DCPH - Earnings call transcript Q1 2022 | Deciphera Pharmaceuticals Inc

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Operator

Good morning, everyone, and welcome to Deciphera Pharmaceuticals First Quarter 2022 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Maghan Meyers, Senior Vice President at Argot Partners. Maghan?

Maghan Meyers

Thank you, operator. for financial today results. you first discuss thank XXXX quarter and joining to us Deciphera's Welcome, I'm Meyers Maghan with Argot Partners. With financial Tucker Financial results Officer; Margarida update to Kelly, Commercial Officer; discuss Chief a Martin, Head Chief Officer; morning President corporate Medical Sherman, Executive Hoerter, are me general Steve of Chief Officer. Chief Dan Duarte, Matt and this provide and the International; and

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

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

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

Steven Hoerter

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

commercial how Margarida pipeline details strong Dan far this standard Officer, XXXX momentum On as established product will more have significant more call, progress about potential. today's share patients plans U.S. of rapidly International the therapy commercial our candidates for fourth-line Martin, in made advancing year, the Germany delivering of Commercial performance our GIST. quarter our have our breakthrough we goals other launch Duarte, of first of the with best-in-class our for in the QINLOCK and provide and in parts performance successfully delivering We world. so toward this QINLOCK the clear our and and strong about will for QINLOCK to Head details of care Chief business,

potential for look then Medical and and with is with this in Beyond our later of potential and combining exploring GXXC the previously we with study benefit portfolio the with inhibitor cancer the substantial in of Officer, and MOTION first benefit the Meeting, at the of cancer progress broad the we is XXXX DCC-XXXX forward the Phase with clinical Phase factor QINLOCK, new we together GXXC of our combination exciting as of update making the an provide pathway. significant data, explore to initiating have III that role American Cancer development study autophagy models. We I on from vimseltinib of KRAS Research patients advance now number the autophagy globally. patients These data Last cancer worldwide. year inhibitors. Matt pivotal enrolling data data to full which presented we XXXX will kinase, preclinical in potential body generated, lung are KRAS of actively ULK Annual the month, our DCC-XXXX, first-in-class underscore ongoing Sherman, in the Association the a presenting stage inhibitors the Chief MEK program

offering week. outcome our of stock last the are Finally, we very pleased with follow-on

the medicines allowing R&D Matt? update even pipeline value to call now deliver our build Matt long-term important over our an now stronger new turn to are our an financial efforts. and provide Chief to Medical to shareholder Officer, patients. advance in us on position, We rapidly Sherman, I'll to

Matthew Sherman

Steve. Thanks,

autophagy rapid XXXX continue and is These KRAS survival to the activate the data designed and XXXX the ULK activate I'd DCC-XXXX, combination Last pathway. as autophagic mutated medicines month, Today, the AACR sotorasib progress flux clinical our in new ULKX/X in adagrasib, as kinases been presented a at autophagy for cell like and GXXC of resulting ULK-mediated highly to by We inhibitor. activation cells control potential cancer. in cancer treatment potent or in results a autophagy, switch Orleans. make an kinases. new kinase start key the across sotorasib we These patients preclinical initiating to our selective to have to inhibit pipeline that for either inhibited be non-small GXXC adaptive deliver we mechanism to important preclinical XXXX the KRAS cancer with tumor line. that inhibitors, with inhibitor lung and factors work first-in-class cell for show Meeting mechanism New shown adagrasib a drug all the resistance. Annual inhibiting

strong deeper not models. Importantly, translated as autophagy presented inhibitors, a with potential regressions activity outcomes the potential eGFR MEK is month GXXC XXXX This with kinase at but preclinical of is patients of alone. The only and clinical combination applicability build GXXC such targeting the importance Autophagy pathway, recently that last to in support section tyrosine compiled of KRAS results the underscore cancer. in a on website. We and available data as this on have growing with with DCC-XXXX treatment medical autophagy inhibitors need. our The for of inhibition a as GXXC set the a vivo underscoring data KRAS inhibitor combination preclinical of summary drug a of mechanism in tumor summary as highlights unmet generated, data compared that to and Investors to also approach the the inhibitors and with preclinical and we provides the MAP inhibitors. longer in the XXXX AACR kinase cancer also well for significant resistance broad sotorasib demonstrated represents DCC-XXXX the of improve has most cancer. in multiple receptor xenograft These results such combination on inhibitors of recent the inhibitor

to excited or metastatic to data we the currently look and we with and We're indications, second with sharing exciting for the in forward the this in a half forward progress Phase I initial made, RAS/MAP to continuing sharing in the look data is combinations range preclinical pathway. advanced year. we of solid are of this We the mutation DCC-XXXX tumors kinase have about in generate across XXXX patients which additional later study year.

be will tolerability us as This the profile, the to in as overall into pharmacokinetics combination cohorts and II the of recommended year. and pharmacodynamic We safety the well dose focused second markers. half multiple we take select on Phase that will will allow this

