INCY - Earnings call transcript Q3 2024

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Operator

Greetings, and welcome to the Incyte Third Quarter Financial Results Conference Call and Webcast. [Operator Instructions]

As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Ben Strain

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

Before go who Steven release, available everyone section encourage by Matteo today's we I begin, and I'm call, to our and that website Q&A. joined for prepared find discussion. On Barry, today's tables Pablo, of to be to deliver the will financial press Christiana, also related Herve, slides follow will our Investors the remarks.

forward-looking point statements materially. out our are that filings certain I statements, would the additional making expectations These which may I on be beliefs. risks like consult SEC to are for detail. risk current our differ to you actual results and based discussed we'll factors our to encourage and and uncertainties, subject in

hand to will Herve. the I over call now

Herve Hoppenot

and Thank you, Ben, morning, good everyone.

total of Incyte for clinical of pipeline quarter for data billion, positive third FDA following growing with highlight demand which the with and revenues will readouts a XXXX for driven was Jakafi net with to progress was very approval the growth by commercial I $X.X of year-over-year This growth QX, our revenues and XX%. performance, key Niktimvo a quarter The in product Opzelura, several by programs. In slides. good XX% increased our ongoing

Syndax, anti-CSF-XR first and we, of the GVHD. X failure target after the August, of for our FDA making associated chronic to partner, it fibrosis along disease graft-versus-host patients chronic the announced prior In with approval with with of Niktimvo approved therapy, inflammation lines

the submitted to the we limit dosing approval patient following X the approval. of vial have and facilitate smaller To sizes FDA's FDA for waste Niktimvo, product

quarter the the the anticipate sizes, of we launching vial first Niktimvo U.S. in Following XXXX. the potential approval in of new

in are The of pivotal positive Niktimvo. Guidelines approval also Niktimvo in the was transformative NCCN for Journal both was highlighting a of in dataset Medicine. with the atopic potential Additionally, dermatitis filed chronic recently this significance sNDA England track of recently second the XXXX. pediatric Clinical treatment, we results the cream in Practice potential for the latest Oncology and on and GVHD for AGAVE-XXX included ruxolitinib were New published the of FDA, half trial in the

data the we with ESMO dermatologic provided encouraging updates we individuals During cancer for from multiple dermatitis, to of on in the both III conditions endometrial presentations mediated clinical potential CDKX and trial important [indiscernible], lead program povorcitinib well that prurigo as with inhibitor of including SCAC. and also this immune in quarter, as ovarian vitiligo, such at for nodularis. retifanlimab the cream, options presented treatment our and data as showed Phase suppurativa At atopic extensive ruxolitinib breaking enhance hidradenitis data

revenue year-over-year. to Jakafi of product increased all growth XX% Slide indications. across X update demand of commercial performance net Moving $XXX the up driven Jakafi. XX%, paid million, quarter and third an were patient by

on new the seen during net $X.XX $X.XX billion. first to range Jakafi Based our we year of billion XXXX, guidance revenue XXXX of raising the are X quarters strength a full to demand in

at XXXX, looking by the months indication 'XX. X first paid 'XX Jakafi and Slide Turning of total X to demand and during

is As again and you seen the this growth quarter, remains robust. unit stable vera year-over-year significant some most disease. with Myelofibrosis graft-versus-host can see, is growth growth while in modest seen polycythemia

continued by Opzelura ] Moving prescription Jakafi Slide U.S., of 'XX quarter supported shown and in last thrombosis year-over-year 'XX, both compared for atopic when X, Opzelura underscores with vitiligo. In year. the intervention growth $XXX to largest benefit were of study, and annual right MAGIC the of become the free to the as year-to-date on the We contributor product quarter its Jakafi impact reflects PV to the the dermatitis data PV and Total which Opzelura third XX% on trends net same from the X. million, from survival. for XXXX on revenues expect up over time, and the the [ Slide early

third approval launch the during third to and now and net $XX month, Opzelura available we Canada. Europe the progress also in dermatitis of During driven is the Earlier million atopic France, and in we with in to in Germany. reimbursed vitiligo retail quarter quarter, by Opzelura continued sales were this from where pharmacy achieved for

We to for revenue want third-line chronic We SCAC that Slide are near X highlight term. to more in tafasitamab begin to million infrastructure $XXX I in available X, incremental commercial leveraging XXXX. current that GVHD, this used could for the for lymphoma anticipate and X collectively products and and Niktimvo in Pemazyre incremental by On be all retifanlimab sales expected for revenues products or the anticipate Jakafi. Monjuvi, generate contributing XXXX to follicular be will

and XXXX, and XXXX tafasitamab Between launches in As potential DLBCL including in in first-line XXXX that Slide anticipated larger anticipated illustrated in XXXX on be data multiple we programs these hold will transformative and XXXX, XXXX. XX, X with followed CDKX each opportunities povorcitinib have for by

the I call over to will Pablo. turn now

Pablo Cagnoni

and morning. Herve, good you, Thank

numerous these As slides, medicines, launches a remain best-in-class XXXX. next the XX to track number we will first on we In of execute programs. on continue to I by deliver than few high-impact our potential pipeline of more or highlight

dermatitis, filed. positive of on Phase the We indications. pediatric data ruxolitinib NDA continue supplemental the cream atopic opportunity in with was Based the to expand III additional recently

potential possibility topical an With to options with million with the AD approval X in we of million effective pediatric U.S. excited the are X nonsteroidal patients the XXXX, providing the for in

