Incyte (INCY) 30 Apr 192019 Q1 Earnings call transcript

Company Profile

Participants

Mike Booth	IR
Hervé Hoppenot	CEO
Barry Flannelly	EVP, General Manager, U.S.
Steven Stein	CMO
Christiana Stamoulis	CFO
Dash Dhanak	CSO
Marc Frahm	Cowen and Company
Michael Schmidt	Guggenheim
Brian Abrahams	RBC
Carter Gould	UBS
Salveen Richter	Goldman Sachs
Alethia Young	Cantor Fitzgerald
Cory Kasimov	JP Morgan Chase
Christopher Marai	Nomura Instinet
Tyler Van Buren	Piper Jaffray
Jay Olson	Oppenheimer and Company
Peter Lawson	SunTrust Robinson Humphrey
Reni Benjamin	Raymond James

Call transcript

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Operator

Greetings, and welcome to the Incyte First Quarter 2019 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Booth, Vice President of Investor Relations for Incyte. Please go ahead, Mike.

Mike Booth

Thank you, Kevin. to quarter welcome call earnings and webcast. and morning, Incyte's XXXX first conference Good today for are investors used slides The available incyte.com. section download of the on I remarks. Hervé, today Stamoulis, the will am and who prepared Steven Christiana by our deliver joined on Barry, call who us for Dash session. the join will by Q&A And

our Before the those collaboration the time, our call ended in well and to and We'll may that forward-looking described today our products of we a XX-K to statements, partners. like commercialization expectations for statements for uncertainties the December including in subject plans you now however, documents. from remind begin I'd results that regarding for time Hervé. statements as cause and of These are with guidance, XXXX are made of number our begin XX, of statements including plans to compounds XXXX, development in our to some the forward-looking during our development year SEC risks the actual call other the the our the as pipeline, materially, differ

Hervé Hoppenot

you, Thank morning, and Mike good everyone.

the of of compared and digit all revenue operators. across strong, year up Iclusig XX% So continued from XX% Including reported first reported the excellent progress be growth of a Olumiant last over on to double Jakavi, XX% and quarter royalties, Net growth strong revenues and ex-US, last currency year. last have of of million, week, continued basis sales with constant quarter sales to first of product the Jakavi up Innovent, XXX we XXXX. in Jakavi delivering QX total milestones we Novartis also

development important across X, of see you side some our of right progress the will the slide from portfolio. On

plan trial of on Our we track recently GRAVITAS-XXX acute announce recruitment from this the work patient GVHD is end the XXXX. in before tested trial GVHD result in with to and naive to plan the and we treatment completed development we

stage half track we this the data indication the to in dermatitis, second Based cream be on the approval also and And indication Pemigatinib supporting phase we are in NDA with second medical the beyond announced with at that the presented capital opportunities reallocation of seeking the will of expect announced participate to this projects Ruxolitinib sharing of year’s make a data look we in which also we that the this early data on to acceleration of presented AACR April, two are co-founding concept We submit portfolio for continues from were value in longer oral trial submission creation. very Ruxolitinib science won’t meeting cream already we inhibitor were development I oral for cream well We meeting Myers XXXX. trial of funding. in successful acceleration the our the received the robust been are the and a development that NDA moving presentations year. as certain at accepted the our the collaboration of where in discovery of in increase ASCO half This patients, vitiligo believe PD-LXxCDXXX that and stage of at now with development phase in the of no we the forward Today, in Ruxolitinib X have as believe program the Lilly. cholangiocarcinoma you long half X during we medical phase term Novartis PD-LX proof Capmatinib represents as results vitiligo, bi-specific, stage in year and in in for and in second NDA of second a to we’re the of a the of atopic data completion for projects late to coming plan weeks. well we June. in later developing XXXX developments X. also of presentation forward the program with such unlimited updated pathogen XXXX, for and morning, at expansion intend importance earlier Exciting as the of phase in from our this X our GEOMETRY will

project But investment that and royalty rate, with earning We impact an us autoimmune already With and that that, exciting is to to to to help potentially of the I’ll a reallocate right inflammatory believe arthritis business. of capital our continue to our to diversification update out treatment on Barry has reach we rheumatoid goals pathogen an and call the turn for in the us the cumulative support strategic place US other in opt time growth. substantial believe conditions. and now over

Barry Flannelly

XXXX by in QX well that QX X% of total Hervé perform first The see to morning, respectively Thank growth increase to Slide guidance you XXXX $X.XX billion sales Jakavi an in to the saw to you, PD was by net with and XXXX. QX and million Jakavi’s amounted demand increased of in over and And quarter, shows can last both and sales our expectations sales X same period Jakavi MS volume. compared good mostly driven $X.XX the XX% and bridge $XX approved QX indications. of year QX We year, last by in continues year. line everyone. patients for versus billion. driven grow full was by XX% of with performance the of for XXXX. to total

of ready and in immediately previous by in are years. approve I'll Ruxolitinib we SNDA steroid-refractory compared QX. note acute the PDUFA net drug launch FDA our this for GVHD to contribute to now are date XX gap required you reminding is finish that on important as the in to manufacturers should effect that coverage May XX% Ruxolitinib that of the or to donut It hole remember You'll on negative highest in to the indication. also is XX% gross

support been to structured already field the and Our launch. has force sized

Our trials we're which continues also refractory planned. year. GVHD of program running REACH global and with over both this the clinical to the the turn in from for I'll now Steven expected as collaboration REACH steroid Ruxolitinib The and results X end of acute REACH phase Novartis call chronic are in X, the development by X update.

