Deciphera Pharmaceuticals (DCPH) 3 May 232023 Q1 Earnings call transcript

Good morning, everyone, and welcome to Deciphera Pharmaceuticals First Quarter 2023 Financial Results Conference Call. Later, we will conduct a question-and-answer session. [Operator Instructions] Today's call is being recorded.

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

operator. you, Thank you first thank us to today Welcome, XXXX for financial Deciphera's quarter results. discuss and joining I'm Jen Larson, Relations. Senior Vice President of Finance and Investor

With Medical are Kelly, discuss a to Martin, and Chief Chief me Tucker results Matt Dan Duarte, this provide Sherman, Head Officer; and International; Chief Executive the Officer; Officer. general Margarida Hoerter, Chief Steve financial update Financial Commercial President Officer; and corporate morning of

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

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

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

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

we provide and from the good Jen, results and year. of to update morning, everyone. today Thank an you, rest as joining first Thank our forward for quarter, you the look financial review the us

to develop with lives improve number achieved medicines new advance year an and and are that commercialize cancer. this the already discover, for important mission milestones critical to catalyst-rich people off We our of of a exciting start to have

treated with or we which tumor imatinib. KIT an a to patients treated QINLOCK QINLOCK, second X the from tumor, with QINLOCK, patient the with gastrointestinal initiate circulating patients benefit mutations exploratory At we population in of and striking stromal showed the Phase INTRIGUE results results, clinical X for of with of year. ASCO session, the plan using GIST, the study or analysis in this study in pivotal ctDNA DNA Phase Plenary these from XX/XX Based presented exon XX previously half on Series January from INSIGHT

In QINLOCK Therapy announced future designation March, This for and standard for this reflects for reflects QINLOCK of the population. of patients, GIST we it granted to group the to potential the clinical become substantial FDA Breakthrough we Designation offer for believe opportunity care for this in this second-line the benefit QINLOCK setting.

additional in The inclusion preferred NCCN, clinical need setting GIST regimen to second-line post-imatinib for Comprehensive QINLOCK's in practice oncology patients treatment National by as was Cancer for Network, the options intolerant for sunitinib. further patients in underscored a or GIST guidelines the

In March, top-line in the of enrollment TGCT, treatment pivotal tenosynovial X report from giant in the to vimseltinib we the and tumor, fourth Phase we completed expect MOTION for study study quarter. cell this or results of

peak a the INSIGHT with later vimseltinib to $X around study this forward We sales of billion. and MOTION worldwide look potential to the of thousands year. results the have patients QINLOCK benefit Together, the initiating study potential and world, over reporting

the our switch-control our early-stage its April, research our most of company's at sustained proven best-in-class posters in potential. and recently Most of presented AACR generate we candidates engine with eight Deciphera's These kinase first demonstration productivity history. in to on research comprehensive ability and pipeline, highlighted product the data

new we that second in strongly DCC-XXXX, this studies, support with inhibitor, cancer in ULK of the our initiate escalation on combination expect in colorectal cetuximab in combination in models, data preclinical GIST dose year. ripretinib with which encorafenib new and half two combination presented We and to models

inhibitor program that announced the research focused Class a newly a the target newest pan-RAF first the candidate, on best-in-class preclinical BRAF X, and key presented fusions. and potential X stress X We our also broadly inhibitor for our development of mutations GCNX pan-KIT We integrated announced response showcased in potential kinase, inhibits best-in-class nomination pathway. we data DCC-XXXX, a BRAF DCC-XXXX, and

research complement oncology late-stage leading, as together deep and supporting discovery, which and company. of form commercial and These programs, early-stage a our efforts position clinical pipeline candidates, medicines novel a our product fully-integrated

And on call, Dan of will our Head share Commercial Europe. U.S. insights update the our first launch today's fourth-line On performance QINLOCK's on the will an International, Chief in provide quarter. Officer, for Margarida commercial ongoing GIST Martin, Duarte,

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

to But call detail. first, R&D Medical discuss efforts Deciphera's to the Officer, I'll greater Chief Matt? over turn Matt our Sherman, in

Thanks, Steve.

