Acceleron Pharma (XLRN) 11 May 202020 Q1 Earnings call transcript

Good afternoon, ladies and gentlemen and welcome to the Acceleron, First Quarter 2020 Earnings Conference Call. At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time.

As a reminder, this conference call is being recorded.

I would now like to hand the call over to Mr. President, and Vice Acceleron. Relations Senior James, Corporate Investor Affairs at Todd go Please ahead.

everyone quarter website addition our The and page available to Thanks welcome & Investors first for webcast reporting Media financial on the presentation our press our XXXX www.acceleronpharma.com. results, the in corporate to of today’s are at release call. earnings

& Financial me Development; Head Officer; Kevin Executive on our Dable, Chief our Chief our the Joining Kango, Backstrom, our Sujay call Officer; Chief Commercial Habib of Jay this Research afternoon are Dr. McLaughlin, Officer.

outlook. forward-looking As a be will reminder, we statements making regarding our financial

In commercialization on actual of file our can be these and activities, addition XX-K those to product most to to that these risks recent uncertainties regulatory, from development description results plans and risks A in subject and are and with found materially research XX-Q cause SEC. Form may the differ statements forecasted.

turn our over that, like call to I the Dable, to Habib now would With CEO.

afternoon you everyone Thank you, and us Todd. for today. thank Good joining

Before address us. the we that a moment of pandemic all wanted to I is affecting get COVID-XX take to started,

hearts you our to keep foremost, who the us on who safe. workers to we and out impacted. selflessness And and First to has been healthcare frontline, the are for other everyone your thank directly go all help

and we stakeholder policy As we work-from-home serve. that patients been engagement. the March, and moving implemented continues employees to a and the have to support In situation transitioned evolve, quickly our virtual, to protect we successfully early external

measures the into are of risk ensure coming continue who our support the essential and while activities minimize related advance still facility. as and laboratory appropriate responsible critical, of business, employees limited manufacturing safety We a taking the number to business to

to to tell minimal will impactful operation. experience have Although effect fortunate been ultimately be, it's pandemic our on at and present we business too this early how

part the and due in foresight, team. flexibility This entire the to Acceleron large commitment is a of

carefully situation monitor and from we and weeks local will and the the continue federal months coming health follow Over to authorities. guidance

we failing FDA day-to-day some regulatory known approved make adjustments our indication, units an the red sideroblasts neoplasm or eight adult Despite second progress two patients weeks strong to of front. requiring ring its environment, the and very myelodysplastic/myeloproliferative month or and operations by on for risk with About ago, the anemia more one stimulating REBLOZYL, ring blood erythropoiesis myelodysplastic agent also with the continue luspatercept as to thrombocytosis. current necessitated over treatment with clinical sideroblasts low-to intermediate cell syndrome with in

long treat now for and red the who patients thousands and adult treatment time our REBLOZYL who option maturation beta-thalassemia, new waiting our patients transfusions, require proud discovered Squibb. to approved now in a huge erythroid as a imagine, important, had mark over are they team Bristol-Myers of with until with been and for for and their Acceleron Celgene approvals a More first can becoming you moment partnership decade victories anemia. beta-thalassemia, ago and approved the for MDS these was of November only anemia agent. in just with regular first blood REBLOZYL cell the

beta-thalassemia. Outside its recommending for in on opinion of patients transfusion-dependent approval positive for and for the treatment of Agency U.S., anemia Human lower issued a Medicines Committee Products with of the European REBLOZYL MDS Medicinal risk the the recently Use adult

this for application the the half We the EMAs expect REBLOZYL on year. of in decision second marketing authorization

Medicine. peer Phase the this first These Acceleron’s on BELIEVE New that recognize In team achievement. were like joint from England reviewed trials the were continued X publications in first quarter, Journal both Squibb Bristol pivotal results development Acceleron prestigious in published and MEDALIST I'd Myers the to the and journal. their of

and Myers our commercial Moving Squibb, of centers our throughout Bristol work excellence at healthcare partner is providers hard launch, alongside U.S. the top team field REBLOZYL targeting to the

first of million sales for $X.X net $X in The commercial revenue the REBLOZYL million royalty months been of and approximately XXXX. have approximately recognized sales We first encouraging. five quarter of

