Incyte (INCY) 4 May 212021 Q1 Earnings call transcript

Company Profile

Participants

Christine Chiou	Senior Director, Investor Relations
Hervé Hoppenot	Chairman, President and Chief Executive Officer
Barry Flannelly	General Manager, North America
Steven Stein	Chief Medical Officer
Christiana Stamoulis	Chief Financial Officer
Marc Frahm	Cowen and Company
Tazeen Ahmad	Bank of America
Brian Abrahams	RBC Capital Markets
Vikram Purohit	Morgan Stanley
Andrew Berens	SVB Leerink
Cory Kasimov	JPMorgan Chase & Co.
Salveen Richter	Goldman Sachs
Michael Schmidt	Guggenheim Partners
Alethia Young	Cantor Fitzgerald
Srikripa Devarakonda	Truist Securities
Matthew Phipps	William Blair & Company
Reni Benjamin	JMP Securities
Jay Olson	Oppenheimer

Call transcript

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Operator

Hello and welcome to the Incyte First Quarter Earnings Call. At this time, all participants are in listen-only mode. [Operator Instructions] A question-and-answer session will follow the formal presentation.

As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Christine Chiou. ahead. go Please

Christine Chiou

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

of in including like are December Before documents. that made We'll remind number our to results materially, the we some those to with ended are in now begin and the statements our the XX, the our that statements of I'd differ subject today call from begin, may XX-K cause call uncertainties during and year you time other a for risks forward-looking XXXX, Hervé. SEC described and to time to

Hervé Hoppenot

and year, strong product and revenue successes first entered and good we further XX% the growth year morning, diversification. In to Thank to able X were regulatory strategy where drive achieve by our approvals. a following continued including you, on the we multiple Christine, to everyone. this XXXX, We of increase quarter execute

We first portfolio continue in deliver our quarter. to across the

be new to patients Our March, and by is ongoing significant pandemic. physician. in which typically revenues globally Japan, progress million, from to and new Incyte. and The discovered on $XXX revenues both grew by regulatory was patient in approved level. first pre-COVID made additional the grew driven becoming purchasing his $XXX progress X% to both by Jakafi community product year-over-year, Monjuvi both further forward the million. provide good QX, U.S., across the a recovered gross year-over-year with product higher uptake royalty Europe and growth continued landscape net Pemazyre the will in clinical internally We to Total pattern launches in with details with reach commercialized challenged impacted segment. academic by of launches start to Pemazyre in Barry and of quarter and

regulatory as X-year and the these FDA, Academy as in of month, program data potential TRuE-AD pooled review potentially at We in increasing as the the data each exciting X the application operator sources X our we Europe, have under from applications near-term. for trial Phase for revenue American also with the cream X the updated dermatitis, of X in presented vitiligo cream RUX meeting Dermatology Last well treatment at and from indications. our including highlighting our a Phase atopic result updated ruxolitinib of X review

areata. announced Lilly in partner FDA-approved the alopecia with positive approved, areata. baricitinib baricitinib for be pivotal If We our in therapy trials also X first alopecia could

lymphomas, ruxolitinib relapsed/refractory to X Europe, next expansion years, the Japan. several over and in in ahead new potential GVHD. the Looking a multiple we to at QD in This indications opportunity RUX in new significant in vitiligo, dermatitis at launched of U.S., tafasitamab in chronic have cream in across and and Europe undergo transformation types are here DLBCL atopic PV parsaclisib MF, ruxolitinib the GVHD, and X with Incyte product includes

to year; by and several indication, end third, base products successfully stage revenue continue of this decisions our expect and regulatory priorities, our accelerating expand new patient at our late-stage for pipeline upon earlier progress the driving for year, by business Pemazyre; existing well to to look before second, the we new grow as and and X key we Monjuvi As the uptake new as launching we our our base program. of objectives have to revenue starts first, Jakafi

and line, which initiative, highlight of In our disclosures list Before take and reforestation on efforts reduce an XXXX we to a Day through environmental this to In carbon we about ESG accomplishments Global in like to partnership upon effort Between ESG among minute the credits launched our And our impact, which would now priority X the Foundation. like our I'd I our objective. in was speak Responsibility, Barry, U.S. improved environmental front. we XXXX. our to the offset I our few areas. pass have the we call emissions the in specifically XXX% measured Arbor carbon then to increased verified call with key

to a product Looking Barry goal neutrality offsets of reductions ahead, it that, absolute the over would to XXXX. hand achieve set through and individual performance. a I carbon we by cover have to combination With

Barry Flannelly

Thank morning, Hervé, year-over-year in and to grew quarter first the good million. sales you, everyone. net Jakafi $XXX

was recall, part may in XXXX large concerns purchasing also in you to due onetime to to XX% increase restrictions. patient over first quarter demand, in in growth a year-over-year, COVID-XX due but growth As

growth significantly Patient subsequent of XXXX QX of of XXXX. demand sales QX of In this and loss softer part were pandemic. declined gross This in QX patient beginning of explains impacts total starts was and graph end the starts on X.X% net slow was new quarters pandemic, of the purchasing patient the due patients first versus in year, the patient since higher to year forward growth year, prior patterns. primarily growth new QX to right than XXXX. the of QX patient growth the new but the year. Our the this in monthly to quarter The net from normal, last a new then start impacted decline in by higher and in shows

