INCY - Earnings call transcript Q4 2024

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Operator

Greetings, and welcome to the Incyte Fourth Quarter 2024 and Full Year Financial and Corporate Update Conference Call 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 XXXX and Fourth and Quarter Good Conference to Call. Year Earnings Full morning, Incyte's

Before I the section today's of financial we the and discussion. our to begin, tables website encourage everyone to that find slides press related go release, follow to Investors

On I'm for available Q&A. Herve, joined Pablo, deliver who will be today's prepared will remarks. also call, the Matteo by Christiana, and Steven

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

call Herve. to now I the will hand over

Herve Hoppenot

Ben, everyone. Thank good morning you, and

we since strong another versus we to reach revenues with steady billion, total XXXX. have XXXX XXXX growth delivered So the continuing $X.X delivered growing XX% year

the performance our we addition continuing In highlighting in non-Jakafi growth revenue Opzelura, from XXXX, strong diversification. saw consistent primarily by our to revenue, driven of Jakafi

$X.X to were Jakafi outside to refills strong U.S. from by new momentum indications. saw reimbursement the X. growing X% year AD XXXX growth in net vitiligo patients all Opzelura sales the $XXX coming U.S. growing and expanding XXXX, and million, Slide XX% in continued with the versus driven Moving and prior both billion, in

the growth expect year. be We to key in next to Opzelura to continue contributor a

in no Our maintaining billion strong ended a allowed $X.X XXXX We cash share repurchase cash to debt. remains flow balance strong, XXXX and while which billion during us $X sheet. complete with

pipeline will in growing of a a revenues deliver in very position very are strong exciting and a with robust that We readouts XXXX. number financial

to the target available sizes, are with that the treated antibody now we patients and we Syndax, This the partner, to the vial GVHD. approved commercial And launch Niktimvo for in excited Niktimvo is month, U.S. inflammation Last approximately underway. U.S. to X-milligram are after is medicine in the chronic way therapy associated who and the anti-CSF-XR the and is first XX-milligram in the launch. and new X,XXX fibrosis the FDA therapy this second-line commercial currently paving announced bring approved our

to ruxolitinib In million an in controlling approval potential suffering the filed pediatric the of population. are half with for to sNDA X for Niktimvo, significant the X track important addition pediatric dermatitis, second address launch opportunity with dermatitis cream from cream was we and With the for each U.S. FDA, of to need this for ruxolitinib in atopic the XXXX. on efficacy we million compelling patients see patient in atopic its in

tafasitamab anticipate study of both We submitted half contributing to FDA follicular for to to begin revenue cell lymphoma These XXXX. anal and squamous approvals for in in results second the be our indications. Monjuvi new Jakafi, leveraging collectively commercial generate X to established XXXX, all incremental will and in be of support products revenue. launches and or products available diversifying We 'XX our retifanlimab carcinoma with potential to the the revenues for further $X and near launches billion by term the these to in Pemazyre, product pivotal both the Opzelura, we in expected in are anticipate existing infrastructure

XX% patients the Slide year-over-year grew commercial fourth XXXX the full for $XXX to revenue million to year for XXXX. Total grew compared to X% when XX% Jakafi full of QX performance in Moving billion. increased An year product the X. the and $X.X quarter to net fourth same in update and quarter, In quarter Jakafi.

XX% now Jakafi. in PV but the indications, this with being is for accounting growth with on Importantly, all of strength indication seen patients across particular

range the $X,XXX revenue product growth and $X,XXX full billion the be expect in for Jakafi continued net expect in year billion ]. [ XXXX of XXXX to of We to

Turning to 'XX by demand and Slide during XXXX, paid and at XXXX. total indication Jakafi looking XX

remains robust. seen see, growth was unit again this vera. significant can you Myelofibrosis As quarter, showed growth most polycythemia while in the growth

become time, to MAGIC on contributor supported early largest PV data and expect underscores its from with benefit the Jakafi the over for by which the intervention Jakafi the PV We survival. thrombosis-free of impact study,

in Moving and quarter to driven compared last the to on million, Vitiligo France. growth this in AD by Slide and $XXX XX. $XX product Germany and fourth in was ex quarter growth by new $XXX XX% patients U.S. driven revenue the comprised Opzelura same million refills, year, when Opzelura in net the of was up million and and U.S.

$XXX grew year and Total 'XX of trends 'XX both million right growth the of expect reach U.S., revenue to reflects continued year and Opzelura growth dermatitis the on million. Opzelura and as from atopic year-over-year of the full range We XX, $XXX the In million. anticipate XXXX the product vitiligo. Slide $XXX XXXX prescription continued in revenue to full for in shown of be XXXX, to net XX% XXXX net versus annual

Slide On XX.

will defining point XXXX year catalysts will a be for provide Incyte. inflection So an that of

As Niktimvo every see near-term as program I includes potential launch the providing in you already This collectively can where highlighted. potential X highlighted milestone is revenue expected XXXX. important just of has on meaningful launches, XX, Slide underway,

our Phase in Additionally, HS to III BET Rux inhibitor, studies, to in inhibitor mild at cream X initiate including ovarian we plan CDKX and moderate least our cancer.

