BLUE - Earnings call transcript Q1 2024

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Operator

Thank you for standing by, and welcome to the bluebird bio First Quarter 202 Results Call. [Operator Instructions] Finally, you are reminded that this conference is being recorded. I would like to turn the call over to Courtney O'Leary from Investor Relations. Please go ahead.

Courtney O'Leary

Good morning, everyone, and thank you for joining our first quarter 2024 results call today. My name is Courtney O'Leary, Director of Investor Relations at bluebird bio.

me safe let statement. begin, we review harbor our Before financial under that Securities including Today's plans, position, expectations future progress, the statements regarding plans statements forward-looking addition expectations and the to in our or XXXX, discussion contains company's of and are business Private of financial Act Litigation regarding regulatory intentions results commercialization Reform operations. of these bluebird the Obenshain, with are uncertainties www.bluebirdbio.com. On risks Investor cause is SEC, on risk based Andrew current filings materially call, results. A bio's are results risks and contained CEO, that website, in factors differ expectations available our subject of number today's could assumptions the our Such and and will on Relations provide from a statements of section description actual remarks. are to that involve to projected which opening Klima, Tom Officer, progress on Chief commercial will SKYSONA. discuss Operating Commercial LYFGENIA, and the Then ZYNTEGLO of launches and Krawtschuk, the Andrew. financial Officer; Chris over to will finally, for Financial will it a I up that, call provide Chief turn And opening before update Q&A. With

Andrew Obenshain

of community, a been seeing disease, this the cell partners our clinicians Courtney, both who joining clinical cell initiate this milestone provide as week, on be worked for patient the sickle announced bluebird, way. nearly step we today to as our therapy researchers highlights. I'm our after also heels tirelessly program, for the update the this our a for commercial first LYFGENIA began recent we sell thank have for every for of commercial monumental collection, and on which who on and and morning quarter an development sickle the you, gene first here call thrilled for LYFGENIA and earlier XXXX Thanks, results for everyone, the treatment we a decade

start sharing updates discuss we poised commercial of builds. I was forward the progress as greater patients throughout in will to now foundation our place, commercial in accelerated call and strong Now more over for look rest in XXXX, to bluebird completed LYFGENIA and detail. Tom is hand a the established first growth with our the launches momentum to

Thomas Klima

we with for Andrew, morning, between bluebird commercial Thanks, good yet patient our at our This another milestone first therapy gene achieved journey start everyone. amazing LYFGENIA. and week,

to to Over but year, and our with seeing benefits we of built past SKYSONA the for for LYFGENIA. first have for the coming are appointed are cerebral today, head And beta-thalassemia the we for also start adrenoleukodystrophy. commercial not X and fruition these ZYNTEGLO built we launches, that only our momentum foundation synergies

our success. X are reminder, on elements launches a core for focused As

First, gene centers establishing compared to a Today, robust network These in transplant QTCs. others of field. or therapy. cell experience significant and activated XX QTCs, qualified have treatment the we centers unparalleled in with are

have the therapies Second, and collaboration access. optimizing timely, lastly, and patients and value requires is And and the provider of needs that patient the recognized ensuring providers patients, high-touch paramount. families experience. Gene approach transparency, of and understanding therapy is our equitable a

a strong our XX over be to activated we patients. allow Our our partner the understanding help gene them focus process, deep experience us therapies therapy as the to bring dedicated our QTCs last months life-changing and their to of

excitement the preparing extremely number of and sickle treatment. for community are the by in encouraged We cell the patients

gene than our are they are more sit we the QTCs of evaluating centers X/X initiation that As have actively and for process or today, more our therapy communicated us patients. prior here in authorization for to half of and one LYFGENIA patients

takes or start journey cell As a patient to reminder, collection a time. the

includes steps the must the then the my negotiations to to coordinated LYFGENIA in once year QX. to drug support initiate the builds. in while starts And for is also the mind, which While as at that bluebird that with washout patient every momentum majority be grow we must the for to a of will for reported path of different, we quarter-over-quarter period the QTC and steps transplanter anticipate concurrently, are factoring often payer typical LYFGENIA and continue reimbursement be for be readiness, hydroxyurea. patient with then occurring considered. With in in half collected, anticipate patient's X-month These enroll -- patients to first initiate product second taking first time revenues health the with a manufacturing cells consultation the recorded a in ensure QTC clinical will

