BLUE - Earnings call transcript Q3 2024

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Operator

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to bluebird bio's Third Quarter 2024 Results Conference Call. [Operator Instructions] Please note that today's conference is being recorded. I'll now hand the conference over to your host, Courtney O'Leary, Director of Investor Relations, please go ahead.

Courtney O'Leary

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

are progress, statement. intentions bio's our that risks to based company's turn that begin, uncertainties plans discussion operations. Andrew Reform section and could over the is that, expectations filings in with contained commercialization Act that A which I materially let involve addition including factors results to www.bluebirdbio.com. With review I actual statements will results. risk regarding results Litigation Safe differ Before plans, Such in and available expectations and Relations to XXXX regarding our position, of me assumptions Private CEO, Securities the Investor contains financial risks SEC, business on the expectations cause forward from are are of Harbor statements regulatory bluebird the of looking subject future these or under a of are website, and of and our our statements it projected Today's number description to current Obenshain. financial on

Andrew Obenshain

joining Thank thank and you everyone call you, this morning. for Courtney, our

past updates qualified and efforts. a reported pioneer QX years, we a with than goal cash out XX stability roadmap reduce expenses gene the XXXX are commercial patients to and network, across we starts today's our from laid QX therapy demand and resources. On doubled by and year, to August, the providers. flow demonstrated ZYNTEGLO stage cash and bluebird's recent since both gene on opening we the will Chief should Klima, have of securing portfolio. update on approval, second Today, Tom LYFGENIA, will provide and SKYSONA. operating proxy commercial reimbursement only initiated As we Q&A. I in on launches therapy comments our some half our center those the breakeven the an FDA Officer Sterling, robust, of accomplish patient Tom. the built for we We we've X additional seeing James vote steps the will our unparalleled proven and a next in our believe over more an over from Operating call our provide for to for of therapies, our CFO, cash and call call XX foundation standalone to hand Commercial earnings results in to now before Since what company first Then the have financial XX% today, market treatment access of we to be

Thomas Klima

good and everyone. morning, Andrew, Thanks,

launches We for network. and to see commercial therapies continue the established third strong our our to in and access clear paths growth with QTC industry-leading an quarter in

with drug delivery. those support to an more we scheduled second half of with have already infusions. Remember, that starts our year. Today, noted, XX QX deliveries between XX been the patient that additional This or XXXX from date across Andrew than completed starts and doubled in continue starts said, patient XX, path in the completed mid-August. portfolio. starts have since we through a future and as starts scheduled patient have been and As breakeven our to starts the approximately XXXX XX rest the sustained XX quarters flow product start in continues Of patient into we And convert cash call strong patient in XX takes scheduled trajectory to see XXXX. we XX to to it to announced of the X demand as potential

treatment across patients are have network, broad therapies. date, to XX enrolled access QTCs. than patients have To QTC our extensive more our for unique particularly that encouraged We initiated because of or

You potential ZYNTEGLO upside first the and the come in will has U.S., remaining significant as the recall XX bluebird highlighting LYFGENIA their network than to patient. start offering more QTCs centers total that in our

need point, double capacity capacity our and commensurate demand. manufacturing with cash to the plans today scaled on in we to breakeven This a have flow similar we we achieve for based demand. where XXXX follows ZYNTEGLO, with launch have dynamic We anticipated LYFGENIA capacity

reimbursement. to moving Now access and

equitable therapies. has our access goal Our always been to timely

access. and We government are with both pathways to which the approving speed by are many commercial extremely encouraged payers patient

more LYFGENIA, a have affirmed coverage on through than all list coverage states published Focusing half or preferred drug of criteria.

in are and denials And XXX has more therapies any million timely continued and LYFGENIA, lives. a been ultimate that representing of LYFGENIA nearly the the for place outcomes-based U.S. XX% prior to least have multiple access U.S. Medicaid state patient. with and agreements than completed authorization X already in for Additionally, to commercial. of approval one both Medicaid-insured sickle at cell has live for of for disease our published individuals ZYNTEGLO SKYSONA LYFGENIA, in Commercially, date use across with

