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Blueprint Medicines (BPMC)

Participants
Kristin Hodous Senior Manager, IR
Jeff Albers CEO
Christy Rossi Chief Commercial Officer
Fouad Namouni President, Research and Development
Mike Landsittel CFO
Marc Frahm Cowen and Company
Dane Leone Raymond James
Charles Zhu Guggenheim
David Lebowitz Morgan Stanley
Peter Lawson Barclays
Arlinda Lee Canaccord
Eun Yang Jefferies
Michael Ulz Robert W. Baird
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Blueprint Medicines Fourth Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. like Kristin the Hodous now your over I’d today, speaker of Instructions] to conference hand to [Operator Blueprint Medicines. you. Thank ahead, go ma'am. Please

Kristin Hodous

Thank we and everyone. fourth you, a press This morning, to outlines issued discuss operator. Medicines' the today. which Blueprint topics morning, And we quarter to results operating welcome financial release, conference plan call. XXXX Good

R&D www.blueprintmedicines.com. well going You can highlights a and Chief our Rossi, our Today, today Officer, that by commercial and to our Mike President we'll will Albers, Executive Investors slides Christy our Fouad Financial our website access business provide review the and Blueprint Officer, our on at will our as Namouni, press Officer, Development Jeff efforts; XXXX update; call, and priorities; of Landsittel, will be the Chief financial corporate release, results. Medicines of the our as section Chief reviewing Research Commercial discuss recent discuss will

I remind differ forward-looking materially include a expressed we events as could forward-looking results would will Before implied by or or like statements. call statements and started, everyone make the we with including Form the SEC. our may from on other risks, set forth conference any those other in to statements get Actual and this XX-K make any that result various recent annual of have we Risk or made uncertainties of section on those Factors factors, most report filings that

We obligation or as forward-looking of today In representing views upon should subsequent relied call any our date. not as any represents views only addition, statements and revise specifically as to of made forward-looking statements. this any on our update disclaim any be

CEO, Albers. Jeff our here's Now,

Jeff Albers

that was XXXX on isn't word but morning, to and to say GAVRETO Thanks, the and Medicines. the With four biopharmaceutical priorities fully XXXX Roche, Blueprint and use tends of hyperbole and our forward everyone. a Europe, global global transformational recent catalysts. to transformation a signed our to a We're AYVAKIT we’re positioned a update bit, in with approvals integrated wave it States quite growth. happy Kristin, next and really and now company, know regulatory I industry a collaboration and our year exceptionally look progress, well for to drive United an provide good a we're

into on therapeutic to As further to One, precision two, therapy expand our build focused to of we pipeline. strategic the adoption to progress clinical wave new global XXXX, three candidates recent our three, a and pillars progress. we're and accelerate of AYVAKIT proof-of-concept; to on GAVRETO; advance

is centered launch. The the first, GAVRETO of systemic Christy as our and advanced AYVAKIT of will approval discuss, acceleration around anticipated mastocytosis the in

as and we're have the quarter, With most opportunity. discussed on date now what PDUFA AYVAKIT our a sNDA the in long into expanding growth we significant second of verge accepted the

while of AYVAKIT future. mastocytosis the also the expand progressing thyroid expanded us trial. systemic U.S. forms further near to advance focusing PIONEER Additionally, GAVRETO, in in launch on the in positions non-advanced for the applications our This cancer offers is continue geographies. to of in approval potential additional efforts in development also commercial the registration-enabling U.S. for the via And the to December

platform. proof-of-concept focus priorities, into third and our cover, therapeutic and second will to candidates to on research prolific advancing Fouad our new The as tap clinical productively continuing

including several with BLU-XXX to lung in data on development preclinical We of first newly named make for our expect upcoming progress double-mutant the cancer. latest data, presentations significant new candidate EGFR-driven and these fronts

BLU-XXX lung initiate trials to clinical in cancer, and for plan We in systemic mastocytosis. also non-advanced BLU-XXX EGFR-driven

compelling months, coming as information therapies. patients target about tumor excited subset the therapeutic over of new particularly given the types, science scope of I'm of Finally, the on CDKX/X more respective we're share to their research who focusing excited of opportunities. on quality progress well multiple the to as a these and resistance programs announce program research mechanism a a a in across CDKX,

at this enables $X.X and an to in strategic by of of cash than is research opportunities XXXX, end there's All also where to our further supported invest the us while our with continue position, to financial which innovation these consider we in fit. billion strong programs external engine, bring more a

to call So, over I'll with introduction, a commercial that hand provide the to Christy? update. Christy

