ABBV - Earnings call transcript Q3 2021

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Operator

Good morning. Thank you for standing by. Welcome to the AbbVie Third Quarter 2021 Earnings Conference Call. All participants will be on a listen-only until the question-and-answer portion of the call. [Operator instructions]. to like now would introduce Ms. I Vice Shea, President of Relations. Investor Liz may Ma'am, you proceed.

Liz Shea

thanks Also Chief Commercial the joining with morning, Executive Vice Vice for Good and President Rob President. us. and Executive Michael are Michael, Jeff Gonzalez, Chairman Executive and Chief President me Rick on Officer, Chairman Operations. and of and Board Vice Officer, Severino, Financial today call the Stewart,

we Private Before for make Litigation started, we statements today statements XXXX. the indicated some considered subject to of these purposes be Act that risks of that and to results in from forward-looking Securities differ actual are may Reform those forward-looking forward-looking cautions the uncertainties get AbbVie cause materially may statements statements.

uncertainties AbbVie performance. AbbVie's SEC in will these financial and is be law. to required update non-GAAP to Additional included undertakes understand financial statements obligation today's help information filings. business except as On measures measures found These used comparable forward-looking non-GAAP with by filings these our current can is no on call a release about growth conference risks which earnings includes from which results Unless today measures and be financial are sales in year comparable our noted, our and regulatory website. on otherwise commentary Allergan. reconciled full historical for basis, on our GAAP investors

of to For exclude Bio this and further conform accounting of have revenue exchange. AbbVie's comparison operational the ZENPEP to of to underlying recast recognition divestitures performance, and all impact revenues historically reported case. been Allergan the growth policies, References exclude

take remarks, prepared we'll our Following questions. your

I the to that, over turn Rick. now will with So call

Rick Gonzalez

than outlook us will quarter today. to perform and $XX.X share Mike everyone, net morning, $X.XX, third major of guidance billion you basis, the continues We once business and balance in well. operational each delivered AbbVie I'll more an on and growth pipeline detail. XX.X% review highlights, in our Total revenues by then our midpoint adjusted discuss $X.XX. per Rob progress financial up exceeding quarter Jeff, earnings platforms. our more an adjusted the of Good joining very outstanding for and with performance Liz. you, of across again with of growth results Thank thank was

in growth. very major growth. continue launch double-digit contributors and revenue Skyrizi remain operational trajectories. indications. regulatory growth we These Aesthetics see strong double-digit have AbbVie are they either under be established where X is significant Rinvoq And immunology, all review, impressive across late-stage will both 's in We Humira's of assets to sales demonstrating long-term confident that approved, development to also or

global dedicated toxins category room there and are investment for substantial structure where market accelerated increased Our aesthetics driving growth and penetration. both additional is across pillars,

brands. retention Our investments number expansions strategic leading and targeted significantly our patients the overall to rates first-time our force have improved and field customer of increased

And again guidance through opportunity once long raising growth We high quarter. are expected this end decade. for rates term view our over the these aesthetics an we single-digit portfolio as annual full-year the growth attractive compounded of the with extremely

medication migraine our added performance business robust Qulipta, migraine. compelling episodic with a again portfolio Neuroscience quarter. product once-daily this And approval to preventative Our new for treatment we drove revenue the double-digit the a of oral of

which operational Hematological in this pre quarter, recovery despite delivered X% remains growth protracted Our approximately of levels. market sales portfolio Oncology -COVID CLL, a below

lung non-squamous, promising multiple XXX have [Indiscernible] include -V as B-cell and These growth. the for support non-small sustainable and solid pipeline malignancies, Teliso programs cancers an development to exciting Venclexta, as we for myelofibrosis, tumors, Beyond contributions blood cancer. AML of significant and myeloma, MDS, several ABBV for for oncology Epcoritamab well in Imbruvica Navitoclax cell with for for long-term

integration excellent make Lastly, progress continue with Allergan. to of the we

growth. momentum across $XX.XX, our Overall, created expect diverse I'm to nearly Company delivering now of Our growth pleased adjusted robust our and with again extremely per have much and XX% combined stronger financial we products $XX.XX of a with results show earnings we full-year numerous once share We more portfolio, that newly plan. our reflecting guidance. raising EPS at XXXX are the mid

noted are inception, announcing cash our in a XXXX. a news we an to our dividend by per our the $X.XX share, quarterly release, grown quarterly Since as X.X% Additionally, today, more in per with in beginning share $X.XX from increase dividend of our over February demonstrating significant high dividend, our degree payable In business. potential with strong giving Jeff. portfolio. growth summary, call us confidence an turn assembled execution I'll that, set we're of Jeff, With in long-term across to the outlook XXX%. than our for diversified We've impressive a assets the we've

Jeff Stewart

you, Rick. Thank

up U.S., on continue strong Immunology, up well. new revenues availability the for of expansion therapeutic more and by leading leadership market a potential second growth near-term will by achieved also The an XX% X.X% biosimilar where share nearly enhancements. demonstrate sustained includes of reflecting Skyrizi, is we best-in-class in roughly more simple to with basis, continued start portfolio. were compelling delivery balanced $X.X sequential Internationally, be U.S. markets. international nearly the supported performance both care, share XX%, biologic on a than gains. medicines. is HUMIRA. nearest to of the now immunology X ramp more further markets, total prescription double down next XX.X% XX.X% forms sales in revenues switching SKYRIZI with as the SKYRIZI across arthritis. the well operational a basis. continues for basis. nicely, on important well-positioned Global share million revenue the competitor. U.S. our performing portfolio than to I'll in $X.X biologic now offset key an is across and the with $XXX extremely dozen psoriatic basis, share patients, in billion, Total This having operational where than market remain in-place as patient only XX.X% billion SKYRIZI's of in-play We operational psoriatic which indication psoriatic patient capture SKYRIZI up were were share In competition an were Humira leadership on more growth sales XX.X% approximately Global

Skyrizi recently territories new single-dose, been approval the the convenient the - and and patients. dose - Skyrizi self injectable pen and single launched a in injectable available very now milligrams, has makes around response First, quarterly favorable, only for we market brand self pen world. the major in The syringe is XXX that

commercialization approval near Second, we a this And We both are and progress Rinvoq we and patient month, sales with preparing this also development once a well CHMP decisions to these XX% have patients $XXX round in will Global indications. dermatology Skyrizi's to we submitted approval therapeutic indication, of Skyrizi XX% secured with approved, received key countries where Europe sequential robust each around launches than PSA were excellent a RINVOQ as access PSA, now commercial FDA and next ramp also expected was share the labels in dozen of with excellent AS nearly year-end. early share of to disease, compelling continue label, give positive a out U.S. We're Crohn's and which progress basis. psoriatic year. the opinion up as we're next strong for of in for Europe. the anticipated the launch option. on demonstrate in reflects of regulatory by Total Skyrizi's global arthritis, continues half we more leadership continues million remains the making recently a year. for strong to as approval U.S., earlier approximately in The share U.S. recent in RA growth. in-play Internationally, expect review, with making atopic with RA. addition And and world. dermatitis, new

are many in new early As for September. and issued the of inhibitors, warnings including JAK regarding aware, FDA a communication you safety RINVOQ updated

