Deciphera Pharmaceuticals (DCPH) 7 Feb 232022 Q4 Earnings call transcript

Good morning, everyone, and welcome to Deciphera Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Jen Larson, Senior Vice President of Finance and Investor Relations. ahead. go Please

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

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

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

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

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

an as XXXX, QINLOCK the now driven provide planned or additional a you us XX for compared today by product everyone. corporate as and update Deciphera. full gastrointestinal review launches U.S. XXXX tumor, quarter in fourth-line exceptional jurisdictions milestones the context our U.S. for and revenue for as very Global well and and the you, we is for good morning, grew performance our approved QINLOCK in year around on outlook results the execution XXXX, world. strong year to Thank GIST, strategic XXXX. from financial Thank XX% stromal of fourth joining was of provide outside

second-line Phase in GIST successful, XX/XX in QINLOCK to These we to key month, the the our initiating multiple our year, INSIGHT we practice the fully market the integrated patients into will of towards U.S. KIT change proprietary ranging for expanding versus a QINLOCK. double potential continue the of in Last Deciphera early-stage inhibitor of which mutations its powered outlined all Pivotal to Sunitinib XXXX. driven revenues approved priorities by GIST the include strategic discovery, lines by for Exon capabilities and platform. international XX in switch-control priorities GIST has believe medicines being second-line potential commercialization Study for half study INSIGHT with to QINLOCK from company and If enable and evolution X kinase second earlier with the KIT

Phase Sherman, pleased data and at few circulating the Series Plenary ASCO study or in X Officer, plans the the DNA, later was very Phase our the a our that GIST for INTRIGUE call ago. data, presentation Chief review were in for from We second-line INSIGHT tumor weeks study. new Session selected QINLOCK will outline Medical Matt X ctDNA of our the

cell with TGCT, another also receptor X of in study in begin tumor, study the year. quarter the inhibitor As of to in vimseltinib, QINLOCK, for or MOTION Phase CSFX switch-control fourth readout this trial, INSIGHT giant tenosynovial pivotal kinase our highly expect we X Phase patients enrollment new selective the we of

we enrollment complete this year. now and very study of top-line been with enrollment have QX the in in today the in pace of report quarter that expect first data pleased excited and to announce the We are MOTION to

first-in-class dose X/X data escalation and kinases data half of inhibit ULKX/X updated our in portion the of to single-agent For combination DCC-XXXX, study designed inhibitor the the initial XXXX. to autophagy, Phase the expect second of from we present

Finally, we to new initiate in combination this half this with and look new we forward were supply additional the and DCC-XXXX a the first data supporting year. pleased in of We to second of for Pfizer year, clinical trial cohort plan very DCC-XXXX. data cancer half collaboration the of along presenting preclinical in dose and preclinical a escalation for that encorafenib agreement new combination to announce cetuximab with study colorectal this

We commercial to pipeline. with complement research our in investment these advancements continue and stage clinical

or kinase discovery first half of platform this DCC-XXXX, first-in-class best-in-class year. switch-control advancing Our including an in proprietary development platform precision has second and the discovered nominated us clinic. the candidate program DCC-XXXX pan-RAF which look drive investigational to data same potential quickly we our was with new growth oncology and present and expect the the agents, using to to new newly brought file QINLOCK, for application opportunities preclinical continues to forward vimseltinib the this drug half that inhibitor of clinical to XXXX, in year we

Chief of and update has Chief XXXX. Tucker our sustained Margarida fourth which We'll end with will ongoing Officer, Europe, Kelly, in International, its strong line on QINLOCK's launch data engine our the preclinical well throughout plan about us working offering Matt momentum full team Financial our a from provide addition, provide to the an will call. on Head other in new to XXXX In will highly as on. programs quarter will for Officer, allow goals. fourth the we performance development highlights will who Officer, share successful follow-on on and our continue then Commercial milestones the detail the from as our equity recent today's review quarter debut upcoming coming and financial that on to for from our results pipeline our execute discovery commercial U.S. Sherman, Martin, been insights more our year research candidate Chief has proprietary Duarte, Medical Dan months programs

I'll First, R&D provide Matt? an over Matt to efforts. our Sherman the update turn call to on

Thanks, Steve.

pipeline made in of have the year. with our in We the this weeks preclinical already and across clinical we few first and are progress XXXX thrilled

As Plenary if standard Steve the care. INSIGHT the of the from the improve strongly line to to based at approved, treatment mutational our study to label mentioned, last study in for support data second on the month, which results and practice-changing allow second-line X patients Session the ASCO present additional at believe ctDNA our time will expand The a to setting QINLOCK INTRIGUE the planned first privilege event the treatment profile QINLOCK's for was it of potential Phase physicians KIT-driven GIST. in we which, potential current outcomes over optimize represents