Christy Rossi

delivering Jeff. a the to globally. we continued precision progress therapies our goal fourth Good In quarter, to morning, patients portfolio everyone. Thanks, make toward of of

launch With have marketing SM importantly, set of in RET-altered the Europe the foundation of as most the GIST thyroid two of AYVAKIT growth. cancer, for in we year, the the as drivers to The a and PDGFR-alpha the launch AYVAKIT be in most ongoing well well, year submission European half the U.S. a SM in the in FDA first anticipated XXXX Germany, will for for GAVRETO be of growth of that now U.S., our applications GAVRETO as significant advanced of the important for of U.S. and approval first launch advanced AYVAKIT of for in

let had million the near-term. sales of set to for in with bringing approval revenue million, late the our $X.X primarily thyroid quarter we product GAVRETO have results total XXXX were net for to the pleased quarter to for in SM, was fourth driven $XX.X by across the thereby the turning Revenue revenue revenues in in launch quarter, GAVRETO. of fully Before me to million. receive product also indications we recognized million And GAVRETO and start expect $X launch. enabling to AYVAKIT. fourth in cancer $X.X We We us

GAVRETO ago, and available should weeks patients indication. these we seen cancer which patients. awareness inhibitor further two Overall, GAVRETO we have for one-third carcinoma, approximately market RET the addition, to thyroid create thyroid guidelines of papillary of are to-date, was medullary treatment and for this NCCN have comprise selective the added excited to In

two Genentech areas. of at the with we continue As to in launch key advance focusing we are partners GAVRETO, our

a we progress to since starting realize good first RET selective potential inhibitor, treated longer our December; The of increasing of where is inhibitor, second the to seen term of which RET selective the number GAVRETO. are identified share the be overall enable will key with patients, is RET us growing have who and on patients a

start with of patient share me our Let new starts.

Following the patients, our share on of a thyroid December, kicked-up in for cancer selective new approval GAVRETO XX%. inhibitor starting about to RET

for We were are fourth community inhibitor majority first of the mix selective prescribers in balanced RET prescribing seeing generally a and the academic prescribers, of commercially and time. quarter GAVRETO the a

increase patient is indicator a starts, of expect revenue we leading duration be clinical new We continuing on combined of the on our will key growth. studies, with therapy share focused prolonged our to when this metric, of as based

predictable manageable to encouraged We daily GAVRETO's safety once which healthcare from and convenient on continue durable by profile and differentiated be profile, and very feedback payers providers deep dosing. responses, a includes and

visits inhibitor, are second patients with RET patients area starting treatment. focus of a of on approximately key as that year. the cancer market in was been in cancer all the shown right and of around impact a here, the the we on is Our as rebounding the U.S., RET Data of impacted two initiation now clinic well is selective RET the overall care having COVID biomarker the COVID. testing have from who drivers of identified increasing RET patients XX% for versus volume the see to comprehensive as are testing XX%. is of the patients of public treated selective this prior by estimate have number biomarker We well earlier increasing positive which as inhibitor percent domain There as lower rates in in in QX

will these We expect diagnosed the approach we half number impacts patients see of subside rebound. and we as that the of XXXX, newly second

effective with can rapidly identification plays testing patients with will of educational their addition, our increase with who efforts driving we market the biomarkers, that identified total will treated. where availability portfolio is of targeted Overall, and combined In therapy we an the as which percent efforts complement a opportunity partnership lung role. key patient have targeted for growth. efforts GAVRETO other anticipate Genentech are and expand, therapies amplify a of area This seen highly the be identification patient another driver across significant Their team. our RET the of of and

