BLUE - Earnings call transcript Q4 2023

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Operator

Good day, and thank you for standing by. Welcome to bluebird bio Fourth Quarter and 2023 Annual Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Courtney O'Leary, Investor Relations. Please go ahead.

Courtney O'Leary

Good morning, everyone, and thank you for joining our Fourth Quarter and 2023 Annual Results Call today. O'Leary, Investor Courtney bio. at is name Director Relations of bluebird My

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

Andrew Obenshain

April that XX-K submitted quarters XXXX announcing for now call inclusive outlook Fourth out and morning for this filing filing. of the that later strategic an X-K everyone, information our extension will we this XXXX, milestones as an joining discuss the for you, XXXX and we Quarter for our than our XXXX. Earlier thank Annual no that first update planned restatement put restating provide We of and on XX-K XX. Courtney, Results, anticipate an on financial Thanks, X and we've morning, our and be we and

this We ourselves discuss with U.S. commercial cash later and the the position patients in gene of bluebird. leader, impact commercial call. XXXX strategy in will a or year Importantly, was revenue. brought established Chris does our as not across to validated that SKYSONA for a ZYNTEGLO both greater the a restatement therapy detail progress significant

for Our LYFGENIA foundation. progress on commercial builds that recent

only position FDA for cell products. FDA-approved then, is disease launch. approval the therapy commercial -- the X the With with ourselves with our LYFGENIA strong a currently December, sickle bluebird commercial hit LYFGENIA for only running team of to last the ground has company gene Since

about start we talked have real significant are today, We before with of lever that head the LYFGENIA. seeing for benefits the momentum ZYNTEGLO. And fruits into commercial our for translate

transaction launches. the deeper now multibillion for Tom happening that into X front capital, X forwards X-year in the This first U.S. I in encountered and XX this our to that million. as We with near-term years. centers call, a highlight opportunity call significant us scale growth and we an space $XXX -- have starts signed start, our expected also to off This activated we Medicaid, to to Capital, our Hercules up to this dive extend is with in a our progress outlined will commercial momentarily. runway year. to in We we the capitalize are hand the funding vision is qualified for set a treatment earnings extending fast on vision additional critical company. into X-year loan the from announced with to Tom will QX therapy patient Last outcome over have cash August, term access the XXXX population. And over provides months. Last XX of we agreement on already beyond LYFGENIA to expecting gene infusion bluebird entered bluebird our stand-alone our week, progress next next of to dollar out path commercial commercial profitability a patients

Thomas Klima

good morning, and Andrew, everyone. Thanks,

we in commercial Andrew foundation year bluebird, pivotal and with built our for ZYNTEGLO, cerebral a XXXX noted, SKYSONA was for As adrenoleukodystrophy. which with beta-thalassemia

head for capitalizing the sickle Today, launch to on start LYFGENIA disease. of the cell accelerate we are

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

establishing First, in of centers and These or network robust therapy. gene a with are centers significant qualified transplant QTCs. experience treatment cell

Andrew to activated the XX mentioned, As compared in today, unparalleled we QTCs, have others field.

progress access. the of are lastly, and the and reimbursement. And value therapies understanding families have business paramount. and a where equitable deeper provider of patients patients, transparency, into high our is timely, I'll Gene experience. In is Second, and optimizing needs the recognized touch patient collaboration our that and on dive moment, therapy a ensuring access providers

will multiple across to treatment be the number excited Our XX the We starts centers we months reported of be to expect preparing that for anticipate to experience we builds. QX. our QTCs, first last to grow a with patient therapy in quarter-over-quarter, be our gene we the will the encouraged them the the year process, the our the deep as revenues dedicated allow our into momentum for treatment and for and LYFGENIA network. of bring scheduled QTC our are extremely patients activated LYFGENIA over as first LYFGENIA today start therapies am partner for and months in that I very second understanding their enrollments to half imminently, is majority help patient's by anticipate occurring share of strong strong. life-changing patients. Three demand us focus We launch,

