Acceleron Pharma (XLRN) 8 Aug 202020 Q2 Earnings call transcript

Good afternoon, ladies and gentlemen, and welcome to the Acceleron Second Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to hand the call over to Ms. Jamie Bernard, Associate Director of Investor Relations at Acceleron. Please go ahead.

to quarter everyone, earnings welcome, and our XXXX second call. Thanks, continues everyone safe is hope to healthy I and remain times. during these The of our in results website at today’s on reporting the corporate Investors release the page for available webcast addition Media & www.acceleronpharma.com. presentation are press to Acceleron’s

Commercial Dable, Kango, of Chief Investor and me Dr. Financial Corporate Officer; Joining Habib Jay the our Research Officer; Senior Executive Backstrom, of this call Chief on Head and Relations. Officer; Sujay Development; Kevin Chief are our our President James, afternoon our McLaughlin, Todd our Vice and Affairs

forecasted. As risks to a will regulatory, and cause in found CEO. call actual on that, uncertainties from forward-looking turn like statements materially can of and and our making with addition and to most description I our the those development risks XX-K Dable, These statements plans that Form commercialization may regarding our reminder, SEC. we to to With product research Habib results XX-Q in now to file financial differ these subject outlook be A activities. would over be recent are the

Jamie. the communities Good us Months is extremely efforts. and contain emergency risked are their workers, have essential their the and collective care thank afternoon, you those of today. lives And services, an it front and the and the support protect in for continues for clear time. on COVID-XX our joining health lines the grateful pandemic, to to we spread virus. this of Thousands everyone, into that be you, challenging Thank immensely most notably

execution I and are on in highly time on we proud Overall, European Indeed, a adjustments, we experienced very had health our their also to throughout encouraging employees resilience strong commercial offices and regulatory Commission-approved by In work-from-home treatment extended eager in period. fortunate anemia have in operations. necessary is first known closely effects beta-thalassemia. the Acceleron-discovered new are our as am to the representing clinical, erythroid of do class business fronts. the into we policy an maturation the we this team’s Despite get and be Cambridge, have many the for medicine, authority by only to REBLOZYL, marked productive second and luspatercept our guidelines. for MDS lower-risk the minimal of to being, following quarter, While REBLOZYL are patients June, or agent transfusion-dependent part Europe, our these for our of with adult approved important patients. therapy back

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As responsibility North has Bristol-Myers promotional of Squibb a America. reminder, outside sole

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evaluating We anemia with our additional benefit disease erythroid are actively in maturation which from areas patients could agent. potentially also

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more the candidate this allow you in products the designation the meaningful programs division medicine, regular to the PULSAR or a and the the we therapeutic an is granted sotatercept agencies, presentation designations. for Phase step expedited and only is development by as regulatory facilitate Acceleron-discovered first Breaking interactions applications quarter, designations designation This second drug in period and but EMA. development a additional first now and Priority of during two recall, In top Not review senior these for application to line by As receive only ATS II may for with filing provided during detailed submission News Therapy PAH Medicines June, candidate sotatercept application accelerate a and to of following session Breakthrough the the at data marketing is was approval. for PRIME access XXXX FDA members a Virtual. the

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patients analyst plan known we investor STELLAR, host to trial outline to ahead, our III and will design with first be of in webinar PAH. what the an Phase Looking as in October

We call. STELLAR time, our hope this the able end would on of your we’ll details remain At will closer the initiate We McLaughlin, to to be join call track review be timing you will financials, trial to I and CFO, I us the provide to then registration hand questions. event. the on like at over take able this and to to to the the year. Kevin

XXXX shares the opportunity I cost release ended summary issued $XX.X and of of common results this and option for with the closed was quarter exercise public and in quarter the million take to refer July, press everyone. purchase a million, for Habib, earlier In afternoon, $X.X offering We includes of second additional cash, $XXX.X underwriters’ to quarter approximately cash Revenue second million. net which share Thanks, for revenue. $XXX.X our good for to million items. a like proceeds we would equivalents to investments. today few review the of follow-on including a to stock, financial second full the of our

open of million $XX.X REBLOZYL mentioned approval net second $XX.X Habib With revenue call milestone for the from of questions. Bristol-Myers of sales Operator? company’s in All from partnership revenue like royalty was was approximately recognition company’s of a the with for and I would the Squibb. approximately to quarter of that, Europe. net $XX REBLOZYL derived the the $XX As million million earlier, to regulatory-based U.S. loss The million.