AYVAKIT, PDGFR-alpha growth past initiated And therapy our quarters. the additional approach, in seen fourth the first U.S. few we our starts to Germany country with launch total quarter. patient first consistent over GIST. patients We've the targeted in Europe, on now In country incremental and in seeing new consistent with anticipate launches. over Turning in we time

anticipated on potential Of milestone opportunity This primary U.S. launch mastocytosis focus second AYVAKIT of as late course, systemic portfolio. a first stage the in the steps largest critical advanced in towards in our quarter. the we take realizing be for for will preparing Blueprint the commercial the our is

major be majority our all opportunity X% about of patients only about SM the us centers. half This represent While an gives SM hematology U.S. overall of to efforts advanced SM advanced XX at these the tend focus patients patients treat of XX% the centers about that to on population, in treated educational to

with I in mind. built organization our As commercial the portfolio we’ve previously, said

side existing to who meet be the So, we identify our of will infrastructure SM of advanced the patients and to treated flex leveraging main launch, largely adapt may footprint our portfolio needs these centers. including

to are forward potential non-advanced for beginning XXXX SM larger in AYVAKIT the population. We think a to also launch

widely making for testing. We priority KIT the and patients. is testing near-term here driver actionable mutation, remove SM increase DXXXV, identification diagnosis available, to will help barriers for to clear patient SM Our with that accessible believe blood-based non-advanced

testing closely now blood-based these has in medicine part been working States. precision in with available And sensitive commercially efforts, Our testing United providers. team highly the is to due

course labs, cover in to of of the grow about We XX% the of expect to SM testing availability this over patients year which U.S.

SM that diagnosed the disease access patients to are other increased testing, with number of and efforts, treatment. will are confident education increase have who combined and We

building the value opportunity Anchored our SM, significantly into on will while is of who worldwide. our the bringing to impact are opportunities the our will ongoing call patients promise for near-term by planned turn Development, significant that our we to R&D efforts. Blueprint I'll Fouad? President course see the Research of we Fouad, portfolio over foundation more now accelerating the expand the portfolio launches, XXXX, & Over address. with the and I commercial early-stage detail of provide translating poised in the to

Fouad Namouni

lead our everyone. and to Thanks, to a in you research speak team. and September Blueprint morning, It's to pleasure was today. I development thrilled with join good Christy,

expanding last future the work as excellence. as It's six Over the clinical our and course our for of will had to by the clinical that and built on recognizing important have scientific team close be chart months, vision. executive the begin scientists to with opportunity our foundation R&D team to our well I

productive Blueprint's believe first XX claim the been in and research profoundly of no two Our has we can with other years company approved a drugs discovered engine make. novel existence,

new now development precision four nominated candidates since also become world's We the We build and on late to this company. have progress XXXX. aim leading therapy

patients R&D portfolio, us, scientific hematology; achieve a this and oncology means to precision expansive the several this and with deliver choice globally; for the stakeholders leadership vision, medicines ways. strong therapeutic strategy our commercial combined and we under the capability our strategy For in to an focused drug development To approved important R&D partner in across continuum. evolve being development of will innovation

the of will lung development mastocytosis teams deepen therapeutic research cancer. areas, leadership in our integration First, expand the to cycle and including innovation our accelerate systemic core and we and

our more on to highly of selective expand by targets exploring while the and rationally kinase engine inhibitors, continuing high build design our modalities address unmet the productivity and ability field new hematology. oncology will in we research to targets of need to Second, identify

the we possible. populations bring expanding patient our transformative data, as and by operate will of designs forefront to drug precision as translational strategies regulatory use our therapy selected at trial of to quickly development Third, innovative

other an high in cyclin-dependent EGFR be in April associated preclinical cancers, inhibiting breast and share CDKX/X mechanism Finally, core our culture urgency its selectivity we explores representing for of will and catalytic an could address towards be is need. excellence work patient AACR ovarian, prognosis, to to teams our I amplification In E value scientific newest more inhibitor, we CDKX. including with selecting plan also agents program research as an E resistance development kinase as mutant We to update At range with an grow of target disclosed partner, our highlighting clinical significant potency, on BLU-XXX, been to portfolio. subsets CDKX of and our R&D our newly to with today CDKX our a not reported a program, plan share patient excited the at for AACR, major also our needs we additional to amplification approach and continue double progress a or poor malignancy broad and breast Cyclin of of brain oncogenic This drives meeting its Cyclin by patients X. program preclinical Cyclin and has driver, as candidate. E, the annual hormone-positive nominated data, data penetrants. data to the cancer. expand area