to ZYNTEGLO. Moving

patient in see of to X linear for starts patient beginning to with continue in since We XXXX, the addition growth ZYNTEGLO XX completed the strong XXXX. starts

metric patient commercial watch launches the for starts the last year. And patients being patient starts, SKYSONA in to the for cell X completed beginning to recognized company, our when patient the as of key a with which early the is this the infused. for the reminder, completed when remains have occurs, SKYSONA starts X of moment value-creating collection stages XXXX, in addition is is as since we revenue Additionally,

you the either patient cell expect process. once started experience, process the in X through the or the treatment the they X collection. remains the on process date, every completed continue purposes, has patient goes that To infused to who has And are following collection, patients in our modeling journey. cell can For quarters

forward, starts patient XXX our to starts plan quarterly guided towards to of work we patient on for the each XX as therapies Going to we updates provide we in XXXX.

to care access bring to patients. onetime Turning health and and and Gene therapies transformative are the to treatments reimbursement. tremendous value system

in and the years, led paths payers of bluebird gene to patients. has therapies way For articulating access charting to for the value

these therapy high today, burden see access where payers. is value success our to LYFGENIA, approach patients. we with seeing SKYSONA, and the both in of Medicaid continue with for same ultimate equitable for ZYNTEGLO timely Payers therapies commercial are a the We goal working. is disease. And timely, denials for recognizing the either And of across and access our X early are

X to have risk-sharing patients for We outcomes-based designed that hospitalizations, typically payers offering agreements followed tied VOE-related unique meaningful with are to years. LYFGENIA,

addition government LYFGENIA a an million including ease In for of policies agreement we've payers announced such coverage demonstrating signed to for at is offering, Anthem insurers, month, states to grappling for need more with for We've already LYFGENIA, program, commercial that essential this outcomes-based types Michigan's X offering a major predictability parity, constraints. Earlier Medicaid and cover also resource XXX for commercial specifically its operational from signed designed with the as seen Cigna. short that these policies, support LYFGENIA first Medicaid covering lives. In innovative XX% that of for from we've outcomes-based addresses total bluebird than arrangements. of national X Aetna, months, agreements close and we

representing Medicaid access in on continue with patients more to of in XX% with U.S. sickle ongoing are for disease Medicaid be agencies, focused XX cell We the and individuals discussions the XXXX, than

access slated in XXXX, on a We to with to outcomes-based bandwidth which are also on who for ability not its demonstration is that could have CMMI serve begin actively their own. implement and agreements extender gene states engaged the do cell therapy as

network. Moving to QTC our

of miles advantages of start ability our of the network for now means network. today. our XX sickle XX% dubbed XXXX. in QTC. that We of of for living LYFGENIA XXX activated across XX our bluebird qualified anticipate to referrals has build people cell treatment One centers, hemoglobinopathies, portfolio most QTC have less a largest receive which ] QTC to within significant are or ready been additional already We approximately our commercial [ centers synergistic the disease head expansion are This with of

in New important to We with we agreements proximity they QTCs with where area. geographies and in cell patients, throughout where also are Georgia, across are, recently York Metropolitan signed sickle meeting patients Florida the

infusion, CALD. We with to SKYSONA ZYNTEGLO continue and our onboarding centers both administer our bluebird validated process table. To throughout setting launch, ZYNTEGLO anticipate centers our made patients growth and our with and centers we From progress the from through brings to XXXX. comfortable to strong with early able activate built been We've for due have to Additionally, LYFGENIA to SKYSONA have we grown for that incredible expect relationships up platform. these QTC these building have of world our XXXX. transparency quickly launches on were experience QTCs progress as linear LYFGENIA partnership to the strong commercial activated are planned, in the and ZYNTEGLO X recap, the in also and

Chris. patients QTC help from start clear value turn journey therapy. And call seeing in access the is to our providing over physicians, of I'd to curative recognizing fully LYFGENIA patients are and We to ready are payers the their demand with the network now like and

Christopher Krawtschuk

and morning, everyone. good Tom, Thanks,

the from release. In in we SKYSONA. details the the results $X.X extension revenue quarter, of we I primarily this million financial product announced in discussing from want our Before reported the driven fourth filing ZYNTEGLO the to and and reported we restatement revenue, highlight total morning, press