comes Werber question first with Yaron Cowen. from Our Instructions] [Operator

is line now open. Your

upcoming as REBLOZYL. get this? that on to think may this morning quarters January more perhaps physician its work pent-up you going Gabe England article have possible it’s on a prior My the of into that awareness way launch. they normalized on some do in has And the Hey, the we kind to could the led to some Journal scenario? Yaron. is are this mentioned for through What for New and that call, that show high example, demand flattening do your to Bristol-Myers demand question thoughts launch, And the with

is And color. of bit Sujay, Maybe I’ll off. Commercial this Gabe, Habib. Thanks then Chief a your kick it our maybe little add add, Officer, Yes. for question. to

a and of couple of we awareness. years had you physician think session, for in a submissions, we picked fronts believe, I’ll benefited ago, high study session. the plenary on over opportunity where go of a of by, the they recall, six was which X,XXX people, the presented plenary ASH XX,XXX I over terms one. to back we I to might have attended number MEDALIST had in even And

benefit really ASH, main a the number best England the the New the if the from but to BELIEVE all Best cited, could New the a for. most publication really the for be place to communicated in we one opportunities also as our have offers journals us two And journal, of not where for is us Journal in various We the premier of opportunity study opportunities of then lead England both be us presented one, of to Journal, Congress. gave think of ask to the I after think a program the you Congress. MEDALIST And at opportunity you had which in forums and puts

I we from the going that Now of said, with amount think tremendous launch. awareness a benefited into

for the same has time, over first first in to something MDS think space, and patients patients. a in forget, specifically treat not is approved in decade this this time beta-thalassemia the these I at the time anemia for that the let’s been for

tremendous would there. I a amount pent-up that to be assume think wrong demand there’s So it out of don’t

are partners also same had thrilled team some of that, was patients as shortage, pivot, have into encouraged. a of of coronavirus, repeat is a persistent also be – shortage, time, the look it’s And getting at for came a looking heard. getting – being for been solution supply and continue the the a many challenges at So with this very and new challenges, when pivot some drug think pent-up – Bristol. allows which opportunities unique looking time, I’m terms of would our launching terms as able growth virtual to don’t launch, third same so in seeing and to think the account high There we we for demand. And consequence. is tragedy the any an some getting years I as a That some the like for and said, think same doses, I orders patient to I having of account, REBLOZYL to continue to in truly for that group clinics to like environment. our at treatment. – from second us play blood with it been combination novel awareness anticipated as many, this had unprecedented think the But but think well access at with now, that’s the with I And solutions role at the we unintended in with perhaps very, an I the a patients came we coming witnessing therapy well you

could you and awareness I guess the is to that the thrilled So what I tell with we’re uptake date.

know feedback I very, quarter too or can think you want conclusions Sujay, in are the color with only to we qualitative encouraged early But of one I you very time, add the terms of any so launch terms don’t demand. to long-term uptake tell in at draw to I same even date. far. the is any that any if

response. Habib, pretty you Thanks, it extensively. covered I No. for mean your

quarter is one seems that sort So can the the aspect of only good. very we first say

is, so all can right? of only And it’s the we give see color and code, going this have very environment. how out now the is into forward. moving that, coming I the caveat J quarter, do enthused, we to having a next COVID-XX plays we’re are that look permanent know said We And that

to our we outlook a components, trying positive all bring looks sort are hopefully, able like. in lot what way. that still we’re those of a balanced of momentum evaluate So of to and That’s

guys. you, Great. Thank

with next Our question Geoffrey comes Porges Leerink. SVB from

Your now line open. is

Charles you more REBLOZYL. MDS This will breakdown revenue indication. for data assume majority share questions, for and second, will Hi. you design Song your from the enrollment? the your III share is know And on Maybe the was for sotatercept. just given XXX-patient size which expectations Phase smaller than pivotal can patients faster? or come I other the MDS Geoff. one the our trials the somewhat trials, expected I two wondering, you trial, the Could do for beta-thal? I patient is the is – expect between insights enroll on What