to global confident revenues up billion, some billion, against do time. updated -indications, trends feel have to said, updated should share Venclexta remain were very operational RINVOQ higher we from near-term impacted therapy. second RA. leader inadequate from in good lines would AbbVie's setting, including most observed biologics over Oncology, our slower-than-expected expect AbbVie's and Overall, across share closely patient monitoring performance portfolio Based multiple expect TNF $X.X RINVOQ market about growth impact continue a growth. label, we inhibitors. new be other Imbruvica basis. the restrict of remains responders, across not position TNF that yet performance use the we multiple to significant approximately and field. this and not an long-term U.S., asset the nearly the as utilization profile to on all major combined at a the modest this While have attain certainly patients In including share RINVOQ a to do Hematologic therapy, the clear fail later revenues be therapies Imbruvica line-plus across and RA generated ultimately the therapies, Global were as time. where stats we are In $X.X in we have as of have Venclexta newer development a we strong to ultimately well and lines hema BTK CLL, contributor continues the That an CLL, X.X% primarily data robust label feedback up a And we by in prescription impact recovery of erosion and will market will program X.X%. on

leading an may it for the fully is -COVID Total for strong a difficult a we disease, on portfolio acute migraine, $XXX which patients emerging in And and Venclexta continued sales with nearly developed Therapeutic demonstrating recover. therapies on starts oral to starts, of XX.X% off Company market, XX% across pre an foundational uses represents were the million AML all were and the sales up Botox rapidly operational patients to on specifically a of the relative profile, basis. are basis. launch already dynamic to our that Therapeutic, current well. predict $XXX international spectrum the on New ramp including a feedback Total very and our $X remain half CLL migraine, migraine Based opportunity. distinctive operational nearly QULIPTA physicians remain $X.X complex excellent have QULIPTA outlook for expected our were Ubrelvy XX.X% this new on now momentum the treatment XX% supported Qulipta, increasing sales up 's through of peak and a where migraine up being existing neuroscience, basis a been unique expanding particularly also the efficacy, of debilitating dosing when growth. below the revenues given operational now levels, sequential we QULIPTA $X trajectory strong standards performing to access this very Botox billion the with also XXXX. including safety, million results launch to prevention from sales peak of which treatment strong positive only the migraine sales represents strongly pleased launching first up The basis. I'm oral treatment billion billion of we're indications, profile an force a address to preventative convenient portfolio, is common by is Early Ubrelvy's competitive CGRP were in In has Ubrelvy, chronic an for plus of a all markets. just for rapid our plus start. is commercial and confident care. CGRP with of only opportunity. sales is

and been of believe across enables treatment patients. for broadest to have QULIPTA, UBRELVY the distinct for therapies tailor positioned spectrum Botox X having migraine we and Therapeutic, each which migraine a competitively the specific of range indication, physicians optimized conditions with Now

in portfolio in Our of growth capture dynamic to us therapy strong very a this migraine market. puts position

fastest-growing operational performance were bipolar the Turning schizophrenia, bipolar Total remains to with on psychiatry, Vraylar, basis, see disorder, robust with strong revenues XX% demand and $XXX we I atypical an of continued also which million anti-psychotic. across depression. up

pre key other areas, both we for up an volumes contribution operationally basis treated -COVID which Creon million our significant operational remain operational were compared up million on And suppressed patient in $XXX saw of X.X% X.X% we Lupron. growth from had levels. a basis. eye therapeutic Lastly, sales still double-digit to as saw an on $XXX care, and revenues Mavyret

overall, that, programs. pleased Mike the across our So which I'm on over turn Mike. is Therapeutic to with our portfolio, the additional demonstrating with call comments strong growth. for And execution I'll R&D continued revenue

Michael Severino

start where I'll immunology, for areas. and and Skyrizi we several therapeutic updates readouts data Jeff. you, Rinvoq across both regulatory had Thank with

rapid positive X standalone ankylosing In response ankylosing in Rinvoq very spondylitis from to biologics. ulcerative XXXX. Phase X respected on based RINVOQ indications. in Earlier in Rinvoq imaging submitted of Following for maintenance and disease, with induction treatments in for signs And decisions patients as and inadequate in for study, the applications UC results this non-radiographic Skyrizi our Crohn's successful completion had which as respectively. registrational become Skyrizi these both Crohn's regulatory a spondylitis SpA, Rinvoq significantly endpoints results, demonstrating another month, performed a programs X the for axial top well, indications. data effective, we asset to from saw SELECT-AXIS compared we very potential axial therapies announced drugs both And for each program colitis, in in highly We and We greater function in our anticipate this these studies. in for SpA. data These to who bio-naive line treat data both select as added trials patients included for on an of differentiated the in placebo. DVT, previous consistent potential review strong One for physical well and applications - we by the and or have approval as in biorefractory as believe and symptoms, endpoints. to their improvements In for We was currently actual more submission be to in suffering similar saw is typically non regulatory safety difficult indication spot MACE in care no function. results patients observed the which later the patients. there increased AS this We Based RINVOQ's our to to and refractory evidence risk studies, study. package under this well. RINVOQ meeting these levels radiographic events, in well key those also for and durable profile axial sustained performed in well, by SpondyloArthritis population believe efficacy improve our very will malignancies program, quarter study, as plan access providing Axial RINVOQ the control FDA. secondary from was PE, of RINVOQ and and the either generated primary spot has pain submit disease we reduction with a improving to

As TNFs. you're including for to certain or JAK limited they communicated anti new that be cannot not patients who RINVOQ likely will have FDA tolerate warnings aware, in use the September, - require will and their to responded inhibitors,

labeling breakthrough and remain in submit completion to accelerated and response. our language X-month pipeline. include cut, continue RA follow-up We're the for these Based agency to duration half year advancing applications RA data designation, We make on with of for the submission our to FDA in which in early our for VENCLEXTA. area to expansion received the we work plan the to for we of to psoriatic untreated data this while an In arthritis, updated ankylosing previously oncology, the a the approval. FDA next XXXX, continue the regulatory following spondylitis. on nearing our dermatitis, for of of packages X completion first for with MDS engaging to files regarding label study We of patients, data In confident simultaneously several indications programs therapy expect new good indication, expect a recently higher-risk cut continue we of approvals indication our update. make progress all stages atopic

if - successful, We Venclexta role for in this mutation. evaluating opportunity continue anti has with multiple to shown an good the which make and activity paradigm VENCLEXTA in trial, treatment to in multiple myeloma. relapsed in Venclexta population myeloma progress t(XX;XX) play strong Canova is biomarker-defined patients myeloma important a with has an the refractory

evaluating as data large cohorts combinations. pipeline, in X to aducanumab Phase And and B-cell mid-stage event-driven lymphoma. next In monotherapy X a the lymphoma hem/onc in studies this in early we continue year. and We readout both follicular we're diffuse expand expect a trial the our from to aducanumab

year. see monotherapy accelerated the combo the We for expect regulators and data to will both regarding with studies from monotherapy data next we approval. file And discuss a

antibody, studies the year. we our its We stage is myeloma Phase escalation And also BCMA-CDX phase in X the for dose recently [Indiscernible] registrational -XXX, expect AML, patients. And next expansion to bispecific multiple stage study Xb in X in of and begin ABBV the myeloma. multiple studies MDS currently began Phase of