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

the and patients for product drug several December Additional at infused of in January. end delivered were

of recognized revenue in this first quarter So be the will XXXX.

well XX%, we SKYSONA, of of gross-to-net we with of approximately year $XX.X the across of products revenue and cumulative net and XX% gross-to-net of outcomes-based million in revenue, attributable For our of XXXX, XX%. In the to $XX.X full attributable ZYNTEGLO, agreements. utilization range portfolio in with as payer discounts XXXX, with to anticipate based fluctuations $XX.X to revenue mix reported on product the million as discounts X million

approximately pleased announce infusion third securities Going of revenue We're deliver million, and with an the into first a available bluebird, on very company. The $XXX forward, This the cash provide year and in expect we in $XXX term with ended marketable for tranches. which the to XXXX. We LYFGENIA launch and $XX provides Hercules X-year financing Capital fuel for to million our a in X LYFGENIA that on entered the million. it's as mission loan of and for up cash the of loan quarterly cash. $XXX as restricted infusion product capital non-diluted basis, provides aggregate, to earlier, includes of of million the quarter by equivalents, helping shared we bluebird revenue and cash and restricted Tom recognition patient plans

this sole The and available amount aggregate, at may over gross to to of million in achievement was subject of tied the months commercial $XX is profit. amount first closing. of drawn may tranche up the up X LYFGENIA $XX next million to an be million, on the and patient tranches $XX of tranche The fourth additional in starts of We draw to milestones Hercules. the discretion XX

and us Importantly, estimates current X we are reiterate puts expected position launch to the transaction and months to the launches first assuming the plans cash profitability. next and Andrew's approach our a executed, capital our extend runway business and as beyond durable on is comments, based in XX our

for full both the and Lastly, XXXX. of quarters restate for morning, the The information announced this relates application year to with of and contracts first restatement statements. during the internal of for XXXX we accounting our non-lease preparation our we XXXX the lease our financial and combine and policies suppliers, organizations finance not annual of did our and which financial components, contract was team manufacturing discovered by consistently X

million of we of million understatement For quarters estimated and well of assets X the as to year, $XXX lease first XXXX. and assets million liabilities liabilities for lease understatement $XXX $XXX and for the approximately the approximately $XX XXXX, of lease as full an XXXX estimate of to million

cash that, finance as interest working expense still the P&L. details, revenue. In and of not reclassified noncash consideration to The will we're or filed to our on and the over impact any the result, April XXXX extension inclusive While will XX-K of our as have an turn anticipate we expected increase will it Andrew. with lease our we a have let we the restated leases to periods our anticipate restatement the be time the we is on of restatement, of complete exact position XX-K, me that through filed XX. And take be for back

Andrew Obenshain

X with is bluebird deploying to therapy therapies XXXX, FDA-approved delivering to gene summarize, patients commercial their our And a and Chris. you, validated families. on taking Thank strategy in place promise

updates year to for a upcoming We providing progresses. to forward our and quarters of we commercial look the be XXXX as LYFGENIA more our company, launch expect transformative in

Operator? that, with to I'd up it open like And for questions.

Operator

[Operator come of line Gerberry Instructions] Our question of will the America. Jason from with first Bank

Jason Gerberry

half to these fourth I to first revenue you maybe in if of the that can comment actual of quarterly to new just seeing recognition And dynamics the just outlook as your quarter, what speaks half revenue an event. and maybe sort what and was year? of for a wondering you're directionally, in speak the to, then step extent can versus conversion you down flow the there, at follow-up, starts second all just starts full the

Andrew Obenshain

about bit and and with fourth flow, and the Jason, the quarter with just of half just second question. the Go and ahead, how the Tom. then for Tom, dynamics for in coming the ZYNTEGLO year patient little a thanks both I first this might the for they're LYFGENIA. ask talk

