Deciphera Pharmaceuticals (DCPH) 10 Feb 212020 Q4 Earnings call transcript

Good afternoon, everyone, and welcome to the Deciphera Pharmaceuticals Fourth Quarter and Full Year 2020 Financial Results Conference Call. Today's call is being recorded. At this time, I would now like to turn the call over to Jen Robinson, Vice President, Investor Relations. Jen?

Welcome and thank you for joining us today to discuss the Deciphera's fourth quarter and full year 2020 financial results. President, at Vice Robinson, Jen Investor Deciphera. Relations, I'm Chief discuss results are Medical and me Dan Hoerter, this a Officer; financial to afternoon Martin, Officer; Chief Executive update With and provide Tucker Sherman, Financial the general and Chief Officer; Kelly, Commercial Matt President Officer. Chief Steve corporate

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

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

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

result reported for everyone, would from I'm entering and clinic in impressive any have our this launched Deciphera of fourth pipeline year. but we Good IND a This ambitious work encouraging expand product you goals of in we new in set XXXX. XXXX for Thank focus, candidate The well progress candidates the for growth. The QINLOCK the Deciphera the and dedication proud quarter of on year, first the we afternoon, been wave quickly, in the you, their pandemic. a year to call. patient all QINLOCK stage our team This the next as the particularly medicine data as positions hard and our of we accomplishing with adapted and filed for product and opportunity outlined joining landmark here Jen. at at thank for this work, as the team us capsule for today's midst achieved which the our ongoing COVID-XX of beginning seek

QINLOCK, we For three have XXXX. priorities specific in

United quarter and minutes. the to to continuing GIST, fourth GIST we launch treatment eligible this of are or a First, to QINLOCK made for the stromal patients tumors successful in of States. we the our the the execute the Chief has fourth-line Commercial treatment delivering commercial of QINLOCK Dan share the highlights medicine fourth-line progress gastrointestinal new on advanced potential the with from great important setting. Martin, in will in patients Officer, few have in change

of for EMA half for and selected the the received past European commercializing last Second, the territories. who in partner, advancing application Canada a approval from GIST, filed our Agency reach for and on regulatory for distribution to rapidly committed validation guided second XXXX. marketing fourth-line responsible China, are QINLOCK partners finally This the Lab and potential approval QINLOCK and in year. Australia for up EMA QINLOCK approval authorization QINLOCK first for summer, we in have QINLOCK, half And this setting NDA front. received we us in are efforts summer, to the this for the expanding In our we Medicines potential Zai of or we in are geographic these

of Margarida efforts patients world, announce in we're commercial International. President, the the very working and to new that pharmaceutical operational global excited appointment Margarida Europe to our of Head expertise to QINLOCK look in an commercializing in deep today asset internationally. As we with to products Senior in around launches as to at we continue will bring and Vice Duarte, innovative of to years industry, joins Pharmaceuticals, Deciphera. to where and I Europe, and responsible continue deliver over new President East a And from Alnylam Commercial She Margarida of number was she be was brings successful Alnylam important and for forward Vice Africa. the mission Canada, incredible to XX her EU most medicines expertise Middle of important recently I with for product our the patients. Deciphera experience us know

enrollment therapy half is of INTRIGUE wholly-owned expanding for GIST second the in focus track study in pipeline opportunity programs. second-line robust on Behind significant offer are second-line line this in of larger to our population. the of In completed the data QINLOCK Phase and X In top The particular, quarter, a fourth a its lines QINLOCK, patients GIST. benefit we for earlier have QINLOCK in we maturing the readout third in pivotal year. for we see to

come pipeline During the course into of the expect of this year, focus. to sharper potential we this

call Matt today, the Sherman. On

from Officer, have programs, rebastinib demonstrated Chief in which data vimseltinib Our Medical both respective will highlight indications. the recent strong initial potential their progress and clinical

development package throughout addition pivotal expect the on more data provide updates for well Matt the year, for pipeline We potential preclinical the newest X XXXX. and DCC-XXXX, also that additional as clinical the share supports programs our to plans. the potential study data design including around will Phase to details both as

turn the cancers. RAS second Dan to the full quarter kinase to DCC-XXXX potential results for inhibitor, commercial I'll of and Chief As Dan? discuss benefit potential sales. group QINLOCK now ULK to the of a our Commercial has Officer, over Martin, with the call large first-in-class we novel RAF the believe patients mutation

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

revenue, fourth-line in equates the opportunity. QINLOCK, of penetration brings In QX, which including with the growth product quarter-over-quarter We and with of we extremely revenue primary million. pleased in date continue million identified million to to our $XX.X to two be QINLOCK we $XX.X U.S. launch and launch U.S., product XX% achieved net total U.S. total net launch goals. the Prior to $XX rapid the to