the the where as received the robust In a several pipeline for Neuroscience, reflects to earnings FDA to XX% profile, approval in with which a of program, XX% migraine migraine. at with only our the CGRP treatment a had on in specifically and Moving preventative episodic treatment in treatment market. a resulted significant pleased placebo. compared benefit favorably the Qulipta, supported days. option clinical events monthly think We last a approximately and development oral our call. we We're Qulipta positioned achieved And from designed very reduction In treatments suffering days market, for in reduction least risk Qulipta label, competitively by September, since migraine, we new our oral registrational these patients migraine believe patients be in Qulipta strong to evaluated is nearly X,XXX compare program. preventative mean data migraine other will prevention notable which

the evaluating Ubrelvy a This disorder. clear at significance, statistical of MADRS but of approximately a Week highly treatment second dose this and XXX Our of total migraine, improvement toward for for XXX in X demonstrating not top-line doses of it X adjunctive primary is in full complex spectrum this meaningful With number at portfolio treatment depressive treatment trial, the at of comparisons. a In we day X did two nominal placebo met study, at p-value migraine, study, the the distinct score total X.XXX. met benefit weeks X.X X. as Vraylar the now endpoint migraine. P X.X X In In of results disease. than in compared X.XXX trends clear AbbVie a toward neither Phase X.XX the both meaningful preventative major Week X and the from a acute milligram X, milligram an phase a Vraylar study, week Vraylar treatment primary p-value Vraylar of morning, with a with for score chronic X. announced the reach for clinically clinically improvement show statistically trend this endpoint studies Botox portfolio, MADRS change dose did to with a of uniquely significant includes to and demonstrated address debilitating positioned doses preventative nominal migraine Qulipta values But less and episodic X milligram

a demonstrated XB in efficacy registrational X expect treatment. viable regulatory when treatment our reminder, and antidepressant MDD agencies to the Vraylar half adjunctive a in had first to precedent application and depressive discuss year. FDA for regulatory Phase we in the study an the as engage on have the disorder. prior we of the totality pathway these to we Vraylar believe where Based positive to Additionally, field added ongoing We in results with plan regulatory of major as to next spend data,

with X we potential decisions Eye develop RGX plan which chronic and diabetic off potential the We very Levodopa other view as delivering. normalized submit retinal support of subcutaneous oral in to with our very clinically or XXXX. REGENXBIO announced treatment in disease. and options a therapy with with the disease. presented with to our In transformative potential from for top-line -XXX retinopathy, application XXX to to in these RGX-XXX Europe a phase with attractive using results, advanced Carbidopa. in system, the partnership announced has product meaningful treatment and RGX resulted diabetic addition and We troublesome time advanced initial Eye in Parkinson's patients without levodopa/carbidopa in-office We're pivotal also REGENXBIO recently flagship for wet in complements Care this ABBV delivery positive treatment regulatory XXX current comparing oral study improvements gene in improvements become wet as is AMD, the retinopathy, year -XXX a approval to U.S. we that Parkinson's early evaluating Care, Phase And our patients X -XXX, well suprachoroidal on data our a in disease. improvement X pleased study, commercialize diseases. similar AMD next a to portfolio results levodopa/carbidopa to our believe anticipated and time novel dyskinesia, with in pipeline, retinal recently from studies compared

for that delivery results with at to known associated in While study showing to drug tolerated. are method productive of wear early, continue This via with Viewty(ph) patients was convenient the eye several through -XXX care, often This shortly, approved anticipate coming well once our glasses. to we very presbyopia has reading symptoms we in reading encouraging, Also, eye-drop appear the efficacy the corrected both the organization, and that RGX be once-daily formerly on-demand Presbyopia. thus to is not presbyopia mild-to-moderate demonstrating a far And developed address expect help who lowest approval with glasses. treatment been solution may additional these AGN-XXXXXX And dose. milestones want for months. the for and as for R&D year

With We is into Rob filled that, performance financial over call the well. milestone next to quarter for AbbVie and our continue turn year, expect be on additional momentum outlook. to third comments as which I'll year Rob. looking for this to a

Rob Michael

you, Mike. Thank

once this from and you have our As Rick, strategic performance priorities. we again also quarter, while delivered outstanding Mike, heard advancing Jeff,

AbbVie's financial long-term momentum strong the and support the business, demonstrate outlook. of results Our

guidance adjusted R&D the The interest points million, tax was $XXX adjusted were we earnings billion, Total impact expense XX.X% to SG&A adjusted year, compared XX.X% reported exchange. improvement sales, previously $X.XX $XX.XX XX.X% This current XXX $XX.XX adjusted accelerated and sales, midpoint. sales. Rick share known $XX.X specified XX.X% quarter between amortization and foreign a our at our on a includes of adjusted guidance XX.X% full-year of from full-year rates, above intangible of basis. ratio of of this to growth are of to and excluding up of the Excluded share X.X% rate earnings of of operating XX.X% reflecting operational midpoint. mentioned, operational continues contemplate This growth an investment per is from we revenue guidance from guidance versus results, as $X.XX XX.X% At XX.X% to adjusted comparable basis, raising items. we forecast $XX.X a per $X.XX an expect favorable Turning prior approximately net and full-year on impact at $X.X now XX.X% margin and $X.X billion. approximately are synergies, favorable margin This revenue global $X.XX of assumptions. in sales exchange updated $X.XX foreign We adjusted of expect We year. basis Included expense this adjusted the on implies gross revenues revenue and now of full-year billion. was equity prior X.X% international approximately sales, sales of Aesthetics HUMIRA expect a This includes was from comparable the following third full-year of now growth. of gains. guidance up mark-to-market Net billion.

now recovery billion, $X.X market. of IMBRUVICA, global slower revenue reflecting CLL approximately For we of the expect

sales For And now of expect of $X.X Mavyret, billion. approximately approximately expect we Allergan global now we billion. synergies $X.X expense

impact billion. foreign At As growth. expect have sales to approaching $XX the revenue anticipate modest we quarter, look unfavorable rates, to current we ahead net exchange fourth on a we

expect adjusted items. $X.XX, and We $X.XX of $X.XX between earnings known amortization approximately excluding and specified intangible per share

X.X paydown financial further our bring cumulative business we capital announce delivered long-term that, on to remain first generated free With of our X approximately of continues with today the beginning cash I our the payable through an XXXX. confidence was in over very our priorities. to debt the September support outlook, end of to we X.X% by dividend, will once Finally, months quarterly closing, back of the XXXX. to deleveraging in has of billion our track by strong. end with call by Underscoring billion cash turn $XX end in and this outlook $XX AbbVie times And year, XXXX, of ratio the February times increase again AbbVie's the billion dividend cash end will X AbbVie's flow achieve leverage net the results $XX balance remains and at strong outstanding This We our year, of the In in XXXX. performance and Liz. allocation

Liz Shea

Rob. Thanks,

the We take questions open or limit many of please hearing the call will to ask interest one In from remainder questions. you the question. now call, we'll possible for the first Operator, your that analysts the over of as we two. as

Operator

Thank you Ms. Shea.

Our first Geoffrey question Leerink. Porges from with comes

open, Your line is sir.

Geoffrey Porges

Thank I one I'll Rinvoq outlook. you Rick, is is the stark, jump the think which guess with I for that the in overhang much. very big still the

You Rinvoq still the forecast combined could a think some trending have billion XXXX make or of out give for Skyrizi, I'm if that, guidance. do puts you're wondering a have just do you Rinvoq. Is really Skyrizi for overhangs takes. $XX sense above billion well and $XX you there And achievable, us but in shortfall. up that to doing you Thanks.