progress made with so we've preclinical our year. this are thrilled far across pipeline and clinical the We

a As reflection metastatic by this or substantial unresectable the Steve QINLOCK the Breakthrough clinical observed in the direct benefit population we is Designation KIT QINLOCK of for exon exon analysis that received of the GIST, in mentioned, Therapy second-line ctDNA adult Phase we we patient XX/XX designation excited study. treatment co-occurring the XX mutation X of for mutations. and patients with are from This INTRIGUE KIT

this ctDNA regulatory Based patients in expanded we results X support GIST second-line these patients group second treat this an of input, select INTRIGUE the of data label Phase positive, QINLOCK plan pivotal to how we INSIGHT If in study the of believe transform of versus on new study QINLOCK a for sunitinib patients. the second-line and year. and physicians initiate the INSIGHT, in GIST will half

well detectable survival data. ASCO not XXXX presenting additional ctDNA forward that upcoming meeting, to as look data we study, INTRIGUE overall the At updated the did from patients as annual have including

second pivotal which inhibitor product we X quarter, announced MOTION will approved believe become enrollment our in completion of study the In switch-control the Phase of the kinase from we vimseltinib, first platform.

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

us year on earlier track the results to completion out the this fourth enrollment puts MOTION in read top-line the The of quarter. study in

potential data a updated of present study TGCT. to safety support continue for vimseltinib to therapy of longer-term from in expect best-in-class this and will X/X Phase that in the be also the year vimseltinib second half the to efficacy We

now driven DCC-XXXX. and new repritinib cancer data well data colorectal encorafenib presented promising GIST and models in that with DCC-XXXX and the as autophagy in combination AACR block demonstrate flux XXXX preclinical and Turning models cetuximab at activation, highly to last with These cancer as and BRAF combination in encorafenib colorectal in models. We month. preclinical meeting VXXXE ULK can cetuximab-induced on

as In growth regressions inhibition that results vivo activation in studies. in block cases, by or these ULK autophagy preclinical in We can extend demonstrated vitro xenograft also tumor showed tumor GIST XXXX positive in models. efficacy both in ripretinib-induced flux the

to second cetuximab expect evaluating Under DCC-XXXX initiate of colorectal plus with no in trial We encorafenib the encorafenib a clinical the at and collaboration patients year. supply supply cost. this cancer half and agreement, new will study combination Pfizer in

evaluating to combination new with the cohort half initiate expect in also the second year. We this XXXX of ripretinib

Additionally, combination we plan the to binimetinib second cohorts trametinib with MEK initiate the of one GXXC or year expansion or in in or inhibitors, half this sotorasib. inhibitor KRAS more the

more BRAF aberrant excellent a residency mutations, on profile pan-RAF all XXXX's and by to potent We RAF selective DCC-XXXX best-in-class a opportunities. slated pharmaceutical both monomers, believe enter strong preclinical efficacy. through enable cancer and RAS in accumulation signaling time, that potential models, driven program single or tissue exhibits an tumor it next believe targeting with penetration, RAF clinic evaluation combination long of providing will of is that we relevant profile and and heterodimers. its as The homodimers both based inhibitor the inhibitor high durable DCC-XXXX. efficacy CNS kinases, support permeability, agent and good CRAF The

to the of IND expect second an submit the FDA to We in this half year.

month to GIST in best-in-class pharmaceutical pan-KIT drug-resistant This preclinical very its spectrum DCC-XXXX, properties, multiple selectivity tumor a in XXXX, AACR exhibited known mutations to and drug profile ability XX regressions inhibitor. preclinical spanning free suppress recent want target in needed selectively DCC-XXXX showing and exposures Like of XXXX models. potently GIST. of the we the XX, also the KIT I presented also broad high These to to which results data highlight comprehensive in potential exceptional KIT enable primary vivo optimized in has exons XX, XX. mutations levels at secondary to X, Finally, models, and XX, data spectrum in inhibit vitro for last drug-resistant GIST and translated demonstrated broad

the DCC-XXXX the We for expect in to IND FDA half of XXXX. an submit to first

patients can with world. we best-in-class cancer you As to benefit the our excited tremendous first with about across see, have be products around a portfolio to opportunity potential, offering lot or of