systemic first report EGFR the BLU-XXX, and from the address X healthy volunteer BLU-XXX. EGFR key include target cell will also themes the clinical data and inhibitors, to BLU-XXX on to clinical in the We our BLU-XXX We develop mastocytosis. to treatment resistance potential cancer from non-small study of anticipate will our these presentations lung path emerging of non-advanced of Phase role agents in

multiple Mike in I for bringing advanced for readouts and the of updates. and in course exciting mastocytosis, be quickly for months, More on clinical systemic non-advanced in States And to coming Mike? be as to time Blueprint. turn important the the EMA our to you therapy mastocytosis forward systemic to the reviews the in AACR, the progress range year. Beyond It's look with mastocytosis XXXX, data Europe updating data sets will patients application over the foundation discuss can. a programs. on we and as with our goal to this across including closely new the we AYVAKIT I an AYVAKIT of FDA of marketing broadly, proof-of-concept call in at are new financial we systemic for building now the of United over data working

Mike Landsittel

detailed we full our results morning, quarter release. in year this and reported fourth Earlier financial Fouad. XXXX Thanks, press

on the CStone. collaboration quarter, Total revenues were in agreements and I'll quarter the few from For the a with for revenue We primarily million. today's highlights touch $XX.X call, from quarter. Roche fourth our $XX.X million during recognized

year. payments second $XX collaborations we the of half primarily towards For anticipate approximately the achieving from XXXX, milestone existing million, of

we product sales. recorded million during of $X.X Christy As the quarter, net mentioned, AYVAKIT by revenues driven

growth stages of launch mastocytosis and systemic in GAVRETO revenue in we later early the of meaningful of course over the launch expect the advanced With an this XXXX. year, AYVAKIT product anticipated

increased primarily Our XXXX, discovery early advance the third pipeline. expenses driven investments total operating to to of our compared by quarter

announced expense of programs see X development, program. we they forward, wave operating and our by to quarter-over-quarter pipeline growth Looking from expect towards programs increasing including clinical progress as EGFR driven research the our next our newly CDKX BLU-XXX,

stock-based expense quarter-over-quarter anticipate compensation increases also We continued in noncash throughout XXXX.

strength advance wholly-owned a in provides financial the ATM as XXXX with we've milestone Finally, development been We over as we're well This our position robust consider to of bolstered strategic to company. in innovation entering as ended from $X.X us payments XXXX ever and prudently the the pipeline revenues, in cash, through strongest billion proceeds our by flexibility opportunities. external candidates facility. ability drug product

turn the now questions. over to will I that, with any the So, operator Operator? call for

Operator

from [Operator Instructions] Our comes question with first Sachs. Salveen Goldman Richter

is open. line Your

Unidentified Analyst

just strategy complement for and on on picture Andrea for so is Jeff, your interested what big think This your BD, hear of what as you're Thanks terms forward in question in a pipeline love Salveen. you would much. could current bringing for in maybe portfolio? you, to

Jeff Albers

Sure.

one that's us think more of identify capability through we've priority about on platform is our exclusively we really inbound a focusing course, about have So, six continues that has way move forward to we built to the say, the commercialization. potential it molecules, capability to discovery know business been become about cornerstones on strategy of And our execute kinase we from the And team and we large there's think out programs. interesting underappreciated to there. is on think therapy. focused over the that But, certainly to precision ready And, the stage to has varying modalities, development lot last combination more I always that the of earlier way place all I been I'd for has targets. months. mean, for a new in when have the the therapies an think where

and out creating but companies, that be inhibitors. very And that partnering and to think, now, selective our blend, the that? blend assets identify bring rather ongoing action those and develop jump it's I five about, of continued kinase think molecules, core can growth are a precision out if think other of beyond is from could orthogonal platform, external natural add will complementary? be certainly And you Fouad, I about than our in by internally? go years a complemented so, investment to in So, in there if there opportunities. Maybe but want we And therapy, we mechanisms by with anything do and are

Fouad Namouni

will new look -- terms that add very end-to-end with and and thing of for a develop the the the Jeff Jeff, hematology, thing and going to targets. high obviously, at all One in we science only really to said, more oncology one company to Thank is, patients. is will are capabilities important targeting be I unmet us need follow that's blend you. the integrate modalities to Yes. as and additional targets continue always follow precision allow