which pivotal expect We will with including X shortly. will XR, readouts, year be Pablo highlight ruxolitinib XXXX data data-rich a

X expect which we generate company. More we data, importantly, believe informative to potential programs to the have the early-stage transform

his provide Head commercial I After dedicated service decade would has remarkable of call the from over a organization. President, to Flannelly update the U.S. Barry decided role to Incyte, leadership retire Before our for I Oncology. Pablo, Executive Vice to like hand as to of

Issa U.S. Mohamed We and oncology, led teams at are pleased successfully announce recently J&J. assumed Barry's neuroscience in in immunology Mohamed role that had to commercial January, and most

call the Pablo. to over turn now will I

Pablo Cagnoni

you, good Thank and morning. Herve,

we year more deliver track to this high-impact As than summarized ago on launches remain highlighted across the XX programs XXXX a from we and by slide, on we portfolio.

from FDA anticipate follicular X this initiating relapsed/refractory to pivotal expected accomplishments year Slide then and We and approvals We third quickly dermatitis, Opzelura regulatory like inhibitor this our programs important for milestones for of a XXXX, atopic On study the submissions which chronic I pediatric in of tafasitamab would cover had year. number XXXX. of during disclosed provided the and later key XXXX, some CDKX some the graft in expected and achievements plus line of approval with including Niktimvo both, retifanlimab plans and host I will XX, to the SCAC in BET we highlight in in inhibitor lymphoma. data including versus disease

our We and American continue the intent accelerating optimizing Through the rigor at quarter resource allocation. of to demonstrating to XXXX, validate of our study an our statistically evolve with at late-breaking and anti-CDXX R&D met the session focused and decision-making, progression in of follicular in knowledge, been survival. expected improvement we that the profile. safety the of was, anti-CDXX Tafasitamab significant This progression-free patients FDA known submitted and well meaningful show study the with clinically generally to monoclonal its safety half its a and data to tolerated primary endpoint approval data with of our the fourth the inhibitor or tafasitamab presented pipeline Society III ASH, The were tafasitamab our BET program in follicular with presented refractory both patients follicular in from and Hematology at results results lymphoma. Annual III of Meeting, first of a the for of lymphoma was Phase Phase relapsed was increasing had This in with is XXXX. combination the lymphoma. an by antibodies second consistent or

as dose ongoing For in monotherapy symptoms both inhibitor, from and well and results study BET in our we volume additional both hemoglobin. the spleen combination ruxolitinib. escalation show as with data in shared reductions These improvements as

providing this year. plan III to additional post-JAK we a into program look on and monotherapy we forward highlighted in As details slide, this later this population, advance as the development Phase to

Slide XX. to Moving

We expected proof-of-concept execute Phase currently and II molecule, chronic Phase being inhibitor. with prurigo in and for a development urticaria in plan selective both in and XXXX. data oral vitiligo in JAKX randomized hidradenitis Povorcitinib highly in are for evaluated studies povorcitinib, III continuing studies is asthma small nodularis to our suppurativa, spontaneous broad

study a painful moderate condition. II and highly suppurativa, inflammatory to severe hidradenitis shown in a patients Povorcitinib Phase safety has encouraging with already efficacy randomized in

As highlighted showed Slide of povorcitinib and XX HiSCRXX, significant in the improvements including the XX, right XXX. on XX, responses side by week

fully demonstrated a of the half standard significant pain, povorcitinib data offering care for we in Phase are X III in to and Phase Additionally, and first expect The year. enrolled, the rapid transform STOP-HSX this reduction the STOP-HSX of potential and current disease. III studies, have this to

innovative with the on Blood, medicine. antibody in sharing the The from by on Turning thrombocytopenia eliminate mutant-CALR detailing the ET potential Incyte, later forward highlighting mutant-CALR XX. and importance of the antibody patients potentially cure. leading the CALR hematopoiesis antibody to year. to and the unlike to this MF mutated recently antibody this has Jakafi, publication mutant essential proof-of-concept or look ongoing developed program clone was was a the of and in data cover featured entirely our This both We functional to studies mutant-CALR monoclonal myelofibrosis, Slide normalized

the XX, a that geometric release AUC was extended formulation for in to the Cmin range. both XX% the XXX% day ruxolitinib Slide reference study bioequivalent Bioequivalence and demonstrated to a of We're ratios ruxolitinib. pleased announce to to within twice falling XR. milligrams ruxolitinib Turning be XX to means once-a-day achieved bioequivalency bioequivalence and

We for the completed. have stability the and this reviewed plan their studies end to agreement, data approval submit year once FDA, by the with of are with

key and X least new III be an study XX X Phase XXXX proof-of-concept results. mentioned, study X readouts will year As including trial for with initiations product milestones, X Incyte over launches, important at pivotal

of Niktimvo we ruxolitinib month we see launch extended with release. bioequivalency that achieved the just have and last As these already Slide you on of X can milestones first data highlighted XX, for

call additional this with I course look sharing to like over of XXXX. financial update. the updates to We the that, the milestone Christiana And forward would turn for over to on