The GIST. to QINLOCK the establish was fourth-line rapidly in first standard-of-care as clear

and goals approved achieving launch. Based made build metrics, to The our foundation a diverse leverage key indication for perceptions we strong strong prescriber second-line product a second on believe and launch to establishing by we broad was a since QINLOCK tremendous toward these performance by among base potential and launch progress our have results multiple users. positive

during prescriber reach voice achieved highest and all recent our that market. research Our share companies of indicates product teams QX, market and the among GIST sales in marketing the

In the we the addition, challenges of two awareness increased this QINLOCK over research the pandemic, showed quarters. of last rapidly that despite have

In treating awareness many been GIST treatment approved for patients, late have physicians the was line fact, QINLOCK similar to for years. of that among products that of established GIST of

Our a over commercialization uptake more prescribers rapid than efforts XXX that institutions resulted from QINLOCK. broad in launch prescribed prescriber through are diverse and QX by estimate base. XXX from We

very with number per total total and priority setting our indicates as experiences which either patients To for QX, QINLOCK of quarter community highest academic During the with slightly from to Conversely, the expected, of favorable is of came nearly half and have half higher academic setting, identified QINLOCK prescribed than than our pre-launch the have had treatment more setting. date both physician those share. and came the or future accounts fact hive physicians, prescribers our in the patients treated of have understanding. of perceptions practice during patients prescribers citing fourth-line. And both that slightly research product highlights irrespective the setting, patient with when users that importantly, the patients consistent from more progressed positive QINLOCK, new fourth-line all market

access has policies QX. deliver coverage to continued market patient broad team to our label. with FDA QINLOCK access remained Additionally, our QINLOCK very Payer for aligned to in strong

the patients that our percentage patients Program, received increased challenges impact that due free to of drug Patient or expected the the to slightly XX% in affordability range. Assistance in year, commonly estimated under was within but late fell our QX XX% higher PAP, Medicare As

As previously their of requires patients coverage and the deductible for reaching QX the the catastrophic reset year, of occurs before impacted percentage Part beginning D may the benefit portion in gap communicated, to coverage tier. pay be the which Medicare our their PAP that by at

to We continue the range on to the XX% over expect XX% average in year. the course of our PAP to percentage be

Until come continuing to will then future Looking by will develops our we our how be prescriber QINLOCK, the forward, of and patient we footprint. data term, approval. that significant appropriate anticipate setting. prescribers INTRIGUE optimize into be that to near persistency our academic positive next with largely from on our anticipate phase will In GIST, subsequent and expand the patients for determined and gradually real-world while focus pending working our with moderate identification growth quarter-over-quarter second-line of efforts growth existing in community expansion

a has successful look awareness we positive give to settings optimistic the treatment confidence including QINLOCK in as later approval, a foundation setting QINLOCK GIST. year, to GIST. GIST this about GIST entry strong the potential across to the from pending and and for Finally, a standard-of-care ahead potential to potential of approval. for a thought Feedback readout academic transform us base both launch a believe leaders, the established extremely second-line to remain in product that second-line broad continues prescriber of we to continue with QINLOCK We the high perceptions has community and treaters, coupled establish new second-line

in increased and our second-line to GIST. over Given programs. QINLOCK second-line now a GIST turn call Matt expect the the we will what to represents be the importantly for patient of Matt? approval persistency, progress discuss opportunity to larger patients a with truly for clinical transformative I most population and

Dan. Thank you,

great our switch make inhibitors. kinase to control pipeline continue growing We across of strides novels

likelihood of Let me enrollment mutations all inhibits At this disease success preclinical broadly pivotal X The end our investigating the drive in Phase across profile study. study patients we therapy. the lines second-line with demonstrates confident remain QINLOCK last in KIT that QINLOCK. GIST year, INTRIGUE of of that QINLOCK has in the of start completed with

in with a the package, Phase only to readout the to to patients not look strong from the INTRIGUE also which efficacy setting patients, this X addition, clinical In compelling may for we the year. in but in plus improve continues that we half in top second-line Phase study, patients and study, to significant have results study We the from of forward INTRIGUE second-line data the X fourth-line with plus reporting line exceptional in project benefits second showing GIST. data QINLOCK the believe GIST provide the fourth-line results clinical

