ABBV - Earnings call transcript Q3 2017

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Operator

Good morning and thank you all for holding. Welcome to the AbbVie third quarter 2017 earnings conference call. All participants will be able to listen only until the question-and-answer portion of this call. I would like to remind all parties today's call is being recorded.

If you have any objections, please disconnect at this time. to like now would introduce Ms. I Vice Shea, President of Relations. Investor Liz

Elizabeth Shea

and Vice President and Officer; President Good with joining of us. the me Chief Finance you Also for Bill are: Development Executive Michael morning Executive Chief Gonzalez, Scientific Board of Research thank and Officer. Rick Chase, on Chief and of Chairman Financial Severino, Officer; today and the & call Executive Vice

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

call, factors with conference measures any our understand performance. to as today, the from AbbVie's XX-K found on Report may or AbbVie undertakes earnings to our non-GAAP that XXXX subsequent required and of be operations no business on other the are financial measures past, today's website. filings. developments, financial will help be affect ongoing On law. These as Form our in measures events regulatory except is by SEC filings financial revisions about as obligation investors information comparable forward-looking publicly Additional statements included non-GAAP GAAP used reconciled a to Annual in release in result which and our can in AbbVie's release

supplement morning. the we'll issued we investors.abbvie.com on this website have of morning, also In content that slides addition our this to news posted at be covering release the some

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

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

Richard A. Gonzalez

an the you and objectives. call more provide at And discuss and the everyone, third results per morning. outstanding delivered quarter financial provide XX.X% operational and Liz. update and our earnings of walk Then, us ample briefly always, answer covering Mike with be year. Adjusted performance you Bill detail. for expectations. the you, quarter strategic this questions. to Thank highlights, our of in time two on topics. will I'll through We were morning, joining Good last up as I'll we'll and Today, versus end $X.XX, performance, quarter of ahead company's long-term your we'll the share another thank

our also with operational growth nearly of delivered operational in of number our quarter versus driven includes the products and at year-to-date global the growth with IMBRUVICA, performance, strong We XX% growth reflecting on X.X%, we to This midpoint. by Based top line strong our prior in sales the results to are EPS which more of guidance XX.X% portfolio. grew a year. of HUMIRA, than XX%, $X.XX sales raising full-year $X.XX, XXXX

the intellectual biosimilar biosimilar of XXXX least global believe the with their until will over HUMIRA. During competition timeframe. all property-related this our Amgen strength announced We're resolution HUMIRA U.S. at the not our to we portfolio that we demonstrates the the confidence and which pleased demonstrates IP of further we with see in quarter, direct litigation settlement,

significant encouraged grow from patients We're with programs, pipeline by that Importantly, therapies trial, color of RITUXAN additional key will a recent marketplace both commercialization range across readouts that allow the these within and treatment An to III The of which potential a differentiated illustrate highlights. the allow We've indication received with also evaluated to relapsed/refractory Phase with to particular, further an with in very the VENCLEXTA the for data will strong combination results risankizumab across robust We're around CLL, both few study establish pleased strong us made have conditions. of leadership for the already Breakthrough upadacitinib MURANO positive this to agents advancements we our in assets. position. immune-mediated the which very Mike be provide and with late-stage a growth based for of unblind our made an regulatory mention recommendation MURANO best-in-class established HUMIRA. will be immunology the late-stage reviewed applications. and Therapy full these will therapies Designation. numerous forward we've the of trial strong of data and the the committee upcoming progress moving highly trajectory. presented assets medical several I'll In XXXX results. in independent strong results number of study pipeline briefly monitoring a on The enter with but the we're the meeting,

decade. This we agency for granted the determines been in Priority announced Finally, FDA have over improvements the shortens this significant we status, Review have well a of review There no received the provide new safety to to and potential a treatment of medicines endometriosis. in morning which is elagolix pain for serious effectiveness in endometriosis-associated the disease. period, treatments

this approved, treatment performance, strong operational, condition and patient for elagolix we R&D outstanding our if summary, demonstrate and represent painful execution. In to an important by continue will option So population. commercial, driven underserved

and delivered I'll the We call discuss comments. over strategic for our financial With our our making and outlook on to results, turn Bill's we're strong I'll XXXX financial and and provide an long-term Mike. pipeline. have in that, significant following objectives update advancements Mike

Michael E. Severino, M.D.