Christiana Stamoulis

morning, Thank and everyone. you, good Pablo,

by results XX% execution $X.X year. X% acquisition revenues revenue of by demand Our Total billion Jakafi total revenues demand QX growth in driven tafasitamab royalty strong last reflect of of result of Total product Jakavi. versus and same increased the in to growth up for were full XXXX. up and million, QX commercial for continued $XXX Opzelura strong $X period as with rights driven to and from were fourth revenues increased XXXX XXXX Monjuvi quarter a billion, the compared contribution

net and driven demand. total XX. a across X% revenue on XX% was in Turning increase XXXX, to driven by the In product Jakafi demand growth quarter of Jakafi increased a product paid strong demand by in patient fourth revenue indications. net year-over-year, Slide increase XX% all

in increase net year revenue X% XXXX, XXXX, in X% increase increased paid QX total versus Recall of free a a in X% full that by demand. and saw and patients receiving the number Part demand we driven significant Medicare For product product. QX increase XXXX, the in D a

patients paid these in anticipated, demand returned we As XXXX. to

paid As full demand a the growth exceeded result, year growth total and year-over-year, XXXX. quarter in demand fourth both

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

was the $XX XX% increase and ex was a representing million. revenue net product year, revenue net $XXX U.S. For year-over-year million, product full

of our in R&D late-stage our Moving same of for quarter expenses. million, fourth the XX continued the an investment on increase period in compared to $XXX Total certain 'XX assets to to due development X% Slide operating were expenses timing expenses. GAAP and in

XXXX, year investment XX% ongoing onetime and late-stage full Escient programs. upfront increased our year-over-year R&D as result excluding acquisition in of the For expenses consideration a expenses, the other increased

of clinical investment would well control certain which the us programs offset development these in R&D programs, as growth. in up expense wrap to the programs, programs those investment in the discontinued as we activities As other increased the development future of reduction we anticipate allow partially of to

timing the expenses SG&A certain well consumer other result primarily Incyte fourth global GAAP $XXX acquisition as sales Moving marketing through of quarter, the representing for an in expenses. the a the to Total expenses in and increase, as rights and as XX% XXXX Monjuvi recording the year-over-year million following were activities marketing SG&A. U.S. program of related now of

us U.S. year as full for in the now and the increased SG&A Monjuvi sales in expenses X% and Europe expenses preparation total product in year-over-year related and result XXXX, investment of For new launch GAAP marketing a launches of the Opzelura the recording

year full increased expense Finally, and versus ongoing for an XX% increase total operating a leading and in in margins. SG&A increase revenues, leverage R&D total the XX% to

a I our XXXX. will guidance on of GAAP key the components Moving on basis. discuss now to

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

We product price growth, partially lower be in volumes. demand of growth continued as exclusively growth by PV imposed IRA increase a net XXXB driven caps net expect and revenue to primarily be result continued pricing offset and in by

we As the in higher expect previous due be quarter quarters in to the year relative previous impacting subsequent deductibles years, gross-to-net primarily are the to that the adjustment QX. first quarter to higher and of

vitiligo launch the expected initial potential for the at million the Opzelura Opzelura in by product AD quarter impact expect and revenue year increased QX continued the on on be Europe. we first holidays, product driven of half of AD beginning million vitiligo U.S., we of sales. in in and of in net to and net the year second Opzelura, planned see the total of in growth the dynamics of the from to dermatology effects conferences to pediatric range contribution to For the medical events contribution the from other expect typical In demand $XXX deductibles resetting for $XXX the sales and year, due of again

As result, the XXXX. QX revenue net is previous saw what consistent quarter, with product we to be a below in Opzelura expected

$XXX revenues includes Zynyz and This of from and contribution Monjuvi launches expect second of SCAC Zynyz total Niktimvo, For approved in indications to range the both XXXX. million half product $XXX current to FL as other and in oncology the million. products, Iclusig, for well anticipated of in Minjuvi, be we the Pemazyre net Monjuvi the in as

GAAP operating Turning expenses to basis. on a

of the range rate Niktimvo with profit for U.S. to net driven from X% is the in revenues. COGS certain and impact The our COGS product in manufacturing-related share expect expenses agreement to by We of X.X% increase the Syndax

portion Syndax's will reflected Our of in profit the be share COGS.

to expected of in of are be by to range billion expenses our $X.XX progression driven R&D pipeline. the $X.XX primarily the billion

$X.XX expenses to be SG&A of $X.XX for the billion the billion. expect range in We to year

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

Operator

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

Paul Jeng

This is Paul Michael. on for

pipeline. the have We X on

given provide at prurigo levels? clinical any I follow-up for plans cancer there secondly, to the Phase Can the another then III therapies Phase on longer to clinical program. dose ovarian with the study, the Opzelura. there's expansion available? dose study some you topical no set a expectations pivotal And just are on And selection? First update What's on factors formalizing upcoming CDKX in the the nodularis? what perhaps bar here Are gating

Pablo Cagnoni

Certainly. Good morning, for thank questions. you the

second one Let quick. me the take real

for we approach what the that trials provide as a we study as we the well We've will discussed, hope course And year, will For earlier, initiate this to the program, a that U.S. as be CDKX details taken approval randomized a platinum-resistant as dual we of in we accelerated cancer. over ovarian the there discussed this pivotal trial plan single-arm in year. with more will be year.

