Incyte (INCY) 30 Jul 192019 Q2 Earnings call transcript

Company Profile

Participants

Mike Booth	Investor Relations
Hervé Hoppenot	Chairman, President, and Chief Executive Officer
Barry Flannelly	Executive Vice President, General Manager, US
Steven Stein	Executive Vice President, Chief Medical Officer
Christiana Stamoulis	Executive Vice President and Chief Financial Officer
Cory Kasimov	JP Morgan
Brian Abrahams	RBC Capital Markets
Carter Gould	UBS
Salveen Richter	Goldman Sachs
Marc Frahm	Cowen and Company
Matthew Harrison	Morgan Stanley
Alethia Young	Cantor Fitzgerald
Tyler Van Buren	Piper Jaffray
Josh Schimmer	Evercore
Stephen Willey	Stifel
Peter Lawson	SunTrust Robinson Humphrey
Evan Seigerman	Credit Suisse
Jay Olson	Oppenheimer
Andrew Berens	Leerink

Call transcript

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Operator

Greetings, and welcome to the Incyte Corporation's Second Quarter 2019 Financial Results Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mike Booth, Head of Investor Relations. sir. you, Thank

begin. You may

Mike Booth

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

you of that if time ask yourself ask I to This and session, question-and-answer the as question limit needed will one During questions allows. enable you followup. one as many to

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

begin now Hervé. call the We'll with

Hervé Hoppenot

everyone. good Thank you, morning, and Mike

same Sales revenues Jakafi royalty products revenue grew XX% by with another XX% when XX%. goals demonstrated XXXX and beginning was of period Jakavi the executed the of clinical increased commercial of compared number set objectives. Olumiant's and by of already total we quarter first Iclusig and in we strong royalties the QX growth those the of out to a XX%, half specific in year. a at on last So have collectively and achieve year to series XXXX and of growth

acute steroid in GVHD. for In announced full approval Jakafi of with granted we patients May, FDA refractory use that the

within portfolio and Our team in immediately. Jakafi skipping ASCO harboring presented the guide NDA this development our continues If would over second were indication in was time. become approved, over and cell sales with by in patients important quarter. could half Novartis cancer data two lung new we for launched this were XX% during global mutations pretty receive alert potential in an in second $XXX exon-XX MET submission to the at indication royalties net updates non-small this There year. additional eligible to XX% and to Novartis of million on Incyte Capmatinib milestones

the has believe of ruxolitinib treatment Phase the the primary trial X in vitiligo. millions World The received ruxolitinib the well with announcement for prior to has of cream and be was we cream was transformative our potential The vitiligo the of at endpoint. of Dermatology. Following data patients Congress of data achieved presented its

clinical strong are second We reporting this to we year expect the months. regulatory look the initiate coming several indication with by of the for begin half important we of milestones Phase preparing X on end and We which therefore development year. momentum to this other forward the and in in

for core Incyte's are to Several efforts now order engine. These we of separate group a this oncology. is strengths fruit. of One potential capitalize of to our years on ago, review in tasked uses bearing outside molecular discovery scientists target our

in and growing portfolio a indication. have portfolio hematology oncology, and inflammation in separate In addition and we clinical to now autoimmunity our

to and as future look two and as ruxolitinib the our of Group currently IAI we concept products know, atopic you are and the several across IAI within cream the been advanced have forward are most in in dermatitis we evaluation indications comparing well concept and proof cream program. vitiligo. The data from to updates date both of indication As trial proof of running ruxolitinib molecules and

and believe potential adding diversify this Incyte sustainable could new revenue established further accelerate that line well of and position oncology our franchise term driver We growth. top on better growth our exciting for long

I update Jakafi. the an Barry on now over for to turn will call

Barry Flannelly

Thank strong. In be by net demand you, Patient Jakafi good morning grew demand everyone. continues grew year-over-year and by for Hervé sales quarter the to XX%. second XX% while

these As guidance. a we result lower data and from early increased of of in encouraging given results launch our the have GVHD, the the end

$X.XX XXXX to full-year sales for now Our Jakafi is billion. billion net of guidance $X.XX

from GVHD. excitement transplant the steroid-refractory learn are We they across by of centers been supporting morrow nation patients received. also approval the the interest Jakafi the treatment bone on GVHD fully very about BMT we launch initial and in performance, but approval as of Jakafi. The new an encouraged the healthcare Jakafi data at for good with patients and professionals impact are from the quantify well indicators seeing overall to has It GVHD centers early of are increase is and

Insurance been at exists Jakafi of to of centers For small encouraging And indicate top-tier outlined U.S. in the coming this look we you date. have FDA number our constrained we updated are also these denials since approval. coverage documented centers example, to forward marrow on transplant have a over we over and initial quarters. has progress aware and our of purchased nature keeping not data which bone that previously the of relatively opportunity XX% the

clinical Steven I'll now over turn the for update. call to the

Steven Stein

and Thanks, is States, years. potential these patients of company Ultimately, six the into transform Incyte to the several numerous a across good morning Japan Incyte treat significant projects. to late-stage running key number projects products over the aim approved currently development indications. with Barry multiple have everyone. next United a Europe and These in

we out. the on made have the milestones few remain we laid to over achieve clinical previously and good that progress months last track have We

quarter. patients like to in the data Dermatology during cream presented June, now vitiligo made I'd were presentations data on two at World of touch Congress Phase the ruxolitinib X in key with the In Milan. of second

VASIXX facial endpoint As versus a trial achieved vehicle week the of at previously announced XX. primary its

the the scores VASIXX highest facial course using Here were over improvements The X.X% trial. can twice daily. achieved and cream see daily you by ruxolitinib of the dose

site Importantly, ruxolitinib associated adverse cream or was significant treatment was clinically reactions application serious any and related well tolerated not events. with