you offices. red new at pre-COVID cancer are the now starts of a patient We lines levels. patients are following oncologist seeing as gradual by to can see And return

of reaffirming billion growth we our are and this guidance meetings $X.XXX the full-year Therefore, their $X.X our launch have confident oncologists, able the treatments, Jakafi representatives being to strong chronic rest So second our returning very billion. with to improved in due for face-to-face expect half we year our anticipated gross-to-net the for of our patients in year. in to outlook are for and GVHD, of

the for see the launch, patients Slide of see Turning increasing an to of to the continues our initial a has Pemazyre, continuous the facilitated to now identification we continue and lunched FGFRX+ And result, rapid drug a appropriate an ability patients. And treatment a environment. in injectable perform difficult of use with and has Pemazyre quarter well of third flow as their testing adoption MorphoSys, setting. the We XX, Since second-line new last launch to with oncologists partner, year. we by exceeded Monjuvi teams in in demonstrated our our expectations. launch of

safety the have maintained we teams leading Monjuvi and strong to XX%. Our and awareness share profile generate continue of physicians field amongst voice, near a of of efficacy

We XXXX, has number are the of purchasing over XX% over seeing QX March. of encouraging accounts of which end growth at XXX since to by in the risen

Looking this half our expect acceleration normalize, year oncologists and diagnosis the of to Monjuvi ahead, meetings. we field oncology benefits are and an of educate of offices patients' reopen, treatment with in in-person the teams in on adoption the as second Monjuvi rates fully able

their in and grow more is benefit Our can now focus second-line earlier share going Monjuvi to from patients forward plan. the treatment in on our so setting, continuing market

L-MIND we'll trial, Additionally, lymphoma. use LEN from patients and relapsed/refractory X-year presenting data be with in at in important of the June, the into additional which Monjuvi insights diffuse-large ASCO will provide follow-up B-cell

results perspective of cream payers topicals most standpoint, for conducted safety be the efficacy to unmet atopic a from Physicians noted and medical as ruxolitinib and their XXX has ruxolitinib that dermatologists atopic patients. and have impactful other itch perceived key external cream to both from high survey a in improvements recently to dermatitis, separate physicians now cream ruxolitinib treatment dermatitis Turning in differentiated systemic both physicians and In need and the a therapies to experts assessing significant our a that opportunity survey cream. of show ruxolitinib a of payers in address attention and willingness a prescribe. nearly we and of large

field force dermatology launch is assembled for rapid and Our upon we are ready approval. fully

they call seek to for highlighting Turning and the clinical of to need earlier novel impacted such with cream. as hosted spoke update. vitiligo life lengths XX, which the living year, ruxolitinib various patients how treatment, to panel quality over the effective subjects, therapies Steven in their I'll disease including the a turn has and go a on to vitiligo which Slide again, FDA this for now

Steven Stein

and Barry, the disruptions or these additional creams from ruxolitinib everyone. data morning, Starting multiple scratching program atopic further for studies the sleep. presented from of dermatitis. TRuE-AD Academy patients. atopic analysis in Phase become pooled such cream, on X have we and impact we you, life year, highlight ruxolitinib dermatitis, cream with presented can and good April, In quality measures Thank other past efficacy to sleep, ruxolitinib important potential cycle American the subgroups. At safety itch, of over across cream Conference highlighting in for demonstrating of and the Dermatology X efficacy the ruxolitinib these And option itching therapeutic to patients an the living lead infections with metrics, the results as in of

clearance XXXX, Slide by vitiligo facial-VASIXX, of weeks at data cream weeks. results for showed serious in at X of X.X% Phase related treatment vitiligo XXX-week XXX lesions achieve ruxolitinib Turning achieved in well for week-XXX. program There the were lesions previously treatment XX%, adverse repigmentation XXX and ruxolitinib quarters from with Phase presented year, showing a throughout. XX EADV received was of this cream weeks produce face and cream who X ruxolitinib BID to AAD X the vitiligo We patients of ruxolitinib treatment. XX% XX. to At tolerated reported we cream substantial updated on vitiligo Nearly nearly events no through

year. lymphoma first-line expect and second to Slide other quarter. R-squared lymphomas XX, combination the read both pivotal slide. of for with non-Hodgkin's a in the the pivotal of PIXK-delta in which X several evaluating forward we program We refractory including collaboration tafasitamab diffuse-large parsaclisib and in in a lymphoma our initiating next with in quarter. B-cell with tafasitamab to our trial results inMIND, later the of our therapies, are proof-of-concept initiate development in relapsed the this or the broad expected tafasitamab another inhibitor study is in trial, second and is should in to combination is ongoing first-line relapsed Turing potential On you parsaclisib to vitiligo excited XXXX Xencor clinical proof-of-concept program sharing topMIND, to follicular out expected plus TRuE-V in start study with by Phase the settings. and cream across reminder look ruxolitinib frontMIND of the

development and program. We continue NDA LIMBER release conference an by data and submission medical data followed to year. is in-house, early our next Once-daily progress ruxolitinib expect upcoming we

BET combinations of in with initiation parsaclisib dose the escalation trials progressing. combination half planned ruxolitinib and this ongoing ALKX monotherapy our are second trials year. Our And plus of are

