Incyte (INCY) 9 Feb 212020 Q4 Earnings call transcript

Company Profile

Participants

Mike Booth	Head of Investor Relations
Hervé Hoppenot	Chairman, President and Chief Executive Officer
Barry Flannelly	Executive Vice President and General Manager, North America
Steven Stein	Executive Vice President and Chief Medical Officer
Christiana Stamoulis	Executive Vice President and Chief Financial Officer
Vikram Purohit	Morgan Stanley
Michael Schmidt	Guggenheim
Cory Kasimov	JPMorgan
Kripa Devarakonda	Truist
Brian Abrahams	RBC Capital Markets
Tyler Van Buren	Piper Sandler
Alethia Young	Cantor Fitzgerald
Tazeen Ahmad	Bank of America
Salveen Richter	Goldman Sachs
Mara Goldstein	Mizuho
Mark Frahm	Cowen and Company
Evan Seigerman	Credit Suisse
Ren Benjamin	JMP securities
Jay Olson	Oppenheimer

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings, and welcome to the Incyte Corporation Fourth Quarter Year End 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mike Booth, Head of Investor Relations. Please go ahead.

Mike Booth

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

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

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

Hervé Hoppenot

you, everyone. good morning, Mike, and Thank

million, Iclusig. as prior Royalties by of and and grew the of to Pemazyre market launch XX% fueled revenues. up we The $XXX XX% launch royalty with commercialized well gains. from other is and XXXX revenue collaboration So from benefiting XX% Monjuvi Jakafi was up product strong to grew Olumiant oncology a year of for growth our the XX%, partners. royalty was up nearly XX% XX%, product up a now Jakafi, share good and year by which our thus revenues And observe product growth Tabrecta by Incyte to demand continue contributing progressing were performance launch from of hematology versus commercialized year-over-year. strong Total for and continued

million resulting revenues We payments increase over XXXX, milestone in total of also $XXX during year-over-year. received an in in XX%

FDA in In potential we of several pivotal submitted these all Europe, These Jakafi and retifanlimab for to from in in Slide we have anal the trials during presented XXXX, positive on cholangiocarcinoma decision CHMP opinion. decisions tafasitamab expect approval in DLBCL to obtained in pemigatinib cell Europe, and filings, regulatory this GVHD, and chronic of Turning Japan X. we carcinoma, the several include year. recently positive and where squamous data

also a in approval submission preparation the commercial from few away for launch sNDA over call additional product and cream. potential our as to on details I Barry well for months We’re as the performance just now the of the of atopic will cream ruxolitinib vitiligo. pass for expected ruxolitinib dermatitis

Barry Flannelly

Hervé, number being Jakafi grow excellent reach revenues XXXX the you, treated, with all growing everyone. total good for high over to indications. remains demand with Thank and in across million billion. The of morning, Jakafi $X.XXX to performance three continuing patients $XXX was

of partial the fourth starts recovery by encouraged of also the patient and third XXXX. are We quarter new in

coming as driver. $X.XXX in and in quarter. up the of increase well of today For growth potential the XXXX, Jakafi The first to provided largest have oncology impact of GVHD year, to guidance steroid-refractory of availability indication expected the COVID-XX in the a for the billion approval billion $X.XXX first Jakafi we in we the as ongoing additional the especially of with with a gross net XXXX, represent COVID-XX, half an adjustment reflects visits impact important vaccines. expect as range would we of strong reach fourth its broader normalization The Jakafi chronic growth

able been Pemazyre has of we have in have to our and oncology. Pemazyre. X. Since relationships launch Turning physicians over on The prescribed launch, quite as XXX to Slide capitalize gone experience well,

for adoption community-based testing expected, driving and is are oncologists patients alterations FGFRX going smoothly. As

with from than purchasing good update, accounts the expected, physicians, to We in treated well. the gratifying identified QX XXX Given in previously that and in BMT good has being have accounts. with underserved setting. our to key strong B-cell XXX. And and is resonating population. we patients, market According it of Pemazyre. we're refill are appropriate the the used patients also bring patient seeing research the versus patient majority is as Monjuvi treatment over the The large a launch population. vast being diffuse in second-line been quarter Monjuvi-LEN know uptick and to seeing much very more is of most therapy safety million rate, $X doubled in Monjuvi reached we Monjuvi is that of Since of eligible profile are efficacy number million utilization are progressing the we fourth regimen this And community the Sales and plus $XX able know the to to QX. believe needed our lymphoma top

prescription significantly NDA which Turning last expect decision in has therapies number regulatory we are atopic new an ruxolitinib recent Slide States. of atopic XX a treatment grown million There estimated mid-year. the received for The patients aged United prescriptions and the submitted in X.X in for the cream as today. years, year, of XX. We dermatitis above Of are XX December dermatitis therapy approximately for introduced. dermatitis in atopic and million

dermatitis approximately treatment, However, report that atopic the controlled need only highlighting with of XX% exists. their unmet significant current their patients is currently

in be driven ruxolitinib allergy. of We medical expect the initial by specialist to uptick and dermatology cream

XX% approximately total identified the the high of of collectively written XX,XXX for treatment U.S. approximately prescribers dermatitis atopic who in for account prescriptions has team Our

to I'll exceptional the optimal reach products is Steven months, in XXX in over fully past for turn mid-April, of several expect been able the clinical – Over volume high we dermatology call experience to update. significant We're these a we prescribers. recruited United to field by recruit an have successfully the launching States. team expected FTEs team which with now

