Deciphera Pharmaceuticals (DCPH) 10 May 212021 Q1 Earnings call transcript

Good afternoon, everyone and welcome to Deciphera Pharmaceuticals First Quarter 2021 Financial Results Conference call. Today's call is being recorded. At this time, I would like to hand the conference over to Jen Robinson, Vice President of Investor Relations.

You may begin.

Thank you, Tolanda. for financial today results. you first discuss thank XXXX quarter and joining to us Deciphera's Welcome I'm at Deciphera. Robinson, Jen Vice President, Investor Relations me Medical are discuss a With Martin, Officer. Chief Chief to results Matt Dan Tucker afternoon provide Sherman, Kelly, Officer; and Financial Chief Executive the Officer; general and Hoerter, Steve financial update Commercial President Officer; and corporate this Chief

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

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

I will Deciphera. Chief the a will and Steve? the turn replay website be now call, this www.deciphera.com. over on Following of Hoerter, to available call Officer Executive President Steve Company's

priorities the accomplished on build It's as to portfolio upon that Thank for in the we across been strategic XXXX. you, year we start execute exciting and our XXXX Deciphera, Jen. all an for

the GIST. make and three lines year, around reach of in focus world, progress approvals the therapy geographic great QINLOCK expanding of moving in QINLOCK areas to earlier QINLOCK this of the by QINLOCK regulatory the US, continue seeking We successfully launching for against into

demonstrates patients as difference US our minutes, in our significant in QINLOCK the quickly the In QINLOCK meaningful few setting. in Chief GIST and this launch for successful the standard potential Officer for its fourth-line need in unmet establishing in approved of Martin, Commercial success a the care Our outline will QINLOCK indication. of Dan a medical offer to

Our progress the of rapid the second-line market penetration by this for potential geographic a quarter, positive future treaters, and in expansion QINLOCK. perceptions solid to goal of create setting. QINLOCK first our expand very made reach In our important the we into the just foundation of

QINLOCK QINLOCK launch Lab, the they year, and were patients both this quarter. GIST China Hong China, the partner from An estimated Medical Administration we China as in to China with diagnosed Products for supporting of approval Greater Our Kong Zai in new National received forward XX,XXX later the Zai Department Health. look each and in

We receive for of quarter from this European expect year. approval in the fourth to QINLOCK the Medicines Agency

patients in As that we and once await organization deliver us QINLOCK and will key the commercial are our experienced markets the allow to for to groundwork we an building actively from Europe focused laying action in quickly team approved. EMA,

we to disease. this the drug treatment the believe treat designed specifically alter the of GIST, As fundamentally to has first potential QINLOCK

earlier our ongoing elements in strategy lines expand One of the the X to in QINLOCK INTRIGUE, treatment of second-line key study use of the the Phase our is of setting.

of the line a QINLOCK plan a to this use pathway. inhibitor. Phase pursuing reactivation in year detail Xb/X top resistance quarter discuss call, Chief are Matt of this the fourth beyond address in of MAP the later by results of INTRIGUE of evaluating inhibition, our with mechanisms more MEK treatment benefit in to for INTRIGUE additional approved year the of We expect study, as patients to in GIST combination potential and of will seeks to the combination an with backbone the Sherman, binimetinib, the we announce that study opportunities our Medical kinase to kinase initiate QINLOCK Officer, later one

US our Throughout significant very clinical KIT XXXX, the deliver Finally, shareholders, our medicines inhibitors the pipeline excited results to expanding believe updates continue QX. have QINLOCK. Dan from potential developing QINLOCK create with discovering, expect Dan? beyond Chief on discuss now to new Commercial significant to about patients I'll turn our we of and Officer, we commercializing we that Martin, to as over mission value we for and remain of call for to have cancer. the regulatory commercial