of Phase mild III moderate which option will to ruxolitinib XXX,XXX the The and XX of U.S. in design study, suppurativa. first Following moderate of patients hidradenitis represent new XXXX mild begin to in interactions approximately to is implant have expected with a the primary the for half have with HS high-score the treatment the FDA, cream in patients with study we could the a finalized to

results is presents a on XXXX. track ruxolitinib topical with in additional pivotal evaluating the diagnosed its extensive and with no as firm enrolling cream. nodularis, currently opportunity on and intensely patients the for III significant a With approval study surfaces of we in for multiple see option are Phase we to that potential located approximately a therapies well, study nodules, patients commonly that XXX,XXX reminder, XXXX U.S., first now the we're and as patients important cream in are PN prurigo of half approved as a the [indiscernible]. extremities for ruxolitinib As disorder skin currently conducting a report and an This chronic this early

is both II in Phase with in JAKX plan severe a and spontaneous efficacy As suppurativa, randomized vitiligo in hidradenitis shown on and III being execute expected XXXX. to proof-of-concept for prurigo our molecule, a Phase already involving moderate studies inhibitor. shown condition. oral currently with continuing suppurativa, encouraging highly hidradenitis evaluated studies Povorcitinib data XX, Phase in development Slide urticaria small broad chronic safety in for povorcitinib, Povorcitinib highly has we're painful to nodularis study in inflammatory patients a and asthma and II randomized selective

a that all achieved a by XX, up XX% of reminder, indicating we symptoms. XXX As week high response, to reported resolution score complete of patients

offering significant povorcitinib current Additionally, rapid of standard this and transform to disease. the a reduction for the in pain, opportunity care demonstrated

strong and studies, III the STOP-HSX Phase Phase available. limited data are effective to II the well, X and enrolling thanks options The treatment STOP-HSX,

XXXX. We expect to by have data early Phase III

and data in ] chronic [ cells ThX, antihistamine, randomized overactivation can is cell on have is itching. alone. spontaneous chronic Phase and patients the spontaneous potential cell-driven are the study patient of population cytokine urticaria. inadequately of of which This progressed of a our patients urticaria dermal refined know ] modulate double-blind controlled hypes The anticipate first cytokines. II THXX-related the for povorcitinib II XXXX. JAKX study by mast over and to [ levels that and We conducted mast disease or guidance proof-of-concept in Phase in inhibition represent granulation to severe now activation, contribute increased ] [ of both which of XXX,XXX being second-generation have production, the characterized in U.S. mast a ] who and leads We half ThX CSU serum [ basophils chronic including

XX, we At ruxolitinib to on in registrational do with into pipeline to a [ syndication inflammation to see not from can and intend cutaneous updated in you study and Recently, evolve. publish like our promising cream As data Phase patients Slide time, of study we the presented future. continues immunity plan a advance for the this study the ruxolitinib cream the ] [indiscernible]. of results II

the registrational study. sclerosus, For indication currently other given prioritization are lichen planning a we and advance programs, to not into of this indications

XXXX. ] a data anticipate we these number quarter [ XXX evaluated studies the first of indications, and a in in XXX are currently As reminder, and for of being

therapeutic new ongoing impact had of Moving and options here we the graft-versus-host have upon the on highlight build patients. number MPNs of We Jakafi Slide goal developing to XX. programs where to has on significant disease a

BET and dose both as in with is escalation inhibitor Our ongoing, monotherapy ruxolitinib. combination

reported in advance update an this program we reductions [indiscernible] plan reminder, as to and provide in later into As development expect to a length both well in We Phase as improvements this III hemoglobin. and symptoms have volume year.

plan in our update plan an for year. provide bioequivalency for early the to zilurgisertib, Additionally, we XXXX. ALKX to And this ruxolitinib data inhibitor, we later share XR,

on pipeline our XX. to Moving Slide oncology

We continue immuno-oncology build novel first-in-class our a and with to on robust increased emphasis and portfolio programs. best-in-class

year, file and tafasitamab, from the III follicular track with study on in positive FDA the we to this patients results Phase approval potential which could we a in lead lymphoma shared top line to with the sNDA For are XXXX.

a in first-line XXXX. first with expected ] combination in [ half data Phase Oscar DLBCL the As the reminder, is for III of CHOP

the or XX% detected. III primary signals a well study a The in September, showed clinically progression study that for in demonstrating ESMO in ratio retifanlimab death risk generally the the was reduction met conference shared safety tolerated no During Phase were new Retifanlimab positive line meaningful of with and pivotal of endpoint, hazard top results retifanlimab we X.XX. the of SCAC.

in XXXX. as with of first-in-class At EX a with of cancer. we tumors, studies which to other Cyclin shared well activity in most inhibitor for from plan inhibitor, EX ovarian aggressively complete as in in small our could patients and stable our molecule therapy patients types, cancer potentially demonstrated CDKX clinical endometrial ESMO, and well ovarian number notably CDKX overexpressing partial we as be disease promising We as a Cyclin believe initiating responses overexpressing also tumor and foundational registrational evidence move

the in trial FDA We with months will coming meeting to designs. be discuss

months. on registrational the you the As in the regulatory coming different this designs to continue considering for program, program slide, strategy highlighted will the and for we update on we're

XXXX. In new to of molecular make closing, focus will Slide entities an with pipeline and XX the across strong considerable or continue a our the a of milestones indelible XXXX potential of patients. These impact the the milestones transformation remainder shows summary with number of on

