Incyte (INCY) 31 Jul 232023 Q2 Earnings call transcript

Hello and welcome to the Incyte Second Quarter Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

It's now my pleasure to turn the call over to Greg Shertzer, Investor Relations for Incyte. Please go ahead, Greg.

Thank you, Kevin. to Quarter welcome Call Earnings and Webcast. and morning Incyte XXXX Second Conference Good today for are Investors presented slides The available our section download website. of the on

and are Joining and remarks the Pablo, call on in will today me Barry, our the participate Steven Christiana, Q&A. prepared who deliver Herve,

cause some uncertainties a today filed actual we statements are in our Before that and I'd that number made materially statements are described to like the begin, to of with forward-looking and risks during may you subject differ those to remind of the SEC. results the call including reports our

will call We with the begin Herve. now

Thank you, morning, Greg, and everyone. good

in had year-over-year product revenue Europe. revenues quarter another the performance strong grew growing XX% we compared and with of Jakafi, XX% by to XXXX. product launches Jakafi So, driven second-quarter net of and Opzelura

net For revenues in driven new Opzelura, patient product flow $XX in the continues growth growth million, trajectory quarter of by the and with second [indiscernible].

Europe Opzelura the is Additionally, underway Austria. available in is to in and and launch Germany patients now

hematology net in quarter, the product the $XX for driven million year-over-year, XX% up of oncology other market. Pemazyre and growth and ex-US revenues Minjuvi were However, by

Slide Now to turning X.

our shown more of these of as evaluating line in axatilimab Recently, many study in chronic progress discuss their program made provide our study important development will bottom the the execute detail announced his high-potential respective on met we positive cream we prepared our the in primary point. top end as as updates ruxolitinib results during evaluating to continue potential slide. remarks, well Steven at programs. We and dermatitis results AGAVE-XXX the on of two TRuE-ADX from efforts. high The pediatric atopic GVHD across

research lead in development clinical and chemistry, research maximizing new and will goal position development Pablo organization executive this R&D of and of We and efforts. And our R&D. Cagnoni early productivity activities. late-stage as biology also speed the team, role appointing member Pablo as aligns President Incyte’s the This and and and Head of strengthened by in with our development

call I turn few for word. the will Pablo now over to

Thank prosecuting a and company impressive working graft-versus-host spent such continue about of more enthusiastic -- the in a organization even of vitiligo. I've a and myeloproliferative Since you, at our range to of success to meaningful and capabilities who biology teams the history Herve. Herve? the I'm our the patients. team redefined an order modalities. few of refined joining disease with weeks major the has We're thrilled neoplasms them join I'm our deliver advances Incyte, standard-of-care for time in to difference about to with look-forward I our make quality and diversity across with science. broad And of with just a to portfolio ago,

to would Thank to And you, like call with Pablo. for I Barry pass the that, commercial update.

year-over-year, future Herve. for demand Starting Total growth everyone. XX% morning, product starts, indicator X% with Slide year-over-year. while were driven continued Jakafi Thank on across up growth Net you, in up million, new patient demand the good Good quarter year-over-year, X% the patient was a patient indications. $XXX all grew for by X. revenues

Jakafi, new of XXXX Given billion. our to full end raising guidance $X.XX revenue bottom to strong are demand we underlying billion a the of the for year $X.XX range

as by patient to the is and unmet address by atopic coming in compared the growing and revenues the net its The driven which growing is significant The quarter adoption of and both Slide product vitiligo. prescription ability on XX%. X. rapid Opzelura launch to prescription vitiligo. compelling last right, and to product physicians prior gaining with positive both Opzelura, quarter. XX% to atopic growth the compared of were patients. is trend, demand dermatitis dermatitis need $XX and quarter during momentum continued both U.S. to continues million, refills profile Opzelura demonstrate on Turning total increased quarter be from strong shown The its in the XX% and monthly up with Opzelura

growth new and impact patient and efficacy only was Opzelura flow where to In and AD, and driven due driven In Opzelura’s educational awareness was largely is primarily repigmentation, for itch. inflammation by by the treatment approved initiatives. vitiligo on refills growth our

and are positive of optimistic Opzelura continue see strong very potential the long as term momentum. about We we to uptake

program revenue where related coming product access XX% Pemazyre early XX in product product in in U.S. the to net XXX% deferred On year-over-year a Europe. net which revenue of for key year-over-year launch ongoing June. $XX up in Slide with $XX the the $XX community revenue includes million, million by and million, outside accounts. France, year-over-year growth in were from in the net the markets grew the were X% ended of increase U.S. quarter to continued U.S. outside X, is $X and up $X previously revenues Minjuvi Minjuvi, were driven million, million

over With that, call the I'll turn Steven. to

Thank you, Slide on XX. Barry. Starting

program have updates from to this As highlight we quarter. two exciting want mentioned, Herve we

safety First or in new patients data. cream Phase top Assessment trial X.XX% for dermatitis will the results significantly No that data were XX. the scientific for in and is ruxolitinib Treatment atopic ruxolitinib Investigators' ongoing to is safety the meeting. term patients showed Score aged IGATS cream, TRuE-ADX profile the upcoming presentation portion observed achieved line trial with pediatric more The previously long control. The primary endpoint the X overall of be submitted X.X% with and two and vehicle was an met Global and consistent at safety with reported signals