I'm Today, quarter Good of third color results ahead. afternoon. as look regarding we additional provide our the sales Thank expectations and you, pleased to to full report Steve. QINLOCK of our

the be date US a to to treaters. launch of US, very response launch, in achieved million net including the we overwhelmingly and with just $XX.X in continue $XX the opportunity to fourth-line QINLOCK total product revenue, penetration from rapid In including million. net we million product bringing $XX.X pleased the positive We revenue QX, total received

excellent standard as have continuing launch, pandemic, efforts and establish shared potential into in experience product among perceptions toward base, cross-functional positive to of challenges prior to fourth-line to we unprecedented we our broad opportunity. COVID-XX have QINLOCK navigate rapidly As building the a care our goals prescriber make of goals. continued these to the the advance clinical progress of the larger launch the of Thanks to were second-line teams initial in previously, our indication, the while

marketing the limited survey, our prescriber high physicians. launch. In Deciphera ranked and reputation QX. share voice since and team companies has commercial having sales team execution first the GIST among need as Despite our and treating in operate metric prescribers excellent from sales across teams the team model, continuing an XXX recent grew base again for market virtual prescribers was every indicates point in-person research of recent institutions opportunities Our largely than performance among more cited maintained evaluated. blinded frequency just sales of a levels in reach, a XXX a market, to best-in-class just over through strong meetings, established to Despite prescriber the that our and

has of days, this nearly GIST. awareness XX% a Our market a positive prescribed treatment attributes. just prior of research, GIST have impact. who and remained also fourth-line high treaters QINLOCK's had clear and execution treating standard familiarity and QINLOCK. In extremely XXX% perceptions initiated that all among physicians very a agreed recent all reported care the who fourth-line shows is physicians the QINLOCK of had survey, prescribers fourth-line QINLOCK within strong XX nearly QINLOCK, again GIST in prescribed of among clinical continued treaters just Further, that

to access and FDA patient broad our in with QINLOCK performance to market coverage of to deliver label. marketing our for teams, remained team sales continued In addition to policies strong the access QINLOCK positive Payer our very aligned QX.

to During potential estimated end data that the XX% the that range free of of to gave of our under from Prior INVICTUS drug or confidence patients to the percentage of low received Patient transform launch, treatment the our Assistance QINLOCK the quarter, has was at the PAP, XX%. Program advanced us study GIST.

who QINLOCK early Though patients persistency received into are fourth-line real the maturing, Now, setting. data early our insight data world benefiting world real is how in since still the still patients see and have the days, expectations. QINLOCK to is that we we therapy for average from our it's launch on the would longer clinical what long-responders. in is median, Ultimately, the on impact data due based to saw to time trials, study, our somewhat the launch, similar the expect prelaunch we from with than INVICTUS of be providing consistent

how and know still trend this However, to out data too play early it to real mature will take it's time in the for setting. this will world

patients a oncology the we may dynamics, year pandemic impact recent and in on pandemic negative QX the projects from be and been year diagnosis inconsistent of impact In persistent treatment continue in IQVIA it patterns is now more pandemic. These GIST our show are the could volume over the patient GIST since Data with will that this This IQVIA who thought clearly, this earlier-line leaders, months. data last approximately and progressing to in referral specifically discussions to market impact with has during impact analysis terms we is that a having continue of broader the the the claims that seeing indicate oncology coming new have in to XX%. volume is volume patient visit for of fourth-line year. consistent data a that showed had of as assess patients, that past likely of decline Further, something GIST. trend

as to have QINLOCK's Given into subsequent be second-line uncertain able we growth near limited from the that setting, term, the pandemic opportunity positive approval. in rapid and opportunity, data penetration continue for impact may the the expand to pending we as fourth-line the expect to are of INTRIGUE well until the

the fact in patients we discussed, QINLOCK This population, estimated is by when for is incident our we've second-line fourth-line to and receive earlier larger on opportunity that experience larger believe indication. of disease. initial benefit driven well their as the compared substantially in as longer they clinical the therapy, course time increased a QINLOCK patient may As

are believe more believe the mind, new we previously, in extremely half to and setting, that made towards made product potential launch. progress of positions the is patients from future of academic than prescribers, community. us also more have majority pleased we academic of tremendous community second-line patients the the perceptions compared in we while positive earliest We As among more GIST a heavily With distribution we base in shared and patients. extremely community to that estimate see second-line this treaters we when our our up awareness diverse we have have and the weighted prescriber adopters, community the for QX, settings In of the fourth-line prescribers both across QINLOCK-treated well established and broadly, setting. came XX%

in earlier focus GIST will course time QINLOCK of will advanced for Sherman optimizing opportunity QINLOCK even impact potential over we a benefit in on treatment a business, our the at -- Matt motivated the fourth-line our same of the has already to help initiating already our to extremely I they Moving and of second-line. may continue potential to forward, most. patients by clinical progress US when profound call the the to be turn programs. our approval found discuss disease, their had are in while Matt? now the launch has the on preparations