update, milestones just I'll Rick. highlighting order brief, to In prepared quarter. of few the keep time from our a remarks the my you, strategic Thank for allow noteworthy

and we significant results across pipeline. As reported In we've make progress to Rick several our continued mid from mentioned, late-stage trials. immunology,

we patients yesterday, XX% XX% compared superior of Stelara receiving these two receiving patients HUMIRA. leading and top In both the risankizumab versus of biologics, with achieved three clearance ultIMMa-X studies trials, in positive and evaluating results risankizumab treatment Data risankizumab studies and Stelara, XX demonstrated XX% from ultIMMa-X line announced psoriasis. skin Just Phase from PASI III trials respectively. in to

achieved Stelara, patients and achieving treated of XXX skin particularly in one these XX% many skin risankizumab and full the year, demonstrated ultIMMa-X compared studies. as encouraged in durable risankizumab with two to the PASI rates We are twice XX% of by clearance ultIMMa-X At respectively. clearance roughly patients with

in to saw this of of rates skin efficacy risankizumab's also evaluate IMMvent with XX PASI responder study to HUMIRA very of risankizumab's clearance growing who of seeing who demonstrating treated And, of from next with demonstrating population. the this the to efficacy weeks in to an forward the risankizumab portion response patients, portion trial risankizumab in response psoriasis HUMIRA, XX% program. pivotal the XX, TNF superior after inadequate in risankizumab inadequate data to were we HUMIRA. year or to with XX% HUMIRA. to inadequate patients had compared re-randomized HUMIRA. In a continued We look trial, potential achieved patients high We Within designed these rates an the the study, study, with compared remaining

with expected in XXXX, for track on is submission XXXX. regulatory commercialization Our

similar the Moving to our the trial, primary JAKX results studies, now secondary adequately Phase response in III oral more biologic in did second six for efficacy and which in study. patients development observed endpoints we at this ACRXX, of drove through week drove clinical respond response selective to In upadacitinib, levels on clinical our remission. of and population, from activity, inhibitor, ACRXX, efficacy of typically difficult-to-treat it indications. DMARDs, this doses bio-naive both We of more ACRXX. low refractory Last ranked as very or levels and evaluated high to were Upadacitinib such more importantly, top line patient-sustained stringent endpoints, intolerant announced XX SELECT-BEYOND levels month disease response all of upadacitinib not who DAS at strong patients. But XX. met week saw

significant investor to be are that PE aware and DVT of interest continues there rates. We the topic regarding event

RA earnings call, the across last upadacitinib rate our signal, program program rate have stated of in and As not population. we in program comprehensive we III consider that monitoring anything in DVT our and we and place background expected have on with is for the a consistent PE the a observed Phase an

rates characterize we than program core trials upadacitinib-treated Evaluation it comparisons read inaccurate rates have event more context can desire X,XXX to of the rates to designed unblinded in event mind the with the background to on our database have patients. upadacitinib studies potential control be for in program The based appreciate safety upadacitinib, subset individual While a or to keep is of in and comprehensive rates that important expected events estimates out. must be of is overall misleading. a to and once groups provide and done the

cannot time. groups of control the trials, premature across have data two database data we remains from as rates compare we and which reported that event not present six the and studies of and that any from or is that integrity calculate could providing Furthermore, fact will impact trials of rates the majority our attempt view ongoing at to something upadacitinib these do. registrational blinded, obviously Given unblinded our the we

investing PEs in to program, The modification. heightened an and or monitoring proceed advancing with safety in and monitoring for obviously internal has the confident to consistent and patient confidence. to indications with order DMC, DVTs this independent in and safety. data, the ensure that are also basis. from all for data our multiple in of place is ongoing without unblinded made upadacitinib is aware a recommendation in have to addition safety access has The data on it In and including monitors upadacitinib program, we DMC committee, an DMC program the setting consistently very in interest We the in manner remain our

two dermatitis, from week demonstrating results demonstrating Phase saw weeks upadacitinib with III data, II achieved strong to reported rapid in pruritus efficacy or doses first recently to plan a the times, half skin across response in Based Roughly for in of positive improvement also and we week the on very these skin compared XXXX. very the the reduction in half We in of lesions placebo. within doses. study in by all atopic first lesions first line all upadacitinib the Phase greater into trial, we within studies XX% In top upadacitinib advance improvement dermatitis XX. atopic patients

for oncology, lines end VENCLEXTA patients data indicating progression-free in the for update combination label we which Moving quarter, trial compared medical IMBRUVICA we RITUXAN, met therapy. DMC from combination of recommended SHINE the in And an from reported expect efficacy, now if for disease survival population. third the detailed regulatory for study patient the relapsed/refractory this application for regimen plan the that of chronic our the with with and we the present one to III will findings graft-versus-host a CLL meeting, upcoming use regulatory we Phase MURANO quarter, and an of Also prolonged data in the endpoint CLL at broader standard more cell significantly population. of the demonstrating in of study support bendamustine this a the to RITUXAN mantle that of of third of in in We trial use year in primary interim failure unblind a to in the the lymphoma, front-line IMBRUVICA in analysis the after support before approval received would systemic relapsed/refractory the or successful study indication.

our We make tumor are continue XX as Phase in good have we of with solid the to studies. XX currently solid in well, tumor I which assets progress than more clinic, efforts where