Importantly, centers indication certain country, challenges the we to the virtual of has to the and including to-date. field and monitor, patients to ability with that launch and mid-March. the we continued public MDS orders model environment manage our are across introduce team’s recent physician repeat appointment which transition for The new health medical as potential the regular continue a caregivers and experiencing current sales does

thousands term from of of for we stage believe vision As we by possible novel diseases. it’s patients platform hematologic become long erythroid a late for REBLOZYL, caused could suffering anemia it to look our mechanism variety of maturation treatment toward enable a

cell in that preparing for conducting myelofibrosis transfusions. for with independent a trial This trials two the BMS of will end, luspatercept and are who pivotal are the called presently Phase additional red To anemia evaluate require third, blood X partnership in inhibitor a trial. with and we JAK-X patients treatment on

steady Between additional risk we of topline we our of vision support treatment BEYOND also a the in as study beta-thalassemia disease of and non-transfusion the in areas MDS to XXXX, true the line platform anemia. flow now frontline from end continue lower the anticipate study for in for and and dependent luspatercept a results COMMANDS evaluate

paradigm progress results priority, positive pulmonary X the top thrilled absolutely topline equally in Arterial ability available on are In currently While Pulmonary with this or luspatercept’s potentially disease in REBLOZYL of excited PAH. we're treatment the Phase in devastating to making We believe PULSAR these disease. therapies. top Hypertension the remains for we're a demonstrate reshape January patients announce to trial data we by

with Designation to FDA an discovered therapeutic candidate Designation for first allow following a pivotal review and and X and Therapy interactions medicine period, Breakthrough Acceleron access in designations trial the results. granted division expedited These PAH. Phase the application application more for up regular was with luspatercept Medicines Priority members, EMA, recently and additional along filing by the Most agencies by senior

X by of plan this early the Global the in trial of middle year the finalize work We half. pivotal to Authorities end second in to a initiate as forward Health currently our year X engaging with Phase look or Phase X discussions we We globally end of this expect development XXXX. Phase at the to

Following due now American host is presentation session in-person to is June. sessions the detailed top-line expected before planning COVID-XX from Thoracic The the now International Society including the certain the cancellation results Conference to Phase to trial of web-based XXXX the virtually. pandemic, end of place of take X PULSAR ATS

and the to it call. separate to will you for that more will We available. investors session. as the information presentation many soon and a We of as timing webcast provide hope how following will becomes Acceleron host the analysts on access join be able presentation

will Kevin CFO Kevin. McLaughlin, that, review the our financials. with And

for first Good release like opportunity afternoon quarter this issued Habib. I and briefly take today summary our a to XXXX the Thanks for refer everyone. to review few would our of earlier to financial results items. press a

the million $X.X earlier, with Revenue includes cash, $XXX.X has share and Habib revenue $X.X $XX.X for loss of million XXXX We quarter royalty U.S. ended Myers was partnership ended quarter revenue $X net with March XXXX equivalents of the cash derived was the million. quarter million, first the company's from The approximately which was of mentioned sales and Bristol in first million. All net for investments. first of from approximately $X.X REBLOZYL million Squibb. approximately revenue XX, company's of cost

that, Operator? call with And like I'd questions. to open to the

from Suisse. Credit comes first Our a question Auster of line Martin Instructions] from [Operator

line now Your is open.

for progress on Marty. thanks is question. everyone. Mark Congratulations Hi This the for my on and taking

you. dosing Thank My there flexibility data-collection impact any patient protocol. COVID-XX into is so, SPECTRA on there for question if was, built has the and been to and due much how

to Mark, hey our for Jay Backstrom thanks Yeah, Maybe to your pass I'll that question. address. over of R&D Head

Yes hi.

we've very So carefully with patient been the to allow to have the sites them to to access continue dosing. working really

the the guidance EMA have You of FDA know pandemic. context both and issued in

under very that. much top on GCP management a we’re For and compliant of

Fortunate denied a to to say, been patients having treatment. without really medicine our risk access so-far being of able still have

So so-far been fine. dosing the has

my taking for Thanks perfect! Okay, question.