Moving continue XX growth patient to of starts the linear we to with see XXXX. ZYNTEGLO, since strong beginning

product experience mid-XXXX, in shared manufacturing launch drug initiated steps capacity increase initiated we adherent the supply and we've the to trajectory. need we to bolster the with and we demand. increase to determined ZYNTEGLO commensurate factor to have market, As meet for in SKYSONA steps supply, previously our Through also

Additionally, we XXXX. have starts SKYSONA the for completed X since of beginning patient

patient early stages starts, reminder, to the key is when infused. this launch which is recognized occurs, for is company patient in watch the the a value-creating our As of with collection being remain metric commercial moment the when revenue as cell the

expect infused can collection. you X continue X quarters are purposes, to that modeling patients cell to For following

expect process starts once In through in patient on the portfolio they and has and commercial cell completed the our our we patient collection, across in continue To XX are every XXX who and treatment goes between continue patient experience, started XXXX. process. or date, dedicated. to journey the the remained

moving Now access to reimbursement.

validated SKYSONA LYFGENIA. from is favorable Our for strategy experience and our ZYNTEGLO coverage driving

is recognized, eliminating peer-reviewed reducing published securing and pain publication million. with April. access up have disease. $X.X pleased cost-effectiveness model opportunities. potential making very impact We patients' publication health cost effective for price have utilization, a being DOE insight crisis in PharmacoEconomics sickle on health great of patients offers are life The of are the associated the and The earnings to found future to cell progress for value well-being, Journal we that The is and care LYFGENIA and significant into may LYFGENIA, that in or our lifetime

has and months launch, for both X successfully patients LYFGENIA. post prior Just Medicaid authorization insured commercial obtained

signed national organizations have with multiple million coverage for have and payer more commercial LYFGENIA in XXX U.S. we published than policies for place outcomes-based lives. Additionally, agreements

type. access Medicaid Medicaid LYFGENIA agencies, U.S. in individuals of irrespective disease Discussions the equitable is insured of insurance with cell patient's to goal always with XX% representing sickle ongoing been Our are timely,

timely denials X across Additionally, for either continued to with commercial has ZYNTEGLO ultimate Medicaid therapy access and and both SKYSONA payers.

Moving QTC to our network.

very due We these Genie's learned approval. for for have transition QTCs QTC established products were of experience ZYNTEGLO. the quickly We have able to a substantial one XXXX. these their for or first second of both Today, started ZYNTEGLO and patient, quickly sites the setting footprint with has centers the built centers XX following have have XX first LYFGENIA to third. of these activated up started and LYFGENIA we've their bluebird majority who our strong during the their centers QTCs patient relationships and started for

centers While pull-through we shifted XX we at has our focus experience gene to may deepening anticipate with on XXXX, throughout a bring patient therapy bluebird's our their of handful additional and centers portfolio.

also along CALD. To linear SKYSONA ZYNTEGLO and XXXX, patient Additionally, patients in SKYSONA. to recap, launches in continue XX SKYSONA for we anticipate X activated with to administer our X strong and centers ZYNTEGLO are with progress starts to for growth for network as planned,

now importantly, building launch, and extremely a for are becoming our in most gene reality the excited the our starts our builds therapy grow LYFGENIA to turn about the We like quarters. And to you over as commercial patients validated States. in is Chris. on We patient look launches in progress next and early forward platform, United momentum our few over the to I'd call updating to

Christopher Krawtschuk

by reported driven million revenue from and quarter, first in total good morning, revenue, we Tom Thanks, $XX.X everyone. In the ZYNTEGLO.

a As we the recognize reminder, upon infusion of revenue drug product.