Steven Stein

years. numerous with approved Thanks, significant transform good speaking, slide a stage the products our running we the these Barry, More and morning our focusing these four on of potential remarks. summarized that remaining versus is These as generate my United three Today, to programs are patients in Incyte six the late on Barry we projects aim during on refractory key over in to of as attention in updates program have them, multiple Incyte steroid the a has Japan several company important ruxolitinib Europe, broadly currently And highlighted touch everyone. graft programs, and treat development host next disease. I already States, XXXX. into are the will across to indications. number XX. expect

significant patches there results in forward the than the on dose and pleased and Vitiligo vehicle X with to inflammatory It impact FDA currently trial at data this Many the that medical X is patients XXX trial now skin, an with States not randomized approved for to which phase you shown a there treatments. patient’s look ruxolitinib control and disorder of these ranging patients of X sharing no announce de-pigmentation X steroids are million significant and try more we re-pigmentation disease in is a the adults in that with the X are United the long to meeting But with or primary phase of for lasting lives. Vitiligo, reached potential plans that was or the today phototherapy. phase soon. Vitiligo development options its have are estimated We and skin. underway. of This successfully are patients million endpoint, cream in

there opportunities by We and of significant a this pemigatinib expect end X provide that believe hopeful are are our patients the will their these phase disease. in be development we the first cream by approved year. And We FDA within meaningful that to ruxolitinib therapy will with initiate program. improvement the

half the supports planning We are in meeting expect second NDA half file the XXXX. translocated that line at second we the the this proposed medical NDA share And also the cholangiocarcinoma second of in of a to to data for FGFRX year.

are The we the second the pivotal cancer. indication are dosing we of cohort bladder currently pursuing for And recruiting is FGFRX pemigatinib trial. X mutated continuous phase

will this indication We reach and the cohort recruitment be expect this that this XXXX. submitted we for of SNDA end hopeful in the are year could full that by

The phase X bladder preparation. first and in recruitment now plans study for also open for cholangiocarcinoma are in line trial first cancer is line

the for which the setting, study We therapy a expand potential opening the the number registration phase therefore agnostic are patients also molecule. X of eligible in a could further and of directed tumor

important stage we first host deadly development two phase approximately update disease. diagnosed Moving efforts and patients very versus treatment. are program, is opportunities disease, JAK unmet the that itacitinib need treatment versus back year. GRAVITAS highlighted of my to in this our in potential GRAVITAS-XXX, which disease markets are early major graft host X versus each line graft is which AACR. by the trial clear exciting launched we naive mentioning acute will results this XX,XXX our GRAVITAS-XXX, in versus is expect portfolio, a graft in investigating itacitinib encouraged which And both the globally, to note has of January, treat and naive, often patients host we host here in ambition of now treatment to graft available recently disease. In be disease were recruitment. chronic with at year. to It The new completed I’ll by before evaluate end end in

now differentiated discovered and molecule a profile PD-LX antibodies. action, Its and novel which the [indiscernible] have and internalizes clinical available versus orally clinic. in injectable could first result inhibitors, in series binds, monoclonal the novel, XXXXX of a is of PD-LX mechanism is We

CDXXX bi-specific the like MCLA-XXX to to data look the Through development a with quarter. year. This two and pathways. MCLA-XXX, the for exciting in are activity direct important a ready micro-environment by enter the immune clinical to targeting sharing I'd Christiana collaboration limit early tumor patient the next we dosed clinical while moderate systemic over is for Merus, CDXXX very agonist mechanism update. we financial program is also call our selectivity activation, this agonist with expect first that, innings, to with forward PD-LX, bi-specific turn to this for This have but With PD-LX. antibody to may CDXXX its We

Christiana Stamoulis

everyone. include non-GAAP good morning Thanks, The Steven financial will morning, numbers. update and this GAAP and

collaboration or Before quarter, discuss no the research with and beginning like at of morning, first new to I reviewing our revenues After methodology a issued consideration I’d that the partners. on to agreements change reflected the and XX will to we press reconciliation XX backup In are reconciliation. slides Lilly. with for baricitinib moving to the of the that the non-GAAP our discuss decision expense this like release quarter methodology existing part the our would in is SEC, the be additional or and milestones non-GAAP and section end development upfront for and with our to for development of results the adjusting deck, of request in non-GAAP our co-funding This in addition, further longer new our reconciliation we GAAP XXXX, in of

As agreement to XX% of sales of right global you royalty have XX% our to we the their on Lilly, under know, Olumiant. net with base

of per the at now to receive incremental cumulative the post a end royalty base rate already addition rheumatoid we royalty XX% if to a and those as Through of at We development expect made levels have in down key to have of date, costs indication. base indication, costs is a development royalty projects. rheumatoid of co-funding XX% development the time. royalty Olumiant grow add Based key the rate, where arthritis pace baricitinib incremental With of time sales also arthritis projects, X% on is receive rate additional in royalty timing decline and potential to the are by spend, is costs entitled structure, the full the it XXXX, over The were Lilly’s effective to which in expected decision to of incurred. investment XX% XXXX the rate our isn’t The royalty especially we given the be over and incremental decision earned we and on to and reallocate in over based the in co-funding XXXX continue affected end reached and to right as incremental rate royalty. the net for the and incremental we could to of to substantial certain we to BOC global baricitinib royalty point, believe XXXX, capital acceleration development grow. it have X% best internal of that additional come balance will the their our other fund this the