We At tumors. ESMO presented last these the have from over forward started to the readouts seeing in mature look from to early many next month, of data we we study neuroendocrine data and months. programs, data XX BASKET early as Rova-T several more XX

data responses cancer. tumors showed reduction tumor the and the are which we encouraged lung are While confirmed beyond cell small burden findings, very by early, solid in in

and study well. III TRINITY, cancer, continues lung study or greater in studies in front-line TAHOE our MERU the third-line Rova-T study now registrational the to cancer progress in well also to both progress, setting underway. small-cell Phase Our the the in lung second-line continue setting small-cell with

actively in see We for available regulators. where for have to support are This final is the used data engaged of study the programs XXXX. to single-arm not our we regulatory in we the our order six-month FDA from development moved unusual discussions will feedback they six-month analysis As data we've durability as TRINITY second the the quarter request. in recently studies year with package. We part being forthcoming like submission that next to that FDA's data been regulatory prepare meet would received of request the Therefore, anticipate to of in approval. be second quarter submissions,

from area to follow submitted early We the our continue this elagolix U.S., received a Review women approvals And regulatory treatment of in and area we the regulatory the endometriosis-associated in quarter, for third virology, Europe, Japan received the suffering our that application announced regulatory submission In for morning, designation a of MAVYRET. we health, Priority to thereafter. shortly from we women's as the in And pain. for FDA. expect we

been already months, the also on additional the that, Bill? With several coming XXXX Bill our we milestones year. and has call a be I'll quarter very While development third and seeing XXXX to a to date milestone-filled will anticipate eventful for comments productive in year, over clinical performance. additional turn

William J. Chase

Thanks, Mike.

the XX% We was up $X XX.X%, compared also and are net in exchange. the the remains front-line XX X.X% product on mid-single-digit revenues basis in point rate Global third second-line-plus than third set the quarter the equity continues prescription experience, in prior and operating with $XXX growth billion, We Adjusted our first-line were reflecting quarter lines International categories some operationally impact quarters. HUMIRA's all the from sales HUMIRA global prior the the X.X% Global pleased XXXX. the operationally, Wholesaler market There quarter adjusted due in patient broad revenues up and million. CLL versus sales margin $X.XX, results. were sales The therapy, operational our demand. of CLL the $X.X position. with HUMIRA EPS midpoint of also net basis. unique of by drive favorable quarter market in share the were market third share of a and reflected uptake reported patterns therapeutic up benefit $XXX leader XX% month to up approaching remains to very $X.XX competition. setting. in were Total below by XXXX. XX.X% third earnings strong divestiture sales per leader foreign quarter strong XX.X% quarter from versus across billion indications, across X.X up related was with favorable undisputed range of all physician a IMBRUVICA exceeded of $X.X an XXXX quarter ordering inventory in With excluding guidance in the contribution. quarter, all third strong HCV and of of nearly of IMBRUVICA growth more benefit over in profile driven dynamics. total customer despite continued were year. million, XX% levels XX% in were growth the billion, price to U.S. share its an profile, years $X.XX in

quarter the the regulatory During received in MAVYRET, Europe, for our next-generation HCV Japan. we U.S., approval offering and

of grew been its globally, has sales pleased early for the feedback initial of favorable. Parkinson's our are sales on in we the Global on physician our very MAVYRET While operational an stages million quarter. launch, in still product we've been basis approached uptake in with disease, and therapy quarter. XX% $XXX the Global of Duodopa, advanced the

the quarter, of sales prior driven sales the year, points XX.X% inclusive $XXX prior Net We despite and profile the contribution Reviewing from interest adjusted sales, an leverage margin XX.X% a in dilutive and SG&A increase of The Adjusted basis pipeline. year, slightly the sales and gross the year, the basis R&D accounting. XX in was impact was prior up Creon XX% million, XX expense to the was to This reflecting points sales, the third of basis Adjusted favorable margin an quarter. down spending funding percentage XX.X% was basis operating third versus Synagis. rate was was over in the XX% points saw strong quarter XX.X% adjusted of related tax partnership of improvement sales. of for R&D a increased adjusted in points prior XX growth in as year. versus XX quarter, efficiencies. the by P&L was of operational also of compared the of

year. year excluding was $X.XX, adjusted expense over intangible other earnings amortization and items per specified share XX.X% up Third quarter

Turning our share, to share as amortization midpoint. to are Rick per range full-year guidance This we the full-year adjusted growth at raising $X.XX to EPS specified $X.XX items. other mentioned, and XX.X% per of guidance, representing $X.XX non-cash of excludes

the guidance updated GAAP full-year risankizumab Our milestone reflect program. recent progress been on overall and has payments to

growth HUMIRA to foreign operational growth line we top a the In growth on global full-year to impact continue XX%, forecast teens. sales contemplates minimal approaching expect full-year basis. HUMIRA This with forecast the high U.S., mid full-year the to in continue mid-teens. We currency approaching from operational

expect For the on on in achieve an the to our January operational international we sales basis mid-single guidance track sales outlined full-year to growth the be in both remain digits. And for HUMIRA, reported that we and full-year other across products we portfolio.