Steven Stein

good Slide Thanks, across Barry, as XXXX, progress we and made pipeline shown everyone. XX. In development significant morning, our on

our chronic in results in pivotal lymphomas, the of squamous trials atopic ruxolitinib graft-versus-host study positive from Some highlights their retifanlimab anal with basis dermatitis, non-Hodgkin's for regulatory in in indications. respective in submissions each ruxolitinib parsaclisib cell disease, forming cream and carcinoma include

We the targeted also also a in positive both atopic announced European Japan. therapy multiple in new product approvals, and CHMP States in and Japan, Tabrecta and patients United opinion announced to a Olumiant including Pemazyre for in and dermatitis first towards bringing crucial cholangiocarcinoma. the States, Europe We’ve recently with United step and pemigatinib, indication for Monjuvi

XX, are approvals regulatory multiple XXXX during submissions we expecting six during additional can year. with expected actions seven you Slide As on and see the

Novartis decision for expected we for to chronic ruxolitinib, FDA XXXX. hematology diffuse For Jakavi an an graft-versus-host disease an half anal we in carcinoma. squamous tafasitamab both in for EMA for the decision submit during our acute B-cell oncology, partner of expect large Japan in lymphoma and disease. cell and And Within and await graft-versus-host the first and in chronic FDA is EU Jakafi decision retifanlimab

expect under assuming an lymphoma and have non-Hodgkin's this to in CHMP approval we We Later opinion, in NDA in following submission submit expect X in sNDA to June, review in positive in the recent CITADEL Phase thereafter, cholangiocarcinoma submit plan successful. trials. year, for receive and on is dermatitis this decision Japan. based a we we parsaclisib an also FDA atopic Within the European for we shortly pemigatinib vitiligo monotherapy to our ruxolitinib indication dermatology, in look pivotal program an cream

a for before year program Incyte ahead overview along be LIMBER brief see, of shaping a and As very in action. development to you clinical approval of ruxolitinib exciting eventful XXXX. this end regulatory XX once-daily can the provides development the FDA furthest potential is clinical the of and with Slide terms

with multiple and or BET myelofibrosis. potential outcomes believe in PIXK-delta, for significantly the have we patients planned We combinations to which improve ALKX have with the development living

side, As patent see expect the right these novel well you extend on can into hand XXXXs. many of the assets for the to protection we

intend expected our tafasitamab of lymphoma. we'll the would this in XXX Moving is combination alone Phase evaluate year plus initiate expected with X to trials. with And or two partner patients. lymphoma. R-CHOP XX, R-squared in tafasitamab follicular versus patients and to diffuse approximately B-cell MorphoSys patients R-CHOP of versus approximately refractory inMIND assess the marginal we to zone is Slide R-squared lenalidomide enroll to and or enroll first-line plus combination relapsed large XXX frontMIND

bi-specific We our with antibody. on non-Hodgkin's trials CDXXxCDX initiating in own PIXK-delta proof-of-concept in combination combination also and plan tafasitamab two and lymphoma, a plamotamab in parsaclisib with lenalidomide inhibitor investigating

July which the ESMO to And submitted was BLA on BLA set data Slide Congress announced date review the from PODXUM-XXX, the at XXth. for at year. retifanlimab. XX, were the PDUFA results of we been has shared acceptance under recently Moving The based the last from priority

also of FDA convene to The meeting development of retifanlimab. advisory part review the remind We strategy opportunity an our to committee an have informed that also for the slide been process. you as gives me expects

first certain strategy to registration-directed of trials beyond carcinoma squamous And cell MSI-high are approvals retifanlimab merkel indications, develop ongoing endometrial in as anal part in other cell monotherapy niche The is the are and available. cancer. reaccelerated carcinoma

potential offers We portfolio, for over also including within more option opportunity. AXL/MER have having an to clinical gives development activity synergistic the utility and strategies substantial antibody, in a to which lung internal A With call numerous of I part enhanced update. X assets there's to us for and run adenosine an potential which of PD-X key that, to related in-house combinations Christiana much cancer, our would study immuno-oncology where the turn the with like of ongoing course financial global Phase efficacy. the XA/XB, other our

Christiana Stamoulis

good Thank and you, Steven morning everyone.

Pemazyre. to product total commercialized revenues over revenue reflecting results, representing strong quarter with XXXX increase and are product net fourth results royalties $XX fourth Lilly for $XXX revenues by of quarter $XX and quarter Royalties Turning million for Incyte XX% from million across an for our million of continued for of of Eli comprised now royalty and financial and and our million of the growth royalty $XX Total partners. the products million by $XXX for reflect our growth product Novartis for Jakafi, for Olumiant. Jakafi Tabrecta, Iclusig million of revenues million $X from $XX of

in revenues year milestone of an development, of an royalty our regulatory billion partners over XXXX. increased over increase commercial the product reflecting revenues product total the billion, royalty XXXX collaborative $X.XX and For full and for achievement revenues for were the from of payments increase Total XXXX milestones. $X.XX XXXX, higher XX% XX%

