Deciphera Pharmaceuticals (DCPH) 7 Aug 222022 Q2 Earnings call transcript

Company Profile

Participants

Jennifer Larson	Senior Vice President, Finance and Investor Relations
Steven Hoerter	President and Chief Executive Officer
Matthew Sherman	Executive Vice President and Chief Medical Officer
Daniel Martin	Senior Vice President and Chief Commercial Officer
Margarida Duarte	Senior Vice President and Head of International
Tucker Kelly	Executive Vice President, Chief Financial Officer and Treasurer
Daniel Wolle	JPMorgan
Allison Bratzel	Piper Sandler
Bradley Canino	Stifel
Reni Benjamin	JMP Securities

Call transcript

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Operator

Good day and thank you for standing by. Welcome to the Deciphera Pharmaceuticals' Q2 2022 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. to Jen conference Finance Larson, Relations. like first to and now today, speaker Senior would turn over the your Investor I Vice President, go Please ahead.

Jennifer Larson

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

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

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

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

Steven Hoerter

practice-changing year-over-year for medicine on corporate Thank successful results revenue quarter the a we everyone. strong with in in performance XXXX. building We United quarter, outline commercial our our initial the QINLOCK the Germany, an delivered joining very and as in further financial review XX%. this good launch resulting Thank and the provide in today X Jen from product States rest entrenching morning, milestones of for of us growth you update and second you, second quarter, our

Beyond additional Phase the enabling for milestones have today's candidates pipeline development advance highlight call, we first-in-class QINLOCK, continued we upcoming the and review our study Chief this opened of will made focus In of study as to of clinical our on our and we quarter, Medical rapidly Sherman, potential. programs. enrolling our advancing data clinical the sites best-in-class study. efforts stage registration progress from portfolio Officer, we On DCC-XXXX Matt the product and second the pivotal vimseltinib with X MOTION vimseltinib,

X/X of We the expect next to at the from present Phase month. in vimseltinib updated Congress ESMO tenosynovial tumor, study giant cell results TGCT, or

ongoing Phase We This also also and announced study report as the is paper. presentation data from for our data that were X we X the oral excited Phase inhibitor, proffered study, data presentation the the our from present autophagy first-in-class initial that DCC-XXXX, at clinical today an of a first ESMO. we're selected will

performance we more in QINLOCK's fourth of potential in Europe. by nominating update Duarte, the International, who country-by-country joined working drive for provide she Martin, the experience an the Both pan-RAF efforts, details Business responsibilities underscore program world Margarida best-in-class Sherman share And advanced fourth-line from to on an Kelley also growth. progress sustained our I'll and as momentum the with strategy demonstrate company's the efforts. where Officer, our the Deciphera's QINLOCK candidate notably, benefit launch of past update Dealhoy recent corporate supporting quarter. served Division. life the from next rating Commercial were And research excited Oncology science in I role. years transform including, the us R&D development treatment to the over developing and at will and our Officer, of excited Chief team Germany in to the QINLOCK brings Business for Europe, This paid chapter a major quarter, provide access program Chief Head forward turn have on well welcome her Vice of additional Matt as President Novartis received the GIST very include Matt? anticipate Executive as we the now to to of post-approval the to XX our business look the the potential Development will Kelley Deciphera, our our of most for to Kelley successful We're leadership commercial to quarter. around strategy Finally, on Dan and initiatives. of development will to as market access her leading France. call U.S.

Matthew Sherman

Steve. Thanks

We for cancer. first-in-class treatment pipeline DCC-XXXX, with continued provide our ULK inhibitor. I'd to advancing our options patients work novel excellent to clinical like make preclinical to potential we and progress with as start

to of are ULKX/X of broad of cells. selective cancer highly targeting cancer. the is benefit potential to by ULK, a mechanism factor drug in has inhibit And the as and of initiating switch XXXX tumor leaders the Autophagy mechanism pathway. the autophagy We exploring a and role a potent patients significant the resistance key mechanism control cancer a survival in autophagy of the potential inhibitor that activate kinases pathway. designed a is resistance number DCC-XXXX autophagy

kinase preclinical a collaborators, address autophagy generated DCC-XXXX of of to of the MAP academic ability and inhibitors. variety induced now by RTK, RAS pathway a and independently body have demonstrating We research, with growing both

this mutation. RAF in the have advanced an We dose study built tumors position agent, X the escalation portion metastatic currently with solid in RAS single of being is targeting in industry-leading Phase pathway. a patients or DCC-XXXX with investigated or

intended an of data that presentation superior for oral paper, a selected was at for ESMO it which original as September quality discussion. that excited includes very are in We expert is proffered

