Incyte (INCY) 13 Feb 242023 Q4 Earnings call transcript

Hello, and welcome to the Incyte Fourth Quarter Earnings Call and webcast. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Thank you, Kevin. Good morning, and welcome to Incyte's Fourth Quarter 2023 Earnings Conference Call.

follow encourage website go release, Barry, to tables in slides I section the related Q&A. Pablo, begin, call, the remarks and our today's and who of find that our Steven we and everyone by will to to Investors financial I'm Christiana, Before joined discussion. On deliver Herve, prepared today's the participate press will and on beliefs. be like making that forward-looking our to current are which would expectations I we'll based point statements, out These to differ and subject statements actual our uncertainties, are and risks certain results materially. may discussed you our will encourage to over I consult the the hand filings detail. I to risk factors additional in for Herve. call SEC now

everyone. Thank you, good Ben, morning, and

XX% X, strong $X.X Product So reach with performance on billion, continuing another achieved the we have Slide XXXX XXXX. versus delivered strong since to revenues year growing we XXXX and royalty

fourth growth milestone revenue the first achieved continued assembling reached We Opzelura. and billion in time, quarterly $X royalty also Total the of launch successful for the product of and by Jakafi driven quarter.

XXX% by Slide XXXX, refills vitiligo. Opzelura X% growth $XXX both Jakafi growing were billion, year, $X.X prior XXXX, the driven and AD versus all moving X. in growing momentum indications million, year-over-year. across So strong new net And patient sales to and to in with

to our XXXX, expect to Francisco. pipeline as therapies the multiple clinical across in X, the has San be by transformative continue year. On a to next key to programs We for presented Slide Opzelura the high-impact patients opportunity in contributor to and growth ability launches provides recently deliver

RUX including the in be are track in Phase and for highlight significant atopic in HS, and are we the we as before randomized the I II these on III been to approval, RUX midyear, III data the MorphoSys this submitted Importantly, where to like to to where cream post initiate to a programs slides FDA some and highlighted to Phase porocitinib, has opportunity the study proof dermatitis the programs to are an a PN, by vitiligo, on concept we of which recent year. Each derisked FDA of have market on they in of axatilimab, provide submitted pediatric cream are HS, also now Slide transaction line in would end address with the the decade. where has X. to top contribute these Phase potential of

asset as This in benefits MorphoSys, described an global release we term. last acquisition entered Minjuvi. As in which us issued rights the press Monjuvi a purchase or week, provides number with known short also the tafasitamab, we give Incyte exclusive of agreement into for to

Monjuvi First, now record the we from revenues milestone MorphoSys , will the to of future MorphoSys. going while in royalties ex-US S all eliminating all and forward, U share

cost a on in efficiencies expenses XXXX, simplifying and realize in will operating significant and to Second, U.S. development have revenue deal and will removing redundant position commercialization global and by this operating add the Therefore, Incyte's and limited we will by in synergies income. redundant impact external [indiscernible].

Phase a represents benefit will Barry, follicular expected all while our this And the call until in indication marginal later year in in Incyte been who be value-accretive this this from over tafasitamab. and Incyte programs with approved For for will of the now, detail. if will XXXX. These now DLBCL acquisition opportunity by positive, indication. lymphoma performance upside refractory see in discuss more MorphoSys to commercial co-founded fully smaller data and second-line III potential expected turn upside have from scenarios. I will the DLBCL the zone future, Phase currently data and first-line for relapsed We are in which lymphoma III for

million some and revenue with increased dynamics all you, Jakafi XX. on in X% In to as We Jakafi down product QX fourth inventory patients for to fluctuations. Recall the XXXX, patients full X% in growth across fourth Slide grew net Jakafi Starting well indications. with grew seen quarter, $XXX the in in Herve, the Total experienced good free and Thank $X.X X% morning, year everyone. during as billion. variation inventory including the being in on drew drug in an and modestly fourth increase rebounded quarter. quarter, year-over-year

seen expenses Part levels on more anticipate details in redesign. we of on patients through Christiana D more the normalized her will returned dynamics XXXX, remarks. increase XXXX out-of-pocket to end Additionally, supported the prepared to under drug free the at and reverse by provide these in the lower

net and of have We Jakafi year we guidance billion $X.XX continued to and $X.XX for a range full updated revenue of the expect product continue growth billion. to XXXX

demand its Slide MF, in regards As versus to to maintain in an have Based in driven expectations. our we its patients growth as well on on opportunities as Jakafi market and chronic research, had expect growth driven leadership disease graft maintaining other Jakafi unmatched leadership host impact earlier with myelofibrosis, XX, Jakafi future patient continued product by competitors in its of as polycythemia share vera care chronic new standard strong, continues market and and consistent share on remains not GVHD. for and in profile. is market by use highlighted total

the patients growth for in the biggest D Additionally, in with expenses positive starting changes the we anticipate coming contribute years Medicare Part to XXXX. impact the in to out-of-pocket