Turpentine model. levels mouse side of an production used right acutely was our results the from anemia and increase On slide, of which anemia. the response, to the hepicidin elicit turpentine-induced inflammatory thus

turpentine, hemoglobin financial in were anemia, closing, As over significant the the with the the the In busy side injected with demonstrated conjunction in I'd our and seen past for given year, call approvals a progress year treated potential hemoglobin given programs made have turn showed can development that, reduced. the improved we The chart, in regulatory Christiana severe developed when less to pink levels. the year. ruxolitinib multiple another to key submissions within throughout With further for anemia mice expect data right ALKX and mice and update. Incyte be like when on that ruxolitinib with with by levels in as we

Christiana Stamoulis

morning, good and Steven, you, Thank everyone.

for quarter, total over $XX and in from the and of from patient in the pandemic COVID-XX royalties sales Pemazyre; of also Lilly in and the million of in X% were D revenues from late the million product donut year adjustment of million Olumiant. first in Jakavi growth Jakafi to product The offset Total during quarter net impact advance forward $XXX revenues reflects $XX Our pandemic higher Part the hole. in patient X% the by quarter product $X quarter quarters forward for representing we in resetting confident XXXX the the revenues product existing for currency obligations annual are net and purchasing cause coverage Jakafi first for of for the first first since the royalty Novartis Medicare to Jakafi, prior supply of of the in grow the patient gap the that and quarter sales XXXX for Despite first product and the driven effects. Tabrecta, net $XX to increase of on partially of typical royalty for by new XXXX. quarter the co-pay the purchasing year, quarter and XXXX Pemazyre and the due and impact forward other impact compared by year-over-year products the or for outlook of purchasing Iclusig, comprised first million million net of like royalties our million the a launches million revenues the prior higher $XXX revenues of through declining growth continue quarter for reflects positive product of XXXX concerns disruption. of pandemic COVID-XX and in of remain the year also the COVID-XX were impacted demand, net our to could starts quarter the $XX in Iclusig new beginning ability COVID-related Tabrecta. The the potential year the decrease to the demand

R&D agreement of with a million $XXX XX% period, ongoing MorphoSys. the on quarter consideration quarter programs. the million X% $XXX prior of cost year to first due quarter, primarily basis, expenses the the continued from prior increased pipeline operating progression upfront our our the decreased GAAP of our to Total first collaborative for expenses for on to expense support which year included for million the $XXX of R&D from Moving

Department the for of of connection the year establishment to settlement quarter the a XXXX dermatology million U.S. to due in reserve $XXX from $XXX expenses. to prior Our in investments the primarily activities support potential civil with commercial as dermatitis, organization ruxolitinib of well a to the new the in includes Total ongoing expense our $XX SG&A the for the U.S. quarter million related expense of for of SG&A first increased of launch demand timing related certain atopic investigative related principle as the million the XX% Justice. quarter, December and from cream the

our expenses total quarter of share for COGS was represents including Our revenues This the million comprised of expenses collaboration $XX $XX Monjuvi. total loss is U.S. and of commercialization the SG&A for XX% operating million. product of million $XX.X net which $XX.X million, loss and net

Finally, $X in strong with approximately ended our cash and be marketable the financial position to billion we securities. as quarter continues

our for we for the reiterating revenue, our on guidance for to guidance our confident R&D XXXX, We year. year Moving Jakafi Please this call instructions our concludes patient new chronic year the for Q&A. steroid-refractory and Operator, give guidance in full approval GVHD. are COGS, the and starts your recent the and potential recovery remain in on later that SG&A of prepared based open remarks.

Operator

you. Thank

is a Cowen conducting today [Operator first from session. be from we'll question-and-answer Now, Instructions] Our Company. Frahm question and Marc coming

is Your line now live.

Marc Frahm

Hey, guys. starts be that of gave the give kind the Monjuvi and Barry, new and color have than DLBCL to slides. lot It you my of starting Jakafi, for the confidence things on on of Jakafi seem has. improve that more you confident? the would the through taking and susceptible would to kind patient and going why diagnoses thanks questions Thanks bit detail little there, trends of of pushing therapy and rest side are you appointments, so little for the you're a a some off indications why things Can a of year. less

Barry Flannelly

is see for is the hematologist, sick. talk need Monjuvi because Thanks these we are profile. claims very we patient from get very about optimistic visits combination. B-cell a Every they're they good time in we're data Yeah, down Mark. that reason our when oncologist, Nevertheless, the diffuse-large lymphoma, patients XX%. about that so, therapies. Monjuvi-LEN excited know combination to question, by to that are Nevertheless, obviously, They

is combination educate that gives. oncologists to benefits about to continue hematologists, professionals, specifically challenge Monjuvi-LEN Our healthcare the

getting we up get data. as to follow-up of X-year at exciting up think able that think we able a as will to XX have offices opening the I better but B-cell We'll see are hadn't with at lymphoma front there. for teams we field opening can front what our efficacy and diffuse-large treaters in again fully, in of response data for of and is get pandemic L-MIND the ASCO are they again, the the them we and not the don't duration share to. been just update X-year months. of be them of But an update now, to much of the because want know Monjuvi-LEN. are keeps and You safety just Again, educate

Marc Frahm

you there's And the how how entrant do see, a coming new into do that market just you well, see as out? playing

Barry Flannelly

have. approved approved Lonca We in We'll the line other the setting. Well, Monjuvi-LEN superior setting. toxicities, a it's they possible how that that that know regimen profile could that have they see be that's the in seems problem. We're oncologist like to so only our antibody conjugates from know feedback does. third-line hematologist, from other We cumulative from regimens, regimens see that drug second Lonca

other have whether that all coming toxicity own The or syndrome. potentially fusions are it's problems, their entrants release cytokine

So we will think and Monjuvi-LEN really first in the the efficacy be of and the setting. stand safety up second-line choice will

Operator

Thank you.