year approved operating in increased global related the atopic for treatment U.S. dermatitis. will and billion to potential the If from a product of R&D a for to share XXXX, product GAAP costs. on the expense the our share impact costs basis, year period period on development expenses due supply XX% of tafasitamab and costs driven launch product and to costs launch. of contribute is to $XXX also for for XXXX R&D XXXX as ultimately lower expenses of Ongoing goods XX% supply the in subsequent point Moving our support the XX% a cream ongoing full million for cream sold fourth increased prior XXXX costs development product quarter the to related specific by tafasitamab our costs the $X.XX ruxolitinib time of ruxolitinib over XX% of by supply of the cream of ruxolitinib expense

atopic review the $XXX dermatitis. the review period quarter agreement consideration purchase priority our to accelerate XX% FDA and a our prior of expenses. for billion the related million our to $XXX year certain of SG&A upfront from year in the collaborative expense increased for fourth ruxolitinib MorphoSys of reminder of timing of for $XXX total $X.X million to of an XXXX due the R&D As utilized expense of million cream expense includes full the voucher with

to the full year Pemazyre to SG&A cream marketing compared U.S. XXXX For potential of U.S. and in sales the driven an by the for grew XXXX, in commercialization rux launch the expense and in to the support increase XX% spend of prepare

XX% Our collaboration commercialization represents loss of million, share for $XX for was the quarter loss which Monjuvi. the net our U.S.

and $XX $XXX XXXX, total revenues operating of was million million. and COGS of expenses, collaboration product was total including $XX full SG&A expenses the it million net and of total comprised year loss the For

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

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

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

products. Given other XXXX Hematology/Oncology the expansion and commercial are of guidance our for total for revenue net we as a providing portfolio, Jakafi product

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

be with being to adjustment the and first XXXX We the quarter adjustment approximately to expect our in higher subsequent year of quarters. in net previous relative gross and the quarter XX% the

products, net the product and range Hematology/Oncology include Pemazyre Iclusig $XXX the revenues million total are in other in expecting currently be U.S. For which $XXX in of Europe we to to million.

previous years, royalty revenues. milestone or not guidance in for As we're providing

We MorphoSys. new product guidance any Monjuvi for potential together launches and the we recently launched are XXXX also not with U.S., revenue which for providing are or was our partner during in which commercializing

expenses, to from revenues. range X% X% operating expect of COGS to net Turning we to product

in upfront the digit of at be R&D in the range the growth and XXXX. excluding the billion impact MorphoSys XXXX, PRV of to expect to expense billion versus representing We $X.XX midpoint consideration mid-single $X.XX the

guidance sales to the the for the organization marketing activities Europe the the our and and a related The and in atopic establishment expense of sales support dermatitis. includes of potential commercial to related cream launch for launches the of launch for establishment new potential dermatology to the for marketing pemigatinib support cholangiocarcinoma of tafasitamab the cholangiocarcinoma. investment U.S. commercial expansion of SG&A organization and Our ruxolitinib activities and of to DLBCL the in support pemigatinib potential Japan in

the in to for SG&A GAAP we a expect million. in to of As the $XXX the XXXX, range year result be $XXX million expense

back to to remain Excluding I further turn these SG&A discussions ahead. now expect call year our investments flat of for the the impact compared the for Hervé expense XXXX will we of to XXXX.

Hervé Hoppenot

as of you, list chronic Thank include important approvals for ruxolitinib These updates SCAC well the provides in the for in XXXX. trial results in XX Christiana. we cream ruxolitinib a Slide vitiligo, and dermatitis, Jakafi expect cream retifanlimab pivotal GVHD. in atopic in as

well month that I Booth UK. who return of the as and want let be into Incyte in Head move take will role Mike's at So as endeavors. thank Mike Incyte closely us line of open to the to Chiou, Mike to end and the seven has I all Christine before contribution years, his we very for working take with to much transition. give this your Incyte of ahead minute Q&A, wish planned know at his a in that, part want past his operator, the been planned Mike very you over opportunity leaving to the future moving With Q&A. a who and to for him XXXX all all of please IR of to will joined instruction

Operator

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

is line live. now Your

Vikram Purohit

morning. Good taking for Thanks question. Great. my

getting we're the advance here. two to be of for wanted next had Phase franchise. I the going to I touch vitiligo in questions And months So on of rux data that cream over X couple the dermatology

then we for most the think about Phase So first, Phase could portion vitiligo? you're could do key at valuable? to population? thinking us you differences rux that for? And be rux How looking this you patient any between you populations about is And of which segmenting the vitiligo how cream cream second, patient X patient where X population suitable characterize for think going be the and should that most are

Steven Stein

Vikram, hi, it’s take I'll your Steven, question.

the Phase Phase actually we X, of the the on in the of magnitude the in of or outcome. terms the be Phase expect differences criteria, and translatability it X the the size eligibility in question the conducted given population to to X, we no it In of geography

surface is I'll be patients to including that XX%, more the in the to of on Phase read X depigmentation up vitiligo We expect just whereas efficacy, X safety X one be the of the liberal magnitude nuance we in the difference. assure, little and to to a the with area limit body Phase Phase Phase the up same. in they’re XX%, to the the and the only difference is X but allowed similar be to and

differences We no the of population. other in and in read-through expect outcome

a of disease common vitiligo more and it's terms itself, probably everybody In much realizes.

it of we condition, the disease they're of a treatment. them is effective therapies, Not component not people as the the the depress the you large available a improving “sufferers” at it, about them given to not with United several all it of to which well, also, from and vitiligo. very There's ameliorating in and disease, as But XXX,XXX terms with well. steroids, rux. phototherapy the and often in know, nothing including estimate, Phase different psychosocial seek view million look you we all saw X to where as degree topical currently people as treatments, If reimbursed want there's States, XXX,XXX and

So the it aim we particularly to of X, X Phase as for population majority include label we the we'll be should the the same on be. sufferers as expect will the and face that's to hands. work it as in Thanks. Phase vitiligo, And with positive expect

Vikram Purohit

Got it. you. Thank

Operator

you. Thank

from Schmidt Our next question is from coming Guggenheim. Michael

now line Your is live.