Mark. thanks Yeah,

you. Thank

comes Our next line of from Yaron question Werber Cowen. from a

Your open. line is now

growth. Yeah, hi number and team strong such see to revenue on great a

unable it inventory of for NF So in MDS the have pull-in do sort an launch. kind sales much how you demand know any do do such and into of And to anemia potentially sense, more was broadly. at sort adoption have with, or my how much any any were have traditional versus of questions there of stage of early [ph] you is you sense early

on Yeah, the with thanks tell Acceleron end for ultimately you things, you the of pleased can we we are – question sale. here and Yaron very I very, first are quarter

patients Just cell represented alone. everyone, that first in for the regular transfusions to beta-thalassemia requiring quarter red blood adult U.S. our remind indication sales in first

Commercial and Officer And second I’ll our that the over add quarter building color. in I’ll to some start Sujay, Chief to forward are pass being it just again, and so it very looking now off the approved with we MDS much to upon

drop of typical here But pass a more the not add build-up bit terms and a shipment method your part so not I‘ll it question. just lot, is of little to Sujay a everyone, of in over of remind on a terms But to deliveries lot really to the in first Yaron inventory color.

question. Yaron, Habib and Thanks that thanks for

said the and order we’ve to and the So ship so a we created the as it right, wholesalers directly the account. to connected Habib BMS is distribution way is model

then of hours traditional occur so if this, product, Plus, they the doesn’t product the wholesalers goes Medicare model likely this within the in you XX out a it that account. where situation more the buy-and-build and in inventory is recognize B and the Part send to hold

have physician's They send through, So to as they office a it XX they we hospital at doctor's a are hospital. any local the patient as and the or build-up orders the of within don’t of anticipate or shipped usually order inventory the office hours in vials whole amount soon the mind, level. a

of treatment build-up two that directly speaking, starting or they so, a almost so are a of within patient be this okay. inventory, wouldn’t normally there on most So is related day to a or

for Yaron. lot that a thanks question So

certainly little know that a follow-up people the issues COVID-XX hearing sword. quick is is a bit edged product of and blood start a that a there's a is also product, been have just of sort on thinners. And some double environment environment supply but This on, we've detailing this a launching to you about new tough known in

can So can tell what – us me Thank hearing what you. you tell you you're so far? feedback

continue. can You

Sure, perfect.

a pointing you're opportunity to. as question whereby Yaron, an raised is So there out you

have donor a So purposes and we’ve going is you of heard has challenge in many supply bit. a the because donors know come supply a from down blood challenge, the the

REBLOZYL out, because So transfusion independence MDS. opportunity with that, pointed an right with patients there the you offer for do regards with is to we as

opportunity, an because line the that's So it provide. benefits do with that you in squarely

patients has that come flip based patients equation, on new down, assessments we the for the there are our side centers, of the also that actual right. On into or going do know hematology

very are it’s So encouraged. of we a it, are early the launch good while very balancing aspect metrics and

wait to we through see well have of are as the effect of with net, to detailing, virtual as early we've because the we overall outlined what already have also launch, a execute are do started period but We is the net encouraged and this, that. start over speaker those doing Including programs, and we time, product those. very of

to more we So as the come second this. monitor in quarter

Okay.

And to is to remember, this had benefit Sujay’s community this is publication complement the the need just and you Habib the Yaron, Journal of from – saying, New with England Medicine. opportunity been in to whose

mentioned as in of the and increased. to awareness significantly that we be accepted to earlier, As were thrilled levels so be I simply result able a publication

our opportunity new market again, for to wonderful over this the anything been been new, for out in in share there opportunity messages space And price. this to get a waiting that's therefore to something provide increase hasn’t a decade was a us to there and

Thank you.

the Porges of comes Our Geoffrey from line SVB from next question Leerink.

line Your open. now is

questions FDA the on a of what's trails, on follow-up your REBLOZYL. data? Thanks. highlighted obviously us give with do possibility just this you Sotatercept? pushed cash to you the about pivotal meeting that to thinking little ATSs wanted bit. Kevin, the directly balance assuming expect firing And a with reserves lastly just latest your I sufficient your requires latest that of, the back some you cash a What's Can is sense Hi, presentation timing and is

this Geoff, questions. Habib. hey for So is Thanks your

conferences on is The moved right. it would other are and ATS unfortunately a Regarding you that has happening been a format. canceled like to actually virtual and ATS, conference what question all done been have many in few they has first days the live and

end of very We will leveraging for presentation a feel we be virtual that are confident them with our that currently the in and conference we before working June format.