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

Christiana Stamoulis

morning, good and Pablo, everyone. you, Thank

execution $X.XX Our commercial quarter with billion, total XX% versus year. up results the third revenues reflect last strong of continued and period growth same

Jakafi strong of product million [indiscernible] were year. the for increased driven from in Total contribution earlier revenues demand by and of Monjuvi as revenue tafasitamab and a Opzelura result $XXX acquisition to QX this rights of growth

royalty to compared quarter increased revenues XX% the demand Jakafi driven $XXX and million, XXXX, Olumiant. by up third for Total were of

net Turning with prior channel to growth demand a $XXX the up within stable Jakafi million revenues driven At for and was [indiscernible] continued normal inventory of range. the QX, of year-over-year year-over-year, $X on Slide gross third Jakafi net and growth indications favorability estimates. product to X% as quarter result million and XX% were up total quarter-over-quarter in a all demand XX. by end to quarter, reflecting

the Turning now well new representing AD refills the increase as of contribution to a across XX. were for in Slide vitiligo from both XX% commercialization and third by continued product million, quarter starts driven $XXX U.S. revenues year-over-year in the Europe. patient Net in and growth for Opzelura as vitiligo on Opzelura

and In Opzelura uptake million Opzelura driven net contributed France reimbursed where quarter, revenues, available continued the Germany Europe in broader access by $XX in is pharmacies. now retail third product of in and

in Third build include quarter France at net product a revenues up wholesalers. $X stock million

Opzelura we third made and including in in the progress on formularies Spain quarter, in Italy. regional significant Finally,

assets. R&D for million GAAP milestone were the to XX the quarter Moving $XXX continued our MacroGenics Total payment our in third expenses Slide quarter investment and to on $XXX operating made to development due during the late-stage and million expenses.

onetime certain expenses investment R&D our to 'XX all R&D and ongoing quarter additional increased for assets, continued Escient in development XX% expenses the the [ to ] from period Excluding third the of same in timing acquisition resulting due expenses, late-stage compared expenses.

and the of R&D ended povorcitinib in to of September increased months XX, expenses period as For studies III prior XX% the compared X XXXX, the Phase Opzelura. a year increased ongoing result investment

third-line in as in retifanlimab and As refractory up development of SCAC to we would to and the partially we investment in activities well increased R&D offset axatilimab those cell lymphoma investment of clinical discontinued cancer the GVHD, non-small as allow growth. which other reduction the anticipate future development chronic us the follicular lung programs, expense programs. tafasitamab wrap in in relapsed programs in control

SG&A representing certain quarter, were SG&A. expenses of million a and by driven increase other primarily XX% the $XXX year-over-year Total GAAP to Moving activities third marketing expenses. for consumer timing

months For SG&A GAAP XX, the expenses September X% ended total X increased year-over-year.

operating for leading total margins. months to leverage expenses versus operating year and XX% increase in Finally, in first ongoing increased of the X XX% an revenues, the increase a

range X of increasing Moving Based on to our the our guidance to on year, to year of billion guidance in of the XXXX. performance full XXXX Jakafi $X.XX first billion. $X.XX are for we new strong months a the

updating a the our months full to million the exchange to $XXX first of also and range foreign million for guidance rates. products year actual other X unfavorable new impact hematology/oncology of reflect to We $XXX demand are

the to billion In $X.XX year includes MacroGenics. for consideration The full million GAAP now R&D guidance and R&D expenses full upfront the updating to of $XXX onetime remains year guidance the acquisition guidance to $X.XX billion, Escient is to [ to in R&D $XXX unchanged. are payment million payment of Ongoing the million million which addition, we MacroGenics. milestone related milestone GAAP $XXX the $XXX include ]

Finally, SG&A. full XXXX we year guidance are and for reiterating COGS our

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

Operator

Schmidt today coming question from from first Guggenheim. Michael is Our Instructions] [Operator

Michael Schmidt

a Congrats third had quarter. great one povorcitinib. on I on

Just early the upcoming hidradenitis year. in to data looking next III ahead Phase

you're in So beyond particular want a Humira effect competitive have any to you success, on order with thoughts market with there top you line hit you to Is out be that -- for placebo-adjusted other and to think do where size where shake efficacy povorcitinib? looking biologics?

Steven Stein

Steven. Michael, it's

thank on question. for your the taking And you question Just HS.

which feeling an extremely Pablo HS. strong, is efficacy prepared XXX replicate XX%, if with benefit remarks, Our was as we that incredibly patients includes [indiscernible] II have his will that the data, in to up we'll and Phase of said favorable really then profile

be [ that to with Phase data predict lesions, and able get to will from read II out. to add differentiated what that III couple and the demonstrate that pain Obviously, we it's pain ] think the a really symptomatology, the that set benefit You other in relief, were how profile will will particularly to Phase will we patients. hard

II is The wanting on good other Pablo on thing a in to study. testament his remarks patients prepared the to alluded is extremely enrollment driving investigators both Phase probably put studies, to data the which

Operator

is Fye from JPMorgan. question from coming Jessica Next

Jessica Fye

longer inhibitor. of the development in a just potential you fitting believe kind announced where strategy all molecules for on in XXX the for to your the had And us you [ follow-up for Novartis needed povorcitinib and determine I impacts BET? time ] the think that And this about both help how paradigm? I path BET regulatory best their earlier development treatment CSU? few then can pipeline. the plans Curious morning, or see thinking forward is your at

Pablo Cagnoni

this Jess, Yes. Pablo. is

me the Let take first one.