As most will you a twice why and vitiligo chosen in X represents see used have data clear dose in Phase in clinical the Phase as plan. with patients of this is slide lesions. primary response day our vitiligo response this the These global facial the data ruxolitinib was On we from VASIXX X endpoint our dose X.X% treating development study. VASIXX show know, more cream and a a the effective facial per at this you complete

expect and before the development Phase of of to we plans pivotal X this Our the for initiation moving development are year. end calendar forward continue

dosing dose We X.X% a weeks intend and XXX of ruxolitinib twice of that at this vehicle facial each. The X at plan achieved day versus in patients Phase to whereas XX% with cream trials VASIXX a studies. both score two treated initiate primary Phase a those VASIXX. to XX as a Note X evaluate patients trial treated none endpoint at is patients use VASIXX vehicle with a schedule of ruxolitinib the achieved will with cream our trials facial facial of in

efforts. FDA will Incyte. Ruxolitinib be and important by mechanism their a with modifying our clear The ruxolitinib in the first-in-class could large data first is agent We approved vitiligo disease. disease are vitiligo potentially cream vitiligo cream a transformative effect a need. unmet has a development have meaningful the with that action The hopeful cream of in to franchise greater treatment the and patients indication therefore placed provide IAI behind a in even of that improvement of with these are ruxolitinib it may therapy very momentum

overall to These rate by non-small-cell MET capmatinib, all experienced been when reduction the and treated skipping Let's presented. lung data RECIST in data cancer and showed in harboring third line in with of which exon-XX on first and of that mutations move Novartis. patients out-licensed almost patients. these from showed with in our ASCO one volume in trail molecules, At developed second patients tumor XX% data patients updated GEOMETRY line June, were has XX% response by capmatinib

manageable a profile. safety also data The showed

Therapy was to an year. then reminder, calendar granted Novartis and a capmatinib by NDA designation of As this Breakthrough the end file expect

flow about XXXX. update news I'll end during my key expected by the reminding you events

expect in second this of line year. to pemigatinib submit cholangiocarcinoma end the of NDA continue before We the to

of We the planning data this presentation submission NDA the FIGHT-XXX for for basis the are the on later updated form trial also which year. will

collaboration evaluating have being studying ruxolitinib running patients disease. end of ruxolitinib to with steroid-refractory multiple by is X expected patients in across these calendar REACHX with disease disease are in We trials Phase various steroid-refractory of conduction and and Both chronic graft-versus-host with results trials graft-versus-host types is acute deliver Novartis. REACHX in of year. this line graft-versus-host the top

seek has data. naïve treatment is you our acute we on States, United If versus itacitinib, year far approval to look in Europe positive, XXXX JAKXselective forward our of research wholly-owned keeping been we thus expect these and evaluating would development the Japan progress. patients and execution updated is in for host inhibitor an are and who based on to itacitinib disease. GRAVITAS-XXX graft GRAVITAS-XXX excellent

the over Christiana to financial With that, call I'd like to a update. turn for

Christiana Stamoulis

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

refer issued a non-GAAP, and section half to to this GAAP back and press release Slide the full morning. please in of of we to the reconciliation the XX deck For XX

representing in product of Iclusig in $XX from products million strong XX, of million revenues, increase XXXX. of $XX Jakafi an from This Lilly. now results Olumiant total XX% the reflect quarter Novartis $XX Slide million and net Turning million continued to and in Jakafi is revenue royalties second our royalties product all quarter $XXX $XXX royalty in million and second comprised performance of across over with

agreement revenues for We the contract revenues also of under in in quarter $XX $XXX million Innovent with million. total collaboration resulting our recognized

$XXX expenses This stop quarter costs year a for of offset development prior advance of decrease and the decreased Ongoing the internal costs the from impact related a period. X% million partially to co-funding program costs prior epacadostat of basis quarter. decrease decision $XXX the a our reflects total on development on quarter from baricitinib lower to Our other by the million to and the non-GAAP programs. was our representing X% R&D year non-GAAP for basis expense

expense place second the are activities the This basis decrease which on SG&A this commercial take timing a certain year quarter decreased million of for half. non-GAAP of reflects to from $XX year the in expected prior the X% quarter.

are the our to for year. of billion the low first based guidance on revenue XXXX, our end results we half our $X.XX Moving Jakafi $X.XX billion increasing guidance to from of the in

development expense in We guidance SG&A clinical both continue and are invest to reiterating commercial our efforts portfolio. as our R&D in and we both

turn now will the call to I back Hervé.

Hervé Hoppenot

Christiana. you, Thank

toward steps remaining news including latest from well XXXX strategic expect next our of progress in the key we and our during With are sustainable taking news program outlines flow important literally organization revenue as our as driving date to partners. So growth. our exciting our XXXX events we this goals diversifying further slide

That to concludes our please prepared open happy questions. Q&A. call the remarks your take and your now for instructions are we and give Operator,

Operator

question comes with [Operator Instructions] JP from the Our your Cory line proceed first question. Please Kasimov of Morgan. with

Cory Kasimov

scripted thanks efficient questions appreciate Hey, great. and also taking comments. and such Good I for always morning my for it.