So that advancing update asked. will we this program and provide as year later rapidly, is an you

The cream in second of part Rux question the prurigo in of terms nodularis.

we point, II setting in think end of look the I well that with and very than this anywhere both are prurigo to patients going on of you as the are for the data the that global a to be topical very important. what addition what if -- as WNRS think we coming require The such in at of for improvement, itching III Phase know, As this II we disease you in when it's terms nodularis. the perhaps a half. trial of the medicines severe availability armamentarium And povorcitinib, data the going bar, assessment be systemic that to vicinity Phase important less showed, is Phase have patients the may those think as

be and it's medicine. record want -- very, cream, the from to a as well-tolerated of all we somewhere extensive safety we Rux very So track know,

results near contribution what going anywhere we're to Phase be be the it's I very if a we're think So to important -- II patients. showed, going for

Operator

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

Tazeen Ahmad

As for indications? half are but also this question in you approved of a that's for only give due us the X HS first clinically one to how statistically going the it to used you the on year, then And you povo be or consider be to sense thinking what this of year, would how meaningful relates number of significant guidance data? maybe can to you Opzelura, not data specifically, got calendar the about are that tubes for

Christiana Stamoulis

Tazeen, Christiana. is this

the guidance. Regarding Opzelura

First of the to million year, $XXX look represents provided range $XXX the you year-over-year growth. at to XX% XX% guidance all, we it for the when million that to

As we primarily patient in increased then this AD contribution continued range contribution and the in contribution vitiligo in in and as by that remarks, of continued also indication patient vitiligo the mix half, the from the pediatric and potential Europe. provided demand prepared level variations we in from well Europe. Opzelura second activation reflects rate The level AD that indicated and from of our the as in launch and is driven growth the reflects of in adherence

vitiligo of terms of in tube, is level the adherence. reflected level In rate and tubes, patient the of especially the the that around activation

therefore, to -- guidance in have is prescriptions initiatives help an average And commented that we of evolving, that we the prescription the Opzelura But We sticking expect have area are that vitiligo. number of in their as provided. the and patients evolve in in and to increase is that also refill vitiligo are the seeing range average use them an number this educate we we help therapy, and and past, patients with appropriately patient. for reflected additional is to patients as pursue continue per

in you how the Finally, be tends the lower to as 'XX. course guidance the dynamics in do and it mind, the 'XX, always quarters. other remarks, about you We expect think in my saw prepared the subsequent 'XX the keep of thing, and again, to it same I the year. see we through in to mentioned that as quarter previous distribute when in saw than we QX,

Pablo Cagnoni

the take me question. of Let the second part

a positive endpoint, important primary the in the So studies X positive look, have case, or know, and the is first suppurativa to which, significance obviously means you that, week in thing for for statistical HiSCRXX study most and is this XX as at povo. X studies, hidradenitis

In beyond you I XX, and strong results think that in thrombotic that data, study improvement very was the profile there arm. the HiSCRXX, events that, the and povo the no of as at XXX with Now well one discontinued to events that the XX due II study, look totality has Phase a on pain showed. the effect high-dose is with clean. when in Together looks povo arm. There at were effect the and that safety the study on povorcitinib when Phase the were II adverse no that patients

results that of the change with profile in the the believe studies, little of I And little suppurativa. somewhere can think we -- realize we Phase But vicinity a of that profile little very hidradenitis the contraction think we bit those the povorcitinib So Phase III Phase saw a competitive always in results seen ,a Phase are II, III in in profile bit. a II. we we replicating in that we've we if there's have in bit overall

Operator

David is Lebowitz today question from next from coming Citi. Your

David Lebowitz

that take? how cap do What [ levels run Given the ] think to you long be go put the the starts And a ensure can showing that up its through what benefit place. in they moved actually per steps do you has us to of to the that sales? it in might through is patient need until must go-forward year, IRA out-of-pocket at processes $X,XXX

Christiana Stamoulis

in this to go they an payments. equal course reduced the have Patients the through. There this a through year have would is a for to ] do the of spread out-of-pocket year have to cap that [ is So process option year. $X,XXX the

that figure them We for expect that time take it process. would some to out

not a lower may we although So away, to see out-of-pocket in benefit see we the continued immediate expect the XXXX. saw as we from right benefit

Operator

Fye question JPMorgan. is from from Jessica Next coming

Jessica Fye

A povo couple on HS. in

are XX% do a biologic-naive. that trials So are of I to Are you the labeled is you the about your patients? And assumptions say there? north for both then biologic powered seek can And you and there III think Or the will of be naive trials, post powering includes patients? anything biologic in within going for biologic-naive you patients label subgroups? expect it Phase experienced the

Pablo Cagnoni

Yes, Jess.

percentage, Prior correct and in we the point a haven't exposed exposure specific III criteria directionally, -- that's Phase as to biologics out, So but it's disclosed terms the you roughly stratification naive of trials. biologics a is patients. in biologically

I'm to data assumptions expect on comment of going on for Obviously, We on and exposure key not the powered prior the endpoints the to the secondary biologics. basis around analyze based the to the study. endpoint are studies primary full powering. the