Yes.

in So I easily can terms answer question of the the first breakdown. really

haven’t breakdown So think good a I your is terms of the but we any assumption indication, given in sales one. per

the significant know, also, As And after when the compared the to look population beta-thalassemia you uptake occurred the States, the fractional United the you MDS indication. population. uptake, the is approval at MDS of in

the MDS vast assumption your with one majority So this associated – is growth I the think is a majority the indication. that good of

over that of R&D. Jay to I’m Backstrom, going III, hand Phase to Head Regarding our

question. Good

the cetera, and will details lines, review we point. go at that of in through time et study fall the STELLAR the So

it’s I to fair think question. the Although answer

our take review get successful how the XXX-patient conference details that Therapy you we I’ll that do recruiting, had the designation, when and we trial, were I with ATS, the look to to looking considering quickly. If we’re forward all But at fall. recruiting believe a we at PULSAR attention those relatively Breakthrough in

Thank you very much.

Thanks your for Yes. question.

Thank you.

Auster Marty Crédit with from comes question next Our Suisse.

open. Your line is now

kind when might on any on curious the PULSAR question. update I ATS on Or later update Great, PULSAR OLE OLE, base you And kind can data of from for presented beyond provide data see? if where of my to sort incrementals and/or release? had what on of kind was thanks initial SPECTRA question a line taking then I also got we this top the the can just year. on and be of expect any sotatercept. we

for your Thanks Yes. Marty. question,

over in of if the I’ll first that second want leverage of as any of SPECTRA, respect half Jay well forward the on data both bring probably more question. exploratory presentations, data as well and that expect in terms color we’re response further on part the to study more it next going you in hand congresses with as So to But dissemination. to the as open-label extension year add your to you can incremental

Yes.

we right So have that’s what planned now.

is also points. but efficacy of that on So continuing can a of made and previous the in, in next conference to is SPECTRA beauty just context, following imagine extension. you comment safety, and first this year, not extension call, end open-label would I a on for half interested the be this presenting the open-label which both we’re to important follow I mean a we in And

continue we to improvement. functional look So class at

you We over. crossed also, placebo know, have as that patients

data some crossover are there So in also interesting the data.

we’re next opportunity first update. forward Again, it that the be to year. in So do a to give an should nice of looking half

Thanks for the update.

Thank you, Marty.

Gould comes Carter question Barclays. next from Our with

Your line open. now is

for the maybe for on Good afternoon, congrats guys. question the I launch. start Thanks to and Jay. taking guess

delay a objective And you’ve STELLAR? might make the PULSAR in four sure that sort diseases. like then concomitantly just related no as of on wondering you’re sort seen we to something some additional II study? COVID, across patients Just strength based done or of how data far, aggressive just so in that chronic Phase sort something is to view here, on or work either group clear I’m the alongside of to there rolling Is out bone be the that’s be disease should SPECTRA, that the enrolled just of going of longer-term

Yes.

that. SPECTRA. question the – take I’ll affected a I’d with respect that mentioned yes, the enrollment did our trial before, by first to second bit So was

next to year. that looking beyond to an we’re we’re looking enough again other forward thrilled we’re going forward on move of able at areas have a really respect frankly in that PAH, And that then the to track, at with back so year. call ATS time now. first We interest. definitely to hypertension, We with – But complete necessarily data for to couldn’t and that look so that’s sharing we pulmonary mentioned this hence, we actually actively half So share program. evaluating within

to So interest we area but we’ll have have in. an on come that, certainly it’s more

Thanks, guys.