The TGCT potent fulfill preliminary the results Phase only with disease from and meeting and significant experienced well, stiffness. from the pain, of symptoms, this for burden development Society Rebastinib, patients with vimseltinib be trial to need the cell Training in or tumor target selective vimseltinib patients plans TGCT. to our a development to REMS with planning potent with unmet additional TGCT Turning report effect. Oncology we of CSFXR kinase. in our Patients including to for which of approved TGCT. last are of for the effective updates Tissue for giant is ongoing selective has thought function, treatment We believe off potentially Vimseltinib, it's first-in-class study and commonly that tenosynovial well hepatotoxicity forward the multiple therapy treatment best-in-class due encouraging warning subject tolerated finalize progressing our medical year. look year, has X/X and adverse Connective in systemic swelling inhibitor unveiled inhibitor event an limited and a that to TGCT. and an and to program and data box patients The At to is pexidartinib, this presented be to we later to pivotal potential the is TIEX sharing an study

presented the encouraged with in last cancer our clinical both and resistant combination ovarian endometrial Phase We the initial are platinum very we study paclitaxel. Xb/X data cohorts in from by year

ongoing. study in one platinum sarcoma in one cohorts. reached breast stage other have of full are enrollment the and stage of completed cancer sensitive the has and safety continuing to been ovarian combination is patients carcinoma two part and Phase with enroll cohort these in carboplatin efficacy enrollment We And inflammatory evaluation for cohorts cancer Xb/X and

For setting. the lenvatinib options treatment paclitaxel endometrial carboplatin cancer, second-line and in are setting first-line pembrolizumab after and there in in limited the

XX%. XX$ survival we from Beyond response progression-free Phase we very generally XX% only presented at encouraging to study, where And these of unconfirmed Xb/X the response confirmed weeks clinical data of the ASCO, started in heterogeneous XX months of benefit eight just second-line. with three is four are treatment rate and and benefit objective patients patients XX%. rate of rates in of to

received the of and nearly had prior had enrolled prior more three All study therapy paclitaxel treatments. XX% patients of in than this lines received

with rebastinib XX% of rate XX% heavily ovarian For resistant pretreated clinical profile Similar XX% to patients very anti-cancer eight the present cancer and the with survival treatment later year. response rate these have encouraged of the population. of XX%. study objective of and In weeks regimens. of of benefit last the line in unconfirmed platinum Nearly safety of resistant of these four had endometrial platinum months combination data We're we to cohort, ESMO generally benefit have combination at more XX%. is patients received progression-free or four our efficacy this prior the and to cancer heterogeneous paclitaxel confirmed by both of disease the response rates three and

paclitaxel completed driving data and resistant we half With the potential with we in ovarian this these to to and forward and finalize in for platinum plan later updates quickly of forward development continued pivotal this indications second are assuming in Our continue focus year. looking as providing combination can, the positive cohorts, enrollment year. we is endometrial cancer this data to as rebastinib in a with prudently program expect

The also study action, we kinase pleased am of RAS we mutations. with to signaling mechanism these FDA DCC-XXXX, extremely ULK RAS inhibitors. the initiating factor broad of is have with pathway. we pathway, and cancers our the about RAF clearance levels the basal regulate RAS inhibition, year. nutrient with autophagy, excited development key with as have second inhibitors to expected, a in RAS The MAP our in autophagy high and combination ULK maintain B-RAF RAF I to use and MAP reported MAP in of pathway first-in-class and again, induce be kinase treatment cancers and have supply are emerging which patients combination studies Mitant survival or kinase with patients designed supports the DCC-XXXX metabolism cancer continue quarter mechanism. in complex DCC-XXXX to treat pathway to and compensatory Finally, in survival. potential particularly kinase cancers data survival in autophagy announce received also cell this the combined that cancer Cellular [ph] that first-in-human for demonstrated a preclinical can IND, inhibitor

kinase by signaling inhibitor, RAF GXXC could and mutant than in in treatment combination showing anti-proliferative activity continue inhibitors inhibitors, genes MEK underserved. paradigm with all inhibition the the KRAS XX% opportunities and in data MAP shared, DCC-XXXX supports combination a signaling cancers. As as DCC-XXXX This us a we of RAS even potentially RAS of establish of RAS MAP have this cancers RAF preclinical the RAS previously cancers the approach, new of human RAS More pathway that anti-tumor these such driven synergistic in mutations ERK of or are and inhibitors, development that be to provides with and with kinase a number RAF for cancers.

quarter determined the after a alone. tumors escalation advanced of trametinib be is excited inhibitor this extension will the for melanoma we'll a cancer, study evaluate -- and patients determined, non-small and approved mutation lung combination After colorectal Dose with FDA combination pancreatic the open the adenocarcinoma, and Phase for with RAS the will And in combination cohorts which recommended RAS/RAF agent initiated metastatic gene. enrollment. in are or first phase dose X dose cancer, cell with second will cohort single harboring ductal the include pathway. year, initiate Phase a or is safety in RAF MEK X the as XXXX tolerability of a XXXX patients of in to with We mutant in

financial to meaningful a patients of and an over progress encouraged of the these making Financial Tucker are each look I We now Chief XXXX will Tucker? Kelly, our assets the the of review by to programs development year treatment across pipeline in turn strongly Officer, believe will with the the the be our in call difference important to in we as cancer. results.

