Incyte (INCY) 4 Aug 202020 Q2 Earnings call transcript

Company Profile

Participants

Mike Booth	Head of Investor Relations
Hervé Hoppenot	Chairman, President & Chief Executive Officer
Barry Flannelly	Executive Vice President, General Manager, US
Steven Stein	Executive Vice President & Chief Medical Officer
Christiana Stamoulis	Executive Vice President and Chief Financial Officer
Vikram Purohit	Morgan Stanley
Cory Kasimov	JPMorgan
Brian Abrahams	RBC Capital Markets
Salveen Richter	Goldman Sachs
Evan Seigerman	Crédit Suisse
Tazeen Ahmad	Bank of America
Marc Frahm	Cowen & Company
Alethia Young	Cantor Fitzgerald
Mara Goldstein	Mizuho
Jay Olson	Oppenheimer
Tyler Van Buren	Piper Sandler
Josh Schimmer	Evercore ISI
Ren Benjamin	JMP Securities
Aydin Huseynov	the Benchmark Company
George Farmer	BMO Capital Markets
Stephen Willey	Stifel
Matt Phipps	William Blair
Michael Schmidt	Guggenheim
Tyler Van Buren	Piper Sandler

Call transcript

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Operator

Welcome to the Incyte Second Quarter 2020 financial results conference call and webcast. At this time, all participants are in a 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 Mike Booth, Head of Investor Relations at Incyte. ahead. go Please,

Mike Booth

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

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

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

everyone the effect webcast still Hervé. pandemic and with that begin important our COVID-XX our full that it caution actions business the is today. situation, We'll to call assess mind like to now to early relatively in is economic social call would speak overall be policies of conditions is on Accordingly, with and governmental, as evolving and statements on I it this the addition, keep able business. In of and the an to

Hervé Hoppenot

reach MorphoSys. in to and execute received regulatory Monjuvi revenue continued Thank the quarter, success approval you, first in believe announced key clinical driving recently, Tabrecta. first growth, well actions revenues collaboration our further our and Tabrecta, grew in and business, And therapy strong to and revenues we the were and adults including potential the In treatment improving good to who year-over-year the XX% to we for morning, to Jakavi in disease. XX%, $XXX relapsed quarter, grew of of the to just million patients approvals royalties of and of QX, second also and we licensed Jakafi the transform since the sound Pemazyre sources or Total for We pleased achieving programs, the And also royalty with six time royalty with two product quarter. Mike, approvals while reported $XXX able Novartis. facets up we the for financial across refractory XX% product million has has product first with is of treatment which DLBCL, FDA-approved Monjuvi everyone. be for I'm it is position. second and various second-line the report year-over-year. nicely, up respectively. XX% our Olumiant

confirms from trial also We proof-of-concept encouraging ever the we randomized from is REACHX, results responses tafasitamab. in data ruxolitinib announced conducted data two-year largest of L-MIND which to our chronic the EHA, presented trial, patients. positive as durability of plus the the At as GVHD clinical steroid-refractory parsaclisib well updated trial well which

line. to ongoing strong last cash over five revenue $X.X shows add at is with billion to years, and new approval our quarter. the Our our and end financial also position we equivalents the momentum of the very several further expect Slide top in recent

of in are momentum the by subsequent the expect both focusing to Monjuvi GVHD. Novartis to look drive successful Pemazyre, and in and of year, of the this Jakafi we additional we following launches launches increase expect growth MPN Tabrecta to both we royalties remainder and and maintain Furthermore, U.S. approvals During the on and in executing Japan.

ruxolitinib plus approval seeking to we in program atopic expect and with Before the also the in we of pivotal to end XXXX, initiate submit parsaclisib the dermatitis, NDA of cream, plan myelofibrosis. for ruxolitinib patients

provide Before I felt off important it's Barry, hand I to impact business. overview on to COVID-XX of an our

any regards development, been have to revenue key side, has the date late-stage we any been there has time not reported no fronts, since impact supply and With on to On on and QX. there to seen not clinical material regulatory the key change programs we impact line.

studies, time impact lines. and largely shutdowns track affected remain original to COVID-XX the While transient, on has we been due certain key the with

example, new have recruitment quarter, the a results to experienced Therefore, pre in to the slowdown XXXX. achievements early These we the commercial vitiligo our recruitment and of has this will call in over in we development announced results REACHX In strong patient important the continue programs while I two expect since progress levels. For XXXX, pivotal study beginning rebounded in products Barry. pandemic call summary, excellent of and year approval since has on announced are parts positive of to from pass performance now transformational and clinical Incyte. top TRuE-AD. for separate three

Barry Flannelly

and Jakafi year-over-year. you, good sales Thank Hervé, increased morning. XX%

patients impacted all were to across May, shutdowns new related and negatively regional We to to continues indications In due see three a and therapy grow. of COVID-XX. continue on to robust April starts patient demand number

customers since years. team that Despite am have – However, the accustomed continue since seen over I and providing of in June have the pandemic, early their the the efforts our of new been starts. of challenges a to we level proud for responsiveness to patient rebound our June, service

are programs with multiple, our engagements, continuing, customers. our field representatives and our virtual are We conducting and have multichannel digital expanded