The markers study. on evaluated pharmacodynamic the overall the be the pharmacokinetic first readout will and profile, and tolerability in as as focused safety well

forward We expect of and ULK to mechanism dose multiple single expect PK combination as in see take levels do to marker half inhibition. recommended we our data, a of not this into initial allow dose ATGXX, action, escalation demonstrate select Together research on cohorts engagement the the Based we of will this activity to the PD agent monotherapy. us that through year. safety and with second preclinical of will measuring the target

sotorasib, GXXC inhibitor. one two MEK with cohorts Our improved combination Phase trametinib as cohort and an include KRAS with study inhibitors binimetinib, in X well will as

good With ongoing approved a medical with durability strong receptor data a in and to We vimseltinib the profile. remains a believe treatment treatment now for for for safety CSFX X/X inhibitor, significant Phase TGCT therapy cell TGCT highly profile. effective we the on U.S. need or believe kinase one the best-in-class be our in Turning excellent a patients, to that from need. tumor, well-positioned giant initial safety with Europe, and has vimseltinib, potential TGCT. patients efficacy is available vimseltinib tolerability and shown study unmet to none there tenosynovial an in the this Based address has

we at study escalation month response poster the rate provide standard-of-care to longer coming full updated drug Phase and continue safety become data We ESMO. sites are of of the of results from patient-reported from will MOTION have and X/X to that the and timing selected has phases study the and vimseltinib We for objective initial to include outcomes. Phase continue estimate treatment registration the delighted updated surgery. to term show secondary with to on and These been patients potential data results rapidly results in these expect that next presentation plan expansion to our TGCT to will provide X enrollment end, enroll study, non-amenable an endpoint believe months. a the To based for enabling open

lives continues candidates our designed product preclinical will focused update people year. the X cancer. from of This highlights patients unmet to mutations innovative inhibitor now our expand program of to X BRAF is Nomination switch harboring kinases We discovery molecules. to provide U.S. to the on Class efforts. nominate We're pan-RAF development need X, to research control Martin, and our Dan commercial I as with new turn CRAF Officer, and improve a best-in-class call later an our development well best-in-class program drive kinase continue to developing Moving Chief fusions. proud BRAF Dan? through this on of first-in-class our of to remain BRAF over the address potential an candidate to portfolio in on and growth Commercial our platform medical this a pipeline candidate track to with pipeline. dual as

Daniel Martin

clear position prescriber and continuing execute on to U.S., continued In GIST, standard-of-care in for Matt. while fourth-line in footprint its experience commercial QX, the the our reinforcing expand QINLOCK Thanks we QINLOCK. our of goals as physician to

During in quarter, $XX.X the we product the revenue achieved in net total U.S. million

strong metrics of product reflect share product Our prescribers. prescriber voice key continued awareness. performance of among again delivered commercial in excellent execution results positive We perceptions and to GIST reach, highly terms and

all for extremely an their prescribers was GIST attributes KOLs our in discuss as feedback and GIST. safety, QINLOCK drove has to to consistent, Importantly, we the highly experience that QX, to In part benefit the in ASCO many including patients and all key across continue of Their volume convenience with payer advanced opportunity that they their settings tremendous efficacy, unit leading sit business both marketing teams in indispensable strong rate it clinical demand segments. with and June, down provided product of At QINLOCK. treatment armamentarium view academic namely QINLOCK had sales access. very and across community GIST their

is Our new now grow pace has a community again majority of launch-to-date coming prescribers very from consistent to physicians, at XXX base the quarter-over-quarter continued prescriber over setting. with the and

with Our strong continued the And for patients and time therapy. access claims market we saw XXX% again during excellent payer quarter. access payable to team persistency on has on-label deliver

patients QX. range. of assistance percentage the or higher under program, The versus drug QX of was XX% XX% in toward receiving the increased expected, percentage to As PAP our PAP, our end free patient estimated

high-end or last what consistent is XX%. this in drug Consistent trend affordability Part the we is as be the in slightly past what estimated quarterly increase of tend progresses we above due at to patient Medicare design. annual to saw year, and to D very the expect QX to that QX benefit XX% XXXX and the saw our driven of percentage by range year challenges This we with with year

Turning to vimseltinib.