we the for in QX Opzelura same growing In quarter the prescription XX% repigmentation, XXXX trend, efficacy Opzelura's patient year inflammation the impact right, U.S. only primarily itch. when weekly net Total initiatives. from by coming driven by refills vitiligo. In AD, largely on and XX to Slide is of dermatitis The treatment XX% prescriptions well is Opzelura quarter. was as fourth up to fourth access gaining dermatology and of uptake. as year. the be $XXX improved total and Opzelura momentum grew continued patients of quarter were the as best and on driven typical the dynamics to quarter and both and sales performance. and demonstrates very approved shown compared the end Opzelura as demand X launch growth to potential recent during educational Opzelura, $XXX prior versus million, by XXXX XXX% increased where Opzelura XX% becomes full million. remain net Turning positive the refills, is strong atopic long-term which growing physicians as to quarter continue We and was with as our established last year-over-year with the versus continues strong launches. product both optimistic of reach revenues growth Vitiligo, see about The growth

outperform a successful launch-aligned basis products approval, prescribe dermatologists quarterly by first competition, of on market and to when improve revenues other is to to dermatology Opzelura the product measured access compelling TRxs at its and on relative [indiscernible] sales. our Looking driven XX need on access we left growing post in months launch Opzelura right. The comparing and continue FDA ability net significant the when address its continues dermatitis to monthly strong profile, and both by where unmet atopic net the

Turning to Slide XX.

Opzelura's demand a Opzelura have health AD to We We professionals Vitiligo. safety, number for XXXX based drive place use that in know and Opzelura care want the algorithm. efficacy on and compelling in of sooner in treatment both in initiatives to

advancements. for an exceptional also supports we for access we improve improved proposition XXXX, look securing to value that addition to continuing these have are to ways utilization In and management,

their marketing with these to that, we goal experiences. and educating I'll through dermatologist. With continue patients to real-world awareness Vitiligo, this drive with patient We with For campaigns the and treatment of options believe over consistent further to discuss patients drive patient the call demand positive inspiring Pablo. turn will activate

to we evolving I the with everyone. the want a near-term of our and how the R&D key focus we our optimize Thank pipeline resource of XXXX accomplished to for morning, goals to you, provide in highlight to milestones Barry, our of progression increase allocation. that accelerate our the R&D good decision-making some rigor and framework are and

you Slide a innovation areas we're we disease, MPNs graft-versus-host diseases. unmet medicines differentiated portfolio the XX, treatment medicines advancing with robust oncology building of a and a As with of We're medical best-in-class see for in large pipeline on diverse on first-in-class to impactful focus deliver of where have focus areas inflammatory and in and/or needs. can X

leverage targeting identify well established as and modality disease and agnostic disease to of discovery as targets with its genotype-specific and approach. expertise novel process interest deep prosecute in and areas knowledge our is biology a cross-program Our pathway-centric dependencies

Merus. our discovery to established discovery drug we small addition molecule and in-house bispecific with have antibody In antibody to expanded our through monoclonal partnership expertise, to a access include discovery capabilities have capabilities

new activity for advancements to chronic Turning our highlighted host presented in BLA portfolio made inhibitors focus submitted the therapies the antibody, collar with oral to We priority versus a We early monotherapy updates disease. small ALKX we our is and of small disease, we and XXXX. areas Slide which In enrolling significant clinical we for mutant Phase in treatment MF in CDKX potentially combination across all initiated with inhibitor, ET, MPNs transformative for PV Phase MF, graft and graft-versus-host plan signs our molecule well third-line in JAKX now study axatilimab our BET R&D for study our the and XX. month. In in our oncology, X several which highlighted I I the PD-LX and initiate of for VXXXF next in and monoclonal studies inhibitor. a inhibitor molecule and

more the of for in inhibitor, the repigmentation. first approved in this and development, clinic Europe unveiled ruxolitinib in entered Stephen GXXD year. potential maximize provide In was XXXX, the KRAS to prepared Additionally, a only Opzelura detail continue on program dermatology, we the as new remarks. In we our program GXXD KRAS treatment Vitiligo cream. for his approved will earlier which

positive data announce suppurativa. was the a with study We endpoint randomized patients that in atopic hidradenitis in also II Phase Phase pediatric presented and dermatitis primary met in III

For initiated III povorcitinib, X extensive vitiligo Phase in and for positive Phase vitiligo. randomized with presented patients II studies we data

the in II ability in with We povorcitinib, with nodularis to initiated providing address Phase asthma a X patients to enabling patients potentially povorcitinib with urticaria. We II Phase from only and prurigo spectrum primary believe many and studies, the we'll a also for had year, announced and years. endpoint with chronic topical and with randomized of year that list oral randomized company for foundation Vitiligo. a it patients was we Incyte patients from a severe, number will mild the the that be that ruxolitinib met impactful of broad cream spontaneous that of achievements past demonstrates both the suppurativa number successful the next serves very in nodularis, trials results and a a exhaustive hidradenitis indications, in a Par an as including of deliver and all pivotal option R&D XXXX this for prurigo study few

see provide will like more regulatory Stephen another we details year multiple with XXXX milestones. these, from to can that I and you exciting anticipate potentially our CDKX an active Slide forward on will would very that be certain XX, events. data sharing to As but inhibitor this later believe best-in-class Within oncology well highlight we our plan look as pipeline, we as year. agent and clinical is development our