Exon either contrast, a a objective XX/XX disease. with X.X with QINLOCK improved stable XX to patients a partial median compared sunitinib mutations, In analysis QINLOCK response of response XX% months PFS to compared there striking across all efficacy all or Similarly, a benefit months objective QINLOCK ctDNA with a on for XX.X achieving no showed rate the were with demonstrated KIT confirmed measures, sunitinib sunitinib. In the and responses greatly patients arm. beginning in for only

resulted their disease a progression XX% by weeks. resulted risk of of the meaning ratio treatment or in death. of receiving in X.XX, that This sunitinib restaging reduction the a died patients half in or fact, at scan hazard first with progressed had In six QINLOCK

not in updated QINLOCK showed number on overall overall landmark patients was survival that had at showed strong in of The a of And QINLOCK QINLOCK We still consistent reduction the subgroups' an are patients. an the study. the arm XX September QINLOCK in based or with of safety median patients XX% This trend death. to also tolerability and to subgroup for OS that the had XX.X a the estimated X.XX of primary nearly patients and was generally saw profile analysis INTRIGUE of cut the risk months tolerated to as of a and in randomized while well survival was hazard that be of reached alive ratio resulted randomized of favor twice the sunitinib sunitinib. months. results analysis the of on data XXXX the

GIST For to INSIGHT, adverse arm X X second-line the treat expanded data an Exon study of plan If with the positive, this ctDNA the second-line we believe QINLOCK INTRIGUE KIT in patients. these and we fewer X, QINLOCK how patients Phase pivotal as compared on grade a patients. select physicians input, INSIGHT the treatment-emergent XX/XX, transform versus new to of initiate in results of Based QINLOCK group patients sunitinib regulatory in XX GIST patients support in mutations will label sunitinib. study and events and experienced for

switch-control believe second kinase about will program to another, I approved pivotal from want platform. our product proprietary one which X from vimseltinib, to the become we Moving Phase inhibitor talk now

the We to potential patients data are surgery. enrolling non-amenable we the be patients encouraged with We by for to have supporting treatment of to clinical vimseltinib standard began the generated strongly TGCT compelling in of care the pleased anticipate Phase the of enrollment very in quarter, enabling this the and in I'm today top-line now to we fourth MOTION us study that to this results announce completing early XXXX, X quarter year. readout date

half study expect clinical the and commercial of to provide and Phase longer-term on the the year second that also present additional data vimseltinib. in and opportunity of We safety focus support from vimseltinib will for X/X updated efficacy this for

a trial few patients of collaboration cetuximab our and We ago. in weeks escalation Under no were Pfizer part DCC-XXXX. supply the XXXX encorafenib evaluating cancer. now program the dose supply with first agreement will to Turning new colorectal encorafenib announce the as cost excited at with combination agreement, for and clinical to

the the present cohorts second sotorasib. initiate or more dose in with from and to combination plan X/X single-agent from of one MEK and trametinib study escalation we inhibitors, and updated Additionally, inhibitor binimetinib the the of KRASGXXC cohorts the dose cohorts the data or in data half combination expansion escalation year Phase this initial

preclinical potential to pathways. in a multiple autophagy treatment kinase about We on based in of cancer combination data RTK, we the with remain generated activity and additive MAP agents the optimistic vivo first-in-class strong broadly and or as for RAS have synergistic inhibitor the in impact the showing vitro targeting DCC-XXXX

of undisclosed optimized plan demonstrating the enter in development potential and IND forward BRAF/CRAF-kinases selective DCC-XXXX, is look a Finally, to in expected research inhibitor submit potent year. both opportunities, vivo combination with vitro months preclinical an slated in nomination data inhibitor development in from pharmaceutical programs as data newest We and our for well second clinic in pan-RAF as expect for presenting on the coming we properties single to program to of its as our the half the and agent which and candidate. this of the profile next additional

over efforts. Dan the on I’ll update to an provide now commercial to Commercial Martin, U.S. Officer, turn call the our Chief Dan?

reinforcing further clear continuing Thanks, Matt. year continued to product for fourth-line status over on our care we million, U.S. XX.X And execute in as full of footprint. of to while XXXX. goals U.S., grew about the sales XX.X expand for revenue QINLOCK XXXX, our XXXX, was to net irrespective XX% in QINLOCK GIST, mutational an prescriber representing of the its commercial profile In in increase standard million QX. the

from reflects drug program under curve our remainder of QINLOCK. was this half with lower benefit Approximately of in more higher received duration average world clinical who from patients and as growth from persistency patients The price fully a came and impact patient an XXXX to driven increasing mature increased coming assistance continues the the PAP. of demand free percentage net principally seen or of demand by volume prolonged volume real therapy the growth receiving

grew months. Specifically, approximately duration average we estimate XXXX therapy to of in that the seven

months. the and to as eight high to reach continue expect could ultimately and increase to time half over of eight a as therapy average We duration gradually