GVHD. near-term with setting Jakafi's launch better first have question as my help that then company growth So be of the as this and items the to we for place gating levers a followup. in regarding in one Can for understand driver And the this us should you about I we key and itacitinib? need looking just more at a is setter think

Barry Flannelly

the go, and levers of Sure had is as gating this at any as Barry. Cory, with all. you access know haven’t important problem access one is Well we most far things

they've even up it's both think have and quantitative qualitative been might launch have the know, before been it using using -- we for we that is fourth measures. well, that it very centers line and even GVHD to now line. later, we Qualitatively know third some second or really early, You or they have but Jakafi going moved

orders use Quantitatively, specialty from or this those it always orders but opposed of that and up [ph] sales that that XXX or GVHD, are specialty new as most for We that that as actually marrow increased. ordering use GVHD think know whether MSPD I've those the assume centers substantially. know said specialty distributor we is pretty so know We spontaneous distributors will top know think generally are pharmacy, shipped account and net We for really can of I about we transplant GVHD. hospitals line orders all well for to the have are to we don’t it, and this $XX up year with before, once our that's million the exactly approval. and have we bone they are as why are

Is it a growth growth driver? Pretty sure, driver. it's a

chronic approval data in itacitinib as Jakafi, gain both As also in first-line we new for for ultimately acute we and and get more the indications setting but GVHD.

Cory Kasimov

interesting very for D, enacted your potential broader Okay, Thanks. to that's the getting Barry. all reform something and can of and helpful And but there? my there, that's noise probably followup just remind be that's Hervé, us on in I'd exposure you and the there's that then healthcare thoughts incorporates your Part extent out

Hervé Hoppenot

the question, of mind for situation for for it's many it's people, sales thanks No, top the and Medicare Jakafi usually in U.S. a

think said for in XX% are I Jakafi business around we U.S. today. our total of the

Jakafi in because an we the we exposure. to co-pays know on there that Medicare our U.S. of look are of idea the today. a of have So is, contribute that the first The size who that gives it they of way Medicare number are taking patients you not at

any So be it's the us, is good are of us of U.S. the the of co-pays of is current because I because reduce first of people today. afford it for but defined will effects for the humanitarian cannot to think it that number system way there one reform co-pay of kind the who is goal in reason also the

treated thing to So the would document on who what Jakafi. difficult like have in patients. of kind one of us the of we a reduction number patients it afford draft for Senate the very what now effect product significant for the a is It in the seen good of quantify to co-pay could be of with have is

wish to Jakafi, for is just two of touching be we and counterpart we net-net general a is really the further it would as be that patients contribution reduced. of huge frankly and it the difficult positive the cancer it's not for the And all would to catastrophic the mean, us will be mean I in I treatment these the reduced. And it's think quantify. coverage co-pay frankly

next the as next What you we move us we think, over the company products XX for to know, what I for forward coming think personally like is a innovative that with market years, in XX this good more a patients is fundamentally years, treatment give thing part to because it people the the fact excess the that for very is U.S. will payments reduced innovative of

Cory Kasimov

Thank you perfect. much. right, All very

Operator

next from of you. Capital The Please Abrahams Markets. Brian line your with Thank question is RBC the with question. proceed

Brian Abrahams

feedback patients, drill design. taking F-VASIXX, for Phase my what or X enrollment bit And thinking for other maximizing questions. of little regulatory little much down X, more whether those more driven your about wanted could Phase should so the goal a thanks endpoints I potential to and we for from to the you shape talk your a there, versus was what the if that Hi would trial there? Chris, Thanks. differentiation timelines on be choice more about how by potentially timelines this vitiligo there studies? be meaningfulness topicals then about for

Steven Stein

Brain, your it's hi Thanks Steven. questions. for

or taking both lower. bar as or But driven it it you patient to it's VASI regards endpoint the meaningfulness you to you gained see, percent as that it are somewhat set you So regard. something you've regulatory with the once is both as and regulators re higher well endpoint obviously the to achieving or whether scores, So meaningful is design is as XX% patient so as and regard the into driven XX% can the that get right? discussions it in up primary is is regulators proving obviously X XX%, patients, achieved whether re-pigmentation by and and relative Phase XX% efficacy in both, input

the how what behaves from it we response the up. weeks. and actually expect is time at – go we XX time numbers these and vehicle the zero is that cream over see What know You'll rate at

study on actually remember for two So of this a goes total years.

beyond. the We and weeks eventually will beyond the there and disease XX given those will way data natural have is and in of at course it XX-week over increase that data this time every works expectation that numbers

is it endpoint. a it future in studies terms of for So achieving will bit both a and set that standard of

require of deal studies is there vehicle response great patients zero patients given regulations, these but timelines, response we require to rate the repetitive, studies. very the low a We don’t XXX to each as zero, terms of the I'll are so per rate. be In again two just only vehicle conduct

we're I give XXX can't juncture. So just it We looking quickly. you enroll patients. timelines enroll expect to at this will exact

Differentiation wise, In there well-tolerated. cream is we program know numbers There application. extensive and exposure that of– of data dermatitis in atopic now is or resolution is from that, XX the atopic no the the that dermatitis hour itch less. has burning in extremely on the patient

as we we program of our know we as have from the profile Thanks. expect So, fully have point we X long a a from achieve differentiated Phase you view. – efficacy tolerability

Brian Abrahams

really helpful. That's Thanks.