the and focused forward commercial vimseltinib existing Deciphera's approved infrastructure. synergies, operational to of second MOTION We our continued sarcoma drug, given substantial are progress possibility study see offer to of which would the becoming excited the are looking

opportunity be well-positioned a opportunity And We market approved well no of unmet quarter International, of market million, this results is therapies clinical understanding in as or believe TGCT. to prevalent of associated of over with U.S. population TGCT have market given that QINLOCK as discuss penetrate Duarte, KOL Head the not call given turn research, Europe, need the from Margarida? opportunity where vimseltinib's We include would are high through in potential now to significant to continued even the exciting our our the potentially of launch analysis greater will data. to our does the $XXX commercial unmet need and second there the for I Europe. our the treatment-eligible engagement Margarida best-in-class of the profile. a vimseltinib claims U.S. additional addressable deepen medical

Margarida Duarte

Dan. Thanks

including we and ensure paid work need market, very European are Germany transition reaches post-approval of this in most. the in the the strong launch it globe France, medicine program entry proud important patients We to around as our who the the access QINLOCK's to into

QINLOCK strong from product demonstrate For of unmet growing the GIST position QINLOCK's exceptional of net million, international in European France. need product represents with revenue results benefit most in second of $X.X the and quarter and of addressing second clinical quarter These patients treatment we landscape, the revenue which fourth-line high reported XXXX, the reflect its Germany GIST.

of achievement. And to have June in only its GIST. is a Germany This drugs in additional an benefit We XX in team are indication treatment recognition. received rating rating. on and treatment I these major am to the oncology QINLOCK the known most be proud for all with and awarded one this are announce indication supported submissions the Germany cross-functional that to for date, possible on oncology submissions in such impressive orphan received evidence and comprehensive receive X% first lead complex its of GIST only of the extraordinary dedicated extremely approximately Europe, this is the Reimbursement QINLOCK efforts. highest honored advanced rating that

treatments, negotiation have perspective, outcome. thanks very are a number rating, from eligible also secured the III a brings starting of we in many QINLOCK ASMR achieved the small believe recognition GIST we benefits, value price France, successful by robust a result which to well-positioned, a underscores a positive traditional orphan of that position With rating the only favorable clinical QINLOCK's to patients. In which we will

the addition Germany QINLOCK for pleased In a application recently NICE and we continued country-by-country access now Financial call reimbursement and U.K. on efforts and to the have results. share the for I'm in France, we financial to that England I EU very to over our market our quarterly Tucker? Officer, in to in the will access ongoing Kelly, And pursue submitted basis. turn to review Tucker a Wales. to Chief

Tucker Kelly

until net was in supply collaboration inventories revenue $XX.X cost expect from manufacturing. Zai We to sale depleted product second the XX, Lab of revenue, will will Greater highlights cost sales which of Cost quarter agreement Margarida. which $XXX,XXX. percentage manufacturing included Total additional of as for in our like collaboration QINLOCK and three June for $XX.X which of quarter of revenue $X Cost increase cost sold. the all the cost cost and do have includes and under inventories revenue is after not include China. inventory cost the revenue includes results. full of with is net million, significantly $X.X revenue in financial and sales months we reflect approximately review XXXX, manufactured QINLOCK's ended Thanks was million and a sold $X sales of of million second full product inventory not of million the QINLOCK and million, commenced to initial our royalty of pre-launch of I'd of zero the sales net that of the

to revenue, added our well successful initial operating expenses in in in Research pre-launch to approximately the Total XX% for U.S. of XXXX. during the $XX.X years in anticipated second sheet through $XXX quarter XXXX. to operating operations second $XX strengthened back expenses we QINLOCK general capitalized the over million $XXX call cash of equivalents turn million. period were that, with $XX.X and to believe million million compared XX sufficient marketable $XX.X and $XX.X expect same were We now and will the in to the expenses June to our second With securities offering. quarter, decrease that Cash, In XXXX. our April, With for sell continue XXXX. expenses our million cash, and into together million be fund the we the next balance inventory compared equity a quarter three to as public product, compared of royalty balance million administrative million the the are in was were development sheet, Steve. very in the XXXX. underwritten period in $XX.X Selling, same of approximately and supply I'll to a

