INCY - Earnings call transcript Q4 2021

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Operator

Hello and welcome to the Incyte Fourth Quarter and Full Year Earnings Call. At this time all participants are any listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] It's now my pleasure to turn the call over to Christine Chiou, Head of Investor Relations. Please go ahead.

Christine Chiou

Kevin. you, Thank welcome XXXX and fourth and quarter Good conference to call year earnings and full morning Incyte’s webcast. The slides investor website. the download for presented today section are of available on our

Steven today remarks; prepared Dash who for very call deliver us and the join Q&A. on who will me Hervé, Joining Barry, the and will Christiana, our are

of that Before we made remind Hervé. are our the cause today call to the to during begin materially, results statements, subject some to and call uncertainties filed We'll SEC. that in including begin, you I'd risks a actual our those with now number with are may our like statements of and forward-looking differ the reports described

Hervé Hoppenot

strong XX% good royalty everyone. we Christine. years. commercial over reach X, to And with you, Thank five past product of million, of revenues XX% morning, CAGR and representing year the a growing Slide so performance $X.X of had another

XX% patient been for grew and U.S., through Japan, this able across the JAKAFI in rapidly quarter, chronic and level Europe launch We launches full maintain robust and indication by the in growth MF product the stream. royalty revenue growing the new JAKAFI, and of to new have execution and commercial continued fourth was up driven and GVHD steroid-refractory growth the year in new XX% for PV. of

GVHD. Europe Opzelura as from as Pemazyre $XX royal not $XXX from Slide On portfolio year-over-year our with XX% XX% million important to grew growth ruxolitinib $X refractory recently contribution this relapse we approved in Minjuvi. year, expect Monjuvi regulatory yet our contribution year, multiple oncology the dermatitis; to and Minjuvi product meaningful launched affects we in full the in and note the and Europe new What's the across U.S. treatment in for to in launches, with is cholangiocarcinoma; in Pemazyre decisions does we hematology and no cream XXXX, million grew For disease and portfolio including other Jakafi in there DLBCL; patients recently our opportunities such re-pigmentation. Opzelura, Later for million look approved for that revenues Minjuvi or in in have growth from products, is this our whom full And for and of chronic vitiligo from include year. for product, U.S. and atopic X, ahead that millions

in and were lung is baricitinib in For and our product also Europe ruxolitinib applications U.S., data new GVHD partner areata. review will is continue important uptake a Japan alopecia review in Europe our cancer. by we Japan under develop of Regulatory submitted where GV with expand cell non-small and launched for capmatinib Novartis, newly new indication. our of year product program pipeline, for for the and driving key for milestone full deliver under and clinical is Europe in XXXX and on

the JAK a has the cream and repigmentation product and became capabilities our into to for A U.S. development ruxolitinib the We the to Before words dermatology. ago, and first Barry in few ruxolitinib bring dermatology in the want a to dermatitis vitiligo, implement the able approved say for inhibitor with successful footprint launch in and to handing to first atopic cream program vitiligo. FDA dermatitis in expanded we years to in of and Opzelura, the robust few I call Opzelura atopic topical potential development were be expanding on intention our approved market.

see since can we you our clinical pipeline multiple development dermatologic on and right, products As expanded include the to have indications.

of U.S. a to far. very translating Opzelura organization this successful support the efforts dedicated a these commercial into have launch established We and the launch also in been

Opzelura, with an more details become to Incyte, share turn Jakafi’s U.S. peak starting to can reach to Barry. we I’d sales And which in the and now on We franchise expect and the dermatitis billion our alone. atopic dermatology call over growth in believe Opzelura important in X.X for performance driver outlook,

Barry Flannelly

Thank Good everyone. you, morning, Hervé.

pharmacies pleased are the making retail tubes our have units specialty we quarter since been closely of products. for to is the and of These left-hand pharmacies. month In January, Opzelura, We Opzelura, pharmacies shipping shipped. performance progress dermatology are given Opzelura the units of on data level data, have multiple of the XXX thus uptake to with on that Starting far, been very launch launching on October the nearly tied is low wholesalers prescriptions are side typically and with to number with dispensed shipped nearly in of XX,XXX of inventory, the fourth hold fronts. significant units XX-gram XX, which XX,XXX

you demand in encouraging. see, trends for As can weeks and recent to climb Opzelura the very are continues the

many treatment on Opzelura. physicians for patients also indicator refills which satisfaction side Protopic and is treat dermatitis patients the the with they right-hand Opzelura, itch the in demonstrates from relief Opzelura launch they a The first the is in past excites by which as XXth rapid is potential our the and physicians slide January increased the with of the On U.S., the an There in new safety AD survey the week refills and of from month. prescribing. a In to there their on both top in showed receiving new-to-brand IQVIA well positive data the there is how total reasons of the about physicians very Slide to shown recent ending efficacy, who of for in to, clearance launch, is with Dupixent, experiencing long-term their Not patients and that and patients RXs XX. includes X, conducted month. which chart, next Results to formulation are field. capturing Opzelura, Eucrisa, the asked the the action, as try highlighting as will able time of number the new, uncontrolled prescribing further over relief most physicians the and skin what of patients the very this symptoms. week positive feedback is be are AD and the were are supported steroid shown Opzelura the are expect nonsteroidal patients Opzelura topical XX% asked expectation XX% as specifically that On and novel willingness atopic with us millions we comprise a the all Elidel disease failures. as find for are mechanism share Opzelura that after prescribed a basket, of market Prescribers to many since were is topical of showing the generics. are how living new-to-brand enthusiasm They prescriptions in of prescribe

agreements payer two three two and the to These have lives largest I'm report GPOs. signed PBMs. XX% of On We discount utilization for now contract commercial agreements management that progressing front, negotiations rebate criteria the been covered rates have under with happy these establish well. base of approximately