of and for our XXXX $X.X highlights Thanks, months to Total million inventory was manufactured Total Consistent collaboration slightly Matt. to the sales as costs fourth be recorded Cost XX quarter, cost gross product sales. $XX.X was $XX.X quarter million of majority December to of would for full initial in XXXX. includes to expenses in as net inventory than the operating period pre-launch revenue. review the were of million of I'd XXXX. at $XX.X to net adjustment for million, is compared ending additional remain was the expect QINLOCK three fourth which total thus sales, in quarter revenue net immaterial, quarter were sold, XXXX third FDA manufacturing quarter million the in Total year million results. cost significant, sales XXXX as the is estimate prior revenue $XX.X lower operating comprised product to of same like not annualized year XX, with $XX the U.S. the $XX.X sales and of and sales fourth and sales related will the financial million $XX.X the immaterial depleted approximately in fourth incur the well the R&D Until of XX%. including full our in for will the U.S. and net we as in expense. expenses in million, product was approval

and the compared full compared were to in million million For operating operating period the million expenses total XXXX. quarter year $XXX.X in million same $XX.X of in $XXX.X development $XX.X in Research fourth to the total XXXX, expenses were XXXX. expenses

compared Selling, for And same in quarter in were period were compared million to million R&D with expenses in the full million XXXX. For XXXX. $XX.X in XXXX. year $XX.X the $XX.X and administrative expenses the XXXX, million fourth the full $XXX to XXXX, SG&A million general compared $XXX.X $XXX.X were the year expenses million in

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

Thank QINLOCK prescribers steps and GIST and necessary proud you, also regulatory be its extremely in by momentum our while taking We a upon XXXX, look the QINLOCK the year solidifying of what Tucker. accomplished to we milestones. of team U.S., with expect among XXXX position bring I'm building patients GIST the significant forward in with commercial to and to launch advanced to the world. around patients the

On development of we significant two programs the pivotal advancement into clinical expand that QINLOCK expect potentially study front, on the readout GIST enabling to Phase larger updates into registration clinical X we And population. the expect second-line INTRIGUE the studies. could support

We be the patients. unmet to call important Operator, Finally, exciting inhuman study first the now bring will like to addressing we for in another the Q&A. of oncology. to XXXX believe largest new I'd to potential candidate a first-in-class journey forward needs product medicines one company's year initiating our open in look for

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

may begin. You

are future hoping determined results the you guys. for this bit I made taking afternoon. could about persistency. the GIST of substantially penetrating growth? elaborate you on patient was of Where of my setting? terms Hey, moderating Thanks that you flying a incident moderating alluded being in to think little penetration quarter-to-quarter the Good by and Is opportunity. do so comment growth question. much or You you

Yeah. Hi, Steve. Jess. It's

really before rapidly really Dan, with color, remarks, in I provide has over we launch and pleased to turn said the gone do prepared established some growth prepared Just as going we've he QINLOCK how some more it the expect setting. that. as the you that remarks, like moderate we the Dan, so provide far think we're in can I as would And to on his fourth-line to color standard-of-care noted in But forward. Dan

for questions Jess A questions. Sure. there. Yeah. Absolutely. of couple Thanks the

So, if just quite on everything, I let know. me don't hit

phrase we rapidly is launch. we the fourth-line to QX, just we've made therefore, performance the we when across So, GIST challenges team, despite community the will both the ability XX% to the that and I Steve said, it we're pandemic. talk of we point clear we the moderate, fourth-line quarter-over-quarter to plus And seven pleased expect we while months, patient quarters the is And academic that been as point achieved that growth growth Steve in expansion the established of standard-of-care about about would clear the the like guess, -- as have until pending penetrate achieve population, and QINLOCK extremely with about And quarter-over-quarter settings. slow growth the two in persistency slow. about approval the into second-line mentioned,

previous as calls, previously on -- And we've so, that is still maturing. data mentioned

important the during then, persistency So, also real-world we'll performance color by move bringing forward some is A on considerations, emotional, mix tolerability, there's by impact important -- as to in to that'll develops efficacy, patient and we and plan such setting. in burdens setting, their develops of but administrative things number both persistency non-clinical cancer additional financial status. that the including journey. how of we the cumulative, therapy And be number the patient really how could line see forward, on real-world as any bring -- be

the So, out they over setting. look that time how to real-world play persistency impact these and are things in the see we'll

just for Got more. that. maybe it. Thanks And one

than helpful -- to QINLOCK there. patient. have prescribers more how prescribers one the many sort data mix curious you on of the I'm elaborate of and about number If useful could the written

general, for There's a prescribers of written I off top that Yeah. there line my our very That's they've Keep who figure more because mind that but have these than of one rare good a rare they're extremely described, only had thinly that late have have setting, patient, particularly written significant and academic diffused only outside head. as is we've good in question. are don't of a and number patients one. the the certainly patients dispersed. sort portion of in GIST one, for and

how our So patients have a significant prescriber portion base they've prescribed far. many that's so of had only would because one

Makes sense. Thank you. Okay.

you. Thank

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

Your line is open.