Steven Hoerter

progress Today's Thank half first made of you, the this updates we Tucker. underscore during year. the have tremendous

sustain an the proud have been and and finally, X pan-RAF number and continued commercial clinical including enrollment initial also next X/X able we study presentation momentum our second DCC-XXXX to data a of the in half. far look study year, from KRAS nomination month; of of MOTION combination candidate the at development and ESMO MEK three updated across ESMO of vimseltinib Phase from ongoing exciting and data milestones, program the and our Phase We important study of TGCT; forward a standard-of-care this of All cohorts the operator, so GIST are that, of open the dose for to GXXC of for preclinical, the around ongoing QINLOCK With the programs fourth-line anticipate like to now position to X of presentation next initiation we from year. inhibitors; world. the cement this patients continue later at with a call escalation Q&A. month; I'd monotherapy of We Phase as while

Operator

you. JPMorgan. Wolle Daniel ahead. question the from Thank comes Your Please first go Instructions] of from line [Operator

open. Your line is

Daniel Wolle

like morning, a forward? Is level peak as a seen of this a level, full flattish at question. of It the of high essentially taking revenue we rate should think we've going in looks At quarters high this questions Good couple A everyone. penetration first. market run Hi. Thanks our U.S. for now? couple of

Steven Hoerter

Hi, question Thanks QINLOCK Daniel. performance. the about for asking

now stable want reflective specifically the in we the for expansion number prepared we're on As geographic business in in dynamics U.S. that U.S. up the and about seeing you quarter, some in put do be course, noted believe growth really the the reflective But comment we seeing remarks, of Dan, of of to Europe. very that we're to a excited that we the what of marketplace? the we're here

Daniel Martin

Thanks the Sure. for Daniel Absolutely. question.

to been to unmet in QINLOCK I really launch pleased have profile with benefit who these launch, and things. powerful that really we clinical tremendous think the really clear existed a hear patients a QINLOCK QINLOCK that and significant unmet setting these standard-of-care One the of been need offers We and as patients really also the prior having it's fourth-line is the need. that from established setting to to had the is So, consistently testament again a couple providers patients. in significant this

of the with launch really were fourth-line a opportunities. successful the As penetrating and we result that,

well who reach QINLOCK. do penetrated. So, of the the We think we majority that opportunity the receive fourth-line fourth-line vast think quite is that patients

use, use to growth And we've as our that settings. opportunities well earlier to uses within have we would line will, such unpromoted, potentially that ahead, limited indication, we or as labeled think opportunities for beyond looking the come in off-label growth believe we look BID while from course, continue so, IPDE of for as that communicated

are that's that while off-label these As uses. we've always it's to possible, think underscore important that communicated, we

drive those. We promote those. can't can't we So,

on but would use the within uses dependent setting. of provider kind listing, those for NCCN also So, example, spontaneous

key when So, really moving we forward, the we that's about how about growth think think dynamics.

Daniel Wolle

when the similar, peak sales think peak you how that for -- be QINLOCK or sales about will larger there, on expect smaller then, And what in to I Europe, Great. reasons too? you what guess, be there compare it we Should you expect U.S.? would or, are there Europe

Steven Hoerter

to Margarida, like that? would take you

Margarida Duarte

the for you Steve. thanks Thank Sure. Yes. and question,

is of strong very progress me in start making mainly saying the the momentum in first in I'm market. with by terms the QINLOCK Europe, European with the and Germany, in pleased of team Let that launch market access that

trajectory comes Europe, early would I still it to launch say our when in it's So, days.

learning it's still And fully launch are dynamics will here how We market about the trajectory dynamics. from the when penetrated market. in and to difficult we will evolve know the or be

say more consolidate in consideration learnings. summer, a we would to is to quiet I Europe. experience So, that in markets, time take historically need according slow my into Also and period that international

we to So, consideration. take need that into also

Daniel Wolle

Okay. Got on the clinical it. And more one side. question

DCC-XXXX, the choose solely escalation is the to Or based to dose terms dose In going results phase is Phase trials need recommended a the the to of the be there from on combination for plans recommended study? the development dose? wait X

Steven Hoerter

to would that? Matt, like take you Yeah.

Matthew Sherman

question. Yeah. for Thanks Daniel the

the for also Phase choose in a recommend in with very And to for then, the RAS combination with inhibitors. did continue study. combination determining excited and combination the escalation dose combination. know, take part of dose will forward with in that once and with And our So, in then autophagy-inhibitor X expansion the we we're And initially the making escalation. efficacy potential in inhibitors combination identify be we'll dose taken forward as study of into level progress multiple as study the DCC-XXXX you cohorts monotherapy we'll that monotherapy that dose first-in-class the we're for RAF in

Daniel Wolle

much. it. Got very Great. Thank you

Operator

you. Thank

question from go Raymond by. take our will comes next question. of Please stand Sandler. next Please the from ahead. And line Piper your Chris We

Your line is open.