Operator

Thank you.

question Carter next your UBS. Please Our Gould question. with proceed with of line from is the

Carter Gould

Maybe morning. on non-relapse in Congrats Thanks kind the just showing taking on target assumption separation for kind Great, readout? of digging you. Phase think we good bit to mortality that one just of Thank wondering and quarter. about question. GRAVITAS-XXX, the profile you the around think when a of Steven, sort as the little more your on of importance for X a about and product

Steven Stein

thanks for question. Carter, hi, Steven, your

is and the endpoints; graft-versus-host as well has else overall very response So mortality. naive It two GRAVITAS-XXX rate for steroid non-relapse as important disease. acute everybody itacitinib

anything graft versus other relapse, progression So host than either infections or that's - to disease. that's due disease so of

and available. a primary response greater the response show rate XX% In public is terms increase rate, and of in study the that we've that's or overall overall endpoint powered to made

to data work study across achieve to endpoints. non-relapse non-relapse XX% a need submission fully reduction six of enabling both line in finish we achieve get and towards both. that and relative for the a In both from mortality, to expect it's mortality concept We months, the terms at proof of our those

aim endpoints are the proof of data for, move. easily we the concept room those, so exceeded we have So those to

Carter Gould

Thanks.

Operator

is The question. Salveen proceed you. Thank your question Richter Please next Sachs. Goldman with from with

Salveen Richter

for my question. Good thanks taking morning,

when regard you dermatitis to market a just study help the pediatric targeted given your study year, in that's with Phase ongoing studying Can your and the us with limits. you. X by this then surface Thank So adults the the in look is you population patients you X plans ruxolitinib versus topical have ongoing? study atopic for Phase adult population to out reading trial pediatric next at understand area and

Steven Stein

thanks for Hi, . Salveen Yes. question. your

So you're mild-to-moderate the and at and atopic covers covers from of years patients it patients correct, the vast dermatitis suffering program that current XX above that and looks the condition. majority

We do safety patients achieve need data the population. But of said, there majority in enable terms represent work doesn't to is patients, the safety but want adequate I to eventually, that once first we we prove in study as no issue the to there. it that of younger

you The are practical are is way body it limits in applying the can't the just surface comfortable the with with are of up. dermatitis we just atopic set Remember nature. cream but apply Thanks. a that again this encompasses we majority program to and entire patients body, and somewhat a

Salveen Richter

Thanks.

Operator

you. Thank

and from Cowen question Please Frahm proceed is next Marc Company. Our question. with with your

Marc Frahm

update Hi, you or been on do maybe you of the than maybe on the like and off that Jakafi? essential the fact yes. expected, it's going the that kind then, but long-term Thanks. update long-term get enrollment guidance publication have inclusion? need or - touched out guidance, thrombocythemia cut to touch support And those slower could regulatory kind recent the of were a given could guideline for R&D One part that in that wasn't thing trying trial to of in update, something

Steven Stein

the -- and Hi, the Barry I'll Marc, part guidance. I'll do hi, contribution ask to address first then to Steven. it's

it's required expected. study this study said said, are randomized get be longer further to cell easy to all or than the you given white taken and eligibility a that we that at criteria post have onto calls hydroxyurea to we and to ruxolitinib the it anagrelide, So, then be either you high been hasn't and in have on enroll numerous patients count know correct and an

more changed as this So said, should a much be very are publication we into considering strategy. whether you

on tell terms currently help if working another It's anagrelide that that. we'll are amendment We and early to enrollment and enrollment allow too that's authorities in may of help the with regulatory will or prior that see not.

the Phase was the weren't Remember, are always that space. be know and well really last that we indication it why from others, patients efficacy more X strategy. and essential [ph] the vast spontaneous reports neoplasm so thrombocythemia anecdotal of have for. into the there but myeloproliferative use, has a who top for that's with drug hydroxyurea, We Elistin it controlled don't in we [indiscernible] majority patients the an publication with turned program, conducted that It's could

your I'll next answer ask to question. Barry

Barry Flannelly

Hi, Marc.

we have in So our billion. $X.X but with to guidance do ET. even long-term Jakafi for spontaneous use $X we're of Steven patients billion without - confident of very some ET, We as said,

I in vast sales and GVHD. think of will continue, but really come PV MF, growth from the that majority continued

Marc Frahm

Thank you.

Operator

Thank question. you. Please of your line The with next question Michael is proceed from Securities. Guggenheim with Schmidt the

Unidentified Analyst

Hi our guys, Thanks this for questions. [ph] Michael. is Kelcy for on taking

maybe bar on that to FGFR with you patients for how tumor this potential heard agnostic we've I warrant so months in affect physicians patient guess, just And coming agnostic little in kind so the if from data duration? pretty label? much. fedratinib approval Jakafi a hoping time. us the provide then an were that what program, needs remind more a long Thanks the of just potentially stay be on cleared of we context, secondly, could maybe First, could color set to Jakafi

Barry Flannelly

question. Kelcy, over and take part of the thanks, of for to question is the So Steven it second Barry. the I'll the this first hand part

which Jakafi we time. So long and of both potential long launch a continue fedratinib, PV as they for therapy on quite benefit that as believe MF patients in is to the will from stay

that's thing of something most benefit else. Jakafi move that on before to So the is out I most the think get they important patients

very Jakafi the to else. Jakafi on that start As safety of Jakafi fedratinib before we're confident best-in-class as they patients that on efficacy move and including other the something far and compared should as to drug is inhibitors JAK

it's to think affect all. we much really at don't Steven? as So going

Steven Stein

the for question. Thanks Barry. Thanks,

a So this is important of program. part the very pemigatinib

complete. So remember the study cholangiocarcinoma is

the expect the this and work of tumor then is We second agnostic third of year this file pillar second also ongoing bladder half to a submission complete would year. next cancer and be the should half program. enrollment is of in hopefully And year. part here The

an also of specific very a in effort driven of neoplasm some translocation. is, me -- program, a in right chromosome But give terms just you be tumors. the agnostic ongoing FGFR rare myeloproliferative have We of X of that's you the tumor terms sense can't in by you're the XpXX there a bar, but let

about endometrial X%, patients cell those about non-small If two squamous look and XX% squamous also about X%, mutations FGFR at is Glioblastoma mutations that you or carcinoma, cancer of head is neck about cell about fusions lung X, for XX% or X%. cell have FGFR FGFR and rectal cancer also fusions.