So discuss more what like, terms discussions, results obviously, with detail. And right the labeling of time. data see and the discuss in at the FDA in we'll we'll looks we'll

Jessica Fye

show When III, what that Pablo, HiSCRXX something can I the I the you XX-week. deltas would it's on said, to be to, the super showed XX-week you competitive. in that's Tazeen's look versus point. think if question. Because XX-week II follow was I if close one bit, differed responses a think the a you I Phase in it II, you little of Phase Phase think And at on time up

you when to Phase of to you Phase II, close close XX-week? close cut So XX-week the mean say the II or do to

Pablo Cagnoni

you're Yes, correct.

is XX% to. II you're at the what I think, XX, XX XX% remember, That's, subtracted at you and studies. placebo Phase if it's HiSCRXX So in the week week referring

is also key or pruriginous in XX. it data, difference, week how at for think, important very intensely public that painful -- PN. the is HS key works. HS, selected patients but with you one when we and look like example, a PN, of And diseases quickly I for Look, not the in and It's just

week replicate don't that Phase number. the Jess. the in My of povorcitinib importance the studies clarity on the a profile that's XX. large what set III saw benefit actual comment was in Phase referring of roughly to III to is running the we want So studies, to We're Phase II. have I

the percentage -- consistent what that not that in any something specific a going is comment now, profile III. see is we -- Phase see number the we're with on expect to right Phase we to the is the So but II

Operator

is from Your Salveen next question today coming Richter from Goldman Sachs.

Salveen Richter

Just povo. a Could just With there? from to the to And just drop for D we how us you the risk this in your guidance, XX follow-up XXXX Jakafi? week regard speak about on saw week to redesign then trial model data, here speak to for read-through may and that you Part play the Phase out also II this XX. and about

Pablo Cagnoni

as both -- see to think, time. arms. on and I some It's over know, trials, week the related have caller, was a in response out, going II, movement in variability particularly with and look, XX, pointed like XX endpoints, a drop curve in clinical efficacy Certainly, the effect, in to there from as saw you're week the Phase What the you HS, placebo that the diseases the we efficacy the where they probably clinical povo to trials. Jess, previous you povo in placebo-subtracted noise was

statistically we only is endpoint, impact points we'll not HiSCRXX week statistically which difference we and think obviously other believe but and And study. well time and which meaningful see what are The the between a key levels to the clinical as concerned We of XX primary at significant, benefit povo include are endpoints, as significant in demonstrate not other about secondary placebo. the studies powered povo well is clinically of that.

Christiana Stamoulis

catastrophic Regarding your the savings to small we D the to be donut question, have since some the see redesign that to Medicare Jakafi. replaced the Part of We on expect given in exception. D to on net do the our contribution for will Salveen, impact participation a now gross by X% second biotech coverage, hole Medicare Part

XXXB. However, these be we savings by in continued increase would offset that see

Operator

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

James Shin

on trials. the Will conference? full I follow XX the data Phase And HiSCR with up program any X you we for STOP-HSX CSU? and medical press this get just release by top-line disclose data? then wanted III to will at povo How update followed on a

Pablo Cagnoni

to HS, have So we to our once discuss in with and a is have plan almost data disclose for our on povo certainly, a investment press is release, we the call the community. results

On at I point. have don't XXX, this update an

this We valuation of last an the preclinical completing in are update we'll still and we described that toxicology, provide the findings year late the the and events later year.

Operator

from coming Morgan is question Next from Vikram Purohit Stanley.

Vikram Purohit

kind We these had sets sets these JAKXVXXXFi to what on us and for hurdle at frame for just for just bar what the one data you're going the programs success mutant-CALR can of moving year. for is for setting to also then expected and you what help this Could proof-of-concept data forward? we later the be for expect learn and

Pablo Cagnoni

me start mutant-CALR. with let So

see That what we year. with substantive both will you all, tell of and you're So and year course first -- out, to you me patients have let over as data about the of of bit data. to just little the expect to this ET be for MF. going point a proof-of-concept What we'll to and amount see, come it's a going

in important We measures follow-up some at data order clarity amount of of dose with of some to different levels the for have expect programs. those success to have on

important also program, only to cetera. early an on for patients over as evidence few importance some in in an evidence spleen, think neoplasms Obviously, a data, can months going but the [ see traditional not ] impact to and mutant-CALR definitive of obviously endpoints measure show myeloproliferative reduction. this we with some MF allele the et with allele to the some discussed evidence of which past ET is but a that it's to have blood we we such [ be want success. reduction, ] of This not patients counts, symptoms, show antibody

part of all the will that update. So be

patients dosing with started XXXF, in We in quarter if XXXX. you MF of the third the recall, later. started clinic

the program. a some bit update it's program And not to impact, this traditional but intend a that year. point that to little So evidence see endpoint We like in well. supply have an to same would basically early behind. reduction ] We as allele [ only of