Allison Bratzel

for This Thanks Good on is morning. Alli for Hi. question. taking Bratzel our Chris today.

So, maybe vimseltinib. one on

view of on Phase patients, indication and X/X? of Cohort just the time you On qualitatively change then, think TGCT incident, And could how interest know about of that factors of seeing the MOTION in your not could TAM question terms from level for And you lines. after trial, enrollment this prescribers that talk sort you B I among data eligible on for patients? the guiding you're QINLOCK. of and vimseltinib you're maybe into But maybe how a the present prevalent separate your expected

IPDE/BID you talk January? U.S. year. I on this think just as to if Thanks. the X was that changes Could now NCCN kind NCCN update mentioned practice driver a a you've of the you much I guidelines update. trends dosing in seen you the say growth just updates wondering quarter, any you months last think, potential it since after little have early for too any just but in too

Steven Hoerter

for the Great. questions posed. that Alli, much you thanks very

order. respect for total respect market tenosynovial question the the like then, and also question we'll you'd and with like tumor impact could Dan, about take use take you vimseltinib. then would data opportunity those And you'd Matt, MOTION of take see take addressable in So, we perhaps to the Dan of about month suggest, And that in ESMO like at any on question the cell I the And best-in-class to what about presentation inhibitor enrollment. then U.S. BID with and potential the to we maybe potential next to trajectory the enrollment giant how Martin, a off-label in think

Matthew Sherman

Alli Thanks the question. Steven. Thanks for

So, vimseltinib study. had the about going in back question to you MOTION the first

this be we've update -- we'll about very or ESMO And we're at progress month. that XXX sites, enrollment next an pleased additional in previous we've follow-up placebo. So, X/X ESMO from study. is on last yes, And study Phase as our to update year. a Phase the providing And the is also at targeting announced this today, we X XX the currently as patients global study have MOTION randomized we're enrolling vimseltinib before, with noted

pexidartinib Phase cohort X been two And such cohorts both were in receptor there Phase other study. escalation X untreated specific And expansion CSFX antibodies forward look to study, who was as had are treated cohorts. A in we reporting Cohort B patients or the previously the and well as receptor. as patients, inhibitor know, Cohort the previously as so, the to with in the also, expansion dose you the in

be So, Australia. to with expect we Canada, open and up open noted, we've continued Europe that the study. And X do but the for currently in there'll sites, enthusiasm enrollment presentation next we're that MOTION continuing month Phase U.S., globally at in ESMO, as

Daniel Martin

is I'll And for said. Dan. what Alli off your questions. continue just Thanks this of Matt

As being to view it that MOTION supportive as relates the the really laid the that market TAM, progress really is made of we've way out the with we the confirming, study very opportunity.

As you'll to additional recall, could the therapy their concerns component, we've broken for currently TGCT. may of opportunity us, for X,XXX believe but which an today who what given over to then is the first relates given that after options. go into we suggest treated surgery, available not systemic recur And growth the the to somewhere patients, be components. systemic patients receiving currently on a -- actively therapy claims a which X,XXX be One which order couple are analyses patients opportunity receiving in that of

meaningful see that course, the incident opportunity So, U.S., just we is including population, population, what in taking million then, together a that Europe. $XXX think the we opportunity on of the not prevalent in based

So, feel of the supportive as with though we, laid MOTION out interest opportunity and the U.S. in and obviously, globally. the we've it's really great progress way watch the

on This QD. always you'll IPDE, updated an year -- so this IPDE I'll recall, is use. have your to second progressed yes, as the of in after relates were January off-label question, it to patients guidelines underscore As include

becomes treatment real we're they really interest that underscored it do that data, what as important we We've heard see actively there listing view of And guidelines, think, something as in in the always that data. fifth-line. KOL in promoting. a NCCN the and by the I use. interesting option view as really out And not some So, essentially IPDE

continue use it's go expect look potential interest, early so, would awareness to trends vast use think time the see -- and know QD than data. of promote coming because we that I quarters. you is see watching will dispersion the still of we that again over of we're and because differently the unfolds to to the that data launch again majority of something we'll a data our can't bit the it But where dose. that with how in But of that therefore, and

Allison Bratzel

Thank you.