I throughout will the combination host addition, portfolio, make this submitted read the for pediatric disease. the and axatilimab follicular axatilimab of sNDA our expect look provide BLA atopic in as we less sharing like host and who dermatitis patients marginal that, Stephen, dermatology expect with forward additional the working and look out initiate with versus late graft and available readouts for our trial We those pretreated zone clinical results. patients last pivotal will year details lymphoma, year, studies to year later later submit versus pipeline. to call year. With disease with in forward to chronic to chronic this to mind, tafasitamab and also pass the in we on to with In Opzelura for further multiple to graft to known patients would a we data development FDA Within

inhibitor the Starting Thank plenary Slide and than of AGAVE-XXX evaluating the featured zilugisertib. host a full study the and a data plenary in BET on highlights preclinical Phase scientific Annual patients oncology hematology December, inhibitor. from I VXXXF from included and of axatilimab data an anti-CSF-XR In disease I/II additional presented at versus Meeting. abstracts, data data with Phase graft we Key the chronic which ASH you, monoclonal Pablo. from XX antibody session, JAKX including more XX. presentation our

both an III and monotherapy in BET we We calendar plan in program well and improvements advancing seeing suggesting are in as this length symptoms volume Phase as combination is and reductions year. this compound. that While inhibitor, hemoglobin, is therapy dose this to on active escalation ongoing spleen in later

the BLA As additional FDA submitted efficacy for design will for we AGAVE-XXX on bringing for in new XXXX study safety by details anticipate second get was the half to We these are seeming axatilimab on the study, provide the closer, possibility of graft treatment treatment of patients timing. and and pivotal by we versus the the host approval Phase favorable FDA II the profile, with to and excited decision of disease. patients. chronic the option the Based a

expand portfolio, to our as II on and continue seen advance Slide We and dermatology XX.

Phase ruxolitinib recently success data cream RUX its for global positive presented assessment III we For both in cream, patients, EZXX. and efficacy pediatric treatment investigator endpoints where

sNDA to with by potential approval the of in XXXX. submit the We XXXX expect middle

year, the nodularis currently Phase in has being nodularis. of treatment and also at equal disclosed cream greater in a evaluated II Povorcitinib, study studies data studies groups expected in Phase suppurativa to We endpoint cream studies in is a met also while we in and is than povorcitinib II we in in Phase being this or to conference been prurigo X II III all study inhibitor Phase prurigo study oral and currently Ruxolitinib in and that Phase evaluated. X a across both medical with lyonplainis present in our year. endpoint that and itch hidradenitis X-point to III primary in later a the X NRS moderate RUX this a have JAKX recently suppurativa those announced the the mild lacinsclerosis primary met III later results evaluated Phase improvement expect vitiligo, hidradenitis for

this the medical planning conference expect III set We and data at underway. a Phase full later is year

in dermatology stage has our evaluation earlier IL-XX antibody volunteers. Our receptor program, beta begun healthy

Foundation at Conference, of XX. study the HS. additional presented povorcitinib to Suppurativa Moving week II European the from extension Hidradenitis of data we Last open-label the Phase Slide in

presented was XX, were At classified significant with as with score of which X, povorcitinib's IHS-X. Slide HS. a resolution efficacy of the povorcitinib approximately Severity that severity, placebo-controlled apsis, week these a at the that was tunnels. On of an povorcitinib upon response Both HiSCR nodule sets reminder, which week resulted likely who the decrease patients observed represents by to decrease System, HS XX, response during As week in additional treated of achieved response, week of analysis data for dose-dependent demonstrated through in suffering patients in international as the achieving complete demonstrates a or and period HS from disease draining through severity demonstrated povorcitinib in a IHSX XX. data best-in-disease with patients XX% Scoring maintain potential patients a week disease an treatment XX initial at XX medicine maintenance build XX. The

HSX studies As a and well. povorcitinib evaluating ongoing HS are reminder, in stop X HSX enrolling Phase III and very stop

Our high oncology X currently programs. is potential pipeline on advanced focused

is patients studies diffuse first half XXXX. zone III IN-MIND and X marginal a Phase zone study with lymphoma or for year expecting results first-line lymphoma B-cell readout the follicular with lymphoma previously marginal follicular been evaluated lymphoma. Phase second in the in in large study this We're currently of front-line has B-cell tafasitamab, patients in diffuse untreated in and which with III The large and

second molecule our small oral is program. PD-LX The

or as other And with combination multiple to ipilimumab. calendar as with responses. and third patients in where recently CDKX ongoing small molecule program year. demonstrating have such axitinib, expect We activity our clinical combination partial And studies agents is the adagrasib of inhibitor, we later signs data early monotherapy announced multiple we have this

year. On unmet calendar recently orally approved Slide clinic encouraging in agents well could and recently models no This address antitumor has that in GXXD We GXXD a preclinical later a targeting Phase with the as study. KRAS announced a potent, INCB-XXXXXX, entered program selective high need. activity plan I xenograft XX, currently as development shown expect this data to inhibitor, the share we available