Part free was the Consistent progresses end above of of seasonality percentage to to patient quarter under as program challenges receiving of PAP As high of Medicare percentage XX%. benefit that range annual the by This is XX% prior is drug the D drug the with estimated our increased what due tend PAP year affordability saw and design. the the driven XXXX, in expected, the increase common quarter. in we our to patients fourth PAP versus QX slightly

double time the XX compelling QINLOCK the start a XX this alone. INSIGHT new million advance The the This believe or XX medical again. addressed setting would the for GIST INTRIGUE, it second-line are that data the we U.S. paradigm on to QINLOCK GIST has for and treatment KIT we from based yet prove potential profile, eager fundamentally advanced to in and believe the of approval QINLOCK XXX study potential in that fourth-line we treatment indication unmet if paradigm we the of label to indication, a analysis successful are plus XXX second to need in changed the million development and peak with the line mutational to a ctDNA on in GIST. major exon expanding revenue Based

Turning to vimseltinib.

have billion is uniquely positioned XX% QINLOCK to an vimseltinib business medical excess the prescribers. of unmet $XXX address We for TGCT we Phase generate in the remain our continues encouraged peak the highly million study overlap a need revenue. TGCT potentially fast together global and given $X readout and the commercial and approval believe and the commercial approximately potential potential we the adjustable will MOTION approaching, TGCT by vimseltinib of best-in-class in team With a among in where to a high to With GIST excellent of within to in have We estimated be product opportunity the and U.S. addition market profile, market X launch. vimseltinib the that total believe prepare

now International the our of in Margarida? QINLOCK will to our call Head discuss turn Europe. launch the to I Duarte, Margarida over progress of

Dan. Thanks,

execution We two are XXXX very very and that proud of key was successful critical solved in year entry. market momentum markets. sustained a QINLOCK’s of the European strengths

progress Our access major also was post-approval significant markets. launch It program France. towards the a year we which other Germany in and in in European market paid access in made

access in submission process and NICE Italy. for in the access to With for Spain. of of market the access initiation and Wales in application the in And to reimbursement the England AIFA

sales These XXXX, enabled that results X.X significantly very in unmet execution million, of exceptional proud reflect significant were fourth-line GIST best-in-class For international strong up from QINLOCK’s XXXX. the strategy team’s full need. such in profile product million the and the performance. clinical And year net I’m XX.X our super launch of

fourth in continued revenue and driven by growth was Germany quarter Our in net international of demand product in primarily X.X France. million

XXXX, QINLOCK’s reserve Germany. However, effective of quarter for six one-time as the did change retroactively pricing period revenue shortening net sales product months. fourth XX for free would from product November include law to in It months the a Germany in

stages QINLOCK In we disclose the last that negotiated a of not our And to in price Germany, yet payers in our reflect the and price team to the is negotiations. details, the remain will final we high Germany. that are brings in confident position although patients value

Spain the on future We our discussions also to forward Italy in advance and sharing well look with continue authorities access to with as NICE update and as calls.

continued Reimbursement the world. to QINLOCK China’s to Turning QINLOCK, see access that List for National to many more our patients collaboration were commercial in Greater recently Drug Administration rest National and released to Healthcare which revenue Zai partner by and their with of for will pleased include the we was look in Lab. We China. Zai in Security provide In updated XXXX, million China agreement to strong execution forward X.X our recognized

which to we for Israel, recently the New fourth-line addition, jurisdictions XX GIST. for In announce of excited increasing the in number we around Zealand, are world QINLOCK is QINLOCK in that and to received approvals approved Macau,

Financial will recent financial Kelly, the and to to Chief turn call financing. results fourth review our Officer, full year and not Tucker? quarter the I Tucker over

of XX.X X.X Total million which for XX.X Margarida. net including full Thanks, product X.X With XXX.X collaboration revenue million in revenue in year, million. sales the was XXX revenue in grew million, collaboration total to million QINLOCK revenue of quarter XX% fourth net and revenue. product million included a

million of Cost in the revenue revenue. X.X fourth was including in X.X cost of product million quarter and million, sales in collaboration net X.X of cost

million net full in sales in and For revenue. X.X million X.X collaboration year, cost of of including was product X.X of the million, cost revenue cost

X.X X.X the was of R&D million net In inventories cost been of of cost revenue. which XXXX. we had in In quarter XXXX, collaboration million million approval product of and of X.X as FDA XXXX, that cost of the cost revenue, was completed to prior was third sales total sale expensed zero

XXXX. same operating in million operating QX, the expenses million expenses total period In to XX.X in XXX.X were of compared