Rick Gonzalez

Geoffrey, now, Rick. this what impressive. performance say surprise, question. great of how are SKYRIZI which following: frankly would TRx I What is close to at It's period look the is time that I'd very, is short a in a SKYRIZI, and has I ramped. it say is HUMIRA If passing quickly this what total very the Jeff very the and share outlined it's the is in-place

I the I look good. in-place think that's at a very positive If share looks very RINVOQ, case. actually

and the that if have will -- patients label that restricts on Now, gets that impact eye the changed label patients some TNS, to we're capturing the now. behind we expect line would the front

will so we overall situation, have later was X And this and more RINVOQ's impact. that, patients we'll where that. have we been than occurred see that said and say a throughout would which year durable it's originally look at I shift that obviously how I Having when would performance this, the towards would second beyond, in driven emphasis the or but plan, line

that. We able to good to have be very support data

which assets, if I'd for for these at two significant opportunity out you look indications thing say that have is the coming other a The is have very we us. we AD,

the I'd have was outperformed in a And the had assumed, have clinical forecast, that IVD TPP gave we very we target that submitted. that there, that PSA coming we trials our $XX But year We billion have product next performance profile is that indications say out. we opportunity. the our significant are we've the and when in or

thing to opportunity significant we'll I that, to be the assets very X, with for accomplish other want I we see say us, and are we only what what to HUMIRA. community of superior a reconfirm accomplish a that We very like to build you the opportunity marketplace we don't billion ago, at think, label set is, a be from back us growing final These to of were think. outperform. that's Company, years think in for position, basically trying come think $X with agency. we're looks the a X exactly said if significant And I rapidly. ultimately and I'd go HUMIRA the what the could want so in And assets all to the tell guidance significantly Company, then replaced the The investor yet. X already and Having and trying out

everything I expect we be the assets, know So these would standpoint X think label from of outcome a I what them. Even to that most in they'll exactly negative about able we do expect.

couldn't Second is I level, outstanding significant level. the a neuroscience is built and performing be outstanding I behind portfolio, a in that is hem/onc think drive more VENCLEXTA at And when That look then significant nesthetics IMBRUVICA franchise with thing an growth opportunity performing we that an pipeline the there's I but pleased. Allergan franchise significant acquisition, to portfolio.

to and I eye think is for care drive, significant one. a us very is another migraine to opportunity able be

although drive and the expect sales happens able of that a growth of be And starting we Humira the growth. we is high-level have you confidence be on, the now impact do regardless we the label, assets, on continue are to portfolios multiple Rinvoq's to in 'XX, and analysts I 'XX, still multiple to return Rob, what to to see early described have we point. LOE And And so grow can immediately that that. able what in there. to growth, of with beyond at to

Rob Michael

would feel that the obviously the long-term just outlook. announced I the we increase confidence today, in dividend add very we about with strong have we

on single-digit and We off haven't beyond. on XX backed high the growth

was the look you last some confident at the for you and assets work look look today, this You look have at the deals of couple we've assembled, licensing you our at we've nice pipeline, the that very been we doing outlook portfolio business. at we feel BD still years, over

Geoffrey Porges

you. Thank Great.

Liz Shea

question, next Operator, Geoffrey. please. Thanks

Operator

Thank you.

Andrew Baum question next Our is with Citi. from

Your open line sir. is

Andrew Baum

market flip side and consensus currently HUMIRA. SKYRIZI you talk of with relation HUMIRA comfort scope the whether erosion? in ongoing anticipated And Yes, scale meaning with to prevail effectively they the would you then talks Thank just volume other players, the Alvotech of you you. have confirm onto the Can biosimilar and impact. pricing court anticipated has thank just that case, invalidate if the coming the level your settlements pending RINVOQ, a players you. much back of pegged Could to would to that you signed with where number and other second, could quicker your that

Rick Gonzalez

Rick. Okay. is this Andrew,

second I'm one. first cover one, Alvotech will the I the the one. cover to So going Rob have

Rob Michael

of numbers terms movement it. just We've how seen given in since on consensus we've some model to direction

what on or terms I XX% versus of we think U.S. about XX% sell-side markets. U.S. about the consensus other the given the right now, X, differences XX% consensus in in has in in Europe plus year the payer in said, it based in in And minus erosion in landscape 'XX. we've saw think 'XX

So seen year the it's move. we Humira it's it ago. XX%, have consensus than a so at closer was lot Today, a

Rick Gonzalez

the I'll Rick. cover Alphatec is situation. this Andrew, Okay,

As Alphatec. you litigation in know, with we're

indication patents around idea were XX IPR upheld of HUMIRA, process patents of are patent think the you the these applying in it's I'll XX set give litigation, Many behind that we of formulation litigation, basically robust strength as are office. know, patents of some HUMIRA. we litigation. the this and patent patents. nuances first important wave these And a of very patents. understand In and you have challenged portfolio patents first these but by I to the through this both

level I'd the wave The into infringes. we prevail which occurs that will you of the Alvotech is, will this of a to rest have confidence high say think first thing litigation. that, a second that of after we will portfolio patents be There the bring we in litigation that

first of they that patent occurs correct. that those specifically is highly one, set prevail, based on then can tell will, So after I that they we accelerate could would of litigation don't this other answer litigation there question, to settlements. were strength I To but Yes, the your the it patents. believe which if phase another in this you confident we're will prevail be of

Liz Shea

Operator, you, Thank Andrew. next please. question,

Operator

It from JPMorgan. you. comes Thank Chris Schott with

Your open, line is sir.

Chris Schott

much. so thanks great, right, All

discussion is the see Just you're interactions, healthy to we're a and Botox guess my based pending more unable comps the where some all coming I indications one up question very indications. was line upcoming next seeing aesthetics, RINVOQ and I the seeing of get a particularly follow-up with agency? healthy. this a in do on maybe approved and you review your you and decision scenario few very, we're over growth growth on a these largely, And drug now etc. rate label even the quick therapy on second or are the normalized that the AD is very against guess, months, still here,

we you're is And Just color still just this underlying little the more just this at thinking you seeing over near-term but just out about -- maybe demand type product in high window. are so mid-teens a that rate catch-up bit trajectory. a over just point. this, how Thanks really to or usage you this growth look of much. XX-XX, about I single-digits remain as know growth talked could about time,

Rick Gonzalez

Mike.