Hi. This Allison Bratzel for for the afternoon. Chris is question. taking this on Thanks

So, that work one just and patients, on earlier GIST line guess most of indicated on I among earlier patients, is docs use, some has just use line setting. in is cannot our plus detectable but survey academic use labeled there some and particularly fourth-line

if wondering launch. color just So, quarters you you're that any couple that now had a on into dynamic

if just could And talk can -- to be earlier use that? growth So throughout you could line contributing -- to XXXX.

will Allison. Dan? take for let question, Dan Thanks the to Yeah. that. I

a real-world majority seen before there's question. before Thank that, things and have, but that, that fourth-line. guys use in line we've Yeah. line we've feel the do We in the been said it triangulate And QX. saw the is consistent with to what said tough therapy that was the of that, use lot thematically setting. see with drive sort data know there with what did a we when use you, it's future It’s the challenging speaking, relatively what the we good of of of consistent said setting, holds. we Allison. majority use, fourth-line sources you label. And We've it's some assess significant again, that know survey did. while What Generally significant the by certainty is in before we earlier that we with to available we the we've in strongly has thought

any we line of efforts that probably toward typical data are targeted of course, of -- all have our indication. our availability can't data, there's I earlier promote, always commercial to my course, labeled Of should our disclaimer promotion, with of that started of we all

our indications. label, And of most in payer consistently in aligned approved so, to this And all it's pretty that is guidelines. the what's to of -- policies, in what's what's point,

So to reach to we've moving is But the growth the that opportunity, as moderate result quarter-over-quarter we've the hard why that color setting think penetrating we that's around, say. second-line until And likely of provided significantly rapidly. we a forward pending approval. fourth-line

last quarter based And just had more makes -- progression. That from, indicated the dose sense. that a of on follow-up supportive treatment interpatient past a think you escalation, might bit year there of the ESMO last showing little had data I especially maybe ID one be dosing, you

hoping plays talk you and -- added that how strategically how where updates thinking terms you're guidelines label could data that the about trends just any So, to those to NCCN or perhaps Thanks. on getting the longer QINLOCK strategy. or of into maybe and in that term GIST

and things sort need use to to be of fact maybe bit to first, Allison, can't common comment on little I'll it. happen more data is of sort the ask for we So what we that despite to would a Dan just do about actually of the course, the what talk BID then see in that, promote what marketplace and

XXX the see escalate to X the Phase you shared last in as BID data had as And reported year, ESMO Phase we it study referenced So, we physicians we the that to upon data opportunity patients progression. ESMO study. from in PFSX. year it dose last And X the

serves So anticipate able those where analyzing is XXX we the the the of present data, and future. allowed approach in to second the context escalate the study, were experienced patients as progression In meeting but really the that similar study. dose being a the our still to to at patients a in BID, medical INVICTUS those physicians for their we're study able point some this on basis interval free compelling approval, so survival was PFSX quite to that relative

view a ability the of being sort labeled you can't of is into set and we're enabling, use this it. this, to maybe physicians just want think would commercially of factors either seeing fact promote play We what to we despite as they So, meaningful what comment finding. to and data on the Dan, don't that

the see you. a a large to Yeah. overall to QX in should -- we've good have continue or some but spoke before, we of BID say uses to dosing, a continue our -- it's it's of question. And use, we been majority portion is which seen Absolutely. I XXX labeled of be the to Steve, spoken we've QD see policies, aligned we what Thank small the labeled the don't We're data. dose. BID Number label to label limited course, we and then indication. promote And driving continue really of -- the this off to our -- same off guidelines point with one, labeled impact And promoting payer drivers dose to use. which dataset our a, dose.

surprise of given a those QD. use with to large is majority not us, it's consistent XXX considerations the So, the that

Thank you. it. Got

next Guggenheim. from comes from our And Michael Schmidt question

line open. Your is

guys. afternoon. missed commerce, pipeline I X the all it, about RAS for Is patient DCC-XXXX. be had will pathway they or be certain my in remind Thanks mutation? study? questions. Phase you Hey, could if initial what Good the but population you question -- have will it selected already for I taking a us may in

Yeah. Thanks you that? Hi, Steve. to Michael. would question. It’s take for like the Matt,

for the Hi, Yes. Yeah. thanks question.