randomized be obviously, presented make to inhibitor, very in past in every ability reduction, has We've blinded with a break it BET we BET control weeks and dosed will this with could dosed to pretty We've very important year, seen important of difference symptoms. that far. our an pelabresib seen improvement opposed believe the update as not the we caveat a data, that the data symptoms, we're So provide reduction. but week is spleen that impressive seen an later way We so a continuously our X we've potentially this as ability [indiscernible] the to happy with year, be over symptoms. our inhibitor of effect on to the

So plan our remains the same.

we III my the we in on update the and prepared a intend before I on end into to provide study, said we'll the when Phase of provide the update advance and an details data. those As an year designs remarks, provide we on will data

the So same. plan that remains

you [indiscernible] the in way. for randomized because in a study in On is of stages for of indication there's concept. are proof We different it very has. that strong anti-inflammatory povo potential Phase as for a both [indiscernible], believe effect know, a in CSU, II this

plans to that. we forward So future and look sharing data after

II dose XXX is for pivotal for full of here we potentially initiated X in dose idea levels XXX to or a the explore once doses a ready placebo. be And compared randomized with at with compared to also placebo. milligrams have we positive studies. study range of Phase XX and XX results, lower a study And with a is the assuming XXX results to

In I probably be these is here difference the how sequence terms on think used medicines of a in with patients how SCAC. both fit, potentially could

the As you do disease. of This progress about know, antihistamines, not respond XX% first of into multiyear antihistamine. or therapy XX% to line antihistamine patients a on is

so be different. The And for designed of the cells in a treatment need best MRGPRXX patients in block particular used has to XXX a that see controls is effect. which Povorcitinib is symptoms to inflammatory the broad mast mechanism skin. to individual. exquisitely one sequence

So will that, we profile. safety believe that an to lead excellent selectivity

how little have once think potentially we paradigm. data the be treatment those So more we'll on sequenced programs, share both in a we can for bit

Operator

is Next from Salveen question Richter Goldman coming today from Sachs.

Salveen Richter

help when how some you addressing you different [ us the strategy differentiation out? SGM think understand and regarding ] the playing development Just see Could thinking these mechanisms the portfolio. about about how of just you you're diseases here

Unknown Executive

Yes.

acquired have X we MRGPXX. programs were with that So [indiscernible] and

indications. I in urticaria. indication. spontaneous where And that with are being currently X is Chronic MRGPRXX just we highlighted So developed

and milligrams data, placebo. we'll XXX steps and urticaria. second versus we have dose next the ongoing XX have spontaneous an chronic decide Once XX of that We for versus study X with all levels placebo, study

particularly inducible X X and atopic of on are indications urticaria, focused [ chronic ] For the urticaria and cold induced those, dermographism dermatitis. other

we profile as these in urticaria, cell the cells, that mast reason patients, make should progress first the think skin not target an chronic also perhaps, of why safety this, for case MRGPRXX a excellent example. but mast selectivity, for type, The urticaria, after and and to like the antihistamines in we some tissues. of just the lead therapy patients And specifically in on connective excellent is cells

option So very clean good for stage very, that very make this at evidence disease. we Together with think a important patients it of will efficacy. safety, of the a

have program primary with [indiscernible] in has XX primary This and that and why bind specifically an cirrhosis you second in We We'll MRGPRXX pruritus. quarter receptor, the as patients study we'll next this And cholestatic bile was a is been The ] bile salts XXXX, data early indications. give randomized of it, and are conducting pruritus, the is steps. We [ developed important patients next for these in MRGPRXX. all clarity acids [indiscernible]. know program. year, [ way ] to we on double-blind same data have once intractable a those in first the report

Operator

is coming Fitzgerald. Schmidt Cantor Eric from Our from next question

Eric Schmidt

all pediatric sizable reimbursement on to doing be efforts again the and to pretty question a in AD you're for the year. next How ensure and with potential commercial what for Matteo half could regard upcoming Opzelura formulary do a marketplace? launch and access you updates. Congrats think on of Maybe the second

Matteo Trotta

Yes. Eric, question. for Thanks, the

XX On old to The patients unmet we're in bring clearly for about need tool and pediatric new to very the AD. years is there. the side, very us X this excited potential

cycling into They're sizing. still high of get unmet terms in to patients for remain and need vastly potentially million on and X TCIs, have that. TCS still us We a there

we're year. Right I have the coverage that will had year. the mean, feedback the for XXXX include, position that In [indiscernible] entire obviously, we we brand pediatric terms we also if a coverage, formulary from next look formulary we're overall receiving, will for of And now the the competitive to confident indication that fruition. Opzelura next for to at

Operator

coming is from Next from Jefferies. question Kelly Shi

Dingding Shi

the to high score score cream moderate the for trial on typically the [indiscernible] use Phase HS. Curious primary using [indiscernible] What XX? for the XX rationale is III ruxolitinib [indiscernible] the mild and over in high

Steven Stein

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

you. study unmet nodules account of tunnels. of HS of to lot mild effect a in need a there's moderate as placebo those XX, reasonable and I X to people have in can abscess our described the just firstly, with draining disease patients about because to phenotype of So no defined And

higher So high hopefully agreed looking It's end and for the a eliminate get obviously, regulatory address that's go across effect unmet finish large -- bar, program. we're need help the to agencies, on XX placebo will higher at score It's the and a point, it a control that. a with line. to