X. to Turning Slide

in than appropriate identifying on the and there We have successful therapy. more already been patients are patients, XXX

issues We encouraging. have not any and patient rates reimbursement refill unexpected had are

much patients. physicians therapy a community proud settings provide both a needed to and help we to maintained of with and their depth prescribers have We able in good academic are to be these

first response We in as Monjuvi FDA-approved the convincing data are Monjuvi, lymphoma. with diffuse clinical also U.S. approval treatment adults prescribing for the a B-cell in of that option non-chemotherapeutic an large included reflected important excited compelling With with second-line about is clinical many the large the the significant has duration profile a associated treatment. transform of lymphoma. forms other for rates patients B-cell represents response opportunity long of information. to care avoiding of relapsed/ diffuse standard a the toxicities Monjuvi of while refractory with and

of Our commercial are team and fully joint MorphoSys medical XXX equivalents. with full-time staffed teams Incyte approximately

we prescribers, subsequent the increase which which have following and We both the launches U.S. in Tabrecta royalties also prescribers. XX,XXX are both and by potential Executing Novartis for Japan. of approximately XX% Pemazyre, Jakafi -- Monjuvi expect to and and launches approvals successful identified

programs place. end we Before broad for oh, -- expect the have plan in market of access already XXXX, to we sorry and patient assistance Monjuvi --

and challenges now diffuse need leave the new lymphoma, are launch. large pandemic ideal B-cell significant turn for in presented believe us company's well Monjuvi's While successful the combined for launches, to patient COVID-XX profile, the over expertise call relapsed/refractory, not With very strong that, unmet by I'll our we clinical Steven. a positioned

Steven Stein

data in graft-versus-host in REACHX Thank importance in you, best the and of this of overall the ruxolitinib in the Barry, therapy announced largest survival. positive randomized JAK reported statistically consistent ever and scale and previously achieved of endpoints. of The key improvements conducted inhibition graft-versus-host primary studies treatment free evaluating steroid-refractory our good chronic endpoint trial with response disease the symptom ruxolitinib morning, patients failure available in graft-versus-host everyone. This six reinforce patient population trial, disease. graft-versus-host at was clinically the month disease. chronic Recently, of Ruxolitinib and success safety versus ruxolitinib with we superior profile rate meaningful significant and secondary both modify its The was disease. met of

at Congress, are preparing to Following and to the the these results, the data an Medical upcoming supplemental submit NDA we we REACHX FDA. for expect from presentation submission

to on LIMBER program Turning slide our development XX.

combinations five proof-of-concept through program presented strategies a milligrams combination plus the our additional management, of we all inadequate and LIMBER once-daily of potentially is we are in advanced benefit our fronts. ruxolitinib parsaclisib response multiple and progress targets, adding including of ruxolitinib daily monotherapy. we of which and have most cycle part with ruxolitinib, formulation showed ruxolitinib As on new ongoing, an patients life ruxolitinib The making with recently within obtained the to parsaclisib development myelofibrosis positive from data,

tolerated Importantly, events ruxolitinib with plus adverse further of both warrant addition are to response were inhibitors of combination study suboptimal and a infrequent delta to myelofibrosis was kinase and patients treatment-emergent in These with we PIX results and common initiate to the monotherapy. parsaclisib of parsaclisib. parsaclisib MF well in the first-line patients ruxolitinib addition the trials planning

lymphomas this complete duration data XX. with of duration These XX.X that The a presented tafasitamab opportunities The we Association, for first median first-line for the L-MIND achieved Hematology trial response. complete We expect been diffuse European beginning months, expect B-cell was L-MIND select we from the expect diffuse slide. our data hope was study lymphoma and patients have this appropriate forward the lenalidomide pivotal and collectively data tafasitamab presentations. XX% in line, the in partial June, and MorphoSys, median R-CHOP two-year of reached. Turning slide we large to consistent of tafasitamab to response from believe other has the XXXX. lymphomas, driven in rate that are from data responders results either which have at lymphoma diffuse and multiple by updated of the B-cell response results overall R-CHOP plus plus we in the prior the or not responders, initial yet combination summary complete non-Hodgkin's large response large with only lenalidomide. In study and were B-cell on a XX% set shown into we based move tafasitamab. as trial Later from in near-term first-line plus combination, for to the Working year, with

to year. initiate end evaluating non-Hodgkin's study the a of before plus in this also We lymphoma expect parsaclisib tafasitamab proof-of-concept

Turning programs now and to our autoimmunity. in inflammation development

studies collect for mentioned upfront, well, our Phase the at patient the track, now Hervé on for beginning of enrollment two dip continue track cream to the the of in XXXX. submit we XXXX. the at timeline rebounded recruiting development The We has to III trials remain NDA end plan are as very on second new long-term dermatitis pivotal remain vitiligo ruxolitinib data safety atopic from our and As since quarter. and results

made significant XXXX. thus have progress We in programs our development key far within

and year programs. positive three have announced this have approvals data product multiple from presented We

expect pharmacology to continue in-house from XXXX. in data studies to We ruxolitinib ongoing of the once-a-day have

the be related for critical until data next of these While won't external a track these ruxolitinib are presentation transient the and on approval sNDA on an year, we submission, seeking are not of in XXXX. once-a-day still data COVID delay means path,

to perm trial ruxolitinib. decided our have discontinue We inhibitor also with to development combination its and

call the underway, cover both the to the of like turn various reminder of that Christiana and I'd for a baracitinib. trials update. Lastly, that, ruxolitinib are over financial including With to studies

Christiana Stamoulis

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

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

million increased results revenues commercialized for of rate later Jakafi, recorded quarter was Moving Iclusig with of as a and cost development a of and represent and the of Olumiant. primarily XX% Tabrecta the decline on continued Novartis of R&D for in from and and over of our million for in increase the representing the Total to product the to the to the increase to of for $XXX products to experienced the costs Pemazyre. increase of a was XX% million of quarter, over we We $XX revenues be therapy Ongoing driven million increase programs commercialized million pipeline for in This was basis, non-GAAP quarter prior an our exception year as the a primarily quarter development. by Jakavi the stocking and stages $XXX the $XXX $XX a increase $X COVID-XX of $XX basis our product the prior revenue result quarter a and expense SG&A other progressing potential XX% growth of the for increase for for X% cream. X% the due recorded Pacific $X $XX quarter. for million, increase year partners, some million, quarter as from for revenues. million $XXX both in an first quarter. ruxolitinib total milestone in over X% was and expenses basis, a a for royalty those royalties clinical representing was $XXX to and is to on expense quarter. net non-GAAP of quarter, represents million revenues, commercialization revenue we share Pemazyre of royalty where commercialization XX% prior tafasitamab, increase preparation of Tabrecta the revenues, both the as Incyte on the the with year second and of approvals of pandemic. product year ruxolitinib Jakafi year Revenue in due commercialization $XX quarter by from trials Iclusig, well non-GAAP over loss Lilly to our Royalties that the Monjuvi. well the net of prior efforts global of of the by strong, across share for This COVID-XX million related million below which XX% for and loss potential Total for Collaboration U.S. related U.S. due growth million for and Pemazyre. royalty comprised XXXX. an second product This growth representing revenues the