is as for first inhibitor. autophagy So study. The two-part a studying conducted a DCC-XXXX, inhuman our first-in-class novel in which the survey

will specific a part they be solid of a escalation pathway. will be all in dose that will study selecting with followed in RAS this kinds be of the patients for So that mutation tumors, the first second by part tumors. part homogeneous selected B-RAF study, And will but will this be and a of be

and cancer, non-small RAS colorectal those will patients mutation ductal carcinoma, cancer, positive. also melanoma, pancreatic So or and cell be B-RAF lung

inhibitors? really mechanistically, Understood. have that then Or activity? combination with think this RAS might aging about single a other is drug a drug this as should we pathway And

the be we kinase targeting in best believe and would RAS drug signaling MAP pathway other inhibitors So pathway. developed initially with that combination this

Okay. and the on makes so much Thanks progress. congrats That sense.

Thank you.

will of Jefferies. the line Our Yang next from come Eun question from

begin. may You

you. Thank

from tumor -- have So, been GIST, the regarding drug astrocytoma. or solid a ripretinib other orphan GBM designation expansion enrolling aside cohort types. you for like in multiple Phase and have X And you have tumors,

you from can an aside So GIST? solid us tumors other update on give

of where provided question. we expansion it’s update we the question this Phase Eun, to Yeah. I back know Steve. what about talked on the and the study X for cohorts and your variety were. the status QX Thanks an goes those on of the call,

and exploring forward continues cohorts. stage we still that be potential and to a going cohort that's that discussed, QINLOCK to benefit focus that or had on patients the at our will data for we number enrollment at GIST. continue enrolling of time, evaluate. so we melanoma as ripretinib to But And The the in completed was

Okay.

tumors I soon, So, guess, expecting correct? from are be we anytime non-GIST going not to data

That's right. Eun, exactly right.

Okay.

time is is X from But the the focus development GIST. GIST. we'll collected going focus follow cohorts we've for the in to on specifically And continue when Phase forward is data melanoma. right. Our in folks update We'll the expansion that on

you. terms year so, And generic then, this go next. Thank in of and is U.S. and EU GIST to SUTENT in the second-line going

generic impact or So, us an there example you a when new -- is examples that drug where settings? drug share with does in cancer can not superior

Yeah. Thanks for the question Eun.

in. if it’s free have and color then additional So, any that jump Steve. you'd Dan, please to to I'll take like add, feel you

and head-to-head And PFS study, a a as months. the that in demonstrate the of demonstrate a that half discussed six know, would three study would we month would INTRIGUE study Sunitinib believe be to to that we've previously, outcome five to over you improvement for so as And Sunitinib. need that QINLOCK range is expect versus in clinically meaningful. the it's a two we to So, we

QINLOCK for clinically improvement month three when a you to that Sunitinib other two words, in to over demonstrate as meaningful. viewed be So,

that head-to-head else could for that? that fact interest SUTENT anything treatment a and don't you'd any standard-of-care, Given meaningful that in going option willingness physician's the this have on to better add a with GIST. a using impact Dan, believe study would generic we the their patients be versus be current that would

X Steve add also just about the a trial. when that add physicians, think stakeholders the gold from assessing in payers. Historically been as has different patients, different to would Steve we been speaking, large and said in I standard would has mentioned, for physicians, but randomized Phase I alternatives comparison payers for products head-to-head like

patient do do, regulations we if positive, -- continue in we're barrier a in will which INTRIGUE position. X patient, always us what the study is believe from knowledge a only really to to positive that with good a laws first access And puts to is head-to-head from to relevant and to And do permitted our would being we costs with everything line prevent and so, then be which we GIST, Phase QINLOCK.

irrespective opportunity So, INTRIGUE again, really transformed overall, QINLOCK great of the a pending we're generic to, very confident that that SUTENT has standard-of-care.

Thank you. question, And question I a quick last have for Tucker.

quarter So, at this as book once in would for of approver actually milestone China, Zai? you you anticipate some year from approval in second that --

Thanks. for question. Thanks Thanks Yeah. question. for the the Sure.

potential So, we've and half. expecting public they in disclosures, from Zai I the what think their regulatory decision a first heard

of provided have have collaboration had have in achieved. that they But the booked milestones pre-approval or those past, in quarter milestones breakdown the not We additional that were we into we we typically certainly, which had, the the have have where clinical any in agreement.

Thank you.

Thank you.

Andrew from Our comes Berens next question from Leerink. SVB

may You begin.

on you else? the going question forward. I Then line, staying approved because patients persistency therapy seeing have inhibitor. a fifth the are a progression? your the ULK also quarter. regarding Thanks. I off nothing going are something they're there's of Hi. have on or on Or on on in are Since therapy, follow-up Congrats beyond comments they come dying the patients

do Andy. to that? Thanks, Yeah. Dan, you take want

Andy. Thanks, Sure.