ULK feedback We target plan preclinical levels subject marker expect the a inhibitors, of inhibitor, the KRAS-GXXC demonstrate clinical X cohorts: we to MEK measuring initial X regulators. as data, from emerging able as combination ATGXX, binimetinib; include trametinib through an approved engagement of have with Based to sotorasib, PD be development X with to inhibition. on to well our updated and

has an treatment and U.S., improved data there treatment need its vimseltinib, Phase with potential despite of highly medical in maintaining strong meaningful clear safety best-in-class on to in that is inhibitor safety patients, benefit excellent we of concept, TGCT an these date I/II TGCT. the to patients, demonstrated potent TGCT and encouraged efficacy shown for inhibition therapy CSFX and selective We're believe and and patients vimseltinib our offer for patients potential promising we tumor. the for CSFXR an with tolerability. durability remains turning to benefit generated from has tenosynovial for clinical data kinase by this proof believe our giant how and while receptor unmet cell to a Now receptor CSFX ongoing that reflect Based effective TGCT study in profile. vimseltinib the clinical the

We and labeling enrollment provide We continue to Phase open estimate MOTION registration of this enroll plan initial year. to for rapidly timing later an study. full sites our III

study we've year vimseltinib highlight activity, presenting secondary patient-reported our based outcomes. TGCT year. updates and at on will also the initial last from Phase longer-term presented this half in in will initial second I/II Key of antitumor the endpoints from results data be safety results of ESMO We ongoing updated

Nomination mutations to this and our plan focused well to proprietary program. as II harboring fusions. program the This BRAF CRAF underscore developing preclinical first-in-class a this kinases unmet kinase as of research pan-RAF a year, our Class essentially proven candidates. our continued patients engine candidate is of platform, for which strength switch Later we will III control best-in-class pipeline. and is best-in-class from Moving product dual BRAF I, to an nominate medical a BRAF development in on and candidate need address of inhibitor

lives programs portfolio We have potential are people exciting of medicines discovery committed improve ongoing our of to new the with to of that cancer. the the adding to

guidelines like since I'd be to INTRIGUE guideline share Finally, Martin, line these the Chief turn efforts. for clinical Officer, update the recent I'll with second provide at the GIST Dan of the for we added Earlier GIST from developments III on for QINLOCK brief our in preliminary commercial an submitted panel to call to in Network the our ASCO session. to update this Phase QINLOCK the line. year, second consideration results in over presented QINLOCK. Cancer practice Dan? study series a patients Commercial to for We've to National results GIST now on U.S. oncology Comprehensive

Daniel Martin

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

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

positive QINLOCK. demonstrate strong of prescriber execution metrics continue commercial performance key Our and perceptions to

the During strength acquisition, safety, XX% voice persistency. of led the across QINLOCK again awareness prescriber levels new among market highest demand, of with in across QINLOCK the and efficacy, of and surveyed. of quarter, Collectively, of all and of positive perceptions GIST treaters within levels prescriber since access academic launch, growth, achieved the payer awareness reach and in core continued the share GIST has community were achieved new settings. this highest GIST QINLOCK access payer Product drivers and convenience both patient including nearly extremely prescribers the we areas again to

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

occurs drug Assistance Program, During XX% PAP This was at the to of contrasts patients of in first Patient percentage of estimated XX% our quarter, QX end the our was low PAP, at QX percentage patients receiving the the who Medicare with PAP to free or PAP each under large XXXX, during which the range. year this to end pay part QX was range. decline that the January. moved of re-enrollment high drug in in percentage The annual due Medicare from process in from to

may and reason recall a in migrated XXXX, patients increased these year, in XXXX. the affordability in We subsequent as QX trend quarter-to-quarter increased can patient same expect may progressed. is year likely experienced PAP, continue that we the the You XX% to phenomenon the as that over of back the challenges say that they of which we to percentage to to saw PAP see XX% we it course similar be as PAP quarters part PAP this and range in the vary

Turning to vimseltinib.

we As are of of the market opportunity. an analysis research, view medical TGCT. high clear to into we we excited given patients strong U.S. study Matt unmet understanding journey MOTION KOL the both claims multiple progress enrolling the engagement in as area see databases are patient a and as Extensive of and noted, need a have market TGCT us continue to significant making

produced as us gives research very duration multiple of consistent all the estimates outputs, our of well these data as product of confidence which share methodologies TGCT therapy. market size current Importantly, sources and the in and have

given XX,XXX U.S., X,XXX U.S. the In population. we systemic TGCT the estimate treatment-eligible that the alone, after and with Of associated TGCT significant market are expected Overall, Specifically, patients given the does prevalent additional X,XXX not will total to proportional which U.S. approved, with if Europe, be their treated a positioned is year potential of We to approximately include greater. we each with our pexidartinib, treatment inhibitor. are to first systemic therapies the a addressable datasets, that risk. know could there few of of because vimseltinib, in and multiple prevalence which will a extensive and need no diagnosed in with unmet imatinib, the in medical receive that experience even majority who million the X,XXX are $XXX the boxed profile, therapy in opportunity that initiate liver to warning, to TGCT, a includes approved of market. We XX,XXX the estimate incidence risk challenging well systemic a who FDA-approved weak these, therapy X,XXX to recurrence for therapy. patients surgery, REMS are Europe, be analysis program product's a believe to only patients monitoring off-label be are the of hepatotoxicity patients claims therapy this and which known requirements According receive known is CSFXR treated with