Our Tazeen today Bank from of from Ahmad America. coming question is next

live. now Your line is

Tazeen Ahmad

Hi, Thank to I focus taking RUX mine my good you morning. for wanted question. cream. on

kind considered have you. to then, You and indication, what press top-line atopic And of you discussions be I soon is get get clinically sense a the the wanted coming expect sense label just the meaningful data I to will a for should with vitiligo. what wanted expectation guys the have for of for of agency. dermatitis And whether started we data? any release Thank data should at what up

Steven Stein

Thank Tazeen, question. it's you Steven. for your

Phase quarter, readout this as the to, of this cream, expect the allude we you year. half on X So both during RUX to get

We replicate seen. Phase data to the we've X expect it

especially we not getting is you remissions date, negligible. achieving time, of require you numbers. placebo of to as safety just spontaneous that's data presented database greater hit XXX-week saw patients XX% The large, And continued data, the now there rate are the that the our even to very saw saw the XX% because to efficacy than in that. rates over You update, studies facial repigmentation seen vitiligo, are a little including

everything we by with atopic we an as It's for benefit that where comfortable we discuss profile. safety to patients we tolerable of So don't that need, achieving regulatory that X-year track in have view, should couple elect hopefully enormous we now X And on gone seen an already From interactions. extremely with you dermatitis expected. to date. profile update Phase is very for We're of remain and then, it. the we've treated sit, the they PDUFA a be point

how Thank regard. in that's So we're that comfortable you.

Operator

Thank you.

Our Abrahams next from question Capital from is RBC Brian Markets. coming

line now live. is Your

Brian Abrahams

Hey, guys, thanks so much for my taking question.

curious, ongoing another the as feedback us that, regulatory topical to some kind have guess, So, utilized just typical JAK you regulatory I picture, And bigger some, produced data are, the JAKs of speaking. is a just this Thanks. safety bridge ties than the guys know and but the to the the I produce into RUX, what AD help discussions atopic had which the the questions class, to plan to question topical oral to sort around of discussions maybe KOLs a of remind review wondering might around of blow there, generally what FDA's unknowns degree improve ongoing just as a of question. ensure to drugs. topical biologics? give durability that a from then, is by around corollary of blow chronic RUX what of And if could sort rather you don't on or has durability you education effects And important be going perceptions that I'm

Steven Stein

it's Brian, you. thank Steven,

Area to terms the atopic about in publicly data Assessment, in occasions, atopic date response, few dermatitis, a to view you In you the we've is our that obviously, terms from with presented itch again, Investigator's already which on view Index, Severity the of of couple and But mild dermatitis. also Global being Eczema see, effect the shown in outstanding leaders' and occurs in our best moderate opinion rapidly.

dominant of resolution their then, resolved pretty symptom having and the patients get quickly, the you effect. skin So

again their hard we setting, of somewhere off the XXX effect. they year effect, a and then, then that durability is estimate the a clinical terms study, in seen of the or We response terms the the trial, the sort that patients around, clinical get But In it's trial of skin and the recurrence, by a what'll durability will to tubes that go and the from and gram because would expect won't in the itch give of real what seen will of see happen sense drug on treat we've of chronic when that to obviously, patients be of be remission, we the data it effect. in clinical XXX own used. condition restart symptoms, we've to from be in setting. you because managed it's in But physicians including

the repetitive and is refer we again, be In that are discussions this them PDUFA in But review, the with of speak regard. terms are to Thanks. about FDA as the And on in we comfortable our to well. goal just date. rule we the to - to labeling and don't finish very repetitive, by review, a it's progressing the where FDA be

Brian Abrahams

much, so Thanks Steven.

Operator

Thank you.

question is Vikram from Morgan Stanley. Purohit from coming Next

Your line now live. is

Vikram Purohit

Great. Thanks question. for taking my

the I X had So LIMBER program. on

mentioned in year. for this that RUX, previously First, you half you the first expect BA/BE once-a-day data of

And as be publicly. secondly, public a part whether it's success presented see what if dataset on dataset? regardless it going there's evaluating program. readout, to study to start So of constitutes itacitinib for soon, is or of looks wanted this And the that I X Phase like LIMBER LIMBER, to internal expected then, an

I speak bit if drug a this for Thanks. this studying in you was rationale So just wondering the could setting. about

Steven Stein

again. it's hi, Steven Vikram,

are correct. You

different the program has that. XR strength. the bioequivalence well. RUX progressed bioavailability of terms It's in testing relatively and completed So tablet We've preset a once-daily of route

There you that's calendar in the Yes, data that we'll to follow needs of curve. the at expect public clinic, to and of forum, to presentation an in and to in have on the we area have be data we within come FDA under on in do And, We house. what you. used what year have meeting to this guidance give guidance comparable and to house. then terms the it RUX the we very that, is achieved that we appropriate a have meet strict