Operator

from Next Frahm question from today coming TD Cowen. is Marc

Marc Frahm

one STOP-HS. a just nuance on question Maybe

us in Pablo, these how kind -- that have earlier use with Just III. an of in III may SAP and mentioned in how a is from treated, treatment II little a bit some to treated II what's remind may we've HS In you being you decline Can just trials drive antibiotic treated Phase not specifically, effect in changes do Phase differ effect. seen how that and trial? to use the of Phase maybe of or often Phase antibiotic that's

Christiana, but then U.S. the given growth, you the the for kind some increasing down label break are on ex of just also there Opzelura guidance, of the assumptions can And on outside happening, versus changes that U.S. U.S.? reimbursement

Pablo Cagnoni

of let first So take me the question. the part

II. same Phase is treated of all, of that the antibiotics the it was first in the way Phase III So in use the

entry. be not So just that on what you remind allowed study let me at is. systemic are to antibiotics Patients

antibiotics Over have of nonresponder. the the as course systemic flare, treated that's started if a patients on or study, a

unrelated if with nonresponder, systemic a Now a the is II. not as that's in the completely started antibiotic consistent Phase for have patients that reason, treated and

Christiana Stamoulis

Spain. from contribution contribution also And 'XX, driven it the France. by that global, reflect is from we guidance, Opzelura In now guidance does terms In of the and in Europe. from Germany provided we countries, increased primarily but Italy contribution increased those X have and the was continued contribution and expect XXXX,

the We are to X down breaking between the going regions. not be guidance

Operator

Shi from coming ] from Kelly is question next Jefferies. Your [

Dingding Shi

I have X.

Firstly, share more color on program. KRAS a little can GXXD you bit

at Pablo, weeks want XX follow-up XX-week programs? could and data, In hints also do preclinical potential what for and of And or quickly, you POC also the sample size actually differentiation far, other competitive I XXX, it expect? based from achieved of kind any a do the plan And to terms both XX think confirm, tumor show HiSCRXX, follow-up? indications on we and XX GXXD so you only for just to data

Pablo Cagnoni

-- me you, Kelly. thank let So

of terms in So KRAS.

the cancer, of space. And which selective pancreatic we indications it So as based to We're aware we because -- has preclinically, a the very potent accelerate that the here We fully us if have what is this can cancer competitive here, are and focus enrollment this in GXXD become profile cancer. program, competitors for that that highly inhibitor, a have believe, trying are obviously, and specifically our compete on doing. accelerate colorectal been space. in we're still we pancreatic

highly at down, it from the competitors, early the GXXD we in to think particularly there's you combination well-tolerated Now space will and our of data inhibitor. we But see. when a to we chemotherapy, lines as still safety selective, efficacy for look that come obviously, that with therapy move

our So continues that we look year, but to data this forward to view. be discussing later

of communicate endpoints the we going a number In povo the overall haven't terms made answered of a bit what to we've this results as we But Obviously, not that's earlier or that we'll terms other we're HS of other in the endpoints, disclose decided. whether little study, to of here. add decision release, studies a have for I other point. at

Operator

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

Brian Abrahams

Maybe development for treatment in the of you post-Jakafi foresee results on the naive a that that thinking then BET out looking move What And setting? talk still for looking your you this from are about And you role what's on latest the to for we data combo amount the path? forward? inhibitor, therapy of year? can are frontline

Pablo Cagnoni

Certainly.

know, ASH, I as that near and antibody term, they with that MF options developing look, the hear more to you'll we That's the as inhibitor. of patients and think in very the second when disclosed provide the line, are year. why VXXXF mutant-CALR we BET Jakafi at think can. inhibitor, treatment eventually second that as after we're inhibitor an the relatively patients we can later progress eventually, the all BET basic for patients better Jakafi. Obviously, to good the myelofibrosis, in progress line progress. But they treatment for we we is design as update much need in And on this addition program accelerating options a today, good with So as

has at is on Jakafi ASH. very at the showed need gave we combination impact to profile on more and think safety inhibitor we update with that a first-line what more in that symptoms BET of patients. which an terms We importantly, previously clarity endpoints terms combine impact In data. BET with need are spleen, of inhibitor, on the in saw the Jakafi indication and We we encouraging untreated the presentation for the ability the ASH, our that and impact the hemoglobin we in in

So by data. we're encouraged still the

have decision need study. a think first make with I data to that FDA to we additional potential another conversation on and

Operator

Jay today Oppenheimer. question coming Olson Next from is from

Jay Olson

on Congrats quarter. the

XR your achieving timeline For bioequivalence. the -- fixed-dose rux also for BET your combination just and also about with congrats ruxolitinib you inhibitor? plans XR to talk commercialize on a Can

Herve Hoppenot

on to the by this end now the end we submit I mean, basically, maybe to of timeline FDA for of stability the are commercialization, study is So the year. waiting the

-- will to a CRL. it's that a response So

in commercializing and window XXXX we the XXXX, look gives And at is day years. us So that obviously, versus goal X.X day single most a is that first with Jakafi a in generic you period it's should a used slightly of be once patients today to timelines, during different as around the most is agent which of it if twice being possible patients. as indications, as a have treated the in as many

which CALR evolving the Pablo the of with a if and it, the speaking about, Now program also, first-line combination. MPN the related think what of you the combination, And to depends of obviously, is in the how was first-line portfolio XXXF. study BET the whole profile about just and rest is our on

decided also happening been yet, it So with year our next to none that's inhibitor. the we be on firmly has but how probably in BET that over can put of combination going