Operator

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

Matthew Phipps

The the that XX [ rationale far of at QX profile [indiscernible] you most should as give on clinical like trial Or CSU oral? effective about data to I I I here. competing the guess, you showed Can arm guys had the just question efficacy we thinking the included in ] you the maybe maybe inhibitors mg update? any BTK think as recently treatments that? not some assume recent us another to -- XXX. for do that with And of addition goes? also trial. going Are another about be as the as look far more is

Unknown Executive

Matt, Yes, for you question. the thank

reason for -- the the explore full doses. So of XX to is to range have the

in range XXX placebo. meantime going XX of that we're of versus out, first as ongoing to decided the a XX with the the order placebo versus to there's doses quarter full XXXX. have study to data second So We That's explored. an point versus milligrams study start you in in the have

So ready in faster. study, if Phase be then to III already to study be -- running the positive XX to we data we'll a the have get ongoing with

CSU. with full dose that's XXX the in explore XX-milligram, of of So idea the to the of range patients

that the comes of cells, which have deplete obviously, reported. mast [indiscernible] with what a expect When with opinion, fits, do, we that well worry don't of same a all before is antibody. In times that to very antibodies terms [indiscernible] you may effects the necessarily our level side is been the you efficacy send series In that strong. have I few of mentioned efficacy

terms safety with BTK in inhibitor little ] of cleaner think is bit I profile. a [

fit antihistamines. alternatives. they Once ideal We progress clean we for need those think if expect a be XXX, in after aggressive to convenient will a patients data patients pill daily shows CSU, very what antihistamines, it safety positive to be perfectly try will profile in for very before more

a CSU. believe for we XXX fit that continue to in perfect So is

Operator

Your next Deutsche today is Shin question James coming from Bank. from

James Shin

ruxolitinib high For point what assessed? I is creams being HS shows look starting III, 'XX approval the the slide, Phase score range the around XX mid time at it When pipeline time frame.

So data is for cream expected Phase RUX HS III in 'XX?

Steven Stein

hard endpoint update Yes, the be we'll and precision how it's of given appropriate and Steven. beyond precision for more that to the to enrolls. with as endpoint. high It's because be start at in And then has try give a we more it XX regulatory agreed much what to The time moment score showed see is agencies. and study the underway on

at well, this, space We excitement time. should later see we'll the lack around expect, that it need, the enroll goes given of it competition the in the and but a how unmet

Operator

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

Vikram Purohit

So one pipeline. the on we had oncology

base business. those success initial for the program then releases the could how the see if For could be the squeeze sets you data JAKXVXXX programs understand Could expected just a these data to for And expect question in scope and we Phase help XXXX. sets? gauging for I I also that on data us [indiscernible] in the you'll and of

update? terms year and just patient how AD per tracking per a tubes you us both for of utilization give sense vitiligo of versus is could Opzelura, your For in last

Unknown Executive

me on first take pipeline. Let one the the

mutant antibody So is CALR ahead of XXXF. the program

now the into a then myelofibrosis it patients, previously, our XXXF advanced As antibody. CALR bit little patients, this and healthy better to it's but in we program started disclosed in formulation year it's we and mutant understand volunteers behind in

CALR to be patients the mutant We large single have of number year, also both particularly as basically next fairly expect data comprised antibody and a meaningful agent, data of but for combination. with will in some available data that the

about VAF been and like. of numbers is right see medicines. to in difficult expect [ symptoms to what the looks consistent to success we when we've I some next with to decide ] think we putting reduction And to start [ neoplasms see disclose ] evidence have it's that is around of obviously allele to of we the we provide year these what that decrease will data signs an addressing update. myeloproliferative some in for What timing expect addition that

Unknown Executive

see On utilization, over tubes per patient per for we AD, Opzelura X still year.

the enough we're the For that throughout that what reliable [indiscernible] as coming is follow is well to up we're from a number. cohort new long the side vitiligo, on meaningful see as well growth On enough you patients following refill. and we the very time make to sure cohort as is the prescription rate actually as

of off increasing part next over put continue and actually to emphasis first focus this At more we're for the we the of this So kicking programs support to on patient overall on we quarter time, same year our time. improve the the adherence, and have quarter exciting population. quite

Operator

question Your today Fargo. Derek Archila is from from coming next Wells

Derek Archila

quarter. Congrats the on

Just X ones. quick

[indiscernible] we've MF [ to on with just the ] with then know the I want terms business, XXX. in the on it looks new And like Just just the just you're of in seen what the in agent reduction characterized if volumes. trials. you've still seen earlier-stage base market, Jakafi patient driving you've

Just the overall more that's was growing? market gains share or wondering if just

Unknown Executive

XXX. first take Let on me one the

we going [ with those deplete cells address is tryptase [ sense XXX particularly same the if by is cells with that to you're ongoing you'll [ dramatic in measuring [indiscernible] think the caution, the see in tryptase that ] that of trials. just magnitude the using antibody. expect ] I in in not mast we are I word of reduction see we ] going of the of to you mast have, the their cells mast regardless depletion of degree circulation. the What [indiscernible] have it's So mean A MRGPRXX in to in pretty skin. circulation, tryptase location, you're a

measuring a decrease not the it. and that as may we in we be report see, dramatic. are it's to which tryptase that As quite of will going But we result

Unknown Executive

the They're increased Patients which third you line. second said, before. market Total starting Derek, patients continues But yes, X% the are first have we being to and are goes, yes, grow. in to to now, growing. earlier myelofibrosis far treated market getting fourth-line is as line because we as even after in patients overall setting, the multiple myelofibrosis. had not go Jakafi, agents seen as line, in and Jakafi fact,