Margarida? potential exciting Given turn the commercial of discuss profile, could and highly challenging from the to our best-in-class of Margarida compelling a launch first now the its believe option disease. International, over to for offer call QINLOCK Europe. physicians Head we quarter treatment Duarte, vimseltinib patients our of I this results in will

Margarida Duarte

Dan. Thanks,

team work in QX. launch been QINLOCK And markets are results demonstrated to pleased thrilled to China. talk including report about has expanding in an have start the be to access in European our as the QINLOCK States, X approvals fantastic by here the the We to very that off revenue doing steadily initial market. I'm of excellent jurisdictions, to Europe first United we with around and the major world the I'm been to

a net For France. revenue strong fourth-line product in product GIST option XXXX, exceptional of the quarter the the IN for regulatory goals. Germany new Europe, and QINLOCK QINLOCK our team in line GIST. the high of and was we first from first medical the and first of clinical fourth the and of most business of X unmet approval the million, setting, The work bring international quarter $X.X reported which to physicians speaks benefit patients the to Prior identified need of revenue to hard QINLOCK Deciphera primary we results

was fourth European establish of the care QINLOCK markets. clear key in to The GIST rapidly as across standard line first

this reimbursement The regulatory in we our the progress second EU where made in approval of achieving most launch markets goal quickly. have was last tremendous to believe toward we focus We on can that November in since year.

launched small sales actively and from patients as patients our phased in in success value financial we year, authorization I to GIST allow Tucker were countries. will In markets U.S. our broad patients QINLOCK European which believe ASMR number is access review sales patients. We the the Tucker? have the in treatments. Financial we and quarterly patient forward and other demand, We the to to each equivalent to As over very the France, We that number in promoting this we exceptional France With which throughout largest perspective, establish clear Officer, reimbursement for will in care earlier to secured providing X seen call have favorable turn Kelly, standard on a a has a with of is we as we diagnosed year which KOL results. launch advocacy positive to achieved on the have rating, pricing National X unanimously the will the post-approval only in now access the successful Germany, across the Switzerland position received pleased that United line of of outcome. a of fourth a by pricing rapid X, negotiation look number QINLOCK by in Europe. program also result GIST in Germany, orphan Chief announced States. process. making believe we a paid building have QX high decided eligible program, Authority access for on our access and uptake a in continued main ASMR under In driven we French and the recognized brings QINLOCK

Thomas Kelly

like all of quarter to for Net for net full We of do Lab million will cost cost of of of of of inventories which Thanks, QINLOCK's of and the which XXXX, until sales the first will in after of to QINLOCK collaboration $XXX,XXX a net of read of that sold. Margarida. initial includes product I'd includes not sold in and million, our was sales financial QINLOCK $XX.X Greater included sales royalty Cost percentage we first additional results. first expect for with the Total increase of $XXX,XXX, under inventory prelaunch revenue revenue. and include X was Zai million. have cost U.S. agreements that highlights QINLOCK product the the cost reflect the China. months for commenced and includes the in Cost net U.S. sales sales not $XXX,XXX QINLOCK quarter our sales million ex ended revenues the March depleted of $X.X and revenue, XXXX supply revenue of revenue $XX.X quarter inventories and of the as X full manufacturing. cost which product manufactured XX, significantly of manufacturing is inventories $XX.X sales

quarter in the in in continue sell operating development to XXXX. compared million prelaunch to and to expect first the million expenses expenses period million expenses to compared were expenses the $XX.X $XXX.X $XX.X quarter the for securities equivalents in of first We of and inventory Cash, to were the cash marketable in same first million during XXXX. operating million. initial were Total period and was approximately Selling, compared administrative U.S. QINLOCK XXXX. $XX.X the Research the general same $XX.X March $XX.X XXXX. for as in million of in quarter million $XX.X XX,

in front common in of on market, raise the warrants. capital ability from successful us to very we investors discount and last top-tier underwritten our a very balance biotech we at to tight execute offering a mission. significant confidence have to have opportunity addition, week. public our able sheet our understand who challenging In of were prefunded stock $XXX.X we Despite added approximately We're million and

supply in forma continue invest developing medicines significant shareholders. us will that, anticipated balance and for for be new together the next to now strengthened We for call and and to years into to X back patients to the to the turn royalty revenues, create product that Steve. sufficient I'll With with XXXX. pro our sheet operations Our believe commercializing discovering, fund cash, value over our allows

Steven Hoerter

and XXXX significant the Tucker. delivering this far we've made about into head of we're so you, the balance on we excited our half. year, focused on We're milestones second as the Thank progress

I and and initial MEK GXXC both DCC-XXXX, study, monotherapy For Phase escalation portion move present to ongoing KRAS study the of combination into data with the dose we plan from inhibitors. the then

III enrolling vimseltinib TGCT, and are actively We the I/II Phase updated we the pivotal Phase from data of study MOTION to in plan ongoing report study.

