Deciphera Pharmaceuticals (DCPH) 6 Feb 242023 Q4 Earnings call transcript

Good morning, everyone, and welcome to Deciphera Pharmaceuticals Fourth Quarter and Full Year 2023 Financial Results Conference Call.

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?

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

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

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

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

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

of a strategic of toward full company for XXXX, outlook and our progress milestones everyone, the you morning, goal joining today approved results and Good thank self-sustaining update medicines. our becoming a XXXX. XXXX Jen. was corporate financial planned and with review provide year you, from multiple year for as us Thank significant fourth and quarter our discuss we an

record demonstrating annual strong growth global drove of our and organization. in the the commercial capabilities revenue, QINLOCK internationally Continued U.S.

long vimseltinib TGCT, believe study will actively successful at peak, highly a III medicine. and We shareholders. products, to QINLOCK and in Phase opportunities both to we $X global runway patients generate that extension second value create over for our vimseltinib our With approved for we billion to are in IP further be for a label expect able With be pursuing revenue.

to earlier-stage help Beyond sustainable medicines in to these strategically of programs the invest people to continue potential build pipeline with key we programs, improve a lives of late-stage cancer. new

priorities month, strategic for XXXX. Last outlined our we key

We to QINLOCK the growth expect in a sales, year of driven be internationally. strong demand, and XXXX continued in both by U.S.

in ongoing towards clinical team INSIGHT III goal double has of study patients potential and to with our mutations KIT XX/XX, in Phase based expanding Meanwhile, second-line the is which peak on sales. our working GIST XX the QINLOCK's label Exon

in Medicine weeks few the ongoing overall to A Exon patients in compared compelling study the of we as exceptional the KIT INSIGHT importance to benefit in from from world's second-line standard study. sunitinib. leading journals publication clinical the of analysis INTRIGUE thrilled announce the and showing progression-free data mutations the with Publication and XX in ago, provided XX/XX, of were significant survival QINLOCK Nature ctDNA validation strong results of care, one the this serves medical and highlights the for current that

the both at survival rate the Nature INTRIGUE overall presented similar the GI QINLOCK we the In recently that sunitinib, publication, the survival showed results to final overall and which from Medicine addition also symposium, QINLOCK study compared to was the for ASCO population sunitinib. with clinical demonstrate safety results show treatment studied a second-line in profile these to of believe We in treatment the the activity INTRIGUE. patient GIST continued QINLOCK favorable and strong with that

and second tenosynovial study submit giant patients track we this an the in to the the FDA of the of MOTION with the MAA upon in quarter of year. III vimseltinib, to to the the NDA year, this third remain in building results For tumor, exciting EMA cell positive Phase on quarter

including expansion of fourth approval indication chronic potential host to INSIGHT, disease, exploring or graft in our versus also Phase study of treatment vimseltinib the cGVHD are potential we With of initiate quarter XXXX. plan the vimseltinib the proof-of-concept a of opportunities, for II

In addition, we pipeline, future investments our in growth. will expect we're fuel focused earlier-stage making our which

inhibitor, is For year DCC-XXXX, our our ULK Phase to move our expansion later recommended select a dose cohort. to and this goal II first

in inhibitor, pan-RAF I our first initiate year. study DCC-XXXX, For to of the Phase expect a this half we

of submit half KIT in IND of study pan second half FDA to to the for the year Phase inhibitor, we Finally, this and DCC-XXXX, first I in an new XXXX. a our expect initiate

million [indiscernible] remain a cash second end and half into the runway at in of XXXX. the cash We with $XXX well the year of

in Chief the more performance and pass outlook Sherman, our review year provide on results. on then of Martin, continued our launch for our now our who Commercial insights detail update the fourth Kelly, fourth-line Medical Officer, and Officer, XXXX commercial development [indiscernible]. Tucker from the will progress call to the highlights the pipeline. and strong with will will Duarte, of an Matt Europe end ongoing Chief Officer, Matt? ahead. provide U.S. quarter share Chief Financial We'll who will Margarida International, the its Head QINLOCK financial Dan year our on GIST I'll for full

coming continued continue development will over provide commercial make Thanks, pipeline success, strides Deciphera Steve. to our great for our that growth Together the years. we with believe with we