For and associated are block now this business, access non-NDC establishing plans PBMs provide policies to to Opzelura.

the negotiations in XX% PBMs, contract blocks. of we covered are active the For under these or new-to-market NDC remove lives to two other

millions towards steps for PBM services managed to prescription third these the of are PBMs. These the full patients important negotiations are for by coverage whose gaining continue For advance. Opzelura

many Turning covered the covered program prescriptions, from of to the where full vast our we of majority Slide XX, in support Opzelura the cost fourth patients. patient quarter,

coverage utilization specific decrease an the in lead As will gross program improves, and Opzelura for to net. the this improvement will to of

In The of as market momentum which physicians launching positive out-of-pocket several are this fueling co-pay of are $XX. disease. a to for for there millions are behind lower factors. the is be to Incyte. unique driver will summary, any reporting the requesting significant of has continue topical Opzelura living refills, is patients has by are of track with product atopic uncontrolled their launch and mitigation Patients much a where as profile growth cost been the Our by cycle into experience program we other on to little allow unmatched and and Opzelura, a strong launch and patients therapy dermatitis driven and

with year quarter, up the Patient XX% in continues all the Jakafi and benefiting indications. year-over-year chronic in Jakafi. $XXX In Jakafi across In to to up drive patient new and growth Expanded turning to Now launch setting transition of commercial the full Access robust Program GVHD, grew demand XX% the growth uptake fourth million. to from the in of XX% product. our from fourth quarter, the for was patients patient GVHD

QX on revenues and into continued account were sales We into patients guidance starts. recovery billion And the expect to GVHD year the in billion. be and chronic of in of product to newly net $X.X between and for lastly, Pemazyre. Monjuvi Minjuvi launched This takes $XX growth indication and million. patient range Monjuvi, continue $X.X full new XXXX new

$XXX a the increasing in sales in make Full momentum launched from consideration $X the was guidance and into product Germany. account recorded and in were penetration year to Minjuvi, in We key Europe new of were in QX, by August second-line in the sales penetration XXXX fourth net approved continue COVID. accounts Monjuvi to into progress of impact and of which $XXX as was of continuation million. last quarter million Net setting. million takes with MorphoSys year uptake for

in countries. to is early, other still to meaningful XXXX, very gain a $XX Pemazyre coming million it to the U.S. turn of the U.S., become continue growth starts with by likely outside that, With and therapy in with contributor we I'll encouraged to to in While call In $XX over duration continue Minjuvi uptake grew initial are from sales new European performance. million expect grow to we as net the patient the Steven. drive reimbursement

Steven Stein

four atopic Throughout data both across the Pemazyre results. achievements. And dermatitis. B-cell the which and following year, made in for include and graft-versus-host Thank we study Monjuvi in in on In in most and Further initiation right, the autoimmune of Japan on parsaclisib approvals ruxolitinib and development as vitiligo States for for we ruxolitinib States the cream X recently, side, chronic Europe in key positive We evaluating Phase progress United the vitiligo. hemolytic clinical multiple Europe XXXX, that Opzelura large pipeline for morning, FDA lymphoma, diffuse United is cholangiocarcinoma, Phase for everyone. good our you, cream with and Phase review Barry. at for X anemia highlights Jakafi disease, announced regulatory significant the listed in under include EMA product clinical X positive delivered the a regulatory

to JAK agreement for granted the PD-LX oral an chronic in in We right combination first axatilimab with inhibitor. shared a data us the PD-LX program, which the treatment in or demonstrated oral with graft-versus-host monotherapy also earlier signed we've disease, collaborative activity a Jakafi Syndax time inhibitor develop treatment axatilimab as with where And with our clinical from the paradigm. for we ever following

vitiligo mentioned, growing United currently agent, disease. the of depression another Many reporting and one true the lack living PDUFA new dermatology in the vitiligo I physical of and with as can may priority approved social to people of U.S. the currently a cream. unmet opportunity The of XXX,XXX options. are due experience treatment with our to benefit their million poor, for treatment States, XX, with and FDA, they to accepted sNDA from there X.X four for significant ruxolitinib quality one only for review in Slide need by patients seven vitiligo Vitiligo date vitiligo due be where a and In represent ruxolitinib reporting patients the for April to XX. Moving patients life cream XXX,XXX in psychological, with anxiety effective like franchise. some impacts was patients a vitiligo represents seek action

pursuing ruxolitinib Within with additional expanding dermatology XX. more Slide look dermatitis multiple, our on portfolio, broadly and at cream, hand to are dermatology we equal eczema. in our including been INCBXXXXX, JAKX greater atopic specific vitiligo inhibitor, studies in area pediatric with indications in also is adenitis Now protiva our franchise to surface and patients for involvement or larger to prurigo X%, of nodularis. has higher body Phase and X evaluated in than chronic

in there of some each FDA-approved HS and opportunity in second this cases, the results half indications growth expect vitiligo where disease. limited trial our portfolio is no of Slide MPNs treatment options, across for are There XX significant potential from year. these the treatments. with in shows graft-versus-host We the in

multiple Within an half agent standard addressing this addition efficacy expect care single to In an of the therapy safety. to patients which combination improve have who inadequate either focusing has efficacy, the ruxolitinib. NDA a a submission by response the we of pursuing strategies or BET we year once-daily are JAK through inhibitor parsaclisib inhibitor. potential the in improving We on have first or upon for myelofibrosis, of

