Earnings call transcript Q3 2022

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Jen Larson

Thank you, operator. Welcome, and thank you for joining us today to discuss Deciphera’s Third Quarter 2022 Financial Results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. With me this morning to discuss the financial results and provide a general corporate update are Steve Hoerter, President and Chief Executive Officer; Dan Martin, Chief Commercial Officer; Matt Sherman, Chief Medical Officer; Margarida Duarte, Head of International; and Tucker Kelly, Chief Financial Officer.

Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. made preclinical conference commercialization and and guidance. statements expectations include of forward-looking XXXX our for clinical of during call this our QINLOCK Examples programs, our

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

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

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

Steve Hoerter

discuss Thank delivering Thank for financial update the morning, medicine quarter, third you quarter, world. provide success in States reflecting achieved the QINLOCK the joining to third revenue breakthrough us and corporate you, good and our an Jen, the as we another United record in from upcoming around our and review patients for this milestones. We everyone. today results

QINLOCK to initiated authorities continued Our reach application process market we global expand in reimbursement efforts access in submitted a the the as and of to Italy Spain.

to of We need are committed proud important the patients this GIST fourth-line lives the most. made difference around and it QINLOCK the of patients remain ensuring the medicine in globe, we has who reaches

advanced escalation DCC-XXXX, initial gene. tumors inhibitor At metastatic RAF Phase programs of in or from first-in-class the the and Congress third with at with We pathway DCC-XXXX autophagy made updates X exciting presented our presented progress ALK new quarter clinical Paris. in mutant a or data across patients and Society we ESMO RAS for dose data targeting Medical European the portfolio the the our in Oncology significant vimseltinib stage ESMO,

data. the dose tested. X X in a the the starting and selected key we inhibition levels enrollment ESMO, demonstrated single-agent tolerability profile, at three target in DCC-XXXX these strong escalation Since favorable pharmacokinetics, presentation demonstrated the and cohorts. Phase dose study dose for We of portion Phase outcomes the completed dose-dependent all across

we for Phase of also these amenable not cell dose vimseltinib, treated to X/X tenosynovial surgery. We giant last of that the administered cohorts At updated we announced the first opened patients study of with today data inhibitor TGCT, combination treatment with enrollment week. the from escalation our CSFX or ESMO, presented receptor of orally tumor, patient

clinical of underscores updated best-in-class potential and activity, data The demonstrating outcomes vimseltinib, a the tolerability strong positive favorable patient-reported profile.

we inhibitor nominated of that CRAF clinical we candidate kinases, to have portfolio. the selective a today DCC-XXXX, as next announced our and BRAF enter Finally,

QINLOCK, has the has to novel DCC-XXXX, DCC-XXXX vimseltinib believe potential us using kinase and we agents that to platform treatment brought the the same inhibitor cancer. our be ability discover of for best-in-class Discovered proprietary and demonstrates

of Head the fourth I'll positive commercial our details now Martin, to in Dan? Officer, then strong to on our U.S. more Europe, Commercial year. momentum an line over QINLOCK’s throughout to its share provide update continued and to International, Margarida Dan the on launch which Chief ongoing performance; turn has call our Duarte,

Dan Martin

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

represents increase last in quarter, we total a During U.S., product net of which QX in the year. the from million XX% $XX.X achieved revenue

all unit teams business volume Our sales across demand again drove key to strong metrics our performance In continue execution. segments. reflect marketing QX, strong commercial and

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

to persistency end Our our under at we XXXX, with deliver of team estimated range free percentage PAP, we has on path The high expect during to saw what for of assistance to program, range the quarter, market strong claims XX% the the our as Consistent annual of XXX% our high and time patient on-label or at in again again XX%. XX% to was we receiving in end patients anticipated. QX of year payer this access XX% the drug saw patients with of access and excellent payable be continued estimated therapy. percentage

vimseltinib, potential to continues clinical continues study, rapidly team of to our for Phase the second the product. MOTION commercial as our Turning the launch prepare in team X to enroll marketed patients

limitations not amenable Given to TGCT the for are patients there research, market a unmet who effective clear consistently therapies, existing for to therapy tolerability. is cite patients desire the having and need and sacrifice of In an physicians without safety surgery. medical