Moving our results. to on financial

product Jakavi For Jakavi net the $XXX the Iclusig revenues, $XX of over from and million $XX of first in is related $XX million of comprised quarter, we revenues, XXXX. million XX% an royalties total million Novartis in recorded $XXX product This of in first Lilly. increase in million royalties Olumiant and from quarter

recognized the in revenues year. million effect the the quarter was for flat the resulted under programs, Steven our decline $XXX payment Innovent, of the and quarter period. offset prior non-GAAP to of the non-GAAP expenses on compared a quarter by was stop quarter last to year across our to in total compared upfront progress and expense impact set in $XXX versus with has the operating also million. has lower in of total partially resulting received And We operating $XX decrease for collaboration and program. prior an income on from million The for million with $XXX this co-funding a non relatively as in The we basis quarter was revenues development GAAP quarter increase revenues applicator X% was loss related million contract expense SG&A R&D on costs ongoing outlined. for $XXX a in the costs to by our of the the in period. driven development baricitinib million for a $XX decision basis, expense prior non-GAAP this expense year, in as the R&D the year basis, in comparison net agreement

re-iterating the our XXXX, our to as are year guidance as SG&A for full Moving our guidance. now we guidance for well revenue

$X.XXX -- received timing range turn reflects Hervé. beyond to range largely of now that have $X.XXX We of future which a announced. additional GAAP the to our baricitinib from to revised will include a billion our any decision discontinue GAAP guidance strategic development $X.XXX billion billion, note have co-funding we R&D guidance to billion our of agreements and the to call does potential previously reallocation. resource I not this Please transactions $X.XXX back

Hervé Hoppenot

Thank you, Christiana.

revenue our news And this newsflow forward growth. you we events slide We expect keeping exciting call we we look XXXX, important questions. from to the open for your With throughout instructions late prepared our take and our accelerating of taking now, strategic outlines next happy diversifying for updated program. partner. that remarks. your to key on are during program, and including are goals Q&A. Our concludes the list of stage Operator, give our Please steps

Operator

from Company. Marc Cowen Our and Instructions] [Operator question first coming Frahm is from

Marc Frahm

and Maybe about think disclose the be donut full Just first going XX%. hole the to just you year the the you of do housekeeping new a quarter? for rules is Barry. net in to kind one how worked Can out with the it around gross still

Barry Flannelly

year quarter, to about net gross highest to you Yes, The going be additional to XX%. the in is gross the the know, is as XX%. net, first full

So of going XX% amounted donut donut XX% to from to the $X the million hole we of estimate. about hole

Marc Frahm

is the Okay, other there so needs thank trial like, that's data? data dermatitis Vitiligo, design there's than be X safety to lot you trials so ruxolitinib, that or on filing? a out obviously then just one, as it out to can the does new anything the that large the a as initial for turning that on phase And phase and dermatitis be you. clinical leverage of maybe for to atopic topical trial maximum atopic else done use X in reading in And Steven, maybe for reading thoughts need

Steven Stein

Marc, your Thanks questions. it’s for Steven.

use proof done concept atopic And there high we with dermatological additional entirety for have filing be to very the that done that, phase dermatitis on than And for package, for study guidance of in So, both confidence obviously maximal other products. be strong the our the data dermatitis that's based of the the nothing Xs. atopic will per cream. needs completing

In terms data. delivered we've obviously, of of the proof Vitiligo, just concept

FDA, encouraged We’re Phase at have with the developed medical concepts, the thinking with meeting on the year. it'll by, meeting be X been X end those phase intent size. now we the relatively discuss to said, to we’re and them start end very, the decisions come well endpoints before presented about and of a and of And the as designs all very obviously at along soon, our is which an

to size, alluding atopic safety be able with studies, will atopic said think from file. Having In you case, that, a have leveraged Vitiligo that a will from and Vitiligo different but be that the you're be there terms authorities. but helpful oncology We be for will from still the regulatory I area of expect dermatitis the appreciable in dermatitis the Vitiligo? to to, be would point the be will studies larger what package package very safety the for expect discussion it's require we

Marc Frahm

Okay, out. in that for a commercial with picture you infrastructure bigger whether the great. it's have to mid-stage past, for ultimately dermatology decision make a mentioned Incyte a market space, then about Hervé, in maybe that ultimately build versus whole you'd and them And right to these these partnering projects,

answer that of to indications, two at ready on you data you that? Now Do you kind decision? that an randomized in are have make in house, least have

Hervé Hoppenot

ago, in terms ourselves in two decided cancer that have we Europe commercialization, America, ago, Japan. was obviously, of That driven was commercialize infrastructure by years years you North and years like So, approach ago, we our to know, now. was, and four three built portfolio

for is, that of And of in the of we basis. lot answer to so regions, attractiveness it's milestones see and would or for alone we review, best to There -- the be cancer. the Japan, be is there are a dermatology? could and And a regional it it to each it commercialize either revenue a complicated we Europe, question and looking a to out here and opportunities also the and or it's and terms a And fully terms partner will basically from market to different what doing have sense find apply ourselves are three does standpoint license that of And book risk. certainly on what is completely the financially approach and the size see in for what the of is make opportunities, most each we that the of at reviewing where we frankly, from US. by at book are is, new in and co-commercialization very less royalties. of looking So first different from the this we in investment what Incyte

are So upon, results – beginning phase of at quality anticipated time it's dermatitis from because the have we atopic of in X XXXX.

analysis board. after probably is phase the next we commercialization X months be we makes to the the data. planning another already will the be And we the use And time sense what So an have phase before with six to there by get are of our in will depth year X, starting.

to based are to on analysis. good a we or on financial basically the make be So valuation decision able track

Operator

Thank you.