Hi.

to be So, recently, on a as what color able to persistency. it's little just seeing we said early with we're provide

think sorry -- now. I just over what been months two two -- quarters we've

is color -- we additional everyone's the some data it. that maturing And so, when to is evaluate how and have bring that and we important that to said forward bring intend have to still certainly understand we models some we've

as some on So, opposed time average because extended remain of and persistency patients product, of persistency, some to as bit early patients in of off over any know, percentage you with of know, and duration therapy on is that the as late, I patients therapy, an talking more come you started for a period. terms stay

see therapy non-clinical mentioned and all all performance considerations, status including and real mixed that out given in of of line the some world by before, So, shakes to we'll I setting, patient factors a just how have that.

So, time. -- data that prime more ready to of sufficiently come, as we for sort feel we is like

But some Okay. the option, are longer BID staying progress? they after even on patients aside from

what from our just of whether physician when we That's hard side to know see the we product. is determination patients don't not side there is see What our a progression. getting or from because

me forward to answer. So, additional that's I are like data we'll just for And how staying said, bring color patients really on on long hard therapy as that matures.

any a inhibitor, part guys then just is wondering, and that's there blood-brain of on or the I drug an you was impact not. special homeostasis? crosses a know ULK CNS I amino And of I whether important investor, remember acid autophagy just concern and the the drug the had concerns don't the about where Okay. are but if the barrier

take Yeah. It's question. you Thanks, do a great that? to Andy. want Matt,

Yes. Thanks, Andy for the question.

concern have but selective CNS drug don't yeah, be designed we to do of potent exposure. we So, to a not was -- this avoid so kinase, inhibitor

So, X we the look to forward of the Phase beginning study.

Thanks Okay. Appreciate lot. it. a

And Lawson the our from from next line comes of question Peter Barclays.

may You begin.

you. the question for taking Thanks a for Thank questions. Maybe Dan.

of Just of use use the a GIST. kind sense in or off-label degree of off-label

generally? Sure. Thanks. with Do or QINLOCK you mean

QINLOCK. With

Yeah.

assess limited. use that to previously, It's by So, is data the it. of shared therapy as is we've challenges available with got line

imperfect confident is we fourth-line of it's but fourth-line our consistent best we majority do only has promote that we've consistent definitely said QINLOCK. a indication. we're way there with what data. the is, a the that to course, majority estimate significant is been but earlier we and significant with has our use We've And triangulate some So, that indication, which been believe, the of said that, our line use,

you. we Thank guess, can the Matt. the initial data XXXX, And ULK then that? see for from that's inhibitors, the So, when Gotcha. I

Yeah. Hi, Peter. Steve. It’s

It's question. a So, I'll take that. good

activity earlier, Matt a a bit mentioned about previously, talked see expect don't inhibitors. monotherapy with and as we've So, to as little we the ULK

drive get trying of Matt prepared the we portion combination the to study his into can that we're what is as quickly in as really to So described to remarks.

don't certainly guidance we'll, we investors year what XXXX. potential might visibility of data. It as at we have have be update to able when specific in we this But time. to be course, signing might that the to report So, be won't as

much. so Thanks the taking questions. Thanks for Great.

back Thank you. sorry to I'm Steve hand about his the call that. for And I over will --

Securities. from next Benjamin Reni question Our of come will JMP the line from

begin. may You

way the to the afternoon guys market kind got it's I'm of good or then then, questions for have trying of on do guys. we at because to of, idea where but penetration, market And the have Hey, taking it an a give just sense you follow-up. can least decent the just a to plateau moderating still closer growth hitting sense, fourth-line quarter. penetrated? steep, just get was as sort it in much so I I congratulations is to how us terms maybe of Thanks you and of you Maybe rapid that future was have steep pretty and we more a go fourth-line? up came a we're -- in guess,

a good it’s Reni, take want you that? to Dan, Yeah. question. do

Sure. Reni. Thanks

I think what you're with communicate. we -- the first consistent intend interpretation is to

-- across it's clear job academic as done result, now we're pretty pandemic fourth-line in and measure, both any the it's pretty a By community standard the has opportunity. despite the the QINLOCK settings. the penetrated and clear just a fabulous as fourth-line we've So, patient executing rapidly established team that

growth, we've approval. significant given pending second-line why so that's next of to that setting that growth that, able that -- to quarter-over-quarter moderate why communicated until the we're reach that's anticipate And phase we being

weighted in of changed validated? Got active makes thinking things BD more staggered want it's effort From been there I That the to just as it's And asked alike. your terms I've the that has there's Is the it. an going is on? know launch. any -- thinking notes, going Have to Steve, in Salesforce just year-end hiring and European a behind if sense. this my case, know new application or likely still before. I launch be of the