with We existing most conducted research perceive market new gain options. to to TGCT pexidartinib, their every on to and across patients, reviewing safety. treaters product with best-in-class TGCT physician treaters and potential commonly treatment vimseltinib, on compares rated highly vimseltinib to it the consistently profile vimseltinib all of standard is key to care. the interviewed recent of recommend their asked for three product interviews Our profiles efficacy they to they what detailed would data When be compelling the to-date for products a After selected establish treaters feedback how and the further likely which TGCT citing be generated TGCT supports attributes. vimseltinib vimseltinib, imatinib,

and to This treaters patients globally. feedback further TGCT clinical best-in-class tremendous opportunity vimseltinib why to we benefit from has to potential underscores TGCT provide the profile a believe deliver the

results and our other now launch around over the Margarida? commercial Duarte, the third European of of quarter Germany in call the are and the progress International, the Head from to world. QINLOCK countries will Margarida to of in turn we discuss making I the

Margarida Duarte

Dan. Thanks,

with the with the QINLOCK third in trajectory market program continued of Germany post-approval are the and We pleased our prescribers of the momentum treatment Germany in the of number We by access growth European throughout launch and paid in with strength the and number very proud France. patients driven QINLOCK’s continued in of very quarter. remain and entry launch

As conclude that and we major period advocacy Despite to Germany, the pricing with benefit perception. very patients. expected France, be reflects reimbursement in exceptional are QINLOCK strong volume in hard also fourth-line we traditional GIST build softness to the by QINLOCK summer some brings product working in that negotiations well very received to awareness continues the KOL driven and

net progress which in million and continues Europe the as in sales the team good from other was revenue and make successfully launch QINLOCK distributors net as for The revenue revenue the well from with reimbursement market International to next product $X.X year. quarter, includes product countries. third in preparing price

lower growth While weakness product revenue outside in by international the negatively continued impacted sales was QINLOCK we the continued by Europe of euro in and Germany, QX. overall

tirelessly on In recent recent continues by a of we and market country-by-country market with and the in parallel the reimbursement in with Spain. progress our access Italy in application access our the basis are two strong to pursue team the submission initiation commercial performance, excited territories key process

in updates Wales forward and our We in future process also sharing on continue to with NICE England calls. to and look for advance access

made Officer, turn call over research our Matt? and to now across pipeline. have to the our progress Medical we will discuss Chief clinical Sherman, the exciting I Matt

Matt Sherman

Margarida. Thanks,

new cancer as last We advancing quarter are to we novel towards excellent bring we inhibitors innovative to our by the kinase pipeline continue medicines encouraged progress made the patients. with have

mentioned, ESMO Steve vimseltinib from was present it the to As a and data the in September. programs new privilege DCC-XXXX at Congress

The inhibition XXXX dose in At study. dose portion MEK X ALKX/X reported levels Phase result with shows tolerated preliminary efficacy well all exposure was on inhibitors single-agent positive ESMO, of that escalation and we associated data studies. anticancer the the were that XXXX preclinical from with in achieved

events in patients XX ESMO, across milligrams milligrams four X. cut with was well being grade or to X tolerated BID XXXX with off and As BID dose from XX the treatment-emergent evaluated most was XXX data at levels adverse

appeared dose across to tested. in and blood cells dose proportionately substrate demonstrated in increase target significant the exposure peripheral ATGXX, direct non-nuclear decreases all inhibition of with ALKX/X a phosphorylation levels DCC-XXXX

dose As to for with the at selection cohorts. inform milligram we further ESMO, extended better escalation DCC-XXXX patients combination additional characterize BID cohorts dose a starting the of to dose XXX and milligram the we noted XXX

more have for the level dose in not XX single-agent I’m and tolerated the dose have XX starting escalation study, cohorts. enrolling After maximum the a selected that dose reached to the we combination announce pleased to milligrams as patients BID

first will cohort combination escalation three include trametinib with as and The KRASGXXC well inhibitors, MEK improved cohorts dose two as in and inhibitor. with sotorasib combination cohorts one binimetinib

we for of for portion single-agent a for an mechanisms open of robust combining DCC-XXXX now last patient. large drugs with patients. across are study from results cohorts partner cancer enrollment the a of of could broad and treatment treated strategy our range the potentially foundation excellent The which provide paradigm revolutionize week, action, three first the different clinical number the of many All

many vimseltinib's profile. has inhibitor therapy. updated and into turning responses Now be efficacy demonstrate antitumor Phase a with continued currently parts X/X to on patients increase and Vimseltinib's to response that highlighted that the data high over a by early best-in-class available strong the study for safety improvement study and to kinase treatment continue time. all at response for rates our support activity sustained the encouraging of was presented substantial TCT from The our potential vimseltinib, CSF-X ESMO receptor to and rates across