Michael Guggenheim. next Schmidt Our coming is question from from

Michael Schmidt

line around, cancer and year. in the a had erdafitinib about bladder from the was do was us second this other help recently first data well. pemigatinib, from news be you your How context you think some the and the that to I top in study question couple if specifically us DCL opportunity what in approval bladder of Jakafi, here Genetics, should cancer, here half as year? frame I J&J can help on net opportunity about regarding of think will the gross quarter, X we the of how any there in the regarding understand then And phase updates guess just

Steven Stein

will answer net question. to and Steven Barry It’s your gross

XX,XXX in and a XX,XXX We pathway second although cholangiocarcinoma, up proof this patients prepared positively. is indication the effective, opportunity bladder as always have striving concept important to in translocated very FGFRX remarks, cancer the patient mutated mutation is substantially, we’re approval caught It's in the J&J So, is erdafitinib than us indication this FGFRX view we're with pursuing, range. or large is very is obviously, we hitting it the gives ahead, said the our continuous that the do and I of important -- bigger quantitatively the dosing. my fusion that we

to conjugated in complete dosing well, probably, year Now, us but data that of continuous to and see this likely cancer be is important bladder of quarter filing well. be different drug we in cohort some third from potentially in a Seattle target, expect The exclusive the addition, year, around we'll monoclonal in as should supportive as respects, you’re where that's XXXX data mutually filing. only the next and,

So our well another importantly, affect program, the then in FGFRX like very of accruing And we XX,XXX then be actually the in potential after population have deliver doesn't And driven This expands if MPN glioblastoma, at it which anything all very obviously, XPXX the study ongoing et we populations. all. in program upwards of terms that's cetera. tumor patients, ASH endometrial areas these efficacy agnostic cancer, could substantially update.

We data pipe. as down be important. turn the I’ll of proof your in we'll safety something the it to note the So, us, extremely net pathway. think for shows We that's that's may approval, that very that's well, we what going ultimately our Barry of J&J terms important safety outlined, label, to concept over to program important view you gross see for question. the and

Barry Flannelly

subsequent quarter be to full to that, for XX%. it's gross Michael, estimate estimate the the to as each XX%. imagine, said for higher generally we a bit was first settles to and January at after February year, March. then the and And quarter in down I I net, little so gets before, speaking, full and much in Yeah. better the net gross quarter, we going first

Operator

from coming is question next Abrahams Our from Brian RBC.

Brian Abrahams

Will out we savings provoking from some those the changes, of and guess What's the how for milestones stage the moving the funding? programs, accounting be the that allocating about right cost way about that? bari what’s into once the of you are year net specifically that forward stage for for and new way effect the I projects, new about guys beyond, to right for think this programs to of restructuring? stage, some late pipeline thinking indications late other think early

Christiana Stamoulis

is Christiana. Hi, This Brian.

of the provided guidance of decision sorry terms a in to the that the in all, and like indicated, reduction we to XXXX out baricitinib first XXXX. programs we we to $XX as some earmarked opt other for of implies indicated, we baricitinib $XX development driven the stage the or desire internal to opportunity revised by on That, rux baricitinib, as those reallocation So see out really cream. programs. million opt late accelerate development XX% augment in that had spend XX%, funds to from R&D we programs includes decision to in million Also in the of the and the was partial some that

allocated baricitinib we XXXX, the and the be looking in those that XXXX otherwise to have to reallocate been in rest capital programs. through to XXXX of would would So stage late

Brian Abrahams

separate you've a from endorsement the an about standpoint. derm think rux the atopic scientific of cream in be the clinical And Vitiligo as pathophysiologically, about bar the X AD it. question potential do phase setting we atopic to or one you Got sort of thinking for way the additional and this as should more what's view readthroughs right reported completely beyond between for the dermatitis this for in very as me, already Vitiligo and meaningfulness -- then in potential

Steven Stein

for Steven. question. your Thanks It’s

with concept to assessment index Vitiligo, terms in in what approved achieve clinical In done, scored, study cream to primary there's study XX% ever of clinically to score The a of the treated vehicle actually This called being improvement activity the in this compared or a area the, was facial therapies measures obviously, of biggest there's the in work Vitiligo greater percentage and of is and severity compound. Vitiligo. and of the date. the the dearth endpoint that no ruxolitinib meaningful proof patients is of

Vitiligo, like meeting the major in visible [indiscernible] areas hand face read obviously, that a the primary important And would be said which keeps psychosocial primary agency will be we've patients pursue of disease endpoint this will as and we we've to field in The the will separate we're going and to year. potentially in re-pigmentation the are then me are And need by which for benefit during of total atopic it middle hands like and data separately. over document body degree getting will the we similar study, have program this this they XXX what -- other addition in the to terms X. with reported be is, to In a be don't through signaling vacy, at a we'll telling discuss of clinical Vitiligo. be the [ph], to the just that registration with patients it’s through patient endpoint and AD, stopping us, a it a caveat, as because for as in a vacy pathophysiology, reported burden encouraged face study a mechanism outcomes very and big in appropriate terms terms measuring is the and see we the psoriasis, the patient at are on overlap to in inhibiting large Phase The gamma interferon I respect. some diseases looked what indications they addition we of accept the studies, but outcomes. patient in It's externally. direction face but vacy to years, as There X will it is that towards are dermatitis current you'll and measuring have

Operator

is from question Gould next from coming Carter Our UBS.