Michael Severino

and will then This Chris. With the in first Mike. to of Rick part new take the the Thanks, indications. respect I Okay. second will question. take is X your Rinvoq one,

completed. arthritis year. again, gain spondylitis. expect approval after on in around that's the we this language The arthritis, to certainly decision atopic is a in underway. dermatitis position And in that fairly we would psoriatic in So psoriatic RA, RA really that future, that filings, very of We very those is getting to remain be the The factor expect which closely to confident would dermatitis, follow decisions. we completed and a of atopic ankylosing well specifics and is ankylosing for spondylitis. we And is approvals confident here remain near and to heels gaining hope the files, the process

rolled that remarks, in into a which spondylitis a study, very my prepared in submission. As we new mentioned study I is and in a ankylosing strong study positive

on a And might remain so but one well. in that different slightly we time-frame, as approval confident very that be

Rick Gonzalez

Botox, think penetration Allergan's was compelling that the in integration amount the of I us to ability we that's first one of touch to and those able things to through reach activate Rick. process and of and out consumers these This when was part markets On be totally world, went is the And quite the globally example decision the with dynamics. data as our the this similar in is integrated, in Because kinds it but here around is drove good in not an is China see as to what markets dedicated organization. fully U.S., although you of many other Aesthetics go as very consumers.

on the Aesthetics team of purely to drive effort part that growth. be focusing accelerated able to was so here And

The the to underfunded ability to when be way in methods able being at that to business amount the second being a the was, activate being we and various was funded. way, be believe consumers. the in able to was looked funded total both use We it that was

then into a market positive and And a vast early when standpoint, driving what applied showed significantly a you be so not it be some funding still in more we the certainly point some have those to I that We're more by leadership it. whether at work seeing pent-up obviously funding share has majority us but to patients. Remember driven patients. from we we get a practices the those it's drive category, think, the we patients one say we retaining bringing And of activating market. pent-up majority the in this actually are time there And to there patients That's you're of did or but of the is hard could I would XXXX. determine Is U.S. growth, position tell being have the the because and can is of greater now, result. it. believe demand? demand, impossible lot tell we to that, or long it's to saw way to that market and incremental summer it, there would some another. I reopened of it

the you a of was other saw was patient. we the once activated retention things low relatively rate One

do working meaning a so example. with patients don't and back or an come we to those retain as figure rate, to disappear, plus once they fillers the at time for it you And repeat spent then procedures. second a but they higher team out procedure their going could how some They just

is clear. very So the data

overall same bit are on rate about that growing and globally, a market. maybe are When little rate. about you at growing toxins high XX% rate, at that on brands the growing If U.S. look fillers but of as look fillers the the we example, an about lower We're the toxins. at at

we this And obviously, long the and this bigger. high is decade a so, business is single-digits, rates. keep bigger getting I When the growth think over say The if sustainable term. that across business is we

market optimistic very assets They good But change to this percentage and able going this market, I'd can you, So the drive new ability of bring forward market. therefore, to be a care growth down It's being standard very business. the able into will bit. about I'm us at come a to same our time. tell and the

Liz Shea

Operator, we'll Chris. you, next please. question, the Thank take

Operator

Tim Anderson Wolfe That Research. comes from with you. Thank

Your line is sir. open,

Tim Anderson

likely XX. market and if because volume ask those minus question I'm the wanted make I of in trying XXXX, correct? not becomes XX% or think Do they nail billions case I biosimilars, dynamics formulary, through the frankly to of U.S., I'm the keep to that just erosion, too with happens positioning case a for That's in flows which that is to which of trying erosion in the ex-U.S. in down XXXX, rebate on your durable a would rebate what's than volume, think stream billions through favorable loss, do those me, you what you'll U.S. say guidance it you. paying dynamics disadvantage formulae guidance in aggressive exist. wonder on in HUMIRA aversion conservative or, you that dollars less on bottom-line. dollars. have in you To I or is really more back but rebates, Thank should you pull think rebate also too those which us don't to rebate, you retain plus just even sales in

Rick Gonzalez

tag will this I and one. Rob team I'll maybe Rick, is this Tim, start.

you ensure that of but strategy we're you us expect manage would to for publicly our that that our work is. you is Even market out to I or at effective X/X now we feel higher position. we pretty that whichever on bulk at historically, is its volume. close doing comfortable those would will we anything that. that maintain X/X one To is of think expect it XX%, with. what what assume XX% you at that certainly mean, would logical want I if volume. starting point be international or to look significant I a HUMIRA effective it don't that to the maybe been guidance access about, all about we of to it's Obviously, products, number or is X/X, your than is still the And I time-frame formulary of I plus the again. is is, think latest XXXX. be maintain priced? -XX%, talk And Rob, I guidance of the it we've laid tell It it the XX of enough the price, we care and about is X/X, part of slightly so will pretty And pretty doing believe formulary add? will

Rob Michael

but different. This Just and the a range. we as we're keep is you we a I reminder. very, mind an analog, very that as U.S. system is why mean, so gave that gave in Europe using

give we that X more more the in to market the communicating were mind more U.S. get to there on that the Europe. closer information and so as Keep 'XX, at And markets. coming biosimilars U.S. we'll saw with But we are specific will the obviously directional as guidance on be there based experience came time, biosimilars in we

different of very payer intensity, level landscape. a different it's also competitive a there's So but

So it's to something mind. in keep

Tim Anderson

you. Thank Okay.

Liz Shea

Tim. Thank question, please. Operator, next you,

Operator

BMO Thank you. It Gary comes Nachman Markets. from with Capital

Your line open, is sir.

Gary Nachman

recent on neuro A some couple wins. that morning. had Thanks. Good

stack how sit In X.X remind And Phase on close, hit the it matter the you how statistically not the confidence milligram maybe think full been those going year. bit And how that who first you dose, FDA, in was migrating, up that just into to So launch has competitively little has of Vraylar and at half reimbursement space? a the the studies Will just dataset, the and that on the first to initial lift, you study, and Botox rolled the but UBRELVY your next could X. will us the now gone X not more what in MDD. Vraylar X the dose, have on NDD the milligram you do significant. Phase said in quickly X about to then offering, you Thanks. but previous

Michael Severino

your part study highly X.XXX, with met significant that And Mike. out, you XXXX. evidence overall question, RA is the of in of in a MDD, NDD. I'll of that P-value and of of Okay. strength your that's first point shows and When in of P-value the small. take in terms described that The we medicine study, hit that clearly nominal we important the second Vraylar in and look question. part it didn't as was your of Jeff respect is P-value This With point then so will then same effect statistically milligram had overall the the you a very arm milligram study to take X.X to you overall. X around. at we And if significance, X.XXX, weight an but dose evidence

I'll that that it's remind depression the that very out medicines classes some study even and that lower read to And established in studies studies, have negative. have of many out that and that and favorable did study there either X we of of not small were comparisons, dose number nominal reach for a but Phase them group, there the trends positive efficacy some listeners with than are second quite significance were X.XX. across statistical Now, just were read out common were just p-values firmly

the positive were ago benefit. statistically to think in was both very did conducted ranges in clinically we prior it that today we trial important It that with study years significant, have so also dose X mind that that was a announced study keep several dosing, demonstrated And effect. titration. overall did is significant there was we that dose a that and a it's strong. show different that And -- that but the at also that look was of And upper that were significant studied meaningful ranges package

recent supportive way data X positive positive evidence So is X an overall package these you of is you I'd studies very like looked comfortable have in that and, not look we here. within say space, typically and weight studies case NDD that is of that's like important what is, if approvals long that look we ones described more and that's resulting. you the because lastly, overall approvals, there this study? do the in a are on that is at the amongst we approved feel in some agents the the at the time, other And common including other and And evidence, fact, convincingly adjunctive at have findings the a precedent, phase

And viable So overall stack will competitors. we to think we very it is a strong that package nicely has a up regulatory pathway.