Our in of cash marketable with the strong, from XXXX. billion to The as financial decrease purchase generated quarter and partially stock XXXX purposes first the flow upfront offset the $X.X and by during we in $X.X reflects the half related cash the payment be collaboration, continues ended to position securities. billion year-end

Moving and our our guidance on are revenue XXXX, for we year. guidance the for to reiterating expense

continue we the COVID-XX, broader believe a with uncertainties including of associated While there risk these resurgence, capturing ranges are to provided. be

guidance consideration Novartis. our million a excludes to the related the with As reminder, $XXX R&D collaboration around

net or loss providing Finally, from Q&A. prepared for profit Operator, and resulting remarks. our U.S. we for Monjuvi stage not commercialization sales the open at Pemazyre this activities or your that launches, on collaboration of in the on give early concludes their the are our call guidance instructions Please

Operator

Certainly.

session. conducting first be Purohit question-and-answer Instructions] question now [Operator from is Our Vikram will Stanley. We Morgan coming today a from

is Your now line live.

Vikram Purohit

taking Hi. Thanks question. my for

two had LIMBER questions So I the program. on

looking to to to a discontinue what design going PIXK wanted just there more I to of to a you talk about led if the RUX you're a would initial and the then be? in thinking I the data for more facet that And studies, wanted like see you're studies setting. first-line to and bit plus perspective about saw you if those could bit refractory the about talk Thanks. RUX in that could is initial see just you bar look what start the plus how success First, from the you for what PIM program? LIMBER decision secondly, combination

Steven Stein

Vikram, hi, Thanks question. for It's Steven. your

program very standing forward. we've some you above interest a chance if program, the success in much terms dose of weren't In as to the the and going wasn't efficacy far tolerability felt and last PIM that we RUX PIM look of at in then inhibitor of and with combination and sort XX that to as high we profile were left of the seen, milligrams, liver know, although had in, pre-clinically And it the in interested get of due able it's transaminitis. R&D effects terms programs, we perm across largely we on-target

those of liver tolerability, adequate efficacy both reaching terms the reasons, two for in and buyers. So

RUX-delta our Turning explored shown as delta program. to in various to program, proof-of-concept dosing our remarks, lead data. and is schedule and we We We've alluded regimens our clearly, internal there's effect. a the this

terms and responses. that, as patients increased for stable in our as on upregulated couple been If a defined data spleen the strictly preclinical months to delta to we you dose saw that response, makes effect we've in proof-of-concept of sense. as well of very clinical with back of biology, a is although had months. pathway symptom myelofibrosis, And seen, this that go Even six have PIX-kinase in RUX the a

study, months responder about on suboptimal least spoken who've people study. been RUX a an we've as they're first studies, two three as not initiating having well a and as for we're adequate at response, line So RUX

of should terms study and those we to have public. start to clinicaltrials.gov to listing. wait go when the They obvious make particular In the up study go endpoints, on up then suboptimal will you're before Thanks. the for that we that relatively the for first-line listings studies these responder be going

Vikram Purohit

you. Thank right. All

Operator

you. Thank

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

Your line is now live.

Cory Kasimov

around And morning of expanding you promising can good to the And approval, for for you're unmet the on the next and label -- to, question. even the setting -- taking syndication? would expect ahead steps guys. I thinking kind there? and the just data more know GVHD Hey, about REACHX I use GVHD. but expect not market you would this to you going you that's describe the out we spontaneous should need chronic given in more timeline opportunity for ask wanted of be Thanks and

Hervé Hoppenot

us start I'll released outstanding will patients press assume REACHX rate outcomes. both Cory, plus symptom six, take. the failure-free for off the study and very of terms the for the endpoint modified and of lease outcome strictly hitting alluding recently Barry, in part month I have to response score. it second It's survival the in of PRO, question, you're primary, we terms put So defined patient the and an overall outcome your then that the at

outcome will great -- that, obviously, REACHX a filed we as we well for So now.

continues work naive, effect various steroid with plus further it Now at be as a with chronic graft-versus-host -- I ahead talking this of doses as you can just dose supplemental year were here. We're steroid disease, itacitinib in before in the as I filing if don't schedules itacitinib we'll work of and that NDA there the soon going with know exploration. also we into label. about terms looking terms getting REACHX initiating

graft-versus-host entire we’re very filing steroid with So then with both naive. the and of in spectrum still active across disease itacitinib

Barry? well, In terms of your question,

Barry Flannelly

use the publication to full spontaneous Jakafi with and or not that already of awareness occur. there's top-line that use we'll the I a will in have and until chronic time, there's spontaneous additional REACHX, in wait we see. only think results may we terms some know GVHD because in use released yeah, Cory, increase. obviously, some presentation chronic Hey, At But from GVHD,

Cory Kasimov

Barry, did that see major transplants was you And fewer place? presumably impact the COVID on front, Okay. any GVHD from taking

Barry Flannelly

a new we patients. certainly decrease in saw Well,

So, as total you the are Jakafi. represents know, a Cory, that part starts new on patients small of number of patient really relatively

they're transplants that back to safe a April requires saw and were So need patients that in know marrow a transplant And we We bone May. it. decrease, when have marrow more bone and do delayed. we their when know that feeling disease perhaps come

transplants up. GVHD So as more then will up, go marrow go bone

Cory Kasimov

Thank it. Appreciate Okay. you.