Now to I'd like James speak to financials. the our to over to turn call

Oliver Sterling

revenue, are following that and we of QX. track you, good $XX.X to earlier this financials third our now the from this I'm in In pleased, restatement Tom, million Thank reported with reporting the morning, normal year. on we back in morning, down quarter, everyone. million confirm time $XX.X total lines

variation anticipated due guided to dip we in last time earnings in our lines. we call, this QX manufacturing on revenues As

are nicely least in revenue at expect million the patients more rebound $XX fourth will quarter with net infused. of as We revenue

the first revenue well of our infusion Importantly, recognized in we completion quarter, third LYFGENIA the target time line. our following within first LYFGENIA the

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

with cost revenue. the prior and down as cost shifted generally was of were the year to expense consistent million expenses was products side, while expense R&D previous SG&A R&D period, On year-over-year $XX.X inventory

we which As cash. $XX of of restricted XXXX, of hand, $XXX.X in had September XX, inclusive on million cash is million

are in a second late we've in in in cash our XX quarter structure. of reduction realized to drug resources September, call cash expenses the obtain And operating cash implemented XXXX. our we QX to in anticipated significant of and additional per our approximately These result optimize assuming to breakeven on half announced we runway. when continue fully to changes XX% As changes we deliveries product extend to flow XXXX, quarterly scale anticipate cost

the As XX Tom next we approximately in we with patients half scheduled for year. per previous confident and on feel guidance quarter noted, XXXX, already that have pace of cell XX we of collection in second deliveries remain

Based engaging forecast, and our cost-saving and week. which contracts reach we quarter expect continued into in next breakeven enable initiatives, our renegotiating cash Hercules We our will vote assumes to to wanted financing secure with key our fund and obtain existing we the on collaborative work successfully XXXX. I of additional proxy current are continued cash flow half of collaboratively year. to cash to as equivalents runway adequate first on a last the us operations provide bit engagement color Hercules, from of cash second

enable are with seen, favor meeting with As X shares you price additional authorized on Proposal our solicit compliance of approval we have to votes vote regain of to of split. flexibility the options. to and we relative our obtain necessary number the December step would us that basis X to Proposal a may X A bid financing in increase issue, a to minimum NASDAQ's until enable reverse to adjourned stock related

at votes to with it that, every Proposal our and If I pleased the investor@bluebirdbio.com. With We in to like favor we've stockholder questions us encourage any shareholders discuss received X. this please or vote e-mail are back so to further, of would have turn want it far of will Andrew. very about to

Andrew Obenshain

Thanks, James.

as investor now in sources our are Operator? our validated to of continuing lives. our half obtain and therapy questions. year like for period then gene highlighted capital we execute changing it As we breakeven to to a across that, on tens patients' accelerated we next work the first update forward as growth, the hundreds second look move open and of we platform. additional we cash towards to have flow today, visibility With to we'd up on community launches of commercial in of progress We

Operator

line Jack question from Allen First Baird. Instructions] with the coming [Operator of

Jack Allen

Congrats around there's see step It kind made administration third the from in follow-up the to still cell seeing is quarter. dynamics And I regard? are the to as after to to it one of wanted the incremental XXX% on the to pull-through quarter. on down have the the you dropout administration progress seeing as quick you announced compared like quarter. you second in them manufacturing relates that And any well. deliver the to a are ask, my as over of first centers? then cells? of I Do revenues cells I Or you seems in an treatment guess team revenues what

Andrew Obenshain

it to hand question. Thanks going to for to the I'm Tom respond.

Thomas Klima

we patient deliver still cells pull-through see XXX% to treated. we a Yes, once being

I the variability, patient think, just in terms scheduling. deliver And product the the QTC, final there's drug it's know, to in then QTC. of you once As we

And pull-through. back. so control a little deliver seen XXX% deliver once out it's it our But once we back, of it bit we've we

Jack Allen

scheduling, relates guess And slots Are success any is it dive those just XXXX into as rate? to XXX% little maybe I also then you scheduling And slots? of XX color the seeing I'll a Great. you're far more. in out on how bit then manufacturing follow-up XXXX my

Andrew Obenshain

Yes.