Operator

Thank you.

comes Our Company. and Marc next from Frahm Cowen with question

Marc Frahm

or of that that quickly context put early relevant you place, your the maybe data you into it the maybe vast doses? you safety EGFR can to dosing have? of you mutant get yes, all speak now could the the therapeutically of Maybe -- doses, relevant in the how And double think development? majority GAVRETO's the and therapeutically inhibitors have preclinical triple kind for in window you And

Jeff Albers

you that? want do Fouad, take to

Fouad Namouni

question. Marc, Thanks, the for Thank you.

cancer. lung highly highly non-small really our EGFR resistance teams in of with the to agents Xth So, EGFR first, have me say the let generation tackling idea rationally that treatments cell potent developing been selective,

own selective EGF to has to which XXX-fold window, very, to but be given while CS cancer, it combinations with about with with when our move for space This and and about EGFR profile over to this very given and the with All-in-all, second in been the mutant, TM opportunity agents. importantly, agent, original mutation developed to wild-type agents has altogether. to majority it highlight It double triple look with our talk the the wild-type lung its candidate clinical with combination EGFR osimertinib the partner, beyond in has for additional a cell a call but to opportunity CS the I opportunity XXX, been penetrants. and development, mutant combine and has combination strong a resistance selectivity we EGFR opportunity need XXX TXXXM both compound cover has developed clear for think, X, only of From covers also earlier the of in Not ability gives an agents to brain the cancer. line also in and me we potency is non-small is expanding mutation your about TKIs. tackle mutation really a resistance be for let the opportunity of or unmet thinking is important our also and Specifically X only that very developed go other because together tumor not selectivity the XXX, the this of mutation, question, start this high other original our patients, lung mutation, XXX triple combining to own XXX. mutant that EGFR. become single-agent line it all perspective, and to its mutations lines Marc, the

quickly. them of both very moving are We

trials agent, we Phase and first the X first are half the will -- XXX, targeting IND right year away an the So, XXX. starting for of this

with unmet in this urgency for there a of meet monotherapies We'll or agents of before targeting mutant year in are our this population sense IND the patients the can is we because second year of high of half agents, believe other EGFR a XXX. need combination both of we with with that and pipeline. We developing be EGFR end

Operator

Thank you.

Leone Dane from James. comes question next Our Raymond with

Dane Leone

on the and taking you the for Thank questions, congratulations updates. all

others. us midostaurin One, ASM color the more me. centers. But, in How little you the for different year? see CDKX has long maybe issue classically, working Obviously, a could the Historically you from gave going color Where interest And utilization CDKX much of to what docs you are the working how the do is it's is been high do area, currently a on premise or bit you in you question my there? on to back your half you Pfizer just can think team selectivity see selectivity of angle programs more hit things You your program. good going with targeting two so? other you access in question dinaciclib, you're leverage to how provide with some on think as the Thank preclinical is for well. get and another of and a in maybe how these and is targeting next-generation your launch of you. of is think of actually terms Do terms to So, CDKs, that patients? there these dial second do not on? can take then you fadraciclib

Jeff Albers

Thanks, Dane.

pass So, why Fouad, then, we'll to for second the question, over take and question. the you don't first you Christy,

Christy Rossi

Sure.

said, So, for and in and approval an about we're launch are the now teams I prospect go second of engaging the as and the to that. ready quarter, excited

this therapy. think, approved is that, AYVAKIT interesting I what's obviously, about is an

are I go ready to -- the indication in we'll SM, we So advanced very be think think, approval I upon quickly.