Dan. Thank you,

INTRIGUE to in need over second-line in KIT top meaningful submitted ongoing on patients. of Based months of As a optimistic study, expect the strong study X Steve We to showed median increase QINLOCK's mentioned, a approximately of in potential we profile PFS, in as with to the months. inhibitor comparing in the broad-spectrum INTRIGUE QINLOCK to XX.X about that farm focused announce INTRIGUE, our Phase to quarter GIST. very we superiority QINLOCK benefit basis of patients will the We the second-line demonstrate remain for line in a data year. the progress survival six demonstrate sunitinib fourth QINLOCK remain study, we the relative results to for demonstrating believe, best-in-class Phase on expected show clinically where X with sunitinib, to X month X progression-free PFS this was

results Phase we study of the exceptional X X.X in INTRIGUE. median Finally, the fourth-line of of a plus QINLOCK PFS patients supports that INVICTUS strongly months in believe receiving the showing likelihood success GIST

announce potential the KIT initiate a our of GIST. provide resistance to address patients, excited Phase the other Despite and MEK the challenge. Binimetinib a and with are remains for combination inhibitors study many We QINLOCK resistance that Xb/X in inhibitor, significant GIST to approved of plans to QINLOCK improve mechanisms in benefit today one

of dual how kinase about inhibition KIT thought deepen pathway to GIST goal may new The can responses by inhibitor. patients. MEK study combining long is the broad whether have the inhibition the long QINLOCK responses we initial from see in pathway of increase inhibition MAP We a using with ample

disease disease a patients most becomes MAP These GIST no secondary XX% increasing has that pathway responds First-line in after MAP progressive MAP longer often regression. with stabilizing but in be KIT progression less of or MAP experience effective acquiring patients resistant the proven can expression. patients, treatment. mutations, GIST most complete experience to than kinase in to care in reactivated often be

QINLOCK lines. that prevented cancer well preclinical is with by apoptotic study therapeutics, of in responses resistant cell exciting EORTC-NCI-AACR clinical inhibitors, in combination molecular GIST Xb/X and colonies in in Phase that showing as was preclinical XXXX, meeting recently MEK Our presented at published data growth with online supported effectively enhanced treatment the and data induced as

the that MEK imatinib, drug. of combination QINLOCK was generation treatment In is result addition, in QINLOCK inhibitors. even the preclinical One QINLOCK imatinib and partner efficacy using inhibiting studies. of to QINLOCK imatinib combination The a over MEK after cell inhibitor did than with major growth not advantage as in removal inhibitor combination combination with superior in resistance of a inhibitor MEK demonstrated better mutations MEK

X the to of open who a with not evaluate least of with who advanced efficacy QINLOCK. intolerant to have dose Phase patients single combination patients recommended evaluate imatinib. and study design, study the Binimetinib X phase and patients We or the well to cohort cohort previously a expect progressed single of are with GIST a dose a efficacy the X or phase. to plus agent coming in an phase will to treated in a will on and on combination Phase The of the been safety, at expansion Sipkin is study label and are safety imatinib. consist GIST, have enroll dose Xb/X in intolerant progressed follow initiate will phase The escalation The in imatinib expansion escalation pharmacokinetic months study with

on believe with clinical this is We best-in-class profile, what patients patients are compared GIST of alone. to that GIST that benefit inhibition potential KIT focused give we could KIT option full benefit a and combination believe therapy exploring provides new enhanced QINLOCK's treatment to the