Operator

you. Thank

by. take will question. stand next our We Please

of Your the Bradley from next question from ahead. line Please comes Canino Stifel. go

open. Your line is

Bradley Canino

the or mutation. physician literature, perhaps a types for patients take you On second-line over-enrollment hydroxychloroquine chosen Thank might congrats on expect And Thank here. perception on then, in dose and based the the potentially you the you've you've quarter. data? solid But case any of reports phase? ULK NCCN or centers based the from action with of that Two enrolling RAS, the metastatic benefit bias meeting escalation an inhibition the timing a you. autophagy a any type solid would on schedule in towards disclosed you the on patient on particular to the tumor organ QINLOCK, GIST do NFX you're have RAF with documented updated and for me inhibitor, tumor

Steven Hoerter

Brad. Steve. Thanks question. the for It's Hi,

to So, I'll comment and NCCN guidelines X take question the respect the DCC-XXXX. Phase with study with first Matt to the then ask on

for GIST up NCCN, in early or coming the XX. So, next meeting September scheduled September, we is panel sarcoma the know that the

panel would the data to that. And opportunity to INTRIGUE likely would so, be have -- and we least expect at submission that an where consider evaluate of that would a the

Of sort this know, of an length process. is arm's course, as you

meeting. comment any insight that panel for that might data to have believe, Phase meeting for from opportunity, want any take or the next and to be you data reviewing they do But the X? on we potentially action choose the INTRIGUE don't that the at would then we as agenda what will be review Matt, the to if the to they be So, on take.

Matthew Sherman

Hi, Thanks Yeah. Brad. the question. for

conducting a number patients. study's with harbor the similar the of in in X And in Phase the X have sites experienced we're investigators in Phase cancer of patients being XXXX human pathway. who and solid at who advanced know, you across in tumors study done first all X RAS/RAF the mutation As studies participated are Phase country, these

these don't I in bias particular particular failed mutations. in prior ones provide typically any trial. tumor X also enrolled this eligible these types, the carry that to trial who patients therapy, expect opportunity failed have for that the So, who X are but more Phase there'll but any spectrum be to are a case, therapy enroll for Phase this onto prior of would be patients

Bradley Canino

Great. Thank you.

Operator

Thank take will next you. stand our We question. Please Instructions] by. [Operator

comes of JMP question ahead. go from Benjamin from Reni Securities. Your next the Please line

Your line is open.

Reni Benjamin

monotherapy that morning Maybe XXXX. taking for mentioned with the questions. good any off starting Hey, you you Thanks Matt, activity. guys. don't just see to expect

of at are outside And see? just patients' in the many way the program that to worth we safety, that, you're possible? help looking of data best be to related to what expecting kind you the how other of that about So advance metrics should

Matthew Sherman

for be selected Thanks the as we're And know is ESMO month. we presentation very by high-quality question. to The It'll looking usually limited followed at discussion which next abstract to oral proffered for was really the Reni well, also forward too. abstract submissions. a paper, a as

to but monotherapy some by a XXXX noted month. importantly, that in measured we've decreases previously, the were will we be ATGXX in look the phosphorylation safety pharmacodynamic also escalation as forward be to cohorts the that pharmacodynamics of only next focus study. And kinase measured of in these this on presentation presenting look we can data measure kinases So, target -- that the or cohorts, inhibition this month. in next will trial. context, not key dose This the the pharmacokinetics in and will And forward from on the on

comprehensive target of forward PK the in exposure month. the taking to package of the safety, the totality and We the autophagy a proteins pathway. sharing very So, look next inhibition

Reni Benjamin

we -- that How will at those do have will plasma, looking tumor biopsies? from be that? be should you measured or And metrics

Matthew Sherman

data in study the blood throughout ATGXX of The cells. peripheral patients mononuclear inhibition the obtained Yeah. They're trial. is initial for done for on

will part presentation that So the be initial of in September.

of But haven't terms In design. be as designed three a provided the will of of patients, number that a in presented specific the plus is three patients study study we number presentation.

think in per might through that range patients. you is patients of So, of cohort the number that

Reni Benjamin

seeing them. about from thinking getting think know the the dose dose this expansion it. might study, seeing It as I first the obviously. -- vimseltinib. that correctly and follow-up, expansion But just should we've of might case, had But if confirm an just gears prior on to time we're And rates I'm this Can -- first-time Got be switching reconfirm? in update I cohorts, of like this you how response be we well? the response. just the escalation long dose be part the we seems durability updates,