first and plan data discuss agencies, of XXXX. anticipate these a the we quarter with also regulatory submission to in We

ruxolitinib can relief about pediatric in million are to the We dermatitis States. the cream excited X United the potential roughly bring patients atopic

met response the all X.X more their trial treatment week per improvements. primary Slide to in axatilimab across two In response therapies at its patients cohorts pivotal XX. of point with chronic response host global kilogram symptom XX% Lee with prior In study, AGAVE-XXX overall modified in milligram rate. the achieving XX% versus two every a after partnership three graft that year, Moving disease with patients endpoint Syndax, responders evaluating decrease or X their dose and scale durable per-kilogram both at and with of one responses X.X a symptom a milligram achieved indicating maintained cohort, overall least the were of rate XX%

presentation XXXX. and The later scientific tolerated, well effects. common potential consistent was this a planned were end by meeting year at with BLA target with Axatilimab the dataset adverse events most full for year is a on submission

of A of Phase graft patient also this planned. being combination axatilimab with and population. X/X severe the chronic ruxolitinib pretreated We potential versus in and in about trial are axatilimab in excited host heavily is disease

Slide Moving to XX, our updates broader dermatology pipeline. on and

the to pediatric X for line three lichen For positive top enrollment. studies Opzelura, AD lichen sclerosus planus, completed Phase have in data, suppurativa and addition hidradenitis

the study and expect enrollment, has nodularis in Phase we X year. to data prurigo this For this completed in indication later Povorcitinib, have

Additionally, we previously and spontaneous X dermatology, announced development the trials two diseases now urticaria, CSU. inflammatory Povorcitinib in initiated expansion have Phase into autoimmune and asthma of beyond and chronic

urticaria. and studies I detail asthma want on to our in Slide On a little spontaneous provide chronic more XX,

uncontrolled that Povorcitinib type endotypes. to data, eosinophal been severe Asthma with is reduction providing efficacy well. is single and disease Type is eosinophilic evaluated Povorcitinib Type endotypes. cytokine, X, potentially non-Type patients of have X actions characterized asthmatic as moderate common In disease potentially multiple has may inflammatory a a endotypes. a in to neutrophil study target a results in Type The most X antibodies and Povorcitinib in non patients. the appears two X response. progression in Type the of monoclonal non-Type X whereas efficacy and with activation, despite inhibits activation THX inhalers. reduce asthma Many both Unlike by primarily superior therapy neutrophilic have cytokines, cytokines, chronic both preclinical Phase driven by X X asthma asthma,

Phase antihistamines. chronic drivers related JAK evaluated driven dermal mast-cell disease, study THXX spontaneous Overactivation of and including production, We of and X in with or modulate degranulation can cytokines. know in are of results hives progressed generation inhibition been controlled has levels a is presenting patients THX, severe are mast-cell basophils THX, and cells cytokine activation, increased second serum mast CSU which chronic urticaria. and inadequately of itch. The on both who

and multiple the Moving high across potential quarter. portfolio milestones We hematology second during our clinical to oncology. achieved

clinical to make continue We at ASCO program. MPNs updated our where data in for OP-X progress and BET presented we myeloproliferative neoplasms or

host CALR disease. the We initiated axatilimab mutant versus also a in Phase study INCAXXXXXX, antibody, of our discussed, and previously graft chronic primary endpoint X as met

enrolled. both oral of to or relapsed in follicular large initiated. are evaluating PD-LX X multiple Tafasitamab and zone lymphoma advance small B-cell continues lymphoma line And in with marginal oncology, studies studies new the the diffuse Phase first and refractory molecule program fully For

have treatment an clinical Immune our and inhibitors PD-LX and space. checkpoint the patients. for XX for remarkable ample and improved Despite update transformed have Slide Turning to is intravenous outcomes this oral there disadvantages molecule cancer in small formulations innovation program. on opportunity benefits,

activity company clinical targeted As a the to first we opportunity for with differentiation. an PD-LX unique agent orally demonstrate have available

may especially small the needed. toxicities offer off safety, burden immune if overall when INCBXXXXX half-life, reduce As related of Which option improved an molecule, can switch oral agents. with short a has other combined managing and which a provides

an convenience and for by quality of oral potential preferred offer often administration of an improved Additionally at-home the may the is patients life.

patients, Phase X current the cutaneous in both studies you squamous and carcinoma. initiated On inhibitor studies the in We've can checkpoint see naive right INCBXXXXX. monotherapy cell of