from expect a So you view. can data point of that

you things. and with With know the other year had interactions health a and opportunity with respect we and is timeframe, to would maybe is to One, our to being QX FDA authorities our and question QX those you received have X on health be filing we’ve shortly the of to like. to authorities, with conversations able back you the get what a that, by of of various you health goal Phase in couple those but know authorities, after your what interactions look directly on regarding that timeframe the thinking on the terms able the QX, invites trial that with that we’ve middle this said based and share the

– significance if study Now remind concept on we on our secondaries. of as statistical and PULSAR to and simply that. ability the everybody, he’d as terms ask the in designed the with primary were directly, as your bit question like add has proof fact color just able that regarding we're I'd question, a thrilled of powered I’ll to to Jay hit the been to like study But on more endpoint to little finish well the and a file

a a our an same for us which hemodynamic functional But terms Vascular the of us its X everyone we that know Resistance some the very be I secondary to and example. was important as think designing able is endpoint, that important all do for at of registrational having in at to endpoint want but be as identify about the studies key time equally walk for Pulmonary such endpoints benefits primary same to important that remind minute sort we would a distance,

conversations the the this regarding data. to chatter and heard ability the on I've file So

would if you precedence that think the past I be at case. not look

we I I level we Breakthrough our having of designing with Phase forward tremendous for you in about soon as us designation, fourth benefit or when the senior that benefit we looking have of much the as registration in added we up as FDA. mean, X engaging well all from a think counsel Therapy we as to gives of if design to be bodies have very studies coming opportunity the and are quarter a in we’ll and frequent, time pivotal study can. with to as Designation that think third that, that early regulatory the regard. And lined that quarter, the perhaps with

will terms what our run our I'll Regarding in goal move dollar, think studies to presumptuous and would right own. have Phase feel I the terms independently for of studies and based on needs fund, the the needs raise conversations more and be you that we're have the the of to we on ability – is cash I able raise studies. our fund need about tell its right though, forward to to X to very to that money we global in funding now to to those – now can pivotal the confident requirements with going studies registrational

anything that Kevin, Jay, would that, anything you if like there's to I to add missed.

Jay. this Hi, is

track know, We're that planning execute our with we I X we’re come previously so planning with and agency stay with we and health clinical think you the well more to front. we to after the really Phase authority. really are said on to interactions certainly you summed and up prepared from the regulatory it process study, engage a time in on

and and question. Yes, for Geoff, Kevin this thanks the is

that, future with that looking million cash be. are think will about and and $XXX to Habib had first cash, forward as you but pleased said we the our always I are in know needs we quarter, the we what

focus standpoint program focus study continued a from development and You as market on as standpoint, forward first, obviously going from the in manufacturing research work know well us will a standpoint. preparation the certainly for sotatercept the department, be our from

it. I guys. appreciate answers the for much very Thanks Great!

for questions Thanks Geoff. your

you. Thank

Our Carter comes line from Gould the of from Barclays. next question

line Your now is open.

I my and the follow-on question. afternoon congrats approval. Good a MDS guess Great! on offer previous the I on just maybe

I got mean around being think least you when obviously be little a the the released, you I at Just just year, kind gating in to be detail. of any where additional into color for can there a terms but you to wait maybe additional to PAH study steps. think color there? other of terms we mention of of helpful kind just later bit sort sensitivities other Kevin little of more just this start steps, bit design stand more maybe in able you about gating give would can and go manufacturing,

maybe, then And I my question. guess reach

get a you. You seem about kind program we be single or Should could Phase single on greater to of of as X detail clinical gets program. disclosed characterizing study Thank the around study. the think a broader kind that when we pivotal

start last Carter. Yeah, I’ll thanks questions for off with your question. the

presumptuous, a across single case. the being that’s well came you as not or study If absolutely

We to etcetera, conversations how we’ve about say terms to had health I’ll the are at gaiting all that Jay hand strategies the thinking until that our of to and those in that of with But not thinking on this some over at ready proper authorities. point. elaborate we're

think thing I trial agreement Therapy the It affords PRIME I earlier, know really you Habib and really think that's get on is to and with we're the authorizes plan. and Yes, with and what actually effectively to designs, the the engage designation. us designation key engage Breakthrough said our opportunity fortunate

protocol lot can essentially in study of take You the advance Many I protocol, agreed development the is of by these full protocols health (we’re mentioned we on a even are earlier, steps behind up there know startup, authorities of ready really a that. getting working and that but plan).

forward, top run geared really trial whom of think know to program are enthusiastic go. the you we've multicenter we're fortunate results. I get obviously with about be We've all to given we a experts, been that going As the that the

something know beginning year. the starting even think that get of about by think the at we end timing had ready up was a and we as X significantly I the the leveraged you we're envisioned, to So Phase

mean I that. so-far to we’ve those aligning have is the and everything sharing much plans all interactions, us more looking of are obviously detail health feedback. authority it But would our health when So, to premature authority forward against prior We’ll be you. completed really frankly with

you. Thank

Morgan. from from Our question of Joseph comes JP next Eric a line

Your now line is open.

