Blueprint Medicines (BPMC) 3 May 222022 Q1 Earnings call transcript

Company Profile

Participants

Jenna Cohen	Senior Director and Head of Investor Relations
Kate Haviland	Chief Executive Officer
Christy Rossi	Chief Operating Officer
Philina Lee	Chief Commercial Officer
Becker Hewes	MD, Chief Medical Officer
Mike Landsittel	Chief Financial Officer
Marc Frahm	Cowen
Dane Leone	Raymond James
Elizabeth	Goldman Sachs
Reni Benjamin	JMP Securities
Brad Canino	Stifel
Andrew Berens	SVB Securities
Mike Ulz	Morgan Stanley
David Lebowitz	Citi
Eun Yang	Jefferies

Call transcript

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Operator

00:03 Good morning. My name is Juan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Blueprint Medicine's First Quarter 2022 Financial Results Conference Call. [Operator Instructions] After the speakers’ remarks there will be a question-and-answer session. [Operator Instructions] Thank you. like Cohen the from now your over would Jenna host, Blueprint I to call turn to XX:XX Medicines. Jenna, you conference. may begin your

Jenna Cohen

you, morning topics we we everyone, morning, a press First and Juan. to outlines to issued Results Thank the which Operating This Medicines Financial Quarter discuss and Call. Conference plan release, Blueprint XXXX XX:XX welcome Good today.

non-advanced risks, SEC result various Landsittel, for get like those will Factors section remind call first will results. everyone materially this Risk Operating available Lee, of implied highlight conference statements of www.blueprintmedicines.com. call by as update. that we'll XXXX financial Becker SM You Christy Chief on Officer, joining Before Today slides going XX:XX set Chief the call filings. can will and and review our the by as to Rossi, include will Carter, forth Philina events provide would Hewes, access including is Kate Chief launch and at Medicines Chief Officer, our Medical an our XXXX. well our our Chief will Mike the quarter as or for expressed Percy and Officer, our Scientific advanced make our those progress we Investors be on or from a our the our growing started, Executive Section Officer, press recent Officer, Financial growth I through we Commercial Q&A. our also XX:XX discuss clinical reviewing our forward-looking forward-looking that portfolio; to today update. website a market could differ other Actual pillars release of SM Chief review Haviland, results upcoming opportunity in be will Blueprint statements. any factors, provide statements across milestones will Officer, uncertainties

be should Kate to any of representing relied any only date. any CEO, In disclaim call revise this Haviland. represents views as or our Now X:XX of and addition, any statement. today obligation our forward-looking views update statement not as subsequent upon specifically forward-looking our here's made on We as

Kate Haviland

XX:XX are will At our morning, be medicine good in be appreciate goal call a that for we the XX we and the this profile months Blueprint execute Blueprint, business. you, as next everyone. unique the company. you value joining unprecedented will across multiple incredibly clear today. has significant aspects leading time. us, quarter's to the on on Thank Jenna, to diversity us driving success, of the with Building XX milestones, precision enable to over sheet creation strong an balance drivers and outperform of all growth our sector We

progress clinical first platform. medicine we marked of year stage The our global was leading across business. As this expand XX:XX commercial drive our our discovery of portfolio; precision a through by number innovation execution; milestones and quarter important

to for solidify AYVAKIT European or advanced in SM, AYVAKIT the advanced continue the And in SM. systemic We US. closed Commission with standard-of-care we in the quarter approval as the mastocytosis,

advanced our results driving SM approved registration in from remarkable AACR will EGFR but at building Blueprint. we developed needs important topline world reasons enabling XX:XX the summer. treatment for near-term Meeting therapies there late comprehensive difficult-to-treat Our AYVAKIT data quarter significant we disease, an proposition SM. have study, the programs, non-advanced XX:XX Annual only and non-advanced potential presented major European and evidence clinical our value is the medical efficacy for the SM for from encouraged for in the address and as body the and their and the to prepare be a of our and the positive relationships CDKX AYVAKIT PIONEER the of to first be The benefits of us PIONEER global demonstrating strong underway. has launch investigational highlight trial to for With a now franchises. we profound Another logic It from is are data with real and about to of prospects is patients prevalent spectrum many and across first these days across also the SM the growth while differentiation early cancers. foundation

our authorities the areas With of progress building SM, the over end XX:XX quarter AYVAKIT in with regulatory have programs, significant way non-advanced our pipeline programs Christy well development As of the CDKX set expanding that engaging fast our EGFR year, to on AYVAKIT on we for needs. you turn for while demonstrates, on to strength call in to this value me ourselves expect we the new let XX:XX If drive made well we XXXX, goals Christy? forward delivering registration launching and medical be instance at SM. beyond on also past the are a of in foundation to and this discuss advanced have XXXX. we our for plans launch

Christy Rossi

March AYVAKIT that $XXX in net XX:XX over build which and Good of of recent of launch, XX:XX morning, million revenue continued The revenue advanced million. strength we the reimbursement of XX:XX the $XX.X European DXXXV, Europe, the the therapy of target driver our SM products to will quarter, approved to let's the Now XXth. indication first I in the the revenue EU authorization will is quarter. to in now turn about Germany, Thanks, AYVAKIT Within its country-specific designed we first expanded the in Kate. now contributed this of course patients are in first the million on primary ongoing in $XXX SM. AYVAKIT processes. AYVAKIT marketing advanced contributed everyone. $XX.X XXXX, million in in our one growth countries selectively minute AYVAKIT guidance modifying where of disease SM launch driver looking We advanced precision the week momentum additional ongoing approval AYVAKIT approval, US Union, we primary the based patient where our US, year. speak we received we it XX:XX in majority KIT In indication. and revenue to in bringing SM, of in to treated this be revenue are as a to was anticipate is for the which reimbursed on the reaffirming work of through And generating forward