Our centers. these key commercial with out infrastructure is engaging

yesterday, high at centers uptake for The degree a were some patients, of at we fact, In there's looking advanced with already we AYVAKIT. treating just see data are GIST SM our that AYVAKIT for overlap looking utilization quite where overlap with even GIST. most

we think, these Certainly, who I have sense of sense are? a are? patients have we midostaurin of where the is a prescribers used. So, Where

SM, just advanced of the I product as underutilized mido before, given would I the say is Although, profile. said limitations in

to see for prescribers, used. patients. being feedback that And will is best-in-class we've expand really these healthcare where as for the we KOLs looking so, opportunity beyond providers, from be gotten the AYVAKIT they certainly AYVAKIT And the mido is profile

education. and that go focus given, is out on So, And smooth, out the should demand approval, we'll would be I there access be upon very I drug available. quickly again, looking relatively and to think,

Jeff Albers

And focus then, in selectivity. the you about Fouad, and can profile, on maybe product the CDKX, target talk

Fouad Namouni

Thank, Jeff, and Dane, to your question.

that highly me let key a the say, reasons. really one really Blueprint of designed their deployed program, Blueprint kinases, and program was CDKX, is joining to selectivity, and potency the first, was for over CDKX focused was This be So, on molecules when I has expertise other in One, about and excited high and making including selective. CDKX very programs rational that's selectivities high for CDK I of others. the

thing the is that other patients The excites the many ability help cancer. me about scope this Blueprint to with program at the and of opportunity

and You like the for of cancers opportunities of as think can breast the cancer, resistant to agents, CDKX/X, you -- are that monotherapy CDKX the for think in where the cancer from other about lines. earlier tumors hormone combining can pathway, development and to all will like be way therapy with addicted tumors

the that will this trust So, CDKX in potential, AACR And -- the very be data you. actually, space. the the at I be will best-in-class we'll I to -- the be has believe show to this best that compelling

Operator

question next Schmidt Michael comes with Our Guggenheim. from

Charles Zhu

the Hey. for for Schmidt. Zhu Good is I Charles there. dropped on Thanks guys. momentarily morning, Michael taking This off questions.

Retevmo? that don't expectations fourth was thyroid, that I performance with color breaks light Lilly But, picking like GAVRETO sales and and that Difficulty] you that of launch kind see Lilly's to I tracking the share XX% I'm this I see [Technical already how your of prepared do forward but building how asked. and patients how wondering of understand up. between if wanted So, the new down the is some during lung quarter remarks, you're relative kind know initial wondering in of and to provided out. of just

Christy Rossi

Sure.

one. that take I'll So,

primary I as really key size of over year. of health the opportunity. variables the that two of launch, the as the the share understand kind the the really Those we at evolving of new course be indicator sort that overall are along is at looking are said, So, I starts mentioned, of of we'd to the looking the the with,

label the year, getting that we were essentially RET prescribers seeing we're I get coming XX% opportunity looks hoping months overall the and we know been It's for positive. think, up, forward. less feedback the focus an being And of So, but last evolve. we And for of of to is year, total, grow So, the GAVRETO good with it's a and from the the of obviously, thyroid year. of for the the to grow patients. utilization through that of inhibitor component thing are or year six that will behind, to the will very patients that RET that will that certainly, full here not us certainly, I to speaks -- important opportunity. we're question opportunity from very we sort a Given by Lilly, it kind grow coming prescribers end last treated we overall, that a right? continue the to that's this not a a of us, then got been and thyroid, like has GAVRETO and course In the third Certainly, give about that's pleased as insight that at thyroid prescriptions that opportunity of got pie to regarding a growth indication have new-to-market fact think right which we of as mentioned majority that quickly of grow really catching we're utilization well. I RET view than key right? just the now, end

with But, seen utilization be long thyroid, we this is had the several at quite there as patients And So, weeks treated believe be our and can well. data of strong. point. very now may that only for duration we've certainly, we've that those

go we part our as focus, So, of thyroid an will be important forward.

Operator

with Our next question Stanley. comes Lebowitz from Morgan David

David Lebowitz

And commentary set? also guess, I that for expect get on their looking insight expect respect view, number advanced mastocytosis, it systematic do the number With be two, the the to will avapritinib at they FDA some will one, data an do indolent well you go look how at to from panel? might as And population? you data submission the you and that the on agency, from

Jeff Albers

The Sure. in do to for for advanced start review that? you avapritinib with SM? want Fouad, path

Fouad Namouni

actually questions be and we But FDA advisory Thank is to We to of data are believe to handle submitted thanks, approval. an the you, also to we committee indication if can robust aware what we'll package believe the for of our the have far, mastocytosis so and will believe and ready one. Jeff, any we are advanced data systemic are the robust and David. a ready started. review We we handle made lead that -- review