Hi, good the afternoon questions. Thanks guys. for taking

beta-thalassemia. Just a couple of REBLOZYL and

The in first reimbursement as that coverage you of about the just whether weakening split any in a remind anticipate could segment, split a result potentially change if a here. that, mix in us is, that in you economy in

could on of you current date sort What provide just label. how adult I’m update look in study pediatric commercial the And the about like relative the and the Thanks. in to wondering update positive generally X then segment, if us an trial. in Phase an with enrolment think dependent incremental secondly, would should transfusion - we pediatric that opportunity

Okay, thanks questions for your yeah Eric.

indications. So for Jay on them I’ll and he it Sujay regarding where maybe a can pass access split, bit talk are we the ask the pediatric the and question with first to to address little about

the Eric Thanks Sujay. questions, for I’m

as on the these in are So largely side equation. beta-thalassemia the commercial these you group be age young segment give pay patients adjusts, going of the of are to asked, of the most

So a that’s be on going Medicaid patients equation. so We've and be for so be are we or believe we the government how about so anticipated of combination XX% XX% would side of the under of about the business commercial, Medicare, could to that’s see be etcetera, going beta-thalassemia or covered that we to the pay, always setting out.

over a I to right, more you as patients over one relation put you put X,XXX there patients and going XX% proportion you XX,XXX-odd versus opportunity MDS a but to approximately could MDS side on of if be larger the side Medicare equation, X,XXX covered lot of XX% in the be Eric, of beta-thalassemia is speaking, it's mostly under to the into the the context pay. color know is with MDS, larger know, a the Medicare opposite versus are business if just to commercial Largely on going magnitude it difference, of just there,

the Medicare business you the answers to Jay, And going ratios pay. gives And into it cover that if the a are the as MDS want to it's pay question. side the comes commercial line, pediatric you net-net side you over of question? context the hopefully significantly that a So to switch worse of

Yeah – designs, certainly, been is earlier And go a pediatric, group. and are an to typical those plan those earlier an cohort approved, know to we for then it's that’s and age down referred you so in as you are often Europe. designs, age you group running PIP pick the of those pediatric and as

its now be days plan to are program, for So early where pediatric we thinking that with days. the about early very

the is we three good of Talk] majority in it’s pediatric opportunity estimate to developed the yeah. so terms At to got beta-thalassemia in four of [Cross or in adults terms population, adult. that one data, the where the the we And Eric, least in countries about

great. it, the it, Thanks guys. got alright Got questions taking for

Yeah, thanks Eric.

Thank you.

comes from of your Citi question from now is next line Nochomovitz Our open. the line Yigal

is very This Thanks Samantha questions. our taking on Hi! Yigal. for much for

two get ATS a get timeframe. in lead when Just the is that to to to going going it are as much on announce the know presentation to happening weeks morning the to time be press are prior release you going within ATS we is that presentation, to how that to one Is – presentation advance coming. going in is or

you to Thanks Affairs going pass address question Corporate that, of if for Head Todd. Samantha. your it over would Todd, to to I’m

question. of so of when it the few control to some weeks at the Yes, our in they thanks out their some up to Hi the in Samantha! schedule outline your actual lead open for time advance expect are ATS would But be a give we bit little hands for a session. session Yes, schedules. going people, to of to the least

their schedules, the would time in could event. the virtual the to to in-person clear able then canceling of you As to be like this event, be stakeholders congress their imagine, to participate give able to up enough with

can time Thanks. you decent expect amount of a So advance. in

background if presentation background break therapies by can then, of patients of a And from. position the will the the you. number ask thank out have the Okay, to you here say we therapies, data know

patients but what on including that PULSAR we pre-treated is presentation vasodilatory were heavily the where that, is for recruited So that the a we're have this of XX% prostacyclin. said to triplet study wait into over we’ll with the actually population, already very effect to therapy,

then just got stage especially another see expecting I for luspatercept. now appears indications you pipeline open where start one indication maybe that Phase X there development guess any to next of could it. And more and that pretty Are additional you Okay, are your developing. start development, this

curious Just have on any you thoughts there.