The there just limiting other rate stability. step is

once for down BE, completed those all the XX-month we So laid BA strengths stability. and are

before data they're of about review expect sort what XXXX should to In if we out. as period, XX-month approval be should soon XXXX, filing goes early to work be a As publicly we the have the But we proceed you this very will year. right end complete, with then of if everything to well, next present early you time-period repetitive, that again, year. interesting. Itacitinib, it's an

So ruxolitinib modulation compared if to a see it's JAKX/JAKX. cytopenias JAKX of in the less effect some in of agent leverage to And which - we're a require relative in to of have to cytopenias. less JAKX patients, we its terms and myelofibrosis and effect is benefit more terms who can that trying

with it So achieve proof-of-concept appropriate drug. will the Phase patients this if X be see a we to there for tested in setting

release including it has cytokine Just you, let settings, well other syndrome, multiple work remind obliterans, work ongoing and in inflammation and autoimmunity. in as some bronchiolitis me other including including

only the for. used that's Thanks. being So that's not program

should the end work, doing of data dose calendar ranging I get in also which chronic Sorry, year. mention GVHD we're where Thanks. we'll work, this some towards ongoing

Vikram Purohit

you. Got it. Thank

Operator

you. Thank

Andrew Our is SVB question next Leerink. Berens coming from from

live. line is now Your

Andrew Berens

in any comments another qualitative any most about of about, sneak question which MF? I was you're have the about then, I give as us one I some could wondering in on programs to Jakafi. them competitive advance. thanks. start and a if commercial impact you LIMBER also seeing Are you excited could Hi,

Steven Stein

then start I'll program, the for on Andy, to hand it your and LIMBER second Barry question.

value mean, to enormous LIMBER, then RUX, has about I brings it's to as it's the patients, firstly, and to well. shareholders patients, benefit to company the remember, So and important spoken us, Barry it

So this is functional, cross an large, at internal and different directed areas. effort many that's appropriately

Then the more work may have it's just second. and there do other to decide you down excited Dash asked, both But you fixed of third we dose pillar, the discovery program with in for there MF on we versus which should to others, and the second combinations preclinical, potential that. endeavors come of we with all more spoke we potentially and and and because his what about about importance the optionality in those it's that specifically, So combination plus once-daily once-daily back alone, its are we about, line, various pillar the targets, terms once-daily P I'll collaborators. work be research other a may in at looking program, mention, the are more up in research end to quiet vera, just pursuing, which plus where

back program, registration that tier open. so the the Just and middle are Xs been combos, to come screening Phase and parsa already to both initiated are RUX directed are Sites patients.

and at that RUX in in volume typically RUX first-line the looking symptoms, is XX% plus benefit to RUX or X there's of weeks Just spleen a then where patients spleen least ruxolitinib, continue a parsa randomized open. then greater. having that first-line versus and to versus of of remind RUX have dose, terms of at you, setting, plus sufficient had parsaclisib reduction months And in alone setting, are sub-optimal X of XX-week of stable response study study but not are

have looking BET is at of of the in internally safety, also monotherapy which we program, We the then half year. half year combinations our want this and this with to then second initiate RUX

tumors we it dosing where were MIC clinic were years inhibition. now to new remind largely at had we and drug we multiples solid of a also a you in the at not looking Just test, ago, few there's

through not only induced It the ruxolitinib that's that and the very said a or this ALKX the want of inhibition prepared hepcidin an as ruxolitinib. be patients illustrated X-fold should little has effect. of that have program, anemia. a compound anemia, plus we setting, then, probably of and will then potentially patients we And mindset, is my remarks, as successful, the in in different ameliorate experience we the which to And XXX-plus already ameliorating So third reasons that itself with myelofibrosis that. more anemia I keep works bit program of principal discontinue one accelerating the

ameliorate efficacy you'll can continued benefit get and of that we RUX the So thereof. use added

that's also an exciting So program.

not because in you giving is obviously X The have I'm slightly priority different parsaclisib all studies a underway. list, of ahead registration terms they nuances. So most

to Barry The hand other year. and it and to monotherapy we want complete the X next question. present for second combination this data you safety year to your I'll

Barry Flannelly

so BMS, for really at besides in no. just Yeah, we approved drug their reasons been and second-line, encouraged And used continue Jakafi nicely so if patients to is from only fact, all, so QX MF and BMS of as launch, the the the flat competition has it's through is grew since reported in that's we're compared if QX. being earnings MF, drug one only Andrew, very XXXX from fedratinib - we're and

the patients So are are treated. office, back coming to getting patients

on getting are MF. patients Jakafi with New started

Andrew Berens

Great. Appreciate Thanks the guys. it. all for color

Operator

Thank you.

today next from coming question JPMorgan. from Cory Kasimov Our is

line now live. Your is

Cory Kasimov

my Hey, taking morning, question. guys. good Thanks for

talk release be RUX have indication, you commercial a JAKX XXX think might of What improve Your press a able Phase Can mentions compound? considerations to upon advancing candidate it? how motivation benefit advanced different the cream and Thank this you. having Or you're X potential to or the the just in there if about this are to into works about in you you vitiligo. see here? is you