Operator

Thank you.

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

is line now live. Your

Brian Abrahams

Thanks impact very guess, with a guys. Thanks. in Hi, any Barry. any patterns you overall the compliance for stockpiling I'm question Can to rebounding changes growth about patterns or if saw expect you're inventory patient to you any seeing now corona. much indications there's taking across follow-up the the any I that question. or Maybe that Jakafi for to with then, Jakafi, maybe my two of due And July shifts August other and in see level curious changes pandemic you also would in persistence? talk use?

Barry Flannelly

of don't percentage I all who to that GVHD are Well, really Brian. think patients due Sure, and for myelofibrosis the changed taking at Jakafi COVID. PV has

York in quarter and patient after have you we new small each the know, each new now particularly week month each new Now June in in to for anyway. and relatively in back. given or patient we July, these week week, given seen East certain of starting saw coming June, have said, regions, Jersey, particularly But as you start New new we but down. small starts, seen starts week, can In increases patients starts I go indications do imagine patient in and New Coast,

of one So, area of sold. again, terms really total another versus seen amount bottles any haven't in in we movement

Brian Abrahams

Thank you.

Operator

you. Thank

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

live. is line now Your

Salveen Richter

morning. taking my question. Good for Thanks

year, forward? data data level this So to as oral what proof-of-concept towards And for move we of from you're PD-LX looking of can help expectations see? look you the frame inhibitor the later activity type on we'll

Steven Stein

the Steven. for it's Thanks Salveen, question.

and present our and of So this half well, cetera, in prepared clinical PD-LX half program. specimens changes in directionally we year be data actual next of data that translational have we the year, we'll supportive we clinical entirety from able and of Substantive to median inhibition, that continuing. program, its in et been terms our progressing the year. data we've from be second in that now cell this show where continuing phase are of the to likely the Thanks. But oral in program, T of the the this we're will presented degree a are want, of more supportive all clinical right hand second PD-LX

Salveen Richter

Thank you.

Operator

you. Thank

next Seigerman coming Crédit Evan today from is Suisse. question Our from

line is live. Your now

Evan Seigerman

much week great Friday. Hi, so taking my with approval of today and all. late Monjuvi results Thank on you congrats the and really for question strong a last

us bladder you And setting, delayed of of just the tumor-agnostic on it just patient population it is then as if penetration the status the remember I eligible So this Pemazyre, trial? the earlier, with you can and this mentioned earlier can't remind launch year? the also on into cholangiocarcinoma program, following the color any

Steven Stein

Steven, thanks. Evan,

well the actually, biology there's not in It well. the probably question, as your much amplifications rearrangements as as of there, all. it's terms in at various need extreme unmet in a any well affected an speaking across as been COVID if activity fusions of testing by well, to as tumor-agnostic molecular program terms enrolled in so So extremely has in

histology So that's well. that they're We progressing agnostic, are buckets. up and different fill

complete you a half continuous terms will be year. bit it bladder program, presenting data, next the the will in dosing data the be experiment. about the Now of spoke second year the we But little the will in of getting

it the program, Barry. then I'll to over that's turn status So bladder of and

Barry Flannelly

Evan. Sure,

penetration. about talk you So

that more most know as continuing. come over well treated I think And for have actually, back there there's – remarks said refills those as patients patients I of my in prepared that already. was XXX they're we

patients something on will what this But is ahead right we the internally. in reported is follow. we duration than XXX continue million $X of that now the that therapy of predicted even to So quarter more and therapy the

Evan Seigerman

much. so you Thank Excellent.

Operator

Thanks.

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

live. line is now Your

Tazeen Ahmad

lenalidomide, on taking combination that study. Good perhaps prefer? you're a I the just of a my at there looking about would in to that how questions. morning, get effect to like Thanks thinking given sense a to priority to possibility, particular it you're profile specifically therapy? be its its wanted that for your is you the As hear might to having of how somewhat relates impact that some Is potentially the I'd thoughts side it Thanks. patients' combo, guys. first-line two of and avoid or desire on

Steven Stein

for Yes. your question. It’s Steven. Thanks

diffuse lymphoma, XX% historically you at with approximately tried beat the the If do XX%, look first-line B-cell easy standard to past of care a and Many remains been rate. in that have hasn't R-CHOP care that. to

that it's and you That's So cure rate. improving really to upfront beat about what the achieve have efficacy bar.

a and in it's bit about tolerability upfront. of because sacrificing – So terms maybe care little

up The the as wash, end yesterday, and going at no this R-CHOP from the key, ends and be efficacy talks is the data getting R-CHOP, we the may the the the plus said R-CHOP that's looking with on that's end either we by of regimen will the see. increased a doublet alone, safety that year, bar. it's safety there's up let's worrying the tafasitamab If get call because to being data, way tafasitamab we'll plus regimen. about plus mostly So talks be or len

yesterday, us this then in-house the on CMO endpoint. MorphoSys subject and that getting still on call the said with to the is regulatory appropriate data As discussion

But have there. just win want caveats the here. to efficacy to I you on those reiterate, So are

lymphoma diffuse upfront. B-cell cure improve to Thanks. have rate in You large the

Tazeen Ahmad

Appreciate that.

side maybe the a they percent Just older this that might to be with patients, given what effects? prone follow-up, potentially more of population

Steven Stein

to you asking have out find the terms age, not for I'll In sorry. percent you, that of I'm what above epidemiology if is XX. sure we'll on back are to to you. have get

Tazeen Ahmad

No worries. Thank you.