Carter Gould

into more the a dig Just in I to little bit co-funding. wanted to, stop guess, the decision

conducted anything I was -- this You the that specifically been sort either assets some in gave front but out. persistent or internal market changed some any guess there get of you effort, maybe for pipeline, know if sort I would in guess I AD of you've you how you were specifically that for and guys you the other shift you multiple your rationale viewing, so keep up kind mentioned what analyses, pretty systemic that, of call would of on

Hervé Hoppenot

start can I Maybe and it. complement Christiana can

number is that based return about the of have baricitinib, way the other I we that lower believe the in decision that the that already on is, on baricitinib, investment previous realize than we future in as a is we ruxolitinib the of fact project important in rate a or is itacitinib, think have that internal it's see there our is we requires so there the opportunity way we investment where return made on that that have royalty always the them investments you is reached make cream. things. the that the return about like investments, we and to accelerate so expand pemigatinib the additional imagine this we a to not calculated One can and we marginal is discussed see us cumulative better give about it's point seen X on

have do we So are a our we that very internal that's of to really be progressing better we conclusion make to to came how promising, in it to came very allocation that been in programs that so it conclusion. investment marginal R&D, that term and that would well

us reallocate R&D basically reviewing where told are we programs. resources over every have it the, allocated sense and time As for regularly you time to we we way know, resources to made these came the quarter, are you reviewing the internal are that's that the

Carter Gould

guys and ask increased cash marketplace of, just there potentially I cash sort for kind M&A of capacity color talk of follow just of guess, based in the up, you on a position that. terms you're Hervé, be how current future an acquirer if I all flows just appreciate terms has and been in viewing could your And the your in around

Hervé Hoppenot

growth strategic looking I two the is we goals at are diversification. mean what really to our and

So obviously into growing diversification growth which the is the revenue, our going is important. translating line bottom way, some P&L but important and in and through is

term The possibility cash to the at of P&L that So have, It's add end think do I get At quarter, gives for ways is our also we that's this top the potential year. is why us time, always clear so our that portfolio to very flow as the at quarter, that progressing some our see business to structure we to and there are very very for strategic will position it’s next internal billion. development that the strong basically us looking ammunition more both and over business the can same of you is objectives. development strong line the cash this well, X.X potential next opportunities. in

Operator

is next Richter Our from question Sachs. coming from Goldman Salveen

Salveen Richter

data set to terms XQ? in targets Vitiligo, expect where X the commercial US all X should For opportunity, in million the in are that the million of patients and we

Steven Stein

Steven It’s Stein.

somewhat it's that potential million seek incidence the that's treatment. smaller, much so The how cumbersome just treatment. X%, actually require X% of you population, best much, for steroids the reasons know and it's have a you who don't So around to terms need that's and That amount feel if treatment that total and for as is there hard they -- could are are to the opportunity. we lack just in just who available compliance estimate therapy, patients patients available multiple and therapies around is XXX also of X%, XXX,XXX currently phototherapy patients are in currently give many seek well to high be terms fact a of can

externally are currently. estimate ones the earlier, that in population of us It's and have are efficacy range to could population implications are have feel hard causing the so. are the will the be hands treatment the disease. concerning, from that in be for face targeted need, areas to benefit will particularly ultimately of that XXX,XXX psychosocial or the plus disfigurement the is areas not treat as Obviously, visual So, will we the that ones I ultimately that like to we that and demonstrate that the said they visible

Salveen Richter

a And Jakafi where Thanks. just quarter. stand, the housekeeping follow up, exiting inventory did levels

Barry Flannelly

Barry. their below is this levels Actually, weeks. So, three are normal

Operator

Cantor Your coming Alethia from is next question from Fitzgerald. Young

Alethia Young

kinase the just Two think on back But, actually. the for PIX I data. program coming with get lot doesn't One, scene, a yours some PIX I me know there including of kinase are love.

a internally you generate have if could like of a there's the capital, you’re kind that a pipeline just with molecule capability. obviously, to from have And and to be my seeing you dermatology? another kind the core just it question guys you maybe long you And wondering may in asking return for It I'm invested question, obviously take you invest talk guys seems in the way, would I your little lot wanted do about differentiated JAK on programs So you a were and the you have, top to how of of it's others. how ongoing second your current then thing.

Steven Stein

question. first your do I'll Steven, it’s So,

this second think registration that studies So, of it'll This the mantle And the part. have and [indiscernible] zone PIX the the quality in reason year. lymphoma of hopefully marginal is Rolodex in inhibitor. this toxicity chemical indications. be of a compounds The is cell data going submission are I enrolling we year were have dialed done generation the to follicular well lymphoma, lymphoma and next we'll to again that seem this directed changes is generation for then complete kinase really and liver the year, most out those

very to to the repeatedly. benefit active to try time, we've see is But from made and compound dosing a safety tolerable and scheduling. initially. term, to as to data colitis, look with degree cell it a shown cleverly, make B you what more highly in incredibly is used concern that conscious that long transaminitis the little the we listed we that know Gilead that doing different year the decision same therapeutic the don't generation of at you active, our But the ways over at it's more of see activity thread get disease, so So for like like PIX-kinase over in concerns inhibition, compounds ago, a is this first

marginal And days dial the XX or do dosing And toxicity point of numbers daily of dose true, And a benefit efficacy it's exciting we've to to weekly term we the want. out to what therapeutic to bar doses. the we that say. place lot those weekly small see weeks a many we’re of for lower the then with high ways looks to it substantial of numbers, up now we because to and able mantle longer executing caveats at front, eight be the milligrams like studies that get colitis, been different So, view. we follicular in pretty patients if early so from a look to a either that's

activity more indications So those have of high those and date indications, not tolerable much as all to remain diseases. the curable profile. And then filing

despite being And very entities. of lot therapies, we’re in So these cell CART why by still encouraged B program. there's that's this a unmet inhibitors, inhibitors, X there need BTK