Steven Stein

for the thanks Cory, for and it's bringing thanks up. that Steven, question, Yeah,

this another good effect relative in-house and you RUX in that disease, maybe, is of being will a risk suppurativa, So patient tolerance vitiligo because JAKX, were patients JAKX bring terms mild-to-moderate may this XXX it's a, benefit of of if to up, to a a view the also from currently used potent spectrum work. goes hidradenitis versus of regulator profile much there's inhibitor different a latter in more severe, JAK a both more for and point the most for unquote, point to setting severe more be need quote view of in there should profile, effect and different more a in in from

- a with from So a just different data. XXX-week to or cream and my a get more look perhaps, able be the in the oral for entity vitiligo [within then topical settings, we idea offer behind that and in and be is and JAK that. remarks, profile an in more holistic manner, we that's both a risk a you to their showed that patients potentially And we also illness, idea for effective testing. potent RO] worth treatment inhibition is here profile would treatment after albeit really way, think having as benefit more an a [ph] I and effect a severe potentially But, incompleteness the therapy, prepared different know would

Cory Kasimov

Okay. Thank Very you. helpful.

Operator

you. Thank

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

Your is now live. line

Salveen Richter

my Good morning, questions. taking thanks for

then, RUX just about pricing the thoughts JAKs and strategies front, the the just for seeing talk on and class? discussions? on out And the you on salesforce what payer could competitor, we're given through on On your with potential progress updates here and separately, cream, here read regulatory build

Barry Flannelly

Thanks, Salveen.

was we affairs, medical think, I is access So on so it's front derm market salesforce, sales, up the said complete. whether what - team, the that

on So They're board. they're all being trained.

Some time have trained affairs team long their having learning a their discussions about external preferences. been medical been already. for already on now more The experts, with has working

been about have talk price had goes price and meaningful payers, - the United TRuE-AD that's to the cover of been studies. They've X top States. productive. PBMs ongoing They've discussions the from that impressed as don't at we and presented in we the clinical point. very But interested including X them far very data XX% the this X by with lives the been As

JAK they've topical advantage the for us, excellent it an think all efficacy. with of So, we're obviously, we because inhibitor the been JAK in that. advantage delayed. about really atopic dermatitis cream encouraged inhibitors, of the profile ruxolitinib course, that is has very and, safety the But like The a patients of oral

Salveen Richter

you. Thank

Operator

Thank you.

Our Michael is Guggenheim. from from Schmidt next coming question

line is live. now Your

Michael Schmidt

filing? you I they morning. Thanks year positioned incorporate to how And approval my the factors might physicians file Perhaps lymphomas, later guess, filing options? I gating relative as my this you is, you treatment drug parsaclisib, in are think in potentially good how on taking potential perhaps the will in are these guys, drug where planning well, for what question a treatment feedback perhaps, all for question. has simultaneously, other X X the been do indications are guess, the to be Hey, paradigm? from to lastly, What

Steven Stein

Michael, Steven. Yeah, for Thanks question. it's the

now, lymphoma X lymphoma marginal non-Hodgkin's the meetings zone free are entities: with in response durable, survival. albeit in lymphomas independently and with single relapsed/refractory; long few mantle studies the at and rates, relapsed/refractory. and datasets again, different a arm extremely parsaclisib updated relapsed/refractory; robust So, are lymphoma We've cell in follicular reviewed which progression

you compound, like inhibitors. really delta with we tolerability So then profile, of of delta generation then the the inhibitors now the profile effect the terms with and and efficacy the in see out other second largely dialing effects deliver acceptable

in of no year's But to other is in all U.S. was the a in a typical and on which operate zone cell still the to file feel out indications gating are these in second and profile follicular, on in together. intent last in requirement settings, half everything's file we follow-up the is merely Japan. lymphoma, X and it approaches filing has XXXX. the the it well. other that So that regions there There's Europe working responders, mantle getting progressing have marginal we as the effect, competitive the We well,

we'll you there's In alluded with inhibitors, other positioned area therapy be how therapies. there's versus lymphomas options, terms it's Bcl-X an chemotherapy, targeted CAR-T in of where inhibitors, other the to, as BTK indirectly

physicians cloud in antibody one bit use not again, said, a early datasets early the - these I conjugates first not now, setting, tolerability are a little and face, they of are There's the on on efficacy area these data drug appropriately look call relapsed/refractory And, the settings, think, it well. and will at as again, out and over As few it there. lymphomas, people toxicity physicians Thanks. list there in seen B-cell the idea and of overcome. terms data we now appropriately combination of in delta that getting data inhibitors with different needs in will datasets. showing robust feel, the really its that hearing to we're of use used some tolerability it But profiles, to a be

Michael Schmidt

you, Thank Right. Steven.

Operator

Thank you.

from Next Young is from Cantor Alethia Fitzgerald. question coming

now Your live. line is

Alethia Young

wonder little there's vitiligo initial appreciated. think about been kind guys, my AD. you've done payer want taking Thanks. bit - proposition sorry, just kind like talk in put would topical on be versus of vitiligo how I just how they for between Hey, greater a about the far so value seen I that there of the efficacy value work you to dermatitis? questions. and Any some thanks kind realizing thoughts of kind if a of have, has atopic of

Barry Flannelly

Alethia. Thanks,

delay the of always to atopic using asking newly really payers, or a dermatitis, biologics use of so think, the up all the the for I way diagnosed either from about it's discussions had can think is is biologics. So of compelling. it far, They're we've systemic patients efficacy drug They the they and safety possibility therapies.

way best and the go. is an value, be needs vitiligo will in say, than one So other topical for that. for changing think it's drug encouraged cream they're be under an that - disease by vitiligo, excellent a with think to terms of that atopic understand effective, and they're that it's ruxolitinib to to very I safe ruxolitinib it's and going is to In therapy autoimmune beginning be treated, is like treating Whether that is very I cream difficult vitiligo. better the to life it's could an be dermatitis that

Alethia Young

you. Thank Great.