Matthew Sherman

Yeah.

question. good a So,

just walk me at ESMO through also update month. of -- on sort at next will be what the Let

-- of the enrollment part that using study of longer initial enrolled of patients. a the the the or But study dose of follow-up. much provide now vimseltinib, year. three first, and follow-up, more at So, XX are different of did dose was patients cohorts levels have vimseltinib, full ESMO We XX year those of part escalation patients last obviously,

B X receptor enrolled but for just evaluable have will expansion we year the And then to initial have are because there an fully with then all on XX previously XX efficacy available the now treated of for inhibitor. Cohort who so their currently And duration with patients the Cohort were enrolling, who the cohort enrolled was And is CSFX the of that's study. and had had previously enrollment is currently expansion not on Phase patients XX be And B. ESMO, into of those two study. patients at specific who've all update A MOTION the the patients. efficacy. are patients initially those patients. similar been those the patients we cohort XX efficacy the cohorts, That last untreated, We in And were Cohort

also update well we'll so, be on cohort month at as ESMO. that providing next And an

Reni Benjamin

the on -- that. some some are to one Terrific. just in raised markets biotech in was be it guys investors Can of capital you the on something sort comment what And investment? that there? Great. considered worst little significant then, of for what quite time, congratulations vimseltinib? bit What Is Thanks focused Any most primarily pipeline? on you so a finally, drove about commentary that. and

Steven Hoerter

Thanks question. Reni, the for it's Steve.

certainly the Europe really in unfolds. we just, around strong now think on revenue interest based expansion QINLOCK I the commercial largely the have successful franchise our be continues today, as launch we in which reported that we're as to growth nice in geographic company and built seeing

course, anchored this have productive by, novel product is, really to around have has about of your anchored of platform a that you data talked is having a meaningful best-in-class revenue. that and or And as that we generate a interest growth think that, I for coming the potential either behind will, product So, drive questions, research some some if year robust really the generating company we portfolio have of updates future the potential potentially that's answered just candidates. really to of additional meaningful first-in-class and candidates And course, of company. all

unique earlier to we we think profile and saw well-positioned we that strong of plans. company this So, in we the on is why saw we're our runway with the continue think part investor year, very XXXX space. the now the that in was interest into executing And

opportunity the we're So, further growth. to in and that position we're excited the about drive

Reni Benjamin

Terrific. Thanks taking question. the for

Steven Hoerter

Thank Reni. you,

Operator

Thank you.

question. Please We will stand now take by. next our

Sean go from Feeney [ph] comes Please question next ahead. Your from Barclays.

is line open. Your

Unidentified Analyst

taking Peter is for Lawson for question. on the Hi. the This and thanks Congrats Sean quarter. on

Just any is quickly pending there. sense data, and now since on year And it's a to filing the of timing be what's that. and potential data there what should filing MOTION what what the for been then, see? And approval is could after durability follow-up Since is? or just quick path that ESMO, for of we expecting to kind we piggyback see another vimseltinib then to expectation on the

Steven Hoerter

Sure.

on take So, MOTION? and questions Matt, vimseltinib then would also you like on to the

Matthew Sherman

Yeah.

thanks the question. So, for

year have as presentation from the of we at So, we ESMO year. another last follow-up we'll had know, initial

duration time. patients treated And large response the know, duration long periods rate there's this that's the showing an longer study. importance important with the patients vimseltinib Phase plan to think to and the results full in of the provide to are but of we in expect of timing as not So on see we response observation might of because we important, to study, when this X year in later the that in of periods trial. for remain patients in as on an disease, that's only an and And study, from MOTION activity for of the being update study time, and the can will, generally drug that numbers provide measured treatment I terms be that do update an speak enrollment well TGCT. In estimate to of ongoing will regard of

Unidentified Analyst

know and we early you. compared in launch expect compare? But does for to is to what the for there color still add France Then Thank market opportunity I days to that it's the Europe launch. how Germany, can any for way QINLOCK,

Steven Hoerter

Yeah. With thanks that would Sean, to respect for the Europe, take you question. one? Margarida, like to

Margarida Duarte

Sure.

related the opportunity Just my good, market to France? to of audio so double question Germany check the since is versus not was

Unidentified Analyst

And Exactly. launch. your expect for France we what could

Margarida Duarte

Excellent. Thank Sure. you.

are both by largest So, considerations, just this course. markets. Germany and driven market France, start with of And is they European to the access definitely population,

the And apply should may be believe with are France, us. in of be the for population main a one differences products, going this epi. to should so of has Some Germany we that we revenue than larger terms this is note QINLOCK, higher where biggest but I differentiators. that

access should to I note for the time, post-approval say, that and to program. think, we selling successfully, it's France I important in have have been recently paid some transitioned also

since different so scratch So, started year. trajectory seeing we versus early Germany to I the Germany this January, expect what from in are we last be in

Unidentified Analyst

Thank you.