Hervé Hoppenot

I dermatology. about ROI the in speak

As seat I said, open us. I mean, it's an for

opportunity we meaningful speed of enormous team, looking like show We administration, indications When if the discussed, and at very indications. look based that it that's have what seems we being of to and you not positivity the to derm and we one profile ourselves. at is it's it having fairly a the world, require and same from US commercial side makes we Incyte. size and can do than flow very a At our doing is you for you would diversification line look a growth. the to looking the So we that be on high as can what the important be are a to that is Europe being in And time, way, in rate of believe look products different important. where systemic as number at it the the infrastructure certainly there real coming And a for in at has decisions franchise, get said, potential important. and are of treatment. plan leaning the this diversify big the so book at where at the dermatology I that we patients with be cost for see from to and cash you both and we goals is the have what able very seems making Vitiligo, the most look looks at rest That risk be aligned that benefit which you said, topical direction dermatology effects and dermatology. specialty observe, if in on ROI the that important sense therapeutic with Incyte also criteria and the an very type the both Japan dermatology very the of revenue top It will could

that to that's two at criteria decision. So we the will make looking be

Operator

next from is question coming Chase. from Morgan Kasimov Our Cory JP

Cory Kasimov

clinical ones I have you. just a for stage couple of earlier

types program. X agreement enroll all, an is sort study the tumor of regulators number with you three of of tumor that need first So, to or different minimum in pemigatinib, any agnostic phase for

Steven Stein

Steven. It’s

at both pathway a areas or for two a the checkpoint in opinion written already in other high that study piece MSI that's setting. So Plus, a far in is sort before was inhibition, an recently if the can you one it inhibitors the comes done when this precedent look what you're for this as drug for approved from you you FDA have reasonable indications a companies around, in validated like approach at least have the principle, this doing proof is will, of that of case, and if way.

the see say, regulatory the endometrial activity And particular be like But in fusion, strict time. So of pathway. approvals what In and FGFR each for a have selection we disease, to won't elsewhere setting, the is that's idea in mutation validated robust very you I don't we that's already have said, obtaining durable. precedent of exact and as regulatory you approval already. a And glioblastoma, want a high there's where, it. degree particular something for we or required the numbers have behind the

Cory Kasimov

strategy you those about MCLA the there trials the will phase curious about and Can for how studies enriched talk second be? initial X question, with your clinical then plans overall the And for XXX.

Steven Stein

days. I think say in best it's early here, it's to we’re with Merus working collaboration

been it's toxicity use before prepared in I CDXXX in toxicity precedent of quite very a with and of bispecific paradigm As lot mono transaminitis. a here. and remarks, my liver of There's terms said interesting unfortunately,

Right. via So it the enrichment we'll subvert with direct here and and where to toxicity needed bispecific idea the to area the is and PD-LX see. try it’s a straight that

but data, our The prove we should theoretic potential expect from there we to areas patients have work that's as sort plans preclinical and where to will exists in we'll second these of together, something mechanisms think refractory for checkpoint thing be that, is, you. both

first. particular any dosing enriching for X a to start will of data have we're more to early -- only to to early phase directly, think standard first just man, safety way lot in it's receptor about, talk your a to safe on not biomarkers, I on, principle early get just it’s in because or the question too we’re answer that about a activity time

Operator

is question Instinet. from Christopher Nomura next coming Our Marai from

Christopher Marai

to patient make have the that it updated this may bit opportunity this have Hi, been with label, you. setting? rux good until Eucrisa? in used Would you've wondering using. there a how derm. Thank elaborate remind atopic that I'm formulation to Recall ago, a more questions. pediatric from differ then I wondering, I And previously, you the a the you on then or formulation, for just morning. been you could And looking formulation was respect was perhaps ointment be have rather expanding you for at if And topical the taking the perhaps a for Thank me, formulation problem does secondarily, breezy modified you secondarily, -- to cream clean friendly? little

Steven Stein

Christopher, Steven. it’s

up So it's pediatric of the part to population good bring the here.

the currently atopic regulators studies dermatitis, population. the moderate mild and the of the So, years in above, which we that are to from do in to covers and we’re permission majority doing XX have

in XX at mild vast to the the the down with et covers with the years we’re population who XX, margins, that we XX below patients like are but the and in terms moderate program treating atopic and the regulators will dermatitis. so In is to it’s interested something of still And on years of something above interested moment majority X pipe, things of age, that's safety cetera. be working

of of maybe Vitiligo, it's and allude induces formulation is it as to and to and and changed a we've question, burning, told have very that had burning in from When the things we it we've if no problem But you both be in seen well people with Chris, and no seems used data the the world heard with particular expect data to that and you we've that one greasiness, stinging. it. hundreds patients. used you, be why wide we that don't to it’s in we've stinging, atopic real terms the In have extensively, It's treated cream. no terms we already not given derm It's of been received. been to There's all problem formulation it that as then date, not we our used. at be, of haven't wanted a already agent just