of we after from includes objective most receptor. study, rate vimseltinib this of prior Phase of and XX%, for initial rate the part a mature study, portion the not X X achieved objective previous XX%. a response first response A pretreated we response inhibits in receiving the therapy directed objective CSF-X CSF-X impressive addition, In including receptor Cohort the the patients the In with B an of the response of time, portion have therapies. was who an the data patients Phase showed Phase of which responses rate Cohort in population, saw response that progressed or on study, is presented the prior of X some who or Even in XX% which also study,

most most the median impressive and increase vimseltinib was study. on remained duration XX.X included treatment Treatment data of on next recent look months duration the data X duration continues data, cut. treatment In Phase of an the update in X Phase which patients XX% study, to to disclosure. the in providing the forward the mature We

pleased Phase longer-term in observed, by the dose B. responses to X profile at Cohorts the updated across In durable very are with addition follow-up A and the and dose we and cohorts all safety X Phase deepening recommended

to with to study. time our well, progress the an enrollment. update providing to of forward coming to very registration-enabling look our address believe MOTION X We we reach the progress potential profile Enrollment full by we Phase estimated data clinical product and with in have encouraged of on substantial continues has and along existing therapies generated the to-date, the vimseltinib limitations best-in-class are a months

Moving X, the selective of to in excited NRAS BRAF pipeline, announce development preclinical are the to inhibitor candidate, DCC-XXXX. today This X BRAF/CRAF-kinases is and inhibits we Class lines. of our nomination clinical pan-RAF our X fusions and cell BRAF mutants, mutant a molecule

pharmaceutical both favorable from development. Preclinical potential pan-RAF single-agent studies combination properties, of and and a key activity in DCC-XXXX demonstrate programs differentiator other

turn Officer, over I to the financial provide Kelly, a will Financial call Chief Tucker our now to Tucker? update.

Tucker Kelly

review highlights Lab like revenue quarter majority QINLOCK Thanks, the is includes of collaboration $XX.X Zai supply which of net royalty revenue financial well under million, our revenue the revenue. as to the China revenue, for commercial Matt. $XX as agreements in $X.X results. million Greater was Total million and third third with in our for which QINLOCK from product quarter I'd

XX, we for sale of been was cost in prior Cost zero $X.X three collaboration completed and in as sales cost approximately net $X.X had million, revenue September which $XXX,XXX approval cost that QX, months of R&D inventories of included revenue XXXX, XXXX. product the million. In to ended FDA of the expensed of

million transition do million a cost compared QINLOCK sales period quarter, of in we expenses increase a in product operating inventory not of expect of of expenses XX% cost third were we percentage the selling full the XXXX. that the As significantly. of the $XX.X in net to to to $XXX.X sales manufacturing, same as reflects decrease operating of Total

September third third marketable compared development million $XX million compared million to XXXX. quarter quarter in Cash, $XX.X $XX.X our fund and were same the the into $XX.X was XXXX. were the and period XXXX. operations sufficient XX as same Selling, the for and in period equivalents general administrative million for $XXX for expenses approximately Research to of in million, cash securities to expenses

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

Steve Hoerter

both and providing made QINLOCK the Thank And vimseltinib updates the breadth to progress Phase ESMO for the combination strong development expanding year Today's first demonstrate to you, stage X forward exciting most patient the this portion Tucker. reach our ahead DCC-XXXX an with in candidate finish updates We year programs pipeline of recently, the our pan-RAF of the a a and at the study from look dose geographic escalation program. across in clinical we've in treating and new for the to from setting our year September. Congress DCC-XXXX exciting declaring XXXX.

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

Operator

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

Your line is open.