approximately continue XX.X% We forecast gross XX.X%. a sales full-year margin to of margin to percentage be as be operating and to

billion, We expense approximately approximately XX%. we also of interest $X expect continue adjusted to the net expect tax full-year to rate and be

guidance other between of represents EPS we share For $X.XX growth and the expect roughly at adjusted per earnings This items, year-over-year quarter, the non-cash and excludes midpoint. fourth which XX.X% $X.XX. of $X.XX adjusted specified amortization

performance We of XX%. to closing, expect impact exchange sales the in growth In our sales continuing the our reported expect revenue And turn would X% successfully pleased And with on I'll top-tier our have fourth quarter, over call strategy. and quarter. at growth EPS executing Rick. quarter back on advance are and exchange we long-term strong we to approximately delivering operational pipeline foreign rates, favorable to a the with that, current in growth fourth while

Richard A. Gonzalez

section apologize Thank advance. I'll fairly long. All right. you, This Bill. in is

we reminder, for are slide to intended a website. supplemental have our to be today's posted resource These As a slides call. a presentation

slides. financial that my company objective biopharmaceutical performance a top-tier our delivered demonstrating prepared our remarks been financial When in our years, was objective. last as a over have with how consistently the we we performance, of top-tier way, However, will at capable long organization over commitments. shown an goals the last very just created and tracking of how that communicated level. we we five while company. objectives, obstacles designed meeting five our over that a Along have And we've the consistently investors We've intend sharing exceeding we still or the taken high also to ability term. years the The consistently is support launched overcome of against actions to high-performing to our build these directly have and to not a capable execute our follow we're have beginning XXXX, AbbVie strategy delivering executing on challenges

group back years, companies past our performed last total of two our we over three measuring date, one periods. evaluate whether over the performance every look years, of in first peer past year, versus four has years, performance second we and return five years, or AbbVie the our As and those in that EPS growth and we're nearly growth or to launch pleased revenue XX shareholder

We guidance have met in or becoming since XX XX in our all EPS guidance quarters public quarters. exceeded company, exceeding a our

To cash to company a that Additionally, in term. a shareholder it and exceptional same of we simply this we boldly to shares. announced declared share shareholders than that beginning payable January in have more and a today robust over and increase delivered build of inception, dividend have isn't share with in $X.XX we've amount February per growth will XX%, XXXX, the of the from cash dividends repurchased of form buybacks. sustain end, dividend to long period, board share, grown return dividend in number acted pipeline the AbbVie significant returning $X.XX over was the we have we quarterly our of significant increase an an that per quarterly our our XXXX. Since XX%,

our prospects expectations our our biosimilars, our strategic pipeline. outlined in aspirations and XXXX, growth including long-term financial recall, through objectives, we around October you XXXX, AbbVie's for As and

nearly are our updates where plan to thought be the well that it against long-range appropriate. as five-year at provide of midpoint time as our period, helpful progress the Now we recap would we

on total and revenue with than XXXX. a to objectives annually, growth revenue we're forecasted to $XX remain deliver annual meeting to for on exceeding more growth XX.X% revenue be the to by reminder, revenue XXXX. we track Through committed growing we of XXXX, or XX%, As our growth approximately billion average

XXXX. billion We to by that also on projected the track $XX target HUMIRA we're sales exceed achieve Clearly, in would XXXX.

$X therapy. by will in billion will the now its remain strong $XX maintains leading billion IMBRUVICA continued such, to We we guided penetration, of confident revenues HUMIRA growth we as driven that biologic HUMIRA that in XXXX, expect we achieve front-line approach will sales target. be XXXX. and As that position as This

by IMBRUVICA. share at franchise acquisition, market or met revenue of have Our our projections guidance We and to time assumptions additional the the and XXXX. exceeded all for our committed we remain $X guided HCV of indication to approvals billion

we in allow still rest XXXX. ultimately on tracking the projection, and currently finally, XX.X% us We adjusted behind a within of a and we're next our grow objective. that regarding midst meeting our now growth deliver reduction the significantly of sales. track our forecasted market, continued to underlying remain will would and XX% than position process, view our achieve performance for the that has we're margin, exceeding target a line, level XXXX. double-digit it And HCV we burden, next-generation high-level based the strong or efficiency remain and any operating indicated of through we're annual the growing for year. the business We that by to And to driven from offset our by shortfall. top our remain the and improvements a our therapy, HCV strength peak-year EPS the operating Through position more a XXXX, programs. of in margin ongoing While average EPS significant will we We of confident annually, period are our EPS to track committed on five-year business, provide on of growth HUMIRA achieve confidence in royalty expectations MAVYRET, we planning committed delivering multibillion-dollar while of leverage on in to high on