Christopher Marai

severe topical for you. the derm, thank you also course, have formulation the to any to to there, then for there? safety And moderate started perhaps Okay, with explore atopic setting of the perhaps have or plans respect do the efficacy concerns potential given, you better or

Steven Stein

Yes.

more is two baricitinib terms there our to have product very that's as clinical The oral in dramatic a that will important relief maybe is range was what physicians for margin know, within therapies you they how And clinical are are and is achieve that severe, then reserved There of and others something use overlap mild more the not data of which disease on days. dictate saw, occurred very safety there have really severe severe other of moderate to and our and the to was the we terms One moderates. the good different terms patients And they’re expecting to acceptable a is we surprise endpoint we a therapies. population then important of and was patients. a that's in some in itch targeted. for trying the has and degree And So quickly have targets very, of moderate. particularly results. been with program program

the that the again, in part, moderates and think, there's cream. patients, we we to be particular mild of trials, And that so we in our physicians goal for will and with if don't And a only overlap. endpoint. that's we most think important target an But document clinical

Operator

is next from from Our Meacham coming Barclays. question Geoff

Unidentified Analyst

on for This is Geoff. Jason

expectations hit the us gross of in have the mix on up. then and give forward, first real Jakafi, a follow quarter. moving considering if quick could net especially Just you quickly sense I price for volume And of to a your

Barry Flannelly

It’s Barry.

terms And volume, to in this XXXX grow sales, growth, from most you was volume continue XXXX, continuing we net QX in as see of of We can mostly. in QX for see this that quarter, over and future. or fact, our year, the

Unidentified Analyst

expect do term of that and a terms in duration earlier terms you kind well? as moving to of see in more factoring that as line, longer therapy, of in And up is of influence. up Or

Barry Flannelly

in duration talk PD at long benefit therapy, to patients really clinical of of patients least we of MS. three And improve And still trials continue therapy, that's want still they patients we We year as and duration to follow-up as at the from the to XX% at example, stay and tried look always back Jakafi. where trials on go on to true When the both about on years. XX% of we it years. of the response, you therapy five were the for five had at we

healthcare therapy, we always to with professionals. want of on to try duration our the So, improve together work and

we it. So increased as stay benefit to therapy from And, they based they to want as decreased them again, suggest toxicity. those or efficacy continue on on long down

Unidentified Analyst

that and provide you discussions your get to and FDA to we you on the REACHX moving are REACH the can some REACHX through regards we're now of here when and with kind expectations for color then are to what those that extent And can, X, that in with homestretch to how point? – read can

Steven Stein

it's Jason, Steven.

the So you're Barry PDUFA is said, as data, XX. May right,

look where the we're on the don't forward data We’re in a to we date. details FDA. in place data give granular our in to confident But the and back forward confident PDUFA with our are PDUFA still we and discussions look extremely date, and forth we

of by what similarly to read in refractory randomized is And through of we reach be concept this versus population, REACHX which we year to it I confident then the Of similarly study wait REACHX and host steroid disease same best in have positive. expect and course, acute versus available we area. against a in will graft And X, for just because BAT, that both and randomized of data said, the the the of data. host have in terms therapy. graft against It's chronic end strong against disease, REACHX proof

Operator

Piper Jaffray. Instructions] [Operator from coming is question next Our Van Buren Tyler from

Tyler Van Buren

reallocation February a you billion updates also to -- with guys Jakafi guess confidence guys X.X respect by market? Are makes programs, related last X of and the, I can you of when in upon term you're could ton in ongoing think Thanks reiterate funding the for to is program to that that year question the of indication to and the your you in baricitinib that provided of that's billion that, XXXX. long about come and and should ET, my sense. based what development, we how guidance PV GVHD seeing the MF and

Barry Flannelly

on and line, I patent can we wants fully to have almost years to So yes, as in the growth there. the Steven didn't XX and confident X know comment confident give we billion I that and PV can left you ET. contribution top GVHD see on year-over-year it for we've ET, and the MF, we really to we actually indications, before, if the think we're we're fully X.X that make don't billion said includes estimate

Steven Stein

we on to remaining for the hydroxyurea then cell with is thrombocytopenia, enroll. at JAK blood work and to you use that's to there not have know counts the have for be the is the spontaneous patients, study clinicaltrials.gov, of as use the which is, randomized again, The BCR and because initiation of every required there. difficult line expectation Obviously, [indiscernible] to some first and a light. see Dominant very pathophysiology, can we central study therapy the it's that And that’s driven. there inhibition negative able issue high approved white study should

study the negative the entity JAK entire study. before this will one up recruitment. obviously trying a and both It accrue an with that the and and formal to we ways we make end high we're disease examine doing count to may continue inhibition So to for end to to is address important improve continue completing recruitment, publication non a white but that difficult being -- try and randomization to an on up

Operator

Bank Our next Lynch. Merrill is Ying from question coming of Huang America from

Unidentified Analyst

REACH Thanks This the just is taking on on I Ying. questions. for differences for I have guess studies. between Alec various our one the

with do and you Jakafi, Jakafi REACHX was acute comparing some in for at available GVHD and FDA in single actually the the mind? see in the And terms this is respond to based of on do X, alluded this study? steroid since any and be arm to the towered You superiority, where risks patients best the study refractory, REACHX therapy