Daniel Wolle

my Good guys, morning, questions. question. for thanks couple taking A of

understanding dose? the chose First, actively NCCN XXXX, can go-forward BID the we second-line will you the you walk happen, for cannot do would how your us to open as depend that guideline. believe setting that of up? dose were And on should addition to think on Second, recommendation? If market you the of that you on opportunity through thoughts on based about QINLOCK XX-milligram that how category

remind And response And in profile for also you. should duration the the overall dose? granted we it treatment AE vimseltinib, about then what endpoint that profile, the primary us and can is Thank of the the opportunity? that for median of MOTION, think means at you overall how

Steve Hoerter

morning. questions. Hi, for Thanks Daniel, good your

to in take me also Matt and additional and couple comment those Dan ask and and turn, any I'll Let color. on of try add a Sherman

respect use NCCN off-label potential for in ripretinib listing would an So question in which be second-line for with setting, your the use. the to guidelines the was first a for

that. with just couple So comments a to of respect

morning. this NCCN have to we the of any updates as First, guidelines seen not

in the the So previously, in the NCCN as submitted data was earlier year, shared Phase INTRIGUE but to was randomized X second our line from study, versus study Sutent we which this have modification we've the at treatment that the guidelines. any yet we reflected not to to the don't seen any it's application, and been as least update believe the panel has yet guidelines not the reviewed

meeting lag some the time there's updated. know, between of you be the as when So can time the and guidelines

use the the for second-line assume guidelines. So setting, in order to listed that a the use in this optical physician drug in is

of use be Of course, by position able the data. aware to needs the and physician needs the the physician to made payer product. then the would reimbursed in administer be to be to a be That

this promote Now use do. is it's an use to important note that and be the the would not a use that that an off-label we it's off-label would it given of can to drug, of drug,

what promotion and product So our that's outside of label is label. limited to

subsequent it's So and and use to update I actual guidelines in when to the too occur terms be. what soon the or tell might first, practice might think that market occur impact then might what in of the

on respect to that Matt the as the the combination dose XXXX, escalation. over selection next to So to I'll XX-milligram your for of dose dose BID turn question with the address initial

Matt Sherman

study. as Yes. we're pleased we XXXX dose the monotherapy Thanks, the morning, in Yes, very Good so part with Stephen. heard Daniel. completing today, of enrollment the escalation

maximum tolerated not XXX the dose course, milligrams Of some we three dose. to reached that did up XX cohorts milligrams, tested

limiting dose also X well were patients dose all tolerated that of in level, those where X. or adverse were the were felt X with no levels we events event. We do any XX-milligram grades not adverse toxicities most There grade see

So we is the able that in ULK target phosphorylation markers the that to of able immediate also of demonstrate kinase lowest inhibition. the have to of we're ATGXX engagement to were downstream with dose one addition good

milligram to XX the cohorts. BID the of selected initiate dose escalation combination together, data the all taking So dose level

Steve Hoerter

Daniel, patient know, combination been escalation you that the As morning treated. we has first the dose in this announced

the part we're and with rapid we're the of combination pleased moving really making escalation that dose the into So progress study.

response question, the rate that vimseltinib next believe, primary being as to in and the Daniel study. then endpoint So I related

what just so potential we've embedded treatment other relative perhaps about seen your is question. Daniel's comment in like question how far that ESMO reported to of was the as I that around you And at we duration would of ask the opportunity think and think that to I'd component on Dan, market.

Dan Martin

for the morning, Good Daniel. absolutely, you Yes, thank question.

we months. data encouraged the We're we've by of it's we meaningful see of claims used is duration from around well in at look aspect commercial patients the were mean, predominantly, the I patients going a ultimately We the we a space difference that So very we to what duration label, TGCT benefit is all treated consistent. really with receive today, really the therapy drugs the so this far. of of ultimately average opportunity. drug albeit And as seen off important when think imatinib, the with is in be very between think as XX of see an which therapy duration that,

of months. see with the much tied safety look we data be the duration concerns therapy that to we set a at profile. eight may think when well-known somewhere in And pexidartinib lower same around the We pexidartinib, associated

when about clinical so set XX a benchmark, to escalation data then we're So we months. look therapy earliest most the cohort. being duration the the our the of seeing somewhat that X study, of to in is speak, imatinib And Phase that in maturing mature the think we duration

months far. We see XX.X duration median treatment thus

see this good way a really we and we ultimately, maturing opportunity. for of So patients, favorable, that in all looks the think, market for good sort

Daniel Wolle

Got on it. Congratulations progress. much. the very Thank you

Steve Hoerter

Thanks, Dan.