in activities, our a dose on the of been presentation Clinical to well GIST treatment data study e-poster Society ASCO are we robust data announce of number of or INVICTUS Annual QINLOCK, to escalation recent There intra-patient clinical Oncology on June. In publications American highlighting Building publication from Phase dose year, landscape. executing last the the at we I'm have intra-patient use present in a presented escalation addition and Phase our the X strategy. X plan in study, we that from pleased Meeting the of QINLOCK to an

pipeline We are also ongoing programs. other making great progress in our

infant of will Rebastinib, data with ovarian presented with year. we for providing for inhibitor Xb/X start be We kinase. Rebastinib endometrial highly the first-in-class both the from program updated cancer selective potential this year. combination activity TIEX study in me cancer cohorts tumor our encouraging Let is in last this platinum-resistant Phase the since and paclitaxel ASCO

prior Imatinib Phase at a from study with of advanced prior X treatment patients, our encouraging The for cancer, of XX data rate XX% regard endometrial only enable first-line the options with In by data present endometrial study and us cohort endometrial limited the of PFS progression-free upcoming chemotherapy have of cancer, cancer a in completed of on at to patients response response recently regimen, was to carboplatin target The paclitaxel which treatment of landscape limited are Focusing pembrolizumab enrollment and this there of in our the of activity agent cancer. heavily to Meeting. will present further in of pembrolizumab with of endometrial and for four for ASCO cancer paclitaxel weekly we paclitaxel follow-up now that paclitaxel is XX% a lines expectations the with We activity with excited are the and chemotherapy lines retreatment patients. doxorubicin. retreatment updated X which arm X.X from a consistent Annual setting endometrial or PFS the we previously and choice after progressed to pretreated to patients XXX, to and and an presented one or second-line survival these X expected the XX% is cohort, to months. the cohort, of rate X setting. This a physician's SGO, Oncology who objective in this KEYNOTE in confirmed Part and of rate reported Imatinib the either months, response later Gynecologic median single showed reinforced compared Society in

Phase from the year. paclitaxel the in ongoing with track In on Rebastinib in ovarian addition, third to study with combination present the updated in we the quarter cohort platinum-resistant results cancer X/X remain of

as We coming for forward possible expect in are this efficiently pivotal we program in to months. driving development with on plan the finalize focused and potential and combination Rebastinib as paclitaxel

is of the in Vimseltinib, or in development programs the inhibitor kinase our for tumor two on of for potential other RAS cell inhibitor potential treatment mutant of and tenosynovial best-in-class giant cancers, track. in remain treatment first-in-class pipelines RAF The ULK our development our CSFXR DCC-XXXX,

Vimseltinib in present for Phase development patients ongoing half. the in pivotal data For with expect program finalize plan updated from we the TGCT the to year, this in quarter third the this second study and X/X

current excited our So, first unmet of needs. make Officer, We now to of results. Tucker? Tucker to the the the patients the are these initiate continued I potential to review DCC-XXXX, will meaningful fulfill and a we to this turn human in lives Financial progress Kelly, quarter. forward call the has difference the to Chief medical of over financial each in which study look programs,

Matt. estimate of our in highlights million net sales first adjusted annualized like was Total which million first quarter QINLOCK, includes we $X which revenue the the the Zai in first I'd revenue of to from revenue under levels that in product The to $XX.X from Thanks, net Collaboration million was by the line included our milestone review was quarter range for in gross net approximately low-to-high our receive Zai XX%. $XX million, regulatory China, teens. to begins with results. a the in in annual sales March. in $XX.X with will on triggered financial royalties quarter Once of US. from based agreement Greater China Lab, license development $X.X of QINLOCK of commercialize approval the million QINLOCK

FDA QINLOCK QINLOCK to Cost expense. sales recorded as three of million the ended and immaterial, additional were annual milestones costs are achievement to milestones. the was incurred as certain sales XXst, March the XXXX were R&D months as addition, we to prior based thus related manufacturing approval commercial for as development of In $XXX majority of sales China, in in of well eligible for on up Greater

million until cost compared pre-launch immaterial initial the total general we same million expenses million to to the said have of first manufactured expenses additional operating development quarter to were million $XX.X the we depleted same is in cost the expenses were period And million this XXXX, $XX.X quarter year. period Research in sold. and the were XXXX. expect $XX.X to the same first year sales selling, operating least and expect and in $XX.X sales administrative will expenses inventory in in previously, of through compared the As of Total million and significant $XX.X of would at and XXXX. of in $XX.X quarter period remain be last not is first compared inventory in the