Steven Stein

Obviously, conduct study, allude may Steven they It’s have can attached XX%, you to REACHX, whenever you XX% a a that, rate, though therapies different there's durable. again. upwards active there's negative best And list you therapies, have to and for fact or be and not risk outcome. tend the in REACHX of as and that a available response

risk can date the activity, seen the in but terms so how always data durability the we we with that upfront in work, outcome And the proof differentiate concept some then be studies studies. obviously, of we've and report the will out. there's in randomized response, our of confident And have of to both on

Operator

Olson Our next Company. coming is Jay from question from and Oppenheimer

Jay Olson

management. if in I fix any extended on to I there about was was Jakafi and formulations potential release lifecycle those combinations. you've curious talked the update past, know

there any will update Thank you. be So, great.

Steven Stein

again. Steven It's Yeah. Hi.

of there Currently, an large go stints lifecycle side, a already bio-available published different to, XX along developing induction. plus on it's be BA, a we've being may have other data we years busy there of compound a life are arena, a of active stint that and and approximate The important terms despite because formulation working safety minus three management. as that. may an profile with it route said, one that anemia left, to in you to play, ruxolitinib, very us alluded forward in team XR, Barry bio-equivalents pillars extremely As to patent with

formulation. on have in active underway terms but those, the speak, you'll So and it's it's we just very to XR as of wait

set theoretic us, and of continuous both evidence. withdrawn well a world it, time dosing. first and The had preclinical at setting plus external this presented second dosing then weekly some some strong in terms experiment in In combinations, we we investigating on evidence this and weekly rux were doing combinations had by of year. combinations long dosing and for as we encouraged beyond from was that withdrawal data multiple are kinase that year delta, line clinical PIX last And symptom are the hadn't went further we’re ASH of and we sometimes with the Novartis the responses that Rux to that than and very been clinic are investigating that the improvement, patients that as rather when saw activity we which there

we strong then and itacitinib. to patients rux So we are of our tolerate combinations do ruxolitinib can't The preclinical doses rux rationale plus perm, it want continuous all plus this in at tolerate very two do year. other in that, JAKX switched inhibitor, it our is and itacitinib to sufficient experiment which a then who or can't

have very an in the so and But third And Novartis speak play and So targets. to safety an this arm arena as of both that are around combination and combinations Dash can it's play. efficacy those ongoing the is that well. then are ongoing. and all a is world important, more is external research

there of of we know know better terms ourselves. wants these targets And area Dash for So have don’t very a add ways in anything well here? drivers and potentially of the tackling further I conditions. an are Obviously, to looking it's important collaboration we extremely if here. internally, then

Dash Dhanak

the of two and number in collaboration academic internationally regard in pillars. biotechs the well terms as we of was in about around both one and Steven after. of aspects institutions discovery really as are than nationally going the first further we underlying a approaches about with absolutely have right. So, a that can what And probing addition internally of, There talking programs fundamental ongoing, won't go inhibition to as number JAK mechanisms, think

Operator

Our next Humphrey. from SunTrust Lawson Peter is Robinson coming question from

Peter Lawson

see the indications? drug PDX, year. readout and oral can at we you What Just next where the on next that would position is

Steven Stein

interested in going in our in last year, patients oral potentially interest really We it's IND of October, we it's being the a the getting December in but well. that with it in compound Steven. of went and It’s into very the year, a to mechanism There's X, filed it's and lot that and of a phase the recommended clinical action receptor, phase X of differentiator, internalization will that translate execution and well, dose, this to going regard. excitement

part clinical at data see year. activity what like lung of this next we this differentiator, and and to show we is efficacy melanoma year, of some better love and to take kind see there you would that'll Looking of the to benchmark -- areas cancer if most

data dosing that oral not we having PD-LX safe of pursuing relevant XXXX. as inhibitor, will combinations in you also a soon schedule, As see be an have are we terms till but will

Operator

question Benjamin Reni next Raymond James. is from coming Our from

Reni Benjamin

drug? thinking refractory and over, the guess just the at naive regarding bit. where How of itacitinib takes at just to indications a the each GVHD itacitinib you off board, quite is you comes will I separate board keep is guys launch be when two look likely a or kind it on rux the laying are GVHD, the Do it about envision steroid kind can coming steroid in you I which commercialization? way label both individual of on and after groundwork rux, quite

Barry Flannelly

have launch, in an Jakafi we to we're because GVHD. we we able will launch to Well, able advantage think ruxolitinib be

right that now. well we're very So market understanding

treaters, the to it we've should profile, understand fact, we've exactly So, gotten when a of approved, better have really drugs in in gets they're at least using. BMT what to But gotten currently cytopenias. know then itacitinib, it does, terms

choice but GVHD. we So and use people itacitinib drug steroid in we the to refractory setting, rux continue of rux or will that really think acute should in that ultimately, could develop be

Operator

Thank you.

management the back have our reached the over floor question-and-answer end of closing I'd We turn for session. like to to comments. any further

Hervé Hoppenot

for your for Okay, thank at you but and thank call we upcoming time for and bye. today. questions. you now, seeing the look you again you all conferences, in medical We participation for investor and today Thank your forward the good to your

Operator

teleconference. today’s conclude does That you. Thank

for time disconnect thank day. wonderful a participation today. We may your and at You have you your line this

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