Operator

you. Thank

Truist today Srikripa Our next from question is Securities. Devarakonda from coming

now Your line live. is

Srikripa Devarakonda

bit sort dermatology, Staying you entail? drug potential soon much Thank to that Thank can wondering to expect but to us? Okay. so the provide how my steps are metrics you launches, expect have I close a access talked about and appropriately. launch was on launch much. of you have patients for we so can Finally, approver model after What once we your the that little you date, curve PDUFA the understand to So question. and does so given what a can to taking we the preparedness, drug?

Barry Flannelly

Kripa. Thanks,

it as So, it's matter soon the to we sellers out how a will a and they few wholesale out? as It out ship be of before wholesalers, soon to right have should we're to ship away, able to access pharmacy. days just it get drug, can it possibly the can the

be as rapidly matter not as a can we it'll days, So of if a week. possibly just

for able every the can metrics TRx like prescription what many we data do new on and data you'll just be drug So to the follow people out there. the basis, a Rx provide weekly for So curve?

for uptake a think be you'll there'll So we rapid drug. that, the see

net over time. to at gross be just beginning, But and may Our we total to will follow continue will. we the and be to Rx's after grow week Rx's impacted able improve like and week, new that that you'll the think it'll

Srikripa Devarakonda

initiate take a combo comfortable for the in Thanks. Phase into inhibitor. do internally can the you to to have trial half? is was with LIMBER Great. you up Or you it more you in X I X that on That X your sneak doing the combo? bar if question, helpful. with plan are And you're Phase the enough one then following Phase forward second What program, BET

Steven Stein

Steven. Kripa, Hi, it's

again, So milligram tumors, evolve, field we years drug this the plus XXX at, lack be - worked much the Constellation are purely the beginning. on a did thrombocytopenia. this the and it of modeled above a watch that efficacy compound, repetitive, effective may modeling out just few mentioned clinic we solid X of ago of lower safety the we're a real then, bar is myelofibrosis. because in XX dose withdrew a We in we at some profile now around be quite multiples we and dose bit milligrams, safety treating a to And, in in had for

document decision that we're around ruxolitinib Do registration see repeat the we to with safety the to of or not given patients alluded directed So of early this X acceptable end again safety, combination. safety a we're to X X which which do we using then the number or will to the proof-of-concept year, aggressive principally that document yet, Phase studies, dose to there the go Phase in aggressive in thrombocytopenia, juncture, aspect. now arena terms milligram year, At and more will and be be. a once choices have an how you profile will or we Phase the just we X, make then enough, to of to to quickly round next and we what repeat smaller of want straight to the be profile have is work make comfortable

Srikripa Devarakonda

much so music Thank call, whoever much. for the also the you the you call playing Star started. before And decision. earnings earnings so during Right. the made Wars Thank

So thank you.

Operator

Thank you.

from Our William coming Phipps is Blair. question next from Matt

Your line is live. now

Matthew Phipps

being completed ones look these in XXX, what rates the in wondering XXX-week some just by reasonable, for at given Impressive patients long responders but to if the responding there valuable data were the a my response do a from bias was you AAD guess, from that are that it patients that at notable withdraw vitiligo could at patients study? patients question. week just recent the there's Thanks not there XXX a shown of percentage meeting, But if we I to follow-up. taking those study, decrease the withdrawing chose

Steven Stein

Yeah, second don't to get back data, some me a the do have on question. to Matt, XXX-week points. have the but part of Steven. your in it's on I want you to I of I'll front XX-week make verse match

or by a you that's just at study time, to So nature database, that you'll there and have potentially missing and seen. partly be what have its missing you visits, database you a you'll the data whenever lock what's will decide and in

efficacy the In extension of on These to impressive are to addition, the reasons phase, I improvement, the they where over go satisfied that are at the various this, for when work elect the to may we because they indirectly things see they not time. drug and out people have with have degree time. we alluding extension think given you're in to

even are get message me, twofold-effect the when study little happening major back - needed thing the to of think the is a is formal For improvement also, come not really wanting present T-cell for want sorry, we interesting, though, people, in plus longer-term time. are But there to one I there, more continued There which melanocytes a visit, COVID example, impact say. area, there's - is bit the the And et is least this you we largely and seen is those conduct for for it But that there, me the understand of you or for a clinic to terms at cetera. is to numbers is study, endpoint. questions that really it's biology, and lived. they of long ask repopulating message gone, long what primary could a and over getting which how good later, major the somewhat X the the just the further. on smaller will withdraw re-needed, the time, And and is be fascinating. you're continued over be ongoing durable patient probably will pike. rates. your At is Incyte you've all down still really the to be years surprised way us experiments when is, in at noted this see a But an And will improvement we as suppression increase remaining comment treatment therapy, here in on

Matthew Phipps

Thank you, Steven.