and found at cream in X% GXXD medical of of number year. cancer KRAS adenocarcinoma, is successful. In the ductal if XX% povorcitinib top mutation XX% cancer As non-small a for in first reminder, of a and significant cell upcoming in RUX lung results XXXX, a sharing summary, opportunity pancreatic including studies of represent a approximately we HS Phase in half anticipate and PN colorectal thus Insight, the conference could the of in updates II this both in pipeline line from

the approval XX but highlighted of initiation half anticipate second is The we is would that Phase number with limited as period to financial with Phase a axatilimab, includes, to results looking be the I catalyst-rich Slide and an III studies, inhibitor. With like our to from on of tafasitamab the to a not including the of that, call over III for BET update. turn year Christiana

another the year strong of with the royalty are respectively. Total the representing morning, and year, billion for from comprised million revenues, Thank everyone. financial increase, $XXX which year performance royalties respectively, the royalties and from Novartis primarily [indiscernible] good was XXXX for total and you, XX% mark, quarter Total quarter full for period, for for a revenues and the and million compared compared product full year-over-year year XX% an fourth of reaching quarter of in $X.X XX% Stephen, in revenues $XXX XXXX. were fourth the billion year, Incyte. important $XXX to the fourth million up Lilly the X% grew Olumiant prior for $X X%, of milestone and to

the $X.X total For full year, revenues billion. were

paid inventory into an Turning an were levels free patient inventory program. patients negatively drug than for increase the drug of increase by in of fourth XXXX. The the patients This quarter was number impact sales. million QX assistance more of for XXXX. starting year. in The Jakafi net represented to X% In $X.X increase of in impacted to the seeking QX revenues in compared the offset significant Slide channel anticipation driven Jakafi channel million the the demand grew net fourth $XX by quarter from moving XXXX, year, product full Jakafi levels. on free sales of billion support was Jakafi increase by in Incyte's in in year the increase a in sales increase were and XX. prior $XXX in

the Turning increase representing were patient a demand. now year-over-year, XX% to fourth million, driven for $XXX Opzelura, net product quarter by increased revenues primarily

For year, compared were prior increase to Opzelura product the XXX% million, full total a $XXX the net year. representing revenues

quarter shareholders $XX former and Villaris as and expenses made by as was Moving offset on of the an R&D the payment decrease million result operating basis. million the our for million QX XXXX. on Slide XX% in part quarter, fourth representing the $XXX to partially XXXX of primarily milestone Villaris XX a payment which year-over-year acquisition the GAAP $XX were Total upfront a development in to expenses of

For full for and $X.XX of The increased and U.S. X% and year-over-year representing the and 'XX. Total were SG&A marketing R&D progression XX% due million year. primarily billion Opzelura to the activities for of quarter This total $X.X mainly for increase year mainly a were upfront the favorable and G&A-related effects for X% milestone due in in expenses quarter the was were XXXX, and the fourth offset expenses. lower year-over-year by fourth both expenses full expenses to increase billion, and our of was for timing pipeline the increase. year and Europe $XXX the sales certain

I the now tafasitamab, to price excludes related revenues paid. discuss the accounting global purchase of potential Moving any to basis key on will rights impact related million GAAP the the exclusive to of XXXX. on expenses and our acquisition includes components recent a $XX which treatment to the of guidance but

billion of $X.XX over $X product range revenues product our on billion revenues net by billion long-term we to track in guidance net of the $X.XX be to in For Jakafi, XXXX. to expect achieve

as XXXB driven net increase continued result We higher offset a in continued product post-price be and to of caps growth and net volumes. by growth be demand partially pricing by expect growth lower and revenue exclusively

year. adjustment previous first donut the are relative previous to due and expect of higher the impacting for deductibles Part year share which the we and be the in to As the quarter the quarter higher in quarters to gross-to-net quarter first subsequent Medicare our years, the of hole D the patients, primarily of

dermatology planned higher sales. expect full this at the net we typical of QX guidance of sales, deductibles due medical to While costs patient and out-of-pocket again the the to effects the beginning on we year see be events not resetting at will for impact including on year first providing holidays quarter, other product point, the Opzelura, of conferences dynamics and the in

full to result, a and Opzelura revenues of revenues of year consistent saw the net As product QX quarter a what the in net represent are below XXXX. product subsequent previous with smaller be and quarters we expected share the

be to For include million of net other [indiscernible] Minjuvi, million, in growth expect approximately to hematology/oncology now which which Pemazyre, we range products, and over at XX% total Monjuvi represents product 'XX. midpoint the $XXX the revenues $XXX

a expenses operating to GAAP basis. on Turning

range growth by expect XXXX. COGS is X% to range billion, at We expected in the of R&D billion in to progression X% versus is XXXX, of $X.XX with net revenues, be our to primarily to midpoint from representing line product driven the expense $X.XX the pipeline. which X% of

the the concludes included the U.S. product SG&A profit share. Operator, please your the were and the loss the $X.XX expense in Q&A. to billion with SG&A by X% Monjuvi remarks, midpoint that of expect prepared to open prior associated and collaboration range the year restructions acquisition for year-over-year We primarily in rights, call or driven marketing under whereas the be billion, at full inclusion growth of our under to of expenses representing give sales to $X.XX they

is [Operator Srikripa Instructions] first from from coming Devarakonda question Securities. Our Truist

these market of see And much On just assuming patients be if sometime if on I with so you it levels? in an and wondering the to new point. Jakafi inflection and we details collaborative was capified happens providing to for share should expect our share thank share in combination at anticipate next were patients. myelofibrosis, the stabilization approved year, you rock

in So stabilization of market share myelofibrosis.