Thomas Klima

the for thanks question. Yes,

patients strong patients SKYSONA. at So the actually new over a of as started we expected, the in year last for building of X With elected we that for we saw start after course be the demand we and the end year. ZYNTEGLO, to the then of the treated demand number ZYNTEGLO for collected year both of year

collections in of were many the be although track So to went in those on on QX, patients QX. infused

for was we of saw positive bit the a demand that patient reason very dip little in ZYNTEGLO. you QX. But on a remain So

strong for LYFGENIA. us demand very are for seeing just also We

We linear the the of year. half year of build vast course the a with LYFGENIA majority the second starts this happening expect over in the of

Andrew Obenshain

drug our fused quarter there. best QX say infusions total. recognized date delivered to on in also that happen would that QTCs And quarter-to-date, what And starts, some where Jason, be said -- those products just we -- not to and too, were had strongest reiterate the had were QX, X but earlier in we to and will I actually we've to

Operator

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

Danielle Brill

Jason's, know start still believe patient XQ. And that volume is follow-up multiple first of as patients up total to then XX% expect would over start this you guess do I communicated imminent, the a in to said that year? I you the make LYFGENIA past, the you've I in but

gating [ getting to patients ] Just those curious started? what's

Andrew Obenshain

Go Tom. that. answer to Tom ask I'll ahead,

Thomas Klima

Yes.

who of have just might takes ready to and to across X month X you are of months. about getting therapies for process believe the their ready in that And treatment we'll patient far package they hydroxyurea first average started a imminently. have it demand. a say mind second different that to the of We through been and for we're the on LYFGENIA, do demand have in QX. X rounds should we're again, momentum. We or that half a number So Obviously, from the to We come We've also keep or again, who at build a about starts patients up larger And be the a the refer seen They through as months excited half volume momentum process to what and if going did expect for would year strong we very patient the of we for roughly seeing have that disease-modifying with the least number our in on started X so out wash LYFGENIA. we seen very of be starting to transfusions, of go insert patients lot much at more look the as soon, medically pick have LYFGENIA. it's each. population, we've they enrolled -- patient QTCs. of you in see is

just get patients it longer a So takes to for little ready therapy.

Operator

Our next of the with question line Baird. Allen comes Jack from

Jack Allen

some it and I potential how wanted the and think you here patients influx you the about to Can as being ask in, color it about capacity waves half provide relates have? half quarters in your it to as kind well. manufacturing as as as And to comes about potentially the think second relates demand the you you in different of build LYFGENIA? what could second really meet capacity we how in

Andrew Obenshain

I'll one. take that

first LYFGENIA. the -- and is that supply understand supply to of is the one ZYNTEGLO the supply So chain important or chain think SKYSONA chain, all, there's for I for

and the have other. meet of upon So than And also don't the each we is demand and both that there. And coming a to capacity anticipate have impede sides, the capacity drug capacity we've to obviously we expectations. expand larger place do our what launch that volume SKYSONA, And anticipation to as designed for product, we've two ZYNTEGLO way with plans capacity the LYFGENIA the for we larger our on in both we designed in. demand initial do -- in and the or that we sector see be

So the of in do year this we have do we of our anticipate that products. capacity launch phase all for

Operator

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

Huidong Wang

early have to little expected start know LYFGENIA? real-world what experience, that for is from wanted now you finish bit I a your to

Andrew Obenshain

ahead. go Tom,

Thomas Klima

So collection X the plus in is time X the XXX that, quarters. time obviously, service is to that biggest and infusion the from and days we part manufacturing XX the weeks. -- between we're packaging cell range saying to just of what And X

back it. to majority vast QTC And the a then when then it's they we to ship of that's So time. QTC the obviously infuse it the up and

So purposes, to for we're X modeling quarters. X saying

Operator

of JPMorgan. Eric Joseph question next with Our the comes from line

Eric Joseph

of provide back guess I to the to we're there on recognition? at do avenues and sort forward? color generation revenue conversion total to rates you collections treatment going of cell collection has a I improve And XXXX, how being then treatment yes, just contributed actually average whether if think patients What between anticipate revenue many time contributed XX, how looking trended? to there you can many explicitly, just more -- -- how and little