Operator

Thanks.

next from coming today from Marc Frahm is Your & question Company. Cowen

line is Your now live.

Marc Frahm

maybe about to Barry, tafasitamab? are aren't and that things on Barry working had to launch just the those about take that guess, I the and to going relative on launch what things how your launch working, expectations. have questions. internal comments my get to success the Pemazyre follow-up you of learnings virtual Thanks some Yes. applied to are your

Barry Flannelly

Yeah, a Mark, I think lot, actually. learned we

this programs, things things really work. that virtual Virtual I visits, -- that speaker despite work think virtual keep boards, these all we we learn programs, advisory doing. virtual pandemic, of we'll

to we these virtually before learned targeted For so our were we the medical that, And positions had want effective desperately new know the of able our patient approved that They to being What how who oncology through Pemazyre, each representatives. to manage And we specialize cancer the terms B-cell and therapies. we lymphoma. then, nurse our their really cholangiocarcinoma, had target time new very help first about them a and educators used GI docs them. population. drug launch and reach is wanted our proved they that relates to and liver second-line we ahead drugs, I for reach that for really in forth. first the Pemazyre that in patients about and large them for Pemazyre for these before. course, need to launches diffuse a it people new that options to of able anything particularly with affairs to out was much Monjuvi, And It's were period, drug never think relationships during effects, this of Monjuvi to use is clinical side docs about and docs dosing want also time hear new hear about

Marc Frahm

even people that demand cancer? in then seeing, or available can't seeing tumor-agnostic some Okay. the off-label inhibitor already you're use the in indication the or initial maybe bladder just that is who tolerate you're And either cholangiocarcinoma all-in on

Barry Flannelly

that rearrangements It's infusions. cholangiocarcinoma Yeah. for the best of have patients our It's Marc. FGFR really all-in knowledge,

Marc Frahm

you. Thank Okay.

Operator

Thanks.

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

now Your is live. line

Alethia Young

to can about program? and progress. ask you Pemazyre your for question, the my It you just then upcoming Thanks. monotherapy the talk a a taking and on talk continued that into wanted for program, Thanks data. focus guys. for of, little combination And I have Hey, on to bit there? the just the looks about now wanted question kind congrats interesting, you the all launch on investment AB heading

Steven Stein

Steven. It's On to the your off. start I'll Alethia, program. question CITADEL So related first

studies So really at and cell the data have mantle all presented route all we points zone, well. various Follicular, the three histologies. along marginal enrolled for

the activity the as we of as of wanted, in have We well response the range durability we high wanted. that

with approval we and filings meet, those So they're designs and but The the for are of conditional lymphomas. different likely over the related combination. world antibodies, likely in are be to about under or with get with that where investment the monotherapy we CDXX will be to hand confirmatory it's the I'll all And to likely appropriate and then, in allude programs, still to of refinement that even we'll launch. marketing include to, will regulators, proceed parts relevant. question which we authorizations. accelerated They the treating in-house, you discussion CDXX as combinations are And need given regulatory or further

Barry Flannelly

Yes.

about that you be multiple launch, said But could to or the we Hervé related So, were guess Alethia, vitiligo dermatology I we're I approval dermatitis. think asking diseases. unit obviously, and it's times building AD continuing separate for relatively we anticipate the AD a after atopic for vitiligo, investment because in get business soon autoimmune

medical affairs out board are already of organization. a So good access team, building on our market we the team. our have commercial We're part

cream continuing our atopic States. RUX And, dermatitis So because United transform of the that could getting we're investment. we ready, believe the really really obviously, that's in treatment

Hervé Hoppenot

the very Regarding, – is so situation U.S., the that's clear. for where just

that we Europe, in indication could of the first – of the where, the vitiligo in submitting. will are the in be be looking rest at Regarding we scenario fact, world, the the

commercial are there. that with months in can are are is I Europe asking going you like have And how able we at the of be time know different time. Europe, And still the of communicate in from the few be our requires to are behind. that have in early be best Europe take going more to looking commercialize So and what for level some timing next more want following – we'll probably we model to division a slightly, U.S., frankly, the and And we deployment we we'll through than it we slightly a really year.

Operator

Thank you.

Goldstein is Mara today from question Our from next Mizuho. coming

live. now Your line is

Mara Goldstein

from perspective question. see program my you question from And a is the from taking CRS? for we there Jakafi a to update trial are retifanlimab COVID-XX initially? and program of and clinical on had an much which secondarily, so are PODIUM the I status where then just Thanks the on Great. likely data

Steven Stein

Yes.

IV terms at submit anal have, and again, from PD-X incredibly in half of all data that meeting endometrial well. cell we cell carcinoma public. this year, Merkel cell will that's enrolled the second niche to a and anal when programs medical of intend Squamous data program, retifanlimab, our In inhibitor, be MSI-high Merkel carcinoma, the

versus to study is there And in respiratory the reminder, and a It's the ICU complete endpoint one with just endpoint that's for care of that conjunction develop that XX. by die, RUX before the or have and evidence XXX patients. twice a COVID-XX, standard obviously, in plus RUX-COVID, hope in two at programs. RUX report that's study ventilation, of was care. year. who in X globally require progressing cytokine we of The Novartis are storm patients have failure but terms of well. out looking end primary pre proportion There's standard of called with data, patients those daily, And an In care day of mechanical are milligrams

in in second ourselves ventilator study United the largely we study. States is run the The

there's it ventilation in care arm because are less XX-milligram COVID-XX terms those and because terms on that. tracking So versus two than standard of a failure was bit RUX, BID care both X-milligram standard there's a BID of people a behind it's again, is with of little respiratory who arm, of avoid associated dosage largely adults with to less are ventilation, and in that has arms enrollment, trying there

data the to tell hope year, on end N hard we of exactly the it's larger. but the moment, at that when you, again, before that to little was you the a just So study, remind

XXX And one, So that there's a arms. day survival patients very to because through primary was was endpoint overall the due course clean any was three of XX.