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

Matt. Thanks,

QINLOCK reach saw And our average and the our in sustained growth, execute quarter, In duration acquisition firmly our KOL core on continue new metrics, patient care highlight to product prescriber including brand market prescriber we and U.S. the and commercial therapy. the research of awareness first in that strength We perception, entrenched clear is goals for engagement, interactions GIST. QINLOCK in standard fourth-line new as and of to continued

during our typical U.S. well quarter. that This in revenue as business net the the core product adversely was revenue million. net continuation a QX, $XX.X strong During reflects impacted of dynamics QX as seasonality

saw we of a Consistent in and February demand healthy followed rebound QX softer with January, in XXXX, by March.

case during a from we ex-factory QX purchases that was reduction as negatively saw the to QX Additionally, inventory modest last quarter. impacted year, the

from a we saw increasing who a a QX more volume the reflects duration clinical gradually the driven received persistency for therapy at long look by average fully real-world benefit to of we curve year-over-year, positive When impact as primarily the results and mature, continues patients QINLOCK. growth

headwinds PAP Although revenue revenue. were QX QX growth, volume XXXX in positive underlying and these net business, the year-over-year, QX of created Both including Despite QX volume PAP to positive increases price net in in enabled X% to increase net net for to gross QX versus of a XXXX. growth strength and gross year-over-year. higher and were revenue, headwinds net

Looking ahead, the U.S. QINLOCK in strength the we business in continued expect

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

by continued consistent has pace, again, driven growth prescribers. community prescriber at New a

We XX% coming setting. XXX had new prescribers have of now with since prescribers QX launch, over the from unique community in

we to as anticipate also and to Average X.X months continues and extremely New been to duration months at patient trends in X payer access ultimately very consistent have peak. increased high be it acquisition reach of could as XXXX therapy seven positive.

continues higher within rest will gradual average volume forward, growth. the growth therapy throughout our And of expect continued QX of time continue to QX duration of in of the price despite to growth we as we percentage key as Moving PAP XX% include net the to as estimated XXXX. mature PAP expect year range year, to last a this fall versus XX% over drivers well

firmly in a exon a XX care QINLOCK the or irrespective we are QINLOCK mutational mutations, XX or benefit pending to of as XX entrenched positive standard excited fourth-line With who profile, for of extremely study second-line setting, FDA INSIGHT and approval. about the harbor potential patients

a study would double the for importantly planned and Deciphera if Our QINLOCK the for the peak we second $XXX revenue of need patients with potential million significant patient is the in approved, half $XXX believe to key a in million initiation this population. unmet milestone for of this alone. There And U.S. indication year the to is GIST. additional

goals believe We the have capabilities also uniquely to strong is be in commercial and and will portfolio a results the While vimseltinib's maximize and academic both with on Deciphera's will life-changing strong offer approval. vimseltinib profile, that this fit commercial as U.S., best-in-class we as continue community vimseltinib patients believe relationships opportunity in QINLOCK outstanding the we living to we for established TGCT. have potentially positive for MOTION have treaters execute well FDA impact positioned launch the from We trial given in for pending our sarcoma built. team Deciphera TGCT, with preparations commercial begun and we strategic to settings

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

Dan. Thanks,

we am pleased are QINLOCK excited very I XXXX. share momentum that Europe continued are start the excellent to in with off in to an of launch We and

continued first For in and bring of the work by net patients to $X.X primarily were growth in product our option to prior demand the very the the from physicians strong and Deciphera $X.X in fourth-line These million Europe. I'm in quarter, results of Germany million, France. proud launch international sales the up treatment GIST year team of strength reflect entire hard the first to and driven and

the value per pleased month In at price free period, we price GIST that Germany, only final successfully the QINLOCK underscoring our XXXX patients of negotiations announce setting. I lower than lease QINLOCK profile unmet the and QINLOCK's am we in launched Germany. need of price initial the demonstrates during to in and brings negotiated best-in-class €XX,XXX this that in in patients fourth-line high final significant €XX,XXX our price XX% for is concluded that pricing negotiated The GIST to for