Phase study two We combination ipilimumab. in with PhaseX/X also adagrasib combination preparation. studies is axitinib and A X/X initiated with third in

virus neoadjuvant fusogenic a activity strain We has cutaneous immunotherapy is RPX bus tumor also product that with with already genetically demonstrated and cutaneous with a last proprietary armed in Replimune, replication combination patients squamous oncolytic a with protein cell evaluate and lead based engineered derived are to substantial Replimune's partnership and in on carcinoma. herpes carcinoma. of the simplex new announced cell for tumor squamous in starting GMCSF. XXX a selective oncolytic immunotherapy is RPX, is we in night RPX study

myelofibrosis. hepcidin ruxolitinib. myelofibrosis patients clinical year. well in we updated added safety monotherapy demonstrated for Zilurgisertib with plan first and continued to We've and this an a anemia have from naive presented we in group dose in for allowing Initial zilurgisertib, XX JAK was reduction with anemia through later patients and escalation. tolerated line data of ASCO, treatment with combination favorable early signs additional ALKX our profile response data At inhibitor with in data patients activity

finding as monotherapy, well milligram an combination ongoing in arm. active Dose as with We daily with monotherapy early dose data. our compound once the as Additional daily XX in in we the inhibitor, encouraging with combination and data presented at tolerated monotherapy INCBXXXXX the well toxicities generally was with It symptoms dose in in and limiting for ruxolitinib. spleen both improvements observed demonstrate is BET arm continued higher once work escalation ASCO volume milligrams believe two arm. have XX

Slide XX. to Turning

We continue development to make progress programs. other in

TGFβRX clinic During entered PD-X quarter, Phase antibody initiated. was INCAXXXXX, the by X a Bi-specific study the and a

Additionally, the lung enrollment in in anti X has study, for received plan was we non-small ouremolimab, to in and study. the later recently cell cell this completed our IND squamous year. Phase cell our clinic antibody IL IL-XXRβ it approved Retifanlimab, clearance, anal enter which carcinoma, the -- and Merkel cancer carcinoma

Finally, we on and expected, data to number have upcoming details milestones additional and we of a XX, readouts this the year. sharing look remainder Slide of forward throughout other exciting

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

Jakafi $XXX driven demand across and with million, driven net Opzelura. strong product and continued XX% for representing increase, channel performance in increase strong an patient Steven, to by growth a very in the quarter products morning, indications $XXX was Jakafi revenues revenues everyone. year-over-year were of quarter by all Thank good a second XX% and QX the primarily increasing inventory. you, total million, year-over-year

QX, expanded product net normal Opzelura around increase a from the second end QX of coverage. in recovered product for the XXX% net of million by driven and had range. the levels The in was end $XX inventory the $XX revenues inventory demand At the year-over-year, quarter and were increase patient channel representing towards depressed high million, represented revenues. increased

of demand Minjuvi related patient $XX million, of deferred which in early to representing XX% revenue to Finally, the access quarter were the million recognition compared other second previously France, of $X XXXX, product ended driven net the increase program and in revenue by June. a dermatology/oncology

for were FX million and for quarter by from million ta royalties Turning Lilly are for to were primarily comprised the $X royalties negatively of Jakafi $XX the Novartis of and of million royalty for million and the royalties revenues, total royalty Tabrecta for Olumiant. Jakafi quarter revenues headwinds. and $XX from Olumiant $XXX impacted

QX of of launch net vitiligo, net to by Slide Opzelura the grew performance sales Net quarter, Opzelura. with XX%. now primarily average Turning to $XXX been and and to the typical date product quarterly revenues have XX normalization very grown last at has the XXXX compared of year of rate of demand the Since revenues driven an of The XX% product million. launch dynamics. strong, Opzelura

our year-over-year development the launched of and SG&A growth, expenses Moving certain pivotal and million the progression for the and on on primarily expenses program quarter, basis. $XXX of The for to the the Slide pipeline, indications beginning second quarter, operating Total the a the support a XX progression povorcitinib timing representing growth, into of to at by XX% evaluating a second expenses. studies. million and in R&D year-over-year the vitiligo were promotional GAAP additional activities driven clinical XX% our expenses were year, driven other of Opzelura of representing cream the primarily including by ruxolitinib $XXX expansion

demand for end a guidance as year guidance range $X.XX are our growth, our XXXX, new strong to we the full billion. to on to of Jakafi of result $X.XX raising billion Jakafi's again of Moving a bottom

We revenue, oncology R&D, other SG&A and our for year. are reaffirming COGS, hematology the guidance

Operator, your instructions open that our call give Please for concludes Q&A. the and remarks. prepared

question-and-answer Instructions] Markets. Capital first Brian [Operator is Our from session. question Certainly. coming be conducting RBC now from We’ll today Abrahams a

line now live. is Your

I [indiscernible] lumber the guess for Thanks Hey, question. in for program. Brian. on MS on had maybe my one taking development I

Jakafi the [indiscernible] challenges the high that and difficulties. bar exemplified sets by Given on

and or symptom hitting thinking positioning One these this forward? the of front with drugs the how's had competitor I molecules the on your second BET going of in Thanks. inhibitor guess, just to recently the a line going the line about shaping score.

point Yes. (ph), Steven. [Leonard] of for it's a very terms acknowledging, you And question. out, but activity in spleen responses, bar the thanks ruxolitinib’s symptom especially It's for And beat. incredible high both improvement. to as

In dose adequate terms study be has one maintain in terms JAK making of going design, inadequate inhibitor sure in you obviously powering endpoints our careful forward. and also own to that intensity of thinking,

in talk And so, our of both just we terms combination programs first. out ALKX to point about

to see can doses, increase an Clearly, increasing where with have very hemoglobin it's encouraging see You starting hepcidin we're we heading. reduction in responses. and