Andrew Obenshain

XX through in has so XXXX, the in infused or of or They're is collections Eric, process. process we numbers in still So infusions. process. is product the still in the with single had that process. delivered given all drug patient either product haven't the been the every gone They've And actually

So delivered first -- and as we year. In the infusion X quarters. some collection that as the in to be to the in send or just we infused revenue will but will not to There always general, And outliers issues have early be But that to X we going is products see something but infused we see XXXX. have hospitals directly. to going said in time happens, infuse you'll patient X QX, I'm quarters. else number QX general, it's X the not this from late you're some there or in infused

more get we As get you we're able kind of to we and precise that a more be you we more for relatively numbers. small data, and number, would with to as but number give narrow collections down still dealing still a

Eric Joseph

Okay. process, there, And a remain bracket patient X-, can a ultimately long guess, to window? kind is in how time of XX-month in frame, there Is process? a I be I guess

Andrew Obenshain

no drug after end right, process just for products. the year, date about little for manufactured It's a really product them drug it or would of there's year expire that So bit the once being longer. you the expiration a in the except a

it this once treated, product get the So they et it's when deliver hospital, very makes again, election will be the cetera. patient events, that they to That's is don't but far. get around process. will in life infused. an that in remember, unpredictable that so anyone back We But would the going schedule we somewhat why to anticipate often

Operator

Partners. of Leerink from next Our comes question line Foroohar with the Mani

Mani Foroohar

market pivot dynamics. bit want little to thinking I to broader a about

volume of You've guidance of of Can of have a can't how do going but deep know currently, LYFGENIA, be that number obviously us there give to patient Hercules that's transaction -- is? with exactly put perhaps sense more that I as you us can metrics what like? And a out bit process patients you potential or guess you can little other part them trying backlog some I you half for demand patients. of backlog much you diligence LYFGENIA exactly around them? as looks of Just the XX-XXX a of data you give engagement understand it? their have about follow-up, and you some give available numerical was color prior what patients talked that with to How to -- identified clarity your demand, into finding said us us separate a can give LYFGENIA due as to your demand well. sense

Andrew Obenshain

Yes.

So LYFGENIA. going about Chris to in just to will interest it talk pass the to I'm Tom. or Go backlog is we've the talk what about Tom Hercules. provided ahead, just

Thomas Klima

QTCs, that had could was sure a mind if in lastly, are of reimbursement. questions which that around to asking And People about questions people year, Keep factor then back to were our demand. also patients you therapy. to get look Yes. goal asking access asking we XX patient in making XX around were people

Now We've centers up qualified treatment and we happen. XX running. seen have reimbursement

We have policy with so positive far LYFGENIA. coverage

their mentioned, handful because we going per want get sickle we've of QTCs bolus huge But through their long patients patients. to schedules. I looking would box QTCs, at market research, looking cell at of expect treat, patients now you're list is are in severe QTCs are XX% checked. And first cell of disease that disease being go patient that sickle have of as be over said who before that And wait they we've patients, have more of seen historically can treated. demand. So approval they a life, treated few patients across a enrollments And also heard have treat multiple therapy their seek think already in multiple just physician. months out play now in we're seeing And after we real a by list wouldn't to Andrew have recommended anecdotally, if a who that gene to

overemphasize excited the can't demand about -- we we're that again, seeing. we're how early are So I

Andrew Obenshain

what you we do on provided comment want Hercules? to Chris, have

Christopher Krawtschuk

arrangement confidence not in having party $XXX Hercules progress. million consensus, marketplace I And that information is right? Thanks That's on and beyond received achievability to that for for patient should the scrutinize that the entered provide the third the the so just should the projections confidence a question. starts that. finance. What received, it they our come viewed With Hercules customary projection be relates but not those what into LYFGENIA though say of you to considering respect as for viewed XXXX, the saw would there as guidance as to

that So not the that our milestone with associated is provided is to XX starts. which guidance, consensus. XXX We