utilization our gross anticipate range to mix the previously as agreements. of with XXXX, on fluctuations net well As mix, in payer based discounts to we outcomes-based XX%, XX% guided, in product as of

to we had milestones, QX plans, runway inclusive XX, equivalents of from totaling achieve of million we XXXX, facility. cash million XXXX. X runway $XXX of current through remaining $XX in restricted This our current includes term and tranches our that receive hand, $XX our cash our cash. have assumes cash the loan certain March commercial we also a revenue including business Based million As in on on ability

Additionally, recognize bluebird that and unwavering and finalizing to finance tremendous the our are XXXX and expeditiously QX want restatement. XXXX our restatement XX-Q. I to we the teams work and the to of dedication work and XX-K thank accounting continue complete file personally

a the turn I'll restatement that, as is back to revenue. With it to our or and position not Importantly, reminder, cash expected Andrew. impact over our

Andrew Obenshain

Thanks, Chris.

horizon. And highlighted with to is the that, we questions. As for near-term like the We growth year monumental stand in today, an bluebird. a I'd exciting up midst the from potential for it open for time with of

Operator

question of the from Instructions] comes America. Bank your [Operator from Jason of Gerberry And first line

Jason Gerberry

quarter, up rate-limiting is the ongoing. think patient new geographical that And a but of, Medicaid your build And sure new of about the the they -- just we all that looking are factor ask a this update Medicaid just context on just I question coverage. trying to to in asked is not there their for last I'll as work a a faster reach? question U.S.? reimbursement relative starts. to guess, reimbursement wanted question in on start at I function one broader LYFGENIA it's update curious, that's competitors' make to I just guess the put a Or I number new the patient more starts you the

Andrew Obenshain

first those in When of to about we hand kind I'll we patient over starts about ahead. Jason, talk order. as Medicaid and then the talk well. don't it the take Tom. Why order reverse of Go

Thomas Klima

of look Obviously, about the with patients the more with is very to feel but a the Jason. terms going lot we're think LYFGENIA, therapy collection. about not seeing you in what starts. going comment competitor head at we progress QTCs extremely and I a We're we really gene we good initiation morning, process Good what of We're about But have what seeing first LYFGENIA. through multiple there. doing, when with so, really ZYNTEGLO for multiple we're excited start in and tremendous pleased have

we've the value our agreement Medicaid, that And have also tying understand As medical of a working coverage many far Obviously, patients years meantime, been they outcomes-based access of sign for Medicaid not therapy, can the our onetime sure have have making always -- the exceptions recognize it's the many, to to can on up therapy. access or agreement, in until process. and rate-limiting policies potentially for they value they with factor. and now as a offering outcomes-based curative

So patients. it's barrier for really a not

Operator

from Baird. comes question next from the of Jack line Your Allen

Jack Allen

as studying to LYFGENIA are expanding as with ask you how Do I it relates as about to I guess things ongoing and study a it relates to patients. wanted have LYFGENIA? younger access your to start, relates thoughts in it to age progressing

Andrew Obenshain

Thanks Jack. the question, for

patients. HGB-XXX patients So is That XXXX, by for QX that complete trial to and X enrollment have anticipate to in we to ongoing XX We a LYFGENIA. evaluate to going pediatric ongoing. that's

of age the to down indication an have we X. ZYNTEGLO, for reminder, a As

Jack Allen

it of Great. give it. I'm reception not system get pull-through on as are patients I'll the support And relates aspect you of this, process? Got have as on experience? anything sure to Do then those Is many I'll kind any shot idea starting a it it bluebird about people in relates that how the of here. but your to to patients ZYNTEGLO LYFGENIA. read there through there the based

Thomas Klima

to a disease. different because right sickle small through Jack. It's Good obviously than Yes. in We've with now our of it's cell pull-through a process look I the for lot the have end LYFGENIA. early individually comment when who at experience. lot question, a beta-thalassemia, ZYNTEGLO going learned you think We're kind on patients not

there But on that, I So excited who a want for will lot are therapy. tell of we really that. gene you don't very patients comment are to

there continue As and process. start across said, And initiating through the they QTCs multiple the committed are once patients process. process, the I multiple they're usually,

we're and momentum the getting to look forward So we're the progresses. just seeing, more year as with we data excited

Operator

Your next of question Raymond comes from from Danielle Brill the line James.