Michael Schmidt

utilization that that would across indications? follow-up emerging safety context? much. of in guys. this launch JAK my I the the from around you in well. in how was context had could Celgene, more so your are and launch interactions cream a oral understand here how access? coming post-marketing in morning. Thanks especially Hey, us questions. my position And Maybe, with ruxolitinib ruxolitinib wondering I when to pricing Thanks inhibitors comes of cream may And recent you broadly data might up question it on with help few think potentially prep be for how affect Good and taking as payers so market AD far AD, you

Barry Flannelly

clinical part over the to preparation it the as very Hi, question, take your Steven I'll an off for part for that's deep the dermatology affairs I'll going immunology. the very team Incyte Barry, in at has it's dermatology excellent development goes U.S. first and Michael, your as with But built well. launch, second the and We a medical question. outstanding immunology. experience in We that's experienced hand of and in and team it's started far of

and team, that we're again, built the immunology has out an access force out sales experience we Now dermatology. excellent market building deep in and

the the we'll the interactions negotiations near of boards process with had with and payers have in the with very future. advisory We begin across nation payers

that is think preparation launch schedule. is we Steven? – right So on

Steven Stein

thanks the question. for Michael, Yes.

adverse thromboembolism, read-through a major rux malignancy, data particularly non-inferiority I topical a Celgene’s the guess, then in question looking the Given asked TNF particularly XXXX. on potentially patients, We've therapy, and since with then market events, to rux itself, RA been venous rux. and you versus at to on the cardiac

we many, on partner, follow-up thousand many Novartis, as patient with have So our years programs. well long-term exposure, of trial clinical as including our

me let trial bit So about a programs. just talk clinical little the

exposure. If and have in And been the studies, both data no of there. are cardiac five that available worrying those the on there. years are is events, lower with response treated and particular polycythemia follow-up malignancies of treated board thromboembolic any the on that years signal prothrombotic published rates the disease, a arms five in therapy the primary events in vera, now in looked you COMFORT for we've best those look In across versus at arm at crossover there's study, arms, the fact, the also that events the of now MF, follow-up, arm,

and applied, in for about X% bioavailability the rux a the in we AD events average that So keeping by experience papers is of regulatory or a on now, in cream one X%. no with of X% box to black warnings cream as about not asked any And you, vitiligo, as our on signal that have just published Topical of yearly basis remind rux that itself, any those these. showing has of for as to in one authorities. we're well market we seeing two

published effective one those are So one pharmacologically – very there papers, oral in and at the exposure concentrations. vitiligo. And is and in and not AD two relevant thus small

having having expect any safety our and sort the don't at itself now the cream So an programs, issue, we given of moment. read-through that compound bioavailability, parent from clinical not those there rux

Michael Schmidt

Great. Thank you.

Operator

Thank you.

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

live. now is line Your

Cory Kasimov

see market AD. relatively same far, of the guys. heavy-lifting Hey, potentially taking about line patients kind I rux launch the for in of perhaps required good your quickly And we you everything impediments existing questioning some pending of wanted here with question. with thinking morning, to you've And mode this could just you. the introduction? I'll cream. data, around said low-hanging the my the do – of given what so for should benefiting of versus and on as the here Thanks just you key fruit how from And the that capture Thank follow-up meds? stick comments who Barry, given administration aren't number be on

Barry Flannelly

in steroids very the as Hi eczema, far very I to we help really impediments a patients We've as we really atopic situation. We see , go, we're can don't all to mild actually impediments. dermatitis, Well, think Cory. way with Dupixent good – many moderate from to biologics. think really up

opposed So broad who that as therapy to rux of range be system that cream a systemic to will fact there use their in cream a we using very patients suppress immune general. in may think happy like is

We very the very we targeted targeted anything biologic TRuE topical, that They've ADX, is that a they So ADX excited – look TRuE activity. dermatologist this they're that the seen when excited. has like in never country therapy, across about know at data talking to from like that were it. that's has and that

uptake So patients is that the throughout TRuE so and demonstrated TRuE to efficacy in we we've and going far the States. the help think safety ADX ADX United and

Cory Kasimov

Great. very you Thank much.

Operator

Thank you.

Kripa from Our is coming question Devarakonda next from Truist.

live. Your now line is

Kripa Devarakonda

FDA And the we guys. atopic to vitiligo? expect about you. you was that your Can rux Staying for had the taking my of much I sort conversation? cream, pediatric with what you between rux wondering conversations can you submissions? similar your Have and be for talk you strategy have derm Thank NDA in any Thank following had questions. filed it so cream further also around you Hey, populations? on

Steven Stein

you about your will in any we've will for that But went conversations said regulatory detail ongoing that. December. I a authorities. in Kripa, successfully question. review as voucher the don't tell expect submission We six-month on the with and the in talk priority we middle year utilized it's us of in action a an We Stephen. publicly, review hi, Thanks give

it's as years it's exactly as of above, going days XX TRuE February, expected, the review, studies, of Given early about in which early atopic that population covers that majority and with submission it's now the was still and ADs Barry talking dermatitis. and the

there is atopic that is that However, a we does also that. have and study a have younger, dermatitis, population commitment to to continue

as more successfully. have example got bone enable to there to is those We sort conducting in as and authorities we'll well. this the that at hurdles studies with for do soon we we've in those two know safety place, studies. population Phase to years regulatory Xs ages, to enabling of studies and given in going effect, we'll completed, pediatric year that determine calendar Phase as young but have look And address you those be what and you successfully the population any let cetera, through conduct X conjunction And is work we'll it's above those et look

Kripa Devarakonda

you. Thank Great.