question. that's a good so Yeah, really

So though this obviously right the asset space that there’ll volunteer I at you have is that be we're Morgan and the where another group We as now evolves. on to the would we continue More the like on that story, do earlier an announced pulmonary we in as focus that can come hypertension. our we JP pulmonary sotatercept evolve else It’s it. ACE-XXXX. to PAH to that Obviously investigating. year. one study, remind more to come on conference program healthy take

You’ll we're can see about it. in more XXXX expect program and taking where you that hear to

of year again about in small and good and development and we have new modulating opportunities the with up just Fulcrum engaged to the their in collaboration last the feeling molecule company approach our end space. that Therapeutics we've Cambridge, locked we and leveraging pipeline finally, we’re a really at pulmonary So pulmonary gene them expression, with

feeling and our prospects development. good in the we're So about very actually pipeline pulmonary

taking the very much question. Thanks for Great!

thank Yeah, you.

you. Thank

Leland of line the from comes question next Oppenheimer. from Gershell Our

Your open. line now is

on congrats products. Hey, afternoon, have questions thanks. already been and my the answered, asked again, great you good but Actually and thank

Yeah, Leland. thanks

you. Thank

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

now Your line open. is

any and and now that any have rates. feedback quarter coming of the perhaps the a progress you on guess question. modifies for that adoption views have in quarters sale I the taking MDS trajectory are will of hearing some updates constitual you views Thanks to in MDS. Do weeks your early full on you your over Thanks. how sales

Yeah Jeff, for your thanks question.

regular the So, happy beta transfusions. of in very we're It is approximately only claim million. cell repeat, first beta-thalassemia Again about. to quarter blood first U.S. only $X that of indication one the just terms for quarter that in and adult sales red very, is

second now which – then with tremendous CHMP the full positive moving now, States, saw gives we us having [ph] about we from are the approval and And continue quarter a of repeat year quarter launch in half you the in as getting the to in second of MDS feel all new the the with that our forward for given forward previously accounts, metrics. Europe, for optimistic for opinion, number had CJ accounts of that a enthusiasm proved the looking of very this prescribing as also, launch confidence well an anticipated United number

what this virtual continue We haven't to we’re the confidence and official gaining. continue I as in world, gain REBLOZYL any guidance, can that you tell traction is that to we launch we given more but more on

Thanks.

question. Thanks your for

Thank you.

next from Our question comes Sachs. Choi Paul from Goldman

Your open. now line is

but if you interactions whether maybe congratulations and all I just Hi, with has and was can our questions thanks your to the first for MDS. the of interested, but you increased know, you on the potential and comment was so know progress. wondering prior prescribers taking the discussions much when with your on you feedback label My MDS number now, come if you have to question not know beta-thal, you you commercial lines for interactions is regards know you you in along the doctors. know back of of specifically have since I’m know with some maybe me

directionally of if since activity that approval. was comment if I you the could just and seen have level your you on maybe you partner the could or just quantify wondering,

a to absolutely this your tell question has for is number different base. cases, you can interactions in over and Sujay. prescriber But Paul I because it increased, of the hand of will in I cases many Thanks the majority

hand to But it that. between will limited. MDS overlap the beta-thalassemia prescribers I add is So to to some and quite color prescribers Sujay over

Sure, Habib. thanks

as clearly base for is the out, our the MDS – indication. larger in pointed So lot customer a Habib

yes, seen So we interactions. more have

is this right orders. these of starting launched the – to right, all for that on indication pandemics virtual to and we MDS are almost because shelter-in-place caveat the occur Now interactions, top the COVID-XX

vertical. interactions that of all with kind a situation, almost are So our now of

how to – a So little promotion. with to our the sort particular that with prior comes difficult aspect bit maybe of in-person this contrast with challenge regards of of

vertical bat, right at we’ve interest of about starting that, engagements you to lot about several centers coming sort sort seen see the within speaker and to even also a of are we of more of the said got all of these is engagements. seen we it. that's ask there know how end virtual large around and which Having these uptake you adoption questions of that occurring, know programs. is these can so the off product we And colored are We've MDS, see in also also, want to that. on the quickly get day, from what them, we've I’ve you questions some been of