Let one and the hand then me I'll the second one, first Tom. take to

collect process, -- starts a see a to XXX% patients we part of right? no, patient the the sometimes manufacturing do patient. is recollections is eventual for we and And nearly to do normal of those natural -- than more That once we part process, not So a an That failure. are delivery. a go the process. on a have once So of

Tom, ahead. go Now

Thomas Klima

Yes.

when we X being in in although really scheduled variability of not out scheduled Just terms and Andrew we patients But but have the variability are to there's scheduled, part over we're is and in X cases, pleased the patients process, XX that we're mentioned, patients being just drop don't we that. to because recollections seeing scheduling out many of -- some patients months XXXX. see do reiterate, there's of as

Operator

coming from with Gena the of line question next our Wang And Barclays.

Huidong Wang

Maybe X.

first already is Hercules, collection, could then have cycle are quarter strategy could LYFGENIA cycle do in the cell X in Regarding addition patients And quarter for cash the 'XX cumulative, quarter XXXX, mainly the patients the for to gap, complete collection scheduled then regarding you these quickly, XX you what cash this What XX the X cell patients? -- And the cash in gap? cover average quarter? gap. be second that these the

Andrew Obenshain

Gena, for question. the thanks

about little kind being of of scheduled questions talk the of how to out it -- the number So I'll for to the about the cycles Tom James hand question the to answer a next question I'll are then go order. we'll year patients for LYFGENIA. I'll about take take those bit out and cash.

cycles The in either X LYFGENIA, we of so patients number end maybe, XX% is on got cycles. in you about in yet. But small, quarter. the comment done that the whether really scheduled being that the clinical of of commercial can't I on patients could for similar X relatively trials We terms anticipate setting. In for said first about results or those Tom, the comment still if are

Thomas Klima

QX, we're demand are really really and sustained excited Gena, commenting exist. of for as not vast between just the we're QX marker patients to that XX on the an we're those demand but exciting next of we're continues the with and well. breakdown pleased in Yes. majority ZYNTEGLO, scheduled although And really seeing, some into that LYFGENIA that year. already are The are

Andrew Obenshain

gap you if that. could cash to and James, then, comment plans on the And fill

Oliver Sterling

asked Yes. you Gena, in particular. and Hercules about

for So on move to extend contracts but a initiatives specifics and the them. in forward. for through conversations, with is helping we're other key this, us great premature those key partner Hercules the a runway partnership renegotiating to with me include cost regular nature and be Hercules contact strategy has expand and in our been It'd those and of

Operator

our question America. Gerberry from of with coming the Bank line Jason next of And

Jason Gerberry

so are conversion new like feel I their On the the I -- you And scheduled assumption guess with had a scheduled far? the is your rate coming gets Or cells is start these just that do LYFGENIA a and broadly dispersed that what's starts starts that wondering few centers? pretty occurring question was other for new start new the of the being concentrated just centers internal specifically, in disclosure, collected? amongst patient on activity where actually the

Andrew Obenshain

Tom. Go ahead,

Thomas Klima

so a Jason, to in don't scheduled about patient very to start, it's high. a essentially excited terms But converting want too ends. we obviously, of virtually -- get and it's being back small XXX% far, just on but XXX% the have they, The variable reschedule converting a of are some to event, an cases, In start. only because of the time is schedule. the come they It's time.

is gene therapy. to So the the and for pleased excitement high, conversion rate we're see

question. me -- As part the second and remind far of as the

Jason Gerberry

LYFGENIA. We see broad-based

Thomas Klima

Yes.

one we have therapies, XX I it's I of our XX think the looking have XX have approximately part which patient. QTCs their pretty said to exciting QTCs, about out. and So But well because most over QTCs exciting for spread of we are that first that think start initiated we is is