Operator

Thank you.

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

now Your line is live.

Brian Abrahams

Thanks guys. for question. much my Hey, taking so

how where Maybe shifting I all wish Christine. could his you for the to and more off, help I'm about Monjuvi, offer to at him congratulations bispecifics if want CAR Mike look the and well throughout just next in talk his you years a it's further little gears to may relative curious First endeavors bit imagine thank and what I in And the are treatments world, to towards T. fitting would real more particular, reach where in like investigational in therapy cell available. used being academic that's to settings,

continue important momentum. community the going to In to that's Thanks. the uptake how be addition current to setting,

Barry Flannelly

Well, up the where will continue in any Sure, like you and of think very the we uptake the move population, line therapy benefit to therapies, new launches, the because try Monjuvi to well later physicians in third- starting said most. going patients therapy, that is plus up end Brian. the move to that's fourth-line patient I second-line and second-line patients for example, try – we setting like into

was in Our for the academic And mostly referred another T to actually Patients available who that academic not eligible therapy uptake centers CAR sometimes therapy, have actually to therapy launch T centers then we well. we're for them. actually follow so centers to I academic therapies need and very do are choose. guess doing they they're at T CAR CAR the

our taking progressed of we up with being and of academic treated and that are the that's largest more we the have of more using regimen surpassing who patients are in oncologist in centers and But launch, As still this the community country the Monjuvi some of are number LEN. Monjuvi center.

will As far as fact, in Monjuvi year. up be bispecifics profile we next very a that efficacy And problem to match necessarily might the of that's and yet. go, we therapies of don't know that well that think coming safety any the new

go population effects ability will patient therapies tolerate choose based T upon therapies. the physicians the of their CAR side far As to their again, as the CAR T

generally country. a for might therapies, be those might select that limited who patients younger they are centers the it number of that's around So healthy again, but

to with B-cell go lymphoma. treating large Monjuvi long way So has diffuse patients with we think a that

Brian Abrahams

helpful Thanks, really Barry. That's color.

Operator

you. Thank

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

now live. is line Your

Tyler Van Buren

Good guys. morning. taking Hey, for the Thanks question.

another Just one on I had Monjuvi.

You talked the share and about uptake academic the successful market and launch the settings community in gains.

I mentioned a could hear frontMIND press be that existing inMIND your B-MIND studies if wasn't billion latest be successful. to and noticed in Monjuvi release. and the need presentation And the mentioned or if product you curious in indication, in you thoughts, the to barely believe $X and the So

going So just de-prioritization curious to hear of if on what's that a was there. a deliberate, like

Barry Flannelly

more million. million and develop could way. first we $XXX about setting and – take to the over the the I to combinations move to it that $XXX just indication I'll front-line current we’ll Steven question, that's is Monjuvi to to U.S. hand we said Tyler, $XXX past of $XXX But in several million reach the part continue the up So, times million and the what And as in in B-MIND. by

Steven for to at B-MIND. that's anyways, I'll and over where it So we're hand

Hervé Hoppenot

Just a word.

assuming will U.S., If the sales Monjuvi you billion the $XXX be million of $XXX million or in DLBCL, look at for world. in to second-line around that for worldwide $X it the it's north

Steven Stein

hi, Tyler, it’s Steven.

your of new that question it’s B-MIND, have It's were study just regimen very changes it's a data particular it's setting and but comparing bendamustine then will the updates. We study. to that events rituximab, is which on there. ongoing of nothing used just as no It's relevant an expected a report. terms study. hopefully tafasitamab to to on in there and a in if In are it, that antibody news in track There studying XXXX, utility had that it CDXX no

Tyler Van Buren

Great. Thanks so much.

Operator

you. Thank

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

Your live. now line is

Alethia Young

as you to use Hey, one non-small there for questions. like in And thoughts a PD-X track. combinations adenosine of Mike, Therapeutics my the perspective do PD-X? biotech you taking congrats being out yesterday, kinase potential kind I market question. of wanted TG Is with that keeping on and would in the and with I One, non-small on your us CDXX, two in guys. positioning about did after cell also access them? to combination. Thanks. PIX greatest ask IRs get to want your your then And Or think that about how approval your on do of also the cell Thanks the that just option? the how field just think you on about something

Steven Stein

thanks for question. hi, Alethia, the it's Steven,

TG approval and clause. unfair the believers the from addressed delta is now overhang untoward kinase has somewhat effects. think that PIX umbralisib Obviously, have an We for we I Therapeutics of think years it ago from idealists’ patients. in many side of good the many are

impact and in our year, this as any studies plans doesn't go outcome. we and lymphoma. So hopefully follicular It a way of we marginal in the with CITADEL in the filings viewed where mantle positive terms cell that