Operator

Piper comes Raymond Our from question with next Christopher Sandler.

line open. is Your

Nicole Gabreski

Nicole on two just for question. from guess is us. Good Chris. our I morning. for maybe taking Thanks This Gabreski

talk of alluded so crowded maybe guess more I other I'm you in wondering to properties around nominated from forward cohort a kind a little Phase Xb differentiating to in cohorts move guess Just this little XXXX pan-RAF maybe then around as your see for inhibitor, development. what in successful And pan-RAF just provide could just newly color XXXX, you you you development? it inhibitors a deem becoming combo on your if escalation bit I dose can to is each just need signals about you that space, the

Steve Hoerter

the questions. Thanks Nicole. two for Thanks,

to with your Matt we the hope pan-RAF ask to I'll study dose first would Phase be to what question of you expecting Ib see, we're to the part happy and the I'd then combination the dose study and of take the well. part selection what So of respect tabled take escalation in XXXX to question and see that as

Matt Sherman

Nicole, thanks the question. for Hi

with two as So and partner in XXXX about, cohorts drugs binimetinib and sotorasib. we're selected dose with inhibitor initiating initially that trametinib combination three the KRASGXXC combination inhibitors, escalation the talked the MEK we've we the

we enrolling enrolled we in escalating both I'm excited we'll be safe announced, and the cohorts complete escalation also about patient to in a so very And first moving, the combinations cohorts, as combination. dose dose

have cohorts, combination looking from we and Once cohorts that be those the indications. proof by the data will that time, show be specific tumors. the defined expansion to talk in to status mutation mutation-driven tumor-specific those tumor move of we'll be able we'll tumor-specific signals about we'll At more activity and into both forward

Steve Hoerter

to And from have then inhibitor, really certainly to our your our for Nicole, with DCC-XXXX. on nominated pan-RAF excited and pan-RAF question the numbers we development is the program respect we're noted candidate that

this research next is So we engine our reflective, bring excited we're productive this so believe, forward. product how to is of

there You're inhibitors, a right, are that of in pan-RAF inhibitors pan-RAF are landscape number among the development.

the We're publish and best-in-class. excited far. next medical preclinical at year being we generated share we've what early it how to view potentially intend and a about further that the as flush as we XXXX that of out is so data further profile meeting We

And could of we remarks, have as about another well during differentiation more we a at Matt with see element favorable year. the as medical talk that again, the think share next properties we prepared data his mentioned we'll that preclinical XXXX. we can I meeting pharmaceutical be think

Nicole Gabreski

taking the for question. Great, thanks

Operator

with next Eun comes Yang Our Jefferies. question from

open. is line Your

Eun Yang

QINLOCK. on Thank you. A question and vimseltinib

that So of update end said vimseltinib, this enrollment you year. I by think historically, previously,

more a rather kind expecting enrollment definite terms enrollment. of than completion are in we of update continuing So

And Historically, little GIST. give So Thank NCCN bit more second update question when what at the the off-label for our guidelines there? you in us is have seen, sales? can look on label, product expect? the is you when in color uptake on QINLOCK you. of products, a update oncology second-line If percentage including should sales so, NCCN you uptake use, we general, guideline

Steve Hoerter

two for thanks And Good morning. questions. great the

I'll ask Dan NCCN related your let the vimseltinib guideline comment to take So question, Martin me related on question. then

really first vimseltinib, remain in enrollment the So with we for pace pleased MOTION of the study.

As enrolling six of XXX-patient back with It's study, giant in we months that course, patients enroll recall, cell we've patients the to tenosynovial ESMO a some placebo-controlled shared that we're were this the a in data, and we X/X study is conference that previously able Phase about study over September. of presented you'll tumor. at XX in

had study. we once activations was gotten enrollment of for base site to That the

we reflect where are So, MOTION very continue be we so year-to-date study, to as far we with pleased. on the

the project medical as able a of last seeking in today see to, alluded need then, unmet of treatment we'll and product, said approved are you might this the to particular, update where community are the we to to who products U.S. disease. months that's patients we that in significant been gratified there fulsome provide approved think But and in there's for the option we're we've pexidartinib, the get Europe, a As no when in coming of for and better as course, number treatment study. systemic of outside more reflective and are in couple we've systemic the one only of the U.S., in patient

we've and which to enrollment their continues pleased we're sites see at So these study ways with. activated that finding to our the really pleased rapid for pace, we're patients a

Dan Martin

and And Dan. is the jump I'll question This Eun, guidelines. thanks for ahead go on the in.