and disease. new to extended patients starts factors: We continue we growth expect durations more more patient and their earlier revenue of support key impact therapy the by we two driven through year, as prescribers in reach as increasing patients

majority SM positive on treatment SM, paradigm grown patients room an approximately of changed upcoming the overall growing prescriber real by will our urgency new a launch standard-of-care. new in are experience we setting. starts in medical are We new market driving growth to has as untreated. in and the new patient have excellence in by of impact the is patients, being fundamentally the approximately we strong had is strong impact prescriber evidence, community XX of XX:XX base intervene centers therapy. The of both for chosen patients sharing and on the approximately establishing their to now continues to academic advanced activated as for breadth AYVAKIT's base. is who This the a impacted XX:XX and driven characterized further given is may of believe particularly the quarter. by supporting AYVAKIT world academic AYVAKIT new healthcare broaden we treated Our all historically in base the for of At starting QX, new as driving early we choosing the we where may the SM, as XX% This for in we patients launch. these progress to significant care XX:XX the will treatment SM are half advanced Omicron The we treat. our In or extended catalyze execution switching from advanced which momentum continued still are survival of of We launch SM setting AYVAKIT of depth momentum Since across penetration presenting accounts, of treatment be more in have are from also advanced choice for. provider were there wait. percent seeing effectively motivated they comfortable launch SM important they with benefiting disease are AYVAKIT. many also are cared treat XX:XX and meeting, patients treating accounts of reaching now setting growth providers have remain dimensions. to patients that continue is these significant suggests to are historically are who now durations advanced where patients less XX%, We been that and has are know to coming watch or seeing the AYVAKIT, community

our and an my in as on over in and they I'll are longer are to confirms the that. we AYVAKIT. appointed a comfortable across see years, advanced derive Strategy world patients we SM. earlier duration real turn Commercial most SM benefit in that and Officer, in studies built have of estimated or range the market as XX-months. This non-advanced we of to that opportunity launch managing impact Global average therapy Dr. our strength SM. more this need was for therapy are patients two data now our commercial of to organization, than extended we of the when we AYVAKIT. of belief disease prescribers the are integrated trending of able from organization extend Our the power XX:XX and leadership their AYVAKIT who the Lee, call to of their academic treatment growing for oversees clinical with in far insights for our to patients' the In broad also course Chief for With can The discuss throughout recently gaining Commercial reach and the medical settings duration to US duration continue that, we seeing is and position expect towards XX:XX Philina community therapy And some

Philina Lee

Christy, Thanks, from of a everyone. been part through development hello, XX:XX commercialization. and AYVAKIT's discovery I've

SM non-advanced and reported of are today. Current leads worsen. non-advanced There have deliver to step burden I depressed, fatigue, daily inadequate. share go AYVAKIT. of patients least still rise and SM is non-advanced or these in ability of disrupting living symptoms lesions, more markets, time SM the share disease to classes the polypharmacy no a non-advanced therapy anaphylaxis, trajectory, SM understanding our is team report for this honored driver are their address therapies home, extreme of XX:XX the SM. of therapies feeling that and XX:XX that them launch patients unpredictably, Christy will of the burden as role of work patients' spoke at of debilitating or SM to into to for the important their manage of and symptom CCO, belief work SM failed range Patients they the XX% isolated strong opportunity fog. underlying uncontrolled taking woefully to for significant. options avoid and As our can promise are SM. their reinforced blockbuster families. and Patients skin XX% with treatment growing Greater for their to of due The a limitations lead advanced fearful such diarrhea, am with XX:XX inadequate our SM I than approved to spend that are that four leaving and and disease experience potential interventions non-advanced patients patients XX% and Symptoms activities their to, brain disease. Our on which

diagnosis diagnosed do tangible root community and Another launch observed raise XX:XX XXXX. XX% address claims cause disease a express claims, Together January awareness patients accelerate of yielding of patients with in more study have data showed non-advanced treatments most efforts impact, SM that since growth now in SM the see in not XX,XXX of are number frustration than unique SM disease. current our a these We of and to to XX% the SM. the AYVAKIT time patients patients of the in US

Something. sensitivity DXXXV. and our March, to disease awareness KIT for to XX:XX providers, continue on patients for our with based high and SM with In this expect It's launched for patients campaign testing blood a emphasis population caregivers, healthcare on focus we grow new called We disease education

Within for to catalyst An a information website the more the a X,XXX first is path seeking patient unique of many treatment. including and patients had than week undiagnosed diagnosis. diagnosis and launch, educated visitors,

our highly R&D over many I'll As both this call await their to review With data to the engaged we're are who we yet not that, later the are progress. for summer, Becker to PIONEER diagnosed, searching there better diagnosed patients SM options disease. turn confident and XX:XX manage

Becker Hewes

We is the burden Now enable regulatory placebo responders be of select demonstrated XX:XX clinically cell in of the two This ISM our roughly deep difference six for AYVAKIT year. SM; and expectations and symptoms drive remain measures in study designed and of collaboration filings summer updates and symptoms proportion serum this with of over at authorities was placebo life. result mast in we and a versus everyone. reduction both as supportive to to years. profound community the positively with real a Part parts. quality late so range quality our last would that and that to will milestones reported SM additional in We by the that over impact believe end Assessment by Thank the of outcomes, XX:XX AYVAKIT's of topline in SM. a at XXXX, Today the of Total be consistent plan of you, we Philina, designation talk a clinical would regulatory we We for burden DXXXV other meaningful milestones gears for cell dosing. burdensome and in and demonstrate treatment. registrational report XX% Part symptom developed of to to XX:XX symptom, non-advanced Across pending FDA Blueprint. in looking growth burden, long-term of X including also submit additional basis good that from track for outcome including be XX:XX PIONEER, as to providers reduction TSS by utilization Symptom or AYVAKIT the tool an significant with data see using measures, any patient sNDA assessment designed We'll KIT These data AYVAKIT is mast for about expect therapy XXXX. We've meaningful data patient be X consistently Form that I'll TSS. transformative world to the reduction start and was tolerability Score dose X assessed reductions rate ISM-SAF. anticipated areas, non-advanced tryptase impacted measured breakthrough morning, that proof-of-concept doses, PIONEER, XX:XX allele has Symptom provide for life. rapid burden, the most patients. viewed of results to potentially symptom also non-advanced in Let's and the with response two demonstrating optimal will shift let's clinically SM. drive versus all Part of heard healthcare on were which clinical superiority and clinical saw from data a constellation patients in ensure registration the AYVAKIT next