X and Phase XXXX responders expect ruxolitinib results first-line and study. parsaclisib setting the for evaluating program myelofibrosis we Our ongoing, in plus suboptimal in the for in is inadequate

due We who Jakafi our many patients these And on subtherapeutic from with area are a can doses PV. addition to patients additional may For to the know use therapy inhibitor. an for anemia, that MF been expertise and to life-changing ALKX we this we options in patients provide of patients. benefit believe has

work to inhibitor, with other graft-versus-host Jakafi combination And including in patients addressing mentioned, with being JAKX with unmet itacitinib, as continue and monotherapy inhibitor. need selective and evaluated treatment-naive JAK previously We therapies graft-versus-host in patients chronic with in disease. the potentially towards the axatilamab as a disease

updates year a of stage this are expected some Turning pipeline. XX, to Slide earlier number our for of

selection. make program PD-LX decisions our data indication updated from year, us a expect oral and could program which lead this on to later We allow

adenosine our year. later expect molecule AXA, data antagonist and the CDXX both small for this AXB we monoclonal our from antibody Additionally, program

can catalysts we're XX, expecting very year to multiple we clinical and call forward turn financial the With for Christiana like update. this and to ahead. exciting I see over you would to another the on year look regulatory Slide As that,

Christiana Stamoulis

everyone. Steven, good morning, Thank and you,

Lilly over for $XXX fourth revenues OLUMIANT from demand all OLUMIANT. with and XX% and Total $XX patient net of higher for revenues of revenue growth million our royalties for The Opzelura, XX% million growth from strong of comprised by for This of of the net treatment other royalty for quarter total and $XX TABRECTA Incyte indications. doubling $XX million the products product by Our driven of the $XXX $X an across increase product primarily for Novartis million, million $X is for and royalties by revenues the JAKAVI XXXX and of product use reflect products million and across commercialized are royalty of OLUMIANT sales JAKAFI hematology/oncology continued and for representing reflects reflecting royalties fourth quarter growth partners. for year-over-year of JAKAFI, million product quarter results COVID-XX. of

COVID-XX, a global sales of OLUMIANT of additional sales, to base As plus for we global double-digit reminder, to to applicable XX% are treatment royalties sequel all royalty entitled net royalty. an net the product the for receive

billion total product and increase XXXX, XX% royalty year full the For $X.X a over and revenues were XXXX.

Opzelura now Focusing launch strong. fourth of quarter, and for on been the the volume prescriptions has

support of formularies fourth of cover utilizing been with Opzelura negotiating NDC and payers Opzelura product so the and support patients we programs get product. million patient blocks, PBMs to to were reduced While cost programs. have to these the that quarter, to we by remove Opzelura have XX% sales are patient the $XX full and access the In gross related

XX% discount In a XX% fees net gross and addition, other of quarter. of contributed to to total for the discounts

million. these reductions, of the result a were net sales $X product As for quarter

for prior cream over regulatory of expenses investments to activities period, from U.S. Opzelura's on organization our year for support R&D decreased the our the primarily with expense before million quarter of million from quarter of year due our on Moving million the of related XX% commercial our billion fourth X% to the XXXX, includes $XXX our quarter Opzelura. of and quarter the $XXX the for expenses expense in to collaborative $XXX the related the prior operating and XXXX X% of full approval. progression establishment increased Ongoing for a the year for SG&A API-related agreement to upfront the million launch primarily increased to dermatology to the year due basis. – Ongoing the consideration $X.XX $X.X year of Syndax. ruxolitinib billion XXXX $XXX new primarily GAAP Total period, the the the R&D pipeline. fourth of prior in by incurred full costs due R&D expense for

the SG&A For XXXX, growth commercialization the year full to in related was of the XX% Opzelura. expense also primarily

million, Our of representing collaboration MONJUVI. XX% net the loss loss for the $X for commercialization quarter was share our U.S.

For collaboration loss the was XXXX, year full the $XX million. total

marketable securities. billion $X.X cash year in Finally, the we with and ended

you three leading the operating resources. expenses, and SG&A prudent growth past our to Looking at years, exceeded our can of the R&D increased the our growth management our and how to product in royalty ongoing and commitment evolution reflecting our financial has leverage in revenues of P&L, see over the

in As previously launch. our of build-out the reflects XXXX discussed, dermatology the Opzelura uptick franchise in the expenses and

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

net indications. JAKAFI, be of driven billion product over to growth which expect represents revenues at all XXXX we by For and of the in across continued the $X.X $X.X XX% billion, midpoint increase approximately range to an

We net expected expect XXXB to in XXXX approximately XX%, gross continued adjustment to volumes. for our growth be reflecting

higher quarter of Medicare to year our donut the reminder, adjustments to Part always hole relative quarters share quarter in the the patients. previous due subsequent a the to gross As D is net the of and first for

will other revenues to and approximately we and the represents ICLUSIG which total the For hematology/oncology of gross XXXX are net products, XXXX. U.S., early its stage which to midpoint in Opzelura million, guidance for million the around launch, I range and in over $XXX Japan not color we providing MINJUVI EU in but additional Pemazyre expecting Europe, Due $XXX some of to at includes provide Opzelura, to product net a on be in will be growth moment. XX%