Our proprietary development a research later continues and engine program plan pan-RAF product candidates, candidate we nominate deliver from to to year. this our new

we call, the standard to in around as QINLOCK care fourth-line Finally, GIST continuing entrench are we outlined of today's world. on as the

and call our every difference patients, for I'd for for the team at opening their They be like have proud to the I so that to to work call the work opportunity mission. open about a tremendously and more Q&A. lies we Before that, excited far, ahead. for couldn't and now I'll operator, make accomplished Q&A, of our With recognize I'm dedication Deciphera here hard what day

Operator

[Operator Instructions].

will question first with JPMorgan. from Fye Jessica come Our

Daniel Wolle

This is Jess. Daniel for

a We couple. have

it X on inhibitor inhibitors, X partner potential today So the we KRAS different on only that you're combination but for XXXX, evaluating a see PR as looks XXXX. like MEK

scheduled data, will us the And sequentially? the push how from you frame in in update? clinical So follow-up, to patients type combos the we when cohorts us you long the or expect out vimseltinib. update, half see what give here? up parallel the of of we how what consideration the patients can how many in X any are second And for follow to the Is color regarding you there provide then we all or are you wondering the should

Steven Hoerter

Great. the question. Yes. Thanks for

we'll those meaty So of good and those try in each and turn, two take are questions.

conference has before presented excited the and the preclinically I just we're of we turn recently weeks we've data variety few AACR been including a to first, KRAS it far different a generated really that over data at inhibitor on GXXC So referenced so at most the medical meetings, now Matt XXXX, ago. about

for you, don't to then And so data can decision the the if the Matt, the wouldn't mind, speak second and to and combination around half. update cohorts, you back the vimseltinib come we why questions

Matthew Sherman

Steven. Thanks for Thanks, Yes. the question.

excited that Steve inhibitors, the presented with yes, along through adagrasib was both combination this data about meeting, kinase had MAP showing selective the body tumor growing number XXXX, the in addition KRAS the combination that increased evidence are the in we're year RAS So generating indicated, our recent The a pathway. interventions and specific of growth. most with autophagy of really inhibitor, of using cell at in AACR and killing XXXX sotorasib GXXC combination pathway

move believe And want So to data, we a preclinical at looking fast program. the class with is this we effect. this

a market agent an lung It's GXXC approved cancer is inhibitor. non-small Sotorasib the agent as now. cell on with single for

it and us opportunity response. provides a add a benchmark beneficial to look for XXXX So combined to

Steven Hoerter

with Vimseltinib, of data to there be and cohorts X ongoing remarks X release, half second recall, then study. expansion we'll updated And this as year. the press respect I/II in the presenting prepared And cohorts, study are you'll the in in from as Phase this we noted in the

in the And the first prior have in A been receptor cohort their So cohort, previously treatment. cell with second patients received patients tumor. B, is the who CSFX giant tenosynovial untreated have is for inhibitor who cohort

enrolled B, population so time population. the as follow-up dose course, part on the in include, update half escalation patients in untreated fully previously to enrolled And data second previously population the we treated well the the patient for would data A Cohort as patient first follow-up were of to the previously now untreated to expect longer-term on disclosing addition who the study the in Cohort the for -- patient of from

course, this cohorts. looking of be vimseltinib efficacy with safety continued profile patient for, both of in updated along population, we'll from these what is So of data

Operator

Yang question Our Eun Jefferies. will next with from come

Eun Yang

study year? you heard that III MOTION vimseltinib think Did I of I Matt, I this Phase could by enrollment you end correctly? saying patient hear be

Steven Hoerter

joining. It's Steve, for thanks

the fact an full providing that prepared expect on this later on was the when in update we Matt commented remarks, enrollment year. So to anticipate what

in think to in later timing. study position up we're opened also on be getting So sites update better now and actively an enrolling. we'll a provide the We this year

Eun Yang

Okay. Great.

So so for patients. calls, system post KOL of opportunity seems of III be an kind sort current or a are product. enrolling it from nonsurgery in this vimseltinib surgery, But adjuvant -- could the you trial, Phase the like man-hour our setting

So planning is, first on the than settings? it's question what that, think And out, do order is imatinib, the not to you you vimseltinib approved? used one But in question are second be you although more pexidartinib, try black imatinib to you of to as approved, pointed given widely in adjuvant box, could need show that once reasons. unseat it's

Steven Hoerter

Thanks, X questions. the Yes. Eun, for

approach to I'll adjuvant So the address Matt this U.S. what then the matter. and globally in imatinib And an question use Dan understanding our Martin disease can for believe of and take then the we and bar TGCT. here is Matt? that data in ask about the in market

Matthew Sherman

for Yes. question. the Thanks

study. MOTION the to back go we'll First,

in vimseltinib with too, in and a us as is activity highlighted well, clearest TGCT and proof the patient today registration-enabling is surgery, study in endpoint or of patients as the randomized blinded So trial a of evidence here for this the endpoint XX-week previously population. our we've symptomatic this III Phase will give non-amenable

going surgery, in forward other adjuvant too, here future. in opportunities well beyond perhaps the opportunities in certainly As following are setting different looking you mentioned, there's with at we vimseltinib the as to patients the expand and opportunity this