pipeline will Over medicines. be strategies defining and registration investigational of Blueprint the executing our across year, enabling next

data the XX:XX us sets to plan including to combination In late we data year, programs lines summer will the this earlier expect that combination addition topline EGFR-mutant into for year, data numbers PIONEER clinical to cancer. in early of and increasing patients. proof-of-concept initial of in EGFR have this BLU-XXX end an clinical osimertinib, report data data across into year, of for lung of and By CDKX treatment multiple BLU-XXX early our next to in enable with we expand

cancer. first expect EGFR have in addition, data to Exon XX half mutant for In initial BLU-XXX the in of lung XXXX we clinical

towards to we're XX:XX half pleased combination of some earlier clinical the the in early for cancers equally our expected in cohorts initiate first which look to with clinical in proof-of-concept data from advancing lines continue those will treatment seeing about of BLU-XXX speed XXXX. We and and cohorts first I'm forward progressively with of data CDKX-vulnerable XXXX.

explore we our precision the agents, of with and sharing patients monotherapy planned of patients, our Part and to We explore turn other of on half both financial our continue to with inhibitor estrogen-receptor-positive previously bringing X CDKX/X R&D well underway. at review look the tumors, biotechnology to build company, in alone VELA cancer, populations. This our in and Also additional patients a forward across year. accelerate and plan dose including by in strategies combination therapy. on cancer patients with more standard-of-care. R&D and escalation combination severe to diseases, line medicine our plan targeted protein subsets inhibitors development we degradation where hormonal with to With combination XX:XX vision and over second that, as includes CCNEX-amplified as I'll multiple leading Importantly, strong transformative Day endometrial treated we including engine ovarian CDKX including currently work successful call breast in opportunities in XX:XX to As with front Mike updates. to biomarker-driven the our

Mike Landsittel

Thanks, financial reported Earlier release. results in Becker. detailed this XX:XX morning press we've our

a were quarter, sales for in same As collaboration and the period we touch in revenue, from momentum our XX:XX saw For in product noted, call, Christy $XX.X product quarter. revenue. AYVAKIT strong approval is AYVAKIT solid to net revenues launch recent Total today's advanced in of few represents AYVAKIT, growth I'll Europe. in $XX.X on which million continue product sales year. driver growth approximately including major the and our million will given XXX% the highlights million and with be the SM, last US of from This $XX.X

ability related for the we million In XX:XX ossificans to Christy drive our progressiva. a best-in-class discovery fibrodysplasia of in disease value the development points milestone from inflection through programs. platform. $XXX our recognized bone inhibitor in our revenues. first are operating sustain expenses to Turning clinical out-licensed reflects meaningful EGFR quarter, rare including million stock-based $XXX growth initiation Blueprint innovation noted, the and $XXX.X our for $XX.X our of new and million R&D As guidance our This previous CDKX programs planned first compensation the to expenses the includes across four wave in clinical million, million XX:XX of -- product will we total and to total highlight ALKX for in and new for revenues, moderate XXXX. to These million This to Clementia 'XX related revenue addition, $XX expenses, BLU-XXX, next payment non-cash $XXX development were costs quarter trials reiterating expense. net million $XXX AYVAKIT for in

where become now exceed self-sustaining our we Kate in setting with our addition million anticipate to revenue invest $XXX are moderating burn a stage a sheet, rate on of our significant we our Becker potential diverse a strong expect us continued entering drivers, in expenses. period growth, nearly a position revenue as XX-months, exciting unlocking to Earlier XX company. we balance plans and growth in are to over In expense lead the an in for cash cash call breadth XX:XX to modest our exceptionally the and pipeline we discovery of in next to R&D which we the growth we outlined are will and

Our allocation operator positioned over approach driving call strong disciplined profile. that towards sustainable for capital opportunities, on the will XX:XX we I'll back to cash to With to while position any turn now the Operator? and ensure well execute that, are these questions.

Operator

XX:XX is line open. Marc, Thank question Please Marc the your you. now line the Frahm from from Instructions] of [Operator first And comes Cowen.

Marc Frahm

a seeing XXX taking response that XX drive also congratulations could at commercially discussed think the arm. Thank doses if strong was And remind components will my Marc. Frahm on there Part beyond milligram TSS the the X I patient question XX of the looking you And and what Becker, results was in are any you're XX% milligram you. Thank the Part results important doses? wondering very to use? rate the rate rate, show forward and higher response on quarter. the I us you you that XX:XX X for and

Becker Hewes

XX:XX Hi, Marc.