We operating continue a of we strong to our increase year, now financial remain for cash potential quarter in million, the first back and $XXX into as of position in to will well ended over our call our marketable We capitalized clinical first commercial expenses in half the with US be expect and securities to and will that, this the launch Steve. invest expect on modestly pipeline, in the execute QINLOCK that commercial launch operations of the we turn Europe. which prepare the now cash, XXXX. of I'll with equivalents approximately sufficient fund And development

Tucker. sustain momentum the this XXXX. of of first year I'm done the to proud built we has Thanks, in in team our work the quarter

the both standard in the pending are world, later with GIST, for As QINLOCK excited this we continue to approval patients as China expand recent in and and reach are approval of around year. to fourth-line the prescribers we its to establish care Europe

has new patients unlocking expected potential significant XXXX Phase second-line. from potential line the pipeline, to QINLOCK our patient as Rebastinib. for development for with announcing also and in potential first bring Operator, DCC-XXXX, is study the like pivotal well GIST, look the the Q&A. With we transformational updates and call plans and to the for Vimseltinib of including in fourth-line results our QX as data the I'd of of QINLOCK open the both, X for realize balance we that, As dosing INTRIGUE top in across forward to

comes JPMorgan. Our question Instructions] the Fye first Jessica from [Operator line you. Thank of with

open. is line Your

Daniel for Thanks our is this Hi, question. taking Jessica. for

time take your of that First remark it data have to will mature. you is, on question for stated duration in prepared treatment

persistency detail? now in of better product you fund and talk on to for you almost some a INVICTUS, similar for year, do when market have can the the when expect to more about With average time insight provide therapy. us you elaborate And

to Yes, your of Thanks set Daniel. for good a questions. this? take It's would question. Dan, like you

absolutely. Sure,

looks So, persistency we INVICTUS, quite saw when with for the patients the to curve INVICTUS. similar curve PFS from received emerging that's we persistency to -- what who since to QINLOCK respect looking for it in Kaplan-Meier similar not launch,

that's as to was in then guide of think different a we data at early kind percent a far. therapy average comment more develop, in thus the these And patients on So, to time we're will persistency the the sort what for sort about that about seeing it time good points take days. of of of opposed

So the year yet. the impacted and given not of we're by be potential course will tail, curve or persistence there as about into you launch, just in long a say, give long average responders only we're a that take,

from data If years to those the Phase multiple clinical fully about X trial develop of long-responders. for sort example, it you took think

So, will to look why mature. time median, we take but data expect if than the the longer clinical that it to some would just to at us date, trials said, was average be I from somewhat for that data we the

come sales forward growth for US roughly it. a fourth-line the good a million that in is second-line, going about or as that And as going impact to for next $XX COVID but use slate think the forward? Got this then lessens of change said will we run of I you've run know opportunity to US, there meaningful should in rate from the the quarterly potential

QINLOCK and during course think this to just there I as the impact inherently that mentioned as that us providers, both with from pandemic, an is think see uncertain suggests year. as as from well it's Dan remarks, in claims prepared and Yes. question has Daniel in we data do the been ongoing and how of a that it's It's his Steve. I good third-party for unfolds

forward growth we that our we'll As limited of potential you're and a result Dan that. as second-line readout the the subsequent view of as a going contacts come to to that, in the will INTRIGUE see get is mentioned, approval