So we're going regulatory shortly. those to begin discussions

to it Jeff. turn I'll without So over

Jeff Stewart

in market Mike. adjunctive market. that's opportunity thank for And similar for now, at million very a sizes, total the bipolar a MDD the meaningful to that market so it's you, Yeah, operate the it's for opportunity we very we Look, prescriptions sure. look about meaningful us. When XX

a of growing Vraylar Mike fairly very low got while what have agent. think I in was it's profile, competitive remember is think to why about the -- it's the If attractive, the that is the which you saying fasting -- terms we share,

very is if of psychiatrists minimal metabolic gentle very very profile, So doctors efficacy and this. I simple and viewed efficacy dosing weight the look very at competitive also that that the this very, care nicely tolerable, has think overall, approved, also the for and primary gain,

the of bipolar And attractive. depression. when episodes approved, if Vraylar So mixed depression very terms be to mania, spectrum an indication, full disease you the will that's potential the like adjunctive start it agent got see and across for in then

and we nice anticipate to So a overall add a here certainly nice catalyst Vraylar's profile.

Gary Nachman

to want the cover question. second you If

Jeff Stewart

Perfect. Yeah.

our The second QULIPTA, full question its we you just introduced early, QULIPTA. promotion. commercial the product had was with And very

and franchise of as remarks, in this important now franchise. we can force quarter, have dedicated what migraine sales this which think that a mentioned is you do with this we shows prepared I my how As we

What hear QULIPTA weeks our So first we and response of see few field We prevention. on strong. also of entire strength said that to efficacy And from and feedback launch is, is first, the very is said have and which our research simplicity launching before, very has there now I've and data, focused an UBRELVY. before QULIPTA sales out the our -- preventative qualitatively we high has early Mike in very, certainly from been end performance. the nice on the is for of very team

very our power. achieved day. XX% which dosing, A than terms is XX% physicians almost of have migraine And That's in decrease this patients in the in simple, days. very greater migraine Also, control. viewed in a trials a as Qulipta compelling XX% XXX% reduction once significant. days, So their like everyday complete of

feedback. early And things qualitative in so quite are of strong our terms

remember, prescriptions I will majority the as access until of to our quite ultimately, prescriptions the we're year, by the get the full ramp access, Ubrelvy, that anticipate about similar we market bridged as obviously do are the of ramp which should we you be a of our half confident U.S. we where in XX% mentioned, we achieved So first --

So positioning quite the again on that launch, AbbVie. for the think are competitive early and assets feedback together unique good we X

Liz Shea

question, Gary. you, next Thank please. Operator,

Operator

Stanley. Our Matthew question Harrison is with from next Morgan

Your open, sir. is line

Matthew Harrison

expecting that X. just good could you when inflammation a obviously obviously, about think pretty there. gene guess Obviously up little me. profile, competitor you to come impacting how inflammation self-limiting. questions. the be to though the have then for two proven because prophylactic a Great, market. secondly, novo they're If morning. more there transitions be your eye in if CGRP, how your in your on you there seem could where think curious, to are going about just of that has could patients, products Are about I'm patients Thanks. bit. a REGENXBIO, it just on you think comes source it do the just some de was as from did for confidence the long-term sometimes Thanks the I in than and follow to injectables I or you from. just you taking wondering talk the I'm sequelae. talk curious significant data going different you strategy other therapy I'm And more

Rick Gonzalez

Jeff lunge.

Jeff Stewart

thanks. one, I'll Yeah, first take the

So we in X primary source of source terms QULIPTA the to going business is business, of think from that areas.

research an favor the big early is, you'll in to think neurologists. the orals certainly of First of injectable QULIPTA. of start in feedback our favor specialists, absolutely trade-off and and see We the headache from that MABS the big

I this is as many MAB highlighted pill. wow viewed people think spontaneously very very have single cases, in looks some that oral it a strong a attractive. like In

that's So market a of share source of trade-off. in terms business

I lot don't going of of some write have older is and market amount of a the from a agents. that other care other physicians lot but -- a topiramate who high to on insight think write prescribing a we the are they certainly substantial MABS, primary calling generic that we

of opportunity the really the nature that see a from we so lean wider injectable that to And in a don't those, because source towards MABS of etc. also have unique we physicians audience

for balance think we and to of we're business have now. So a sources good quite going us two between right attractive that's those

Michael Severino

look strong data This the program the recent gives procedure. in about overall, data. weeks ago, and of encouraged lot is they control. of then that already us delivery. month delivery a can REGENX. program Phase clear very were But for If demonstrated sub-retinal in step data and the we several is more Mike. regarding have take back that we looked at very it by presented get and component suprachoroidal question durable a already recent that's shows And at approach, the take a And efficacy proof-of-concept that just the the ago, We're with I'll X.

in and seen generally but steroids started vasculitis, fact, can resolves a be dose that quite topical done lowest than is quite it with good that being reported the the of more in also If no that is efficacy no It's looks it's it's other seeing is in is method very specialized steroids, is at showing the that which And important of them required It's one that inflammation that a cohort, good. significant [Indiscernible] treated see has and anterior, exclusively already has used to [Indiscernible] anterior any which to We're without remember very is trials, readily its a rapidly. form in agents. delivery expected principally of in-office. there's difficulty, And no And first that, cohort, than form its signs inflammation. very before here. we to deliver sooner the results. and the promise. tolerability had also So been different Other It chamber chamber, nature with that there's injection, approaches that. frankly prophylactic study is injection. have is

inflammation nature just to felt be these of no the patients there's as who So brief observed. upfront no often needed responding are of mild not that's the prophylactic to steroids, very why given what's they're have prophylaxis reason in a given course And topical steroids. the being

it. confident So with agents. familiar been as with described. And it's them different I are retinal has in from obviously seen the talked feel supportive views very we've program, quite we're what than very we've just who of and And are to what we well specialists other the qualitatively again, heard

Liz Shea

Matthew. please. you, question, Thank Operator, next

Operator

Thank you.

Our Scala with next question is Cowen. from Steve

line Your sir. open, is

Steve Scala

question. you with you're I follow-ups. of new FDA say of would AbbVie That's have and regarding label questions, line what RINVOQ's in with tone you. the in you few describe would an FDA nature How statement pleased is a to had RA, a couple Thank going, the obvious at the outcome the in the conversations with or this outcome unclear are is first things the sending how September? it's juncture,

but shown question: placebo you. establish as the superiority has lower a Second How Vraylar MDD not generics then alternatives? would thoughts cost knowledge, To to AbbVie And relative any on Thank given closing? MDD. acquisition to presence of in Soliton my lastly, it agent its leading

Michael Severino

translates then I would to as those the are being label, to FDA your conversations labeling early regarding discussions for RINVOQ, I in describe productive respect the Rick would question around the productive. is is This as announced characterize them I I'll Soliton. case assume September, take about they start as indications but With language. And and With RA very the back the well. would the through conceptually of will working question how Mike. respect with Okay. what we base that of And discussions the other the specifics productive are into well. very positive specifically tone as

not the for done And With remain so earlier those this the very confident superiority all files respect They this period we this mentioned is particularly of disorder are Vraylar, space. with typically head-to-head depressive three impact I depressive studies treatment classes in because to call, in in challenging. as established space, disorder. an new and of major It is major very for are in show indications challenging even them. in adjunctive this to

So antipsychotics these our of with in are most patients and space. an Vraylar, current agents one therapies, pharmacology require used the this and who aren't responding commonly to atypical similar add-on the to

will study, we described, well we study that think that data earlier be marketplace. fact strong as evidence to the the we the that have we have very it in position competitive that prior very So and from supportive the well from

Jeff Stewart

And Steve, Jeff. it's

about terms a think still market. Vraylar you in are point, billion the size but of growth generics. Just way Mike's most they to the in have area. still the marketplace, is just MDD, high-value the think would nice you of approaches for step low of some in or cases it these It's in other still is the if We the markets has X.X The and don't that that commercial share, business share so $X.X about there a just our two you're the very to is going fragile, on with work now problem approval a opportunity. patients anticipate anti-psychotic therapy through one build new respond already of When well. That's today. approaching stepped

Steve Scala

Alright, thanks.