So those Thanks. studies. that's the of status

Mara Goldstein

again. Thanks,

Operator

you. Thank

Oppenheimer. Our Olson next coming question is from Jay from

live. now is line Your

Jay Olson

the trials on quite And the question. follow-up thank where goal. RUX PIM plus have tightened little into parsa taking on moving the LIMBER RUX wanted a the you plus by discontinuing but few and you've pivotal still on Congrats you focus to for Hi. shots progress. up you're a I program

of and which are of those success clinical was the probability I So differentiation? the you most highest with excited wondering, about you. greatest Thank

Steven Stein

Yes, Jay, Steven. it's

all plus important diseases myeloprotective obvious a beyond neoplasm the reasons, the passionately the have just So us ownership ruxolitinib, of program for even to about. we it's lot of an scientific very extremely feel space, we

Just remind you, the LIMBER program has three pillars to it.

file down work pike The that intend and a of believe going our potentially we may well, which we remarks. sNDA And next also from prepared once-daily in about is itself year. is point and view, mechanisms. once-daily fixed-dose first we with doing in work, formulation it itself one lend to important us the And other the to is formulation spoke that and combinations convenience the

to second to enhance In both. remarks, prepared plus RUX arm, and particular study program. this the have about a the or efficacy we first-line data, either the suboptimal disease the we're in year. or well safety internal as is proof-of-concept the spoke we are programs, RUX initiating we in setting ways lead the responder both feel terms study as which parsaclisib Those Again, of myelofibrosis one

underlying will due in the disease, the terms play on like efficacy although hepcidin importantly, on see go to we'll that And could improving combination the very in setting. inhibitor, The longer to leads chosen, the it quickly then surface, as important of a not where improve monotherapy to if second-line BET potentially other it to we'll ALKX us first-line that works, looks work the the well. in anemia, inhibitor, to Again, be program, of safety that JAK RUX very the stay in then there. a work patients well then only myelofibrosis are and this due as we've our resurrected anemia, as should allow dose improve to also that prove we're but really just to doing or and at should are us. inhibitor tolerability and a mechanism setting either so year, the programs And effect

ways efforts hopefully, monotherapy then now in, And obvious about, but the is of that safety combination, the So all by which it's this again, run and less third we end for ways, be or may should out reasons, looking shop itself. be other new PVR announced if other those that they obviously at when in we get other interested in targets clinic. of epigenetic discovery targets, will speak around the also to and pillar, even year. go to Dash And

program. the entirety Thanks. the that's of So

Jay Olson

Thanks Okay. question. taking the for

Operator

Our Tyler next coming Van from question Buren from Piper is Sandler.

is Your live. line now

Tyler Van Buren

light results, I a question product had guidance, was seems on pandemic. which Hey the in to Jakafi the and conservative. revenue ongoing quarterly see good reiterated morning. Great of the especially very

new that June. rebounded mentioned in You starts patient have

You end guidance if flat of have in the a and growing demand And an basis. tree patients quarter-over-quarter pool at a all in of the relatively or still top growth on lower you deceleration guidance, it's absolute assumes year-over-year robust look the total the yet second indications, of the half. growth midpoint rates

in just potential Or the it's year-over-year guidance to the that are any there the So uncertainty factoring due factoring also pandemic? should that consider? pressures ongoing is we

Hervé Hoppenot

Tyler, absolutely right. you are

half primarily this grew you coming first of volume, to XX% look coming first the demand. compare the growth XXXX, you the half in from XX% Jakafi when of If we year, with the growth at over from of

to this we think the of low low the look this, up you end would in the of were if QX. you The at if that point and flat would at a be, implies to end QX guidance bringing year the anything, guidance. So QX

broader point that had set this the to broader a that able where risk it's it to year we from significant appropriate a resurgence may a to uncertainty to be see we guidance the that see in So in may remains COVID-XX, resurgence, year, the felt to we the keep that impact COVID-XX. at we impact from address keep any this around given guidance for potential

Tyler Van Buren

additional Okay. Thanks the comments. for

Operator

you. Thank

today coming Evercore ISI. Schimmer Josh from question next Our from is

is line live. now Your

Josh Schimmer

Was Thanks peak in that a taking complement so, like? cells question. of guidance further data $X considering positive might cream? Jakafi? dermatology And for ruxolitinib reflected what expanding REACHX if you long-term Thanks. your are the look billion your to for portfolio And

Hervé Hoppenot

here, Hervé I'll take it.

are -- study. the results than positive. REACHX expected, very obviously, don't And I but So say very certainly good it's more a it's

terms they mean the And You to guidance in opportunity came see the are have does it when the will long-term question we what up results. of of the results saw when published.

your appropriate. think is question I totally So

We billion is said have see said Jakafi, where can going. $X.X in the billion this in to you for the $X year past

there are system health the is it general So fact we the in open from looked standpoint. to look political at ahead curve, in a you of care of What and number uncertainty that reimbursement if questions U.S., also and are at related products. of that the we still the

is publicly, this best us it way is the about long-term see and look need, have year. guidance will the the it So how and see think Also at with again REACHX we the think that's to I give evolving. of after again, that opportunity this an something will to them then that in both if to probably of data end we be

dermatology. second is The question

dermatologists TRuE-AD is exposure made must of a profile evolve are systemic the the lack had what has of months, very cream. our franchise, from in us you sessions and in over of that that feedback on RUX expectation level of we a there product hearing board topical. level with number advisory from and And we in expect of a and we So, I of Europe other is them that few have that say, providing the past the are excited. that you that efficacy U.S. because from no that saw are safety the can and obviously,