I'd updates. First, with to like our start QINLOCK recent

mentioned, results study INTRIGUE As at conference. overall survival in GI presented from Phase final Steve the III we the ASCO the January,

in X follow-up INTRIGUE hazard in survival XX.X may The include you QINLOCK at with to with on very XXX XX.X of XXXX. versus Median based X:X GIST in months [ or a X.XX. the sunitinib As analysis intent-to-treat similar additional overall at sunitinib. recall, data trial, were resulting QINLOCK months randomized patients the the of ] population second-line months, in cut final March was ratio receive

rate profile patients due of with lower sunitinib. with X consistent a safety to X, was discontinuations long-term treatment showing and primary fewer TEAEs the Grade The analysis, QINLOCK versus with TEAEs

the the results in on show treatment whether third impact versus in Irrespective sunitinib, at was patient line line, QINLOCK second of QINLOCK differential with the outcomes with any similar. that looked second the line treatment the clinical outcomes in third-line treatment. after also We

Median months line for PFS for INTRIGUE months sunitinib. that offers therapy X.X efficacy second-line versus results for X.X next demonstrate versus in studied in similar QINLOCK on QINLOCK GIST the final was population These of sunitinib the INTRIGUE.

in another a an leading The QINLOCK Medicine and the was sunitinib. the from last GIST Nature medical of from death KIT Exon with month practice-changing reduction XX/XX world's journals. one the in publication results patients In XX% resulted risk showcasing the ctDNA Deciphera, achievement risk potentially major XX% INTRIGUE exploratory of to analysis in second-line mutations, in treatment disease with progression, compared reduction XX a for and of

QINLOCK for to showed rate only objective the Median when sunitinib for benefit XX.X represents sunitinib. compared patients overall these sunitinib. Median patients striking GIST an PFS XX.X was versus data patients. to X.X survival response for a of QINLOCK QINLOCK second-line the for reached, months months compared QINLOCK. months X% the to was treated for clinical XX% not Together, with

that label the now INSIGHT outcomes enrolling clinical excited the improve study positive, INSIGHT actively understanding study in we on of for is same patient patients for population and GIST will the We're tumors. the III If extend believe patients. based support and results precise our QINLOCK of Phase significantly pivotal the

as on patients for quickly as III get by the to Phase approved medicine NDA hard outstanding MOTION study, as working an and MAA are its filings remain submit also to second success as of for of well achieved key TGCT third quarter the week with second of are potential X our track supported the We in to XX in secondary the of quarter primary all patients endpoint possible. We XXXX. at These which an endpoints. vimseltinib ORR XXXX,

treatment the for and incredibly clinical mobility. such decisions and in interest benefit. severe be disease chronic TGCT, associated critical outcomes pain, of secondary a on a plays can These therapy. stiffness are how role of function patients as as well as important condition drug TGCT starting an difficult deal loss swelling, with endpoints patients' staying In of and measures in

activities of and including quality really All work independently. of their function life, ability these patients' or continue to can limit to daily

profound life. as active a effective an this to can forward to available making impact a their diagnosis to Without possible. healthy look medicine quickly have normal, as these patients a we lead new on treatment, And and important TGCT ability

plan in second ongoing the meeting We medical as well to second the major this present a from the results MOTION of year. the study at study quarter as updated in half of results XXXX, from Phase the I/II

best-in-class a and of stem this the initiate therapy. chronic vimseltinib patients therapeutic full cell potential proof-of-concept as that hematopoietic medicine the XX,XXX that GVHD of move Chronic To candidates allogeneic to need CSFX Phase potential unmet significant plan in an to in inhibitor. and to medical refractory patients There affects being XX% U.S. steroids, end, recipients, to are and of remains towards XX% its with estimated combination GVHD of a study we to II XX% explored. overall, with product receptor Deciphera on a decide is treatment transplant prevalent based committed with setting, ensuring

in with CSFX has been targeting and GVHD pro-inflammatory validated receptor an clinically based CSFX Inhibiting pro-fibrotic antibody pivotal for macrophages receptor. recent the study, the on patients with

As an in agent, or option a with therapies. vimseltinib as a oral other receptor may best-in-class oral CSFX agent offer combination single

future. potentially utility on a a of for putting study the initiate proof-of-concept in us by the the vimseltinib of to expect end patients We this to year, path expand

we growth. QINLOCK about and clinical fuel very research and Deciphera's remain excited our vimseltinib, to for potential the to pipeline

cohort. to Phase II to move expansion first DCC-XXXX earlier, in Steve into a select expect we our As XXXX recommended for mentioned dose

half also in We I DCC-XXXX for the of initiate first Phase expect to XXXX. a study

of IND a second study the Finally, FDA with of first initiate Phase we half an XXXX the expect the half XXXX. in to I submit DCC-XXXX in for and

call the commercial Dan? to will I turn our Dan U.S. updates. now to Martin over discuss