So lines the prevent be RUX in thus the terms importantly maintain along benefits JAK intensity an development inhibition in line symptoms. in potentially the those ability and spleen get anemia looking of thinking setting first would very maximum to at, and dose and

we year go. in to able we'll as the And we've said so of terms by that's want and And heading. dose to repeatedly, safe It's tolerability. where escalation hopefully, that's complete be next incredibly declare where

we're to So continue the to at able dose moment. escalate

tolerability. of bit terms terms a In the BET little program, of in higher on different terms of it's a in in going of in target doses. no thrombocytopenia, terms one There's toxicity thing of

there again, hemoglobin milligram at XX response, So dose monotherapy. the we're terms dose limiting in response, back and spleen we encouraging in milligram, seeing, toxicity We're saw at the extremely XX occasionally also of monotherapy, and symptom improvement.

there's obviously, about But where terms think there's year, suboptimal your symptoms, carefully later And, the to so or also our study. very And, BET data repetitive, have we setting terms good. this to to line powering competitor to first a of in be to first you point, ruxolitinib go, careful be have going because which of in in to line is again, carefully. watch reporting we're

that So timeframe as in terms the we registration end where year, directed like declare go efforts. well, we'd by of of to of next program earlier year in, the part year

the you ET now. antibody the patients completely the in even Potentially remind then and are to CALR just also you in terms CALR a in and And even eliminating the then dash of different in symptom population of XX% in the curative and change the you population. is of clone. MA clinic be eliminate completely completely. response, you'd thinking And the can wouldn't disease trajectory be clone different modifying the that be spleen And way efforts, if that disease could thinking

So program at that's Thanks. where are we the the with moment.

Thank you.

Kripa today Truist question from coming Next from is Devarakonda Securities.

now Your is live. line

lab Phase axatilimab question Thank the reported you question. have so X from trial recently. my about a I much for taking you the data

question the around is we've been response. unusual dose big Now the getting

if it's rates. could data, know and been a few days of I reported So, been be since potential you (ph) too but that might sense had [SAEs] there? impact we've understand response a it's importantly, you've regulatory heard going digest to review? have more what's might not this Wondering the of since how of you affect take what because days to on the And it many data. this

seeing in it's And versus how then for being continue a as through you difference Minjuvi, EU, are Thank in you used you. in work U.S. EU? in to reimbursement

Perfect, It’s axatilimab I'll Steven. with your start question. off

schedule study a had and So doses the AGAVE-XXX difference well. as three

up responses and a similar at other territory, best there it in a XX% so a difference some on overall is of you if we across response but ways rate, looking very look there's think difference clearly target likely on per don't at in X on per the who a effects third milligram the the kilogram milligram X be pleasant including actually that kilogram inhibition, right, milligram four X you're XX% X with was you're across the QX, (ph) QX, not prior per per and So all clear, two level overall in then X.X dose. [indiscernible] at excellent really dose when more terms not QX. patients to per just worse and regulatory of is we in the a transaminitis are with having increasing of surprise and in a cells and certainly kilogram And had terms the there's And different, medium gets transaminitis. level therapies in prior tolerability, best of likely [ROK] is that milligram liver activity kilogram dose X.X, first dose. response, That had milligram kilogram, you're a response getting

and discussion the early days the BLA excellent in activity but in showing of And versus get we're in be of still submission both rate X.X that the by the of end regulators, the -- like on with working XXXX. regulators this early overall response out in with terms X, tolerability. it'll year that we'd the to the So calendar

over I'll Barry for to your turn second it question.

take I it. would I Europe. take Minjuvi on it. in That's would

overall mean, ways to U.S. are in patients Minjuvi are that there are at I who two basically dissimilar you stands the using the profile a Europe we So are we it have who not what good not get have in of it. eligible that and to to look in is many group we And patients of to good be that a [indiscernible] CAR-T, with Minjuvi have safety patients would that very obviously, and obviously it's can profiles eligible And not by transplant. frail the are cases, you efficacy attracted there. very seeing

Now the U.S. extent which European to different in different countries, the is CAR-T from used

uptake say bit on is we the that up would a volumes that earlier see being I fact in that we a it's So group patients maybe and end are little from larger And the the Europe. for as what we curve, eligible seeing. in that Minjuvi see of

Now few Europe as in curve have but we U.S. for it's it… of have rest and a of Europe is Minjuvi volume. adoption full and and in But the other curve, in Spain, doing in we in faster the to we what reimbursement you in the continue countries. access, Germany, the than Italy, work, heard, saw to France, fact term

Great. That's very helpful.

you. Thank

you. Thank

Bratzel Sandler. is today coming question Piper Next from from Allison

Your line is live. now

you the questions. Good Hi. Thank taking for morning.

atopic just First, during vitiligo. And us between you seeing the the you're just Opzelura. to understand on derm and Could also gross quarter? net the help mix trends

last it of thought quarter. to think for scripts vitiligo was I be XX% were

we're you persistence refill now second that half in of year? of and vitiligo? are the guess that what rates in I the terms is into And seeing consistent Just

just XXXXX in of indications you. scope evaluating And that new a What secondly, Thank agreement expected that the entering start just give that RPX's you now? the Is about confidence trial have to Could us in to Replimune clinical on in rationale other or adjuvant for and CSCC. derm registrational you yesterday. the pipeline, data year. help CSCC combo announced going on [indiscernible]? question oncology talk the the understand aspects just of And then agreement early