Operator

Next is Lebowitz David question from today from Citibank. coming

David Lebowitz

middle, any at the in in be current the in understand up of could I played Jakafi looking following year later might catastrophic Just outline role question. Jakafi that we their then growth that Has forward step down uptick at the what out-of-pocket lowest you year. year, type $X,XXX the in they'll And next on to are ASH? the per see the the actually in quarter? in data costs

Unknown Executive

and So I'll hand over Steven question it take first the Pablo. to or

cancer always what Jakafi, So Medicare be use. patients well, so yes, Part [ that believe not out-of-pockets barrier are should to patients, D who we ] really a

over catastrophic thing a the of thing, very whole Part D year patients rid next getting year very good especially and out was Medicare of going smoothing really on to pocket the of coverage a time. this good So for period $X,XXX is

will and vera But because the in vera they better. is have they mostly when really, that pocket physicians earlier. Steve? that polycythemia polycythemia patients we've demonstrates and said, free thrombosis mostly, So when MAGIC from given patients patients of PV, growth of start see survival earlier demand out are that's from we is which on starting any start Jakafi Jakafi because coming largely the Jakafi as improvements from month and results and

Steven Stein

will premature Yes, be seen to ASH. David, it's it's Unfortunately, Steven. what on comment at

that the wait provide update at We and then for point. will have we acceptances, to the

Operator

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

Marc Frahm

that bar is given you of what the kind after was in XXX, you on necessarily of use back perspective of Just kind talk from your AD as antibodies get market to those dose. about the it that? potential justify levels dose But XX-milligram trial, And here. Can And different data branded this drug has need safety to at obviously, would just you in just an [indiscernible] mind? adding completed over believe you from match a efficacy informed the what led of antihistamines then CSU, the when by I summer. the adding for all minimum which that improved don't the to

Unknown Executive

Yes.

So study, study, III was is separate any that study indeed new in let and They the with soon from it data transaction of the with possible with seen we We was cohort me to after but we've have the XX made is made was at soon once as all, first decision process for based desire decision that ongoing the a closed, placebo. data. really totally That early our as to [indiscernible] do nothing a a very time. start it had versus -- on to ready be decision Phase it the program. that milligrams

to the the ongoing the In all in terms study patients look, antihistamine. bar, are of refractory

patients will be an to So obviously after basically, CSU. XXX in safety excellent is the be after in for that, what's remain over right option showing we the placebo drug with antihistamines the question be believe context, the for is that first assuming efficacy best to efficacy profile place some sufficient convinced patients? be option believe and of the for will this the used, randomized trial. what these obviously, We in that, that We with

Operator

question from Capital Brian from Markets. Abrahams RBC coming Next is

Brian Abrahams

line the any meeting And about into updates considering the and of on on think and companion and there's late more that drug? that progress. on how plans around Congrats for the I'm versus diagnostic next you're the the exploring then the the FDA upcoming you're thinking between aspects if sort CDKX, maintenance? any as balance pivotal color quarter Maybe steps the about you all curious

Steven Stein

Yes, Steven. Thanks for Brian, question. it's the

refractory there retreatment. But cancer his months, a in. divided gray into different both. divided broadly interested areas settings terms a that's time there are a approximately Pablo interested ovarian needs numerous speaking, and setting we're slides, as we're in And the in platinum are population, X said and of in getting unmet by period So although of platinum-sensitive in each

late of it upwards XX% north responses got is We a rate, maturing go may but ESMO. at where be up. of still response data update actually the data and the there may saw You

So profile XXX the range of we work. plus patients seen. really in like we've done We've dose

a and place in schedule. very pick we're So we think to a dose good both

X of are cancer the ways refractory it. there In setting, ovarian about platinum thinking potentially

get single-arm of do For in the to across setting, it one a finish study at line. response primarily the could rate and the looking FDA, U.S., that durability response

for progression-free randomized drug As single-agent endpoint, a which And as their require numbers, setting. potential would time ex will [indiscernible], the like a And was U.S. cetera, confirmatory that with we to event it of study and of chemotherapy that survival. that in approvals, like slide deck, profile there. study the on their investigator the be et choice against

] bev [ to bev and design, maintenance be of terms plus we'll rates, so maintenance We about and terms obviously HR ESMO plus deliver enabling setting at other we its we for deficient seen placebo and We're there. in of is majority EX lot, ovarian interest potentially the platinum-sensitive you that's in complicated longer a ratio. deficient and particularly now. construct can are of gets maintenance, us. cure of bevacizumab work far the drug work therapeutic you setting, it the But is disease we've patients, a CDKX, maintenance it safety patients HRD-proficient of the focus cancer look And would PARP spoke and an the that in because little CDKX improve there is Cyclin just later. like us, The used. simple that majority population interest extreme the inhibitors. those on terms HR pretty versus But use need the to where if of a doing a quite and will here it doing There's of the bev positive. enormous now and that's at with That study profile be there, we're

interest the designs. are terms of areas those So study of in

diagnostic, On this at what on of given population. per we but se again the haven't X ways details there's companion our is, looking cutoff

doing and expression, you at where a look of we that's EX at cutoff, bigger in IHC, can gene, diagnostic right determined use showed now. at the we of internally. than more assay ovarian and we Cyclin was with others protein to gene more using probably the and it's is CCNEX our regulators of the and data amplification, ESMO population. we by companion cutoff But have Without in. need or the on can CDH expression look that the are with But much terms You discussions that focused. half we've cutoff And cancer that our

