Deciphera Pharmaceuticals (DCPH) 9 Aug 232023 Q2 Earnings call transcript

Good morning, everyone, and welcome to the Deciphera Pharmaceuticals Second Quarter 2023 Financial Results Conference Call. Today's call is being recorded.

At this time, I would like to turn the call over to Jen Larson, Senior Vice President of Finance and Investor Relations. Jen?

Thank you, operator. for financial today results. you second discuss thank XXXX quarter and joining to us Deciphera's Welcome, I'm Finance and Larson, Investor Jen Senior Relations. Vice President of and Chief update Tucker Officer. this a Dan and International; Martin, me morning and Officer; discuss Kelly, Margarida Officer; financial With Matt Duarte, Commercial Sherman, of to Chief Executive Financial general Officer; Steve are results corporate Chief Hoerter, Medical President Chief the provide Head

make on we made that for we of commercialization Before expectations harbor our our I QINLOCK any historical Private not Act to guidance. would pursuant the Examples Litigation Securities our safe statements of and call you remind this preclinical facts begin, like the provisions forward-looking and are of include programs, XXXX. Reform that statements are to clinical

uncertainties risks include assume results no in you as revise other Forward-looking or We filings. risks expressed we achieved. expectations by could on our SEC uncertainties well and to materially as Such differ update statements from cannot XX-Q statements. report quarterly that involve our and to those any statements, those obligation cause substantial or Form be assure and the forward-looking recent our most implied will forth that actual forward-looking set

available call, a replay the Following this www.deciphera.com. will on website, be company's

Steve? With that, call Deciphera. turn Chief of now over the to I and will Officer Steve Hoerter, Executive President

work so we dedicated provide and from far progress the to good Jen, team results and year. of to We've Deciphera. update morning, everyone. today our Thank exceptional an thanks you, XXXX, rest made as at joining second Thank our forward the for quarter, you the in of look financial review tremendous the us

XX% by quarter drive over generated business increase strong QINLOCK, an QX million in results, Our which to QX year. continues last a revenue, record highlighted over $XX for commercial

opening and the XX by first we the patients include We XX circulating or sites grow patients QINLOCK label mutations, Exon encore at KIT we milestone study DNA Annual XX and to an Phase toward INSIGHT the announce expanding believe featured can and today significantly goal. Phase with the brand the GIST line important The in study. of of INTRIGUE from GIST The are pleased analysis III to that an second-line Meeting. results the of the presentation second tumor were III of XXXX for compelling ASCO QINLOCK that exploratory

new sNDA. to serve designed the feedback physicians in is continue data who eager which basis INSIGHT generate These are as very to positive to or enroll drug study, application, a supplemental the from for patients

also are for X with and announce we that ripretinib. and to encorafenib initiated today We proud have new DCC-XXXX, cohorts cetuximab combination with

cohorts. in Association At DCC-XXXX, will the pipeline, both XXXX On data expect pathway. from IND the new excited escalation additional we share and Phase of program, data update American Meeting first the today's of posters We're escalation the Cancer our initial a including including in for the call, first of combination pan-KIT Research to I program file generate from our early-stage presented April, inhibitor, we to XXXX. we potential this data autophagy disclosure first-in-class on which half agent the single the X from an targeting Annual

control candidates with presented sustained product and of generate highlighted proven we productivity our and potential. switch AACR data The at its to the kinase engine ability first research best-in-class

the tumor giant the are top III vimseltinib we cell MOTION the second inhibitor. half of moving line best-in-class for submission as pivotal an tenosynovial we year ahead, looking study and DCC-XXXX, and readout Phase for the approach into pan-RAF IND of are Now exciting potential

working decades almost where to to retirement. has thank and found in Officer, best in Founder it of an whose On his and Chief announced today. the the is innovations his Deciphera honor to wish very I to ago control Scientific It Dan, Dan company moment our for and inhibition, been have recognize kinase X Deciphera Now brought alongside team, switch behalf our entire trailblazing his last want I'd like to I which him was take vision retirement a Flynn, week. him

excited Dash Scientific Officer, Deciphera Head Insight Dan new the background Martin, brings of Europe. was over President of for most and welcome Vice Dash Dhanak, share and drug commercial Scientific a GIST Margarida an on next Officer. Officer Executive the We're an month. Duarte, quarter; to will provide QINLOCK's On Chief our our fourth-line International, XX exceptional Commercial years on he recently Dr. ongoing where Corporation, update experience insights as will our from call, in in performance today's with as leader Chief second Chief U.S. joins and launch discovery