Cristiano. It's Allison. Hi,

the take the then Barry to part I question of it and Let me to Opzelura discuss mix. your turn first will

average gross XX%. So to in net net, to was of the terms discount QX gross in the

down from was in XX% that So QX.

we highest expecting, down the we're and co-pays then higher to this net QX through pay comes to As has the down given the year of gross deductibles the have year. and that at that

gross average in XX% at to are we So net QX.

continue that utilization. payer that terms saw thing And QX dynamics, has increasing In one see a with QX of in in to of an in QX we increase we percent total continued in as was and Medicaid the mix. Medicaid

So, Barry. Allison, it's

questions, prescriptions. now as far as So your vitiligo XX% represents total of about other

In tubes we with two to two dermatitis, to terms expect of we before said two are AD. tubes so I atopic where patient. three and we've three over think for refills, per now We're refills patients, that, that's, – per

coming need yet. number on, can For time don't vitiligo, the time reach of we you the and new as we have enough to refills. of Most imagine, more patients vitiligo average are

past, expect be As average we've progressing to we the said we're year. And the towards that. in per around think we tubes XX

to it turn over I'll Replimune for Steven a question.

Thanks, Barry.

not cell in cancer Allison, of entity an that's well just treated, by with often groups way because the carcinoma, very cutaneous capture it's that alone, it's surgery squamous of terms statistics cell variability, captured the So, States of may and XX,XXX million deaths. cetera. enough could be United of the et actually it cutaneous X squamous there be the north in cases across upwards carcinoma of that But board common

a it's with problem So a of lot medical clearly morbidity.

we've and with expand have serve on clinicaltrials.gov, on we you, registration now, with own itself, for forward pike ranging as determined. then up dose some and XXX we'll down a could cutaneous a XXX, carcinoma that's as that's to the ongoing squamous be potentially and For doing effort, study work going declared cell outlined but its dose

cutaneous in that's with complete activity cell a a Why outstanding already response of in rates checkpoint advanced Why the Replimune? responses range. carcinoma range, terms in in with inhibitors, It's virus XX% oncolytic XX% efficacy actually squamous demonstrated RPX? tumor

are really outstanding intravenous. but really with checkpoints activity with demonstrated, So

we'll with administered though, going proof concept an a in this exciting combine is and with the oral study, forward. then Given how and This as we injections, path potential is view to neoadjuvant agent of there XXX this it setting, a in an itself registration is afterwards. determine intratumoral if really like lends

for the question. you thank So

you. Thank

you. Thank

Next today Purohit question Stanley. Morgan is Vikram coming from from

now is Your live. line

Hi, Thanks for good our questions. morning. taking

So we two, on had both Jakafi.

So base? you the to moving where us that And secondly, what purchases contributed XQ whether outsized steps program the then on dialogue comment for there your on any or could with FDA QD Jakafi's forward? RUX remind this stands large and are first, could were inventory sales you just Thanks. next

Cristiana. Vikram. Hi, It's,

first So terms inventory question. of in of all, your

end an the and may QX increase within As of see end you inventory in brought that in you inventory within normal And, an range, was inventory the back end range. at towards of that low recall, higher QX that but was quarter-to-quarter variability order. What the below because it I we of the timing range. normal that say, was the from range the of normal the of saw would

So we I And net back commented million sales. the represented are in QX remarks, range. as increase at $XX during normal the during my inventory

second the for of the Barry to [indiscernible] question. it turn part me Let

Christiana. you, Thank

CRL that So Vikram, there to not was [Cmax] from efficacy when of at the in and RUX in a concern a state, area IR. FDA the potential under and steady the Cmin not and XR, the theoretic of a (ph) in it terms was (ph), compare terms lower remind XX% curve to just you you, [Cmin] resulting then around concern

clearly that a and may way take them itself. need RUX discuss and a effort to little And loss potentially go that's can't you the regulatory to timing have of of So the -- ready then agency, both, the work, longer for with and potential approach we a we'll be before involves at modeling that exploration quicker in we're able submit give yet longer and for that. on there's terms moment, we but doing forward, and

to too regulatory you it's both give early but Thanks. underway. are timing, efforts So

Thank it. you. Got

you. Thank

is Next question coming Sachs. Richter from Goldman from Salveen

Your live. line is now

for morning. taking my Good question. Thanks

what standpoint? will and share in us the help just ALKX combination out from where QD you of is data the on but can strategy thinking half, and understand stands on a in the BET cycle play how Jakafi and life overall this second the context more management combo here, your You could combo

Yes.

to Both So -- both then intent the to and also ALKX, thanks, as dose the just Steven. activity watching about and Salveen. and very well. the alluded combination. with progressing my are remarks, space. it's in monotherapy then ALKX clearly BET now It's prepared in be for I its declaring tolerated. registration hopefully And may well treat QD on effort then We in anemia of maintain the a first And own, potentially outlined that effort the formulation improved terms efficacy. tolerability And can continue dose and see keep its then in BET because ability and the escalating line just that I RUX and and both to development. intensity. of competitive

in combination availability with and to then We any we And dose working will the fixed by the in with combinations impacted for time. pivot that to studies should ALKLX. we that ALKX, done it on both are also aren't and work be BET want BET bioequivalence with and at use CRL IR is way, pivotal when those BET that but and the those likely bio that FTCs, ALKX, we to with go

very want them much before the Thanks. to complete those exploration aggressively. we again, of of loss are should and of complete underway And itself. All efforts RUX

how So does follow-up and kind this CALR strategy then into a CKXXXX as Just of here? fall well?