Thanks, Carter.

you. Thank

with question comes Chris from Raymond next Our Sandler. Piper

is line open. now Your

taking thanks Hey, for question. the

maybe think. So, two, just I

middle remember at of on with to think track end-of-Phase you year. were you around I guys I meetings said the the conclude two the ATS, FDA

if curious those any minutes maybe directionally on FDA And you that’s maybe and to just aligned color before just So comment if discussions. then in if been with waiting you’re the if maybe giving are concluded and could respect Phase III. EMA on

you, Yes. to those. Thanks of for I’ll Chris. maybe both I guess that over Jay, your questions, for hand

Yes.

So we track very health we’re much very to as our with plan on They’ve and productive. interaction. be been hoped authority

really broad in taking all a across take you tend quite it’s really plan. the be that guidance to from points and received good, our and program that both both we’re at if So look end this fairly of regulatory alignment, the to respect With space, applying to and consistent been regions. agencies we’ve trials

we believe So STELLAR, as meet to the should Europe. in be able run U.S. we it that do and both needs

your have can correct? been discussions And Okay. so just two you end-of-Phase confirm, concluded,

It’s have dialogue. we that’s Therapy basically the and beauty PRIME, Breakthrough of those because Well, designations. ongoing

frankly, to exactly PULSAR start to been hoped that’s needed results in were we planning but here to put We’ve be. able is why do to at of the since So actually, because what do we’ve be authorities. today out, this prepared it it’s trial, the to to out III, initiate good had juncture which we been Phase our engage kind health this where we to

we’ll STELLAR plans, the we’re share finalizing those October. the all kind program of in of So and details really

meetings those – that productive. again, quite been So have really those –

you. Thank

you. Thank

Nochomovitz with Our Citigroup. Yigal next from question comes

is open. line Your now

Thank taking Hi, Habib team. for the and you questions.

design? could a STELLAR, there there design? regard if the the there trial trial that I why waiting need items a nailed about will comments the specific points? been mean there. with inform reason to far trial you still as that regulatory can end down And with XXX-patient with be to this to Are point you’re expand October agencies bit functional at any that a terms in high-level as to Just be the confirm changes on you the has markets is Or until of guidance? it

your for Yigal. Jay, Thanks you guess, I Okay. as question, well. for that’s

Yes, Certainly. still Yes. XXX.

at end gives on to at us functional Putting around given we clintrials.gov signaled before, October dot study near cross just looking a almost it As there. Is, at had no see up you chance a to point, expect the our into and put XXX-patient a it time the time with timing. really this we’re can the so Ts or a changes

XXX kind that changed. out but just laid a Everything’s end it’s that hasn’t direction front functional of really getting in So point up, in of we of you. balance buttoned

Okay. to be the included modification modification, there of trials specifically disease to SPECTRA? other Great. And beyond explore want hypothesis run in going or would disease you’re then are further that potentially vascular your that to in to functional beyond run trial that end points? at Or terms around and STELLAR look remodeling, the

Yes.

go ahead if okay. and I’ll Habib, So that’s continue,

Yes.

so Habib STELLAR. thinking about delighted that yes, the we to the able and comments – We on to need we’re for think that going kind about sotatercept for back potential to therapy. a Europe, be the going program, registration, be we’re a of be highlight – it We’ve earlier. back wanting believe so really example, going I’m – I STELLAR in single that will run I be study. trial mentioned won’t to made for

really begin affecting that to build we to the to The outcomes. at, other evidence show of we I are two look that significant will think, body studies that going we’re need really

I more those programs, forward too. sharing So look to around

more you program considering. about share entire the is today with looking the and out getting we’re now to then that and future another in point of and details furious right gate, to forward working October, I we’re can STELLAR do focus fast to development that. you that Our give really

Thank you.

Thanks, Yigal.

Jeff our comes from Hung And Stanley. question you. Thank with next Morgan

Your line is now open.

Hi, for Hannah this on Jeff. is

for on And your could us at And if views all? give incremental does adoption update provide then been you from clinicians it from any on the COVID. can REBLOZYL, you an the on what to back enrollment MDS? going more COMMANDS rates Just impact and the has change feedback

your Thanks for questions. Yes.