Operator

line Our next Stanley. Hung question from comes Jeff the of Morgan with

Lee Hung

referrals, sites online collections with that For what QTCs that factors LYFGENIA, were And the have already in different might XX at proportion time I of year? what of are receiving in these XX the for first the And then their have beginning the particularly might cell first lines, year? a patient of half follow-up. sites the the result gating

Andrew Obenshain

Tom. Go ahead,

Thomas Klima

haven't specific but lot say, on a board needless LYFGENIA of approval. Yes, late and guidance per given were really launch Yes, for QTCs QTC, year sure. coming in we to last anticipation

for to patient be go clinical pretty might expect would on about list, getting wanted appointments. in QTCs to trial, through therapy most cases, are patients some to started patients for patients a have waiting we LYFGENIA. In of in those cases, try say, a gene And regular faster. excited come our they waiting if that they a most then So a their for

excitement that we've about the for gene or X and therapy. the So we're and out, excited early multiple dynamic just QTCs, about we're but really, not enrollments the seen X excited across will play QTCs,

Lee Hung

would for to profit by see of reach third starts first by the facility, need the the Okay. term the half to 'XX? track tranche patient in loan what to then million the of year end you end on the the be of milestone gross $XX And of

Andrew Obenshain

Chris. ahead, Go

Christopher Krawtschuk

we're going on commented with patient associated on that. by And the tranche, our XX start September, tranche profit. a -- comment the third not detail of XX going provided we to exact end commented metric So the the going year there's we we're of also, to to metric gross patient for the of provide the get the start and that. that the equivalent we're the number. that guidance but haven't was But not gross then by to associated for second and profit the not on we to What with then was Remember, LYFGENIA. number starts level patient

Andrew Obenshain

Sorry, think tranche, first Jeff, asking meant the -- second... you the said about I you were you third the

Lee Hung

talking Yes. tranche. I the about Yes. third was

Andrew Obenshain

of starts And the So of of XX gross keyed tranche which off metric the by million, XX that off profit. it's $XX which of different XX second either then tranche the year. third a -- a end the a is is first keyed there's tranche or is the $XX of million, there's

Christopher Krawtschuk

to of $XX associated Hercules. December then is the tranche tranche million by the clear, -- first is is $XX at with XX. was million, Yes. is starts, the as $XX the And of LYFGENIA the And third just I gross discretion And by million. tranche then, XX second profit. the be is patient the to the as XX course, $XX million tranche attributable that September, said, the fourth

Lee Hung

guys gross -- you for you on started wouldn't million the profit. the $XX Yes, you starts comment said number of patient that

Andrew Obenshain

That's correct.

Christopher Krawtschuk

That's correct.

Operator

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

Salveen Richter

understanding trajectory the How update the drug? reimbursement of on Just the onboarding dynamics, about dynamics. here and right commercialization. thinking various of in the seeing you're just the you for are opportunity now And line for maybe that ex-U.S. an peak

Andrew Obenshain

Yes.

hard So for you I is but Salveen, the I peak little drug? what was the think -- to a hear, opportunity asked

Salveen Richter

outlook. commercialization ex-U.S. And Yes.

Andrew Obenshain

Okay, got it.

let take me that. So

-- now, do see there's U.S. a as do with U.S., There's multibillion-dollar are as in we So U.S. company, partner. attractive focused Ex alone. ex-U.S., If the there certainly exclusively well. on opportunity most a right the we a peak we, that we this a very do think at opportunity go as we

as Europe dynamics gene the in therapy We the key there. that a of will of determine watching are very closely reimbursement That's well. kind opportunity dynamic

Operator

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

Samantha Corwin

covered cost can goods by as if how and and continue. of LYFGENIA assumptions the curious a you your percentage to change granularity in of of you in was for speak to more private I the launch across this your Medicaid to expect insurers? them then margins the And provide portfolio gross you as patients be could any launches you year terms little expect our the versus

Andrew Obenshain

sure. Yes,

So Chris let of part go I'll in the LYFGENIA Tom then second to me have Medicaid. with explain the first, percentage and

Thomas Klima

Yes.