Thank you. Yeah.

an So or the fact, overlap of VXXXF else. XX% earlier, I in on as essential with And mutant thrombocythemia. exclusive, [Miple] XX% mutually own, CALR myelofibrosis, its or to XX% is of said on driver entity anything own oncogenic doesn't its that, it's and about is

clone terms condition. you tolerated, it the eliminate and clinically because paradigm and the looks own work malignant well way this treatment the entity different of to thinking, be the of on off should so idea pre it's its and would an And would in a potentially be cure be

that et action so no the you'd is all why potentially and is symptoms, clone to disease exciting. the about then pan would have a of longer there that ALKX out JAK be antibody should that way and of those a need got care BET own at end, And So be plenary inhibition, no disease the the a causes taken their cetera. for the on third inhibition, with each and of entities would inhibition,

XXXX entirely. improve marrow. is single effort to the well, change enriched are cord Cellenkos' as myelofibrosis to natural T-reg and different cells history bone in the to umbilical of shown a in potentially fibrosis effort they've hone case a already And small, safe. It's and there that be The also to studies,

the So that modifying point of to to the And given this comment strategic be it's too Thanks. that'll that. disease therapeutic idea want it's But go show we on from of on to again hard days is and data year, view. where early there later modality. a again

Thank you.

is today from Evan Markets. coming question BMO Seigerman from Next Capital

Your is live. now line

This for on there. Thanks our taking MacKay Hi questions. the quarter. for on Congrats Conor Evan. is

noted this your increased you're we're patients vitiligo. now demand to press a Opzelura. bit release wondering, just and come had that starting stopped the into you on Could seeing or patients launch if -- you morning who Opzelura on So comment just inactive I'm treatment in previously seeking in to further any you. Thank for previously

It's Conor. Hi, Barry.

first consumer to all were, have inactive. But have you patients available time effort new their to about that those in do is them learned want can't the vitiligo. And skin. there direct treatment their along really very have treated can see obviously the just let their patients want repigment to give numbers know any our treatment go then, their patients about at we entire to of for that for help to Opzelura vitiligo to for that any of in been I part a fact, patients -- actually who seeking we that So is activity all number and to who dermatologists.

to that's patients drive what do to office. Thanks. the So the to we'll back continue

Yes. you. Thank

you. Thank

from Olson Next Jay coming is from Oppenheimer. question

now is live. Your line

on and question. share Europe in Can U.S. you the you revenue comments of might you pace Opzelura about growth versus the Opzelura you congrats Thank Hey, could the taking momentum specific for the uptake talk guidance of when the you. any provide Opzelura. and on And quarter thank on

this the of European I today. can do -- take the European part I'll

the Germany So days in place June. the approval end the and the Austria and in of It quarter. launch was took the last at of

are So we the process. in

uptake. a see Now X.X we we have months, good

anticipate Europe. obviously it important to to it's in market, the the continue next where long we year, the most see countries because and important we effective In for will other in that take Germany, fact, to almost most the reimbursement become adoption be in

mean, So countries entire there the the or label the from in being what was be Austria what was -- Opzelura of another in And the see, Europe, the the we anticipate I when – in safety there in where profile. terms excellent. and can you where main Europe is U.S. the different Germany is is would used. only approval It's months XX lable

in no Europe. has it fact, of Box whether Black In equivalent

very the of and So been been of exposure Europe, importance issue by at speaking to impact the from than vitiligo. number approval everywhere the And physicians all treating visible has this the the JAK TVs European differently in patients of has on has across repigmenting and U.S. of media authorities FDA done about had looked we systemic very what the of

So the is high. already awareness of Opzelura very

place optimistic to in And will for are we a fairly will of good have can. We have to where it put demand, potential. it trying and we reasonable Incyte, have be help product a patients a that we are we lot programs

And part second for of guidance the question about your is Opzelura.

can you . think I

So how been therapy of into come that It's few to in terms and uptake. quarters guidance. to be of active have on patients, before want still in more a to we provide we want to a see able the see earlier information position are more also still to vitiligo refills the We early. guidance, especially discussion,

you Great. Thank for questions. the taking

you. Thank

Securities. coming from Mara is today from Mizuho question Goldstein Next

Your now line is live.

with Hi. could forward filing question. comment on you of program XXXX? between free for seeing rates And first projection, and towards rest then the Goldstein. can from vitiligo? well? you are the Thank looking potential commercialization This drug AD axatilimab, and And and on with a IQVIA Starting difference share and our Thanks for moving are the is as Mara Incyte planning Opzelura upcoming you. BLA [indiscernible] you responsibilities for the the how maybe Syndax taking

more don't but really we that of don't between any AD see and So difference, know. whatsoever drug with on a Obviously, on are for drug. Opzelura patients there's Opzelura difference vitiligo. [indiscernible] the dermatitis Jerry, that drug atopic for I free We said and vitiligo’s Opzelura patients growing before free for number