Matt efforts, our data will Chief our provide Sherman, Phase an update Medical I/II including on Officer, DCC-XXXX the from study. R&D

will Chief Finally, the Officer, financial the Tucker Financial Kelly, review our second from quarter. results

discuss I'll our QX commercial Dan? First, the to turn performance. Margarida Dan to over call and

for our brand QX second million record and launch-to-date of Steve. revenue XX% We in quarter of represents versus which net the terms revenue product core QINLOCK XX% a of achieved Thanks, many U.S. product increase XXXX. a in quarter, increase in as a was U.S. highs year-over-year the well QX net versus metrics. as QX $XX.X was

of drivers growth, average duration saw demand, During new core including continued of prescriber momentum in patient therapy. we acquisition the and new quarter,

as Together, driven drove factors bounced QX we QX. volume in the softness growth the strong in from demand back saw seasonality these

in slightly slightly declined quarter-over-quarter. whereas QX, versus net path QX increased gross Additionally,

high positive very physicians. and commercial both academic the a among awareness Our and this high execute any and perceptions delivering at reach continues level, again, highest frequency team product market of shareholders and in to maintaining company

QINLOCK very QX, to pace. New prescribers launched product consistent In a date. we at continued surpassed has prescriber X,XXX

to that country. sit continue and many had clear in the in sarcoma the opportunity market ASCO is June, firmly the Our of At leading with to across KOL highlight research as GIST. fourth-line interactions entrenched QINLOCK from down care of standard experts the we

KOLs experience with efficacy impressive be to which in and challenging can that and year. with or combination QINLOCK patients. for the clinical the U.S. of positive second highlighted tremendous to commercial patients In QINLOCK continuing has very in the their remain tolerability, half execution forward is our QINLOCK highlighted a pleased momentum receiving We they strong consistently KOLs impact the GIST the particular, look noted deliver to sunitinib and their regorafenib.

We estimated see with to the to expect of to near percentage balanced continued path. XX%. years, QX a expect Consistent demand prior of path and growth increases modest end be XX% in high our range in we in QX with

over we our to Head required Margarida? reduction the launch inflation Europe. discuss in progress by see of In Margarida of to inflation net to the rebates the higher act. I to gross the Medicare Duarte, addition, International, QX the now turn expect call to modestly related in QINLOCK will

the business international Thanks, Dan. excited We with in the Europe. launch strength of QINLOCK of momentum remain very the and

entry quarter, growth second by revenue successful from pricing driven of the and Germany $X.X partially continued a the year, XXXX Europe period the markets outside For orders in offset Europe. million, distributor was up of in by following international prior price free by lower volume the $X.X and the from in in expiration from million monthly timing

fourth-line medical based strong setting. we and dispersed well work received its to the more benefit see on to to GIST. as unlock be in In and high in Europe significant and patients need fragmented we physicians Germany, opportunity very demand community continues a the unmet unprecedented continue by in QINLOCK

strong continues the work with the the in we On the reimbursement on for Germany, diligently and to Spain, United pricing authorities achieving of achieved France, Kingdom team heels QINLOCK in elsewhere.

announce Last to to today, we that shared launch the close we and very are coming delighted quarter, that months, to launch. we we expected in QINLOCK Italy are

forward for waiting shortly. successfully getting IFO of in the finalized and the look resolution is in publication have step We the launch. negotiation QINLOCK hands are before patients the gazette, the the We official process in reimbursement last Italy which to of

agreement step to Turning to to in the supports reimbursement. our of finalize were the of the listing first QINLOCK successfully work Pharmaceutical are access is the already Canada reimbursement negotiations provinces and in completed. public to world QINLOCK we with and the by GIST. excited in major public the pan-Canadian with Alliance rest enabling provinces in fourth-line available Canadian is that ones a with and remaining patients continues Canada partner broad The

all, in the revenue growth in continue positive recently reimbursement markets. expect international to agreements are for world initial we Additionally, we very our All developments, alongside and pleased from as and approval grow QINLOCK launch the received to to have are these around approvals Singapore. our achieved are

I will on now turn update provide clinical the call over to an Matt to Matt? programs. our

Thanks, Margarida.

clinical to success There complement continue and preclinical across for DCC-XXXX. growing substantial the commercial of top a position solidify Deciphera of oncology of to all company. from of and as study to pipeline enabling its the cohorts opening at III programs, is to progress We MOTION Phase excitement the our results stages upcoming the leading of our the with INSIGHT trial our line start pipeline

to confident cancer. we about capabilities apply have to prospects benefit commercial I'm the patients and discovery, with our development