As milestones or also revenues. guidance years, are providing in not previous royalty for we

of XXXX, expansion dermatology clinical growth GVHD upfront well midpoint as consideration tafasitamab our investments the expenses in in to reflects to we GAAP at $X.XX our the rate billion our representing to excluding as LIMBER program, development operating $X.XX Syndax from XXXX. of PD-LX the of to range in The versus the impact is program. and primarily R&D basis, range be expect in on billion, product expense Turning growth X% expected a COGS XX% revenues. X% to

primarily $XXX support to for range SG&A launch. the in expect reflecting billion, the to of $X be continued year Opzelura We million for expense the

of expense we impact XXXX, than expect cost, grow the profit expect we a to for our in rate U.S., MONJUVI the at of respect break-even. With less Excluding to in Opzelura-related to around X%. SG&A share be

mentioned, to you to As the we early are while to of related Opzelura due like our discuss I what adjustment not XXXX. launch, I could providing the stage previously net in to gross for guidance would expect

we depending net to relatively XX% QX we QX at rate begin to flat fully XXXX, to gross QX decline in to of for expect with normalize and gross Opzelura to a finalize to compared in coverage As net payers, and of XX% loaded on be support Please timing your certain Operator, and prepared between Q&A. QX, the QX PBMs remarks. discontinuation concludes give of patient the programs. blocks call the by of NDC removal open the instructions that for and our

Operator

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

now Your line is live.

Vikram Purohit

questions. Great. Good morning, taking thanks for my

So on I Opzelura. had two

expect to have of reimbursement see the to secondly, XX% patients who you so have on body see just for the guided speed of have first be the and the is areas of product. early, The what which patients progress. duration late to you XX% suitable through which I far wanted find gross-to-net at to the for been working you that might in product the for to long-term use gross-to-net I if learned understandably XXXX most expected wanted terms while on tubes? it's And received refills

Barry Flannelly

to think a can have bring the make question. But things hope the therefore, the and future, going future Barry. stabilize manage payers it's year. gross-to-net of to I When is value what I continues predict patients, we to to is answer I that product. your and high, XX% Hi, for we to we that say reasonable Vikram, the and for we to this certainly, of can't sure what that. that The with physicians the is really into continue half know product second we that can work XX% after the first the

The the predict. and everywhere. is using product second areas, to a product face question on sensitive including are other is their use Opzelura good on I Obviously, hard face. patients like mean their it the just areas. using to They're hands, sensitive non-steroidal

I'm far, coming of of are refill They're patients one So month. more the with The areas a every on, will it's have have they're then come as refills, component them future, refills the using a about for continued perhaps gotten have more continued dermatitis. most them more very eczema, data our gotten in. to and obviously in I that's each the have But all of sure as they don't and XX% Obviously, refills and increasing and particularly know. be far body areas drug growth. going problems so with those tube continue. you where as and atopic We'll of important on,

Vikram Purohit

Okay, understood. you. Thank

Operator

Thank you.

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

now Your live. line is

Brian Abrahams

Thanks on so Congrats for my much guys. all the Hey, question. taking progress.

how additional secondarily, hurdles to with the maybe we're aligns and And to to Another clarify initial patient through shift curious guess question bit patients half XX% granted, you gross-to-net guess, the uptake if and you on support patient tubes journey use can we for expect per your of I the of potential by adoption obviously, reimbursement should from evolve might Thanks. asking would the I'm just a and programs as assistance? rate co-pay the I'm year expectations days? this Opzelura, barriers launch the initially how differently, sort this equilibrates period? refill the back current of number then year prior early wondering once any I little question

Barry Flannelly

patient Today the atopic of States, United that potency patients as they've cycling goes, dermatitis. and potency I there's then far TCIs. As through journey millions have obviously, been high steroids, mean, low steroids throughout eczema,

any the with the increased and We experience that continue anticipate whatsoever. from the the And more from barriers future the physicians to really drug, have so more they we for product, there, don't drug. are because demand happy with both anticipate they patients

in you're launching covering fact, or coverage. to atopic areas have a like dermatitis new psoriasis, common, into in of where period So this while for I – mean, we is products time

with help. will every able be time going going by the And coming to now if we're of day early one make to – single sure that it's say will a by is we the it. to improve is prescription it our be is be if barriers, comes coverage patient of like online, that get a get in periods there to gross-to-net and is be any that to they're able online as barriers, to But dermatologist, that which going of the dermatology expect removed. Sort is things the to the going a we written office,

new As the far see coming early, very to it's Patients volume, I volume. you'll new move will the are refill continue and better. into We'll all with refills that then actually as we we and And even as prescription this be refill think obviously, back time those vitiligo, patients things well. percentage the as will will have increase up the coming back even and going get for Rxs continue. think

Brian Abrahams

Great, so thanks much.

Operator

you. Thank

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

Your line now live. is

Tazeen Ahmad

And Hi, what this of an it us what do you elasticity should on view couple A seeing Can Opzelura relates as end seeing treatment? gross-to-net on about beyond good And give can switches? What is? max, days? where you year, give question, are that will of is me demand you have taking the to in the a us second out co-pay much where of from any are as well. you Thanks. your patient idea questions. patients range pay think will Or kind be? do on to treatment have coming towards Thank you for at to you early from? of if is these how my And color any of when Are as before? switches, normalize coming think, you naïve the morning. from then of kind use that the we pocket

Barry Flannelly

Sure.