of In reimbursement under access France, French Authority sales for negotiations. QINLOCK's the we the and continue post-approval to progress National we Health successfully make program, grow as price in year, our good strongly Last paid orphan supported foundation QINLOCK treatments, a ASMR achieved provides which strong a small number the believe for reimbursement granting discussions. pricing is unanimous successful by an only which of X, we by

of rapid which following reimbursement patients. based NICE we committed effectiveness, Wales, to are not with and And QINLOCK the for for review positive with a working remain uncommon. England we is discussions recommendation cost a the advanced For towards against in GIST on outcome agency

our made I to in we thrilled in be Spain we launch and am And QINLOCK the significant Additionally, discussions have in to progress expect Italy. a access coming share in months. Italy to advancing position

Germany, upon the establish European reimbursement our ratings continuing as to a standard was reimbursement we and Europe. submissions and France, QINLOCK rare. major complex have work are possible forward benefit, our which rating, year, notably markets. care where in to in launch where Building awarded Since additional last highest is extremely QINLOCK progress in QINLOCK for achieved for strong our there look GIST fourth-line of multiple Most notoriously in a we

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

Thanks, Margarida.

for million, in of the revenue, and period net QINLOCK $XX.X million revenue collaboration including product revenue revenue XXXX $XX.X for same includes $XXX,XXX $XXX,XXX $XX.X net of and to which collaboration revenue first revenue Total $XX.X quarter million of XXXX. in million was of of total the QINLOCK of of compared the product

Zai agreement reduction of following in in Drug royalty comprised National a distributors XXXX. sales revenue product Collaboration impacted for purchased January China, revenue was to under provided this was price Zai. by prior product revenue China's rebates inclusion in quarter QX Royalty List our a with QINLOCK the in was Reimbursement of that to

sales were of the XXXX XXXX. first quarter compared of sales of cost the to of in Cost quarter $XXX,XXX first of for $XXX,XXX

In quarter, of and period XXXX development same the first XXXX. $XX.X million operating first in million to administrative in XXXX. expenses in expenses Research for compared and the compared for the same were for $XX.X of to expenses of for operating million $XX.X million period Selling, total the first expenses quarter $XX.X quarter million in period general million were the the XXXX. XXXX $XX.X $XX.X compared same were to

to of clinical expenses operating across driven additional for quarterly the remainder to expect activities increase by continue We XXXX, our pipeline. modestly

runway successful we this public our In strengthening and million gross raised year, through in further January financial offering, our proceeds a very cash position extending XXXX. $XXX.X into

and marketable cash As of were March XXXX, million. equivalents cash, securities $XXX.X XX,

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

you, Tucker. Thank

forward of already made results of we X progress the significant the and top-line study, multiple half the second for filing cohorts announcement this of of for X DCC-XXXX, initiation to the the with have of year. exciting MOTION Phase Phase study, XXXX proud INSIGHT the initiation are an combination We DCC-XXXX. of NIND from And look

our future As to which first at growth. engine continues new evidenced potential, product we proven to best-in-class AACR, fuel presentations by our with and our candidates expect discovery generate robust

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

question Van line of Cowen. Our Instructions] first the [Operator you. Thank with coming Buren Tyler from

open. Your line is

all question. guys. to progress. Hey, taking Great morning. Thanks for the Good see the

expect you're impact but late it something QX you update? you. just QX, and in the speak guideline sales commercially is Thank came following second-line beyond? this seeing to can the that U.S. in I And what QINLOCK, in For you know NCCN about

Good Steve. morning. Hi, Thanks the Yeah. for Tyler. for It's joining call.

see the something to guidelines So us see see for continue sunitinib. we the what on updates certainly the a the And calls, early patients to data. treatment GIST in yes, impact and in preferred too were future NCCN our quarter as as option intolerant data. monitor. we'll treatment list pleased And in who on second-line first we to warranted just to really for are based it's update QINLOCK we'll any That's their with provide in

our from moment Jefferies. coming Thank our for question Eun And the One next Yang line you. with next of question.

open. line Your is

Thank you.

