-XXX will and you that go enroll HGB-XXX sort with So, sort the start level I cetera, little that a sense. so if we of there as continue to of to color they’ll have be can provide patients get infused, and to and as they product

period. this here through happening will be that So,

refocusings scale suspension this, benefits we anticipate that’s that is can to of the make of external internally, we for products, an positive way. one we’ll our as in don’t very execution we the agency continue some this – as the of thing details of all refine and something a here facilities with then the obviously. the from standing internal facilities point. capability very And are that’s although that’s So, well we at – point on sure that view certainly, dedicated so the that don’t happening exact And anticipate on to

a to knock we these but I’ll that’s that’s of Chip, emphasis overall an speak most patients. that – that there? of But, here, get transforming they really lives And cost can but products go-forward anything on know the add now on basis goods better, the let importantly obviously you’d lot Chip, additionally you are wood the

Chip Baird

No, I said. well that’s think

model the it it, we business component setting want just gross but But on that’s around a expectations boost gets or into back to yeah, that a big key deliver suffice financial that us it where to be commentary on be. and to gotten – gets sustainability, some haven’t therapies curative and is that not of that sort. suspension of of at scale We things to to front able margins on say,

top So, for we’re – it’s getting the us, suspension priority over line.

Operator

And further questions at there are time. no this

Nick Leschly

or can for everyone morning. have thank And I’d reach Ingrid, or you, myself that do time everybody. we’re to good taking think anything, to this call. Excellent. questions and if like Well, to out I you follow-up the with this Thank you

Operator

concludes This conference. today’s

may disconnect. now You

Ingrid Goldberg	Vice President-Investor Relations, bluebird bio, Inc.
Nick Leschly	Chief Bluebird & Director, bluebird bio, Inc.
David M. Davidson	Chief Medical Officer, bluebird bio, Inc.
William Denise Baird	Chief Financial Officer, bluebird bio, Inc.
Joanne M. Smith-Farrell	Chief Business Officer, bluebird bio, Inc.
Alison C. Finger	Chief Commercial Officer, bluebird bio, Inc.
Cory Kasimov	Analyst, JPMorgan Securities LLC
Salveen Richter	Analyst, Goldman Sachs & Co. LLC
Mani Foroohar	Analyst, SVB Leerink LLC
Yaron Werber	Analyst, Cowen & Co. LLC
Biren Amin	Equity Analyst, Jefferies LLC
Dane Leone	Analyst, Raymond James & Associates, Inc.
Mark Breidenbach	Executive Director & Senior Analyst, Oppenheimer & Co., Inc.
Vincent Chen	Analyst, Sanford C. Bernstein & Co. LLC
Matthew Luchini	Analyst, BMO Capital Markets Corp.
Jason M. Gerberry	Analyst, BofA Securities, Inc.
Michael Schmidt	Analyst, Guggenheim Securities LLC
Alexander D. Duncan	Analyst, Piper Sandler & Co.
Gena Wang	Analyst, Barclays Capital, Inc.
Benjamin J. Burnett	Analyst, Stifel, Nicolaus & Co., Inc.
Josh Schimmer	Analyst, Evercore ISI
Raju Prasad	Analyst, William Blair & Co. LLC

bluebird bio (BLUE) 11 May 202020 Q1 Earnings call transcript