For were XXX.X a million the approximately compared XX% to operating of full expenses XXX.X year operating XXXX, expenses million, of in XXXX. decrease total

to XX.X development million quarter million fourth same XXXX expenses in XXXX, expenses were XXX the million XXXX. in XXX.X compared and for million XXXX. of to Research In XX.X period compared R&D in were the

were expenses of the quarter Selling, million fourth in compared general, million XXXX. QX and to in XX.X administrative XX.X

year, compared full the XXX.X XXX.X to million was SG&A For XXXX. million in

very cash that and the extended in ended and received as equivalents our year to our multiple XXX In financial further additional marketable with approved with and increase proceeds become we in investors cash, million. strengthened value to company year, successful products. we us We existing offering this raised of runway the of a securities an strong through million support net approximately position January public from XXXX. cash shareholder a new into will The offering both strive allow we XXX.X

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

we’ve the with XXXX Thank milestones approved a to path made along Tucker. The company the you, becoming at puts outstanding around products on world. over Deciphera with multiple progress past year, us our the firmly plan

prepare to INSIGHT MOTION we our announce to As X initiating completion we enrollment also results Phase later our and forward study top line Phase near from look year. X this study,

We to are inhibitor for people proud a with deep and cancer. living difference pipeline proprietary kinase to switch-control leverage platform make our

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

first JPMorgan. with Daniel from Instructions] Wolle [Operator comes Our question

is line now Your open.

Thank you question. morning for everyone. Good my taking

a of Just couple questions.

of combining – trial. First, QINLOCK for the pivotal for INSIGHT, idea with the with considered

there the Second, escalation DCC-XXXX, acceleration antitumor for attribute from be expect for from you're expected you. able data? half, investors with not an And should to timeline MOTION half second until should first then you what enrollment XXXX? can activity? are XQ this dose for completion And results Thank combination study XXXX to while for expectation refine What specifically, to? the initial

three for for and thanks joining the Yes, Good Daniel. questions. hi. Thanks morning,

those let in So order. me take

I Operator… with INSIGHT. the it to repeat of your on for was part related me? question up Can combination. broke you you just respect to a believe first that First,

Yes.

Go ahead.

idea I of as QINLOCK one the the arm guess of considered pivotal the would was Sure. question combining was, study?

I see.

Okay. Thanks question. for that

take on the and INSIGHT I'll XXXX expectations on second the escalation question to the half here for just ask MOTION, combination speak Matt So and data. to then in dose

first, activity we beginning year, So Plenary the disclosed we, last very, to Session being as very the to QINLOCK of that just relative view ASCO terms Daniel, group in of INSIGHT, in Series course, at the patients month the the we Sutent. with and of presented compelling at of of data clear, very respect this

not adding looking patients. third combination the a the So a to result, Sutent no, did don't selected of would we group we consider a combination that particular, arm because with activity as in in add additional study at a believe

And to very get the really of we be announced how enthusiasm full of respect that And is been study we nine the six allow in one going quarter. to four quarter, us first as enrollment the it's of in investigators year, previously with here MOTION, this the the really last this telegraphing to enrollment patients months, study. been and MOTION enrollment With we enthusiastic faster pace that study the to quarter pleased that allowed instead and and anticipated pleased were enroll are in full in this enroll enrollment course to of in than still out year. study, we've we've to as us first enrollment over pace the we'll today quarter the the the reporting of to reaching half in of

in the the this reporting quarter four out of to to to study year. speak question? So want do we you XXXX Matt, look forward

Yes, it's Matt. hi. Daniel,

last profile PK, very the that a we're know, XXXX in in as escalation good that showing proportional able with also to able present to we and results the autophagy regards very of dose the the ESMO safety pleased to yes, you had good we're treated So and monotherapy we we XXXX. inhibit patients year, target had dose at with were program, data

inhibitors, well, the well and the KRASGXXC X as earlier as forward trametinib, as binimetinib in escalation with announced cohorts inhibitor we as So combination sotorasib. MEK that taking

have the update there the have drug. as of is year this continue a an in in terms small if in half cohorts of the cohorts designed there our pleased as and safety expect signal the be well efficacy, it of patients, to certainly, profile dose as half expectation will escalation to this of very to PK we've updating of that information So be second we'll we'd And as the is year. of efficacy, announced, course, on the later for show to combination but, in second

actually development Got One late-stage multiple select as continue you Okay. market the the and you to there development? best for an fit partner into last With it. as question. KRAS advance XXXX, development in is inhibitors of you opportunity on

addressing approved Yes. previously, when a KRASGXXC we're XXXX with not a respect to reported Thanks for right variety a the certainly And U.S. escape you're effect we the And see. question, we've are with specific is inhibitor agents mechanistic now, combination Daniel, two see It's there inhibitors. KRASGXXC inhibitor. is individual what with an in autophagy that to the It's used we of the – KRASGXXC effect an in as effect. that class

So that reported sotorasib, adagrasib. with with but we've that and also at both preclinically, seen

So would opportunity an going ideal for to a as consider XXXX partner for the forward KRASGXXC about we potential combination. additional KRASGXXC think inhibitor us there be combinations

very you thank Great, much.

for our Please next by stand question.