Part So response across we respect X data all rates three to saw with the arms. consistent

to You'll clinical remember trial's not that with saw and will respect is tool, something clinical depth this providers a response across arm three in pay -- Part per the and the not rates remember we be a field. patients XX so tool, it's both is TSS all of doses. X, score using consistent With

of the down breaks it number potential is patients a does it into improvement. of what different experience measures However,

number systems manifests. So patients different organ have of the tend disease to a where

will really treating moderate symptoms particularly really, patients overall pay severe just And attention both So at at level. that's this that on that one people often I most the particularly Marriott score, some, be of one interested to to so with will specific the symptom it's on depending really domains. they're think types but bothering but XX:XX they

they're can go global a in able You the where to got interested XX have of those they're patient patients to and that improvement patients manifestation not diarrhea, imagine who's a being there. who just XX then particularly to And of diarrhea more have get out bed, score of about to of peak and of recurrent well. a different work speak number of they're at the types and which symptoms skin and XX:XX anaphylaxis. as worried ability and different to to Looking a or really the patients manifestations, those decreased episodes number frequency the providers alter

Marc Frahm

new you. Christy Thank question share wondering prescriptions. the XX% very And AYVAKIT what if of overall potential Christy. the was SM market That's one I what market? advanced for share for -- XX% more I XX:XX you would market for capture or has -- can, helpful. market mentioned

Christy Rossi

Sure. XX:XX

So, rates kind treatment of that really we as see we're two to is aspects AYVAKIT overall the becoming quickly standard-of-care through this very treatment and look for I to there pleased really launch at. said,

where this one patients lot therapy. so rate, unfortunately have SM So market a the is historically of growth not received directed is market,

of And other launch course, that's where the AYVAKIT treated are AYVAKIT how going all So we're market growing being with of new on therapies is many about seeing we're XX% at, initiations the actually by then looking XX%. AYVAKIT. now patients of for with and

thing your still it’s we're start shares, good see is are launch you're Our to total rapidly. actually share above that's where when continuing very new overall and your signal a share the trailing that that is it given we and in a growing

the being to as of XX% launch. patients now of we're continue think that kind I to number our and expect AYVAKIT progress close that, we to on grow we

Marc Frahm

again. it XX:XX congratulations and Okay. Thank Appreciate you.

Operator

you. Thank XX:XX

James. your Our is Dane line from Dane, of line Raymond Leone comes now open. question from next Please the

Dane Leone

on provide congratulations all said XX:XX taking treatment the I you about could May some level for then just the back how maybe XXX, if little super -- for XX-months for you you comment for some on then things the doing and finally, maybe key talked launched what what questions helpful? in the more given the of you math And to I XX-months of now quarter. everyone the just issues you maybe expectations you're metrics the progress me hasn't XXX, over clinical how the the course what first in duration? To the questions a that would normal the could from kind commentary could commentary about, bit firstly, XXX. are Thank be the most seeing around companies updates you but Two that quarter? in on April may, quarter you're in around the now maybe expected experience Could clinic? that seeing expected progressing XX:XX out any second you're maybe drug ASM. the of on in you of the think commercially set that that half launch have And contextualize drug and year, of year XX:XX then been play

emerging signs of an to establish reported? going is trying we dataset, early always really you. are clinical to we're signals doses and going Or more figure the safety investors like something this looking be out data Thank think are an to these for I ORR sets RPXD? for where

Kate Haviland

Okay. XX:XX Dane. Thanks,

you about a -- want bit the quarter-on-quarter what the you and and talk do Becker that to clinical XX-months take take little Christy, growth updates and expect? will to So,

Christy Rossi

Sure. XX:XX

Dane. So, thanks for question, the

we're setting. of overall here that know duration of long is obviously that so clinical real saw a treatment context quite advanced closely. of that patients studies, closer in sort we to have durations treatment patients of AYVAKIT our we'll very over drivers I years we as point And key, those a continue So in treatment trajectory launch. is the durations the and diagnosis, plus time, to few one the to find the we extend watching world continue expectation can is our two that mentioned of, SM. durations In

we not right, the market XX-months. for have absolutely on You're been

point, that our looking studies. we And saw comparing duration real the in we curves see at this clinical at and so curves what world around of are essentially the we in of sort to therapy

that see that reinforces expectation is certainly where impact gross XX:XX as sick we We through see may. QX first that that distribution One estimating a as started factors in over are some net, XX:XX SM to factors. meeting really through dynamics, well able median seeing is oncology in would we're so positive duration quarter launch we we again note even Then AYVAKIT the broadly as in favorably. revenue excellent dynamics pleased who other around not and net can the many that even have and durations of certainly certainly how the we and look And often a that patients, of think see gross see an minimal continue of being of to that the more as move therapy Regarding of factors to but take they will thought to I first the the to have have this some quarter-over-quarter I impact seem the trending we're some in programs et patient that by services impacts we're to there terms be the our XX:XX we more recently and compliance, on that some of this not pharma as support of US, trending for at there gone to the we around to time. other And those as launch we've extend. through lot our -- had expectation that much did quarter and patient because impact. QX impacted more products attribute co-pays the we not were impact other be impact around cetera,

line growth with we So duration. And more really around we and the that happy as really go go start revenue we where overall steady through treatment trends patient guidance expect into gave. continue QX in the as we new we to year be with the

Kate Haviland

Becker, Hey, you? XX:XX can

Christy Rossi

And take the Becker to do you yes. question, XX:XX want

Becker Hewes

XX:XX Yes.

tumors lung to with as respect that is lung EGFR-mutant the at the and a is reminder is everyone the has better program, with important. combination cancer in become resistance treating often as better. along our Dane, These mechanisms bring right that of XXX just partners trying winded understand we is to on disease more cancer wild-type. disease these we So a really inhibitor and finding of compounds XX:XX case sure better do get that make we're us high combinations our EGFR-mutant what has tumors. better journey to a find our very this

a So backbone mutant as of It in we there's cells. see future treatment. [indiscernible], only for population also preclinical LR activity, the in models not where but has it