Okay. one, of significant inventory inventory? is pre-launch exhaust estimate depleted additional the have an you and states that sales will is the not the when And and until sold. last you PR of cost that manufactured inventory be initial Do

we it's that, Tucker, in capitalized as So, terms the this expect to don't, able other time at we'll inventory provide look what guidance it might than don't that that move updated be we like and year of selling not we on the cause be forward, material be of when approval. we'll was

you Great. very taking Again, for questions. thank my much

you. Thank

comes next from Chris Our question of with the Sandler. line Raymond Piper

Your open. is line

Hey, questions. thanks the for taking

math me help Just the bit. little a understand

say you is I math, the that respect hear low, I guys XX% quarter of think first saying prescribers maybe, but COVID, I I guys a and of remember on I XXX just quarter last that. mentioned think multiple what that's I my just percentage pretty growth you about prescriber heard with square you think if docs this therapy by you're was And that still more patients quarter-on-quarter. and to can than maybe there had that all

a anything that revenue flat you talk with can Thanks. quarter-to-quarter growth, revenue? does you've like dynamics also got with square drug that If like any And how maybe or number. respect that the sort prescriber impacting might free be, of to about XX%

those? take Yes, thanks for you questions, Chris. the to set like would of Dan,

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

mentioned contributing mind, new doesn't given cancer to all any so you patients key the quarter. physicians in that, insight the to quarter. key the every once and is prescriber GIST can growth especially in prescribers contribute patients you of get and that, fourth-line each said fourth-line in every mean may contributing that every only that growth setting, a those months. community keep a see that's here XX We've see we previously not therefore the since XX So patient one launch, is are rare prescribers to but that This one XX% is setting, onto thing

that's that it's the a driver just, you. really square bit rare math the I it's and hopefully So little think, really helps for

than But raise inference, $XX that sizably GIST I getting of investors, I lower some the Well, if that of aren't questions is think of I'm you from is if guess And yes. patient market sorry I'm for that sort mentioned get to kind -- have was what there, fourth-line you treated, seems sort folks? patients yes, it the does. happening numbers I I what gotten. just I with know how getting COVID that we've of any guess million. question opportunity these also some but the just -- but the sense guess dumb

question. No, good a it's

in of active persistency that think in days patients in, to an of overestimate a when it's And shared number given that average patients at couple I plug that that recognize -- therapy the early things So tends to of important amount keep to mind. on the really any point. time We've the you of a when support to you use launch. previously use average that important reflects number, use you curve,

shared what done the we've physicians you've from opportunity opportunity. academic great is previously both and rapidly in has So prior job approval. for a think is in that, I we've we pending I a how sets But calls, The I the that of great the response think data been in up don't all and given built penetrating call delta if it know in your and overwhelmingly second-line this that community can larger model. the positive say

you. Thank Okay,

Thank you.

with comes line Yang Our of Jefferies. Eun from question the next

open. is line Your

you. Thank

was the last of November So, patient completed enrollment at study Phases year. end X INTRIGUE

want PFS sunitinib want One, at I been assumption couple occurring months? question with is, I in a there. if for around expectations? six ask of have So, your [indiscernible] to you you your with ask events PFS questions you second And just comfortable line -- still are to

Eun. hi, Yes,

questions. So, those take happy I'd be to

from hasn't that to we'd changed. I expect the think view of see first what about Sutent, with respect question our to

of talked of we a pivotal we their that PFS months, historically also very from environment day months somewhere Sutent this about As heard expect we of day, present is that what study prior would leaders. would with based the -- which the range and day -- present expect see in X.X calls, in in feedback the that's Sutent to we label, on PFS six and to on the for a consistent and the thought

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data confidence very of and totality our the study the for in think we positive clinical positive a data we've QINLOCK -- unchanged. so remains read the is INTRIGUE with the So potential generated far

of course haven't of we expect just -- terms on the when of be. clinicaltrials.gov, top the view expected a the the what the operating. that had of endpoint accumulation sort in loaded at of that number June of in of in But terms of and for environment things pace study we that the we designed year I which primary also we're of readout a study of to subset to would in along of subjects number this line QX refinement really changed we change. in time information would that and would we guidance of events terms the as comment the terms first being and we In of of in don't the have get events, study the way, note our

question combo on the Thank you. Binimetinib And study. a then

months XX already in close So mentioned, to of you PFS. second-line, as are seeing you