U.S. for Matt. QX, very with XX%. fulfilled by earlier range of gross were was duration was expected assistance percentage our our to net our through increasing or business, was product [ XX% results and program, that $XX.X growing line a year product XX% from million, line successful demand and was fourth and contribution patient PAP, revenue core end increase million, the $XXX.X XX% to the in XX% over a XXXX. the demand In [indiscernible] a XX% total was QINLOCK revenue the average of driven strong of between Thanks, XXXX. ] in to high net therapy unpromoted over at These use. In QX record net quarter, XXXX U.S., increase

the whole, prior XX%, was PAP Looking expect years, be and we and between similar at XXXX XX% a as with PAP XXXX. percentage to consistent in

to XX% it Act. Reduction Inflation we Medicare in to similar in XXXX be expect inflation of net XXXX by result and as and in the range XX%, the a a was required Gross between rebates

off-label unpromoted use XXXX, continued standard earlier decision, therapy the expect growth physician driven of QINLOCK as lines as duration revenue of care in physician on well potential therapy. We as a increasing fourth-line in based average in of by GIST,

to seasonality QINLOCK quarterly we the prior record XXXX. to in seen have business year revenues including potential strength this industry confident with for Further, expect the consistent dynamics. another smaller year We what in and our a pattern remain of years, we for QX follow in

Now, data, addressable patients we estimated X,XXX estimated believe TGCT the opportunity Based vimseltinib, oncologist. X,XXX I with X,XXX potential million seen will in therapy systemic approximately an is prevalent to medicine. [indiscernible] by diagnosed, patients we incident by of and are TGCT received on opportunity on engaged treatment the our estimated include the see not approved based does total recently with for treatment the in who have claims surgeons. the exciting oncologists second market analysis the turn U.S. U.S. $XXX This our seen or patients U.S.

opportunity our X provided there recently the approved incident in comparable increased We GIST. of European confidence to the commercial ability X,XXX treatment that team's is deep has number [indiscernible] no for our in treatments. additional the largest where patients patients market in our treatment believe are experience landscape these We these there given insight in patients reach markets into a and

and the on claims GIST we overlap and academic use positioned is awareness in and a segments. to uniquely community for the that Based our analysis, in TGCT, prescriber XX% both base there are we XX% to believe and drive

commonly a vimseltinib which TGCT. U.S. of used tested profile but patients not have product manage pexidartinib, blinded Europe, approved to is in and off-label with in We is which versus the versus [indiscernible],

to managing tell the TGCT. highest treat The view of for the when In with surveyed study, key selecting that vimseltinib patients. market TKI rated showed XXX% important is results physicians measures the that agent as tolerability and vimseltinib across patients market qualitative from same the they most their profile TGCT efficacy research the us as research of physicians preferred selected their the

activities prelaunch launch to strong upon on we We rapidly to capabilities are working as diligently commercial prepare leverage approval. our vimseltinib

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

Thanks, Dan.

in that notable are XX% enthusiastic more international Deciphera's we while the our We the accounted delivering about very XXXX than future for growth. total business, for in achievements laying made of revenue strong results foundation

generated Zai QINLOCK as million up Lab revenue, XX% $XX.X China. XXXX, partner, in net In collaboration international $X.X million well from product our as from Greater revenue in in XXXX,

fourth international $X.X XXXX, quarter product increased net of and $XX.X from collaboration fourth million. the last was an of year million, revenue XX% revenue to For additional quarter

unmet initial Italy, strong advocacies, the the for the Europe, entirety multiple progress high are full growth off of to market access strong rating is with Last excellent launch QINLOCK Italian highest in the we remarkable and the the authority, launch year Italian needs, in was the a in price disease, in innovation which the accelerated milestone to outcomes, which noncurative an seeing has across a results medical KOL year testament a to and the [ are many The for a countries by ] in business, significantly exceptional start. granted Italy regions. significant

underscores good Our to that opportunity the and growth is of example type the Italy the remains to in in unlocked expansion in recent business. entry geographic be overall importance a of of Europe,