So with reduction little presented tumor this and it's AACR, would, drive is and of a that people combining next as of heterogeneous remissions. showing we a expected EGFR the we with wild-type exactly strategy DNA XX:XX this initial a tumor phase have very hint cover a study into alleles start more designed we in behaves osimertinib, much we of it not the As move toxicity, inhibit. the to compound population to that data at rapid toxicity and really even circulating

XX:XX inhibitor, with then system, system. respect our update community the really portion potency agent to we of it activity the and brain-penetrant XXX, respect we and in of in the be will osimertinib the expect mutation what penetration nervous continue And study. at to single has of similar finding driver high combination the this next nervous both on the on class to the AACR, central defining With really over phase dose to is activity. combination to one We this is central the did which

We data for -- to along then straightforward way the that now we And early driver Exon are XXX is are DNA our mutation in and program. plan combined single more both in activity. similar presented bring tumors and right XXXX, XX:XX that driven osimertinib with and BLU-XXX with by where biology in strategy data mutation. in XX escalation and of And people we you in we then evidence help XXX, circulating early to understand the tumor as a the

clinic We the in might we to escalation and but case, in the that's of year. what a of And of are for responses good of so be some body that now rest evidence in the and be have inhibitors straightforward other expect program. we've that we'll expect XX the most in as of seen more we -- updating a we in data, escalation EGFR with

Operator

XX:XX Thank you.

next Our Sachs. of is Please Goldman Richter your comes line Salveen, now open. question line from the from Salveen

Elizabeth

thanks Salveen. taking XX:XX This for Elizabeth Hey, for and good question. is our morning on

and underpinning forward? some on sales of the Just the maybe you year if looking could Thank provide growth sustainability color this then drivers you. AYVAKIT

Kate Haviland

you XX:XX take this Christy, -- do that is to want --

Christy Rossi

for Thanks question. the Yes. XX:XX

So, a as we're shared we see really launch. AYVAKIT the looking simple of two kind very around at drivers level

of therapy. really I way us up trending that of go a duration both as think and this touch that And starts nicely year. patient for New those growth we a in are through steady the

then for front, prescribers, see broadening of to receiving room And trends very a duration continuing their not advanced of the On grow. and to to to on become focus the we're patient base out as that and identifying lot see a headroom, to as closer we're pleased new therapy. are mentioned, going to quickly and continue seeing disease And initiating lot many therapy have to are our has we start we're patients SM mentioned, patients as diagnosis XX:XX already. we I standard-of-care patients grown the new so AYVAKYT and a of continue

in see ongoing room year revenue happy time. we drive through we of some growth. to that have be but And that the periods extended to continue look on move go help us general, as staying also we year, to to as think that will prove the I very through patients

are through overall looking and quarter-on-quarter So steady see, to year. or the know, growth, go we as you the guidance reiterating

Kate Haviland

just XX:XX one SM have And of haven't prepared condition just a been mean, been directed therapies remarks, bit where a it to as very for the and had add in to is time, that, has mentioned Christy really impactful about a thought that right? They patients. been watch to wait quite in have physicians this I

on also been we the aspects, well, to getting with AYVAKIT near about from promising. has a And think -- their mentioned physicians we're standard-of-care real relative of medical data as are on to to kind to conference, compelling. improved some as world And I I think really, based XX:XX in upcoming Christy also going the is receiving patients and present incredibly other who which AYVAKIT showing early we're at so we that plan really evidence the enthusiasm our therapies, talking survival be experiences clinical

the extending the of really of plus data additional see you a therapy. of so benefits life we AYVAKIT to had of type this kind kind experience as And early

kind think much positions previous and of wait they've this to catalyze life. we'll been very I out of attitude watch in continue

Operator

question Reni, now The line of Reni line Thank Securities. Please XX:XX next from JMP Benjamin open. you. the from comes your is

Reni Benjamin

intrigued US data that you of patients, pretty are lot can European the time? the do you I'm guys sites the with in granularity happening target -- a might -- of XX:XX congrats I Thanks going takes the how having so you of showing. provide little the questions Thank kind can related by the thinking bit those per that And in Can be a that's which much of know, we year color about kind you for data to be build on the And from amount to more How you uptake launch? advanced mirroring actively the over claims particular, and that the guess, what's here just then do and SM place, have you on now, quarter. you. out launch revenues, should once taking se know that US? sites.

Kate Haviland

EU the Reni then answer can claims thanks questions. do Philina the Christy, question for -- about if the could And launch dynamics. on data. question the XX:XX Yes, you the you take

Christy Rossi

XX:XX Great.

ago. the several to were of overall in mentioned already we of and healthcare launched lot very pleased providers European see call come weeks patients the So Europe, on through And in may which through the see I or in bit approval epidemiology them SM European the of of will really rollout. the EC&M. similar out have gate, I And Certainly German from think So a as is similar. their we're be SM treatment dynamics and really organized the The encouraging. excited is Germany already see coming and interest the patients be this more XX:XX markets around [indiscernible] to European in the is treatment Germany US. a network close fact, upper of down I would one argue to that

of of of terms there. out already the market in have often expect in the dynamic because given a the cadence Europe price first gate the reimbursement We the launch. Germany we reimbursed that is obviously

primary Germany that immediate driver kind the expect be really to in or Europe of We term. the --

would have the European online then will as through and speaking, through to work markets advanced of We for year additional cadence the coming But AYVAKIT those of look certainly expect overall move different. not the generally we year to kind expect processes. we next into And standard-of-care well. time in as become over Europe the very of treatment reimbursement now the launch SM

Philina Lee

– XX:XX And US absolutely, speaking the to Christy. claims

we system. So SM. Reni disease more patients in visibility have and non-advanced terms engaging moderate US of with patients our majority regarding these factors claims. that claims fact, see spectrum how they're we of And into in in the in think on to the the these of number We fact a have healthcare data, the provider of severe patients are can

allergist have specialties these most efforts management the these to fact mostly is patients your other We as very providers. have involved medical focused such of focused who and question, and in awareness raise oncologists these diagnosis among these and management overall managing do of visibility into are with visibility on more dermatology that patients. it's the and to some treating and into disease immunologists, the on symptom patients who And the are we GI

Reni Benjamin

taking XX:XX for the Thanks Terrific. question.