growth revised our adjusted bottom for to AbbVie XXXX. EPS level we line guidance $X.XX XX% in industry positions XXXX, For to of the to XX% approximately growth midpoint be once among of from again representing This XXXX the range. growth $X.XX, expect of of leaders

years our commitment our as XXXX level EPS though, our the call. growth have sustain fourth an XXXX the long detailed earnings an to We'll performance demonstrated company independent the pipeline. ago. needs for company or Ultimately five adjusted exceeding we our midpoint over order inception. The since double since company reported AbbVie's like quarter performance ours significant of a We we meeting on has a our year is to in guidance guidance first of provide than independent objectives. delivered in became term, strong more this robust high

a attention have to assets of of the amount is that growth our pipeline spoken length tremendous over programs level about We've We pipeline that derisked ensuring industry-leading benefits. have our to focused a full performance deliver These drivers, and designed differentiated of term. high a fuel long collection where regulatory clinical of at with will we products confidence commercial patient and compelling are differentiated in late-stage profiles the of success. probability distinct innovative near-term

to As key we're XX we XX near-term over been our related past back each to that development we the drivers. of objectives successful have look growth in months, achieving pleased the

date to us respective that of their a confidence strong high successes these Our give achieve degree positions assets within markets. will competitive

will the developments, Based more virology, biosimilar focused of from played more direct segments until unmet areas significant immunology, dispute treating including in the a defining worldwide. we in pipeline decade integral at protect actively the standard indications care. XX of span settlement patent of with than assets we including healthcare, of portfolio of least stems from fit. XXXX. and an attractive our our U.S. most neuroscience, and confident unique or of remain immunology experience Amgen, developing have with where need, investments HUMIRA X HUMIRA in role and IP strategic leadership patients strong than competition on some AbbVie's oncology, Our recent for that areas million HUMIRA in has the other

to our strategy or competition, direct following of curve. believe a and Over enable its entry maintain manageable share will And erosion market meaningful the in HUMIRA next five strong the we U.S. whether growth. with continue years, biosimilar drive to the position internationally, HUMIRA meaningful will

to will As immunology our industry-leading underappreciated source of for is equally years company cash Another our portfolio remain yet pipeline. important HUMIRA a a flow come aspect for the significant of immunology many result,

potential have and significantly of risankizumab assets, standard the to pipeline late-stage two advance upadacitinib, each care. Our

therapy our HUMIRA single into commercialization assets, immunology from With anti-IL-XX areas, dermatitis. has these Risankizumab, will to move product franchise a the all from antibody diseases of broad to of efficacy, portfolio a that restate of across potential forthcoming dosing. a unmatched position monoclonal atopic set leadership the to therapies two of potential with effect, convenience providing and with potentially Boehringer evolve as an new the quarterly and licensed and a transformative such by our in durable of has of become a indications, the Ingelheim, immune-mediated number safety our current level

As with of and levels we results application our to mentioned, we're which week, pleased skin look Mike the strong demonstrated high this next reported we year. very Phase clearance, very forward III submitting regulatory

ulcerative III significant next believe III a colitis to just to approximately opportunity for I an and extremely reported billion AbbVie. estimate risankizumab potential in Crohn's with particularly where the start the highly the being is for is We there's strong outlined currently believe in inadequate to excited potential We option and in colitis, evaluated sales treatment asset's high Crohn's need. disease psoriasis, year. risankizumab We mid-stage Beyond track activity, data begin about in be disease, remission arthritis. endoscopic and a disease response where could population Phase an impressive represents risankizumab Crohn's and The unmet the a ulcerative is biologics, risankizumab XXXX. risankizumab important psoriatic this with in be program IBD segment Phase risankizumab patient four in nominal $X to response growing remain for indications scores. year, this and demonstrated on patients We program expected

favorably and secondary Phase key top six extremely both in studies results and profile to from other clinical levels studies reported disease results activity our has in which the RA. asset, meaningful now with development. late-stage immunology and therapy dermatology, development. could upadacitinib line Moving on We advantages to from a expected. in inhibitor and response upadacitinib, remission studies, late-stage all upadacitinib today Upadacitinib data drove first in meeting the the in primary be produced as inhibitors rheumatology, compare and very indications, development high strong are studies other our well III best-in-class This on offer to Upadacitinib endpoints, in the summer, from mid for oral RA previous over we JAKX selective and and pivotal with program safety JAK or two endpoints, of in a selective we in performed products has potential line the think market both GI.