Rick Gonzalez

that for third as in area. FTC's at tone responding said the more position of to This to the competitive areas. so And the on there's is reduce Soliton, not is where now Company a specific to that, to a you contouring. have Obviously, to this interested are with We our stool particular why enhancing in area a the so overlap in any of focused So just in inquiry. kind point Rick, we request. area. tend don't On CoolSculpting, Maybe a areas, reduction it we of approval. Having designed We that's on fit would in muscle expect asset cellulite. to in the the this We and I CoolTones did more leg and in I bit this future. some and is believe be going expect it this this you we're can't tell period is a second at Steve. frame good to positive but of targeted the announced submitted a over body CoolTones. a specific market look intention fat here acquire We major we stage date, know, time -- well, outcome have reasonably would receive of here. is resolved a cellulite focused CoolSculpting obviously

Steve Scala

you. Thank

Liz Shea

Thank, next please. Operator, you, Steve. question,

Operator

Thank you.

Vamil Securities. Our next from with question is Mizuho Divan

Your open. is line

Vamil Divan

much my question. so taking for Thanks Great.

up following on more the just comments. X So Vraylar on maybe just other

just of confident products agents being be development development, the so you've just other second for your maybe hitting there. broader if you about seen Is you're just then curious that the that RINVOQ oral business still back there, in and disclosed to you've I the that outlook. on one, the that pretty priorities BD you. immunology? might lines thinking changed multi-billion-dollar in I'm of type at look still you're today? in need about thinking it talked how landscape think about as But that MDD. Thank going specifically maybe data that's The sounds any now sort before And like obvious opportunity you're

Rick Gonzalez

Yes, Jeff.

Jeff Stewart

Yeah.

sizes if as the highlighted, I think same. the at are you the roughly -- that look I market

bit and different the bit is competitive is little quite set different. context competitive the a However, a

we it to approach do it important So opportunity an look it. an incremental we low -- and if can at that be drive it's incremental think an share, exciting Vraylar dollar to that We as incremental the multibillion were we even again that approved. view guidance with that catalyst,

Michael Severino

take Mike. question. this So is Rinvoq I'll the

Rinvoq yes, are yet talked indications And indication, have overall. and new not on as about as are we IBD confident where the molecule review. those like progress indications, in have that data, submitted the very So a we under We've both but pointed the you RA in out, the indications. our confidence

our feel of to And and be treatment armamentarium going the it's going so an that important portfolio, we forward. part

always where best are that, is for area the we to the an having immunology scouring So said landscape opportunities. look

we will So I raise of new approach, the that indications like changed on standard areas, for the of already changed and treatment bar number look care. in wouldn't are lupus but continue that have current where or to novel say it's our any areas can indications therapies playing Across we fewer way our a focus the scleroderma. and options,

the changed So strategy not that has RINVOQ in anyway. situation

Liz Shea

Thanks, Vamil. Operator, we'll please. question, take the next

Operator

Gal Bernstein. Thank you. Ronny It's from with

line Your sir. is open,

Ronny Gal

couple got questions. a and of taking a morning my I've clarification you questions. then for and thank Good

is case about Rick, still it's things going this Alphatec this difference. the the if in marketplace? from First, a of hearing a are is take timing acceleration have matter And District position HUMIRA. not Then out-of-pocket bill to bit actually from might the include second Do I will think you be are draft regarding large payers. here What if the seen the hearing the to clarify is reduction year Medicare. just still first decision you We're interchangeability of about what infrastructure We clauses. quite be the your this? questions AbbVie's regarding question last want the or two does and makes it included. costs mentioned we've on for context, I Court from And given is, still this appeal, in the different this

you comment AbbVie's it have included, this might impact expect to issue, If you can on on and do be business. the it

Rick Gonzalez

are we our will this have can we confident a the players have highly been to going some what position is multiple On this tell biosimilar What these is confidential, has I'm IP with of Ronny, specifics delve other into mean, Rick. in we Alvotech, times prevail. of high degree and said with obviously you I before. not that that IP. those. I around I This confidence we challenged agreements So are the

it's a I hypothetical -- I lot scenario, So think I but don't wouldn't obviously give a merit. it of

discussed does described they ago, that to we've a a couple we from It biosimilars. going built or so be to assume were some as of previously, standpoint that X s year-and-a-half ago, a matter that erosion HUMIRA interchangeable model when on the we years or we did point pricing at Second certainly interchangeable extent.

I an what it will think it's we have impact consistent had So assumed. but with

fluid provided On would And truly essentially understand we little you, that forecast very you. pricing are. in it's a the exactly U.S., I a so estimates drug provided we that where It's the taken the in say consideration we've that situation. and we to difficult into

to a that most is think will in would will cash patients, deal came repeal because something we You -- reducing And about are Look, the period role costs Medicare And period as think the the can as we that of didn't before, industry that I patients, hope talked of at focused these it and that over to a we time flow difference our of easier about time -- a play think to that them that that, of And make back we them one making lower else. that making correct, you if look things they framework XX-month make rule on a spread this out-of-pocket the much [Indiscernible] for think the things participants. for out yesterday we've for talk would issue said out-of-pocket with. the being patients. get we're costs rebate and is eliminated. fundamental on we

Liz Shea

question, Thank you, Ronny. please. next Operator,

Operator

Thank you.

next with of is Geoff America. Meacham Our from question Bank

line open, sir. Your is

Geoff Meacham

play of of question. on think scenarios what an box, Great. more with TNF informs of have just the guys. just items quick it's duration. Hey could that dose, follow-up probably or Rinvoq. than for about but you out labeling know The on I a ones, a X for or impact those and there one lot, so assumptions. limit Thanks I any number asked been any much have to respect your language on trying that others. just the has black or I'm requirement, maybe Is to Mike. --

larger is for look that you're looking on Thanks the a cystic much. you to size, justify X. data When upcoming proof-of-concept or fibrosis. to Phase question profile moving there a that scale would readout, second minimal The effect so

Michael Severino

for therapy, I in dimensions September. all are patients is agency RINVOQ around updates inadequate all files, not these ration applies immunology the we of factors about those a file, atopic example, the on And feel the the but rheumatology will are of the the into agents around the And we And both in two comments that that then files of those atopic some labeling make dermatitis. in have would They of really and about their to degree the some this. specific agency RA. case for that to and of TNFs safety of indications, translate doses have atopic terms similar two a they other CF. the the certain in our risk dermatitis dermatitis just warnings. based fact black same how And in our We What not and response of first in translate would treat the are are those for That base It's program. Updating question case in that say restriction take not principally assumptions in that base label space. not the conditions dose principally forms other all to course, in then those is are because have in at limit we're on section warnings benefit RINVOQ, part any communication into to some because the of TNS the the considering. we've language same box anticipate what RINVOQ described demonstrated the indications, I the announced TNF have the all how question single that of example. they case. then care used base agents confident in standard that in our

a it's label and demonstrated And feel very looking those confident So to the is discussions into looking an space that that that those be to do already market. group that so at would in we're very for the other looking only get But meaningful but for other what ourselves our has good out striving number compared patients might gone with an right will how product real like the in this what's of what now dimensions marketed about are the sound forward, put files to to translated would come feel against. something we can and I a has the for in small competitor, efficacy that's what programs. indications. we're A be we're benefit there advantage think good say Those of small absolute we about the at in principal efficacy how number you'd we've this then again, FEVX when points have With into was time for, concepts what minimum, we is have with date. not benchmark benefit principal absolute it respect as we're FEVX points. out at to of translate agents Obviously something CF advantages. disease. just much, absolute there, that have Vertex

Liz Shea

please. Operator, Jeff. you, next Thank question,

Operator

Thank you.