First, with a is I'd first-in-class cancers. like to agent our range to DCC-XXXX program. across start be wide designed combination backbone a of XXXX

continued we cetuximab both we forward that we combination As the and with for to for as of the to Steve today first XXXX mentioned of to work new to encorafenib cohorts, have cancer. look concept opened treat excited clinical progress announce autophagy site earlier, mediated XX are second ripretinib. We X and one demonstrate proof the inhibition

of the ESMO the that the cohorts. cohorts. single At initial Moving updated the and now update study. from discuss escalation presented BID the at of XX escalation initial our data dose combination striving year, last single-agent part with of selected for the we to dose patients both clinical XXXX on Phase data first milligrams I/II agent combination escalation XX In

dose well single-agent I'll XX XX In from milligrams to the first on BID observed ESMO at data dose the includes And dose-limiting additional to X provide with remain tolerated patients, data doses prior XXX escalation X ALT with a have full single-agent XXXX Grade AE the brief milligrams increase patients. reached. disclosed XXX XX only we profile milligrams update generated tolerated from additional that at a be toxicity was was no BID at BID. maximum consistent The shown XXXX.

combination pharmacokinetic exposure appeared profile the approach exposure XXXX associated BID BID in exposure shows with demonstrate with increased At continued to the XXXX profile that XXXX to The XXX The XXX PK between plateau. milligrams anticancer milligrams associated doses XX efficacy updated the preclinical of dose and studies. variability.

to effects continue in were that We efficacy associated preclinical pharmacodynamic anticancer studies. with see

evaluating began binimetinib and X end XXXX of the in sotorasib we At solid year, tumors. MEK last inhibitor with and advanced trametinib inhibitors, KRAS patients with GXXC the

enrolled of for were we binimetinib. As variety of of on of Based August XXXX combination QD the XX data XX of study with dose the milligrams the X, reduced [indiscernible] combination BID and the in cohorts with combination cohorts. across updated the XXXX and from the toxicities to XX dosing and DLTs milligrams single-agent patients have trametinib the PK once-daily preclinical a solid we these Dose-limiting both NPD and at escalation tumors. dose in XXXX, XXXX, approved doses trametinib observed combination binimetinib of

the XXXX and enrollment DLT ongoing. In Rapp the tolerated QD dose the of to BID cohort, milligrams with milligrams subsequently We so first QD XX at and was level sotorasib XXX XXXX no XXX escalated well dose milligrams is observed.

expansion We excited proof PCC our the dose continue demonstrate invest remain about escalation clinical escalation decisions opening will expect to data in and X expansion the half XXXX concept. KRAS X opening of we next our GXXD of combinations. combination clinical combinations to follow data by We right first have to completed we cohorts the XX after to cohorts, the make sufficient have new in to

results of the first in track to which switch enrollment the III product We remain in on quarter, will we second platform. to inhibitor vimseltinib in read become good completion the the for believe Phase out study, control Motion announced our from kinase on we Motion line pivotal quarter. fourth top Moving

and to also We in from I/II longer-term present Phase updated fourth the quarter. data the expect efficacy study safety

supporting by compelling surgery. to standard the patients we treatment are care We for data of vimseltinib strongly with clinical TGCT be the generated, the have to encouraged nonamenable potential

forward of the for an patients. KIT to Insight, support second-line tumors for understanding and will also first XX to Exons the opened the patients. based of clinical or mutations results QINLOCK study GIST in best significantly and XX physicians on the patients INSIGHT patients GIST for label We enrolling sunitinib select with of precise positive, therapy allow we QINLOCK and a improved the new outcomes pivotal If their study first that a the for XX in site believe versus expanded more look Phase III

IND new an in of we pan-RAF Lastly, potential remain quarter a the track submit first to best-in-class fourth on and for pan-KIT DCC-XXXX IND another XXXX. in for DCC-XXXX, inhibitor, the inhibitor half our

the review to over Tucker the Officer, quarter second Financial call Chief turn Kelly, now will our financial I to Tucker? results.

of revenue Matt. collaboration revenue million of product increase revenue of $XX.X quarter of QINLOCK $X to of of $XX.X quarter includes royalty Total agreement compared revenue for million with Zai. revenue, $XX.X million including total The XX% second quarter collaboration our $XX.X Thanks, in revenue. XXXX, net of which an of the million was the million and in product second net XXXX was $X revenue this million, product comprised under

in compared quarter $XX.X the the second compared were XXXX. operating same quarter of XXXX of compared of second million Cost of $X.X were total cost to million XXXX. to in In same second in expenses of for expenses million million of period sales year. the $X quarter, quarter operating in Cost product sales $XX.X $X.X last in of revenue period $XXX,XXX the was the second million the to

compared million same the second administrative were to million the $XX.X expenses development XXXX for compared quarter million million Selling, to of last the and for XXXX. Research in period $XX.X general year. $XX.X and quarter the were period for same expenses second $XX.X for

We in expect expenses of quarterly the year the XXXX. operating what to we in of consistent saw be quarter the second with half second

cash, XX, into guidance our marketable equivalents $XXX.X remains XXXX unchanged. run XXXX, securities As million, and cash rate of and were cash June

to With back I'll turn now over that, the call Steve.