Daniel Martin

what and vimseltinib think and see Dan deliver we today we Thanks we market imatinib. upon question about what in the for is Martin. with This need improve the to imatinib, to

is in what that safety we of consistent XX%. And noted, with has a not you around which really that we've at see as a imatinib entirely all multiple you datasets, have commercial market claims high the we really outputs the launch. somewhere know how in surprising, think in good pexidartinib U.S., been noted, issues So because is predominant on drag we us sense, have share, datasets today. the as the very confidence looked the structured provided And that's

that offer vimseltinib both really best-in-class we opportunity really to has think worlds of best have so profile. And the a and the

you identified and a has studied as XX% have for the somewhere has, We in imatinib. response in setting. in to that retrospective been see imatinib whereas approved, So not trial say, randomized TGCT studies rate not XX%

that space. we're efficacy, a and patients So this better what able pexidartinib, looking that's then product exactly has for we deliver than to and are that think binimetinib better if safety in physicians

Operator

question will Sandler. from come Raymond next Chris Piper with Our

Allison Bratzel

Ally Bratzel on for This Chris. is

we X. So have

on this is related The prior question. first just to is DCC-XXXX, and a

So on to see that data the Phase framing expect how just Or secondly, trends. guess, QINLOCK expectations half, the utility combination, then we on should I coming activity is escalation the data? single-agent ahead monotherapy in given drug dose are used this of you second be of to I in during initial clinical update? And those maybe

any changes growth seen if BID since you could just to that to wondering, dosing NCCN think you've how you of update to a January Just post the since January, an just or patient that? in the or to just year? dose escalation to talk Or uptick there's receptiveness practice BID guidelines now been this include progression, payer the driver as

Steven Hoerter

Thanks the question. good for

Matt? and to dose what address the that can it QINLOCK question Martin to and expect now dosing monotherapy escalation I BID ask first later XXXX trends. IPD then in about and trends update impact Matt take data U.S. the seeing guidelines the that from any Phase the this he's or So is your in And the listed question I'll Dan to year. NCCN

Matthew Sherman

activation is is upregulated ULK the to look would we've at so of RAS the of agent the be is at mechanism and typically you've the becomes to a of and ATGXX the We phase Autophagy downstream under kinase study. target see as of the a inhibitor single pharmacodynamic deescalation of the as potential what's survival well marker cell this the protein a And XXXX folks as safety to preclinical to inhibit so update is would And autophagy pharmacokinetics an understand and as single-agent strong potential data from very the ongoing monotherapy one indicated, downstream highlighted much looking autophagy, as plan of kinase immediately one we pharmacodynamics phosphorylation growth. inhibition pathway. of ATGXX, agent, tumor pressure tolerability on to with and expect activity. is efficacy the which really Ally, and for expect the by-passive the as that don't pathway. single

only to one antitumor see that would it'll in activity XXXX. So combination expect of be the

Steven Hoerter

want do Dan, the take Matt. Thanks, to question? you QINLOCK

Daniel Martin

you Thank for Yes, absolutely. the question.

-- that of to in positive quarter since we're really seeing that, KOLs my awareness in consistent this IPDE, among excited as terms And as QINLOCK data, we it I'm in as great about the been prepared the we launch. we've of in So extremely said in and this remarks, what GIST. have there's marketplace interest said really particularly perceptions before, product the relates

course, recall, you'll as dosing. data well we potential off-label trial And opportunity use, always over to say, could I of time. and should off-label this we NCCN Phase our that additional the that BID patients promote Guideline be for January. and for -- therefore, the really I an from QINLOCK data say. Committee dosing can't growth a the And I potentially has pleased indication But clinical think as shown benefit the were see our to or it. As INVICTUS who guidelines study that receive in this won't for is added or We IPDE as XXX this

spontaneous. So be any use would to have

the terms In translate candidly early bit in say how this will of it's a we're what marketplace. to seeing,

that's in now the few, barriers piece, evolve are that You IPDE-dosing place payer payer it's works. how the would where to this guidelines we to mentioned typically in the expect fact the

coming things keep to but eye we'll on promote the evolve quarters. we can't So it. have just -- see it, we'll how Again, an in

Operator

question Guggenheim. Schmidt next come Our Michael from will with

Paul Jeng

sales that, earnings jurisdiction? And potential will when uptake at that previously, And see spoke where on last the we next you think over European then you the I guidance relatively some the the Paul is could some call. on Any given for newly factors was an provide of on if approved in of start sort of whether poll there the Michael. for Europe. the strong Wondering you additional think months? on launch view several underway? play, in just could at about color One QINLOCK the trend updated the is patients initial This