We'll or our the systemic from mastocytosis systemic Indolent compelling But, approval mastocytosis systemic non-advanced advanced totality mastocytosis case separate have the make the the between opinion and an to available be this mastocytosis, sufficient data are for of PIONEER XXXX systemic is of indication of later be In a data indication. we this to when a on interaction this I mastocytosis. they the for systemic in data we not happy advanced FDA. in and terms indolent the submit approval will the data indication. of submitted do think, see

Operator

you. Thank

from Barclays. comes next Our Peter with Lawson question

Peter Lawson

if revenues And, cetera? Just the SG&A be changes be thinking just R&D sense for P&L? of a should GAVRETO et XXXX around to the how Mike for there's and modeling be more total else, for how about XXXX? accounted payments in anything for that question thinking we about, of should than in in should Roche, How any and we

Mike Landsittel

Thanks, Yes. Peter.

built ask our early pipeline further our last we driven that by and primarily quarter-over-quarter for we this infrastructure we've we growth out our year. will of in move stage to XXX to I XXX in expense year. And expenses, expect clinic. is commercial into terms through the be to operating R&D start increasing see the We So, as operating what investments guided SG&A, think

SM think I some will growth will approach we one So, forward. launch. as advanced be there the R&D incremental the drivers of still key be that But, for going

it in as towards In milestone in, accounted year. -- guided is back $XX think the of anticipate of to terms collaboration We for million up of as that to in. the going XXXX. year, middle in revenue weighted will we've collaboration be we comes be half kind that the year, be payments revenue potential the what to come for revenue And that's of back that will half to approximately

Operator

Canaccord. next comes Our Arlinda from question with Lee

Arlinda Lee

I have as this year? frontline. the guys could sales ASM missed current I at sometime then, that next, XXX and for half combination and up year you channel be two. be more would AACR, alluded this midostaurin prepare One, And launch indicates or be data XXX to disease whether to of secondly, you that preclinical later in sales. just would indolent our

process preparations. might how So, you. your regulatory I'm affect wondering that your Thank and launch

Jeff Albers

Arlinda. thank So, you,

data. in first take the the terms On of question, timing I'll of that,

data agent year. be to guided been have range EGFR both guidance look half the the has then, the we'll for share but data the And of is EGFR, AACR Fouad data conference the what single for updates course of busy towards we've of for additional this XXX. as -- combination we'll With programs of across respect over to second our programs. going year, in well a laid out a is with as preclinical us So, as to to programs clinical preclinical

second reference I I'm Is your got wasn't sales process? to I not completely the that regulatory that -- and of sure On the question, question I what it, how was? sure impacts midostaurin think the but

Arlinda Lee

midostaurin how current have -- might from sales disease, though they launch an of Sales of your and ASM half regulatory even are label. I'm indolent preparation? the really that only is wondering affect

Jeff Albers

Okay. Christy?

Christy Rossi

including certainly know disease. is So, in SM used the that in midostaurin of forms we non-advanced broadly,

a for these exactly is patients challenging, with world, single see hematologists really driver that less we've think how that, be the for alone KOLs to talked and previously, is issues. frequently. categorized I that across but knowledgeable may patients speaks the two disease differentiating One even most may is SM as these one

a spectrum speaks just it that need I also SM. unmet very significant the across we see of to think,

Our mido may data think a would looking you -- different at of suggest than I that mean, use is probably be I half. non-advanced in data. less but

that I therapy. utilization of and overall the limited, sort think is both of midostaurin I profile -- of as by just safety the said, tolerability efficacy

with allergists see the that and well be filing non-advanced engaging they the disease have certainly, to in focus. in initial may really earlier, SM. who will appropriately time, patients be we are indication ensure patients well. both who assumption. identified forward more looking as I that think forms going our to And mentioned. just used real disease. factors -- that the to indications be driven over utilization How world as by filing we there we'll will of I and we're But imagine hematologists Fouad As AYVAKIT would as our for our in And be significant of is and the others That's having the these are being and advanced in diagnosed, that's said

Operator

you. Thank

Jefferies. from next Eun comes question with Our Yang

Eun Yang

Thank you.