see XXXX. XXXX in additional this and to expected in from data data study and more later pivotal regulatory trials year, We commercialization expect from with our two an submission

rapid Crohn's addition Crohn's with be reduction this In believe additional diseases. all results ulcerative and doses. positive across in top psoriatic further week billion skin novel the of doses we're and a weeks potential sales efficacy profile. All in will two atopic has clean begin high Based XXXX: growth IBD, with response immune-mediated strong saw believe dermatitis of broad advance market. on to recently very about be We're colitis, and dermatitis, we excited segment response similar safety disease, upadacitinib In across This the the products in We with six III by a into within nominal in show demonstrates within soon. II time, significant agent discontinuation promise we of this driver first studies and arthritis, across AbbVie, for endoscopic may the upadacitinib that impressive first and to first to half data, strong launch improvements ABT-XXX plan current in approximately where demonstrated JAKX five of XXXX. remission RA, line to we atopic within Phase all IBD, to holds ankylosing has we told, reported risankizumab, in atopic approach and scores rates, in $X.X range selective itch for the In a III studies Phase inhibition pleased these waning a the therapeutic a drug's demonstrating indications XXXX. in dermatitis, indications expect Phase results, disease, and this response potential and spondylitis.

remain multiple We've of combination. to of IMBRUVICA across high. mechanisms have new our transforming of that including one set of key relatively action oncology, assets, our has position and capable assets a vast the malignancies. hematological is unmet With VENCLEXTA, Despite Moving built alone needs already that emergence treatment that where now in to AbbVie treatments a strategic improved have portfolio is potential priorities by We're of strategic a and of AML, expand outcomes, multiple in blood other a in market as in in of non-Hodgkin's XXXX. ability conditions. cancers, other two and activity therapies a These market, and $XX billion medicines oncology of to wide range $XX and create cancers. us broad giving as to CLL, $XX leadership the alone extremely a range expected to strong position billion the demonstrating lymphomas, grow with billion by well are targeting XXXX myelomas strong combination today, hematological

the landscape, we're the our of hematological malignancies. in BTK establishing positioned foundational and drive portfolio, other and CLL continued therapies evolution Given treatment inhibition well to BcL-X as

of cancers. penetration data the transform IMBRUVICA, thereby goal the The growing coming patients therapies, in therapeutic CLL in achieve to other drive body both support malignancies long-term of combinations other and and control deeper increasing Our is driving growth durable, more novel to years. will and for blood responses. hematological label VENCLEXTA, in approach, expansion, of allowing therapies Through better we'll

multiple benefit non-Hodgkin's beyond in strong segments care. we've and and of Our the strong with and confidence patients treatment and additional in CLL first-line sustain market approved achieve is data CLL deletion potential truly a in expanding in diseases. our impressive XXp providing this exploring in IMBRUVICA's of IMBRUVICA lymphoma the and response the position by greater to second-line standard changed of indications We're these in both has the assets. paradigm durable stems from within gaining over seen ability a from leadership superior and already use strong momentum survival

in prior IMBRUVICA VENCLEXTA's and reported relapsed/refractory the to greater deletion $X including also positive with MURANO inhibitor. billion We've than and of response study months, combination combination another prolonged AbbVie. trial. on the program, sales where CLL showed difficult-to-treat data to the of from progression-free the made a RITUXAN to results, of offer has that with patients B-cell data to a line shown who and relapsed/refractory CLL. XXp rates from bringing seen relapsed/refractory the in forward with patients results populations, We we the for in an potential with results the CLL Analysis treatment Phase our treatment option outstanding new positive coming We broader patients look failed clinical has submit strong to population. to treatment this with patient plan continue VENCLEXTA the and monitoring receptor CLL, survival CLL expect unblind committee in therapy independent RITUXAN We the may regulatory strong which III VENCLEXTA recently recommendation versus high have application BR. market relapsed/refractory Based top

for time These the strong across potential AML, XXXX results, and seen AML. malignancies had billion. myeloma, Breakthrough cancers, that adding potential to in designations value VENCLEXTA's programs also Therapy where We including believe in two other hematological VENCLEXTA in three- have is start development significant supporting sales five-year promising in blood data we've indications $X horizon. approximately multiple the We nominal to multiple

and and in AbbVie for both solid leaders unmet We've made significant investments, that groundbreaking identify the a internally to partnered with priority in across field promising strong strategic Another of platforms, and need exist We've solid in significant efficacy, address advance establishing demonstrating foundation area. assets technology more is additional many trials externally, continues the therapies XX tumors. made human early this than XX to and several the signs into progress year. least in the to next tremendous clinical currently We advance years. and development, assets over have over to expect at tumor past we've

first-line early indications. and as we and cancer lung advance which of acquisition into asset of Rova-T development the opportunity other Rova-T attractive in a revenue provided was a our well small-cell platform. strategic Stemcentrx, a as investments represents multibillion-dollar AbbVie as highly One late-stage peak discovery