If with drugs you look those reported independently on than cell higher with activity the reviewed like trial face is and of with of follicular many on caveats many, it, again comparisons, mantle lots in all cross marginal that but caveats. indications, umbralisib,

label And their prior And encouraged and our we’re profile, looked repetitive, efficacy burdened think impact. been both versus we we've and their cetera. We plans. with we products. and obviously et with somewhat important So we're Tolerability by class very to no the as we, proceeding unfairly well. by discontinuations again, efficacy and parsaclisib, is at ours again, see, like safety obviously, has the be seen our

terms about compounds, announced earlier adenosine JPMorgan. programs inhibitor, we In targeted at AXA/AXB enrolling clinic adenosine a switching have spoke molecule we in and that one already, to the you open and of that’s small

in We shortly following model up inhibit at a showed that pathway. or the that'll his antibody also higher in together, a – in CDXX said And least production adenosine preclinical two the we'll synergistic. with be Hervé very

to require these feel also early therapy potentially be top where a too to where We a PD-X. checkpoint this of have an area may say triplet on is It's you'll that going. you and add will

programs, in-house patients always antibody CDXX particularly I'll of to of of proud program would of Thanks. terms interest. interest, are the I-O current that'll in histology, just therapies lung you that be also and lung we're In them. respond the that remind pain, and don't adenosine very remain so both

Operator

next today our is And Ahmad of from coming you. Bank from America. Tazeen Thank question

line is live. now Your

Tazeen Ahmad

taking Thanks my Hi, questions. good morning. for

start cream the to follow-up. the quick I for will margins the you wanted I margin cream then you're have on rux approach little gross a rux get see just a bit how color might differ derm you from Jakafi. gross about As for more with how And atopic launch, that thinking

Christiana Stamoulis

this is Tazeen, Hi Christiana.

billing the for the rux to result R&D. In as API we the been lower being the use and XXXX, under which that the we would up as of indicated, the cream terms and have of supply was COGS have well. X% reflected supply near is in that provided cream we In cream that in guidance we does X% rux already COGS expensed on reflect that rux term, on for as we COGS

Tazeen Ahmad

Okay.

So have improve? would you expect indication once that continue to that COGS a you would second

Christiana Stamoulis

we'll So go to the COGS launch, have back from we of already expensed the API the take obviously – starting a more with levels. we and normalized have the will over benefit COGS then that that period place time,

COGS. So we'll as be in has already lower what expensed, reflected been it use we would

Tazeen Ahmad

then and now, rux just be? between might cream are can difference Eucrisa where are how rux as but of thinking how the and rux cream it on physicians And understand based viewing they officially market to kind the you Okay. are relates it, you benefits cream of

Barry Flannelly

the this try said I spoken something really data and They that we've as using topical most the they've TRuE-ADX physicians Tazeen like TRuE-ADX unique. to, I'll topical therapy really handle the the seen many as dermatologists that and as like dermatologists therapy really ever. see and they to all this country, I effective Hi, is think, Barry before, it. see across there's Well, the

side from dermatologists profile so to had doesn't but think good, certainly Eucrisa that some what they're it turned they when burns rux far cream. and excited application it So very pretty it to physicians, seem and be from The effective. it on effect about away see launched, I is actually it have disadvantages

Tazeen Ahmad

And think physician steep need so that be you it there does it a education still get initially? if would uptake do approved. to would some you think Barry, have Do or

Barry Flannelly

think there's go going education, as necessary patient physician but the as Well, well. education that to we is that's always well be very perhaps uptake

Tazeen Ahmad

Okay. Thank you.

Operator

Thanks.

Salveen Sachs. Richter question from coming from Next is Goldman

Your line live. is now

Salveen Richter

Good morning, us development give stands kind could updated Thank questions. QD beyond. my thoughts on the you And of and if the formulation you. where XXXX Could study you just LIMBER Jakafi you Hervé, then look thanks business your us for of strategy taking remind as to from initiative?

Steven Stein

start. Steven hi and to I'll completed. is it’s once-daily formulation ruxolitinib The Salveen, work continues well. bioavailability of The bioequivalence go being

complete a an thus stability XX expect stability in and now to review XXXX submission before and if from put everything would goes of months smoothly. We of expect to XX-month in. end that we need then the approval the We’re

of terms required the in BA/BE. expected strict on everything within are guidance We

a this will So be hopeful submission. successful we're

Hervé Hoppenot

So, Salveen regarding BD.

a year, we looking We to very fact with approaching MorphoSys how strategies. what where year the we XXXX is was this In see last good we in our what complimentary are portfolio. maybe like deal BD way at are – did the it had

parsaclisib. we the in You both are we There combinations on and U.S. lot now a side, in the that commercial Europe see, with doing are synergies can of have

are there if to So certainly to opportunities continue our looking diversify. us to would be like to that, grow line it I interesting and revenue think

So that be would aspect. one

about did myelofibrosis. was company technology also called with that deal We and Cellenkos a a

be you we looking some revenue internal in mostly portfolio hematology/oncology and the things portfolio are our adding as it it opportunities be as dermatitis will timelines look, that but that that program. part with available, could at dermatology be launching the that we can be different are this there priority. is, that And the also in we then on LIMBER were to And are vitiligo also if team we'll thinking that imagine would next could our to way also So we U.S., general, of that would products providing opportunities the if about our the be be atopic year, first fitting additional year.

to urgency no is short there the that So term. in to add

say would and I the maybe that could of and a hematology/oncology period launching type be be we products we’d at time, we between XXXX. in assets looking are So short-term of looking the at over longer immuno-dermatology XXXX

Salveen Richter

Thank you.