with the So had they been the is the doing are from our population, very interest these joint as respect well are that asking indication calls with that with my I’ve us interactions well. the reps early questions strong we label, have and BMS as reps, patient with have physicians as reps to which

favorable interest REBLOZYL. I So very see net-net engagement and a with

still part know longer in you can follow the the in just incorporating about or data and just for I That's – our very elaborate you terms additional you of for that. updates thanks helpful. very XXXX? Okay, could the you taking comment I squeeze your the potentially as presentation, how here question any down but place, you're just do much PULSAR is on, data maybe if of road then data And plan with over the is pending more yet Thank to questions. maybe of it, you, registrational term can up My strategy? thank on thinking one follow-up regard course

study and Yeah, label the question. over six endpoint, to get every And Sotatercept. yet just really the to randomized thanks for patient actually into that a an had one of on months everyone, additional an the high remind dose opportunity had month roll PULSAR primary one dose XX low a arm would to placebo study Paul. That’s good extension open and

was we the was again, being to open was And around every patient results when everybody just out patient XXXX. end eligible extension, at eligible December label January, extension. still line patients open remind that At share single there eligible roll the the of the in cut time into rollover to first PULSAR to who the top the over are once label of of of with XX the of XXX and cut-off, data

for So we alone reasons. comfort lot that statistic from a of take multiple

Paul, the updates, year be to view. continue terms answer this over and safety to in an come dataset you year there'll the point of course of analyze question efficacy yes next both sharing with do from to and and this your plan we And to of more the

you So for your thank questions.

you. Thank

Markets. comes Kennen from line question RBC Capital next Our from of the MacKay

open. now is line Your

thanks question. taking Hey, the for

tremendous see you to made targeting secondary Bristol reignited and Thank obviously endpoint X with ATS data yes pulmonary for Is – data. that meaningful as and test. Has the progress in secondarily is hypertension? interest Have PAH outside minute exciting. the most excited you You’ve additional that, this this you. out, in PAH really indications like obviously pulmonary Sotatercept carve the with a mentioned tremendously of idiopathic something walk

distance of walk was the minute like our X appropriate terms that just reason secondary X it The Kennen. key distance forward endpoints the in have conversations is the pivotal highlighted, endpoint is question our with moving walk obviously for your because for We is highlighted study, with it key thanks you're fact the was will our secondary. would being look regulators is Kennen. seeing so merely what but minute Yeah,

with point, the Sotatercept on develop and to hypertension. is remind thing Sotatercept, respect is That of Now versatility with indications this our able commercialize to and it our to and to one is within to that our respect is at pulmonary pulmonary intention with own. again pulmonary you be goal Sotatercept

obviously but Hypertension right that, the in is Group but pulmonary that grow own. disclose really would and One develop perhaps on to very, beyond and commercialize conversations appropriate now to occurred are we beyond those Anything focus time, Pulmonary hypertension at opportunity if we carve we Acceleron ever for the very fortunate out on to our Sotatercept for the opportunity able that, are

TGF-beta a actually to because only fibrosis, respect question also state, of this is you're asking mean not this good met perhaps really but particular because disease need. because obviously superfamily of the – idiopathic relationship the with high-end Now of in the pulmonary I

we ACE-XXXX. X. an not X TGF-beta one talked and did have Again, targets the and I of specifically designation fast and regarding mentioned analysts question ACE-XXXX track to has has that earlier part about assume earlier be from TGF-beta it – patients identified the unmet as indication the indication, an rare real going to fibrosis as factor being to but of it’s that within the pulmonary you can Now contributing disease, need.

area And solution be disease, could looking targeting lung other an that point, but that that very be so you within we’ll at scleroderma, make could that group, be excellent obviously is closely. interstitial very, idiopathic pulmonary there fibrosis, so

your for Kennen question thanks So

you. thank Well,

the At to Habib showing remarks. would you. Thank turn I'm back I no time Dable questions. call closing for further this over to like

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for everybody So thanks call today. joining the

our As never had you’ve fundamentals strong The very been heard, a stronger. of company quarter. we have

ahead out productive We year free for Thank and and are have wishing you you feel always and reach successful any a questions to safe if please as additional you. all evening I'm well great everybody. positioned a to for Todd

participating. this Ladies today's and concludes call. gentlemen, for conference Thanks

may now You disconnect.