the under population ] Central distribution EMI we for which time umbrella, QINLOCK countries, announced the a Eastern a all and agreement Union QINLOCK people. XX has new GENESIS to European geographic significantly commercialization Europe. Central reach will of countries month, Pharma for with Europe Last accelerate expand to with and of XXX of received the approval these [ regulatory in million to Eastern already combined

to negotiations we in address excited and pricing Spain, announce and also and price submitted Switzerland. France in reimbursement that Netherlands, continue are have We the to

markets for buy XXXX on launches. growth continued successful expansion to and key geographic new drivers a Our focus include open

to pleased agreements positioning international world. achieved revenue reimbursement our We more ] launch by patients to reach initial of grow execution, our markets, are very our are from and approvals the growth strength around to the continue the expect we and as alongside [ QINLOCK

approved in of a U.S. data, markets number patients higher [indiscernible] III the the is as is there we possible X comparable Phase believe largest surrounding are outstanding treatments. Europe MOTION and in Secondly, excitement is European the the to no there

the and ] earlier quarter first with NIA third look initial submission commercial for I HTA in are hard working our We towards and engagement preparing the agencies this the year, to forward [ launch.

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

Thanks, Margarida. revenue revenue. included in in $X.X QINLOCK, $XX.X $XX.X fourth and which revenue the net product collaboration million of Total million for was million, quarter

of $XXX,XXX quarter product sales $X.X and fourth $XXX.X full sales includes compared to cost of year, XXXX. the grew of of $XXX,XXX which of product of the in cost For million, including XX% to million $XXX.X total net sales for sales collaboration revenue quarter million. Cost revenue of product $X.X fourth million, the in was

including $X.X $X.X $X.X product of product of 'XX, million sales sales in to cost million sales, cost sales full compared the including were year, of cost $X in of million, million. For of of cost

As XXXX, approval in a sales cost prior inventories completed as been of that to QINLOCK third R&D reminder, of XXXX. FDA had we the quarter the of in expensed X

million compared quarter full XXXX for in the XXXX, million expenses to development of $XXX.X compared and of million and for fourth XXXX. the for $XX.X $XX.X quarter million, were $XXX.X to Research the fourth year

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

with million. million SG&A the For of We compared $XXX.X year marketable XXXX. was equivalents $XXX.X in securities cash, cash year, ended approximately and million $XXX.X the full to

that second of extended announced we into had half unchanged. the which our runway January, guidance cash XXXX, In remains we

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

at Thanks, in for GVHD. QINLOCK, including for as we advance vimseltinib clinical approval very growth vimseltinib regulatory XXXX Tucker. to develop TGCT, and continue excited plans our We're and to seek drive commercial our pipeline,

in late-stage momentum our pleased evolution clinical a and Building commercial excellence self-sustaining by with we continue company medicines. off into multiple our as global XXXX, execution approved our we're

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

Fye first Our question comes from Instructions] JPMorgan. [Operator Jessica with

Two from me.

First, happening are use? latest who are Is about to in as seeing for the of are hearing what's line of QINLOCK it this otherwise result fourth for mainly QINLOCK with pickup using second you the when [indiscernible] doctors any line? treaters experienced turning just you're unpromoted of prescribers new type Or that a use?

frame I the of a you little more how appreciate second, And about you think just vimseltinib. details on Can launch that ramp? shape the bit

use both off-label the based and It's here for Steve. on X Dan? one in the potential to expected decision, ask second QINLOCK ramp U.S. the Thanks a the with those then for questions, Dan the physician unpromoted launch in of take I'll to questions. respect line of vimseltinib

Yes.

it in the So do where as challenging about to contribution your exactly and relates to able for terms to what be sources use, just question of measure the great. data we've noted, that it QINLOCK, as aren't to seeing line us earlier is we're of

believe mix new that prescribers. it's do been existing a We and of

we So role across a therapy reflects for really something that ripretinib the that for broad patients think appreciation of lines in it's GIST. of

always course, that's that, Of an to use. I underscore want unpromoted

to promoting we're out course, on it that, decision. based of So and needs happen there physician spontaneously not

second respect more right But ramp, approval. a we the we'll ramp, now the of [ who the expectations that the in draw therapies. existing and details the unmet ], the on a strategy telling physicians know keep With space from launch and question morbidity into the need shape upon are opportunity is what we're us, there's DTT potential exists with of to significant we to significant opportunity have patients a that improve your real about on suffering to what closer to as launch focused get

launch as be rapidly really as work continuing So pending we to look forward possible ready to vimseltinib to hard to approval.