therapy. Ultimately, from over in of third-line the improvement in third-line XX% in data Recent and This see mentioned, in this showed regulatory is second study rates response at quarter to lung small-cell year, from I-O/I-O As both and second- thereafter. Mike the combinations soon Rova-T mid-single-digit we'll Small-cell application level indication results plan I-O submit next experts we the cancer devastating at cancer, for a meaningful objective our approach a have responses TRINITY is lung will response five-year progress and approximately in combination and demonstrate promising third-line-plus, where have levels of with prognosis. this the XX%. extremely ongoing in There monotherapy a been with Rova-T estimate be collaborations setting. and are data higher expected of to And I-O therapy has evaluate believe patients real-world are field currently data typical treatments, disease. poor no year. initial initially approved, next efficacy, and we is survival we X%. could in I-O the and the the There setting approved patients Rova-T

expression we in in Additionally, front-line advancing that studies and And suggests pancreatic, we're be these The tumor glioblastoma, a in useful melanoma, activity some prostate, in in Rova-T metastatic ongoing Rova-T's have the solid number tumors and studies settings. and tumors. second-line parallel, DLLX of other types. validate to colorectal of may

Beyond Rova-T, solid additional pipeline additional are and clinical others. it the lung development including cancer, programs, currently trials, covering which novel to acquisition a human ovarian in small-cell from among of tumors with of Stemcentrx seven also brought compounds colorectal cancer cancer

tumor In that continuing solid enter trials extend year. reach our from Stemcentrx to on pipeline, Going the to will early-stage advance each forward, track our new to human technologies three assets novel market. oncology we're we're explore in roughly

to programs the broaden to bi-specific For next-generation I-O we've therapies. designed We're close in with to using proximity elicit immuno-oncology responses of what including our deepen wave seen beyond and activation T-cell technology first novel cells. example, approaches, are tumor

forward studies clinic, several immuno-oncology next years. past data entered and to have the assets next-generation the year, over look the Over from four these we

early evidenced AbbVie our late-stage our major work, oncology. have next XX major and the by further and strategic commitment beyond, to driver As growth development and be years pipeline, clearly presence, Oncology a our we over on-market a for business. will discovery diversifying our

contraceptives a and conditions attractive such a medications. and and These options. elagolix through multibillion-dollar advancement chronic virology. In with AbbVie's believe large uterine women in fibroids, and treatment neuroscience, health, development highly new and of are and activity women with women's women treatment limited prevalent significant with elagolix markets for significant In underserved levels unsatisfied for oncology, pain. have to health, their oral We emerging a for opportunity our of immunology advancement addition and high-growth externally cycling to treat women's currently population neurodegenerative There focus as is and are potential are develop In pain and a represents represents rates for Parkinson's, other Alzheimer's, from injury. internally of we to ribavirin-free such and in efforts neurological as suffering potential We're pan-genotypic, dealing sclerosis. to millions investments represents the SVR cord medicine spinal genotypes strategy of AbbVie. investing and both AbbVie, evaluating mechanisms of endometriosis includes this has disease XXX% and therapies modification conditions in approaching Alzheimer's, recently for therapy multiple weeks therapy virology, degenerative translate patients. we which disease-modifying our launched to and Neuroscience anti-tau next-generation the eight area MS, across treatment, majority like RGMa, an MAVYRET, once-daily, HCV and including conditions, that with

and is feedback highly a is clinical our early, within physicians, from launch market. well, the profile that global strategy, While with product it's this on strong its progressing payers MAVYRET and patients, extremely positive competitive still our go-to-market confirming expectation

unique business and growth industry-leading business HUMIRA launch, achieved which Germany, returns. shareholder which the including market XX compelling platform, company, weeks shareholder provide industry-leading our pipelines the XXXX. our significant in pipeline components the its long-range both the will cornerstone where long beginning launched, immunology need. the term. these share view over areas own strong compounds with public meaningful development in after markets value. MAVYRET we in plan, HUMIRA over and marketed share evolution growth and investment, promising a unmet of channel. U.S. both late-stage forward most opportunity we've revenue have our attractive sales offering combination a late-stage our launch. market remain industry, assets predominantly uptake products and promising the our we of We in high-growth market products our of growth franchise. one of produce as to strong high for Clearly, position of our after from Internationally, look and two with our has driven represents growth R&D weeks a nine The over assets, MAVYRET contributions and in a of our There Just XX%, story of leadership robust of are position impressive AbbVie high the should market seen a we've XX% the achieved by to

in sales deliver approach expect degree And HUMIRA high continued our to $XX of performance. we confidence a in now have I XXXX. mentioned, ability We to strong billion HUMIRA as