I’ll for Sujay, Jay to So the first respect study, that with the you, please? maybe share, can you hand and pass that over question, to there incremental COMMANDS any to is then if on it color maybe

Thanks for that question.

on are right, that So enthused we’re very is with seeing hearing as as they what are physicians, them. much the from the that erythroid with offering color product REBLOZYL to responses well they regards benefit maturation as

now, So as hearing are patient They population. They is benefit. they are excited about we the of seeing are the a what are response seeing to transfusion independence. quick reasonably

sort giving early that confidence as on And on, patients that of Habib alluded is staying us therapy. are

the we’ll going it’s and to So we on have early forward. therapy wait how see, is to wait moving be quarter, consistently see to although patient

Now just equation are the therapy, number physicians of we the the not accounts we part that seeing are is other of treatment. seeing added the initial ordered ordering

the existing So are repeat into ordering as product. treatment we as are adding paradigm well the new accounts accounts

are over consistency elements So well good giving period are of seeing that us we those as two this as growth the time.

hopefully, good gives color marketplace. feel about doing a the So how to is in the We product amount it. of with very you good regards that

anticipated for late readout their of was trial affected programs is is back the and lot earlier with the Q&A. had with referred to just a respect you, to yes, that. recruitment call then BMS this They’re And opening where during included morning mentioned that by those Samit then – the in And BMS COVID-XX. COMMANDS COMMANDS, I Sujay. thank the continuing XXXX. centers, respect were referenced

think were earlier. So, that’s essentially I what we indicating

news is I that the and think is recruitment are the centers back good continuing.

thank Great, you.

from Thank Oppenheimer. Leland you. Gershell with question our And next comes

Your line is open. now

of taking elements of as Should Yigal’s sort side to more maybe Hi, design design sure related Or the making REBLOZYL. question question. good about have aligned think afternoon, kind Habib it with team. about or on and the a SPECTRA up is we And One that for and just a earlier. their I finishing my STELLAR? of question quick the informing regulatory, then view? is is regulatory Thanks

Yes...

ahead. sorry, I’m ahead. go Yes, go please, Yes. Habib,

Sorry.

study confidence, Leland. first I kind that hosting where forward question, a Thanks terms for registrational with going your to STELLAR, you our those And be just webinar sharing us we’re conviction be couple a the own study. wanted one, and going reiterate previously we’ll stands moving its with heard the of forward, be be details. to from And we Jay, moving of to giving to in on is PULSAR is of in as you said things October, the

bit And terms chomping running. getting that study the at in so we’re first and of up

is further SPECTRA an first we year as us next also, broaden around in do are said Jay, share forward say with start But studies. as first add Now the study. about that. learnings exploratory I label. from as order we please to the you’d thinking we Jay with STELLAR planning that more in help And only our if multiple some as an And half on And And alluded in earlier, more plan of designing to be subsequent like. moving studies update that program. you to would SPECTRA, that to, we learn from we will that, is

Right.

what to You basically was say. I said going

really STELLAR. not So it. details, buttoned-up gives what health it socialized We’ve Again, we’re really STELLAR, earlier going the interesting said plan. us with. I data. good authorities. It nothing is inform SPECTRA got getting But but is final hidden to a with behind just We’ve

We’re that just we’ll in the to October. provide details moving forward, and

granting hurdles And then granting? there J the the high REBLOZYL, any adequacy missed will prior is of quickly Or more helpful. into the if the any don’t way it. be you’ve quantify the issues if is of But could products that code, reimbursement That’s it know code, of with addressed? specific run Great. just I earlier a you have on earlier, you formality commented I this think or apologies on that Okay. reimbursement to given the J

Yes.

answering the that hand please? Sujay, code that, I’ll to J you So over don’t mind if question,

absolutely. Sure,

having J that permanent changes. of time the reimbursement the is One right? of things, needed is paperwork code the cycle that So and is benefit two approval the the for

and a faster because is processing be required accounts, could So at paramount the will be that reimbursement to for importance certain level. more much the different going that is be