comes Buren Tyler question next Cowen. with Our from TD Van

to on submission the ready the quarter? Congrats guys, progress for needs discuss to else vimseltinib what the during done next you, be filing Can quarter. have

And will a related that not box approval? to that, what confidence program upon warning you is or black see a your REMS

Steve. Tyler, it's

filing first, QX. for the So MAA and here EMA on the very up coming we of to then the X for remain track the in much NDA quarter vimseltinib in

data. the in So are that confident very usual as we of activities it's MOTION that on prepare just based we really filing customary engaged remain the in. We vimseltinib profile for the and

endpoint that is know, you primary drug tolerated also patient study points, As the the secondary well in population. demonstrated the achieved and the end key all in X

So a a the drug profile off well-characterized for we the believe to would expectation that the that -- continue we have and expect with or we is black warning box pexidartinib, have fatal an effect. [indiscernible] be clean seen is believed a program REMS with very potentially to safety reason there's to no and and hepatotoxicity

So to remain our and for we're on potential we next forward approved patients. track to the excited medicine bring filings,

next comes Jefferies. Eun Our from question with Yang

QINLOCK's patients So it and that Exon intolerant of by XX to with XX/XX second mutations? -- or largely patients line is use, is Sutent were [ [indiscernible] ] driven who

Dan seeing off-label we're the Steve. on earlier in use Dan? is decision. that I'll this on to Eun, question take the ask lines physician based

Eun. Yes,

ends we've from use. earlier the year on line So behind are contribution last seen that we earlier line believe significant that use, occurred the that X what's promoted

score, showing that noted, listing of the for think and as fit now data really the I but that noise is level. with treatment publication So we the noise this the exceptional dissemination information, that as and of ripretinib the second promote, increased have Sutent XX/XX presentation, something as just line, raised Medicine, published there certainly don't the the was in was well patients this presented in both certainly have the Nature XX mutation. We are patients dramatic who those the always the, recently of intolerant level. offer can natural Again, [ NCCN through Exon that ] you

excitement factors, in ripretinib it's patients discern which bottle real opportunities indication it's to are -- study pending [indiscernible] think that which energy driven use with of patient, have that see So the important we the reflective hard in and we study. for to think interest note to by a a those that the we is approved around we positive potential And being both that course, of GIST. level of but

And Tucker. I question have for X

slightly in OpEx SG&A XQ up. but is sequentially down So is

would give as some how could XXXX guidance So us well you the OpEx in on collaboration as be line? revenue level

Sure.

than are end SG&A. year the in was side, There's items So more the we OpEx and some little on it think items a one-off that higher of exceptional. sequentially

So we wouldn't that run [indiscernible] rate have going expect to SG&A. necessarily forward for

half that's revenue that prepare from second revenue. of said, the composed expenses well. And in of launch the really And collaborations. we've some, components. as we revenue, in then the of is couple for have vimseltinib terms as as a often will our of collaboration there's revenue always much get year, the We One The supply episodic. is royalty more supply we secondly,

some we goods quarters, in see and collaboration the have predict. some was in revenues, that's There some So for line you'll of supply quarters, don't. to the quarter, we it, difficult cost this revenue

guide think be for then I we supply expectation we [indiscernible] coming. do revenue. people try always there'll on to have quarters where And the in So royalty and upside focus the

question next Schmidt Guggenheim from comes Our with Securities. Michael

as possibly planned [indiscernible]? in had Will Phase sign differentiation who's on pretreated potential one and comment be plans of on somebody you that II of space? study? how do I can think GVHD [indiscernible] your include about the your patients? And in patients naive you from about and that you like GVHD, Will vimseltinib of vimseltinib

it's Steve. Michael, I'm to take happy Yes, the question.

So.

beyond potential potential expand we're matter that TGCT, utility vimseltinib. chronic us XXXX, certainly, decade, vimseltinib which of doesn't long TGCT in excited addition strong GVHD. takes a the and us do that to data to the us for to the that First, that patents to of the plus enables to end is and secondary patent the we in believe and takes one in the PTE, the we its now And we indication of that very factors include in have vimseltinib, have about composition runway IP new

take it we'll into patients. where to benefit us to the them So opportunity additional have additional investments in ample for indications to opportunity make

differentiation that now So of CSFX disease, at target and how we of this very this landscape see the in in the first, I important. would validated comment terms is stage, certainly, clinically early just which GVHD receptor is

like So addition have or add-on derisked disease tumor current add-on vimseltinib and that care, the against could giant a as oral potent is [indiscernible] to cell that be important GVHD. in like later inhibitor of data regimens, oral all to JAK receptor very in And an mechanism believe therapy, We play target. be the inhibitor the monotherapy that and whether a where an current CSFX demonstrates in agent backbone a role inhibitor an an in that merited of we it's a an a believe lines, a whether in but therapy [indiscernible] we selective as example. it standard treatment as drug oral