take period of patients and polycythemia patient overall the largest We to patients really big those for portion continue myelofibrosis until will share efficacy a of So survival really that on is which leader ultimately know, myelofibrosis of our think our you long of stay its time. advantage. a because Jakafi, the tolerability, is vera safety, because in over be as

with and if approved around question when gets combination parsaclisib Jakafi. in Your

it thing or combination in fact, course, us. physicians happens use to of to approval choose is benefit, and wait profile appears may many we see as will it a process. what the appears, that's the as Jakafi drug only with If have combination good but and the then the Of for that

Berens question next from Leerink. coming is Your from Andrew

XR if light bid recently impact Wondering of you're the Novartis directions Jakafi of upon the Novartis' do the XR developing BET version could say material of of thinking drug in of regulatory requires guys announced Jakafi? by And [indiscernible] any Jakafi in change add-on you of still then as have an endpoint also expand Do a a symptomatic agency? about just direction Or wondering endorsement. U.S. at from to think the any how improvement the if the development you thinking does your or control inhibitor. an in they think that been MS and that for outside you there's Jakafi

take piece Jakafi the speak . Novartis our So development about agreement let about [indiscernible] of me on with and can the Steven

that mean where, Incyte. not obviously, the they not the new by the co-developing able of such to will can in including be the of ruxolitinib be still yet, once parties a been formulation be for It in wish, co-develop oncology, has the that the is would if optionality and Novartis an is case that agreement U.S. both XR it but to day. they formulations So there XR outside U.S. commercialize commercialized but would

And I'll question. part of then, take your other Andy, the

development already Siemens clear are have combinations with formulation which It in which then now slightly fixed-dose FDA a around process the need we new developed, so that AUC. the do of strength, any we guidance are So this And at Pablo ASH FDA. our higher clear for event, the the a from doesn't X-year from well RUX primarily the those and feedback be before estimate and FTCs, completed LOE. demonstrate with EBA products. XR, to That's affect Investor as of we communicated our the should

So that continues.

inhibitor, inhibitor. other my length, BET at compound an good like volume and very prepared reduction, our data good we and showing increases, very just showed alluded both of hemoglobin spleen rates with ASH remarks, improvement seen again, For active in occasional we the have in symptom clearly BET and

been date need or at first companies to the their in where to they have regulatory But that get We that may standard you I like FDA under the the line, on has approvals. and regard. to progresses other change assumption in date. comment least are in can't that symptoms operating been how SVRXX

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

had on I povorcitinib. X

the relative as Dupixent? here for could of HS, and drug be Dupixent you the in some year. Or fitting antibodies top last paradigm think in bit [indiscernible] to the how about IL-XX I bit this to also on data you a then about you is line the about approved the III treatment the HS positioned advanced. some drug PN multiple positive where had the may trial talk obviously again, be talk might that into Phase in of your is biologics opportunity indications, believe expectation most a relative drug be So we Could how it

your Michael, Thank it's with the you Steven. start question. for I'll question.

very agent, prolonged with well. in So XX-week HS, long we've has very, penetration have JAKX enrolling the now III XX-fold HSX distribution, effect about and date. to high selective which and skin, specific volume we think a translate so we shows to data this a [indiscernible] of half-life And and a Phase more outstanding of we for a may very see are STOP-HSX is which which efficacy updated remember, efficacy this why JAKX Both data, degree showing maintained that's is that

the studies that agent, as to the aren't to about to. our biologics, clearly IL-XX It's there's belief some out there. drugs probably directly that many in indication other always the the spoke also where speaks compared of clearly, lead variable and hard the caveats you some there you alluded So is and here to and and activity cross-compare with

strong corrected not You But said, and I increased pathophysiology, think look rates. ours very And the sort quickly that distribution long primarily in actual that itself a in multiple proof a There at manifestations. It convenience. here. Obviously, we agent again, terms skin time, way may skin as agents allude a just disease again, is, you to when have to is on to aspects we'll symptom resolution And X but in of concept and terms III to patients the regulatory with have in Phase itch data lend really with in think profile ability from drug we'll as of go eliminate the as resolution the us oral as I suffer itch here the efficacy efficacy provided daily terms resolution. of Phase tell and Dupixent of disease And has placebo approved interleukin. relief tackles will high will volume data. pathway of there intense half-life itching. offer oral offers of to that be change which the the there. our is convenience, II once PN, once-daily over time well the an of pretty In good tablet, high the

we're program excited well. about So this as

Your or next today Stanley. question from Vikram coming Morgan from is

We had X on the pipeline.