Michael comes question Our Schmidt Guggenheim. next with from

open. now Your line is

on Thanks study. is for recruitment Paul morning. for Michael. This good taking on question. our from for the Hi, us INSIGHT One

only the as of ctDNA of sort mutations a a portion discussion cancer. detectable your about is ctDNA So just relatively through GIST ASCO and patients analysis Plenary suggests there KIT at shedding low have that some

that potential I on secondly, speed Thank maybe So see target you the on and combine that once the of kicks cetuximab population patients and cancer? INSIGHT later this anticipate year this for for off your whether mutation colorectal and then challenges your decision get color encorafenib in just to And on provide of drove study with you any XXXX, some combination just to wanted recruitment in expectations what you. that sort aspect? at where of

Steve. It's Yes, Good morning, hi. Paul.

then and you I'll XXXX, the speak Matt So the INSIGHT combination. to and ask cetuximab posed encorafenib that take question to

demonstrated clearly GIST with to now studies and that globally. INSIGHT very randomized enroll to we've these first, enrollment study, in capability So the large in respect

up terms in be have we So very for fraction shed looking mutation specific and versus other similar a rapidly. with patients to who and is them GIST don't studies solid patients clear enrolling running getting that of With we'll these respect tumors. a ctDNA, capability this in the

we don't differentiating as being So see that factor. a

And with that with of turnaround a barrier X simple a blood-based XX to we rapid being see diagnostic at days, don't all. as time a

it In group the at selected reported study. as been of a and I not and for but the only QINLOCK as an amount sites in advantage now terms Matt? to enrolled just is to think being getting fact, in also would continue we and I thought enrolling hear running, that's from up see considerable the patients a offer getting enthusiasm that's to investigators study. And from of lastly, of then serve data potential tailwind we what patients, given leaders going real of the that ASCO in on

Paul. Hi, Matt. Yes. It's

we've cohort in of in yes, obviously data with inhibit to to with to tumor preclinical RTK, very showing on killing. and cetuximab, MAP overall encorafenib that or along show synergistic pathway date regards combination can an So combination a we additive in even multiple XXXX combination kinase a excited the and our the XXXX we're with plan generated RAS initiate nodes effect and

years and in colorectal number activity BEACON rate and these cetuximab a and cancer we've looking treating activities now while a So demonstrated the approximately have of in study as ago, encorafenib that combination PFS an number unmet at cohorts the XX% about of medical response with objective of months. advanced-stage X initiated was limited somewhat of the need

opportunity showing this lot improvement they're of for and XXXX be these recognizing colorectal cancer. and might a huge patients headroom treating a in So for

Very helpful. it. much. Thanks so Got

Please stand question. our by next for

Tyler question from next Cowen. Our comes Van with Buren

line now is Your open.

I Good Great, you. a thank for morning you. couple had guys.

are second help Germany And centers TGCT, understand presented of The analysis, you year? you the in other and was is and for for vim an reserve in concentrated the excellence? data that QINLOCK throughout the extensive sales one-time given what the on this so throughout in cadence points claims you've confidence but the expectations us necessarily of country diffused what patients more for elaborate magnitude market, sales not your the ex-U.S. first in give is can of

Thanks terms And Dan, as I'll Yes, of what reserve why the good across questions. ask the have take to then, of cadence the first and in Tyler. see commercial perhaps opportunity. respect comment on question analysis of don't can set final in to Germany. Tucker confidence with for the then vimseltinib Europe. you the on size claims we morning, Tucker? the you you Margarida, business the and the comment

Sure, Tyler.

of law that change German November. It quantified six be law. based Germany used folks, took the changed haven't remind the So the in fourth to a shortened to we the got months effective you in retroactively free that amount quarter. November to reserve had on authorities XX-month period of what that pricing and that is we just But the in happened in the

because third our sales quarter, fourth pricing net based had we booked So on the the price in reserve the sales free fourth in that quarter. estimate we quarter, not still then we the final where at the pricing. up of with booked And German our we're took in a in Germany, but in price we an Germany estimate the an end may authorities at on at were think

wanted quantified as it at larger in a but that number make we product looked the change in to the sales. certainly sure So haven't international understood quarter-over-quarter people we quarter they was it, that

the Tyler, take Thanks, Okay. I for one. the will second question.

rest cadence Europe for key strategic come say year the in of the that the drivers. two from will would I So

in base. to continue offer that the awareness where – and would the the demand is expand seeing continue don't say, yet to I'm pleased new with is so far demand in extremely the we to we we strategy to one that execute see. success say access, would the also prescriber first and successfully to to the I on The one, launch that continue our have markets to second in successfully and price reimbursement so are to can And launch future; to and strong raise I we drive and drive And continue countries that with

gives And on in I'll Martin. Tyler, is your TGCT take us the Dan question what this confidence market.