Operator

Thank you.

coming question Ren from is Securities. JMP next Benjamin Our from

live. now is line Your

Reni Benjamin

morning, good Hi, questions. taking Thanks guys. for the

for you Let's a just quick to any this for is there pemigatinib sometime with? X are receiving key at And continues have you're the that moving just maybe are from and longer-term the just RUX focus should data I that data guess, I primarily you indications second. L-MIND other is going follow-up, grow, in Or how as sales And can on that forward keep competitive to feedback BA/BE big continue? ASCO the down other environment, talk Well, ones? given and points, year, Thank on once-daily have updates that especially through a data us written main later the this the mind? the might we strategy maybe you.

Steven Stein

sales talk embedded performance will Barry questions. your of there. question part development clinical the answer I'll So about the

And approved just the first product. Hervé rare the in uptake showed globally cholangiocarcinoma, well our then you in talk global a internally launch far Japan which and as entity. on excellent So, is second-line Barry to said, so Europe now discovered in as in indication first about our

potentially a that driven. that in of more FGFRX cholangio is good the molecularly way, there most more an IDH, is again, and there patients are other of And getting carcinoma FGFRX discovering However, like in common and beyond given now entities more unknown targets these awareness one profiled, are more of origin additionally, cholangiocarcinoma. now they're beyond

first-line feeling profiling be as of is with there treatment molecular entity itself lend driven, ongoing we have to our as study. when FGFRX may approval, cholangiocarcinoma So an that and gets part that a accelerated pemigatinib. Remember,

in other et you BRAF, So different lifecycle profile even Cisplatin. entities drives so plus, against look profile earlier tolerability you It's look migration that's MEK, you And cancer at to this versus where terms ends critical idea Gemcitabine of a cetera, in targeted molecular lung of obviously, chemotherapy. behind with particular oncogenic settings a being see melanoma have first-line a management. line that's a chemotherapy EGFR, that first-line therapy. in terms an or that and the Cholangio, with very And terms driver in up tumor, of if

that to is driver as of and the around We agnostic tumor that any there buckets molecular have optionality and an amplifications, ongoing well, then fusions, or there now there looks side histology we not other signal, enrolled there then, agnostic potentially large is pursue belabor to this, potential setting, study that at And that to there. but different strong-enough are rearrangements, the a at particular setting. data tumor a two, do or is if either a there where to gather standalone work in look a may be driver and

use of largely EV because paradigms, on and and go, pemigatinib. earlier has focusing calls, think the in inhibitors. of as view So checkpoint on those of with clinical are that point cancer this of development how we'll very is the way plus important said prior be year from the changed We earlier environment we've terms don't bladder endeavors to a there to treatment us

that just spoke pemigatinib the Barry the will and we speak performance the lifecycle about. data So on that's side about releases side,

should said, Barry bioavailable publish L-MIND performance an at forum since it can important then, of and bioequivalent said the incredibly duration topical RUX. response the is X of study it as present have results, continued ASCO. also have idea in up we on Ruxolitinib the year. Phase with the obviously, pemi? we'll - particularly actually very this in XR, on have side important present also is And or Barry, you follow with to So appropriate of X-year the data, the half about to the data vitiligo to I appropriate for what forum the intent speak

Barry Flannelly

Sure.

Pemazyre's so performance we're so yeah, very with happy far. Ren, So,

launch when really of primary, of a FGFRX them some have you actually a unknown don't many therapies, are tumor is some be of alluded might patients, where no disease other into sometimes those fact area, carcinoma patients may you fusion. out or rearrangement patients think there. know there in type, the I how cholangiocarcinoma Steven to

what that's the in to therapy, anticipated, XXX around regular have turns there then, our United of X,XXX experiencing that patients to think our So than population. the might assumption States. it I initial duration we're estimates is and perhaps And study out both in than the the just patients be from more been from longer patient we

So nice that's therapy, because, fact, getting in competitors that Pemazyre. nice therapy. getting excellent patients It's, tested, helps in first. with think with therapy, it's have staying to drug, FGFRX on space do in us. they're to we it's that encouraging cholangiocarcinoma getting are I And alterations, then very an one, launch And this like launch

drug benefit from can starting a ultimately patients its all with will duration Pemazyre any like for prepared still we're but we So think of efficacy, and therapy we offer. competition, that that safety,

Operator

you. Thank

coming today Oppenheimer. from Our from final Jay Olson question is

Your line is now live.

Jay Olson

could the guys, priorities Europe? RUX commercialization you development partner specifically, taking for business seek comment plans on a any for to Hey, for thanks about year. in this curious you. your And question. Thank I'm topical

Christiana Stamoulis

discussed So in in have of all, us, the past. terms the changed BD we of for first from not what have objectives priorities, the

diversification existing for and develop continue we our and look leverage our could the that contribute to them. expertise, mid-XXs So where assets in we to could timeframe, infrastructure growth plus to commercialize and

remained So same. this has the

the decision. our of before indicated from of we best regulatory wait little point in vitiligo And more determining timing cream we in we have for of going are therefore, for the Also, we file what there. forward bit RUX terms the In are a a approval. in is view, Europe, way to time we we before as process data past, finalize have

should the So next it we at can and months we on follow few that that finalizing in up point. be

Operator

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

Christine Chiou

everyone, call. operator, great on day. you, thank call for available and this questions us We'll following be the today. for Thank joining Have a you,

Operator

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

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

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