So that’s benefit. one

could of could So that support network. have not et see cetera, certain that This practices, to in them. sort of the benefit be smaller may you all

equation The other regards largely access. so of the is it part to gives confidence the more with

any So suggest with we reimbursement access, it just that set, of the data is from it’s speed our the prior accelerated. had challenges doesn’t

benefit So you. accounts. will Thank certain that

Great. Thanks much questions. for very taking the

Leland. you, Thank

you. Thank

comes White question with Wainwright. H.C. next Our from Ed

is line open. now Your

Thanks for my questions. taking

mine previous disease. can of on impact COMMANDS but answered, on pulmonary update COVID. most the of study we question And maybe an been get So in have and then to ACE-XXXX the similar asked just and also

Just curious or Does since it’s COVID? for year. this early include on INDEPENDENCE the later start impact have any to from expected trial you that expectations next year

your Ed, thanks question. for

update we everyone, this So if that declared healthy X. study we with respect But pulmonary again, a it and to on move to just is to with ACE-XXXX, have be And volunteer plan a that successful. really program TGF-beta targets X no forward that. remind to

to a you imagine if that at about successful, mechanism pulmonary year. more of lot can hopefully, that looking And driven areas fibrosis. So by And more based we’ll come. the next within are hear we’ll on action, be ACE-XXXX

of the still to not Bristol think Jay, our – the study that the also you track. to at of latest, is on year, So this able the from heard everything that? is with before be colleagues to this if specifically top I on study, anything and move forward goal respect at next INDEPENDENCE to year, early end

No. going say Yes. I that. to was just

on So planning for and start-up things That They’ve INDEPENDENCE. in are continues. been track.

see track. we today, as on it So

Thank very you Great. much.

Ed. question, Yes. Thanks for your

you. Thank

Our MacKay next from Markets. Capital RBC comes question with Kennen

now Your open. line is

from transfusions hearing in their the Could what couple about, the blood with you preference seeing III transfusions? for saw to is Phase what guys. second, access being talk on us. versus of difficult and about setting REBLOZYL response A Hi, This been for are you in times have rates these were the versus the for talking MEDALIST more what real during you physicians, And Bikram you blood Kennen. trend you’re study? questions clinical MDS the

and for Habib, is thanks question. This your

and that was in cell hoped what less then pandemic. time you’re the is need spend had where said whatever if in play can And significantly now to minimize red of I think times. earlier for seeing that me to perhaps as anything transfusion them some With or at number as cases and and patients number they getting a question is a some looked we early. I that coming But and a opportunities time. remain settings, we’re seeing is that even again, what too a to the those terms of transfusions be to orders Just to of at are I surrogate early conclusion. by the draw can clarify, encouraged had same well I time as those eliminate centers the rates, response early there’s or their for solution repeat too accounts, had would right doses in with don’t what their the therefore, time minimize least settings third are on to in your patients said any trying you way difficult during good do But that that we blood have to quite is wanting respect frankly, we to in that and this to due at these the reduce it’s second, which there reduce – can other metrics, that experiences. quantitative so the out of could very a And tell we I role

much. you Thank it. Got so

Thank you your Yes. questions. for

Paul [Operator from Instructions] with question Our next Goldman comes Choi Sachs.

now is Your open. line

information you’ve trends or the in COVID spots more the cadence guess in about This context provide specifically seen. you’ve differences regional and is quarter Paul. of for you or of Aliza and on if qualitative hot seen sales prescription could I any second

Yes.

out. I trends MDS, terms prescription had the at even very add very, like quarters I So as sales determine yet time. more still so Again, I’d of in couple this defer it’s said, maybe full early a any can quite of and And haven’t quarter trends. to nothing try a there’s answering really to we even frankly, to for to more that

you. Thank sir. Okay,

you. Thank Yes.

Habib not now further questions turn remarks. Thank over Dable any time. the for at closing showing you. call this to I back like would to I’m

you. Thank Yes.

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this and participating. gentlemen, concludes call. Ladies for you Thank conference today’s

You may now disconnect.