I confidence factors. think what is gives us several

the typical the of analysis, TGCT presented We as opportunity. component findings was up both in for on. our a conducted really the a build size totally sort methodologies, as analysis overall That conducted a mentioned opportunity. and claims of patient We epi you different First, terms separately, we similar literature-based couple addressable in similar the which resulted a more conducted just well of very overall answers. actually of that claims of of and of journey we've the gave all analysis the

X,XXX that it We set, as the always the in noted patients – that incident really that the sees that it opportunity Rx-treated doesn't in floor to patients. being we've U.S. one real we data have patients this because an the is of as the provide actually to as X,XXX confidence us and gives the a this viewed claims relates of data, analysis indicators patients,

can we confidence. the us so And great which in being see gives these data, patients treated

from Lastly, we've crosswalk products the database patients the set. or one only there get claims of our we've view as that the share, the that of in used things to triangulate enables And laid about the this presented data space sort in that to out. of market received the findings of of well we that us showing I XX% pexidartinib back note is that would opportunity and asked just sort and

we in land is places opportunity views gives very confidence different similar that us the the multiple of there. across which market great So

in developed academic a being with note that patients space Lastly, successful and and spread that real specialty is a really that is GIST diffuse know of community very very the I'll being way. GIST of because just settings overlap between and GIST. TGCT description similar ours. both between one that of We've And the more much in bit point that frankly, as capability we markets that's high. is

So for there reasons, we're that all the and successful. be great to uniquely have market confidence positioned that these is we

Thank very you much.

question. by stand for Please next our

Yang from Our next Eun Jefferies. with question comes

Your line is now open.

a actually Thank you. questions. I have few

know, on data do And that XX subgroup analysis in that to predict. something But INTRIGUE months. second-line you of on you expect and of I QINLOCK Exon this do in expect treatment NCCN be increase expect Second the NCCN question duration data. X patient was it driving and you. decision of in I don't the increase you X.X something to is – months cannot population, year? XX for in submitted is First, your light Thank mentioned duration? subgroup? have treatment understand you we XX, the that months to for the the it's X.X guidelines. the X achieve What's to that XXXX, could But

questions. Hi, Thanks Eun. good the morning. Yes. for great

to I'll QINLOCK then respect So I'll the question on the to Dan duration and NCCN, real-world cover for we market. with treatment ask in experience first in take that off the second U.S. the see

can not is data to NCCN Eun. month, with in last right, the update Plenary update. So the for might exactly in the that part the or very we the terms to group you're going that QINLOCK. NCCN, from this something guidelines excited when whether ASCO compelling data It's just first occur patients the what of in We Series subgroup predict be Session were guideline of might present as of reflected

about excited that. we're So

of excited the the the the it field presentation think will session you about at as have and from January. is ASCO very at the end I seen discussion

await you shape for form we to potential the be any predict so And timing might in that to guidelines, as difficult in. us updates or what do or

tuned if updates. are see So and we'll that for any there stay Dan?

that important Thanks, the for growth year-over-year. of question driving dynamic duration solid Yes. a we Eun, regarding key average in therapy. was that the It’s saw really really

in and a prolonged from in study. PFS just curve, now who said the the benefit the now real way duration in patients noted world volume growth about was driven world persistency extended that this million growth duration of we And by fully by is I the pool median XXXX. saw of my growth. remarks beyond in QINLOCK average for And As with reflects just And we volume of we have up XX% importantly which the therapy number the by driven a principally really real sort another prepared that of that was driver increasing factors, that treated of or XX of had but demonstrated pulls remarks, maturing year-over-year see. maturing the average that the U.S. – therapy prevalent more INVICTUS

and I that points gradual but achievable. for driver confident we eight that’s feel therapy eight And be we into, We of potentially to important a and and that which that number there’s really we is go a of expect proof certainly reach a average could eight months, growth eight to ultimately had half very month over duration to a expect continue could to because that time. half – noted

a That’s that’s However, will over see phenomenon. develop gradual time. gradual that we trend a expect noted have to we

something of that’s to don’t in, that predict will as of time. to underscored, sort duration that dramatically we timetable quarter-to-quarter, we expect color additional over So peak why that a it’s likely but And be see as exactly average something on will we that share changes so that hard what warranted develop therapy. we

Thank you. Can follow-up questions? I ask you some

ahead. Go Eun. do Please

Yes.

on So a the question INSIGHT trial.