GVHD. But now haven't end this particularly at stood full strategy of get the our the up the incremental benefit excited study clinical disclosures yet II patients. have disclosed I'm potential sure vim Phase of additional we in the once where to year. So we're details we'll development can expand over time, about we places

Piper next comes Our from Raymond Christopher with question Sandler.

pretty the I is vimseltinib. running past. opportunity. has question, you adjuvant in study come sizable as in that's noted go this setting? the to your As And even on what do to you points know guys guys no-go the opportunity. sort But another up I a a of the guess, adjuvant this in landscape Just slide, market see on

that sort there any plan articulate? you can of guys Just

or of label question chance there could a be is, opportunity is a that part an of a that that maybe you adjuvant inclusive broad potentially And setting? the then second get

Steve. it's Yes, questions. Really Chris, good

label cell course, of give So will about the us data initial giant tenosynovial MOTION, excited tumor. this from in which

the patients the remember, population not are to in MOTION surgery. that who treated is you'll amenable patient we study As

of So ultimately it's too, decide giant [indiscernible]. exploring a like role what cell we, investigators But lines as statement tenosynovial heard comment also tumor. vimseltinib label for the in for to from earlier have on or vimseltinib the interest in an me early too or other inhibitor indication in lines for treatment of FDA will

is this through of localized is alone. that, recall, particularly, in So a disease the the curable form often disease surgery

be adjuvant probably neoadjuvant be not a be potentially we'd but with amenable or patient surgery, So speaking population to amenable to surgery could that about would treatment. made

So comment in have with that again, for patient us we too certainly, study, the any early on plans. activity very now clear But evidence it's specific the to have we [indiscernible] strong with pursue whether us further of disease vimseltinib vimseltinib, may patients opportunity this characterize to label-enabling studies or enabling be to nonlabel to the and there studies in for potential here. benefit

comes Andrew Partners. Our next question Leerink from Berens,

This on Andrew B. for is [indiscernible]

duration X months So think, I about potentially guys, fourth-line you in QINLOCK come that up saying have started to setting the [indiscernible], increasing been average X.X. the has for now, to

wondering, I'm penetration be do the any you have color that could fourth Where in line? now? on the about right

Dan, to take Yes. that? would like you

Sure. Absolutely.

average the of So mentioned about yes, you had therapy. duration

our fourth to opportunity, XXXX. to the continued line a In in and We line our earlier fact, questions, we think about we look average unpromoted as we've contribution of think noted that's use. really important to strength duration from continuing earlier [indiscernible] continued therapy, growth increasing we as in look

looking record about forward we year the opportunity to QINLOCK. think for as So XXXX, we're in U.S. the another for potential

setting, to said we've our past, of ability need relates unmet that a at penetrating the as it really a to good penetrated it's and opportunity and feel we that done execute number the as not drug really though a pretty a in highly fourth-line high strong only the we've penetration last in years. result job of opportunity As as over

next with from Our Canino Stifel. comes Brad question

some for do think response you function the to for in chronic recovery. many degree noted for the and in working vimseltinib. how in I'm Another the use antibody allowing proof-of-concept study plan hypothesis And wonder GVHD? inverse doses I around on question light me dose asking there of you macrophage of the

to Yes, take on that GVHD? Brad. like Matt, would you

Sure. this is Brad, yes, Matt.

well, X T and in so GVHD, [indiscernible] [indiscernible] much what doses pivotal response, prolonged of indications levels So because that [indiscernible] tolerated dose been to antibodies develop unique a doses. those of And to demonstrate more what different cell to know you're much had some too. where be is we segments in more And the it's as may did antibodies we lower higher with yes, tested effect and inhibition to schedules in antibody dose done difficult on-target other the referring they as in inverse led the has where clinically. the

as study about in our half of second in So excited the earlier, forward with GVHD. moving Steve said year this proof-of-concept

study, yet and to the to are details we that of the given But that the what closer expect the We to initiation achieve. we study design haven't as study. of of [indiscernible]

[indiscernible] question with Reni next Our Benjamin JMP. comes from

just a review NDA the terms that U.S. line scenario then of of the the Or the the to start on to Congratulations to off, are a on are unlocking that just just of some of take and because trial get case up? get you sort of to as second in Have long that's Europe in that's filing MAA. progressing the just all be a key that ramping already progressing? decision? progress. of Any as kind the INSIGHT Any with priority does it how And well seems any all Maybe can as study best us we chance opportunity. And color you Europe? you're sort and color -- could standard as Steve, follow-up both review? the vimseltinib, how still sites, is in sort kind how they you hit give

Ren, it's Steve.