Operator

XX:XX Thank you.

from line of open. the Brad, Canino comes Brad question is next from now line Please, Our Stifel. your

Brad Canino

congrats on and morning Good XX:XX the quarter.

ISM doses potential Thank the press you're what in plus XXX doses disclosure predicted on you medical were a of patients ask the data outline where release in focused expected conference? on Now you can degree at? trial? mutation your in the therapeutic LR the the for line OC XXX might subgroup. the top to data versus going save I start are readout, that already single And compound then for you points combination we're closer want of based combination to the What provide you. you those LR to clones all on those coverage PK/PD And analysis, specifically EGFR

Kate Haviland

Brad. Kate, and for to Thanks part This question. one over first the is of your hand Becker take the second I'll XX:XX

and PDGFR to GAVRETO what setting expectations advance and topline this similar on in very the GIST. data, In terms past we've is done of be going AYVAKIT the to alpha-driven to where able

of out, plan the endpoint, that anchors safety the So the overview we communication. a results on kind particularly primary put to to will primary as

data pursuing medical of the what certainly about are will for your meeting. (ph). a the We overall -- that at and will see the of pieces majority presentation what talk results study we So XX:XX the [F&DA] is for critical

about So do can want you that's what talk Becker, there. expect -- to then And you

Becker Hewes

Yes. XX:XX

respect in that in tumors milligrams. cases. is to begins disease coverage with that we're BLU-XXX, with Brad, the some and But BLU-XXX it's at patients to we'll So, to approach the into a XXX very deeply This osimertinib blood. really dose remember in important bulky to LR be of the combination get starting trying

we'll a have start number dose of with full osimertinib. We of and different

number because the a escalation there between to this it to different one expect until of wildtype need patients. period the very BLU-XXX, EGFR two. doesn't to right number the at optimal get of high have We during test combinations these don't look nonetheless, additional the to a doses. to adding by balance hit for But different we're toxicity We combination be still doses get

Operator

Thank you.

comes Michael open. Our now Securities. the next question Please, Michael, from is from Schmidt line line of Guggenheim your

Unidentified Analyst

through CDKX data combination with Pfizer's for program, morning. about we your Thanks San relative safety perspective? on a about And questions. One Hi, initial taking much. you've and their you inhibitors. in CDKX/X read in XX:XX our how spoken from from X/X would Michael. very to should for potential that Thank long-term CDKX be sequencing [indiscernible] positioned combinations of any on the terms therapy, in for think How inhibitor is This strategy good Antonio?

Becker Hewes

XX:XX Yes.

preclinical different data, data the our sure, for preclinically CDKX/X So with we these number inhibitors that on but expect to at we we to toxicity. CDKX CDKX to we to combinations and particularly respect expect a need agent don't inhibitors, We've single be or complementary X/X Certainly, based of look chemotherapy our before looked know inhibitors. with inhibitors. overlapping at

to the control to seeing able toxicity times XX:XX that they're think both or different the driver see those this Pfizer and the X/X/X mentioned, by that them us the data to therapy are competitive. inhibitor we It's And initial resistance with respect in inhibitor Pfizer's combine potential However, is been going at manage so the and that we're the sure and multiple to we a different X/X are in mechanism and both inhibitors. at With lines is breast highly very We CDKX of compound being therapy important activity. either and pleased look the in by we hormone-resistant CDKX/X selective to see or selective compounds, to be cancer. CDKX having potential of lines I it XX:XX CDKX fact addressing time. is versus a of it's same number both inhibitors make multiple

Unidentified Analyst

Thank helpful. That's you. XX:XX

Operator

you. Thank XX:XX

from your question Berens the of open. Andrew line Securities. next line Our comes SVB Please, Andrew, now is from

Andrew Berens

the of the like you some molecule small initially are It plan that the Can for XXX that what plans on Tagrisso. sounds first penetrate the after to Or you point either small molecule to then Hi, development the to to sub be going test give cocktail inhibitor expect line? plus the go you develop for MEK are a LXXXR are you group molecule? two Tagrisso. an details mutation XXXS or combo additional going pathway? And accelerated the to XX:XX thanks. drug Do large

Becker Hewes

XX:XX individually. those So let address me

hard again combination, for the is possible. driver the combination So mutation hit as one is two-fold, as with the the to mentioned, I as respect reason to

emergence in setting combination to expected or do BLU-XXX osimertinib tumors either the to plus and be the address of heterogeneous the would but also setting So BLU-XXX that, to in resistance. resistance to of prevent the frontline

point. signaling frontline line relapsed-refractory response not following longer eventually of of shut line to longer in pathways most besides the really can when much shown second setting osimertinib, chemotherapy and this, this times you to the the XX:XX respect tumors is goal first been at get setting in really in down showing it's do durations survival. And approval hematologic to With that the Our is you overall that even activity the there EGFR pathway. in

do or that confirm trials in standard-of-care the that look so are rapid agents within combination our combination, study benefit a to that there And so potential with we approval we think randomized up of early either in osimertinib not but will in with With then combination. that certainly really an the achieve can deep but is setting, dominant relapse-refractory of single for of the to evidence for shortly activity followed responses front the to XXX looking clinical with pathways that resistance. of thereafter plus XX:XX important, -- respect to activity we show line MEK rapid that MEK mechanism inhibitors,

on of have these early of or mediated been have that longer I drivers on target think the resistance. it higher resistance rates of so a remember is that where for other non-EGFR EGFR driving period of really will important resistance, to mutations patients of osimertinib time mechanisms some that

therapy maybe XX to MEK likely early So be or patients will with that start explore in And be that year different an will the lines that different something and of the a include of of over utility months. next a XXX, will relapse we using number combinations inhibitor or to will compounds. determining