So Barry, again.

of steroids, it's – the majority have So treated switches They prior the with everything. been of vast off but are steroids. patients coming

with with with treated or fact, all getting they're off prior relief have have to therapy In maybe Opzelura. patients TCIs, treated getting been now switching been relief coming and and not or they're Eucrisa drugs with they're who Dupixent those

way expected to all what atopic we this steroids So patients of think really up steroids, for from patients beginning, the we product help mostly perfect injectable right it's and dermatitis with millions biologics, because we and can the this is that there the from drug. that's there's with

part out pocket. second of your The question of was,

patients said So plans, $XX that pocket. insurance more and that more I of the will pay out pick no think will I of course, to of the of we drug. up more than is expect, is the cost what have their What

Some by to low. them out-of-pocket have a obviously covered drug to the of of be patients what low commercial them some guarantee. have cost companies just them many patients that’s we when $XX pay some insurance. have They that’s honest, do. than keep and But they’re more other And deductibles, deductibles, no what have to co-pay will high quite of $XX,

or the we big that Now, patients on $XX it the tend pick then co-pay have that X to could co-pay, Tier Tier has up. no Tier average rare is average $XX different patient have different tiers It’s they to a a somewhere have really X between that X. co-pay co-pay gigantic at and or and a $XX to if it’s

Tazeen Ahmad

a Okay. gross just asked potential I’m that was the your about desire than asking future earlier, make it no think that to more a because question that to could the is more be variable $XX? your I potentially out net making in to in as to of sure net role future driver pocket to your what than gross bit a play of be? Did this you the expect

Christiana Stamoulis

XX% at that indicated. the the co-pay range XX% we Tazeen, in assistance steady state reflected So to have is

Tazeen Ahmad

Okay. Thank you.

Operator

you. Thank

coming Next question Olson from Jay from Oppenheimer. is today

now Your line is live.

Jay Olson

Are lot progress diversifying mostly a do you’re U.S.? question. expect since like thanks Incyte portfolio has lot dermatology that wondering you for update questions. product especially expand a I diversification, a picture growth of a the business, which you revenue seems from geographic on of the revenues beyond growth expecting Since revenue the made Jakafi. taking beyond your there and priority place opportunities big for U.S.-focused to your opportunity? the how a Maybe was Hey, much of

Hervé Hoppenot

here. Hervé Yes.

a years see to our of remember you you is Europe. the decision If to and result own can ago, we that go Japan that And made in few starting and emerge. build organization

and Japan, Japan. Minjuvi is to launched Iclusig number had small have that launching we also number will day, to we a Pemazyre have we and a have we organization Pemazyre but in in so of that diversification, a for So which now in development contribute Europe, years, this

As of we world, give partnerships of that you well. rest in speak, around, are very And important have know, for fact, we we will in and as us layer China another signing distribution very that agreements the the are, diversification. doing

the development applicable, very across these map the it’s that are Incyte project, And keep studies the And Europe years. of few next the applicable intend for includes important standpoint, the U.S. think time to most today always map is So that for from and know a Japan, world. because for we we every we

As the partnered of with have the we already pipeline products that China, could looking with new are footprint big where developing a we we future. of do at a some Incyte what are of and the for we number that for products question are

risk the it’s majority So sales. our And have. if still our it’s it’s aspect of big we Even that’s U.S. I an portfolio business. a today, the think on the picture of all important of based that is not

Jay Olson

Thanks for questions. Great. taking the

Operator

Thank you.

from coming Marc from is and today Cowen Frahm question Next Company.

live. Your line is now

Marc Frahm

taking my for questions. Thanks

that terms Or to should have ability of free to in is in once drug issue? contemplate to some we through come guidance question baked the of things? of the guidance and Just contracts, Does being already lot of vitiligo trajectory the and reimbursement Or kind expect some that launch the adjust kind the that that a a bit of into indication? that rapidly on labels year little maybe more your more. these

Barry Flannelly

guidance the included No, Barry. vitiligo it’s launch. is Marc, on Sure,

little the a for time. add vitiligo other takes it it time the with criteria. prescribe and is dose It Now take their so you add don’t Opzelura. because hundreds that GPO/PBMs utilization the when back of is for we update to approved, various or available bit course, to write now plans, that each of obviously, little can to do plants, contracts have have again the own it to utilization just downstream be criteria But formulary But their vitiligo available. to patients of and and has of will the new a of bit that, formulary go and drug drug their than plans

Marc Frahm

That’s some launched out that – and the in can the related you then Great. samples, initially update marketing don’t activities, kind see Okay. relaunch just to terms and marketing. And there’s of of if getting maybe with I those a helpful. know you those which as of an texture of the on of Barry you there, the ability issue importance to provide and kind the samples, follow-up

Christiana, the is need side, or Barry contemplated here, already prior previous in no? ads and guidance that On have on talked for in conversations, possible the guidance about DTC the SG&A you

Christiana Stamoulis

to question, me give you Steven an the issue. texture let to the I’ll and So it on start turn with update then last

that I worth reflect terms guidance the DTC. the with as as all guidance, as hemo covers that SG&A and well at both look and In is it the marketing does of associated thing launch, one Also Opzelura think costs so for including R&D, provided we it and have costs you with commercializing dermatology. supporting noting, associated SG&A

So the Opzelura. SG&A associated guidance with fully costs reflects

have hemo we there, we part guidance the revenue that However, provided, of business, look at when have the on MPNs. provided just guidance including you the

So and part well other the in have of as the part Opzelura royalties milestones. terms don’t as picture, you of have the you

Steven Stein

it’s On texture Marc, Steven. your issue.