Jerry, it's Steven.

in both appropriately worked with But BLA, the really quality, cetera. high of Syndax well, well companies study the well, have way. was together. filing executed be helping The brought activities, along leading will In terms et the obviously, Incyte

On Herve to it. address question, the commercialization I'll ask

U.S. AXA of of commercialization rest The in Europe will the and different and be the world.

in field to So the FTEs up if option of XX% led in co-commercialization there choose filled Incyte, to. U.S., by revenue and to the it's where an force would the they is we for booking be Syndax where

to a will they And do them And to at we the if that. do the split in of U.S. commercial end, that be would profit decide activities XX-XX so for the want

royalty Outside to all related commercial we a of paying where will and we and be the for U.S., license prosecuting a activities to axatilimab. regulatory will Syndax, be it's

Thank you.

question Privitera from TD Next from coming Eva is Cowen.

Your now line is live.

the And Can nodularis? on profile Congrats What in expectations be efficacy a you povorcitinib what's quarter. bar that the you. for questions Thank would Phase into A considered help prurigo moving from disease? set us. few for X. in

Phase that's oral Yes, really is central the these why approved in severe is nodularis PN the with itch-relief feel of inhibitor Steven. then lesions. patients the a X prurigo and in data enrolled those patients what and have JAK itch is well. an year. [duplicant[ (ph) it’s There the provorcitinib later general. in very we want terms in nodularis. appropriate really obviously, already The for drug severe more we'll patients But It's this problem skin intense actual and prurigo Eva, is complete,

This and terms is relief talk itch well year. then about we X So we'll of the there development, the profile study. this later want Phase lesion a we regulatory the advance but established. to path study, get Thanks. we'll resolution, Phase in is that X pretty If proof-of-concept

Thanks. the And Phase a [indiscernible] has Can a for enrollment you on give update question AbbVie X quick You . Phase another povorcitinib. that know for recently opened HS? X

Yes. you. Thank

So give progress. we we as numbers don't

enrolling before obviously them. up We They're and started have We two Xs Phase really going. well.

et when been excellent. vitilago, I cream, you RUX back AD, has general, think to go in across dermatology, cetera, our operational execution

So how knowing we've But space conduct studies. don't and we at to the patient-by-patient updates. got really provide Thanks. good derm enrollment these

questions. for Thank you taking our

you. Thank

Securities. from Next question from Schmidt Guggenheim is Michael coming

Your now is live. line

be the rock on is remind res positioned morning. just on see Phase guess, taking Thanks us just might you're in you had setting? Good Michael. with in Hi. I setting our might previously I two for question. And This just tell need the Thanks third-line axatilimab, a us study any line advance trial, on into you maybe that order the based then, maybe in competitively Sanofi's outcomes. how to specific much. to you versus how for Kelsey could data? could it the top frontline combo X planned so Jakafi what And tracking efficacy announced

Kelsey, it's Steven.

prepared the eligibility the four. data but won't again. was prior actually for had patients the my remarks, them through more or I two AXA median therapies. So go is I in criteria The on

So But said we'll the regulatory be drug United I that given line have exact XX% agencies getting set. to discussions. as the It's were rock label. terms in But that's United be And where have the to will as in discussing line be States seen obviously, we're the premature given data in given to what until is remarks, across States including comment in the that post-res of to prepared in of approved. in the it's least those those with somewhere a of we territory board, were on that patients. predominantly therapy labeling my efficacy likely third-line at

into assume combination interactions, one, of terms In in large disease you want combo in again. a so disease Can it's active versus -- very run appeal a now because, small very MOA, with macrophage with molecule theoretic with of no host huge have there's really move to drugs the graft a terms talking and I appealing. JAK molecule in don't we a graft treatment the host paradigm. up monocyte ruxolitinib, tox. two you're inhibitor non-overlapping about concern versus drug, you theoretically And expect targeted drug-drug work, we And a then

going where with lot as soon out, tested to go. the in well. have that see line are as because we're (ph), first, see There start then as toxicity, a we'll we activity but appeal second line first work to appeal also [Ruxinaxa] setting line possible and to combination active that and is So but second dominantly want long-term go are there of used there's steroids in likely

an So us the that where leads we'll data time exciting see combination. for at

congrats Okay. the on so quarter. much Great. you Thank and

you. Thank

Next question Citi. coming is from David from Lebowitz

live. now is line Your

patients per the overall growth patient? extent that patient for by much question. as to the the increase more taking therapy Thank detail you on or in coming just my you Opzelura, per Could to the very was provide to on quarter of curious tubes number new tubes in driven where

Sure.

it's David, So Barry.