the osimertinib For of mutation cell the of cancer, the that the first-line post frequency to is lung EGFR after line use? non-small in similar second program, CXXXS

Jeff Albers

the So, as back of maybe then actually start, have two think I'll in well. jump I'll up and development programs. And these about and Fouad I'll

triple then inhibitors, recognition our product emerge, course, of as of a that when Fouad challenging create then The of followed is that's mutant the sparing molecule also about, first-generation early there range on mutation traditional a penetrant. a TXXXM wild-type you really while that developed path a once or CXXXS have mutation more and mutation talked was the very by target So, thereafter. mutations, program was osimertinib frequent to most brain profile, hit a was EGFR and when BLU-XXX,

classically it's a interesting to landscape So, a select is understanding determining an osimertinib or patient that because change, models, program a likely based earlier. BLU-XXX time. and me of started of more and appear the on where discrete based that preclinical very on would mutation molecule was And first-line resistance watching the that over population. would to was much was moved go Blueprint that CXXXS

landscape. generation it of The an could that first of We're what seeing osimertinib from And emerge. the significant to a lot see so, ways, interest program. that's we molecules. KOLs definitely beat was is for that BLU-XXX osimertinib, In evolving EGFR

So, But data a of evolve. to continue maybe of little patients form the that XX% osimertinib, that XX% sort that range is to range, lower of again, date to resistance. and develop up perhaps bit

hit is a wild-type the molecule. as on the we've molecule molecule, sparing that fact a and profile with Fouad Importantly, created brain-penetrant a very selective

being XXX combine including about or to we you any as so, therapies, set landscape, of up anchor to think potentially the others. and well XXX serving an other with patients And treatment see could EGFR as evolving

can prepared two the we're journey. at some But of the evolve. we treatment with time their continue to cover So, the watch along landscape we patients think vast to majority molecules,

Operator

Thank you.

question next from Our is Michael Ulz with Capital. Baird

Michael Ulz

the Thanks. will sense And I target? CDKX/X plan might what how relate And preclinical going driven indications Obviously, development curious a of you're after a there. you that the program. does if to just had the some mutations then data. on I have by inhibitors? CDKX you for still in be sort it of But, realize, just follow-up also, resistant to

Jeff Albers

Michael. Thanks, take want you Fouad, that? to do

Fouad Namouni

Yes. Thank you, Jeff.

a we see CDKX CCNE, of we really broad CDKX and high-selectivity earlier, parts as few regulatory is where of and developed and be major as cancer give I program, high-potency CCNE as look will the two role can cancer or mentioned could solid CDKX against I of cancer are and we where this a And a in the a examples other with its So, know with range program, at developed CDKX really target. agent agents. monotherapy combination partner, of when player.

ovarian an in this -- about cancer that ovarian to think is you has addiction there cancer, cancer. pathway If

cancer, esophageal but the combination breast therapy cancers are cancer think agent is development include of agent, about this also monotherapy of will will breast would gastric we in I It in a in a combination moving the breast a variety broad. from include the is all if scope CDKX/Xs lines. with today, number back of hormone the really cancer, there and arrear There such If develop you we'll of be to I exploring. as cancer with have in and and like not combinations. types that to strategies, other such a cancer step to cancer little and I of treatment to agents, way say, hormone-positive other an bit, CDKX/Xs resistance But mean, only really patients opportunity opportunity, the variety

I'm CDKX particularly are very, we very announcing about this So, program we are today. excited. excited very

Operator

I'm further back the you. I'd Albers for at no to over showing Thank turn questions call And remarks. this to like currently closing time. Jeff

Jeff Albers

Thank you, operator.

financial conferences, half progress year transformational execution was clinical then, continued flurry data And the about for of So, we by Medicines. like SM you've XXXX in first multiple the talking starting a how the year for setup upcoming avapritinib I from the both second position. second efforts the potential advanced a in have Blueprint started our and a feel and half, fully in all approval of across with discovery of that a business. execution off various integrated for programs, really strong as quarter, at and preclinical got call hopefully, XXXX, just across And underscored we sense opportunities

further day. the this always, over the months. with appreciate as coming forward to us, it So, spend you and good we taking time morning Have to look Bye, bye. updates a

Operator

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

disconnect. may now You