XXX the sub-group the need INTRIGUE. looks like may patients you’ve to on XXX done based So patients. screen you that from to analysis about It

So XX question it take in secondly, imatinib to a patients? Thank routinely? after this number done you. the analysis is one enroll currently is about how And long would mutational do in think you practice,

Thanks two Eun. the questions. Yes, Good for questions.

I’ll So both of those. take

first study, INSIGHT the right. to you’re respect So with

for We – to multiple our capability run studies Our in have large sites, open capability for find large patients this we sites the these screen we multiple from the which global a sites as with need for to to study, enrollment INTRIGUE, eligibility have will experience demonstrated to enrollment. course, and patients and ran of study.

know they diagnosis. primary turnaround will that their and patients. of we day the to easy be physicians using liquid or there’s time generally five a their know level site XX And blood simply a time draw biopsy patients liquid the At for status will of mutation already furthermore, diagnostics to from where identify sites course, an

we for study. So in primary at consider their would of they really secondary the in course, understanding profile as expect exon XX and what mutation that enrollment looking patients, them would be physicians interested their

capabilities based have confidence running running looking of of this to on of our and in And a we the we’re getting INSIGHT up demonstrated year. area forward end So this lot these studies. at sorts of

tumors, even hasn’t looking know Now treatment. other biopsies, solid been the we to with or at – sorts But within consider now to liquid good the practice that cancer of imatinib looking there what other at emergence these until up post physicians need is a secondary U.S. respect whether it’s from a mutations lung of need isn’t blood-based for analogs, adoption. or these very diagnostics see globally

sent five As a to run. with XX tube day easy a simply blood these are off a turnaround lab that’s to to of noted, time. It’s I

diagnostic a So data expect, we given in adoption the a this use to presented with all. we’ve We barrier especially group patients. don’t now the expect at of of nature to be of that QINLOCK don’t

be among fact, status to a enthusiasm think their there’ll considerable patients and what secondary is. In of physicians we mutation understand amount

So QINLOCK second-line they’ll setting. an them know for in whether the could be option

you. Thank

Please stand by for next our question.

Raymond Our next with from comes question Piper Chris Sandler.

is line now Your open.

second in just trying setup? if can in that in diagnostic maybe line Thanks patient the for if is analysis questions. regulatory there ctDNA setting? included and XX, Chris. identification. the taking the would you to about it’s differences XX guess of companion in Are KIT I terms NCCN approval This potential just understand for get morning. guess, diagnostic Nicole you cleared companion integrated data the Gabreski is have good two if using as versus to the important One, any approved setting. a us. subset we’re for XX, on Thanks just Maybe from a exon be guidelines early I in how talk or

And allowing stay to vimseltinib captured patients And label. I we guess X ESMO over around back pexidartinib that the into will on does ORR at Phase that understand the translate presentation vimseltinib, that MOTION then potential a were that know that last just guys but time, XX-week the highlighting But year, longer. the point how time maybe and effectively your you safety and responses therapy deep study label? profile going within I second match will to be be the key differentiator, for how

Nicole. Thanks questions, for Good those.

potential the comment then that these the that the in ask approval. ESMO of label do in touched first your a I’ll population, question think regulatory at would already then MOTION take And and collecting are me data the the course, let absent and for approval Matt the drug and just today, year of in MOTION practice? patient blood-based this of data Nicole data study the setting So inform on day last profile upon what could part panels even the we’ve we’re first I and source a know available. ctDNA But environment, a just ctDNA was in as presented present of question. physicians We of for and QINLOCK on commercial to

So and Health like. from Guardant companies like Foundation the Medicine,

for today, it inclined, could physicians And if of so send blood analysis. draw off a to to so tube they Foundation were and or Guardant

just And will up in the today panels pick on and secondary these back that. mutations report seen patients

they make decisions off-label they be so if do analysis and today. could physicians, So chose which then treatment so, would run – to that

physicians for MOTION? would something So that physicians these use. and decisions in the patients. make have interested obtain then to treatment vimseltinib you are for coverage comment is point are promote would secondary available then that off-label or we isn’t diagnostics want But just to. insurance my that their who they this can But understanding provider the in to could work patient’s for guess to status Matt, I do on today mutation with

good Yes, morning, Nicole.