Operator

Berens Partners. question coming Leerink is Next Andrew from from

Unknown Analyst

This Andy. is for [indiscernible] on

So out with HS dynamics. for straight commercial the looking povo, the just one upcoming ahead to question,

wondering I'm see like drug agents black strong I commercially? you povo the I safety and other to even look you if might are the guess anticipate efficacy box the agents? asking how JAK the other it's of now label, HS, ] [ a So developed JAK for how impact the oral. concerns was on being class relative if reflected that

Steven Stein

I'll Yes, are II bit it's upwards the inflammatory spoken a how The going. going we enrollment And saw XXX high profile the It fact, XX%. we've mean is very Phase address that. about I with Steven, in is studies well of score disease. an well.

have there black labeling or terms effect in will box. class a a reasonable a than chance reasonable more is of it So that chance

case So we going do be expect forward. to the that

] set JAK-STAT can in to one potentially disease that's [ more a biologic, will rate. we'd data If definition, profile the in example, inhibitor then Here, of only saw would and which interleukins, by we and you for attack, Phase like as pathway, broad we IL-XX. coverage a look data, better the result different at the have of control that versus II

Operator

Chen coming from Research. next Our question Wolfe Andy from is

Andy Chen

topical you curious you remind into inhibitor. capitalize PN on derm to us your your I'm existing you how the the I'm sales pediatric heme AD your to and and also of and derm force trying would are down others? on get your going it's you to size across SG&A and spread figure JAK Are sales as into going out if synergies? double if the up trend force? can Or

Herve Hoppenot

Matteo? work the most U.S., launches in you that U.S., and anticipate do about teams have around may the world, are countries, in clearly the When way most the in comes to the that people picture is that how they for but Matteo a now in -- Opzelura. be guess I we the now mean sized do speak will the place the where it of I established in IAI can have are and for to increase, Canada, povo very many is nothing very, that in we in that. have I indication, high. required dermatology European of the big be a marginal new So able U.S. of be we mean fact, a up, absolutely in

Matteo Trotta

-- competitors. across ] other it footprint we couple all full around line is The It's [ of with people. in teams see a XXX

while saw a data from a the also year. next staffing to field see of look like We current But Phase what synergy We forward full the HS. to force footprint staffing looks exactly competitors have. up up be III mix it's now, dedicated with it [indiscernible] going capturing to we

Operator

is coming from Oppenheimer. question Olson Next Jay from

Jay Olson

or are X gaps have thinking the Congrats reshape how which catalysts of future over your about near strategy year? you on talk can X quarter. you business in the term number line any top are next development portfolio? about could are catalysts Since in there And important? that the you a growth, And the most

Herve Hoppenot

is we presented Yes. if to go Maybe basically Slide so I'll in the saying the it's in mean increase take I you of the that. has I [indiscernible] recently is just the happened in what mean probability if line XX, as you slide, of in them be collectively, presentation, I around Niktimvo and something together, end SCAC. retifanlimab success in third million. And up would my you with for [indiscernible] put that approved said $XXX we,

them. XXXX. is contribution meaningful relatively when this So by them if want to a each together, you to classify modest, But put top them the of are you line

ruxolitinib first-line coming soon is XR What CDKX, in and DLBCL. povo, have tafasitamab we

So probability is of that's, data the good. that -- clearly, have has for mean, where recent been CDKX, again, I number success projects events. the the with of increased

is for have some tafa, the CDXX, lymphoma setting, first level data the combination. good improving For accumulated is is showing also fact, success follicular povorcitinib, the where And combination that which CDXX CDXX, doing II efficacy. the in in very Phase we CDXX are we of of the first-line data way our chances in of

step. second the that's So

well. very is [indiscernible], moving go early that the all And pipeline into then we

some it we development looking does or ask find dermatology which we early of really in would that commercial would would things are hypothetical like and from us expensive. would where of of for, be acquire, what we in interested can is oncology maybe that, and learn quality that to situation some deals very that also common terms is late of very type very at stage there technology in where business we So the very not in are products be always

a at new very expenses. not XXXX. quickly. well our the pipeline looking we that's Jakafi where works recently us in of patent [indiscernible] some that or R&D late around are the we we that the exploration need compensate to way, in the line And And giving the very short top very at have acquiring today a either plus for early have to we or very are position done that internal in we contribution lot what will term require portfolio we why done assets So come a would with look acquisitions is that

Operator

coming Next Gavin ISI. question Clark-Gartner is from from Evercore

Gavin Clark-Gartner

you I'm think [indiscernible] potential be patients? Also had And there naive one versus IgE as any with patients study? the on experienced in subgroups efficacy, XXX such low just could wondering CSU. are how greater many in if

Unknown Executive

thank the for So question. you

patients have So other all refractory that to we're going than provide details on in any to prior not say therapy the antihistamines. study to

I'd opposed the they but the In the this I'd at [indiscernible], about an point study. time. this subsets rather in for the not of as you into different the results, speculate potential pathway, to know, -- results a in anti-IgE for XXX, to a work not which of future Obviously, antibody rather speculate efficacy, very as different it's have point at mechanism better certain terms is,

Operator

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

Evan Seigerman

readout. Can few this know despite you a the XQ. about program thinking [ in gives going in forward? I downs and and has your program what want much, feels the ups in this the but highlight ALK on overall maybe kind update speculate mechanistic like too the really I'm program confidence don't rationale. you confidence readout the just in It comment to maybe you ] of