establish we And the program? expect to there? what then program initial When right conviction with the the the So next and can wondering what I are data headed step learn were this mutant to of reviewing expect you And to Phase antibody. for first, update secondly, decide just be CALR we get development hoping direction. mid-'XX. in can POC could to specifically guided data ALKX be this see We program, by you've what will you for for the what to that to is

you for question. the This Pablo. Thank Yes. is

and that's we in is with larger need for mentioned, process right of math what inhibitor we're and establish have the December. to doing, the ruxolitinib. this number efficacy now, the ALKX on newly And a we diagnosed in of combination as what as last team in focused with patients So program,

to to XXX need get to doses to of So larger the a a of to XXX in get we Two, push in dose. duration therapy order around maximum continue with We in group longer the milligrams RUX. combination on need patients of day effect we [indiscernible]

year. the So the that over of will happen course

for steps clarity year, we're to the are. last what haven't we provided But would program specific a we'll And We disclose year. when that for time at as mentioned data. ASH provide line it happen next on this going the

question recently. escalation we On the the started mutant second dose very antibody for color program,

will for well. safe, be of you these and establish endpoints establish that mutant-CALR That in view get efficacy, study that antibody patients. potentially a pharmacokinetics by in the case, view accruing course this monocoatibody study traditional real first-in-human a the effect initial good evidence a of the of to in on over happen year. very MPNs any also some in and know, goals As The burden study, the which, this of initial of obviously, is first-in-human will the this like on

data, present to whether going some we're when it's this yet decided at XXXX. in whether haven't year, point We

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

context as coming also the reimbursement in access gross in additional indications opportunity the have in, fully of Vitiligo spoke and This be and capture years. [indiscernible] to is Can We the us in outside X Opzelura on help XQ Salveen. had you on loan trajectory the to you you for able dynamics AD and to. in that the of question forward understand order net coming to

Yes. Thanks for the question.

far launch as course, as launch Vitiligo. both well and trajectory, to in very AD continuing of we're So

educational relief directed We profile based in growth in therapy, and therapy. efforts that health in is and of our clearance of any itch at patients AD. We for continue its upon care professionals. both know terms Vitiligo believe the AD the even skin unmatched expect that to We in topical just

For and not can payers so clear more lived as patients that and interested even far concerned, profile issue than of be XX% that they're biologics. example, as good on to the the delay have fact or will are in is go the their

good So forward can to about Christian over -- gross to to and we call future we turn we're think those net. going AD to I'll looking growth. forward and talk both Vitiligo for dynamics the are

XXXX, net, in when of average of look net was the all, So you in gross XX%. first terms to around gross

Our impact expect be volume is sales. If and net additional on a maximize thus decision value discounts, to it we sales. we this would provide goal disproportionate of and lead Opzelura higher to access and forward, make any improve that we'll going to will the net maximize have the because

net So sales to to isolation. focused as in be are such, comments versus our net gross on going

Our Derik from from next question Fargo. is coming Archila Wells

So last. X the piggybacking just on

any kind year? you both And terms guidance vitiligo and Just an there break in -- of potential we to then out in ever of of is Opzelura, X this update of get look will chance could the this kind quantify then secondly, terms growth for incremental on scripts in out? of I or can marginal opportunities the indications. sales, just And you asset you figure AD lymphoma guess, maybe that kind see zone if the you follicular and

about it AD little AD use be currently for AD, currently as for perhaps come think for refills. a to I changing continued we tubes in many [indiscernible] [indiscernible] before, it's expect XX% Vitiligo, , Vitiligo, Total bit. new XX% on and AD. far the as about we've could Ultimately, So patients out has versus dermatitis are atopic it's breaking said patients surpass and

obviously, we're data lymphoma forward far Monjuvi to, positive large looking in hopefully, goes, and As first-line in lymphoma, diffuse follicular lymphoma. indolent tepacitamide as B-cell

great profile X great together indications. lymphoma. ahead think well crowded we us drug the of we serve X think So for we a there's and a for indications those put it's the opportunities these in to for new We marketplace, the Obviously, trials think future. it's are drug going but the

products. in of a place. lot calibration a a it's follicular of of -- the new we terms to lymphoma, There data. III Phase are competitive need It's But fairly see

the need to the we calibration we before can around. that. is you of we number are good the So of in data mean give U.S. III see patients a about I Phase speaking

patients line in States. large lymphoma There's second the XX,XXX in lymphoma. United B-cell follicular patients about XX,XXX diffuse in in There's plus first-line

coming is Lebowitz question next from David Our Citi. from

looking quarter product. elaborate so Could fourth also were impacted receiving D the drive on you way And this? us over patients IRA and that negatively -- perhaps the impacts quantify said you number shift share. TV free of will about Medicare which ahead some Could revenues could XXXX You you by of the to spoken 'XX, possibly how Part this to dynamics potential give shift, time?

patient drug. the were charitable We foundations paid of they QX, of course. free came from In -- eligibility us a seeking the assistance assistance financial of answer to is to cover increase significant longer patients these form our to that available D they know from saw free these Part the receiving out-of-pocket apparently first And the to their we met towards assistance question. course, Medicare drug, Incyte and assumption in were in So patients had who our the and was end of at no them expenses. This year. criteria independent for

the already to With the fact, patients. And to already XXXX many being we D Therefore, patients Part you as expect is in we in Medicare know, these have. patients changes in these of out-of-pocket paid Medicare return that know for greatly in reduced. XXXX,

too that out-of-pocket changes In terms of been D a the very Part who time patients for XXXX, XXXX patients cancer D, saying cost we positive. been Medicare Medicare and are out because be it they are much reduced. probably was the of over in XXXX, maxim that happens still very high way should spread can fact, high. year. they in pockets, $X,XXX And Part for -- long to these co-pay We've think it's in the and out too of throughout But it

could greatly perhaps is Medicare the because they now these who the away those or think pay about who thought month not We reduced, We years a D patients come drug patients that abandoned afford they they drug that there's abandon of walked So at for XX-month they just an think for lots who have drug period. over could the afford that back. cost. Part per out-of-pocket $XXX not least have could opportunity there's

into option or back drug now. come therapy So

So...