U.S., the to the were gross the in in increases that quarter first net this understand I as So there in as well program. assistance year, discount patient

So mid-single-digit assume that somewhere on around percentage is based patient the growth, and in a to sales volume growth year-over-year? it is reasonable like that

is question on Tucker R&D. second the And to

quarter First higher you fourth obviously, is in enrollment the Phase R&D trial. the quarter completed MOTION last than X And year.

the R&D down about increase, remainder you So And OpEx quarter-over-quarter do expects of R&D how modest for we but the the year? Thank you to run quarter? from first rate think think you. mentioned should the go

Eun, two for questions. Yes, the thanks

off respect make Dan me us perhaps the business to QINLOCK and some first like of business. additional with outside and U.S. Let couple a then to Margarida, color the of just to kick U.S. ask comments, offer global you'd And on comment on the I'll

remain solid future the view in U.S., to I we strong very additional of of But and to QINLOCK our Dan comment So will prosecute reimbursement we the additional of to negotiations market the had and And fundamentals, continue the revenue, territories, outside here quarter. course, performance. really dynamics see we we fuel in in quarter access continue which pricing growth. think quarter the say, U.S. our unlock that will a very of would on the solid is U.S.

but year would seeing remain how fundamentals say So the we're forward looking very the strong. to the of I balance unfolds,

you to comments? some offer do additional want Dan,

Hi, question. much Eun. so Thanks absolutely. the Yes, for

continue I in it's dynamics all seasonality of the underlying growth, patient see little remarks. payer described uncommon underlying strength of continued the new always in acquisition, business business. underlying prepared really on. and a to some access is tricky see we with new mentioned, these including importantly, core of as of the not our terms business, prescriber So But we're metrics, that that pleased the we that therapy, QX duration bit as in Steve in to key and really saw so average strength

the And we net net we X% so that noted were to overall, to we're able that definitely revenue, the despite year-over-year. revenue progress grow pleased with relate headwinds

longer that -- -- communicate to the impact so enough decided to plan that that provided the for that, I that than we're we there month-to-month, a with rather are direction somewhat we've have we quarter-to-quarter, quarterly. the evaluate of and But on think things hope volume look detail at We to growth strength appreciate to timeframe headed. underlying business you

Great. Thanks, Dan. do dynamic? European to international the comment Margarida, on you want and

Steve. Thanks, Sure.

that to that will that exciting of to launch see just access by future the we as the very have start we we allow to are markets So in And it's the also saying making the in countries as achieved far progress regards market to reimbursement unlock first strength see well new strong with so all launches. the ratings Europe. which

success is strong the of the play Germany, So say role a I have a continue continued be driver also to Europe. business strength the Europe. actually, that expansion current in we growth like to where like already we in to continue going access And also QINLOCK would key the France, geographical of in countries in

Tucker. it's to your right. Eun, with OpEx, question you're On regard

quarter-over-quarter So QX. OpEx about overall in grew X%

we balance modestly the the kind in increase expect of I to OpEx would the through of prepared remarks, As overall said year.

was little a G&A noted, bit. actually R&D in the quarter, increased down you As

And the was R&D the that So see more forward the you as Q, to R&D, to in on QINLOCK that for front. the it of you'll most around going high additional increase expect due we sizable that the XX% at be year. about wouldn't of balance look with expense quarter-over-quarter

high quite for be the won't to we over R&D, expect the it of growth a balance would modest but as R&D, level. the more at be within year So overall but

Thank you.

Thank of our the Guggenheim. you. And line next with coming question Schmidt from Michael

line Your open. is

have for our for is morning. questions. I taking Thanks Paul two. Good Hi. This on Michael.