of couple a thoughts. So

data last Sutent. than lot itself, showing a First, one the better the as this ASCO of at and activity plenary clear data regarding at previously, KOLs fact out they profile ASCO product comparable then from that meeting overall for second-line, laid we really as feedback we've safety gotten in the efficacy the two interpret injury on presentations and year after the virtual the the have

number the this, submit and overall course, in challenge that ideally this or might do, considered with just use know interesting of as it we include no we we'll for may The the They've way us its find guidelines, QINLOCK companies to and supportive and data it how although way they to make all that have something profile one, see not committee the whether clinical second-line into not. told the be data is the that to to really the of chooses NCCN setting. have or

here. and and really therefore, I'll do can't it And promote then this and will This consistently, something importantly, won't we is just underscored that it. off-label we've be again

has Steve there number guidelines are so in and steps of impact sort mentioned So be be that. we that aware and to where the have to update a of payer have important marketplace. of to the the could use promoting and this Physicians driving data, won't the to what of of there's a or any desire dynamics

marketplace, have we'll there to it number if So just one, and is then two, out the update see, guideline is. how number plays in there a if

question of listings are do really what updated. with those how a kind other because in so had, what off-label the areas. a guidelines in space it comparison in products impact do other to with areas lot oncology many has make It has may about therapeutic to different space, are alternatives the the it's direct different, Your so to and hard treatment exist

So, here. it's we out it is and say XYZ plays how what tough really typically that would to expect

So updates may we be what, it like were if eye you to and see keeping eager an are forthcoming. any on

Eun Yang

you. Thank

Operator

Guggenheim Our question from with comes Partners. Schmidt next Michael

line Your is open.

Unidentified Analyst

taking this our Good Thanks for for question. is Michael. morning, Paul on

other shown your you depending in patient conserve plans combinations sort data be you significant perhaps you've wondering risk secondly, in observed if XXXX, EGFR up for just any they to with following study here. what's your first, So and the get the the vimseltinib. increases then in with data to more update with that was ESMO wanted on damage CSFXR showing to inhibitors some patients of sort vimseltinib, I to of more muscle compare some Just and going perhaps invest just have on any see of on strategy? that where your great would guess, hear CBK into or Do baseline preclinical RMAs. segment to And how color tissue I on plays it characteristics? sort thoughts you current

Steve Hoerter

and and XXXX Paul. Thanks, the to Sure. your questions. to question Matt the for I'll then be ask vimseltinib Thanks two first, take related happy elevations. to I'll question take CPK

So us inhibitor our which, ALK explore we exciting of as know, XXXX, a the key think really partners. gives a about combination is we we the believe which first-in-class, variety first is way clinic, and advantage different into as you

meetings, of with broad the the preclinically kinase As last we combined of inhibiting like activity very years, two either at we've see osimertinib. or pathway course inhibitors kinase presented when receptor MAP medical gosh, autophagy tyrosine over inhibitors

Xb is of So ahead a there's whole with now for as The is combination. a task – we're us begin the for whole those. doing host prosecute range of possibilities Phase study to to each

to as clinic the preclinical we prioritize the go going data see. then those So we that into bringing and through and combination what to exploring forward we're pursue, partners clinically we see what

with partners to terms additional combination the program. of in come future more from So there'll us be

is I preclinically tyrosine can't osimertinib, combination think specifically a in XXXX. on of example, kinase inhibitor, where with strong comment receptor I very effect when see great that's used While a osimertinib we

do broad cancer to the you suggests applicability question? mechanism want targeting just to of that So us potential Matt, CPK very generally. take the in vimseltinib, autophagy to escape this the approach

Matt Sherman

Paul, and for Steve the thanks, question. Thanks,

we've noted to of in we As CPK vimseltinib seen before, protein blood. the elevations enzyme inhibition the is the patients with from due or of of that clearance

enzymes as CPK. leading of just from proteins laboratory of inhibitors and are clearing slower the So proteins of those the blood they are those clearance vimseltinib CPK the inhibiting know, with macrophages such within elevations macrophages such receptor the context we then normally cells, asymptomatic blood. In enzymes from called resident to as responsible and as or the for those, Kupffer the the circulating the protein levels liver

classic small biologics directly effect a to been CSFX has as noted molecules This all the and different even the across receptor. the

this and profile progress program felt to very MOTION date with about talked very the the the as the Phase study. in morning, comfortable we've we we're Phase seen with with X So in certainly, X/X making that vimseltinib safety pleased we we're enrollment