So nice I of think a growth it's ahead. indicator

Operator

from question with the Leerink Partners. line Mani next coming our Foroohar And of

Christopher James Yeh

than CJ this? so, This like expect you previously process? for when testing was time Mine just out to you from Have accelerate a Mani. do on is expected. to figured cell completion regarding -- fully month manufacturing shared collection If is longer that taking realize how to of this you

Andrew Obenshain

the not reported Thanks that's question. before. actually I'm that sure for we've that

we XX, time There's seeing days around LYFGENIA. for that. days pretty are There's XX some a XXX if say to XX variability we have bell We consistent curve -- ZYNTEGLO, for lines.

So pleased less But faster. slightly in timeliness. point we general, of very quality actually that manufacturing that within we that delivered for actually than first that frame with been -- time and out I'll LYFGENIA, slower, LYFGENIA. deliver, are that patient the that some the our we've are some for

pleased very our we're general, in manufacturing. with So

Christopher James Yeh

degree I that starts drug patient per is quickly second another If to what year? next ramp one, and add that could half by achieve ability your manufacturing limiting XX to you're capacity like to at aiming of quarter your delivery

Andrew Obenshain

Tom?

Thomas Klima

Yes.

drug been about product we've to support quarter our and the flow and we've adequate that XX getting cash about. current breakeven been to per us is to talking So the projections capacity deliveries to able get talking ultimately that

projections. on working sickle But capacity have LYFGENIA. we to will capacity now, the that grow and belief capacity for our disease. based our hit would for demand are cell in We we that expanding manufacturing continue on We our LYFGENIA announced adequate and to double XXXX, right that's

Operator

question Salveen And the with line from coming our Goldman Sachs. of next Richter

Unknown Analyst

Can This going the ramp scaling by second quarters? you the in what how off just of is your few evolve one. last Lydia to deliveries product on expect to guess over confidence quarter XX that for Salveen. the drives I next you half speak and to and XXXX this per

Andrew Obenshain

Go ahead, Tom.

Thomas Klima

at when strong we is the year slowing things. couple SKYSONA, always and for to for Lonza really see It's this not strong growth we demand sure. and there continue ZYNTEGLO continue expand at Number for would of capacity Yes, ramp look and we steady a manufacturing ZYNTEGLO. one, and the demand continue it our and said XXXX. did capacity LYFGENIA, ramp see We two, year second down. to that for Number you the in half into of our

and to look you which demand more next looking that our QTCs, market. see of of signals we patients for the at QTC XX nothing We than already network the in first are at over are of As year as start XX strong the patient. their but scheduled XX look

in cell disease. people of we're need unmet So there's with with growth. living more importantly, our lot But a pleased sickle

Operator

with question Fitzgerald. And of the line Schmidt next coming Eric Cantor from our

Eric Schmidt

James you that issued shares the how vote to against at how shareholder for? you're currently asking many be Can many on last shares to stage. you additional the and One speak went are for authorized

Andrew Obenshain

Go ahead, James.

Oliver Sterling

XXX about to about issue authorized shares million shares under So to authority. sorry, -- current available now right XX issue million

Eric Schmidt

the And many. how for request

Andrew Obenshain

increasing of shares don't stock the of I the front in number came request the the of reverse relative effect basis. the me. which has split, a on authorized of in form a So number have

Oliver Sterling

depend and XX. in shrinks -- of how stock be XXX shrink that the will authorized what depends split therefore, million It number so the do the range what remaining be That's or on depend on million Board XX and going will down, to that Board will to to just issuable -- a outstanding how XX -- down. XXX The stock it will chooses. on

Andrew Obenshain

Okay. XX million will be fixed.

Eric Schmidt

quick one one then maybe Tom. And for

the terms process, In way speak total the dropouts patients all lost scheduling through? time can how you've the collection along of many from of to you

Thomas Klima

Yes.