Thanks, Tucker.

second positioned milestones The now first we our strides pipeline. important the to to significant of be Deciphera. year the expect made very in achieve for was as business are a across as and strong we half year. XXXX half commercial start well significant early our a of late-stage And well We to what

We as needs patients top readout become unmet fourth study and of of Phase quarter are second vimseltinib the pivotal our III in of has for excited line MOTION to potential program the the TGCT approved the the this significant medicine. address

treatment study first we the for and advance III patients enrolling second-line look while pipeline. we Phase paradigm of XX INSIGHT clinical seek XX, in or Exon Additionally, XX the QINLOCK to with mutations continue we to to as patient pivotal forward KIT GIST all the earlier-stage change our in

the With for open call Q&A. that, operator, I'd now to like

comes [Operator Cowen. Instructions] Van from TD It Buren the of line Tyler with

And how For related next what quarter, update the quarter registrational for a next reading saw from success, out relative we is follow-up which should TCGT? as can file what them question, look assuming quickly you MOTION trial to last we expected a the forward likely, to specifically I/II or Phase year?

Steve. readout filing. for update. And question questions. the for and Matt the ask potential Thanks It's first for comment timing I'll take expectation to I'll the about on I/II setting the Phase

to noted as with guidance line we on the for top report presented cell in potential to patients that the for we the be year. to So III reiterated the get data this far Phase X excited We of of out treatment We're themselves think we the so it in milestone. demonstrate the best-in-class quarter study call, our MOTION for clearly tenosynovial to tumor. giant

X, on in a we line. time then line an provide of quarter update in to And potential the out we'll top filing believe position so report to get when we the be

transition GIST. and this being And the in of to a to Of FDA and here has overlap the commercial outside we the that we allowing program, get you with nice we're very existing usually multiproduct next because and will as about that product be with with company. high out, there's a potential conversation the excited And as likelihood have line U.S., ordinary once very course, the report we for we in prepare with filing. to top QINLOCK U.S. as do have them we of course we base the product business prescriber for know, think the us engage our

comment on want to you expectations? do Phase I/II the Matt, So

Yes.

vimseltinib data to TCGT that the regard Phase we updated plan of I/II year. the in for So present study this and to later

dose the you cohorts rate untreated with both in to presented previously ESMO and and escalation And the B really year ago, at we meeting. we objective at for treated a or were very As patients able response cohorts that know, the time, XXXX a TGCT. put data A strong

follow-up, respond. So we patients may as with one previously, saw

as well information. of safety that be update longer as part So would the

looking important measured for that function. patient importantly, pain And again, out both stiffness previously, those and also, are about patients how and reported quality measures had very and feel we outcomes at because the

those be data there So updated for will well. as

Jefferies. line from comes the Eun It of Yang with

randomization So showing is III And a of Phase in of just According PFS XX in on One is primary questions. began. months the with couple QINLOCK clinicaltrials.gov, completion the trial X:X INSIGHT is a XXXX. this II intrigue. which Phase to the February

for XX is does maybe So some months, enrollment question about of second months this XX to Tucker. line And period? XX time

that for what to year rate, in revenues $X this a revenue year, Zai million. second And first half terms be the kind collaboration we aside that of the Lab run In partnership is royalties? year around this based collaboration of half going be this on expecting understanding should my it's are from of the of

second for Thanks inside regard questions. question your Tucker to and can first I'll then question. X take the your take with

be there So to opened we study. and you sites excited, announce notion conversations we've that first as really in this order the tumors for for enthusiasm were in been study we've able palpable and leaders, thought the GIST. INSIGHT better with genetic in the of the to heard understand to with having now therapy of guide profile being patients' continues for And the to investigators

this And able this in in advance as is, we're essence, time in the you GIST that way. to field first know, the

as begin study. then forward sites looking screening to now and we're open So the we additional getting in enrollment

to expect the study get we enrollment before, enrollment, into the better cadence we'll when updates when out. of read much and might a in a to get As to to as study position we we we'd in be expect we've think on noted provide full

salt I that the a moment will of more having enrollment, have until the with sense of open, enrollment better way as would the sites that said, more into I for participating ct.gov So in to just as forward be. we to, what And along we But what we opening provide going listing. a really from take pinch would looking get cadence of sites updates use so study. and progress can hear the be are and enthusiastic the study. on we're share investigators said, who we'll I about we our I remain

question. for Tucker your second It's

Labs collaboration So as the of revenue, a China. under reminder, our recognized Greater Zai collaboration at exclusively revenue QINLOCK, moment with in agreement we for

so historically for almost The million well we have exclusively quarter, revenue as this components of collaboration roughly. product supply it really and X was So commercial far first year, In year key as half the $X.X this revenue. second recognized particularly in been royalty-based royalties the revenue.