commercial So the a as of in we’ve heard, healthy maintain that. for you a and to successful midst been able launch, we’re supply very

as we to a for for is supply XX. well. commercial as that vitiligo PDUFA April the date said, Additionally, And we healthy have want obviously, very

due we’re want the supply. but time, focusing the done bit on at early current as will of of samples manufacturing that, terms it little to commercial in Given get on a have We to possible, soon later on. knew wait the to We as that of focusing solution, and of solubility on improvements the we’ve process texture extremely and was avoid out that this crystal API know formation is has small improve that ruxolitinib. will amount we been an come It’s issue. this that

continue Some these and thereafter, we’ll of regulatory able well. within wait approval at specifications focus the very for vitiligo, maintain changes and and back the require submissions both feasible commercial manufacture AD implement. implemented upcoming immediately, then we’ve forth with as and supply and can and soon as as and to, are the the on samples possible it to and be FDA But been to time, a present the some healthy NDA

Marc Frahm

helpful. Great. Thanks. Very

Operator

you. Thank

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

live. Your line is now

Unidentified Analyst

the is on guys. Tiffany Thanks morning, This for Cory. Good for question.

case in future you And removed, Incyte been you the block might block sales that the potential the that, on reversing Just one the in confident other is major How payer on for Opzelura. speak one can that isn’t NDC plan? to second impact anticipate?

Barry Flannelly

Well, we’re very – Barry again.

we’re So the removing blocks. confident NDC very in

We’re in active advanced negotiations with them.

The first agreements. base part is signing these

specifications get up. of So all to contract locked the

for know one there sort example, base steps, that to of would of rebates approach. how are, proceed thing, the a we So rebates the Knowing is if sort step, be a forward. what what menu two it’s going

negotiating actively is team now. right the So

the demand confident. drug. from very a There’s downstream push for We’re great a plans. this There’s great

they’re As on getting of rebate insurance contracts many many already insurance PBMs you insurance they’re just criteria. companies. many working And establish one course, know, at paying And of established utilization and these formulary WAC. they’re aren’t getting company, for now Opzelura have working those companies. for for not They’re any put and all

of when you the block, pushing NDC blocks can have prior medical a that to block and even overcome exception. an approval all with still they’re patients So get removed. a NDC And NDC

to So other clear not time, of particular to able forever effective patients who are because payers the therapy. physicians, – other two XX% negotiate over be need do them, is clear blocks treated, confident the NDC able any to both we’re and with this companies we’re that to going therefore, PBMs, be one might are become offers or also live themselves value don’t because because to with but very this most they that an proposition patients and therapy of they

this fees will desire. able formulary on the them and rebate make really contract proposition they under their have want that it’s and that product to to to be value get So

Unidentified Analyst

Got Thanks. it.

Operator

Thank you.

Schmidt is coming Guggenheim Securities. from Next question Michael from

now Your line is live.

Unidentified Analyst

our Kelsey for on taking This Thanks question. for Michael. is

Another one the for done I contracting kind anticipated launch? for prepare Thank there sales on say process the of label Opzelura. being I what’s what then guess, regarding the clarifying into expansion the And vitiligo? guess, you force, to did prior on a was question, you.

Barry Flannelly

The their contracting have will go we’re – that then the that downstream to process. PBMs back is and in just formulary. GPOs that well, with process already contracting across what were I contracts that explained add the it before is that for we with step full plans But we included to PBMs the currently have to don’t – vitiligo and the to and be NDC the the block whole need country

So that’s just a P&T committee decision.

across as Our those after to launch. formulary criteria soon on market access place and works in with plans of team as the that possible get have country utilization all

the with data hopefully, soon vitiligo about and In drug talk now, them indication, the launch, after all on work formulary. fact, Xb they will very for them can of have the

we to don’t for to the again back have So go vitiligo. PBMs, GPOs

force the is getting as admit. to tricky. have is it far sales ready, I As

patient the We’re it’s of our people launch. is drug a and same groups, that this of these very There’s going first And we concentrating that vitiligo deal great But helped very suffering. and drug the the been hopefully both it’s What groups drug very of need repigment the dermatologists. is interested It’s emphasize team honest, we size AD patient-focused To – sales skin same and the FDA the approved because sales it. improve with life sales are about really the course, was getting the really force, can is for a same going are from the dedicated the you’re vitiligo. vitiligo on the dermatologist. for for a a have our launch. meeting the working treatment like for the in interest, work accelerating excited that same And development be asking the see Everybody It’s payers, quality what on of to of held patients them. advocacy force. true well. on great Opzelura number vitiligo

So there’s no expansion there.

advertising year. laid SG&A but into in that’s we Of promotion, figured already out this for the and course, that there’s some investments

Unidentified Analyst

so right. Great. Thank much. All you

Operator

Thank The Ren JMP call Securities. Benjamin you. is from coming next from

is now live. line Your

Ren Benjamin

Good Monjuvi until the going guys. find just for you NDA congratulations outstanding we A for you And us, rollout nears? update a think any guidance on that why about forward. might or Thanks to once-daily as have questions and board, does is the wait revenues. of revenues, talk a patent and think right And Europe? So to but you away? Monjuvi’s RUX just sense Europe, the a peak morning, And thinking occur about then I how submission, the throughout Germany maybe us. quarter and launch you so about noticed in there. I’d to questions can then from might review? more think with peak in If you as way it’s can we the strategically Europe, the taking couple of an kind question, don’t second about XX-month love on remind is do expiration rest its just you’re it Or how get is twice-daily something importantly, strategy this of market the