the covered like mix a about will would XX% early XX% covered to about hard you of stats by It's people the sickle predict will give to who Just the seen disease and cell small portion time of payer by out be, insurance Medicare. that play again, then are but living we patients are or over expect patients Medicaid, historically. commercial with we've

Christopher Krawtschuk

and slightly I'll the sales is the cost intending, different is which answer margin. I just of gross way, And on think you're it then maybe covering what a

and for So will we the the company with margin. we to filling company, margin the fashion we scale, with gross a said as gated scale kind margin gross to we the as capacity to then and And time improve that infusions, capacity of would not in to discussed. the over scale achieve we've that only get XX% will as The that continue continuing a improve XX% gross needed.

Operator

] from Nisan Yanan Zhu Fargo. with (sic)[ comes Yu question next Wells line Our of the

Yanan Zhu

collection pre-transfusions, you period factor, is for factor when imply it's And from cell the time what just say does main the gating enrollment LYFGENIA, multiple the might those washout insurance? the gating enrolled be and So also curious, not you enrollment patients to approval see. of

the be Is very LYFGENIA Also for that SKYSONA, quick any for and about if XX% different expectation number? date. follow-up, the ZYNTEGLO and from as a different talk significantly to that between can to you gross-to-net gross-to-net XX%

Andrew Obenshain

question. Tom, then for the address Chris address the why enrollments, have we'll don't you and question. the gross-to-net Thanks

Thomas Klima

Again, the excited very multiple across enrollments Yes. we're QTCs. multiple about

obviously, did than with the weeks. there it road on a ZYNTEGLO by we about little other it's taking an big with mentioned, X of insurance second we're approximately medically of making the and as this to being [ think is for you average, covered are, is saying, it, being X LYFGENIA and ready, washout is it And indicator components they're different ZYNTEGLO. With bit that was part the as demand. call a period sure their and there's ready medications. ], multifaceted, strong of that's LYFGENIA I The yes what

and therapy, months for X transfusions, X to discontinued at also X For before example, month go they're transfusions supposed start apart. has for hydroxyurea to at least least they be

they're lot going if already be they're transfusions go once needs they're and of not medications once doing transfusions, a faster. they're one discontinued, they on not and the So doing to process, mean I through already can the enrolled that if they're

for just So thing company. continues is give depend early to value-creating an right is the because an going now demand. that today. the The the number a little the enrollments you patient forward it's of to patient Enrollment watch moment of on I'm starts average hesitant patients. And provided be going we to indicator to

Andrew Obenshain

then, you comment do on to And gross-to-net? Chris, want

Christopher Krawtschuk

then higher the Medicaid is into associated where expect LYFGENIA. to the increased X comes the with that And we products. a X combined XX% fray population that to gross-to-net LYFGENIA of with XX% associated all you between products, a an saw we provided as basis not. XX% And that's to population discussed guidance agreement, SKYSONA has between outcomes-based characteristically, just combined So what and the the does ZYNTEGLO go-forward ZYNTEGLO SKYSONA, difference on

Operator

from with the comes question next Luca line of Capital RBC Markets. Issi Our

Unknown Analyst

This like not the and is ask, achieve PRV, mentioned ultimately, Issi. the receiving wanted with potentially engage meaning receiving outcome I that after the positive to approval last during call a you'll agency to the PRV. in you [indiscernible] just attempt discussion

wondering on there if that. was update Just any

Andrew Obenshain

for Thanks question. Yes. the

to We for agency the update when clear provide and we discussions request have not submitted we the LYFGENIA ongoing and why reconsideration a an We're to We'll with with elaborate be going our discussions. now, we have a awarded PRV. on rediscussions believe but compelling for rationale a conclude agency.

Operator

now question-and-answer closing will Obenshain remarks. Thank This the turn today's you. to over Andrew I'll session. call for back now conclude

Andrew Obenshain

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

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

Operator

This concludes call. Thank participation. today's conference your you for

You now Everyone, a may wonderful day. disconnect. have

bluebird bio (BLUE) 26 Mar 242023 Q4 Earnings call transcript