Steven Hoerter

Paul, questions. us, thanks for thanks and the joining for great

I'll second with color since the let respect year. then now far, so given first some that guidance. in if like would January of So she the on that, take Margarida underway Germany provide And to to this launch ask commentary is me question

guidance, given revenues launch are we're the with in not for with that provide to we position a indication QINLOCK on the in mode guidance again to fourth-line So respect across year. Europe, in

provide more So have steady guidance. until state our may a preference wait visibility to to that to trajectory is we and we the reliable our what so be, approach could better get and

we'll additional update so to strong our offer to the we're some would start excited and in color? progress on So really quarter-on-quarter, that Margarida, you like continue you by Europe. far we've seen

Margarida Duarte

Sure. the Thanks, you thank for and Steve, question.

work As in results in are the launch and to the our markets strong we team demonstrated QX. I has fantastic on been off remarks, QINLOCK noted an in a with initial excellent doing my revenue to start prepared first European by Germany focus as

KOL in exceptional setting, all demand in the Germany, are Germany. these need, data medical strong seeing the unmet high the strength the as contributing as execution we the the Deciphera that are the to fourth-line say seeing are the responses strong in we that would well team of that by I So

Operator

Ren Benjamin will question JMP from come next Securities. with Our

Reni Benjamin

Congrats great on quarter. a

Did new submitting? mentioned if NCCN of of on guidelines. NCCN I correctly? heard that kind Matt what I correctly, out for data And the guys so, And guidelines out are that hear review? are you data next the of I think kind what hoping get you you planning INTRIGUE additional are the for you to submitting

Steven Hoerter

to It's Steve, so I'd that. take be happy

right. Plenary the to Session we of the was have the Series end exactly NCCN, of noted that now from INTRIGUE as ASCO presented remarks in that submitted part the his January. So at data you're prepared Matt

when as the consideration I September recall. So data there meeting meaningful usually those sarcoma NCCN for are NCCN for fall, companies as do, companies next updates the is time in to panel the annual guidelines. data updates, The the submit will early frame,

excited a NCCN the may review that what into NCCN But submission the outcome So to or we any of don't data the data for update have that to consideration. we when might be. as visibility their get we're the provided

Reni Benjamin

were QINLOCK. Okay. have And jurisdictions think I for approved X she maybe already then there that mentioned Margarida,

this And U.S. do approvals year? under many many of or on kind As countries other ex strategy, the ultimately, about be to your think more might belt? have how hope focusing you how we you

Steven Hoerter

Ren. Thanks, Yes.

to take So expect happy to be respect across specifically. with that we what I'll Europe

I'm her -- Margarida about as and talked prepared in noted across we've previously and market access So staggered. is remarks, you recall, sure as European major markets

can to negotiated product just sometimes anywhere period for depending don't a across from months, simultaneously XX the and And last XX reimbursement depending of on and expect we key XX, on the situation. So achieve price that to markets.

rating Now under we're -- that product And French France. regulations. have under ASMR to pleased of and there Germany given course, an really priced to that me, we're German excuse the we, do allowed launch in III in receive

have before negotiate need free a to we for price. pricing We year

launches So in the or we to Spain, us to would submissions additional moment predict for achieve will Italy when U.K., exactly be we to it's we'll access. difficult And at go, for market updates additional market our resource provide gain example bodies territories but as we to markets. we very in those this make in access as as in or those continue approach HGA in

of with Greater in region, with come territories will of X additional to on we able I'm to distribution know respect guidance the for outside other to provide partnership partners working there where Canada, Europe, that that in as well with and of year we're territories have but some in Zai as access territories Australia as we, course, to you And incremental the our Lab over Now have we're China. sure specific course don't be call. coming today's markets, years, online,

Reni Benjamin

final biomarker with you intriguing maybe one just as a Got strategy that there especially are might AACR, some regarding it. XXXX. thoughts at I very the one mutated be just thinking for move combinations. of you We about see any then data at wanted forward? to And if looking saw outside KRAS

Steven Hoerter

for Yes. XXXX. that final question on Thanks, Thanks Ren.

So about the remarks in we prepared this. as talked about And I'll this in we're opportunity. to excited chime ask on Matt the potential of breadth

the course, into along inhibition are Of the matter, the animal pathway have and pathway for in demonstrated ULK clinic, we'll Phase tyrosine in inhibitor preclinically models. with the receptor we that the the kinase regression XXXX MAP And results data this combination you growth even as I year. kinase know, or first now meaningful we've later tumor and

So of what Matt, kind coming you terms this of want on, markers do comment back data to PD expect to specifically? to the year, I Phase later in

Matthew Sherman

for Yes. question. Thanks, Ren, the

terms One dose question on back in emphasize what but -- cohorts safety not only of and they this show our PD also go did potential I parts. in for forward X try I answer which moving what recommended to with coming up focusing a your marker. to and think year, I may II is which Phase Phase business in in are combination the

So be that particularly autophagy interesting kinases. called be that of market that would a And ULK involving would autophagy-associated would protein be pathway. immediately the to It's us downstream ATGX. protein one is

decreased target by So one selective kinase inhibiting ATGXX. inhibitor, as ULK phosphorylation would see of that

question inhibiting a strategy. clinical The So also look a as that seeing of to biomarker mechanism -- a trial. in an question forward one our also of asked on-target you about autophagy update could potential