Eric. question, good a it's So

schedule. seeing rate. part, we're actually we're any seeing they if So for comes ultimately patient the What on end schedule most reason, for the off up, a higher-than-anticipated back is the a pull-through

high of give who an hurricane. impacted patients lived rate. some was And We have area came seeing year examples. for So reasons. schedule Actually, dropout them were hurricane by we're a XX off I'll this X They in related. did the not different that a you

the they far, come schedule. so schedule. off But came So patients of all have on the those back

again, So ends. it's small

that So we're it's pull-through the early rate give pleased we're with out to but those predictors, really seeing.

Andrew Obenshain

versus from collected, can actually essentially have XXX%. the be occasionally SKYSONA do that for process patient if for need a on delivery, a The recollection, we collection that comment -- -- product to only. patient is give where gets accelerate is exception I to free that -- a that not the then we and might and once would sick for SKYSONA we And for

converting that would example the a be of And so to only not patient revenue.

Operator

the And from with our of line Capital. coming Luca next question Issi RBC

Lisa Walter

on is Luca. This Lisa for

Just the remain margins. one goods the to in. higher revenue gross cost continue than of The coming on

you high if or which what the So pull reduce expense Is can the assays? to And help goods? understand is here? this production us release lentivirus the the of can driving levers wondering component cost you

Thomas Klima

associated the So it's for part, our associated and work. fixed FTEs are with they the high manufacturing with manufacturing with the costs providers contract leases and most

result quarters of seeing on 'XX you're change now, costs to as that margins expect do going these in including so negative high gross relatively a We in And of meaningfully the at low profit. volumes increase commercialization. and positive moment the volumes the as early

costs So well, most the manufacturing there associated testing. is, like of and vector manufacturing the as with of high course,

Lisa Walter

of treated believe with LYFGENIA getting slightly I versus a more then come LYFGENIA, cell a if could it Is protocol just manufacturing uses -- ZYNTEGLO. follow-up. are I If different cost the down? patients goods sickle And recall, there

be color any helpful. here So would

Thomas Klima

correct. that's Yes,

is with cost LYFGENIA ZYNTEGLO. than lower vector suspension Our

an ZYNTEGLO So be there there, to we is to adopt able savings as over we advantage expect to and that. switch those

Operator

the with of Corwin William Blair. question next And our Sami coming line from

Samantha Corwin

you due last So until their year, to after infusions saw in holidays. in the a QX revenue some patients dip delaying

infusion the have have access and might guess then change you the million out QX? negotiations cell gene is much of So curious And $XX of you to I therapy how gives confidence you being into timing second if year? how question a any already you states in was sight And rolled access and that that revenue I hitting expect what kind with CMS' line of in and to model next in place? supersede

Andrew Obenshain

Go ahead, Tom.

Thomas Klima

obviously, that Yes, infusions gives very sure. closely with getting that in that Yes, number to we're QX, projecting. along of infusions tracking scheduled us in the the already have right now. the million happened the $XX confidence are we're That

Andrew Obenshain

Sami, of us? can then repeat And was, you question your the part second that for

Samantha Corwin

Yes. might cell gene therapy How change negotiations expect out to being CMS' access and access that next supersede model states you the place? with and in already have you and rolled if any year to revenue

Andrew Obenshain

Yes.

are program. to is early -- a mean would hear said CMS That are sometime expect are about We would we having where well. with have it December on with with we we -- program the the I in of provide where -- that. them So before, We, would conversations national CMMI been they collaborating could access direct that have already a and access. course, as states framework states we

So the would accelerator, other. it more anything call is an than one it, I replacing

Operator

this Andrew back Mr. closing for the And over remarks. I call further turn now time. I'm to Obenshain questions at no will showing any

Andrew Obenshain

call next joining look everyone, much, for thank we quarter today, the So forward first and in updating very you year. to the you

Operator

your you Ladies conference Thank for gentlemen, our today. and may that disconnect. does you now conclude for participation, and

bluebird bio (BLUE) 14 Nov 242024 Q3 Earnings call transcript