Unknown Analyst

Casgevy on either particular Danielle. you And Any the deciding Daniel QTC for chose to patient pull have reason therapy? payers any like a both caused and for pursue the the treatment question had is seen We This on and LYFGENIA? from is with LYFGENIA. for push

Andrew Obenshain

go ahead. question. Thanks for Tom, the

Thomas Klima

centers. far both therapies, offering obviously, XX start, qualified with a as treatment have Daniel, we head as

centers expectation therapy. our other therapies, will the qualified is that it gene and LYFGENIA most However, offer treatment both

many other going exclude or they're one seen haven't or We centers to offer or saying the one other. the

And both they handful, good. a the already, I they patient think are both have a present choice. becomes is -- only onboarded most centers patients small if believe that choices patient to then for and which they

Operator

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

Huidong Wang

the how manufacturing? know collection Maybe of many XX also were asking start many cells to the these, for about And active LYFGENIA? of cycles actually also Out share in order QTC. the if patient, can that first these I of you how detail, for don't

Andrew Obenshain

Gena, to I part. the collection. for collection reported for the the that actually, first over That was patient. the and We first, think hand Tom, -- part second the first of and first take I'll their it

collections ongoing that So we haven't many how right whether need that, reported now. they will -- manufacturing is

So go Tom, can't that. on we ahead. comment

Thomas Klima

XX the about process the that. really they through we're go Gena, to onboarded Yes. centers, excited if to Centers don't have do patients really of want not treat. getting

for qualified we that December. go that centers approval treatment as treatment believe just the patients will board how at ZYNTEGLO evaluate LYFGENIA if center, And So on we the forward. have come half almost we XX centers you the have build in out we of the qualified and/or dynamics of look since

the board on through starting many to centers So you of we're build the that patients. following really them the continues momentum of as centers patients the already process at now going excited XX the and and are look

Huidong Wang

if sorry, it clear. make I can I'm

XX LYFGENIA. referral XX last think quarter I for was received out of

wanted these out XX of XX, LYFGENIA? of full receive many to just know referral how now So

Thomas Klima

XX, XX them a of anticipate website. some will completing final of website, almost cases, matter all of them our have Yes. them of It's on be to about some some of chosen on we and that be the you listed And It's soon. in our just board all very not steps. see on will

Operator

the Your of JPMorgan. Joseph comes from line next question from Eric

Eric Joseph

more what process And you're is it's bed whether here more sort pretty sort initial capacity perhaps QTC product a bit added I about The first Times providing patients kind you collections capacity way to follow-up of your LYFGENIA. any treated strictly? And group that a XX pre-authorization has something year. demand National talk then do patient little patient gene collection anticipate of Can -- little talk far the support about Can has your Do that network wonder QTC capacity article therapy XX balance? with so notes or how expand capacity of I representative you the or versus color within featuring about about you kind that Children's had this the in the to treatments a a that a to that of have interesting. QTCs network? The the moving is article would on the first XX in across efforts separates that uptake? of a that

Andrew Obenshain

Tom. ahead, Go

Thomas Klima

Eric, questions. X great

can I X different first ways. answer The question, that probably

QTCs. to end of half then if XX we you I think when we dynamics rapidly focused -- the really year. last start consider of on the most the for into XX the the of brought the year and first on We of the and this first last accelerated year,

If treating XX look you're or going their second patient least to XX, seeing now XX initial at treat or third and to X those at roughly you patient. on

component second just The is time.

discussing ready, from process journey thinking and go center. at the the center, it one the [indiscernible] second look medically hydroxyurea adopters back the your X seen seen we're to get going cell, seeing through faster for the calling going the their I for through to say already advance, process. early sure to New and question about start. And you if were consultation disease, you've in transfusions. sickle a why treatment would say you've months patient the through and that's article, takes of Times approval, this very qualified If the and of some then I authorization treatment patients inspiring patients York around see QTCs just prior part they're start one of off you're prior time qualified sickle in and saw cell the and it of being would getting going making their initial the kind family with the stopping

representative, So large large would say I that's the say of necessarily therapy. I that for gene but QTCs are most building that, and out wouldn't capacities cell