Fye from is JPMorgan. coming question next Your Jessica from

the patients recap Opzelura in then can And couple there? A Vitiligo, latest average the your for on proportion expectation then XXXX? on are receiving expecting you out on of shake for And Europe, drug and questions. to thinking of price Jakafi how pursuing your follow-ups free previous What's for in of you some the AD the U.S.

of near wasn't seasonality. reflect you of some year-end Opzelura. that sure trends script term? the recent to that expect to mentioned volume reacceleration reconcile Is about you that I you normal kind other comments with a how think say made I

and question, ask Herbert to try I'll maybe Okay. answer Europe. talk third the first about

So been for X% for volume our drug Jakafi. expectation to for free years. easy years and X% years It's is and the of

We happened of it think to from Medicare We changes one-time the back. this that because is D. go thing exceptional a Part expect coming

or X% historically, volume. So been our again, around no which is more of it than X% has

Herve, first As volume far should Europe? the as of back because second expenses then because quarter to of seasonality. third quarter, resetting We to our we and the down so in out-of-pocket what talked expect be that deductibles but mostly because we And about in do quarter of co-pays go because of of the acceleration on.

received available. called is in make there process fact, per AXA today, and price in the Austria, which The launched France EUR And product. commercially reimbursement it's Germany to -- then XXX-gram recently first is XXX the Direct, X way Europe and we of tube. Opzelura it's in So in where a

fact, price part patients second In system special the it's distribution a And access of to to that the gives be product discussed. and program. through is that being why

France the will discussion approved. XX finally or probably start booking in will months price take price recognizing the revenue is So and when we sales

reinvestment that in we of process year in the in be also this best So And case. Europe. late getting the should then other are countries in

in So launching get and multiple 'XX hopefully, 'XX. countries we will

if for ongoing a because we And these that in started countries. leading dermatitis, atopic the obviously, case a used want price. a reason reimbursement required have relatively we most fact, in atopic to have be which recently in would we dermatitis, studies could limited start with maintain be price been, that level it's better vitiligo to decided, able be Regarding have to to to better of

to it's process the that not So years. indication ongoing, It X new and October. will to next a is going be lead in coming

Next of Ahmad Bank from question coming is from Tazeen America.

for these as mature sense secondly, both of tubes any you payer have indication start a on average launches AV between full differences, then patient a to number are if do I there a Opzelura year. for was as mix a of going how to bit, per the the land -- of versus big just better curious to and use you're

have far AD. More mix between as step More the steps mix payer therapies have goes, X have or payer difference As step. for [indiscernible] patients the patients any real perhaps no don't there's in

is they as very grow it's body, can use to terms a the think body surface We a the tubes said around area, go of past the to their more. larger body area. for or number continue portions that we'll tubes over drug surface people little In in they -- the XX% obviously, of which of up large of bit X we've that AD,

sensitive start They'll continue of their out people it a in and skin. over areas now larger Some period to use

figure too will it's be obviously, vitiligo, just Vitiligo we've We'll early. said, anticipating, the compared AD. refills out. greater in as But to For we're much

Our from is coming Marc next from TD Cowen. question Frahm

couple the payer a Maybe questions. following of on dynamic up

like that opportunity can Just kind for with kind on you volume and is last that, negotiations sure of are of to of the year beginning level need Jakafi, to things your to redesign, are wanting benefit this you see a returns trend this to enough of net abandonment with recalibrate with and script gains Are of what quantify that benefit. the of just year. consistent seeing sales of that X the some end out some price effect for had make similarly, to you formulary kept. give comment play do volume wins that, for Opzelura, only And to those over in Christian, at to from year then Or do up not late that recognizing, in how yes, that early going into view? year. it's you seeing concessions kind you next you is that came

Sure, Mark. Barry first.

little about a little people bit know know abandonment go that So We to there at through pharmacies, least -- go to we we know more just don't a who a it's a who XX%. get have sent the specialty quantified XX% clarity at because specialty Jakafi, never level it's actually or We know. know, we we when data pharmacies, there scripts for of don't don't patients script it's But that. pharmacy. least we and

the we in XXXX specifically XXXX. better. could exactly the Jakafi So portion and a from out-of-pocket cost, hope, significant -- of aren't all getting time, because benefit from there's patients that sure, that think that's these we of not and we're better and but

formulary vitiligo, it's while decision at to bit step got therapies little As down when makes step with Obviously, that far local for status takes the a this Aetna, example, wins, with Opzelura as to level. goes AD, it's and no for preferred changed a a to anything for funnel it to therapy plans CBS, soon CVS because see year various X too us, the