Nature INTRIGUE month. first, should for I the published aware, you're So results INSIGHT, from the that in last we note analysis Medicine as of first

Medicine, top-tier the in for INSIGHT the at generated, presentations with now that publication study. journal. exciting with Nature real a of been the And really has data noise a tailwind ongoing enthusiasm So terms such building ASCO in and both has analysis see that, to the in

been patients So so the and in but excited, study. analysis tumor enthusiasm is they're advancing a using investigators, and getting tumor from sites also how good published I we from that's presented patient's really the insights far DNA. make not that based potential only [indiscernible], screening of be part actively think in And really enrolling the of the to into GIST second-line INTRIGUE, on really open, circulating just continue treated to progress data about

will that think, that a outsized an and in or of on tube of and simple a versus field help order demonstrating leaders sunitinib the the I secondary That this study, prospectively patient in the selected us believe about, drawing in is population. understand QINLOCK to their mutation excited So INSIGHT a are of field participation really goal achieve we blood benefit status. the aim thought to goal,

So INSIGHT we on moving continue with have we'll our in over very coming with and I'm progress updates. queries much on be GIST. forward the track is sure, schedule on to specific second the line study that and study further

question was application. respect to of timing, to expectations whether may regulatory vimseltinib with question second review your in terms related Your what and priority review with specific are was the enjoy we and and our

it's soon the that. us make So not will qualifies for too to review. application certainly, for as whether we're on FDA priority And that determination comment the

by As you status. FDA with the application the and reviewed pexidartinib for may priority remember, review was ENLIVEN study

So that certainly is the present, in if this you disease. will,

at course, forward the So we're the with looking terms as dialogue that of second we'll, or review review to and right a priority in make is disclosures to regular FDA prepare we discretion. at ongoing appropriate productive whether FDA's our of a in quarter, the time file the continued and

of that, in European process, a you may process. terms review as lengthier remember, then And the is

we timeline expect application into the on we expect would But review. once that, FDA to take we action might to the than potentially being get longer with the dialogue EMA, better able cast filed. gets it So our as as further that will when a

our are we looking super delivering approved the medicine about to we're very of to But MOTION second remain the compelling, profile and drug. and clear excited The potential data forward patients.

of could And Dan in activities. something Is just I prelaunch given the that mentioned that overlap, if have ultimately a vimseltinib Great. what just I think involved just in we should can this be that Or something conducted as of be the need -- prelaunch significant bag and regarding then follow-up just are given be to and dropping as could easy it kind this is call, they're that and running? into activities of this off sort market? be the sales there

we Ren, is of believe the overlap XX% to XX% to activities. you're there on the I'll Yes. ask comment base. Dan prelaunch prescriber terms in right, But

as meaningful you prelaunch with existing further activities? on Europe So for well the as want commercial both in organization. Dan, synergy the to meaningful a really U.S. opportunity our in comment do

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

market or that is So investment important. in activities development prelaunch we think

locally educated education, isn't a bring to be This largely want raise deal that common is thoroughly light, to paint burden lethal very make how on to function. with. significant and patient impact that treaters something of one on disease, the that be will are awareness. focus debilitating of that course, TGCT Our really And these and can is picture, that but all sure patients it aggressive a patients the disease. that really a is have and -- disease really on how potential we feel It's TGCT

med our need. studies, information so, and the coupled that, know will organization this of of sure part that with our be prior physicians, all they to that certainly, appropriately affairs, launch, making data So from

at launch, TGCT of synergy. uniquely with GIST with we and vimseltinib. And opportunity think tremendous yes, to in then there's mentioned, both positioned opportunity take We we're Steve really think advantage QINLOCK in the as the

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

you've seasonality about two, how guess, versus the just ex U.S., for first out I the as XXXX and that Great. think on invested we revenue. model U.S. should

then as your GVHD, versus and an on other ability to into that thoughts space. moving the just regimens GVHD around with safety combine potential differentiation and And efficacy well antibody in just

Peter.