Unidentified Analyst

you. thank Great,

Operator

comes Cowen. Our question from Buren Van with next Tyler

open. is line Your

Unidentified Analyst

on congrats Tyler, the for Woods Good quarter. [ph] all on this morning. for It's taking thank and you questions Brittany our execution

provide X potentially for potential Also site On and the commercial XXXX? of Thank additional on moving of recommendation activation ex on U.S. you. color the you MOTION QINLOCK how NCCN strategy on at also Phase is proceeding the U.S. sites? balance all can second-line into trial, your affect any that would and use,

Steve Hoerter

questions, the for Brittany. morning. Good Thanks

turn be MOTION the to the study, on to I'll to happy question I'll and just to the study. NCCN over So respect with second-line first take comment Dan then it

prepared noted promotion really release, to how pace we So with our that's remarks first, the of pleased with also the study, respect earlier and we're today in the as progressing. MOTION and in enrollment

the said I reflective I the while that ago, X/X. think As the of it's far Phase from we presented so data strength of a little

I in it's reflective geographies of to the patients. of available treat a different unmet variety absence therapies being of and these terms good think systemic of need

of that seen and while it's listed sites. sites patients clinicaltrials.gov, haven't are MOTION those pleased So commented the on open now of for specifically number from the on the that there XX study, number that we open, exact are we've sites are enrolling we're certainly with

on studies. patients Europe of number a we enrolled U.S., the as and well, We of in from in both a of number have sites sites those have geographies seen

comment when might once to making, do So we're question, in in was NCCN pleased sight Dan, with some of as want study response and forward to and saying, more question? on update, patient fulsome we're progress have that the the to occur. the you Eun's I the looking to last providing we're a we line

Dan Martin

Sure. Absolutely.

to is, our question just The question heard would the a And change sure I commercial correctly. make listing I want so strategy XXXX? in confirm, to

Unidentified Analyst

Yes.

Dan Martin

Yes.

the Okay. question. you Great. Thank for

off-label be time we would important note as So answer listed use, that the each The even guidelines. really is that short try NCCN the that underscore this it's in point is an no. to to

we are we commercial sure make a to about on point careful label. have of and from view, our So we promotion always stay really

So we promote can't listing the and in off-label won't guidelines. any

on-label to in can, to to care share to high Our our of really we viewed commercial as opportunity QINLOCK make attribute as XXXX find space, fourth-line is the focused that strategy patients on standard it within execute work to high making that voice as sure to the that continuing fourth focus is in continue rating really driving setting maintaining relates [Technical the possible the every continue sure optimizing have awareness, it treaters, today in line really be We and QINLOCK amongst product Difficulty] just high will and that the continuing for be of a in we the U.S. and would

Operator

Our next question comes from Peter Lawson with Barclays.

is open. line Your

Peter Lawson

how taking kind up, any it just for the came about and quarter-over-quarter through Thanks you. late, you wonder looks our if flat. I this question. for revenue so kind the sort XQ? apologize of of I growth of can EU if Thank of underlying dynamics I talk joined

Steve Hoerter

Good morning, it's Steve. Peter,

of reminder, received So the end very to off the I'll European a ask the at on versus we earlier comment and also then as we've just seen Margarida so start year. quarter last But what year. approval trend this in our

QINLOCK been to the As market commercially able to launch first QINLOCK where for in been you'll recall, that's provide to paid a Germany underway, so France our year. able that to so has in this post-approval patients patients, also were under access launch far program. We've principally, sell we and was

looking in as and reimbursement also we've has contributed to Spain, for forward, submitted prepared that the the to we also submitted process noted in England had revenue same European remarks today, we now undertaken that Wales. for Italy, previously and noted we then So we've in NICE our

other make conclude go coming that and to through year. where territories in So we're a we progress have likely continuing pricing it's processes those the across Europe process and will in reimbursement to

European in time, particularly you a So get some to to reimbursement this, to approval. as and get to quite access know, take markets pricing market can Southern

as medium about five which largest markets excited population United the represent across about of States. of really look over the these term, to opportunity to the the we're patients same get So size we Europe, the QINLOCK in certainly the

So epidemiology, we same. expect to be the

the number to same market So would in in opportunity some on and comment to you of and that QINLOCK. quarter? for of to be of then we unlock patients for want get to the able saw to we in once able that GIST the what we're also Margarida, to company specifics patients access terms get do access, territory

Margarida Duarte

Sure. Thanks, Steve.

Germany, me have far where QINLOCK ratifying to and the received namely only how is in we it Europe, we is launched So by continue that saying in growth so start let country which very being is our see trajectory. well

the Europe higher QX. in aggravated summer Specifically performance, headwinds on the was despite which in net despite in so QX FX and revenue also QX period

let number the the when QX, lower Europe distributor overall say However, outside that so the was in me to markets revenue impacting of compared for QX.