QINLOCK is on first The potential and guidance.

a this end-market given at sales of plans made any XXXX that some the is year, or of more point have for do So and beyond access to in Europe, you've some guidance possibility? you progress provide

that secondly, about and you're QINLOCK GIST on just evolving the future with potential moving landscape for or of XX/XX and are of are also other in (ph) just XXXX ahead Is against GIST? opportunity Thank sort exon considering you. the or lines then to how approaches wondering development strategy, second-line it you XX in other [sunitinib] path And second-line. that in likely program, thinking the regulatory remain given head-to-head

Steve. Good the morning. much it's Hi, for very Paul, Thanks question.

first question to and take with me your to let respect had ask Matt guidance I'll respect the that address to then XXXX. with QINLOCK you So and question

in initial the So and study for provided for top of we opportunity first, here second earlier based peak on guidance INVICTUS brand. saw And guidance study indication terms of fourth-line going business also both as of forward QINLOCK the the some this the on contribution what base year, for U.S. overall, and in line, second-line we being the opportunity then you'll recall, in revenue the the the the the fourth-line INSIGHT

the selling U.S., to combined. two of a So, opportunity see U.S. those the Europe in in we we've and with a to the the outside of peak price excluded key that is million be opportunity of in up now of markets. going course, net reason $XXX is negotiations revenue line view middle what peak that, excludes the a $XXX indications clear as average on And have we because reimbursement And still sight million in to until don't pricing we're

today, price respect encouraged news disclosed and German to some value and the we benefit we're we very some given on of to up to certainly that the where the offers in territories. it recognition end the really early we Now near good price our guidance brand patients. had But for might price that in to term and for the with too around that other uncertainties of it's us just provide see

Matt?

our Hi, Paul. Steve. about thanks, to regards question Yeah, development pan-KIT candidate, your inhibitor. In new DCC-XXXX

analysis we data the the And line show the setting. QINLOCK very that able harbor in with who to And in the patients have have QINLOCK activity in pleased a with course, the XX XX for we second-line activity. of emerging ctDNA strong again, exon patients plus very by Of now fourth-line or mutation. XX we the we're were with that

of there's another combination in agent single space lines therapy, can opportunities a pan-KIT and of other also as such or course, that either potential therapy. for a as But XXXX inhibitor GIST be the as

we So closer IND, filing that forward our sharing as to get to the with look molecule. plan development about we more

Great. much. Thanks so

Thank the you. our with of Bradley from And next coming question line Canino Stifel.

open. is line Your

Good morning. your Two on pipeline.

you pan-RAF, of the the unveiled the of medical clinical in molecules for molecule those emerging pan-RAF same with, this would at that valuations were First, by meeting difference data as met where lot I companies. there's a the several of reflected say, market by sets

in So what see I defined to development and those that you paths? to want point data valuable know did

this based decision And the INTRIGUE yet additional been study on your then published advance was data to that molecule for pan-KIT, presented? has not the Thank any from or you.

thanks Brad, two for questions. the Yeah,

the to Matt the Let on ask XXXX I'll take then and question, inhibitor. XXXX the pan-KIT question, comment pan-RAF me

about So, excited the AACR spectrum XXXX really favorable very inhibitor properties. a as broad selectivity disclosure we're and to exquisite pharmaceutical at make with

of developing in We you a GIST. have, lot drugs know, as experience

on think, along with to of clinical that pharmaceutical enrolled those patients with a data studies. GIST I access or company. have, that have any largest we We lot treated number on patients from of additional biotechnology of comes study And the

potential to this benefit in both bear with about as in in we research XXXX expertise totality, been So that disease. as patients brought clinical and that well its has to we've think its built development, as

patients from benefit expertise, to role that that from well we QINLOCK hope, we a both offer leverage bring currently patients to GIST as perspective XXXX beyond for try continue development we'll a perspective, to, a with forward where disease. bar plays So to in raise the as research as and

you Matt, on cover to like off would XXXX?

Yes. Hi, Brad.

gastro-PHs So in good And in activity allow with to developed the studies. vivo that able you cell, both properties, excellent pharmaceutical solubility CNS know, really in we've and that tumor as of really residency we've we in to penetration, trying access pan-RAF vitro properties time, do to these molecules to the at on-target demonstrate XXXX, binding, accumulation in feel been physiochemical regard about optimize the tumor.

we've classes also able So this drug (ph) that taken way. on RAF feel has to the too. to ability [serving] And a existing be other to of we the able for very been do demonstrate in may our across exceed our properties in this well mutations drugs market that all further confidence drugs molecule as together, activity in the significant development develop and that the

One Thank our line Securities. Reni the And with Benjamin moment JMP question for question. you. next next our of from coming

is line Your open.