So it's be category other potential it the of that not the in to topical really the product has is product, a transformative.

was study big now quickly. how is, as we with that the new it it moving describing, We at could of Stephen be. eye So looking very in terms a vitiligo still have are

in approval it gives submission XXXX, us approval So XXXX for in potential AD, and a vitiligo submission in in vitiligo. then

portfolio. would science potential own complementing have could the be potentially And could so group we products immunomodulating that that opportunities two And of obviously new to external programs good a years. also at that is be at are that be cycle with that is applied many dermatology to we for indication. for other an looking looking the ongoing apply already franchise. complementing sort have product are our we of of a next Internally, could there So the coming what products

be So to growth years next potential think to the is and there now over will and that with of add could cream, have in very hematology. division a oncology important that literally cancer the I is and the the built five being starting a Incyte new have RUX we that

Josh Schimmer

Thank you.

Operator

Thank you.

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

now live. line is Your

Ren Benjamin

studies? make the morning, Good Can congrats seems and once-daily can see Hi. patent extension can taking to and quarter. about guys. continue ultimately about patents we have developed that be talk particularly to think extend to But the patents? being the liver the your combinations we questions bit Thanks evaluated, obviously, formulations to strategies? sense on I once-daily well as as are they these there. the little in Do definitely a how for do the extend,

Hervé Hoppenot

from I not the would patents that. RUX, mean, comment extend on I

help franchise So us what improve extend ruxolitinib of in of in a is patient the part the and our that is our and to clinical MF obviously, the it and our and plan do benefit from – will to potentially PV way standpoint, GVHD. in life

at a it's looking of the day. has a in have is products goes with two So we combining fixed-dose patent with And are two a the beyond for Jakafi, exclusivity longer itself, one other also fixed-dose our that to itself, product patent the have combination. oral we is that pattern think the on than of life obviously you're of products And way combination reasons, with portfolio. sided very it QD by it have that ruxolitinib the then do is when as And you you this important twice obviously combination. once-a-day, being if the possibility doing increasing you

and we ALK superiority parsaclisib and the first, are for standpoint, the us give GVHD. in of possible, to testing the clinic, have establish MFPV field could you of that ruxolitinib maintain partners we combination that potential clinical if develop, an think and and from those that to can fix opportunity certainly be as So in the helping the would BET leadership then that

that's the looking we it. So way the are at way really we

Reni Benjamin

we Can a And follow-up factoring? net just quick assumptions to the it. then you just gross us that as with should Monjuvi. Got remind be

Barry Flannelly

is Barry. this Well,

gross with are we'll comment through partners really on be, we assumptions. on net Obviously, didn't average forward. we really we will have price, net price. gross see go through required that together the some. to our the so programs, But CMS the government monthly the about we're forth. So to what said and discounts And obviously, working as We haven't talked

Reni Benjamin

for Thanks the Okay. taking questions.

Operator

you. Thank

Our the Company. today coming next question is from Benchmark from Huseynov Aydin

live. now Your line is

Aydin Huseynov

Thanks for one my Monjuvi. have I on taking questions.

expect is authorities? any this pay think, budget pay given So you than more environments that given especially conscious a such as combinational expensive is I EU French already or drug, agent $XX,XXX. Revlimid Do resistance in impediments,

Steven Stein

take and outside of I'll first United question, the So part the the can address Hervé States United States. address the

So we appropriately. oral of priced this drug injectable think and the together combination is

benefit the that For the regimen provides.

If combined actually year, look month, others you per higher. priced the with Revlimid approximately price for to are or injectable that are myeloma, drugs other same analogs, and per particularly multiple in example,

to that's therapies, same range are T it price per Hervé? And complications in sort patient. compare obviously, different you of but obviously, the If there, CAR there many

Hervé Hoppenot

and we are And already when on EU. expiration timing number look They the in in cycle of is Monjuvi already EU. in is for approval lenalidomide countries of today, for Europe, the it just large for countries. fact, timing or reimbursement it almost the when going many The of to is patent lenalidomide is at generic approval that tafasitamab in coincidental a comment different available generics and in the

Europe, to So in do drastically. is to these have where negotiating the what cost of all price we very down will the we be countries as at lenalidomide time going the anticipate of in be

So should be in Europe. good be be price a a by reasonable able it's little to timing it a have to chance, but bit it good a for tafasitamab should

Aydin Huseynov

Thank And I it. follow-up regarding one Appreciate have you. Jakafi.

sales So in but indications, how growth, Jakavi MF what's showed versus only And Because the in of curious compare growth XX% you Europe? was growth? just would actual Jakafi both Jakafi X%. the MF performance Jakavi grew

Hervé Hoppenot

is price in products. Novartis standard and the these and And on done that's the sort Jakafi job statement seen No. all not we excellent are the classical in in launch a that The became Europe. think higher, Jakavi of the where has versus in of GVHD have care yet was of U.S. a REACHX the The an outside general submit done obviously, what launch volumes of Jakafi the curve Europe I since U.S., comment to are in ensure MF been REACHX. together decision PV. to GVHD, lower on has

is general, fact, that ever be are to will because of price So for studies in together. U.S., reason pricing to be new that The will reduction. to pivotal used related every outside and the submission do leading two there large, largest the indication Europe that is used in

was decision. It that the And by a to very we together. certainly Novartis fantastic. So REACHX know the do decision good made results now is it of are

the evolving. see have the GVHD overall, of and both has U.S. we parallel than must the sides So growth in first, been how I seen will ex-U.S. expectations in what for and has U.S. and say happen but exceeding expansion we very later term been have MF PV been

a of well. it's XX frankly, that, years So been story for has very partnerships now good working

Aydin Huseynov

Okay.