So that. amount small a only outside of

was they this The in a first based on NRDL that quarter year. taking been happened a the had bit listing, which earlier different adjustment price

think QX. any I under for a royalty we've the $X we So million as in balance the of for And got was nice to revenue haven't year. Zai just quarter brought guidance

we the I the particular over commercial more episodic, in that as you expect be but should provide time, we'd supply continue piece. may and time the to think the see would royalty is what expand revenues in from say they well, market revenue guidance. But increase to royalty then as And China. is that opportunity consistent to revenue time we don't quarters,

the line Guggenheim. from comes Schmidt of Michael It with

what twice related you target? Could I binimetinib some Do could single perhaps given with about combination these one more? off DLTs you on DLTs? agent think just XXX DCC-XXXX. milligrams the you up was the some were dose of XX to and a It's mechanism in at talk It's had cohorts day. interesting tolerated. trametinib And or be this interesting, mentioned that

else if going combination. Just on that anything in particular curious

identified XXXX DLTs back updated recently of XX tolerated. the milligrams binimetinib. As to level. last we dose identified in as in And and single that the There's well in ESMO monotherapy maximum ALT and doses toxicity you initially the dose go know, just no of BID presented reversible BID some of tolerate we've milligrams, combination agent elevation of trametinib XXX at to that cohorts the data the BID XXX-milligram one up year a patient XXXX at with to reported today, there's cohorts, dose asymptomatic the only then was

for the agents. the in of doses drugs reported Interesting, level and agents. DLTs those BID trametinib both of then agents, as with a few of And did cohorts both milligrams in at both combination those those with have We standard DLTs. been XX starting binimetinib single single observe of the dose the those labels

So look and the if or binimetinib most common with changes diarrhea binimetinib. for noted the rash you at and And noted. are regards cardiac ocular for precautions also and are trametinib, changes certainly warnings to

agent drugs. the be So those standard single those of of may to related care

in the course, of drugs trial is because combination. the the attribution But clinical to given the study combined, are

combining with So milligrams binimetinib both we escalation proceed the sotorasib combination XXX for cohorts in escalated sotorasib. we've to and sotorasib, in dose QD we're with for trametinib now with XXXX, and addition and also

not seen have in toxicities any We cohort. dosing that

combination, inhibitor down stepping cohort that MEK is the are to in there completed? opportunity you So XX after escalate is to then but QD,

Yes. drug. Per care protocol, there's both the XXXX modify combination doses standard opportunities to and/or of the

So enrollment next information, be once look to to about we'll able the move decisions in that the levels to and able to cohorts at those make in we start those dose we'll combination. be complete all

MOTION do Are [ be the in data, other CSFXR focus there completing might then curious a how discussing that of in for ]? interested other the pursuing you question just that future? study, indications Obviously, vimseltinib. and you on but opportunities And the about on potential a lot for the vimseltinib think

Steve. the take It's question. happy for I'm Yes, thanks to that. Michael,

So disease in I of chronic example. as CSFXR graft with recent host an you're familiar think reports inhibition versus

potential role So inhibition other IPF. an role the literature CSF-X fibrotic about like some treating inhibitors of with confirming potential for in and diseases recent in have that There receptor data that reports the disease. a been antibody,

broaden future And for and vimseltinib pursue are to made vimseltinib opportunities yet, know, about we very the role to of them. diseases. to as treat we with plans potential evaluating a but So might we'll with variety actively indications that our potentially have you disclosures the time, we opportunity any for disclosures haven't additional the at respect additional right

where stand. we that's So

how a oral we've vimseltinib, potent which the with continues to make we're But a on our think very like see field explore hands, being already want we to evolve. we we And to certainly, great have and sure we profile demonstrated agent pleased with selective, fully. being drug an

comes It Sandler. Piper with of from Raymond Chris the line

Maybe X QINLOCK. point. Can at on just maybe got seeing I've about setting first you talk the line commercially you're questions. this in what second

You had print. second strong a pretty quarter

Just be uptake kind of to as And study. curious primary of think second there's any from to might that give at if the any question least endpoint can as that color NCCN you talk don't meeting guidelines in the the that? vimseltinib. then line I I may a on MOTION terms be the suspense, investors of driving

can talk got You've maybe deepening bit set? what of expectations little But the just you'd rates response dynamic like kind of about time. you over a to

of XX% lower at have the guys some skew a stuff this to time the is the would point, got XX-week of any shown. You've you end one but is study, likely on which argue

So of set that you number maybe when readout? should just terms actual see in expectations, the what you if will, be