for XX-week to patients in had So, what reported they’re similar these know, TGCT which a labeled. yes, for study ENLIVEN, study, as vimseltinib, the the response endpoint also rate, pexidartinib then we also [ph] the we were as response study Phase know on was a and And you TGCT XX% But can patients a that. continue response for months X the beyond the the cohorts longest reported in Phase XX% we and rate X/X who study. overall in have therapy longer was on six for escalation the dose than

or label study – for study. it’s pexidartinib label, it’s in shows response that’s can a based current their also open And that label also the the the of ENLIVEN XX% also of you label terms label portion in pexidartinib. rate in And ENLIVEN’s noted overall

could we may a So for higher and that response longer-term expect vimseltinib follow some contain rate. our label up overall

Thanks. Great.

next question. stand our by Please for

with comes Brad Our Stifel. next question from Canino

open. now is line Your

in the comments. I ctDNA to to on previous on few do your impact you paradigm the physician I practices Steve, want of second KOL to guess treatment the guided know, a and subgroup sales? the and proportion follow-up you. next analysis, years enough to adopt line material thank expect Good feedback morning QINLOCK based a maybe

And reach for vimseltinib about When comments data readout to you would top is about it that the you successful, to package add for you degree an any the then with take XQ. slated you. a FDA second the to line the NDA how of long in you question expect think Thank can include filing?

thanks, Yes, Brad. good Two questions.

being to the presented an practice it’s at today around that expectations and taking we’ve changing data uncertainty. respect or that with translated ASCO So

we have we’ve the label. us So of experience don’t whether use. that promote can’t of in QINLOCK extensive for is has an market that been our use use been physicians so that seen research basis. off-label What has approved far tells drug We to the course adopt generally our will on within

line time. information to in having what us is the to don’t change share practice, reasons continue moment that to how drive that And is to conduct to So in label promote ultimately and second to monitor occur. Clearly INSIGHT label study the to population upon But is any approval. line a setting allow changes this to respect second able changes and a that at what one have use over we’ll utilization. physicians, if decided the that how be the of choose the they will might we practice with drive we’ve and patient in understand seek

I related this NDA. the year a And QX. for complete around morning your to quarter Your enrollment study vimseltinib of Brad in the this announcement potential first in read think timing question was was question, and to the we out and second that expect our

in to in This study of an thoughts share some our for a certainly fourth topline filings So get the – the with that us of What from QINLOCK and has topline could be premature NDA the time could what demonstrated to timing our sure of our that we’ll have around with our I’m additional move in. filing U.S. And we what different. top of I will to potential for around no can timing label, readout be for really readout. is when be post results, to it’s and line offer say outside a line quickly a be ability the the the readout filing team U.S. position data a color

Instructions] next question [Operator from Our Peter Lawson comes Barclays. with

Your line now open. is

my you. Thank taking questions. Thanks Great. for

Just inclusion XX, from are NCCN exon XX? guideline looking XX, guidelines GIST, for for you to gain

Yes. question, with Thanks NCCN. for to respect Peter the

guide So what our do with any to we’re going to will any guideline continue update, respect to decision of monitor decides and NCCN data. that to future about submissions

So respect forward. plan that’s with the to going on approach we taking NCCN that

that – as you. Got mean, [ph] doesn’t data mutations, second other various Does plus line make I the the XX NCCN will changes does exon to judgment call? for come the XX, that guideline XX, difficult make them

plot. ratio And plot. a benefit XX, nuance in where sunitinib. is mean, center the hazard QINLOCK from have patients the in detectable XX what of group and the certainly I the not think virtually versus think result forest of clear the we is we ctDNA that see Peter level the complexity learned this is that The the is I of terms data. to XX, in of very QINLOCK forest there’s whom of we’ve analysis I for population, PFS on – Yes,

to available We unclear do. in interested treat NCCN So I might with think is We what choose are patients. just having that to think any know options that it’s the at moment physicians different. don’t situation this generally more their

of going will to physicians would So providing options patients panel they forward. to think expect be as we the about on interest that

you. of think could next help how the kind you on of opportunity of about the And should China, we revenues couple over years, and XXXX kind XXXX? Thank pricing then just size you. how the Got or think it’s of whether it just

disclosures? Zai address would China Margarida, to the Sure. like you opportunity and

Thank you. question, Absolutely. Thanks Peter. for the

for this patients So forward. moving we positively as very Chinese listing access it’ll increase and review affordability

a But positively. volume extremely be of details lot we expect that have how we to these do of in a happens contributor quickly growth all key not we So view all, time do over this yet.

Got you. Thank you so much.

Thank you, Peter.

Steve would questions Hoerter like for time. to the I to back turn I this show no further conference remarks. at closing now

you doing today’s call. our day. you, at to of this look hope continued for balance on support of Thanks for that you for a and of updated here Michelle. us joining to you work you Great. great Thank forward year, the the all have keeping rest progress we’re your on We your Thank Deciphera. of

call. This participating. you concludes today’s conference Thank for

may You now disconnect.