So grew is the XX%. by from said basically, driven that I mean, where we they're RXs total

and XX%. that's and So AD across grew vitiligo by refills

than So over expect XX%, be refills that going to much we to and up fact, higher continue in grow more time. than

two to we'll achieve the direction we'll we're and and far each. fact, to dermatologists use growing, XX both and the are both reinforce refills it As of and vitiligo, in We from patients, AD the patient we as terms the growth I in drug before, tubes direction for now, in in discussed to patients, expect, in how think hope number. that of AD starts vitiligo. continue both we that think we to AD right for headed new three and continue patient vitiligo with for get average an and that per least that with at to tubes

for Thanks taking my question.

you. Thank

Fargo. question Derek Archila coming Next Wells -- sorry, David from I'm is from

Your line is now live.

morning. This our Two me. Thanks Hi. question. Good Derek. Srdan quick ones for for for is taking

of on competitor HS opportunity in about what how second, First, And oncology be data? your priority assets? are what thoughts your are you thinking the povorcitinib would And recent light and for M&A? I&I between

take the to You want HS.

first. do I'll second question So the

the year in HS medical a earlier presented terms which So we meeting for profile outstanding this is povorcitinib, at of efficacy. in

XXX been a it's response. we has first time -- in can And we reported that this compound that, think I by far complete the by a as tell, as Heska mean, that fact, In a ever entity.

profile going access, completely povor. encouraging So for for forward really And is nodules, that's disappearing. fistula the

You're of right. need. drugs. of active many There's including research. unmet It's targeted IL-XX now there's an biologics, space lots And

studies, that compare when activity other arm And in you Phase outstanding. is to Thanks. in on look Phase placebo a well I the our are the as potentially X, replicate at look profile would concomitant we we say that. administration, compound obviously, carefully comparing. saw just antibiotic allow we'll patient carefully But good it's then didn't we And that so when address best-in-class at have studies. our if X there. And that populations, trying people

is mean, Maybe can position we The promising. is very existing I the growth about pipeline mean, a say I where, as M&A. in I see, a of very are our can strong. you word business

have a We projects, didn't but and some stage, the about number at products of speak of good early developing are also stage they interesting. very that very very we late much now are we

at we the doing could be north we could looking cash the licensing, we growth are be could portfolio. that we add this organic it how So could best of have to are use that now what we diversification development. with $X and It be business of have, our billion M&A and or

with Lumber the license a also Syndax and it's adding and with and the Jakafi. we from was strategically see You combine helping can program axatilimab clearly that us portfolio mechanisms

could that's when in portfolio beyond, or XXXX, assuming we point. the that when where them see because need would add at find be really oncology, contribute dermatology to So products these XXXX this have could the acquisitions potential them, the acquiring the that or to to in we continue we be of growth to and that we agreement that type year

we So are quality versus of using. science, and of the And sort to portfolio. of be timing question agnostic we onco criteria and would the the the are of the that's quality our product derm, we really potential products of the the the think I adding is

Thanks. Okay.

you. Thank

from is today Securities. question coming Next from JMP Benjamin . Ren

if in small how are is a a taking talk the nodularis, Hi. and these positive, Can little be how studies opportunity how for current should forward? how and be be questions. and Perrigo this studies quarter, might bit great big you. we you they should thinking Congratulations going on about thanks or the about pivotal thinking Thank we opportunity big

size get need Any would and helpful. and be of it’s just a up a as you ultimately going might of think revenues thoughts of forward that And there we some is, these that part will a something question given when be business, to the this conduct picture part bigger derm the at Incyte taking something might indications? about is that spun maybe of the for other point, kind studies significant off

Yes, Ren, it's Steven.

itch, So precise hard States on their and north that nodularis not XXX,XXX is earlier, I life. prurigo United often or to as it's of in PN. epidemiology, biggest the is but quality they're on the be morbidity patients It's underdiagnosed. said around a or diagnosed probably with of massive And impact

The terms there. get for powering the what that's how in looking to premature regulatory And proof-of-concept data there. part until X we're to and talk DUPIXENT of been approval and has povorcitinib. So already defined by we our about sizing it's see Phase

outcome more it's and is the seeing interested and studying ruxolitinib we're Opzelura PN well. active, Just very also as cream, way, obviously in in the by of something mild

Herve. In of over I'll terms to second the turn question, that

see I meaningful really can yes, -- question is a the to has of yes. a mean, and I answer to And to it. and you be is yes business is the we the that So size, mean, believe continue potential dermatology you can grow

we believe see derm, or need we vitiligo are a new on five RUX that for there is medical the four developing can cream. are You top of where and and program indications atopic prosecuting There are we clear where.

ways in a way a that case with best-in-class good can and but profile is again JAK of way now choose fact, there feasible. that very and you positioned. biology, the it patients are interest, topical competitively we these it of from with in see in has the fact And is approaching very a to has believe good pack is povorcitinib indications and efficacy develop really power inhibitor that development is coming this number fact, ahead of first We the some interest. the that other the being that the of is to biologics with In process JAK well in safety the help where we very or

that is could also we very to then new have promising. needs [indiscernible], And a be mechanism which be but proven,

or complementarity time to some for next one cancer apply over of inflammatory at other see view have we developing And on of are IAI and this immunology research autoimmune could and the in can that portfolio equally least corporation on how doing for hand inflammation, we it it in or how the in the in contributing the cases, revenue in to few So disease apply that years. lot we hand. disease the of dermatology be an to the growth will a

is all that of that established. now well So is something

building U.S. the filled now on team it the have in fully side Europe. the we are in, and in We commercial

be picture think the next in derm and Incyte onco I both years for So five a it's will parallel. of

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

call team the available your for The Thank the Thank IR day today will you all follow-up. be in for rest of and for for questions. the you, and participating goodbye.

teleconference and Thank today's you. webcast. That conclude does

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