indication, are to at the already that recent got an hopefully probably come with you has All work have then has checkpoint MSI-high date hits is indication. on have an to as and tumors been, that well, in precedent juncture oncogene with an of most drug The -- you those ones blockade have allowed they the if been established obviously guidance cholangiocarcinoma regulators there cancer checkpoint and program. blockade already shown bladder will an to from

obviously given is where NRTK histology novo de of there is indications across board the now that the are agnostic. terms inhibitors In

durable. are So to rates response you need reasonable that see

example, of tumors a higher lot glioblastoma is would there I you need. unmet where number mentioned, require a than those of Some for

a would be bit case-by-case it little on basis. So

mutation data genetic view, tumor agnostic rate long the driver those As bigger a from point possibly all drug causes all than if that's for and there. add other mutation get with tumor indication of up, driver, hits types. set to opportunity the a as is whole actually patient that The expect response durable, you a the the a we cumulative the becomes

a important very to us. program it's So very,

Unidentified Analyst

so sounds great, helpful. really Okay, Thank much. you

Operator

you. Thank

is Matthew proceed Harrison with question. Morgan question from your Stanley. next Please with Our

Matthew Harrison

differential on but could about talk, two Great, ask GRAVITAS-XXXas a question. guess, comment syndication? of think need there do about, force Thanks. sales then little the bunch think just to able you expansion, more taking available, good what to morning, you you cheap And I to a for briefly on what need well, here, the uptake? sort there side, solid and the premium given have parts wanted achieve you commercial to of I I thanks to to generics could efficacy are pricing you just sort that bit you have guess of maximize talk be

Hervé Hoppenot

I'll let off with the pick start up and on for Steven and beginning, I'll potential then force the drug. the sales

Steven Stein

So, go briefly We spoke question back GRAVITAS-XXX. your endpoints around important in just Matthew, let them me to earlier. about

versus are There overall there there graft remember, is So mortality steroid two this host disease. non-relapse and endpoints. then at naive important day-XX is acute and is the response a rate obviously

studies conducted an powered a and that's exactly itacitinib So the cheap and alone it's a steroids being to show in combination of and steroids steroids why both. appreciable versus and you difference to alluded generic,

be let then see overall So absolute to the and or in justify better months just a address rate to the it XX% in your six use improvement we in to response you response with coupled addition inhibitor on remind relatively that that to rate, both me need Barry get better and mortality steroids was of JAK a question. population. or non-relapse ask to commercial has XX% to speaking I'll

Barry Flannelly

and problem be endpoints endpoint to drug. laid steroids, I think you're don't think Steven of we'll there premium a Non-relapse like if what again will getting an to be have mortality out, pricing price is So this the a implying. able least that's for at significant adequate with much generics I that compared

that mostly a covered we'll to far have itacitinib to be little force and about increases have United drugs in think but As States honest. need bit, certain as the sales in for Japan, expansions and have to Europe other will we force the amount. in it we that We in the coming, that including then goes, might pemigatinib a are sales

Hervé Hoppenot

doing just Europe, is word did, have that targeting in there the in and very force same we transplant. calculation marrow are fact a on recently much bone we sales Iclusig that Yes, that today we fact did the centers

be So side. would increase, marginal the but regarding would be European it some there relatively

in need have of the we the to really because hematology, sales love it a product GVHD that oncology. hematology. of small as And in Japanese be our people that again force force for And compared is to that would feasible something would relatively sales with traditional of in in overall to centers is itacitinib commercial limited compared to would number first you the Japan, launch reps, need number be for

Europe, are So almost we there.

marginal a is there increase. So reasonable. Japan And be very it would

indication line be an would growth, driver of bottom the but good us a would to the for very contributor be that line. it's also So top

Mike Booth

get can the question please? We next

Operator

you. Thank

next question with Fitzgerald. line proceed is from of with Please question. your Cantor Our Alethia the Young

Alethia Young

question. just guys, some Hey to to have the thanks next I data you year Congrats there taking go PIX-kinase to emerge again. is for obviously know and my coming the wanted starting I progress. PIX-kinase. as on they're

what XXXX? thoughts So wanted reasonable data get to on of drug the the updated I Thank your you're profile just kind about how you. in thinking thoughts some of into be and your this heading for could

Steven Stein

Alethia Thanks hi, for your Steven. question.

question But in XXXX enrolling approaches. of will by against we've PIX-kinase delta which follicular own well. this of really think have submitted complete program and the zone their are be mantle lymphomas, durable. the third against lymphomas, and in that the They alluded combo will as response are three as And on way, In RUX is cell in activity the data, then there ongoing also well, we lymphoma. high terms I'll get in neoplasms We'll of directed your lymphoma, we based are as of the expect, one is of indications. year. to particularly myeloproliferative meat MF. the I other They to remind the One terms in registration seen you half enrollments second each against potential all rates date marginal you

is There lump to potential lower grade a lymphomas. together

to crowded need standalone. So in inhibitors, BTK marginal have cell lately is approve need BCLX of All are seen zone of you attached and is mechanism alluded additional a areas all example. there of cetera, terms together those remain unmet could more as Mantle do willing inhibitors, but incurable. follicular regulators et and in space for agents. CAR-T to therapies, unmet There you action, even we've conditions probably

So far. we the confident thus in remain approach,

And conditional there approval, the be more will camp. accelerated probably in approval

studies likely data datasets should will those in the of program. confirmatory more up being justify the see entirety set work, Thanks. the but XXXX. All that's likely studies you them the combination on So