Peter Lawson

And kind the then Germany there what flat in dynamics underlying for for into kind on do just Germany, or there's curious that digging you weakness of you've the quarter-over-quarter. of think France? in topped-tailed Just been

Margarida Duarte

for Thank the Sure. you question.

Germany, executing the that of GIST in advancing the I patients benefit to hard will high also able add medical Europe can strong net in need continue that in negotiations growing in achieve the with like not our both of in in in great Germany in and but we and so the speaks and work we the be It prescribers. QINLOCK of is clinical and team the note also can terms in-launch important dynamics final we fourth-line exceptional continue So the the our the you are to I with our should if far impact the price of number data treatment and actually, in setting, our mode in to results access that terms tell that future. successfully say QINLOCK that price the unmet launch strategy. will revenue we of

Peter Lawson

much. Thank you so

Margarida Duarte

welcome. You're

Operator

Our with Brad Canino last from question comes Stifel.

open. is line Your

Brad Canino

interactions to volume you like quarter-over-quarter vimseltinib. into been like It price? increases One mix of price growth looks has one then QINLOCK. the price comment and on I'd then U.S. how morning. to attributed that's this and and year on captured the for question much on ask growth XXXX, just Can Good that for shrinkage and provide is I think the comments reject benefit. on any quoting for profile. activity but did can didn't tumor CHMP shown European differentiated efficacy, strong you clinical the for both feedback establish really your you've EMA's for drug the Turalio, on vimseltinib. do KOL safety U.S. that heard regulatory the We've QINLOCK two net And safety

there the you. be about comments any just great. the EU opportunity in Thank would So

Steve Hoerter

question. Good morning, Brad, thanks for the

to So take I'll QINLOCK ask the question related first. Dan

Dan Martin

Yes.

this Thanks So the I'll for cover question. briefly.

in taken X, X.XX%. February have one July this two X one increases and we of So in X.XX% year, price

X% overall gross approximately So perspective. impact on a is there the

our we've have haven't We being always and spoken ever it said to of continue experience net average. exactly experienced but in gross are to on that what quarter, the we to numbers each XX% range

net a be of can changes of get that the percentage attributed use we metric and that half there a be growth the can about as quoted, and to you year-over-year, favorable net can attributed the volume half to that the XX% from that and in PAT then about So, to to price year-over-year.

Brad Canino

Great, thanks Dan.

Steve Hoerter

the specifically we to And how to the drug think about Brad, and how respect profile with opportunity. and we of the vimseltinib question about European your think

that. on comment just me Let

Our definition, think we're and three reviewing categories. drug view of regulators really we the the in will it how profile is

efficacy, about that to tumors very we and the of we potent data on certainly, themselves clearly ESMO. demonstrated inhibitor showed based So efficacious have shrink we a that the ability patients, we that's in at believe have and selective highly

again, and in noted, tolerated. you as population we we've tolerability, is ESMO believe this important vimseltinib well around incredibly also that's is patient that second demonstrated, The that at

some a and that's And Phase efficacy, will outcomes see measure product. prescribers from on from be category recall, be the the to we patients think relevant so think to to for the measures to for you and experience, going very the of also meaningful we the pure that's study, is regulators, of relevant, patient and patient-reported X/X related the time reported We we ESMO, impact at to third as where a that certainly reported first will different European data outcomes.

have be on study, on be Europe evidence to world. successful which territories the market the other we're the and in a around now is focus allow our So sure conducting MOTION that in provide required in the based us to U.S. to also will profile making we that that's going

While we've we designed say and regulatory was that into as that the for feedback don't program launched regulatory and can interactions, study that on I front we're the with the study. comment MOTION on consideration that the taken all pleased specifically we received vimseltinib

Operator

further Hoerter to no are to closing like for back turn over Steve questions. call I'd There the remarks.

Steve Hoerter

and us thanks Michelle. of you, just Thank forward all at this call, your Dip] great to have for to hope work the year, day. doing rest continued you here on today's I We [Audio work a we're joining Deciphera. and your continued support for thank Great. of progress look the and of want you that

Operator

This concludes the program.

You may now disconnect.

Deciphera Pharmaceuticals (DCPH) 3 Nov 222022 Q3 Earnings call transcript