Operator

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

Unknown Analyst

Great. Two here. for Emma Eric. [indiscernible] questions This on is

is evolving What povo data there well, study? data arm? the share the be first-line HiSCRXX, what guess competitive in one HS, and and do first ranges meaningful would you on as HiSCRXX and XX shared landscape? of you XX of weeks. and And think in about [indiscernible] you could over you tafasitamab meaningful any question there the the then I as The terms see DLBCL the second on

Pablo Cagnoni

Okay.

secondary a clear. and we obviously, show key there endpoints endpoint, the is, to endpoint. what with what to it's to one, going are I for I'm povo not to placebo. set statistical similarly have the obviously, significance difference you a on similar have clear think see which to to HS, give are answer bar to don't primary on earlier, powered, first really productive a The I've but want for So important given

at XX% think week for XX releases you the If data the look with really povo, HS. are and in results at XX in week study Phase from the prior context I II strong data the subtracted with placebo at XX% of those patients

if vicinity to very of important we those results, the are in So think be going a I contribution. that's

first-line In terms of this top line, line first is study, setting. as a curative the you DLBCL know,

as even modest which patients. a the look of still think, frontline I has endpoint a of if impact PFS, substantial And important. the to benchmarks in So Polivy adoption be impact that primary such data, small you led at a really, it study, on really showed the on could recent

very to because improvements wide a indication therapy. where you're potentially it's about think lead I could a modest clear talking curative adoption potentially So

Operator

Phipps is Blair. coming from Matt today question Next from William

Matthew Phipps

you Two trial the on succeed can line you that can trial us remind where were incorporated for you think fails? maybe learnings me. just from robust front the that One, into when

type program, could just remind type to therapy if be in saw CALR? this mutations is us activity And preclinically, can Jakafi any we And combo? mono differential you get then Or you versus for that also between going X the X some year? mutant-CALR

Pablo Cagnoni

with are So -- going disclose. combination to we're terms we mutant-CALR a antibody, of have details haven't Jakafi. what the in decided initiated really we The specific

data. we'll possible Jakafi of decided. really But some development haven't important combination part It's the that We an plan. disclose it's

discussed that commit previously, as a possible mutant-CALR plan well symptoms, points, when We'll as on we and future the discuss it's to induction really Jakafi of but Jakafi necessarily mutant-CALR we've other with development a know, none and for As mutant-CALR combination that rapid antibody. therapy long-term short the the strong for with development could we then you of a a patient particularly be as paradigm, But -- data. mutant-CALR don't with disclose because end antibody plans of maintenance the decided. been combined has development treatment the antibody impact the

gene. different. And for types type X, type X have is was X disclosed of X very in structure the what discussed into type for the that antibody these pretty affinity -- we've mutations different type that we the versus What these are is previously X these are the in

have discuss level see the that In types have possible data we'll terms of expect when of in to in of we it's we we a clinic, patients the but that activity what different different mutations. with results,

Operator

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

Andrew Berens

XR. Congrats the quarter XXXX. Cmax. Jakafi A good the in commented don't couple on you on more think on I

Just And stability there gating that wondering that's dose how the [ studies? approval Cmin to that looked either anything ]. is increase else boost as you the the

Pablo Cagnoni

formulation once-a-day purpose So the with that. in compared the so cannot the twice-a-day FDA a of that was study. And replicate look, Cmax terms not you understands of XR, with The formulation.

the at you state state. see you have you to and meet what have -- what steady AUC steady at obviously that, Cmin So is the

slide were of As endpoints both met. we those deck, disclosed in the

studies. They're stability only is the factors gating

on in expect my for that study FDA, we mentioned the and we the discussed the results resubmission of I be necessary done for have stability As to of an prepared and the we response studies have the CRL, agreement the them the will the year. remarks, before end with that, with

Operator

Next Andy question is Wolfe from Research. coming Chen from

Andy Chen

only you from trials? dose high what antibodies? both What differences doses? here? in HS to especially specific the protocol trials, trial have you expecting be doing your can are to and or other scenario, So And also on again, your And IL-XX amplify povo be differently base learned efficacy the might between approved you talk you your case about then from

Pablo Cagnoni

it's hidradenitis out Phase design to of details specific studying think difference studies all have effect opposed are we that get we the Andy, that an suppurativa. difficult that the as wanted We don't with the to it's that protocol advanced since was to point Hurley So the with high to there. III of way emphasize slightly percentage And of because every we that's We reduce into our III Phase the patients with II. a a III is That consistent designed in competitors between more patients Hurley important studies to important wanted emphasize. order disease. patients in have harder point was an placebo to with

Phase II -- make was I did series in a by the that consistent investigators a couple consistent assessed trainings Phase in careful what which to there did in were sure with we did We what II. of with we run we were the as these with we as is think patients way the are the that sites. sites, things of selecting well that