launches Hi, would love about going? opportunity? of picture thinking questions. for negative kind ex-EU, And of at as dialogue European what good when while U.K. the countries other little in you just you morning, the the we I to might you kind opinion. guys. expectations ex-U.S., taking the do the off, Maybe evaluate just again bit enter this start point? how hear got NICE kind And the the to of Thanks the the is we're international, can just think a talk

the ask our questions. Good really those progress NICE I'll on for Sure. England Wales. Thanks for there Margarida good morning, Reni. to Margarida? development comment and and

Steve. Thanks, Sure.

by which start, of Reni, launch since me Europe. It's saying year, we have best last the Germany. reimbursement So was achieved the some not in our in ratings let the that very possible case best,

So difficulties. has based experience to for is way when a when to outcomes. cost-effectiveness treatments, comparative new uncommon available especially not of comes treatment to which is it is new comes no treatments, on specific NICE, it decision-making when NICE This

the a which we launch future. believe to when be solved. open Wales NICE enabling offered in So rapid able for be questions, the review, outstanding in England opportunity we And remain can issues the happens the will were in and resolve confident we

So discussions agency I we and the would the confident will to NICE. say the with we we around this with be are able situation current is remain currently turn that having

the outside progress. how would continue second thinking in speaking, Europe, of really those we just that relates that of think are offer to outside opportunity you I And generally the question U.S., make to, I Reni, then, territories. good And had we about the

and that just Zealand come territories. Rim, second. We we have other Zai In back I'll collaboration, a our for to New distribution of a have, course, in Australia, the Pacific partner

distributor U.S. partner we Israel to of have the a going realize for for the outside where evaluate We other we company opportunities can also Canada opportunity and and QINLOCK for forward. to continue patients and bring

as quarter, National the that remarks, China. the good Drug is the mentioned the in news Tucker on Reimbursement his drug prepared now In is List in

to believe market. continue we headwinds So from company. Drug China we and country. over in on. our Zai's quarter revenue It's listing see, experience rebates that ASCO that the we coming overall our Chinese financial QINLOCK based at their reported the substantial to had revenue expect to associated And Reimbursement as contributor be National a saw that provide the But to some time, a the collaboration clinic additional in to the with China conference. and a data subjects to we've have with Zai up royalty contribute on performance to overall in just distributors that the will in that going

product find for of continue So the we'll work our company. patients where revenue U.S. to and also markets introduce to the outside to the we can continue to generate

you kind remarks have some what expansion positive, can real of more assuming when it. in the kind And is And of vimseltinib, Got Any I activities, there? focus that initiated? Dan that end year, to really that of guys pre-commercial on little the what activities or the you prepared been just I talk next started think you've by could again, activities of a then quick pre-commercial think gears his bit expect about the year force? we maybe early the activities. sales it's trial switching positive, assuming already an pre-commercial mentioned will color including is

on them. Reni. Thanks, Great question Yeah.

flip previously to vimseltinib patients. that that that fact it as also how the see TGCT. we patients the U.S. had when profile, data the to to physicians The for about what of overlap potential let excited we've profile they -- the vimseltinib the And their we be year is prefer we when to vimseltinib. reported that it we last continue U.S., I And which the outlined in with the the Before We is update high. they really just we at vimseltinib market select me continue think say of see and of to for be ESMO they quite shows product benefiting prescriber treatment patients treatment TGCT. as for for the clearly best-in-class blinded opportunity as test with over Dan, we lines in use what

in So study need globally, we're and in the the to enrollment population we the data also well the as underscores in up think excited to rapidity get MOTION of QX the both that they're U.S. unmet in readout, in coming Europe. the MOTION this as from

to want the specifically on activities? commercial you maybe some of Dan, other comment

the Yes, question. thanks so absolutely. Reni, for much

which as mentioned opportunity. really of least the uniquely So this best-in-class is that be in I prepared a And likely that speaks take the not advantage of vimseltinib. we Deciphera things, to believe think a we is positioned to what profile number remarks, the of for to

built quite and built addition some as been And GIST to best-in-class We've that, them. know, closely working those real, commercialize think, academic you then tumors to to in with TGCT. also we've tremendous capabilities now we done time port in community for in demonstrated ready with sarcoma and of really really we've over setting treaters to And the that setting capabilities importantly, a are relationships successfully. rare process that, the I now getting and really with

that the in launch capabilities GIST sales plans, We out of building how up the identifying that TGCT. built force. we the the likely wouldn't thinking team, we're laying So will extend for expanding to through engine, days we relatively be early

it's we going expansion. all, think of to don't major a First require

the second when get talked adds whatever But make we we'll and those we certainly we've this may incremental the of will speak bit to One road come a is product previously down the there. things synergy about provides.