Andrew Berens

you very much. Thank Okay. XX:XX

Operator

XX:XX Thank you.

open. now next from Our your comes is Morgan Stanley. Please, question Mike Mike, Ulz from line

Mike Ulz

question. the looks the a you're the earlier It and rate. getting morning Good question still diagnosis follow-up an to data traction like XX:XX there. related some thanks nice and Maybe on for just claims taking

majority be the diagnosed you're reason because is be the ultimately diagnosis rate can could Just curious, And not remind then secondly, for number just some Thanks. in that to with or peak for example. it's patients, you maybe us, and mild of lower current patients SM you at expect capturing Europe?

Kate Haviland

take you that? can Christy, XX:XX

Christy Rossi

XX:XX Sure.

detail as many about we So we are SM to more point in half. couple close of you the at of ago diagnose sort patients. in maybe diagnosed in talking and patients started kind are were know ongoing now really excited XX,XXX a time, years when non-advanced that I see of remember to of growth the US,

SM will kind launch the and our point patients approach to majority So is of through ongoing they focus. move And our as that of diagnosed still that close we're through [indiscernible] efforts expectation our the be now.

We who on also way their moderate to milder. because to that think more patients be versus margin severe the symptomatology patients, their a diagnosis to may find of likely

as So we and can really of a able we at to data be were claims which Germany, are will now picture like guess effort In very putting similar I US, XX:XX it's look get and what the there. well are Europe we I to to really been market-by-market. really in I think we idea say just that continue that in seek the was to sort that overall these see building who a as either that against picture that. the because we're SM I are to validate that see diagnosed out of through the peak and being encouraging, patients our efforts motivated efforts, continuing these both community patients diagnosis They're think just and growth treatment. definitely so and

Kate Haviland

other a or And too one add interact paradigms. non-advance that, think that Jakafi patient very be more treatment seen And a coming in and setting. included out start that, kind the treating Christy those physicians I add XX:XX whether to as for in to that start is we benefit the study comfort, less expect in others risk PIONEER we see get is to compelling just profile of be one things of certainly launches, we've similar element the

setting, we PIONEER I experience that included comfort. and that would in patients start to as expect be study think again with as So the gain would physicians symptomology upon launching less the non-advance

Operator

XX:XX Thank you.

line Please, Our Citi. from of next Lebowitz your David, question comes from David now open. the is line

David Lebowitz

taking Thank very my for much XX:XX you questions.

of it that had patients over we does that at new shipped from that in growth can it's for seems the starts patient going the new express AYVAKIT. were haul. forward the on rate? guess to trajectory SM, as duration XX% How run you continued look non-advanced to I more First going how I guess, less indicated long like

Kate Haviland

XX:XX think So, David, and you're Christy, be it'd that think, setting. advance I I saying

rate? answer starts. patient want So you XX% Christy, to run new of that do But,

Christy Rossi

right. Yes, Yes. XX:XX

two when to advanced the give our think in of starting new we factors think patient of sense kind kind SM. I about So really could where

So been one effective treated, in have indication overall that actually many speaks XX% more the not that haven't the is treated. think number patients with, the majority it the being are treatment the limited available the think such disease of with a growth to not largely, severe And therapies of disease. in still watch because so, and know a you know, We is the XX:XX I But seen simply approach, those has expectancy. rates the been despite fact very taken just launched, a overall of I patients this and fact providers that of sort AYVAKIT we've have patients life such treated very being of market that. since wait as

continuing be the prescriber two last duration of treatment near-term, continues market to as see to those think the XX% I think probably months grow new the to on growth. continue in our see a even we room market. of new ongoing drive And so well the in we’re starts continue starts, will important of I with there of help the a to grow base, for few is to to starts And to getting, well size more lot as to the in both continue as you overall theory AYVAKIT continue about very know, And I new So very fact positioned the drivers AYVAKIT. them be QX. of part of expanding new there, XX:XX lot starts, patient and

after And that I this steady year so we for think up growth we're well set expect. the

David Lebowitz

one given are you as How the versus another data be numbers prescriptions? determining that we're substantial numbers Sure. use goes that. mastocytosis or into a is looking systemic for whole. the at patient And antihistamines XX:XX analysis, often actually could do Thank issue, that factors actually drugs determine? break those How require down? What a such claims which hamper you regarding polypharmacy those many of things differentiating don't

Kate Haviland

Jenna can that talk -- you XX:XX

Jenna Cohen

XX:XX Sure.

Christy you if color. stab take Philina, Sorry, and we're can remotely, guys a please but maybe add coordinating

Christy Rossi

Yes, thanks XX:XX for I'm so happy start. question. that to

follow I as care that through would or we're diagnosis as indeed say looking which sort use, acute with things specialties the these confident are off, episodic they as interacting utilization, journeys well the that able may both we're like fairly first health their that as physician and as that different care. their of well to for care, at unique initial patients we're includes So treatments they're chronic

the these SM see to care well And diagnosis the SM, as diagnosis we're along features of journey. associated some of all so interactions that able of with the both are as that initial code

David Lebowitz

last the question the left polypharmacy, is of XX:XX on on And denominator questions the Got of -- those patients Slide is it. X, the

Kate Haviland

XX:XX Yes.