I important. very think that's also

was the additive data with looked MEK whether we that kinase or the trametinib adagrasib, as across the or the we various sotorasib show was inhibitors, a effects XXXX inhibitor or across clinical pathways, As inhibitor combined it RAS-specific it with of combination XXXX. preclinical could RAS/MAP whether -- such as binimetinib

biomarker cohorts part that, plan going indications moving with indications, updating each forward our into beyond specific with tumor-specific of into we've of dose we're outlined those We're trametinib, binimetinib the as trial. and a X and So tumor development has X escalation strategy. clinical combination sotorasib,

And with would PDAC KRAS strategy, pancreatic we'd GXXC biomarker pancreatic looking DCC-XXXX. adenocarcinoma be cell of obviously lung mutated or which accounts cancer, of non-small cancers XX% probably combination cancer. for and be that sotorasib XXXX example, for pancreatic For plus population responsiveness KRAS-driven ductal at for for sotorasib in

Operator

question next with from will Our Securities. SVB Berens come Andrew

Andrew Berens

assume value respond to to Stivarga? not you Can I of second areas that to safety been or could the neither the suit, And guys NCCN for lot endorsement a line? an us are have the proposition data get summarize to addressable submitted amenable patients of the of the give size the reasons. be patients where markets. idea efficacy these in Would for committee

Steven Hoerter

for for as Thanks joining, question Steve. well. thanks It's the

in that NCCN, So presented Series Session at to of the aligned the January. what much end submitted terms with it's was Plenary the ASCO at very of we data

and this patient generated this of the the in be differential in So sunitinib equivalent showing that in would safety population. ripretinib study showing PFS the PFS INTRIGUE then patients an data to ripretinib the profile

NCCN ask of would to think off-label would your basis totality part comment here, market I'll on to how Dan we about submission at that to this of to And not the that promote. Dan? related we use again, made really ASCO the form for So data be that able second question just that of that reported recognizing the the be the an the drug we recently.

Daniel Martin

Yes. for question. Thanks, Andy, the

pretty straightforward, really. So

off make for any, It is submitted or presented would really us, we submission. ASCO the the consistent any as data. submission, hands after presented updates case at with As this if year. know with guidelines it's was of -- Steve mentioned, what, We committee was the what And don't the course.

on would access regimens In the compendia. to market a if the in opportunity, is, terms second a in of make is will we list they the easier general line physicians are other dosing things would the in that would that product the be the listing, promote, it a lot think payers think listed vis-a-vis patients we for we ever just cover for would And although the if about who the indications and to and way and typically depends -- data about gain thinking how sense, not is it guidelines. this there really something

So to additional our as we, if to can the updates what, provide some on waiting see like color committee be And you, makes. will any, that, we interpretation. based

Andrew Berens

to just what just of So doing in potentially? think get using, doctors you efficacy certain any using mutational like sort the What sounds would I'm if -- now? than endorsement really do drive are are Stivarga? for a Can it's trying guess, choice a -- I follow-up I patients a in there? percentage it they safety And driven sense do for you uptake Ayvakit line? could rather And question? of just an second ask difficult -- it's Sutent be a get tolerability Are Are what they they burden.

Steven Hoerter

ahead, Go Dan?

Daniel Martin

follow-up. for Yes. the Andy, So thanks,

in So is from about KOLs, our a how Sutent, and it the our when physicians to general, line we treaters view. its research, point I has community one about talk thinks the obviously, of to tolerability in challenges, and second particularly of market safety view, products, point talk in these mean, when option approved think

hope lot a as Because optimism efficacy was as be there can of we to data challenging has, mentioned, so that Steve generated approval product second Sutent a tolerability would what The get be and generally hear efficacy, in is and And line. that we and viewed positive we that a INTRIGUE would commensurate in the been give. profile. better that efficacy, similar QINLOCK

not can our questions about, to that looks, something see from would able like I'd do promote. off-label But just and have use, we'd overall, this an positive the this submit to in again, to do KOLs for how any, get last patients." be all to we time, make. is data It the to be access what, line. we they So if like the NCCN, then And profile one underscore update "Gosh, a second therefore,

So the would use sort to way. in have that be of spontaneous

Andrew Berens

option? getting do Sutent, like are docs Okay. And to getting something are prefer have even the maybe else Or you Stivarga or Ayvakit? the still patients would right an though think now they

Daniel Martin

Sutent speaking, the the -- yes, generally within mean, second Generally I has largest share line.

get second have in is line. an a have in Some Exon the if general, in XX mutation. Sutent they But second predominant regorafenib the may -- line known product the patients -- to perhaps,

Operator

will come question with Lawson next Barclays. Our Peter from

Peter Lawson

Great, thanks update. the for

Just on revenues.

and revenues you kind degree the that stocking through if patient all was then of any of the Was ex And talk of kind revenues revenues, use? what of or inventory U.S. there any the about off-label could buildup? total demand? was think we total the product As --

Steven Hoerter

bit Yes, I hearing little Peter, the difficulty of part thanks a for question. second had the of question. the

saw was part inventory first have any driven the might example, outside builds, question U.S., about that of revenue. for the we whether Your of

me? question, the that of for part second just can repeat The you

Peter Lawson

off-label of degree the use. About

Steven Hoerter

U.S. the of outside or Also in totality?