Eric Joseph

National just treated or a quick Children's with any follow-up Maybe Okay. to ZYNTEGLO? Children's Did that. National has patients

Andrew Obenshain

are the comment are obviously going X on to think they We of treated but QTC not by that individually patients. QTC that's I by XX information,

of so and I'll say come now on So have it to in many their that QTCs second third, those way. just

Operator

Cantor from question Eric of next Your from the Schmidt Fitzgerald. line comes

Eric Schmidt

XXXX, new the start? it you're a that of start. start has Does time the from first new new point start guidance or maybe a quantifying new how been finer collection make patients Is terms of just want on a put a to In for I completed. them qualifying

Andrew Obenshain

Tom. ahead, Go

Thomas Klima

been cell the cell so collection believe Eric, patient that a the new beginning. how first we the we've the through pretty that consistent unique of infused we've at day. in once highly is entire the defined journey and collection it's We treated to that goes patient since really is they'll complete, the end believe starts process, get through metric that watch ultimately when and go that likely the

we So completed. first unique cell collection define that it being by

Eric Schmidt

for OpEx, with there now. say restatement. Is kind right COGS QX? Maybe Chris, on we're waters state to cash your into financial able struggling uncharted I regard in being to anything with you flying how can I'm guess, understand of trending, are burn

Andrew Obenshain

Go ahead, Chris.

Christopher Krawtschuk

have that will the with I'm to not patient an the associated will an on trending. as cetera. that's First, where other the I'll of make impact not on elements on cash P&L impact we et comment say the And the why message. we're starts, restatement metrics company, going lines such of continue of that to the key have

fair Just in to of because or process appropriate we're the the and not [indiscernible]. restatement, it's

Eric Schmidt

you those have see numbers? a sense Do we'll better on when

Christopher Krawtschuk

line we're complete working when We not have to with time the occur. that restatement. will associated We're the expeditiously sales a that providing

Operator

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

Unknown Analyst

through go the to we X-parter of some that, talk were do kind pace wondering QTC the whether We reach of as start it's for then off for cell team launch, of This about physicians, end accelerating to of the taking support, Mani. just you into accelerate of state how at to to year? a a the think see we point, the specific actions et of can cetera. we kind year? And your with steady field should dovetail we going on one. is Ryan about LYFGENIA what Kind collections the this is guys Are LYFGENIA help engaging

Andrew Obenshain

Go ahead, Tom.

Thomas Klima

said centers we QX and they're and on really their of shifted patients. trajectory year Ryan, the the field has centers new QX of ramp to Yes. on And and the now from we've into our really through ready accelerate we pull along, to making in team focusing that QX. the all -- end have patients -- starts to treatment bringing sure focus treatment pulling completely qualified qualified through supporting board in expect

So we're completely shifting gears.

team and -- has with built field Our years. the of over relationships the credibility patient report, completely X.X focused A great is last but now treatment pull-through. supporting qualified on centers lot

Operator

comes Yanan Zhu next from Your line the of Fargo. Wells question from

Unknown Analyst

is Yanan. on for This Kwan

So LYFGENIA. first, question quick a on

colors So patients have any started many how their high on [indiscernible]?

Andrew Obenshain

So I the out. wash started was question patients think many have the how hydroxyurea

Thomas Klima

Yes.