Operator

you. Thank

Please last We from by. last SVB from of go line question. take ahead. the your will comes Andrew Berens now stand Please And Securities. our question today

Your line is open.

Unidentified Analyst

This for taking for question. Hey. Chris Andrew. Thanks on is the

Just on two questions vimseltinib.

got EU? -- number how the prevalent we incident Just additive for size population the the the million for in vimseltinib opportunity the in size assumptions TGCT. wondering you to And $XXX about think for the then, and for and what the population to about the can

Steven Hoerter

Chris Thanks Great. for the question.

-- both got like the then the you opportunity prevalent additional with to take how to see. you'd and market respect So questions vimseltinib, question the if about we TAM Dan, opportunity for the we that why to don't the

Daniel Martin

Thanks Chris. Sure. Absolutely. Appreciate the question.

in laid of in that we've are effort globally. how XX,XXX diagnosed out systemic potential to the each many lot but corporate into real about year likely have are XX,XXX with those the to vimseltinib for deck, sizing TGCT, as the newly There a eligible be of is So, patients then opportunity U.S. question and therapy. extending the we certainly put for

done work have in through we've lot put these multiple only literature, work-streams similar very claims And questions answers. claims a the data, that so, of And answering toward data. U.S. also but resulted we've through not

the numbers confidence And we've great out. in so, it laid that gives us

of X,XXX year. that principally therapy $XXX each see And systemic to component so, the X,XXX million first on the of the made is patients we starting up

incident the component that's treated incident So -- component.

their not systemic first component therapy other to treatment but who is have see can the within failed may on The patients we currently go surgery, paradigm.

agent extensive example. the benefit We may just known has But of for monitoring, Now TGCT some of know some the because program, from challenges: we know REMS for the hepatotoxicity, -- patients today approved them may options challenges accommodate derive boxed surgeries. liver systemic great. be deal pexidartinib their of one those some therapy aren't lives warning, AE also may subsequent that and with significant

who believe challenges and the or systemic TGCT, used studied pexidartinib. It's being we receive today actually developed so, many patients AE off-label largely And for therapy with because which off-label. of not receive imatinib, is is

a so very we've and that real, So, that out that U.S., that to million we given that to think A opportunity to a offer growth clinical getting think because speak, unmet we the and think vimseltinib something don't in We could -- is opportunity access improvement best-in-class the therapy just improvement address sort patients profile, is profile real $XXX currently. $XXX can in need. have really laid addressing systemic those patients floor, today. see we million the the of additional

patients months what time in on We not data do but claims we to we understand say Well, to a to or about therapy principally what of That's look how the more from offer get therapy. for looked TAM. not total best-in-class Finally, to and those numbers? the XX deriving to get imatinib. option on the -- to be That's seem duration they option might we claims what see today. that's vimseltinib data buildup therapy, we on better time use imatinib, that in a

an of in entirely opportunity. U.S., terms in million the $XXX largely or what on together, -- see incident taken we So, driven the

then exactly But we've or believe opportunity where math the epi the think and agents for even we different. opportunity versus haven't in approximately little higher. are the that Europe million the the how U.S. population. -- believe there the U.S. is no unmet an We prevalent, in without clearly, we And $XXX about a prevalent is estimate sized no the laid approved reason out Europe really the need for that to is in there's That X,XXX different provided considering bit so

imagine hard a vimseltinib not it's billion-plus in for all $X space. Taken together, to this opportunity globally

Unidentified Analyst

very much. you Thank it. Got

Operator

will hand the back for you. Thank I remarks. call closing now

Steven Hoerter

forward you support us much today's and for on next everyone your joining continued of and We on Great. have at to very month. and some for interest our and to Deciphera. day. to Thank great very look you of you a forward rest you keeping seeing call updated progress, thank Thank continued and much, of your ESMO look you

Operator

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

disconnect. You may now

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