Operator

Thank you.

is Next Goldstein Mizuho. question coming today from from Mara

now Your line is live.

Mara Goldstein

much Thanks taking the so for Yes. question.

like, some the the your a derm touched as I'm that? support, to hasn't curious thoughts some pre-COVID to And that cream. could areas around enhance products if well. also so I'm in company trying little And Just a rux and just a the dynamics Jakafi patient of touch of is you launches, are associated understand on and is the and PV perhaps to wondering on of type as one program in with that couponing that most what bit the follow-up efforts while on are of on population.

Steven Stein

both Yes. cream PV. answer try Mara, then rux those on to and on Jakafi of I'll in

products you when going prescribes it. in as when we to dermatologist, we're particularly for cream, see, possible newly know, easy just where the the the that products to dermatology, that rux States, plans it's you but physician as patient a throughout United have like that So many we launched in place obtain ensure

ways able that pharmacy the begins And once working to you few get first help approvals sure make possible, co-pays with we PBMs say, as possible. payers a for and to through, program, other restrictions deductibles us with market to or counter be that manage as as the that. and their to couponing patients So prior with to access, as as there's then few

continues well our PV, biggest in faster As – far goes, activity PV PV long-term continues and than about impressive total as suppose data time. grow. because grow Jakafi the first around very are goes, which the And undergo disease we our talking important more studies, they Jakafi it MF. in MF of of I of and our we better. continued though over the the had number that suffering is, of Jakafi vera awareness continues we're get to patients patients even response number are symptoms grow Jakafi and to in to campaigns But when PV. does the they're continues looked also that had polycythemia very, follow-up The – getting doing just to who

So effective their and indications, as the a patients we're it's therapy polycythemia very for in that as they our hematocrit. pressing vera encouraged about need the symptoms you other their but Jakafi sure to indicated most to have care those as future make of of well take

Mara Goldstein

you. Thank Okay.

Operator

you. Thank

Company. from question Frahm Cowen Mark from next Our and is coming

line live. now Your is

Mark Frahm

now need and what do offer to then comments, vitiligo their there And guess, condition. Maybe Steven's next thanks covered in true medical consider to I of with plan and a for me by also of relevant today and let his that Hi, kind also the for do questions products. to the we get grow what and Barry, already step sense your and my to consultants hear be recognized do your a a Mike are in reimbursable use this indication, this to of cosmetic number? kind percent between my as population efforts who comments But people taking that congratulation certainly as number to off-label of plans, has from reimbursed launch you what's of a various career.

Barry Flannelly

reimbursed, educate because this you that patients dermatologists X fact, XXX,XXX other million we to impacts payers. and both what because have many very only XXX,XXX talked between disease not patients very therapies, covered think are an therapy. million is aren't currently talked for maybe may but autoimmune millions States, We tell vitiligo, And number about educate may do in to be seeking think continue there or but lives. phototherapy patients therapies X Steven somewhere way, therapies. I very one really of about have it's, are the United drastically Dermatologists the Steven can have topical many to that I don't therapies that's effective I Sure. know there patient's in much. to that's aren’t that

can disease us a having those quality cosmetic that for pay is is like thing enhance life therapy it's educate a is it to actually So for greatly to upon committed think autoimmune responsible patients. issue it the of an and essential payers vitiligo, And we cream rux this the for that not

Mark Frahm

to similar launches kind same type there of that of that point you'd have kind historically dynamic. the happened Are face of

Barry Flannelly

that Well, comes to mind.

it bleeding very that awake infections that's we not example. other payers impacts many come is I that lives that older of we but think thought think even to haven't pick might just examples that wanting night, and example, can so that is So, one and had important, that's sure for payers there's vitiligo, we suffering of itching this of across course fact staying say we important, and might've at but Education I'm overcome hurdle. of and you it lots the not is go think they want launching, something manage out much, elsewhere. they're where very diseases but prescribers up, when there's they to eczema, even where products house that and to in patient's were don't

Mark Frahm

Great. Thank you.

Operator

Thank you.

from Seigerman from coming is question Next Suisse. Evan Credit

is line live. Your

Evan Seigerman

everything Thank I to will over want be missed. of to past you all. taking quick Hi my just for shout you out Mike the years, for couple question.

I So LIMBER on program. ask wanted the to

terms physicians physicians patients potentially really the you demand on or patients? of of switch you've QD to both from some And from advocacy feedback see current formulation characterize and kind want be rux it what can the gotten in this While might maybe do among option Jakafi? early, QD to

Steven Stein

would Okay. Steven Others is to the Evan. with has program very do The was one one over pillars. twice-daily, as numerous efforts you. potential once-daily people the The an work to LIMBER potentially pillars. behind that people Obviously, compliance benefit I'll start. although tend Thank improvement umbrella that. was oncology want Hi. comments. of for twice well may those It's add formulation of itself it in from who daily, but

we fixed-dose to Should lend BET develop, or in does it ALKX important with ruxolitinib give the be itself on very us PIXK-delta, one example for down could once-daily, a FTC. combinations. Additionally a as optionality combined it line once-daily

the would the the with we approved anemia a to be enhance to stay one pursue drug, anemia and direct patients drugs efficacy of the a And patients reasons on may lower it If as then have of it discontinue which of they that rate would result, a once-daily, from longer. actually the well. allow is, file, of is think in be one as view, at benefit lower that a tend and that. the which from from could at because causes peak, MF that's nature We Cmax. once-daily, point differences the we be really, route important After it So stability pharmacokinetic of bioequivalence, really hopefully the end and have have finished bioavailability XXX(NYSE:B) of through the slight it'll of just profile may in look by a lower for clinical things example, that its a very XXXX.

anemia. of are potentially upside first there optionality an about ameliorating lots the So program, aspects lend It's compliance, and wise. approval itself on getting to fixed to which its may step on dose combinations

Evan Seigerman

you. Thank Excellent. Thanks.