lot closer will get organization will on. the in engaged go launch, be will there Med it's of be to well. certainly educational a we as But not Obviously, team that aspects this. the be commercial just as Affairs that And very

very So and exciting more lots going on, come. time to

Great. the questions. Thanks for taking

Andrew line Instructions] Securities. next [Operator SVB the coming from with Berens And you. Thank our question

open. Your line is

Hi, thanks.

just I thought I the Sorry, you CSF-XR wondering, Maybe for in I guys just this potentially setting? there if if that think was you and moving late. asked ongoing if Matt. the in trial was class there's a them drug GVHD. about has potential a but wondering was previously, came into question that And

get are in based course, data at But any of alert on receptor believe of our ESMO for can that management product, been X And patients and the of MOTION study September question. And the patient aware X/X and vimseltinib, updated we great a for enrollment last year. focus in indications. pivotal That's which has Phase of Andy. CSF-X cycle life population we that Hi, best-in-class readout and inhibitor potential today TGCT group course, of results. of the on top-line now we course, last certainly Phase with the other full

inhibition mentioned, graft shown has has CSF-X you disease host activity. As disease where been versus a

certainly course, program, that share you as the in think be entire future. opportunities with we of other will our can we there So through

Okay. Thank you.

next please coming Barclays. our you. Thank And our the Lawson line with moment One question Peter for question. next of from

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the question. be INSIGHT how for group? And for here we we far. XQ XX/XX morning. This expecting be in And it's of and could physician (ph) on that you rest benefit we about taking NCCN XXXX? it off-label the clinical any the rest thinking tell for use think using of is for sentiment so into from a maybe ahead incorporated early around progress good I to [Shay Feeney] One of maybe can't is Thank the Peter team promote the Hey, of our should guidelines be bit XX, from guidelines how contribution data? Thanks year? Lawson. it data appreciate being on for the our exon whether But reflect the to should would sense that you. updated about

to the Hi, respect for great with Yeah. guidelines. Thanks Shay. the questions

treatment at Q&A, incorporate of the to As the to as intolerant the we were I for mentioned guidelines earlier are regimen QINLOCK sunitinib. in the top pleased who preferred patients NCCN see for a second-line

can promote you're a it's exactly that not that given right, will we or to. off-label, use that's Now

to So breaks difficult here whether report use utilization, guideline dynamics as NCCN. try really compendia might seeing over what of for predict on spontaneous and monitor use, sit time we us listing. the that trend, then see additional of if extent a the a to And any, occur the we we're It's the result today in we'll to we'll understand a and market to continue in the as provide go-forward the basis. result as listing certainly color with here that U.S.

For this ASCO year expect kick study, the XX, the can make XX the the time. off to subject reported the which or earlier data we of based plenary we of course, INSIGHT the in series NCCN, and now to XX year, on at guidelines later second-line use the the updates at this any

updates make curious data. we'll So those be to based what see decides guideline to on NCCN extent the to

the As in Matt data there there at data mentioned that those in and prepared changes will that guidelines. the remarks, reprise presented forward if of additional we June, in presentation ASCO and any this of month of to to be June, seeing a occur treatment are also at his end look

Hoerter any And I questions remarks. Steve back closing you. Thank turn call to like I'm would at further showing no this Mr. the for now to time. over

Deciphera. and our Thank everyone, day. forward progress Thanks, very here continued on Great. on great a today's of for joining Thank rest look updated for you your continued your we keeping support, to you at Have much. call. you us

our Ladies you for today. and that conference conclude does Thank your gentlemen, for participation.

disconnect. may You now