Steven Stein

the review on of start first I’ll Steven. it’s hi, Ren, question regulatory related your RUX. to once-daily

remind for in different have then FDA just we the bioequivalence stability. the you, bioavailability to put that So specifications strengths within and down work completed and

As this soon half we the year. first will of as file that completes,

review. standard a review, XX-month a expect We

year to just clarify likely that, get it’s that regulatory at to action we time. So this next that be to right early the of a year, related end

are... dynamics As for launch there the

Hervé Hoppenot

mean in specifically seen, mean, can have speak very – the Yes, has been about I I Germany so I that. as you good. uptake

through the sense is Europe, usual, you is of as there taking launch countries. it’s place. that across a well And we where So a as have reimbursement number know, go doing in to

So we And new are on taking next coming where what will you same there. see months are over launching place dynamic the board. type the of hopefully, countries

Minjuvi, Now never peak for we disclosed it.

be because of or in but lower in somewhat prices know, U.S., the you Europe, tends to we volume have higher access. As prices what universal are net than

Minjuvi will is the of end us. day, we And the the for potential be for meaningful, so it think contributor a key and at

booking know, we you the but U.S., revenue As rest are in of the the world. not are we in

revenue net contribute product will growth our that to next So the year. over

Ren Benjamin

regarding on hit the Or once-daily does you that you to that – hopefully approval, is until an does clarify, away? RUX that just later? hold right it. Got market something once And back get that plus

Hervé Hoppenot

we know Tactically, also the that's get I key approval think key to frankly that so as it RUX, strategic delay? combine ability be in we you will once-daily yet. or it know, We will the aspect. is launch of aspect products the the are don't once-daily there day a used myelofibrosis, the with

So be it impact that we kind have And don't would that I overall on to precise impact could because we at information what the want it you looking want negative. to business. to a of give – what are obviously, JAKAFI

that tactically So at be But we or later, it. a are something looking I the depending would could the time best on it be think may of following – in it available the but franchise. from what's the certainly years little at today, be for approval

Ren Benjamin

Terrific. again. Thanks and congratulations

Operator

you. Thank

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

is line Your live. now

Matt Phipps

primarily compare later on what in the Good the independent expect combination, for looking of update but results? with Is we with change that you what and we morning. one some are another going their the maybe recently year? it LIMBER really saw levels? on with patients this ALKX to conversion program, have hemoglobin Or can to the momelotinib transfusion I'll focus

Steven Stein

Steven. Hi Yes. question. I'll your take

first-line work pivotal in we which and in LIMBER, Baton our studies, of multiple settings, the the with spoke ALKX a is part of just is aspects. which the advanced So there parsaclisib are suboptimal the program. And remind to about then the once-daily formulation most formulation. as combinations, There's just different then and

a why For alleviate at seem program. hepcidin to this weaker potent this that probably is by because monotherapy What for to and and effect, excited we're a inhibitor anemia there ALKX the we're we've safety the with favorable. but you JAK specific it's it does which inhibitor off-target ALKX of ALKX, escalation so are tremendously which with in as is moment and we're opposed in momelotinib, dose excited that's seen kinetics that and already mentioned,

and way know to increase combination's and We'll combo. RUX to a be iron maybe translate we'll kinetics very going have even go that, want. this ALK demonstrate working should work. of And time we'd concept With anyway; quickly decreasing, is doing safety to to RUX that we it's of the trying that promise be we year. that's hepcidin or and the threefold. the proof twofold a we'll is we are wanted mechanism so hemoglobin Over So action through what

we the can't of know high and ruxolitinib, underlying one, and drug, address will discontinue XX% itself So XX%, to the of tolerate potentially for about then sometimes because that. drug have while doses patients tend anemia with it myelofibrosis or anemia for effective incredibly an

intensity disease, So dose translate alleviating and you the from well as RUX efficacy. a also the underlying maintain better anemia to anemia of RUX allow to alleviating the will

So we that data we plus this and safety believe to hemoglobin large, is combination year hepcidin get a lot the and in promise well. of both data want more as Thanks.

Operator

Thank you.

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

now live. is line Your

Unidentified Analyst

Salveen. Congrats on Hi. on the Thanks, on this Opzelura. for I is questions Matt quarter. two had quick

chronic First, have discuss should you're agreements the eczema PPM, Thanks secondly, before this I data a Phase lot. expect kind you PBM confirm year? expectations expect could And you do year-end? you sorry, third the a hand want any with third What that this III that? year, to you starting to And then expect opportunity? the potential just timing of we there? dosing would on of And be finalized

Barry Flannelly

Sure.

the jump So of Steven in little the I'll first can bit chronic maybe on answer question, hand. a part

year. we and all board the for I on this expect that agreements NDC the year this blocks PBM yes, all PBMs So of the discussed, of removing third the then coming

hand our effectiveness will opportunity these the to it really think us. expectation for is. It's that disease. to Opzelura I what severe I is eczema, So difficult that's demonstrate patients. Chronic an and it think a handle, It's provides

Steven Stein

Yes.

seen of during eczema. become to hands. in see during providers pandemic, quite and more other gloves, health terms particularly care contact people it you And COVID lot physicians in the wearing where and aspect prevalent distinct hand label Barry. and Thanks, although that. involvement a said Just to hands any there's of patients as maybe Obviously, a little very Barry more can entity a the on treat body, clinical where only of there's within upfront, part get color their severe a the you've dermatitis that contact with it's

clinical So stand-alone the idea as robust is addressed data. that the a gets we indication separate that generate opportunity

condition. the study XXXX for the premise that's this to enroll studying calendar data in you XXXX, expect have behind and that then and We year through