Peter Lawson

For the totality. total product, the

Steven Hoerter

sure. Okay,

ask So of second take to part Dan the the question. I'll

to seeing of of the represented that that the in is what the is a patient numbers new all the at performance. On the that starts we there ongoing is that organic law. under named program short as is just permissible think contribution first in patient in that participating We in significant the the that we're We of no. inventory believe QX don't we've which for part we're French seen Germany, terms really as well question, U.S., France, presented answer outside is that

from treatment think organic fourth-line piece? is patients waiting Dan, we new a that's coming you option. all demand just been comment in So off-label setting on the this the want do for to who have

Daniel Martin

absolutely. for Yes, Thanks the question, Peter.

are the IPDE And how was listed, course, but the be But early data, and listed date, out see important INTRIGUE the the January, because the also line, are listing NCCN if garners. what any, listed there is the far. in to to therapy, so physicians example, and play we those experts because line NCCN that So settings, we so IPDE if we of space for data. in on how wait payer NCCN use on that's the just INTRIGUE we've and we'll the dosing, the the and there's we it's able of will NCCN off-label of think of in line nature the data off-label from before, and point submitted to think X not and And the or then as the the dosing that -- not given only There's BID these flavors earlier of to too support recently as that evidence-based second that the for second of noted, we've drug to we sort about. talked said view. in this that that guidelines that listing, provides from say

we in a of at to use still evolve. continue that our continue significant the use the has date IPDE line, of we But of see things, our side majority then the our on been launch. how will dose. far, And say so large as the it's in to majority QD to see fourth the case the So bit early to

Peter Lawson

how on how ex does U.S. the just through XQ trend then the U.S? look April ex did And or demand, look

Steven Hoerter

Peter, Yes, Steve. it's

take I'm to So happy that.

really we're call use on we the pleased Germany our to strong and the the with said this prepared As the remarks, quarter French seeing in see in performance under program. launch the in we're with that

strength in data and the it's unmet think need we the high line driving the utilization. representative INVICTUS, of which from So is of the fourth

markets. strong in whether or advocacy thought the in physicians, participated be her As These Margarida clinical who have leader noted very it studies, all major INVICTUS. European INTRIGUE across mostly we are the comments,

kind of the good that And treating and the fourth-line patients that specifically. with so I is approach generalize their drug And Germany think they with drug they that seeing their have that in firsthand GIST. to we're now translated commercially available experience patients knowledge now as in

Operator

Instructions]. [Operator

Brad Our will next question from Canino come with Stifel.

Bradley Canino

do it For samples measure that the for read patients patients? you biopsy the way phosphorylation ULK, to not effect hard more can how you We've speak be in are to be it might -- blood the ATGXX about maybe physicians might because robust samples. in from the to heard plan the pharmacodynamic some most

well? measurements conduct the to discuss see So And will as of you you for how can the what patients? you change degree hope

Steven Hoerter

the how Steve. ATGXX, take you we're on It's would that? to questions measuring Matt, like

Matthew Sherman

were when to about didn't concern talking I Brad, what other said their And was you you measuring phosphorylation? what Sure. physicians, ATGXX quite hear

Bradley Canino

just measuring than believe way that was it more have having Well, to autophagy. the particular, was that They it robust in might do ATGXX blood-borne. something been not biopsy sample a but

you're kind So then I wanted to how and see? your of you're it, and measuring what to know the measurement exactly in confidence hoping

Daniel Martin

Thanks. Okay.

interesting the I samples with understand. the we'll tumor, of in fact, I what because we a metastatic actual always see effect while biopsy it's is one in the in dilemma an patients in tumor understand, specifically, might biopsy heterogeneity -- lot Yes, want to Now there's mean, disease.

very that a which that often tumor successful that's represent case. is it's has tumor biopsy it patient's formulates -- secondly, So between burden. site And not the liver to first, a correlation by site totality lung in be in of site good primary lot versus And the a of tumor been versus the it a box, has at, this elsewhere. does not looked in the when

that So the actually blood-based using experiments this on of and mononuclear that's well, in peripheral best also evidence give in a been And validated preclinical our cells based inhibition is will as question of other -- assay nonclinical too. us autophagy. has blood

of we that and we effect will each what be terms would type one see, reduction baseline patient. a in expect we of In potent levels seeing autophagy inhibitor, XX% least have of in at the type

broad in a achieve clinic. to guideline terms what think, So I that, the will in we'd be like of

Operator

I like the Steve turn Hoerter concludes our over session. question-and-answer closing to for back would any conference remarks. to This

Steven Hoerter

to keeping rest and your for for thanks We Thanks. joining of to Great. hope updated progress. continued you all on Thanks call, you us look a you on I your forward future day. today's support. of our great have

Operator

now for you Thank presentation. today's conference has concluded. The attending

You may now disconnect.

Deciphera Pharmaceuticals (DCPH) 8 May 222022 Q1 Earnings call transcript