Hervé Hoppenot

on And just, just that. followup a sorry, quick

As far that think of do as safety with Thanks. going goes, help kind you of what those mean I kind you differentiate, to what doing mean there I been with as really have that's and well? is

Steven Stein

some highly the think with work inhibition, very I because but took colitis. right. knew a in hit with active, did of PIX-Kinase away long-term because you're scheduling We tumors even Alethia we careful particularly toxicity drug We that. the is literally dosing delta timeline and Yes, B-cell melt

weekly, So we in switching at and weeks that then induction dosing milligrams and weeks done eight of regard. for to for lot then and work to looked we at dose for XX daily, looked switching daily lower and dosing induction a daily eight daily we've

changes dose quite and schedule those of both substantially. like ameliorate safety looks the It profile

this see dataset. at we colitis to to We this the complete have at for juncture. example, still For little wait no date,

dose this and juncture to, daily alluded the likely lower you'll should us response, then because desire to we milligram and XX induction switch this critical. that that maximum get to it's likely you at see, like to X.X of I daily, therapeutic be will and it eight maximum the for daily effect, ratio dosing think get week

You'll profile. have hit and efficacy Thanks. bar then to have safety that tolerable

Alethia Young

Thank you.

Operator

you. Thank

Please your Piper from of next line Van with with proceed Jaffray. question. question Tyler Our is the Buren

Tyler Van Buren

to speak parameters it your mortality, Good you where therapy like rate response on GVHD we what about comfort spoke see powering and had you what course best for you by chronic could and the GRAVITAS-XXX over that for would the did much year, all of I we'll with the progress see question the about achieve to you to REACHXin the overall the non-relapse see REACHX and end guys. or expect will thanks respect of for a Great, in the quarter. to what success you available need assumptions with show?

Steven Stein

Sure. Thank Steven. you. It's

each and REACHX wide It's listing given but the not can for we that's trials to your we trial Remember on question. There for are have list powering carve meat assumptions of is the for best against So, REACHX and [ph]. available randomized GRAVITAS-XXX, both a analysis REACHX open. haven't REACHX out statistical therapies. plan I specific the like talk available clinical

methotrexate, inhibitors. few include photopheresis, BTK available in chronic a like dose MX extracorporeal therapies best therapy and For including inhibitors REACHX mycophenolate, low others

what's not response yet. haven't that rates. study correct. I XX% rate the data So concept therapies XX% date the the ruxolitinib approved while in we'll mean get done X I our for you are been assumptions we those our the available to Phase therapies. have with had and with powering published response higher proof response We the the again to shared totality, mentioned studies that's has Thanks. beat to we available therapies. best best those to beat setting in know - have But publicly but of durability response, shown All and from

Tyler Van Buren

thanks. Okay,

to I So guess study is incremental Jakafi kind data that most a uptake of do REACHX, is what setting? in as on continue just you in any there important followup think that of, to facilitate

Steven Stein

I Barry don’t want talk a arm different afterwards. study. from REACHXwas REACHX. -- perspective. a know clinical anything again it's add from I'll if to The single will

You've seen full a data approval the said the set. I've and already FDA that we got on from data as

from view nothing required in a the point REACHX. it's U.S. So for of regulatory more actually

dataset therapy. available that obviously, be this best But an is randomized will important against

refractory therapy. from expect the different in available setting and from need We be will that steroid point want rate globally what it the of if But a sense response REACHX I to file and of get to for or we'll They'll From don't sense you response terms actually we seen data of see we've get that a versus safety a of Novartis. with that don't Barry, in is using randomized add best in of a a response view. anything? set durability regulatory acute

Barry Flannelly

professionals introducing fact just Yes. it set this them have like give Jakafi treatment hesitation, to a an data devastating said that might in so those about more Steven used hesitation people be will No. some of for important still have drug might another BMT, this that that drug disease. what Obviously healthcare is the in some it's solid confidence that

Tyler Van Buren

much. very thanks Great,

Operator

Thank you.

with from your Our proceed question. next Evercore. with question Josh comes Please Schimmer

Josh Schimmer

whether you band might Jakafi first, net? more topical of dermatitis came be less drugs kind quick common? taking Hey, can versus be common from the you of would GVHD And indication premium then for vitiligo a which for in quarter-over-quarter topical to thanks that versus and are growth franchise lot that atopic can MF versus much account asked two how priced, quantify that a gross get thinking if I on PV questions, both Thanks. so, is for indication price what improvement

Steven Stein

Sure.

So, question. Josh. Thanks the for

in for XX,XXX quarter, MF others for So about and quarter patients, given quarter. the patients X,XXX for about continues any to MF is patients so about PV accounts given is there be, XXXX in any patients, if about X,XXX accounts

so for GVHD. for grew grew can't net PV So, the accounted grew for X% quarter-over-quarter, always out for we quarter-over-quarter in growth, MF that gross break was much quarter-over-quarter. new How in quarter-over-quarter, patients other patients total and was to for

better then the you in as know gross to quarter. and net the the impact gets has So, the it quarter second biggest first in

price, has I'll some if turn it comments. As Hervé far see as and over to premium he