Chris. Thanks us. joining Thanks, for

we saw color X Europe do more second So question, in take in say in the excited to Matt remarks, some that the I'll here want geographically to the over growth Dan start the before and course, offer it first just quarter But said that really in continued we're that can prepared to the to turn we ask strength and Dan, launch continues. and the the commentary you expand and Dan on the take U.S. of I we of opportunities U.S. and performance about saw business? the business and what seeing we're our and in as

question. Chris, for Thanks, absolutely. thanks Yes, the Steve.

saw virtually quarter acquisition others. to average prescriber growth, among we be And QINLOCK QX, setting, our new with therapy, duration quarter across patient new standard for with. of in really the results as including continue brand extremely U.S. is of So in metrics and record pleased really all the Clearly, the our pleased in core which performance we strength and of entrenched a QINLOCK importantly, this care fourth-line

Regarding growth in your question off-label about could be setting. the there

June, is First, this. don't I'll second that to an always there's use really, and we excitement we've that elements as of ASCO One at and by for do, Meeting sort the the we've note, ASCO the excitement continue any virtual the just announced hear INSIGHT just that is Plenary that use as real And data. potentially practice-changing as opened. call where we that line KOLs around in Annual we it both great presented we study well They promote. can't therefore, X that XXXX/XX data off-label to

And option. for appreciation have to prescriber some is to prescriber be intolerant And is it you for variation from another then QINLOCK how the that's listing may an of albeit second option, another of is we there who touched component on is piece, common having the what them entitlement which a of patients having sunitinib. guidelines But hear KOLs really patient that terms for in of sunitinib. certainly appreciate always

So with able be monitor. in dynamics bit that impact, know be may what both that to of think it's still continue there's any, a to of business. to what having those or really we early of those on either just terms to just business, those, something discern if a And bit strength we're extremely pleased direction no question that's overall, the the of having. early It's we'll certainly and the

Chris, Matt. this is

ESMO rates regards across at that you as So with year vimseltinib response all objective very data really groups we with noted, we're of first in the as reported pleased dose plan too, patients X we of last strong to have later we And today, update as to cohorts. the noted the earlier data I Phase that to an from this X expansion well escalation TGCT, year.

regulatory this is previously and agents, previously how has with week be journeys approval progress as rates at for endpoint as will not because malignant the that just continued important patients' will been the noted response noted, and only for disease. XX. not a treatment, with up, these it's importantly, go And we we really other But shown

normal have life they suffer patients disease. So expectancy, though even from their

approval last So too, as will Patient-reported critical year. part quality This measures, because pain very first to pexidartinib their But life, in of drug. both With of stiffness. of this really they well, had patients of of meaningful pain in really regard last treatment these a as reported worst patients' in life quality important quality including we've chronicity well, a incorporated as of X of the and for lot the the of year evaluations data and was are missing to importantly be missing well outcomes had changes we as the patients. use as reported life. those we stiffness

motion, for too, our they endpoints function. feel ask In and importantly of just these and is but range if survive a one as other they is how patients diseases, well, how important of addition, not this really

measures So and the life motion speaking the will quality range of look important particularly future. to endpoint in be to secondary that an we forward can of

Yes.

build or Phase is question beyond time expectation as on additional When saw reported responses what we data that comment, setting. that X-month on we this point. Matt good week yet, last at noted, we noted we a But Matt's year, XX%. on was the that I/II ESMO to the Steve. rate Chris, Just XX saw a at last was response

QX. solely the with that the pleased look to totality, in very the how based So forward is how will it opposed the the Daiichi in getting this Phase today line pexidartinib drug But data, up really I consistent on think I/II the follow-up, and when it up endpoint. to totality ends be PEX performed of the markets comes success, data top XX as which including reporting on is week longer-term product to we're based commercialized with how assuming

is that been report the on we've number the And patients. nearly therapy of the updated report therapy had those for an the duration for this question longer We very those the the on as we follow-up XX-month follow-up escalation more cohorts, with additional also able last to And also comment in in is we longest. duration year. on X, for could of duration duration patients that patients, therapy to later that study well, also were with were important year, one patients. that report too, as of number therapy we'll expect an for

Berens line of the from with comes Partners. It Andrew Leerink

progress, Congrats from on couple the A guys. me.

us XX? have give Pan-KIT you that one Exon idea how it you on agent. trial? some trials and How XXX, the to screen insight QINLOCK, XX the long you do opening, the Now II XX many identify or think a of that you enroll think then And patients to to could with take can question Phase

the just on issue agent on minimally because follow-up Michael's company a how of a and has about sounds PK-related reactions maybe mechanism increasing Braftovi and skin dialed the thoughts hands insights or that? got with metabolic then back set Any dose like levels? or reactions, and And Pan-KIT out XXXX efficacious that's question. to before toxicity It can avoided. be Another it that