Operator

for Thank two you. Ladies more questions. and gentlemen, we have time

Our Benjamin securities. next coming question from from JMP is Ren

now is live. Your line

Ren Benjamin

to program, best a in curious, an quarter. just just just Can and Maybe Is to what ongoing, X as maybe fallen timing the good find two the just about address, MPNs? Steven. is optimal is rux this to both the to on trying this determined Great talk the probably we or you for dosing rationale to these collaboration maybe kind it might was that a when cost, was bit starting need seeks questions. lead how already more collaboration? LIMBER Mike readouts for parsaclisib. an Phase just And of the amazing for I'm mentioned unmet Congratulations there follow-up, Hey, a as this and guys. little response trials rate guidance Thanks and taking as see off congrats morning that are well.

Steven Stein

your it’s questions. Ren, for Yes, thanks Steven,

LIMBER again in we about work. to the the first question formulation back prior around So, program pillar just the spoke about

combination we PIXK-delta in first five responses to there in determined study as study, site suboptimal ongoing. use the setting to has but terrible had or ALKX or setting, very you symptom obviously as two did safety efficacy is issues the alluded a prior are had least And open delta rux patients pillar like long-term is that second which with important versus rux. we rux. response can And line ameliorate question that who Xs that because have came for and And dosing profile. plus itself, delta what in terms a site are milligram ruxolitinib, enhance not The ALKX, for we asked the you adequate titrate have alone. work spleen suboptimal Phase around like of as thrombocytopenia. had that's The One dosing and had stay with proof-of-concept that who on you at if initiations now the you dosing, and delta was control. that specifically know The is well in that's either program both because important how a an safety we optimal enhance months ongoing both three with open combinations the initiations then rux The inadequate from how to based are and work rux randomized potential active anemia to patients or of in now. on

selling for option number mechanism a small to shown some who way a toxin to derived of bone then patients small of regulatory data that then action. CXCRX In in cells it's have which terms regulatory heavily with of allele pretreated, cells very plant. We of because finance fibrosis the the umbilical drop the it's response And improvement. There's cord marrow. burden new deal in we costs, they a are hone go like they've T maybe that anecdotes, completely enrich structured It's enticing are in We clinical clinical would and the T a smaller to the even have – some an some off-the-shelf a MOA. really early. cord completely way with And exciting, we’re up. new a it we umbilical it's then and work, concept take of it's proof

that's the Thanks. that one. So drivers behind

Ren Benjamin

questions. the taking for Thanks

Operator

Thank you.

from today Oppenheimer. Jay is Our from question final coming Olson

now is live. line Your

Jay Olson

thanks his clinically details LIMBER the if on the Hey over what on was you rux versus thanks BET for any on wondering of plus just could Thank appreciate benefit provide years. for And level theme and your progress meaningful to taking help I inhibitor? I would of the the alone Maybe And you. Mike of there be question. all incremental SVRXX continue combination TSS? BET program. to your and Booth rux for the inhibitor

Steven Stein

Steven. question. Jay, for Hey Thanks it's the

Either a patients. said, I of just had solid north XXX a treated, a trying drive dosed reminder, MIC much at with a to compound. So compound ago. in not in and It's terms toxicity we than our in target the a the very we solid We thrombocytopenia of were new as clinic inhibition, adequate this we we inhibition had BET mind lot We of patients frame and more efficacy is years in but XXX had tumor time. not inhibitor, tumors. on

second-line to signal. interesting patients first-line ourselves program monotherapy externally, field with speak. shelf, evolved then an setting CPI-XXX combination that on put in showed that data obviously, has rux we in or think hold in setting So, we and the as on And MF the in the then the so

up year, reinvigorated COVID and safety the hopefully, this BET enrollment but now second go the own with get is It's in and inhibitor we and behaves, calendar in then program. half combination the potentially safety is our studies. to open year, So then ahead and for our with with the this pivotal get idea rux first of half, monotherapy

this that model dosing of will at clinic prior think well we'll it's the effect, how a our one-third weave because decisions MF external end asked unacceptable of of were and differentiate, different from with calendar the one-quarter have own with the in so we able safety we not make in terms otherwise have therapeutic who the in year. we and as it one. it's different thrombocytopenia. You pre-clinically of external not does dose environment before. had data data looked Thanks. at rates BET We've then then about our effective to ratio we a We any But to once targeting were terms know data way and in completely the of bigger scheme inhibitor in the

Operator

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

Mike Booth

your questions, of your Kevin. and Thank for your you Thanks all course, for also kind for words. time today,

be of the you will in for with rest You I'm available all follow-up for day and the excellent sure, now, of hands questions. Christine, both for are thank us goodbye. very But and much, any

Operator

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

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

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.