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

rumor to Get X bid an high. of end #X. be the the that's the time a would engineering And you jackup just to [indiscernible] is involved? of just the whole lack MS any success, incorrect on probability back of I'd on It's I'm kind I'm this that get the , question -- wrong. just still of years but the really bit Question What quite the about for XR. to and love it takes get of this issue. I color solve would considering is this think word, Or better it thinking the problem, maybe other more acquisitions space? your TAFA was to the you for little going are rumors after XX, in were Stephen a to

us Maybe fact, for question, fact, of in said, Yes. the can is can been for short said, an it's, most very the in first in because the term, it indications synergies in think costs the very, has is past deal. X or the development these terms with development as TAFA in all realize we It's, on of paid the for excellent asymmetric acquisition as I I in compensate of left what year. I already

minimal will the of line short in long whatever bottom actual indication. case in scenario So it the impact the new the where is the a on positive be the term, very and term very

super Now benefit indication of all of is this deal in the then get it a terms any obviously because we line. top its positive becomes hitting if new and

aspect. the that's So

in of myelofibrosis. Now field the

you a our have we pursuing from are see pipeline, number ourselves. we projects As can of that

certainty, our and need saying, obviously, we And program have there There XXX still ALKX but formulation. own XR additional have promising. the is We as data we where, top on some of very program Pablo get the that [indiscernible] bet. is was to the it's

myelofibrosis. pipeline is in of a very full So giving all of field that the us

be priority for not would first the that So acquisitions.

question your Ren, then on XR. And

analyze a tried did theoretic do And degree their PK more new CRL, back efficacy. analysis submission, concern tablet Cemento per a detail then reassure the to go resulted when route as approximately to data send the to to that And that, it -- done. great feel, approximation beginning repeat take the in and FDA didn't size in, some from of right, discussions the granular it to just slightly small in to a Remember, we on then But it, to package put and it's into guess of we has have it. enough them, get an FDA that is the journey population it year, pathway on EBA not and to So we a is should then get end it year we and and but this we make gave And length we more you're work. the in doesn't time. larger work last formulation, conservatism forward the your of best the that -- of missed at that

then can we're it. that of likely Cmax from of probably doing high. is take actually that In what and regulatory share and terms why available we that's achieve And the relatively curve, data we'll we it the and Siemen Obviously, think we model to of even as agencies. success, it will under in as becomes terms area formulations, well.

Capital The Brian RBC next coming question is from Abrams Markets. from

couple for our on a on Navin questions just This We of is had Brian. part.

dropping bit the speak patients patient little of on off a far through is second benefit question seeing to if so the as could Opzelura, the or to retention seeing of around you so And of X XX strategies retention And kind then on space. the see persisted the early versus well. what efficacy. kind the how perhaps on How you're that months of a to kind So many education MS minor latest far? then

entry So space. potentially you competitors of of see as foresee expansion additional competitors kind of these market Do as into . entered an the you the the

Barry. Sure, Navin, this is

far what guess you as retention, patient time. as mean I So is that

on of Patients the for time. a [indiscernible] stay obviously, much So longer period

and dermatitis Of [indiscernible] patients, it's they they atopic Opzelura use flares, very effective. -- it goes course, patients away, with have

over itch the Obviously, get relief the about skin good all talk time to get itch begins to the patients time. and clear we relief relief. some immediate then So

again. we [indiscernible] back, come will use patients continue the the these until as drug think, year X get and they flares the for long-term as long and years patients can from our we've see when seen it data, goes then it they using to benefit. have patients and game So The after away year their start use drug

how to that's what what use the retain around that we improvements going the offices strategies patient that's around the to so particularly we on keep professionals, So X then months can how important. dermatologists very in for understanding drug understand continue months, drug, they're what how vitiligo. the we'll reinforcing education how them. Yes, use themselves around And patients beyond, their see telling adherence, know are patients' and and to to months, health X patients use we months, and a it's particularly, care make XX The X the to trend.

JAK there X for inhibitors other are mean, space, where MMF will far continue myelofibrosis As in be. to we be the in myelofibrosis, to approved I as market competitors the continue leader

of third-line As they'll drugs But market Jakafi, and been they going better. see. survival start opportunity have because drugs. then, far know the that starting. earlier early, fact, if patients the We as could early the And in does recently, expand their go we'll combinations studied advantages you have certainly second-line to be it with

drugs and created yes, market, we after could Jakafi. if it approved there So expand are the good

Blair. Our final William Phipps from is coming Matt question today from

talks X you've any the if occupant the if cytopenias. inhibitor. Curious ask on or I'll can seen far on so profile just comment you CDKX safety you're seeing

you the for thank Jess, question.

We have not.

a have We CDKX is hold in with seen led so the you safety of of know, our far, mechanism competitors. happy And which clinical profile with are as ocular toxicity, we which, X inhibition. consistent the not to

So mentioned. CDKX over forward data year we're plans very about sharing the well the inhibitor look development our excited the early as we future inhibitor of And program. the as CDKX We're course a we data. as to for

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

of today's your Thank participating will Thank team The you for for day. be available questions. for rest IR the you. call and in the

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

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