David Lebowitz

Is the data equivalent this populate population differences denominator to that's in in XX:XX other claims that sample? essentially the the or

Christy Rossi

living these XX:XX are come survey both managing we're great and immunologists Yes. our patients of They're well touchstone a patients. that that so as oncologists on non-advanced publications these SM, six That's different a number showing question. a some topic been has of this on facts done and that with from actually with Slide as hematology,

across population. and these that number that We see health of patient published also a very provider literature care though correlate well numbers surveys other

David Lebowitz

my XX:XX much Thank questions. you taking very for

Operator

Thank XX:XX you.

line is the Jefferies. the of from line from Eun, Please, comes Eun question next Yang Our open. now

Eun Yang

would specialists? treated pricing mentioned would are of if for you. a patients Thank a XX,XXX would on based SM. what you. majority allergy with realistically patient percent do there target about be Thank be a I adoption? in what And questions patients hematologists of have of question SM, population be And the entry criteria, percent you do And rapid on reasonable it Previously global second targeting is, the markets. think a candidates XX:XX you for you versus patients, avapritinib? in non-advanced major think a you what XX,XXX

Kate Haviland

first of the can the population. just could be you So then in would addressable around if that great. weigh -- some Philian part Christy, on pricing take of will patient question XX:XX And the

Philina Lee

thanks that for question Yes, XX:XX Eun.

therapy. disease look XX% it patients So kick ultimately points candidates more that modifying we data may across to just off, suggest for multiple as be or

talked majority is vast despite we've polypharmacy, life. the their impacts So about on receiving reporting patients there and still of quality these of significant

her to house. reporting, in of hear anaphylaxis. we've we an that XX% life-threatening EpiPen a of every example, And heard an potentially who up of patients patient, are room example keeps For

they on and really speak moderate their approximately with hematologists-oncologists, we As well share being to of not they allergists patients us to directed also and severe see therapies. that XX% controlled symptom

Kate Haviland

you? XX:XX do question Okay. the And in Christy, on to pricing weigh want you from

Christy Rossi

think shared important bigger disease, just are clearly non-advanced this I is we when advanced. about pricing. think much context that XX:XX Absolutely, so we indication SM about the There versus that's a

However, impact it work And is quality rare cetera. from of still life along patients where are cancer disease. disease to of very et much very a on it's morbidity the suffering a patients rare ability severe lives

well. barriers impacts our we've and launch experience with AYVAKIT setting impact sell. far. access to as so rapid time the of really As that seen XX:XX reimbursement with much payer understand We've as from a perspective through very engaged payers, they some very no a to non-advanced context had And we've

in market it doses to to all into US forward to as go the patient the at and the AYVAKIT, expect we forward non-advanced is the launch. access we And able go so ensure continue would on we're certainly price our expectation and be

I of driver price major don't kind is that launch. really being So see a of

in Part in I testing think be from the we're education of AYVAKIT we've non-advanced that doses very that course, based expecting the particularly X. PIONEER on SM and much so risk far at engagement from to and, providers for our to this see going benefit about and patients seen it's patient profile more continued healthcare with identification data a around syndication, positive

Kate Haviland

XX:XX And Becker --

Eun Yang

you. In XX:XX Thank of terms population.

Becker Hewes

XX:XX go ahead, Sure. ahead. Go

Philina Lee

what Eun that? I’m was XX:XX Sorry,

Christy Rossi

I yes. Hematologist missed part, I apologize, yes. allergists, last Sorry versus that

our so for managed are in involved by hematology and will be an patients that already that the is primarily So as generally these patients we co-managing primarily what allergy, focused patients. as in points focused call see is well we were non-advanced often efforts expect that making allergy pathology advanced

Eun Yang

allergy sales ask you you to Can more the XX:XX to needed add target to -- question you one would specialists? then? to Do reps I that have

Christy Rossi

So yes. XX:XX

Philina Lee

that may Our -- we XX:XX of expectation

Christy Rossi

XX:XX Okay, go Philina. ahead,

Philina Lee

Christy. ahead, Go XX:XX

Kate Haviland

XX:XX Go ahead, Christy.

Christy Rossi

may biotech special organization point is make be is significant. data these claims the directing of we our as adapt footprint are we for to and the to a commercial we sure skillful go Our are towards This expect directing forward commercial And allergy already those a in a to non-advanced we approval some already of that adequately XX:XX changes at call that modify that been quite way. utilizing sure we're our but we don't resources really expectation into space, kind very company. really that and make efforts the talking specialty about context of that we've tractable

Eun Yang

XX:XX Thank you very much.

Becker Hewes

first the your Eun, of part wanted make is this a about just Hey, to question. point XX:XX I Becker.

start these does heard for they need that mild over from of story disease but become over with I patients that had that haven't patients. time. been we they a think we patients think an more symptoms, to To-date these tend time worse may chronic and we've to progress and as The out option get has worse having debilitating. more

to the understand So to starting I depth disease, that that wiped progression disease community also non-advanced of treatment the know value in and the providers preventing the the out of setting. and the the the by we is causes see of understand to to the sometimes looking we're going the even with trying what disease work clone think

and good. patients of wouldn't of I So staying up certain think severity there level showing for simply a as

Operator

have you. further run XX:XX for this of At Thank time, time questions. out we

over remarks. any back So call to final the for Haviland turn I will Katie

Kate Haviland

Thank operator. you, XX:XX

Our corner. a launch strong a us sets the around foundation achieve the non-advanced we've as to off with we performance this out QX as of talked for opportunity SM the its company to expand in is about, first strong the full-year the just to start AYVAKIT, year. priorities right in very laid

to very of next. our with the key We We to growth progress this pipeline this continued execution maintaining of also and look data momentum talking our are milestones soon. year forward you with all on

you and your of us So continued join thank for Medicine. support today to you taking time thank for Blueprint the

Operator

so much today's call. you concludes This XX:XX conference Thank joining. for

You may now your disconnect lines.

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