So it varies.

really guidance It to center. on by that. by treatment patients, going We not but aren't qualified give varies only

before concurrently with on qualify on have of are to the we the some patients when guidance precursors some to start aren't qualified different some that that's consistent. want need do. of patients of SOPs of readiness treatment they the But washout Some terms medical kind start hydroxyurea, the prior some in cell Obviously, work they of centers period. not, have collection. pretty that -- they authorization And giving some

Unknown Analyst

manufacturing. And Got question on one quick it.

a want investment increase you any needed capacity the in So additional there for current capacity if LYFGENIA? to future? CDMO Is what's your the

Andrew Obenshain

Yes.

capacity question LYFGENIA, the and drug think probably for think about I I -- product capacity. talking the about So

supply volume. a the more we So on of for ZYNTEGLO, anticipation SKYSONA in higher separate then chain have side we LYFGENIA do LYFGENIA robust that have do supply

as We in. see come supply ability also we the have demand that increase to

to going we've we new with on So capacity how see come we bring we're match the how demand always in. --

close possible. is there to So lockstep as

Operator

comes RBC. question line Your from the of next Luca from Issi

Lisa Walter

This is Luca. for Lisa on

whether wondering reconsidering Just launching about if talk you ex in you can are geographies. U.S.

about For that XX,XXX market, instance, region. in stating really there the patients are your excited Eastern competitor eligible seems potentially Middle

an either Any all launch, progress. distributor. utilizing So appreciated congrats U.S. partner you there a a are the and reconsidering ex much wondering solo if thoughts or with on

Andrew Obenshain

Thanks very much. Yes.

partner remain on focused -- entirely The go are very and focused -- If and the that's ex U.S. we the it geographies. we probably U.S. the likely near and now, the alone. right watching not we for with there, go on U.S. future. we'd are and least we a do most at will midterm So --

Operator

Sami Your from Corwin the question William next comes Blair. from line of

Brooke Schuster Gray

Schuster This Sami. is Brooke for on

XX total them ZYNTEGLO also is the I activated, been say So with would in initiation that all treated guess of a centers of are to QX have had some the if or the what starts. in patient already? collected you biggest cells of we patients QTC bottleneck of And wondering

Andrew Obenshain

Tom. Go ahead,

Thomas Klima

-- takes So through would wouldn't it's time. call to go time I it as process. I a just patients It characterize it bottleneck. for just the

from some go are a ready cell basically and one currently blood are sickle are of beta in If disease, mostly at to to you already on through writing. going for cell disease, already to sickle treatment. When in are are beta-thalassemia, not patients cell it look and identifiable sickle cell these not transfusions They're them transfusions difference doing big of thalassemia, medically patients them -- in hydroxyurea. regular QTC. many of comes with Many

patient process longer perspective, LYFGENIA. obviously bit go for with little insurance of from cadence little be the medical first takes ready takes into And understand cadence QTCs. treatment The to it of and a patient a longer, more bit well. QTCs little the time takes to the a the usually a patient, So for about a in the it that a just until the get to process through starts first start payers readiness as

really a time. se. not takes It it's bottleneck So just per

Operator

of question next the Richter Salveen Sachs. line And comes from from Goldman your

Unknown Analyst

start patient And you for this Salveen. This confidence achieving these of patients still do Lydia come is year? LYFGENIA? half roughly to discuss intend for just from you in your guidance the on Could

Andrew Obenshain

Tom. ahead, Go

Thomas Klima

centers, gene a excited terms of SKYSONA, therapy. gene there how lot for therapy are positive lot experience with the in building a patients patients that and of is qualified launches we're going. of We're ready we seeing XX momentum and about feel with with we're consistency hearing then Yes. ZYNTEGLO, Obviously, treatment with pleased with what

not on the what also get that obviously, year running, based So treatment the ramp but the we're as will XX centers the starts in through based today, this second in confident of we're did what And we the that numbers process. the prelaunch we to in kind only XXX field hearing the of year. half and remain on

Operator

And this does I over our hand for conclude Q&A session to back Andrew call to closing today. the would for remarks. like

Andrew Obenshain

Thank for call you. everyone, Thanks, questions. your our and joining for morning this

available management like and Our is reach connect. for calls to please follow-up today, team out Thank Courtney, would if you you.

Operator

This concludes rest today's day. the of Enjoy conference your call.

now may You disconnect.

bluebird bio (BLUE) 9 May 242024 Q1 Earnings call transcript