Hervé Hoppenot

have placebo. a a ongoing that dermatitis the being X we to two is concentration atopic So, two X following, ongoing, Phase different compared in with situation Phase the is

vehicle initiating XXXX next different study. X year somewhere in the we Phase are and versus two vitiligo read that So concentrations, so would

where really So fair first-in-class the between disease of a is vitiligo we your pricing, pricing a there competition. two amount one comment and identical dermatitis is -- effect, for indications is where another of modifying atopic them your question have about the is

very I remember treatments indications. of are important the think two it's very, between the to that duration different

dermatitis XX-week show that the duration aspect, of fact the you cases has should go treatment You period. treatment weeks. over the just Steven where look at per the XX published many year in the is in If we'll in a been it XX from that atopic data the that heard one vitiligo is weeks beyond XX few if a but trend continues, weeks weeks,

-- different see pricing probably during data be the between the when point that So to to yet. the resolved concentrations, frankly, be two data able be will something is to and question right need decision we this in make dermatitis. it the indications We will entire not done atopic and more the have

is, a price at excellent the frankly formulation, the what the could than can that is we from treatments with made value we have topical the that topical an accumulating case is level alternative because made a see so is to that be fairly there Vitiligo on a around what a Can see of frankly premium fact in that formulation case I economic value indication. it can efficacy is have, there the data data about ruxolitinib there be we believe is are looking this expensive, that better giving we is vitiligo question. of

Josh Schimmer

you. thank Great,

Operator

Thank you.

your coming from Stephen with Our next line question of Willey with Please is the Stifel. proceed question.

Stephen Willey

question. morning, good for Yes, taking thanks the

of new a think growth Jakafi I on looks X% for Steven. high-end less quick question Just than guidance range like the one implies, going sequential then the forward. and It

a from Just there discounting in want implied headwind there that is sure to nothing make or perspective?

Barry Flannelly

This is Stephen. Barry. Thanks,

low is sales. think guidance confident in growth XX% the year-over-year will upper the end So, the come discounting. guidance. at that our of is by growth that the our no, XX% lower The guidance We're net high-end of We end of in there year-over-year. lowering is guidance no end

Stephen Willey

of then Got acquired Steven, it maybe are is just including it. quickly expectation of that And to for mechanisms the have pemigatinib inhibitors FGFR resistance? landscape your going competitive shared

Steven Stein

And just We a they have whether erdafitinib and out in terms Yes, obviously more slightly question. all first are the promiscuous cholangiocarcinoma, in there. good They other now profiles the of specificity it's is there cancer. There other should bladder in for different emerge be each but receptors. that to approved sequencing inhibitors have patients of profile the of not early I easy to because we that is too may and may highly the for be of of mean, ultimately resistant biopsy that it are collection do. them. just It's different that progression encouraged know.

with diseases, like the witness mean, there TXXXI I myeloid historically works. of a chronic which other you entity Right? ponatinib leukemia got of you which for tyrosine new inhibitors if take the mutations disease forming is introduction a kinase drug And

profile mutation drug the I resistant at different don't give agents We the will will like because the at upfront, may you just the for of look moment. more receptors suspect know what slight what slightly others. versus see differences moment there be So, the it's you our each develops. can't

Stephen Willey

Thanks.

Operator

Thank you.

Peter SunTrust is with Lawson Robinson Humphrey. Please from question proceed question. Our with next your

Peter Lawson

Thanks the taking for questions.

Just the durability the to it should think individual just about about as can we we durability? case-by-cases of think see tumor about would pan think need you on or should how pemigatinib, setting, a as collective kind of we in kind that

Hervé Hoppenot

Sorry, Steven. we have we just, yes,

Steven Stein

a second. Sorry microphone issue Peter, got we've for a

cholangiocarcinoma second few then rate with and line a care to pan-tumor in I'll a is the XX% So, just thing. XX% first response months. short progression-free very of survival standard chemotherapy it's study. The of talk currently about Remember

Thanks. if would in have to setting, the look then entities, beat as endometrial carcinoma, that data. the and we versus I So It's have survival glioblastoma, the to and said, that response you to different to rate at Pan-tumor progression-free wise progression-free need different hard to get one point each to see made. going comment just case-by-case you're that you now. a durability will you survival the be

Peter Lawson

a uptake and followup follicular just MZL? potential marketplace hinders the that in And what a think of could the on intermittent crowded the changes scheduling, do you be in kind PIXK, and dose

Hervé Hoppenot

a it's question. think I good

and You and dosing, looking which back we'll be data like or with a be the just future, purely daily driven may dosing will that have did compliance will issue. weekly to data But dose. toy this scientific with a it turns with in up not it's still it know, had may it we have as different out,

will X it induction lower followed So by daily XX milligram be for weeks, a a dose.

be will So hinder there issue uptake. that scheduling going not is a I to think

in doing to just the - most first responses nine weeks. because we're higher take the what thing eight think the dose I is all right with place the about induction

and the then and you tumor response don't manage maximize hold see scale issue with tolerability. I you your still but to check uptake an the So back that.

Peter Lawson

you thank much. Great, so

Operator

Seigerman question. the is question Please Suisse. Credit with with proceed of you. Thank from next Evan line The your

Evan Seigerman

more and you mentioned you had some you on in Christiana, BD Hi, cholangiocarcinoma? you. against for of potentially compete one the the One congrats all, cancer how opportunity? you you Thank of opportunity that and remind progress. the fit this broadly, can into then do so thank strategic potentially how can your [ph], remind us and the you have taking Incyte? And And us pemigatinib, estimated do of J&J question priorities some potential for bladder capacity could the ability just on to

Steven Stein

it's Steven. Yes, go thanks I'll first. Evan,

if XX% look of about So cholangiocarcinoma, at you opportunity XX% have patients FGFRX translocations. to intrahepatic the cholangiocarcinoma

major So and markets intrahepatic be patients we estimate that in about there. XXXX addressable particular cholangiocarcinoma mutation with to globally X,XXX should we first