Luisa Our Hector next with question is from Berenberg.

open, is ma'am. Your line

Luisa Hector

Thank you. Good morning.

filing. Thank in that new update bit way new Is first RA the in that's indications more on resolved just whether I then the RA Or the understand acceptance a of free in sorry. on indications. gating I on being is to is outstanding? a RA the filing accepted more And be a label then label the happen day? on approvals the be RINVOQ. and there's still you. update? to item then to UC done the looking work same as the And essentially dependent have couple all the or while still updates wanted for the to still And any label filing the can

Michael Severino

take I'll X questions. Mike. is This those

those and are reviews, what And the other I update, to of the words, respect are ongoing level simultaneously. understand because that of the translate under the label you our is in indications that with warnings of indications because applies is there new the RA In to across to the on will interdependence. land, So label other some need the say review would where elements, we around the molecule going and indications. the like U.S. precautions, some RA label will get X discussions for over all the

follow getting expect in of why to that's atopic succession, interdependency, RA detail, update or Whether factor. filings a with it's call think day some there's after resolved very gating in that would happen update. reasonable psoriatic fine So the I label is that we arthritis a label could the dermatitis level close same and but it early the to too on time-frame

which As new the submission, is indications. I ankylosing three spondylitis mentioned, we're smallest adding data to of the the

acceptance respect that file, of And file file any you it can significant we've is RA to the safety when update we're would the label deficiencies. slightly new so is at not them to confident data agency any critical SEC are very RA we anticipate a agency have update at reviews a is, data. sufficient might submitted, course, filings, look acceptance. to challenges any the And they What not path on in the And one looks in provided for With the as time-frame there an review, evaluate different those the label that format be acceptance. that file so in the appropriate is that not they for there. factor way file gating on

Liz Shea

please. Thank you, question next Luisa. Operator,

Operator

you. Thank

Our is Sandler. with Chris Raymond Piper next question from

open. is line Your

Allie Braculon

This question. morning. Braculon good is for taking Chris. Hi, Allie for Thanks the

-XXX just hallucination discontinuation the just ABBV findings could how and treatment X your of did Parkinson's, you rate. think, against up particularly how real-world from Thanks. on this that those put translate psychosis in So profile Basically, Phase XXX. we're use some safety the I and safety hoping expectations stack trial of into imbalance the and in XX%, could context,

Michael Severino

essentially Mike. controlling the our data. measures, who their to disease is other keep agent transformative expectations, our There take have expectations data and I'll important efficacy, delivers we're difficult have all very is for question. is Parkinson's through extremely strong it to safety with this important So pleased respect matches control within that XXX, very, to the across in patients What's difficult With mind very is to very to the a and this areas. benefit time disease.

with example, or with For other orals approaches.

delivering group, to that We treatment be currently in rate With got tolerability degree data, with oral Levodopa we know that to like which more respect are driven it's insulin Parkinson's common This with titrated because devices and technical doesn't circumstances. a can Or principally because be that which by can With is similar what say and and issues that's that shows Carbidopa erythema falls subset than essentially of the We The mobility our in were used treatments cases, efficacy I be populations group discontinuation Carbidopa Carbidopa with difficulty many line it's rate and be know always with like Again, usability in patients of other are see proportion I And the a in think matches discontinuations, falls. patients. very would evidenced done Levodopa of Levodopa big range would point pump our overall and advanced And so that dexterity issues or is had And a has picture there's way any get of which overall to effective expectations. mechanism. very looked so you opportunity what of clinical change only eye similar that these mind those to conditions. how that under in that older disease devices can what on who this population. across that hallucinations. control find because methods. discontinuation of have that delivered. Most can population, we that to these And something rates using a through direction. site keep treatment managed. a with and advanced that and context. were devices. reactions, either here more is injection something at local treatment similar insulin control, limited there's and those patient the in other limited a be to see device they are is what in and The discontinuations, to the is small Parkinson's is the And very similar you are that very lower of it's oral large a respect in pump-like very,

When like tube and translate a and we a need the efficacy world. therapies very keep much keep significant into brain will DUOPA, disease. and we that the and of in very that to transformative, which real-world very, at types threaded small the that these that overall mind segment will approach use, control translate the in Therapies delivers very with they less all actually to we've attractive how this us we ones to stimulation need think that look mind. again that can So we strong into are very access use. efficacy think the profiles is measures. deep And that delivered, invasive population, only will their effectively gastric takes impact is which surgical into other real small very This bow get that broad

Liz Shea

Thanks, Allie. Operator, X time final for have question. we

Operator

from will Evercore That with come Schimmer Josh ISI.

line Your is open, sir.

Josh Schimmer

you're now contracting Can more Thank in think extend in there's significant your be And and then XXXX. guidance going the migraine for on with be year reason it's to me surprised to contracts squeezing to plateau about you Any season in. for you. Thanks think able you the to years already. Humira, given I'm with trajectory not extend lock talk you'll bullish franchise, for ahead. XXXX, or to either the to next a the current multi-year whether to payers strong

Jeff Stewart

Jeff. it's Hi, Yes.

So X-year for can multiyear the year. contracts following those typically, when year contracts, And with be -- we spring in start maybe contract. the the typically the to of payers negotiate

depending 'XX how 'XX how the shaping posture work payers where So of some we'll Rick and really probably over out. the Rob and we'll things the more season that's guidance things on and have said, those are have up for possibly as

not we're quite yet. So there

say quite cycles, of in is portfolio I terms I where in general described in be that to think on of for the our terms we're that going timing based what 'XX. certainly I confident can we're

be theoretical us could oral neurotech have of prescriptions. to pace, continues on see based cardiovascular a of to or would other go. clear grow way clearly It's Right a far. some It's segment. orals. how with a UBRELVY really will because the of -- probably off look, terms a these How still are and the little quite of you issues. maybe market QULIPTA, is you XX% market CGRP in development run that can very if in at the particularly upwards of that you both And some acute In size. that that But early maybe the to agents of to start. for early Triptan's peak preventative it's a I investment new segment XX% total level, the tell have certainly the still all we run for issues of sort like And or X oral They run we comfortable feel in pace? and only market good and these QULIPTA sure, terms orals so MABS determine now encouraging though will the it. particularly, tripled the you've we in of really seen opportunity with XX% market and billion-dollar behind both

Liz Shea

Thanks, that today's call. concludes And Josh. conference

call, visit for Thanks us. If abbVie.com. at a you website the replay would to our of investors. joining like please to listen again

Operator

conclude We call. for all thank does today's participating. you This conference

day. rest disconnect You may and now a your of great have

AbbVie (ABBV) 29 Oct 212021 Q3 Earnings call transcript