So by you. increase likely are or side post achieve? Thank Binimetinib effects to aiming you what considering adding potentially the Imatinib,

in prepared and really that data thanks, inhibitors, the remarks, free Matt as QINLOCK generally. It's that Eun. that the as to between generated, showing Yes, I'll excited now synergy said mean, in Matt well. we're Steve, published, real I chime has MEK please and been his about we've then take feel

and QINLOCK. that monotherapy potential potentially that is treatment as in anything on see already generated. add patients that the if goal commentary that's into the So on as real our us INTRIGUE on we the earlier goal And now is you this of to that to we and this But, terms year, with based there potential an INTRIGUE. think in QINLOCK have for move in monotherapy as of advance clinical benefit of we to preclinical some drug else disease established that based certainly we given our we maximize for with Matt, case of the combination for follow the really science, standard But line would responses in for the that, the fact the deepen we've based monotherapy will reads prolong combination? a to is indication certainly data data to QX QINLOCK as care and relative out been MEK potential expect fourth-line, generated, the that hope we potential be when the of the

with and increasing Yes. the questions therapy of on QINLOCK. responses. the that the the based supports mechanism of that feel mechanism but and durability just responses increasing Thanks those feel today for Combination we oncology And we Eun, preclinical the we -- biological that's with here. highlighted data be in available, add, tends about the of combination way the combination. also mean, good to to very excited a And I very

the certainly may what we've well escalation heard the that safety, that as to with manage binimetinib starting any know terms doing label a based a we'll feel and safety by be events in in very that In dose on combination as from occur. able study be investigators. good QINLOCK profile we'll And monitor what's has of and we off adverse

ripretinib additional more you meaningful would question about benefit what PFS specifically months So, if in be is XX alone to of PFS close second-line? show with

continue opportunity be an simply, may that Eun, think raise Yes I put the think to there we to bar.

monotherapy So, from as that of in better QINLOCK but outlined to in the opportunity, approach as that there here months, with we're combination an is for the with QX, through really a combination we're not longer up PFS is extent backbone INTRIGUE not certainly to data a drive we'll interested pursuing. see satisfied that's something XX.X coming certainly patients, the response and

you. Thank

Thank you.

Michael question next comes from Guggenheim. the Our of with Schmidt line

line is Your open.

taking study. for a thanks I guys, had more Hi my few questions. the on INTRIGUE

the I quarter, the been relative data guidance there or fourth change in in rate the has to guess event a censoring your the on expectations initial refined Just rate? perhaps for now

question. Thanks the it's Michael, Yes, Steve. for

the half. We earlier and for earlier, the response within the rate, range said an question, know, is was But -- QX this haven't to refinement that. in certainly disclosed fully we as second to as expect the to to accrue events what previously, I guided of the the you event to timing when we

a the can we better, the bit a So made we're now that just reason in little where we is today. narrow position that down which incremental disclosure

Perfect, thanks. Sutent the we've KIT of then depending a question on And perform type can been investors getting from mutations. how around differently

well. mutations? XX/XX exon remind percent of could I exon relatively how and patients mutations has Sutent Sutent what to second-line us perform relatively think I patients have perhaps XX/XX ripretinib been specifically XX/XX where you guess performs in in exclusively GIST shown to exon specifically

Yes, thanks Michael. for the question,

when and I strength generated the I'll and the know, designed the for we Matt. the spectrum X, a very I'll talked Phase demonstrated in mutational in commentary of would So goal was terms data QINLOCK to start in drug, about is off later broad year. a here out offer fact course, inhibitor, what And think convincingly INTRIGUE over we've this you turn broad you as and report we specifically as of based that of inhibitor to this the to spectrum we're that previously, now background But we've think design of we've or color GIST, in then and second-line? the on INVICTUS the additional data looking also Matt, from it forward

with the the study as that results some overall their patient last have fourth-line just very the Yes, most in the are just heterogeneity we of private burden, clinical I showed side of PFS, those also meaningful survival. INVICTUS broad and results could what we genetic we presentation characterized strong and as in the that's in population, benefit of -- to of in patients the well think yet patients where have mutational forefront year of and the increase mutations outstanding despite the point the

again productivity multiple the against mutations. Ripretinib reinforcing So KIT of just

has that the combination the down something pursued just GIST setting or post-imatinib strictly Binimetinib in then in Okay, road? on is perhaps that take be that to thanks. on And strategy, the imatinib is a combination first-line could that

in MEK and that seen potential I the for preclinical we've a of Michael, this with inhibitor. good his the combination QINLOCK touch imatinib Yes, of prepared he But to you setting, the Matt noted remarks, think on in can as know well. the as it's to plus be question superior MEK

in So better than course does in job of much a from efficacy, emerging. imatinib QINLOCK at mutations preventing KIT additional

that think has do potential. we that So, combination

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Great, thank you.