Yeah.

great a it's question, Remi. So

So, last as by NAA point that EMA you occurred year. out that been the validated has

that of second could Agency European half the targeting application. we we're on the believe action so And year. That's Medicines this take when the

is today territory. potential a hiring and as launch for International -- now also that be International. Duarte Europe Head hired role now nimble President We Margarida ready to in we've Head And Senior the on to of going that of of across be building the taking she organization Vice or announced

wait this launching anticipate to and that just to launch pricing for completed of every alluded you drug. and introducing Remi, or that course, the note, to by each important we the negotiations have staggered will, the be be it's where fact in of reimbursement think and we virtue country to I

for launch So the is Italy, with to pricing don't to to to would as Germany, least initially. negotiation, those months territories, just hiring the after negotiations some where of at be go XX be those the territory rest Southern launching and come where the Spain we we the example, as would on likely XX the at we authorities. depending have territories for the Europe, well reimbursement could we expect expect approval, of it to with pace take associated then first later, and be through But point

COGS you inventory Got just keep be it. you'd until will in we material do And how -- it's if The And inventory sneak should in the Tucker. remind about used up. and go When talking let us inventories to? used you what me for can the one think up? COGS that

question. answering Thanks, Yeah. for Remi, the

which is moment So, remains the any level. that balance and it said that What we we be for the we've haven't will QINLOCK. repeated the we cost what at is low of provided for the on that XXXX, material long-term a year of should goods think it today, what for we very guidance think remain

tuned. cost We'll as you stay we have get new product. of but and year we'll this understanding, for more a not and goods when try So, update larger

very Terrific. much. Thank you

from you. with line our will last Karnauskas come Truist. And Thank question the of Robyn

You may begin.

taking Hi, and guys. on all on the for the question the launch. Thanks the work congratulations -- again hard

This a silly questions. two one So, then one. first, maybe

question months? second to anything anecdotal that touch GIST. continued setting support talked academic So doctors? Have got would six XXXX. you supportive second-line in it be you're the is talking five SUTENT them the setting, and to supportive? And Does data points the and on around as for any treatment helpful about of So, of you anecdotal doctors PFS as to the to you community more

their be been adaptive So lot path to -- being designs quickly thought there's -- best? shortly, space that they've Have for quick Amgen, of work kind designs, XXXX, to market of approved trial very combinations certain obviously oncology quickly competitive and you carriers best? combinations Thanks. could what design trial be work the quick and a given is able very about see there exploring could that any adaptive

Thanks, It’s Steve. Robyn. Yeah.

I'll second he'd So, question XXXX, to question let or like me and your design then Matt if the question combinations take trial the take ask and about adaptive first about forward. then going

expect with front. respect first what really nothing's would changed SUTENT, to to see from we So, on that

in all trying coalesced second-line SUTENT thought months leaders setting to understand six right So, as what months. lot PFS SUTENT investigators around SUTENT in time all of and those for the best designing the spent you And estimate know, to and second-line -- we the was the of to is to PFS a in the -- and at investigators use. estimate with label, and thought the five use as for we six were leaders, treat when being

certainly INTRIGUE that not months right change view So, our basis on the the And for estimate of is front, use. new setting. physicians that learned would anecdotal six we conversations design from that our with anything that haven't was to the individual then

want the about So, Matt, do that you to question second part of XXXX? take

Yeah.

question. good -- so really a Robyn. yeah So, thanks, It's

not we going to gives high to -- well, and to data design expand evaluating be that's of for a fast partners that coming data started And And there with able XXXX -- start to generate rebastinib some the in that authorities. level perhaps the or off, a the XXXX inhibitor and may a we'll MAP could if pick to as be that move can of using combine to it with. addition other first see rebastinib for current ULK to brought forward novel be And certainly they be patients, we've pathway. compensation so the determination of registration. we're forward But to And activity inhibitor look adaptive ability regulatory -- combined just it cohorts via data too. we kinase to whether can

the beyond in go kinase pathway combination. could it So, MAP

you. Thank right. All

And not at you. showing any questions I'm time. this Thank further

give over the further turn Steve now back any I'll call to to So remarks.

you on of Deciphera. on all you continued you afternoon's Great. only Thanks, Victor. to your look as Thanks with Thanks come not programs we joining for our updated launch, a I development support further and call to balance great keeping but QINLOCK meaningful have and hope the all continued data us the of all forward also some for evening. and of our this really this progress We provide again. focus into updates. year

gentlemen, you this Thank conference participating. call. and Ladies for concluded today's

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