GVHD. expectations Margarida then for XXXX seasonality I'll comment So to the and in ask patterns. your respect Matt usual year with vimseltinib the to and question Dan And ask to take expectation on second I'll of and our broadly

first? Dan, do go want you to

Sure, absolutely.

is we revenue, which made U.S. XX% for in to on progress increase which increase. year-over-year a was in net and the the speak we've call, XXXX, XX% the million, $XX.X product the -- feel noted year-over-year we as really the $XX.X fourth million in pleased full I'll a year excited with delivering that quarter, So specifically, the

pleased really with feel we So that.

the recent use. in look contribution we success And noted another drivers of average from we we core our earlier, then as QINLOCK, XXXX, drivers for as some of our And think duration core to to year record specifically expect to increasing core of the therapy. be strength business, be of what continue line will unpromoted earlier

a of we when look themes year reason back and and as So are our a for the whole, the take those at the excitement. sort step

wanted end to think a seasonality the past QX, a seasonality relates year, sort we the expect of reflects holiday strong which note can as of year pattern years, to in demand specifically industry impact as the pattern at demand we to or would quarterly about some that well QX the softness. see potentially that pattern, buying as dynamics, early the post we some in As it very to quarter-to-quarter common similar just

in of throughout the to in would this that PAP typically the the true and noted with the year see PAP early a part we the the course, play year to other also increase which past a factor Of expect we've gradual form is out year. dynamic, percentage lower

some we note. parts moving are of that those to Margarida? So the wanted

Sure.

regarding let but delighted launch, me how Italy. by contribution revenue ex start which by in launch the mean, U.S., I performance driven strong So that with the also existing are the saying last it's was going from quarter, growth in strong we and from the markets,

each towards It more second reimbursement always different timelines price given market. new and this when successfully I continue we to our the happen difficult So markets, there, of expect But expect will as would different QINLOCK processes to reimbursement predict advance in in the in to launch to I continue and international. is and to say grow we XXXX. get assuming open, new that part markets we

exclude future is to while cannot expect another variability. we growth, quarter-over-quarter So that note thing we

in So may again see in and past, this we future. the have we this the seen

the Central -- expansion can you a that like transactions in future. the example XXXX. all with QINLOCK is Europe a for us good geographic for the key well would positioned all, deal Eastern of focus recent GENESIS type I for growth. is is and in So and of expect from

those want question? take you vimseltinib to do Matt, Great.

Yes. Yes.

graft TGCT vimseltinib sorry, able our very study of to remain differentiate So your I'm proof-of-concept plans to regards the year. disease initiate in and versus in do this this, ability we half in in to host about be excited our -- question, to [indiscernible]

have and of patients disease, antibody well III limitations TGCT, both And can database disease and given the [indiscernible] based X for we large would a some and be the intravenously, from from a a every skin there of MOTION chronic and study. to study particularly That's safety patients. also, as pretty as is Phase the with I/II of the burden weeks on significant And involvement, mobility, as very Phase GVHD. have joint therapy a such be chronic vimseltinib on

combine therapies. other So as one with oral of the major agent oral of vimseltinib features using to an be will

on too. a oral it's the As steroids whether standard agents, primarily well, of inhibitor, now you and inhibitor fact, JAKX care in [indiscernible] kinase as or know, of consists

the And so vimseltinib antibody II Phase is with our differentiate from to pretty our significant pretty, ability study. in

drive from, oral an any see to I data guess, or an any there differences or durability antibody? differentiation in way efficacy that If of Is drug safety? you versus preclinical think could

disease. joint [indiscernible] fibrosis that's preclinical these the of as and most satisfactory contractions. [indiscernible] [indiscernible] to currently of for several the particularly the in of role treatment a [ -- the because can macrophage just pretty is important And too, medicine lesions current stations I not the particularly mentioned, think GVHD. even skin also, the profibrotic [indiscernible], I have and patients severe data skin ones is particularly in speaks regiments organs, And ] the and

really macrophaging, in could in those organs in for role these particular the in So vimseltinib benefit disease. macrophages a be

would closing call to turn any over to I now remarks. the like Steve back Hoerter for

today's you thanks for joining course updated during a our of forward and your to Deciphera continued here Yes. us you We keeping for Hope look at year. progress on the great day. Thank you on call, support. have the

your Thank you participation. for

now may You disconnect.