Operator

you. Thank

coming Markets. Farmer question BMO next Capital from is from George Our

on Your mute. line handset. is is proceed. Please Please now live. your Farmer, pick up perhaps your Mr. phone

George Farmer

me? hear can Hi, you

Hervé Hoppenot

Yes, can. we

George Farmer

I'd that about see more combination BMO inhibitors? strategy in to And your Thanks Okay, JAK with how you parsaclisib great. do in fitting with and like other talk MS. ruxolitinib

Steven Stein

It's Steven.

set up. we the So again, as program, reiterate, just to it

two So there studies. will be

plus RUX. study -- first RUX would in be part first-line The of

standard then being that there. combination down care become So pipe if successful, particular the there ends up the of would

at is looking added volume are that in response then announce In having months defined of carefully add to it's have But terms to people symptoms. ruxolitinib very on three benefit, goes will parsaclisib responder study, reduction add for a the earlier, of patients on that, because inadequate different on terms and/or the And but who the said inadequate least ruxolitinib. you stable I we'll profile dose, patient patient point of up very for a when who've are suboptimal at had that go we live these study and and spleen been you clinicaltrials.gov. for particular segment, end response as a on

wins if down there and is in are head, pipe. the first-line play more responders efficacious, then less you study with out patients this If inadequate the your

patient you flow lines work therapy the of out So that's through how in various myelofibrosis. the

George Farmer

great. you’d that file should clarify about you had launch Okay, And Can said you how launching in in dermatitis bit -- you maybe little Hervé, with meantime just vitiligo on more RUX then AD. the of could we think maybe a that? for atopic comment vitiligo, ahead or Europe, ahead

Hervé Hoppenot

if there do will Yeah. never on we with this was sequence I the said that by than discussion we happen. will followed first. reimbursement launch a price impacted of end can very if of lower what the by how like a point, looks we believe that, and – up will because But that I'm know we at and be be it what vitiligo, vitiligo do much today, atopic derm not is you sequence what

emerging to is that launch So that's there now to And the are vitiligo. was Europe be saying compared because that, we on U.S., the start in commercial think were the what the may questions Europe. with I in if in model lot seems be what we thinking about. a of I delayed launch

George Farmer

Okay, great. much. Thanks very

Operator

you. Thank

question today next Stifel. Our Stephen is from from Willey coming

now line is Your live.

Stephen Willey

in implies endpoint I Yeah. for Thanks still adequate guess, dialogue that's ongoing selection regulatory your RUX in. – there's me maybe Steven, the responders comments there. for in Maybe squeezing some it around trial, like

the of transform thresholds? a AbbVie surrogate as this just it the potential about they're using looks primary. I posted setting, we around and relapsed/refractory regulatory lower around details I in of SVR like as SVRXX should a X the flexibility study think think use Phase guess,

Steven Stein

wait as is likely Yeah. have line. at established you decrease further we see XX% in I'm that be no we the you'll know, well the SVR first-line outcome moment. when established that’s to its first not in But endpoint secret, going and published any their to second satisfy to the it. the That studies endpoint publish an you at line, with my in did they endpoint response, the for because we the

but up. to put – to to negotiations until regulators, So what our you'll you'll completed we we’ve just go, Thanks. see with have and we're wait we wait have set it all to

Stephen Willey

All right. Thanks.

Operator

Thanks.

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

live. line is now Your

Matt Phipps

Good associated lot vitiligo, to RUX Hi. bring it editorial topical you. of a a face. recent with publication Lancet the morning. acne the potential and Thank An of limitation, up the does given effect side exposure on

guys exposure? any more So therapy? -- I with impact, on it does temporal any think duration and mainly transient this this has do of wondering, acne. just was Or nature associated was there's of commercial chemo it if Is you then potential

Steven Stein

Yeah. little It's Steven. I'll a bit. comment

the seen particularly onset problematic. We per haven't se nor been temporal it in link terms of acne, of a has some

study, see that's Obviously, thus that Phase been patients and other patients, just So But the follow-up, it's data we something from we're how be of total, in particularly XXX north terms of we'll now have far proof-of-concept being long-term important out. as in than that's you, is we've – that use reported, problematic which with conclusion. large plays for the far. telling adverse the thus event Xs, two not the enrolling it'll longer

Matt Phipps

All right. Thanks.

Operator

Thank you.

Our final Schmidt Guggenheim. from from is question Michael today coming

live. now is line Your

Michael Schmidt

there's Steven, level program, on your Hey, heard this candidates. guys. for wondering there. just some bispecific antibody interest other seems asset Maybe, is It like similar from what MCLA-XXX. excitement I had your product a you've and question of what based on

curious might from you and Just we the are data when where study? see initial

Steven Stein

No, Thank of PD-LX. X-XBB with it's you target point program. or a doublet our from very biology view. a It's bispecific mentioning CDXXX as there Yes. a for interesting – coupled

other and the in its of on history long trying LiverTox. past, a it into own ran has X-XBB particularly So companies toxicity,

was is program There program take PD-LX hands, to mechanism get we're the encouraged next been amount associated probably progress to toxicity PD-LX and get either the data We'll a see it. sort we've seen of the what areas. the or from But delivery then going dose a people expression in so it far the is field the and We efficacy of would balls tremendous then with in enrolling it. speak it enhanced coupling But the to continues to and Thanks. year the well. our additive to done plus work a that avoid wise, thus X-XBB safe is to as data theory well. this interest present go year. and And from well. by synergy So around who pretty won't

Michael Schmidt

you. Thank right. All

Operator

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

Mike Booth

today taking join So thank time us on you your for questions. all and call the the for to

Christine the Thank goodbye. and now, for and thank we we'll close I will again, course, Of follow-ups. you, available call. for for be rest the the and you of But day any

Operator

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

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

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