Thank you.

the next line with Benjamin Our JMP Ren question comes of from Securities.

line Your open. is

how rest world more, going the in And to two? revenues the this what you of accounting one questions expect Hey, quarter or about delay? we just one we thinking the the US could good kind afternoon big should Maybe guys. is quarter of taking year second provide Tucker, how is, preparing it China launch. going you we expect for Thanks be? there, like force trajectory. an be guess of Is about come for in get just congrats thinking just are as the on how How the royalty And the Labs focusing maybe is on the idea thinking Tucker should to would the or Zai how the be in trying here things their for sort sales should I we the or of in is things are mix some more to how there as I'm and be or, of an to can a approval, Thanks. launch quarter. any along do the color

Reni, it's Yes, Steve.

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move it just want much continuing is I Thanks guys. make was Okay. to still sure very -- to forward.

Thank next comes line Instructions] Our with [Operator from you. question of Barclays. Lawson the Peter

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the thanks for Great, the, for update.

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forecast historicals operating look and update at every Yes, going Peter, and Tucker. Apologies. sorry, our our forward. it's expenses we Absolutely quarter

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anything talk the, Thank you. you're real I QINLOCK the then for And on you. Got the just can treatment seeing, of you world through? just guess duration if setting there's

to on that? you Yes. comment Dan, want Thanks, Peter. do

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Thank you.

Karnauskas Robyn Securities. Our with next the of Truist comes question from line

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Robyn. for Hey is guys, on this [indiscernible]

go please Yes, ahead.

my Thank for you taking much so question.

to especially of around also impact setting? of this been enhance relation ongoing. from you you're safety concerns Sutent getting remind you've real do sort line is hearing the used QINLOCK, the if for down feedback levers about COVID what world second barring program that's us dosing about any Can anything and and around to safety line, So fourth see uptake the that's in regimen in in you additional doctors

Yes. Hi, it's Steve.

that your And if Peter will listening come question. to still back take question. you're I'll So

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consistent So reduced how dose the is world some feedback real challenges. is of tolerability physicians who drug common to be from as mean we and used use with setting, respect to in very drug result it this yes, Sutent I for that the that investigators it's a hear and

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used So I as option being the drug a well-tolerated is think for effective patients.

may. I if question more one and Great

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you much. so Okay, great, thank

you I cell and based to to Great, with thanks. generated more back you Peter see of expect to simply might I prolongation that ask question And asked that killing the a of and published then we now Matt preclinical versus response more whether to we've like [indiscernible]. on a just wanted come that data or with to been and that what's your MEK response combination combination respect tumor on satisfied the would address to wanted inhibitor if

data imatinib. of than today. study so The a was ripretinib, an to And The the presented. of survival overall and single that was for combination that imatinib of PFS single-agent rate patients, reached reported not again in about been response very activity that was combination survival of months, objective about from had greater for compares XX.X the XX% XX study progression-free the the favorably XX.X Sloan-Kettering than I responsive Memorial -- study same think cohort there Yes, discussed that was a ASCO was MEK basically pilot rationale the the was able that done, an of was very last that investigator is was year show that important at to Sure. recognize it presented months. combination XX% at to historical preclinical we've investigator

data the us So this ripretinib to gives early it real again, planned combination support imatinib with of study. in world evidence some some and

turn closing the I no over would to in the Steve queue. Thank call further back you. remarks. I'm to like showing for now questions

look of you. you for the progress just of great our to continued all thank Great. updated support evening. Deciphera. call, keeping you Thank a you and today's forward rest Hope have throughout thank on all your I'd like We you for joining of us for XXXX. to

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

may You disconnect. now