Andy, joining questions. X thanks great for

other on there So in the some inhibitor. I'll take question comment from Insight offer the commentary additional enrollment I'll Matt, XXXX can and you the question and setback the the XXXX Pan-KIT you then had may first expectations, question. to and also on want take you

So first announce we that on the today open the Insight, have sites first Andy, we to for study. were excited

patients think on enrolling thought on an for move feedback positive century I the patients. we to customized XXst from Matt treatment hear excitement a progression investigators, and based about better continue be into and able treatment offer also and what's GIST understand has their to INSIGHT finally driving patient's enthusiasm from As really leaders and individual to said, very

that ctDNA we're and study reception reception from itself. and to INSIGHT excitement to the pleased with INTRIGUE in So the we reported the really the analysis data the also

which the As trajectory early on to for and some see too with respect perspective be in to enrollment we when study. we study full are and as we going in offer that. really get commentary what just much able to enrollment better the us be and meaningful It's to color offer start we're enrollment to reach for may a the see underway, color in to position the we now study,

assured rest to in in a INSIGHT despite study. from a year. calls additional expectation they of as to as toxicities, tolerated, were that Palmar-plantar provide namely quarterly setback referenced, some we've disclosed, have next see been significant competitor Andy, But lot were seeing, will And well patients. you unfortunately the for first recent erythrodysesthesia that reach and update promise for sort agent a then future on unable file And noted, the cadence exposures we XXXX XXXX, IND of expect created, of the you the half in of enrollment we as

same success think, selection in forward. we've believe, based earlier And design take AACR we which regarded or profile very So our candidate this reported to for on that has ripretinib an at selectivity of than demonstrated, well those our being ripretinib, previously the this as selective tolerated. our XXXX year, designing we've even more profile like and is I now skills We've us, applied candidate inhibitors as QINLOCK. to

you to the forward understanding the question? on then So patients. filed and we're patients this into to and then profile drug in do the Matt, want looking XXXX comment getting getting IND

Thanks.

XXXX those what and So been we other trametinib about as with binimetinib. to events I clarify combination with seen dose agents alone. noted, see we just have those talking with were living toxicities did And earlier,

the binimetinib course, we trametinib So been But combined. both relatedness alone. in know the drugs, the clinical either both DLTs setting, trial with related have of to I that noted is that or drugs seen

Would the of levels that issue those a suggest that it's a PK drugs? increasing metabolic or issue exposure

all. at not No,

there no So it single I due with commenting drug on have effects the PK that combination, that could or was the What with these it be might to issues. see you do the agent of anything metabolism when alone. to was the is thought

adverse that warning use you the in these We reported label. single have know. If safety some events, questions agent don't events,

inform enroll totality about inhibitors. that will We it's MEK patients XXXX continue the cohorts in with to right overall those us cohort of of in really combinability and the data the to

very as pleased we've We're the progress with had the we to trial. continue But now, patients. in enroll that

as So too. continues well, roll cohort their acid to

having future. to sometime So look in an forward update the we

Stifel. Canino from Comes with Brad

Two for me.

levels? R&D. Tucker U.S. how I the in about you normal flag where changes any on for a versus inventory to are and then guess And would you question think First,

around You're million $XX to where the you pretty were close entry a following the before optimization quarter results.

the investing pipeline? peak And spend? towards expect the us and saw you end XXXX? in help should in takes are and the as we continued of insight Vimseltinib puts spend we increase ramp you into that the the And get study, you're So of understand likely to exceed

the questions. one. the inventory I'll take to Thanks like one on first then Tucker and for the take second you'd

as results. see driver Brad, So we of significant didn't inventory a the in quarter,

versus was and the So in versus quarter growth first principally quarter demand prior year. driven this by strong

the So question Brad, expense. on R&D thanks the for

$XX had be $XX So what second million we OpEx year And in in of said saw second million is we quarter. of was we quarter, the of R&D. today expect similar total that of will what in for from overall we OpEx that terms the the balance the

in of was prioritization. $XXX of 'XX. for had after you year, watermark high million the the a We last expense R&D there we As $XXX kind R&D restructuring our the million back on noted, based results had portfolio of

roughly that forward think don't how to on year, you our pipeline. for 'XX million then roll of we'll quarter. depend will we second kind back the I XXX again, can if get the just quickly move in and really And the balance So in this success $XX and beyond

the So of really success, and in prudently we've on area invest right to continue assets would place. got and in lot development things going in a great our assuming clinical we the

year the there really we're think depend and of the in clinic. the success that will So I this getting don't back balance on

commentary. on Congrats the the appreciate quarter. I

JMP Benjamin It comes of Securities. from with Reni the line

to was Maybe you remaining database on the quarter. is on locked might top the Will takes patient also remind that us about enrolled. it steps? do required EU? simultaneously? the there the U.S. long and data Or in be talk a think is how more be Quick the When line remind the you last question lock both to EU? can from going be in when Vimseltinib. us, the And Can filed and the results? Congratulations you that's reporting database filing