Steven Stein

Steven. Yes, Evan, it's

of patients' of which the released work been through we've to from go break then to year, of and to you, sufficient disease and trigger we've future on color to so the to achieve data alluding from have hepcidin it's you at potentially and the on say underlying a meeting program, potentially efficacy As seen to safe relieving just to remind that [ gets improves disease. year iron doses hemoglobin ] drug-induced sort I inhibiting more the in try update higher at end and desired last We'll to date and go think then the yet this that. point time, more would at And give we the effect program. haven't registration and over an a that higher appropriate

you, we ongoing remind to though, ALKX. that do Just have enroll an with program in to continues

Operator

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

Tazeen Ahmad

you so little usage of HS, you of seen for cream vitiligo? terms in cream for but you rux do and different still sense, that versus And for in to think the will about know be have it also, a how I As clarify think povo? do you you compare HS how would early, can AD have RUX it's a what bit you far opportunity, think us for relative tubes

Steven Stein

So On it's first question. Steven. your

and number disease of classifications tied So HS. draining fistulas. mild, [indiscernible] Hurley of moderate of by that [ called number They're the in spectrum abscesses there's ] and a goes stages, and severe to nodules, the

the tend of this, nodule XX to moderate underdiagnosed unmet disease than they're be the a and with time tunnels is in between patients to for to to lot setting XX of approximately on XXX,XXX be To There have score long the will XXX,XXX tend Just less up the with a and in to patients count. need. These to conduct particular count you draining to treatment, to to how diagnosed cream to long It's and be. and to would population limited and getting get there may chronic address exactly before the that hard fistulas earlier, for we the need X study treatment. readout mild XX. no until and get is appropriately seeking targeting, now said are nodule the abscess determine to it high the the as have study, our moderate which I abscess endpoint. And have mild

at of the the right disease. terms looking In spectrum it's of povorcitinib,

from need to as treatment higher the lot tubes will the if and in can his counts draining will abscess towards of it severe readout, with needed to with And abscess a and potentially, said remarks, unmet will So of III at many therapy, the of huge be care be tend and ballpark Pablo a will of then long of called removal endpoints again, which score XXX, high of but moderate chronicity the morbidity. Phase takes fistulas, be population draining resolution nodule obviously And presence how come everything, the prepared tunnels study and addresses the moment. you tunnels. complete just go and fistulas it and a want nodules

Operator

question Next Securities. from Devarakonda is from Srikripa Truist coming

Srikripa Devarakonda

congrats the given you on you're pivotal ovarian either of data? wondering we I the some see in? quarter. should or landscape I data peers was program. CDKX your any of the can before cancer other drug trials, if back And discontinuation indications about you see from competitive were how FDA the of any move you with their investigating And conversation additional into have expect the the But help that or CDKX to before had the you of your I know a answered. question just announced the us program. the one questions already understand

Unknown Executive

Let me take that question.

the So program. we it in little the a developing CDKX, think comes of competitive it's terms right? I in mean landscape CDKX are for landscape, cancer, we of competitive ovarian beyond ahead when mechanism, to terms a bit

disclosed we -- as data, the are We know. you

patients XXX very, profile. efficacy of treated. of range safety manageable a over We've doses. We have a and evidence explore We seen clear very

registrational next intend to doing We're work endometrial year, ovarian comes studies inhibition when puts in which front in perhaps to we other think in CDKX also it cancer in start and cancer. that So indications. I us additional

well being of as for full bit landscape because patients CDKX ADCs, target approved targets other ADCs. certain as the alpha the in complicated additional receptor than expression. more a are is same there's just Now is ADCs developed [indiscernible] company Obviously, little ovarian a number for cancer. There with

comes points one, with in as there when others, I some important more overlap is, might complete will the be would convenient, very pronounced. the long But it'll for be maintenance overlap CDKX one well-tolerated because think the believe isn't it our Perhaps for run we of at the that now I study number make of be patients. to the with oral, reasons least receptor molecules X populations, alpha-positive us inhibitor. bevacizumab is the that perfect setting an in why combination such the for

So differentiate our target platinum-resistant in there, the only against aggressively while from also to CDKX market ADCs. we intend not maintenance other will to but move we a entrants into patients same the get believe strategy program, faster

Operator

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

Reni Benjamin

even Congrats from And And what just file currently positive longer-term approved share for therapies? to quarter. market need we feel to relation might Steven you you how think know has in III away? right Phase I approval patients you guess HSX, on you of about talked treat? XXXX, do I and used of able being how XXX,XXX think assuming about do data? than when the data but do you kind the STOP-HSX Or this an be might in see potential can do like you kind follow-up think do ultimately you greater patients, you achieve? many that

Steven Stein

can't Steven. part the Ren, lot regulatory aspects, of an NDA, it's we about first a speak first obviously, your least filing. And the it but is I'll at do question. So to a

needed, time. at XXXX that appropriate updates to we'll at be a and be approval guide we time, to safety the data will So but provide the continue that there'll for

be terms In lot a are There what unmet of a therapy. and biologics efficacy terms of orals disease, will in patients really cycling there'll you ultimately of it lot -- in see terms be of or up need, the other to profile through with lot of vis-a-vis of the use. a

drugs XXX,XXX from with will setting. biologics versus the I III to on between profiles severe Phase orals, patients think then depend potentially of of in give therapy this the the is the total, in numbers cetera, et use and to we terms seeking XXX,XXX of moderate

Operator

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

Ben Strain

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

Operator

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

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

Incyte (INCY) 29 Oct 242024 Q3 Earnings call transcript