XX,XXX about indication J&J that probably issues. few right has globally a bladder in patients first. You're the there, This erdafitinib with but FGFRX is the mutation just

see. we'll So

look of of way tolerability hitting We'll as label profile there we different have at wanted, efficacy will that the did If are terms to but obviously have their they better we different better able around to they desired, they but in in an tolerability a ocular the XX%. tolerability in XX% compete achieve said if have, to you hit efficacy see I a upfront receptors tolerability they issue terms of in profile. bar and and

So the long as way as differentiating that's one efficacy. have you of

see approaches will forward we cancer trials on what study already then, and terms you'll different are And management, it out up of we going doing study not. a point is And they on view. of it's and clinical lifecycle confirmatory from be, bladder needed first-line in have the

that differentiate should way the we work, other one jump a that's So there. get on will and market potentially

Christiana Stamoulis

[ph]. BD the on question the take I'll Christiana. it's Evan, Hi

our First focus of all, is on as we growth. diversification have long-term previously and discussed,

pipeline and of help very to activities. to June supplement cash balance the So opportunistically the when our achieve is us our objective. gives BD of late-stage on nicely end same the up us billion we that ability shaping our of have look time, that as at internal look internal sheet $X.X At at you pipeline

mid-term top we So diversification BD to adding when and of growth line it long-term would the type on line of with the timeline. corporate objective same look the be at driving in more focus on and

Evan Seigerman

very thank you Okay, much.

Operator

The with next Please line with question you. of coming proceed the Oppenheimer. Jay question. from Olson your is Thank

Jay Olson

thank pemigatinib. quarter the wanted questions. just to for on congrats I follow taking up and hey, on my you Well,

use updated X and would Jakafi comment wondering force, you the cut the I cholangiocarcinoma force promote that was would sales sales were you this you on about going data said to overlap would in you an of later your present you think I Phase there? year be submit pemigatinib, could you year. talk if can just also which NDA the to and later filing

Steven Stein

So Jay, Steven. it's

the there'll files, with go we has be, in a of half the are cholangiocarcinoma give correct, the oral of have half an that, presently meeting, year You're the content FGFRX although With data, in the mutation. it intrahepatic year that the in the but meeting of presentation hand, be of can't second will we and as in well. the at pemigatinib this will have what's you that the that preparing we the NDA data we second submission have this in exact

Barry Flannelly

and Barry. it's Yes so Jay

and number keep dedicated GVHD we're of FTEs are exactly working a of out on So how reps and certain a sales that we're will still force it have we'll XXX of next number year the have and roll MF, basically to but to to currently promotion our pemigatinib, FTEs pemigatinib. same we few the PV and going support the add that sales people to

in that community at the setting. and United basically in least fact everything oncologists throughout treat know hematologists You States, the

pemigatinib. So we're many of the on really offices today with as calling same we will

Jay Olson

questions. the Great, thanks for taking

Operator

you. Thank

line proceed with have Berens the question SVB question. Andrew We final Please from of Leerink. your one with coming

Andrew Berens

morning good Hi, guys. thanks,

then I approved Jakafi was of to frontline I with then couple opportunity on the the refractory a I and there if Jakafi was or changes the wondering the itacitinib question sneak in in Jakafi? franchise a derm setting, questions GVHD does also franchise how setting? could just have And for the has GVHD any in I treatment of too. formulary wondering change on been approval is in one So maybe that the

Barry Flannelly

Andrew. Barry, is this Hi,

them in access for management tell and in in future always the from write in and or had change for we and Jakafi really the no GVHD. acceptance the whatsoever. launch, payers fact mean, No, I we've no great know. MF, not, for had Jakafi anything as Whether don’t Jakafi for for have the So insurers far actually and PV of patients access does utilization it restrictions they'll GVHD. with as we've can we have for Many

But patients generally marrow to bone access drugs. speaking, all with getting have transplants

think think itacitinib both goes, going in that to itacitinib it's think that as acute We far will help will have world. of As going it together, but used in many it's us and do the be both worldwide, to patients We that setting. be GVHD. around very itacitinib countries can launch in and obviously live important setting drugs for to chronic first-line we that the to

will So, possible. get patients ruxolitinib certainly it's get after they itacitinib,

Andrew Berens

on derm that Okay, wondering the thinking just opportunity franchise about for just thanks. maybe question developing the outside you're U.S.? then And how Hervé, I'm the is

Hervé Hoppenot

diversify Yes, in case more and our to U.S. U.S., a more lot what past, for side is portfolio, book Thanks. and us the promotion commercial obviously on self. getting in too to said the convincing sales, that the we is do the our of to the work the

for still much very open is the the As of rest the the question is size of the this required study world. really

think would a Europe and this I point. Asia is probably about at the really where part having from you can we imagine, question benefit of partner XX-XX a world the is

of make the we that could second are the that there We midyear help the year. and have say the half of decision in the we dermatitis, in collaboration will at before because different looking fighting time us, options let's get and we atopic

there thereto from approvals be XX So will months another at European least.

have two years more. we probably want of the decision implication strategic that away of basically Europe, that are time from we in Europe. understanding launch and to least - at a from financial And full take So for to the the

Andrew Berens

very much. thank Okay, you

Operator

you. Thank

of We have session. end reached the question-and-answer our

back Hervé So additional I'd like to to any floor the for concluding pass over comments.

Hervé Hoppenot

all your you for your questions. thank time and for today So

we and you and but investor at you the call upcoming look we your today. forward in medical So to participation you conferences, now for thank seeing again for goodbye. Thank

Operator

today's conference. for conclude does lines participation you disconnect at we may this Again, this thank your time. and you gentlemen, your and Ladies

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