Operator

Thank you.

question from from coming Our Devarakonda next Truist Securities. is Kripa

live. now is line Your

Kripa Devarakonda

you but run and taking are versus any was Middle it's you question. level half in XXXX, I metrics wondering going JAKAFI. you flattish how is that for the JAKAFI? in your sort the much midpoint can you any did with for to this you. year my the Hi, of year-over-year implement half talk about about executed in were guys. the a implies that which maybe of for you recovery a implementations talked JAKAFI. guidance there you about vein, guidance expect second growth, XXXX. morning. And Good Thank that Thank so rate. additional XQ if to in The Have of gave growth leverage also strong you can guidance on second comfort a provide or long-term you to of question

Christiana Stamoulis

that Barry me But here. for at to can let XXXX start range So you we JAKAFI add guidance X.X. and provided X.X look when the

So at XX% to $XXX of end million the the or growth a of XXXX. look if range, implies year-over-year high in you dollar it relative incremental revenues terms,

low may in growth the line by and all end but the – So year, that seeing indications how been and The where really especially use. level of reflects GVHD, we've And COVID-XX most of incremental we this two the GVHD revenue growth reflected chronic and approval recent very is that much continued across the what in play range pre-pandemic. have with assumes around the growth of uncertainty is out reflects that's the range. for ends how the

Barry Flannelly

happy launch sort are the effect rest big throughout the benefit of add patients Obviously, that the is with with factor to just GVHD starts, new we that. the actually, And as of the chronic recovered And over very chronic mean XXXX, in a even I GVHD a Yes. patient for in especially QX. indications. halo it. to

Christiana the things we fall, better had year, into COVID. then guidance end moving thought uncertainty the over as of summer said, hit. and low Last Omicron we simply So were the getting in is

patients of fully that the growing just oncology physicians that can down. to have stay our that survival which in fact, – benefit to indications are because of we're of expecting with as the force a close coming hopefully, to well. duration increase. offices GVHD good the as not now as we and – away COVID-free, therapy that have starting believe do field year happening offices, so what's chronic to patients patients far MF Myelofibrosis so JAKAFI And I the the myelofibrosis offers to PD forward said, rest patients. access tend are But JAKAFI, earlier very continues patients for staying

the in care to quarter life-saving our So affected patients of GVHD to we PD for course, with of we vera. continue. and life fully chronic great quality was the – that can expect obviously it's on expanded will in we The steroid-refractory access switched extend of hope, better a expanded growth the standard myelofibrosis for MF, growth a provide high patients little acute patients commercial. expect, the that fourth program life, over JAKAFI nevertheless, But by GVHD access and be GVHD. quality a to polycythemia of continue potentially And of and gets life

Hervé Hoppenot

remember, closer. and if you And guidance, to closer Yes, much I franchise. line. in is we for long-term mean guidance the – very long-term getting it's are the this the applies

So in launched have be – years, the the it in new next the being gave – the in products few included $X would would in past. where situation will we guidance it it's billion we

Kripa Devarakonda

know candidates on at Is PD-LX I if of how recently expectation your candidates pipeline. IO we the there the you – multiple provide you listed ask Great. platform strategy as part this to out collaboration but year some big pipeline a to an picture see point? question. And I CDXXX opted of develop can plan still bispecific, IO

Steven Stein

an day we've I'm on decided. sure you its that, not, we'll Yes. conduct R&D Kripa, Steven. or Whether we wait not to tell

very Just the program remarks, alluded stage in as IO to terms in platform, at of we the PD-LX the of development. a is oral prepared exciting

no clinical We products behind all activity. clinic, further other have the two year. decisions The whom of have neuropathy, in make want products to Pfizer have three peripheral shown we this and

reignited and we positioned – there'll more ready TIGIT the with at beyond program. molecule healthy that. year those of we're well we moving And I'll antagonist and now some field be program, TIM-X been both alone are plans the then oral going a the areas in a and potentially The tuned antibody, LAG, give sort is have on them. through well leave just We're all share and when clinic small stay data checkpoint which very IO also has adenosine We pipeline. to we'll as LAG-X our and CDXX XA, an this also But on have PD-LX. XB targets clinical it exciting

Kripa Devarakonda

so Thank Great. you much.

Operator

you. Thank

is from Mirchandaney today from question final Our coming Maneka ISI. Evercore

is line Your live. now

Maneka Mirchandaney

for Great. Thanks the question. taking

just Opzelura with on a In than are just broadly? quarters? as coming found questions. follow-up one but going prior do a seeing Just curious just the some are are expect second well, ops those? some what you're so the to you requirements what it deductions, topical In plans payers through forward steroids? XX% of of far, prior Thanks. then more acquiring for for And engine your seeing step in the clarify And the in that discussions looks you other more we like

Barry Flannelly

Sure.

patients topical with treated as step already of calcineurin inhibitors, far there's they said, continue. steroids, that they'll therapies Like As millions been go, vary. I have

steps. have have two will Some some step, one will

will be low-potency and a high-potency Some therapies, be just steroid may steroid. two which topical a

the of part other question, The you...

Christiana Stamoulis

second part. can I Yes, the take

as you related have as and fees fees, may we XX%, that and other well assistance discounts In terms distribution of well. as there the providing co-pay be the bucket of that for discounts

Operator

you. Thank

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

Christine Chiou

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

Operator

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

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

Incyte (INCY) 8 Feb 222021 Q4 Earnings call transcript