II as And to we as we did Phase in in data, endpoint So lesson important I provide XX in based which order think quickly try the endpoint us III we improvement, to selected was benefit in study. we can obviously, best an our for week as that was see on how Phase much replicate the a really Phase mentioned Phase primary patients the to I II. earlier, II also with

it's have doses FDA. discuss but possible when that of we to of different a FDA, with the we'll range we'll terms the are data, positive, have with both if label discuss broader In obviously. the lead with doses, we Yes, when that will dose, data we

Operator

Syed Salim from from coming is question next Mizuho. Your

Unknown Analyst

This is Salim. Eric for on

at looking XXXX. just modeling Jakafi through So

the through we loaded the second about half, should Just more change, year? that? the think growth And about like how in we XXXX? that half, how should It's wondering anything think versus first

Christiana Stamoulis

guidance growth that year-over-year we provided the So to a X% implies X%. range of

of side, is the will this at quarter continue And see to the the quarter. than of to how D, continue on deductibles have remember to that through Medicare Part of it expect it first which even the to prior the this an spread terms the year. get reset because year, the through model the on patients of course and year, And would of beginning in you the In of commercial more always impact unless the year. lower the the the quarter QX to of lowest is year, it

So lowest to and the to be relative quarter 'XX. QX lower expect QX of

Operator

Seigerman Evan question next is Markets. Capital BMO from coming from Your

Evan Seigerman

Two for me.

into a launch? how like? given Would a Just ever povo, a you is want as here. I'm yourself if coming standard walk a as initial up uptake for consider the hypothetical Opzelura a in adalimumab here. second, me curve could through trial look assumptions And pediatric you some to it this your that systemic of of guidance? much head-to-head getting does HS initial in thinking kind What of care factored And establish market. the branded, this is biosimilar help kind just leg in this and versus you're market, you of an

Matteo Trotta

X We're Obviously, steroidal majority take the will to of about business. there will the in around because I'll between very here. XX% excited launch. of overall, the much on ADP's from the of net see or XX% them pretty sales. But at opportunity that, to also the think our terms in and help therapies. patients sizing we these that years half Matteo Yes, second XX opportunity of contributed we very are atopic represent uncontrolled the uptake vast that old, have anywhere still dermatitis the total Opzelura the initial peak, year, indication and we

Pablo Cagnoni

take the one. me Let second

to there. conduct past whether the couple a head-to-head study We There's adalimumab. points in have with of discussed a not

this has study, been relatively seem on to relatively The reported about are First with in future we'll of that been for hand, HS decisions data challenge let's coming. X the progress discuss drug to physicians, the replicated in has wait the -- all, Humira the since data with progress seem original -- we while that Patients is past -- you Once is to high which between studies fast. we the presents HS-X for see failure the when quickly. data not and reported the Humira make have the was the that response that has development. with HS and been

the with indications with amount this is has data, in with become companies because a reasons real such a So the market, Humira. dissatisfaction of one important an why important of there's fair the world such HS results number of for the

Future have in haven't So it data. after to development a at head-to-head. point, we we go this decision discuss the made HS we'll

Operator

Next from question coming Verma UBS. is Ashwani from

Ashwani Verma

one. Just

potential your from canakinumab readouts wanted value I HS, and povo that is have upcoming Rinvoq on for of would ]. You your market? in the view How competitors? So proposition understand [ impact this and povo what to

Pablo Cagnoni

So at being risk repetitive. of

Phase very week the number profile HiSCRXX, competitive places, a have of response, look we if data with and XX, data think of XX, week totality II povo. at both pain XX, the we the we've reported we and the in XX, all that So endpoints across a XXX

Phase with data, when that Phase competitive put a [ we Assuming everybody that have and saw in certain efficacy with III, profile together Phase ]. to the Rinvoq from the believe you level certainly we with II safety all of together a has biologics profile we II, the very correction

Operator

Next Devarakonda question Srikripa from is from Securities. coming Truist

Srikripa Devarakonda

PV new primarily like growth. driving getting expectations about population the to in duration patient the you're seems be in growing? think inhibitor, and or And uptake? on are primarily it On you through adds Jakafi, talk management therapy VXXXF where is Can And footprint your any what which additional beyond for plans as cycle patient XR well? Rux terms Is of life PV, it growth? the

Herve Hoppenot

of see, it And can incidence early, we PV on mean as is the can that that by treating fastest. X reduce thrombosis. I speak. the driven growing basically mean, data of have is I is that's is by the Yes, indications the -- earlier the and one shown you you treatment, I based

survival. over help also as PV co-pay which as well Medicare this PV. for in year, have the that sharing the is and been are with in driving the seeing the was basically, thrombosis-free And has patient, the been in adoption a longer that So that patients physicians we past study change it helping Medicare have we MAGIC

said prepared observing the patient flow indications in the new by largest we the we of duration we as PV. become think we, patient time, X of over this -- PV this are in driven new the earlier So treatment remarks, will and

of is in of -- Regarding portfolio, U.S. the PV obviously, to XX% the cases overall the VXXXF, XX% course mutation XX% the

So of generation be the the products next that of for will key Incyte. driver

Operator

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

Ben Strain

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

Operator

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

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

Incyte (INCY) 10 Feb 252024 Q4 Earnings call transcript