X to questions. happy those I'm take

of III first, to study. for the respect Phase So timing with the MOTION readout the

which in we've in to of know, study guided the you QX, enrollment ahead As was QX. We schedule. completed

as primary endpoint with really And X the response weeks pleased is the know, enrollment. months. XX pace you we're at of So or

And all time work data for then be get do for out. to so do clean the to and database patients point then analyze and to able for once the the block ready efficacy, report to we're that get evaluation to need to that able we

question absolutely, to in intent consistent may are been tenosynovial guiding to couple And in the and study. to vimseltinib So where of cell QX in with to treat of And last the tumor approved no you file course, in a recall, our why agents your there giant is Europe. respect this U.S., file, here we we've readout U.S. in it's for the may the quarters Europe,

we can filing. in U.S. And so our a to be to would goal close file as Europe as

close drug U.S. filing. But given need success our goal guidance patients course, of is line QX, unmet in of in medical a filing European to get approved to to could we unmet make So we on study significant in how know need to the top as time line can. to no of as provide in we assuming get get better we'll we also, readout some position be Europe filing agents quickly a U.S. think we the there's and the and here the a And the as

be good maybe then especially track year? you then follow-up need Or that doses to trame we just that Are the kind Phase on And the end would on by do combinations? a point a for and to the as really And of II feel to… decisions, you XXXX. maybe report recommended of bini

for you there We the bit question. of Reni, lost it's Steve. your last

cohorts. about for question for your recommended getting think was doses I combinations to in the existing timing the

continue across So noted, as escalation combination also seen initial dose think, what Phase really cohorts so we bini enroll escalation the Matt of full in data. patients the I provided, to from trametinib, terms sotorasib both update the I far, dose but monotherapy the the a Matt and data, updated we've

the we in we'll really of Meanwhile, first expansion the to new the data terms to now science in that We year, we dose remarks also might might of continue make of also announce pursue. next now prepared pleased data potential we'll the expect combination first half which expansions in that opened decisions we around in have the cohorts pursue. noted course, sufficient to we escalation that for be were the sites cohorts. we've and by guided which today And

Encorafenib Pfizer and second supply clinical collaboration the is for those combination. a know. agreement of with And is One with result you the cetuximab ripretinib, of our very as

get were those for open we X So enrollment sites for cohorts. to pleased new those

potential in a first make the we of make think good in half progress, and position, about expansion. So to we as be year I now continue said, decisions next the to we'll

line It with Barclays. comes the of Peter Lawson from

if orders, is just organic get on stocking versus Maybe bit better could thinking one-timers any a we of growth This more U.S. bit for X should you Peter. as wanted there's speak any be the Shea in U.S. such on about, a little components, ex growth sense volume the benefits? these for I to to a pricing

a you provide to just little but here that update? that might uptake still more suggests appreciate to the it's term I line point follow-up is that And line any in metrics there look you or metrics component. could early, near any on on second the a second color the give

for of great set Thanks It's questions. Steve. the

we're and So And question in versus I'll about then the saw seeing in business Dan what ask year. growth to your QX Margarida we comment the the on U.S. that international versus QX answer business. and last can

U.S., strong the that was In questions. driven had principally the for we quarter Thanks demand Steve. really Thanks, volume. by the

talked the So for versus growth kind down about from price. we year-over-year The of that delivered you was And XX% that largely therapy revenue a growth in driven quarter we volume several demand. sources, net key duration that to average comes understand in of how previously. by really breaks it being asked one

We that will gradually though continue as to increase. to continue feel

in X was months, that to about believe We've X.X on gradually and achievable. said grow we expect very to and to X it continue months XXXX, that to previously that's average we

was the primary during driver in demand So U.S. the the quarter.

market the launches which start countries, progress in international in are that markets in great to So continue our with new Italy examples. for first all see we unlock of to that to it's regards making saying let recent see allow markets, will the access international by Canada to very and future the to launch and me are exciting strength

Italy. international future, and tends strength, expect continue be positioned to QINLOCK driven be to come last revenue in softer grow year. to which our growth, strength case of mind as QX we But quarter from to will going markets a soon as are new well saw for is holidays by overall, the we we online, that So keeping in summer historically very especially the

turn session back now. to remarks. And ladies for and the Hoerter will I I gentlemen, Q&A conclude Steve closing it

progress Thanks thank continued your joining for on a everyone Hope at forward look us you day. to have continued today's on and Deciphera. you We of your here our you support. great updated keeping rest call, for

for participating all today's you program. Thank in