Following pipeline and our share the generate beyond. cash will fund U.S., the of competition capital durable a to cash shareholders repurchase. with to will will return direct dividend position that a flow fuel curve. growing robust ability market through through and and and flows strong HUMIRA XXXX our provide in maintain These of our strong an biosimilar erosion to HUMIRA entry continue a manageable attractive we expect

a which attractive base has stable AbbVie platform AbbVie. business significant HUMIRA, Beyond pipeline, a for and highly a underappreciated represents growth

over of than our which of to This line top-tier derisked over of billion biosimilar years has next annual industry. sales by estimates, business, sustain new revenue more consensus be our peer growth XXXX, in a indication top our to quartile the five third competition. strength multiple to ranks Our projected late-stage Based our trajectory supporting product of and entry of the approximately on non-HUMIRA the XX%. pipeline, compound group, top the billion, our is expected growth while reflects AbbVie's reflecting direct to the P/E including bottom growth $XX of in growth ability grow currently $X.X despite in lower launches or almost today XXXX, is rate XX

our performance, consistent be room multiple So despite our stock valued shareholder the for significant strong for peers, strong to biotech our recent returns. P/E with still has top-tier potential expansion offering

build performance. when top-tier Our long-term delivering company launched a of we to was was biopharmaceutical AbbVie that capable high-performing objective

to performance We record our objectives, our investment or and with as are of we for management We the our achieved our a execution, company. we and coming have commitments our track we're investors. certainly prospects excited of with share team investors met engaging exceeded the and vision weeks going forward proud the in meet consistently and our about company that strategic AbbVie's community forward. to has look and proven We're a

outstanding on to shareholder high call a strategy With continue successfully in the ability deliver that, execute confidence have We value. and over to back Liz. to degree our our turn of long-term I'll

Elizabeth Shea

first Operator, Rick. call now Thanks, We'll please. for the question open questions.

Operator

first Jefferies. Jeff from Our is from today Holford question

Jeffrey Holford

much few everyone. questions. you. Hi, my for Thanks very I've ones quick a taking got for

reporting. off, competitor's and seemed the sudden one decline be your or around commentary to psoriatic psoriasis arthritis there. wondered on see of there other markets. I'm growth seen some a just sure that you not if first you'd the focus the of yesterday of the around of in deterioration market I Just growth like we've lot companies it in to the comment what

right there. you're elagolix, you launch. just what could not is note Then deck least XXXX? until is a $X you early competitors the know referred by looks impressive won't obviously can last in not then That's of there be just women of just of billion it with deck you than interesting, one you that is I through really which Priority there? that up. say that's in on Thanks endometriosis. be be kind through a the give below use really that But for think are probably the little know confident be background just year I rate XXXX epidemic, particularly you that said. XXXX, trending to opioid the be indicated very could to around what solution I at much. a Second, based on light confirm the steps you're the make this going which for the able more perhaps you're Review. the to on slide that's looking X.X, C, particularly to XXXX, And or in the and but support case bit very I we on out $X billion MAVYRET wondering labeling I'm what slide current the contracting to below having additional part just But based the in you those what rate opioid your numbers, hep upper seeing that rate to upadacitinib your of as other is you're end the of

Richard A. Gonzalez

you start don't the why then and maybe cover rate, other I'll Mike, three? the Okay. by talking about

Michael E. Severino, M.D.

Certainly.

we the data. So monitor we is on upadacitinib, that aggregate and the carefully, we've very look at what said program

the it's rate today we that. looking to our a we're blinded that when so data a important at manner and about data upadacitinib And entire can't because stage, a rate ongoing in monitor I database. And that I talking you across without and unblinded do give studies, this is understand can't

are background, aggregate that is the So aggregate true what talk rates that the And that around rates. consistent we've with in what are background. background, variability remains what is said those X.X. said I'll do but I'll we about and there's estimates And those

program that It that that that we all And consider a us are statements hasn't signal. so still we've that our we seen changed also haven't And monitoring made hasn't the of anything the changed. tells holding. aggregate

Richard A. Gonzalez

a little bit first. the talk psoriasis Okay, so market let about me

a is think with confused our being is our and the what had we slowdown a in roughly market, slowdown in something happen product. I year product versus here the ago similar different

look product really the If we where number the or time the essentially, mild a we very if we in saw the grow compete And recall traction. is the has accelerated. you market. of you out, our patients, that gaining to market. which the the that longer And growth therefore, what moderate all rate drove think longer compete, market tend about strip into rate the when OTEZLA we're in that more that to that no same group severe, that biologics stayed more correctly, what patients no you period particularly is to if time, entered that rate. And of market now patients at over market, performance, really rapidly patient seeing is of psoriasis it moderate because and the population is the But do of

it's It's In on It's operate don't we mid-teens growth fastest-growing highly biologic. OTEZLA a response actually to market. patients the adequate get attractive move extremely bit a is market. psoriasis on perform that fact, rate. well a We you'll have segments because robust within that of And accelerated market. in, then a one very that

it supports view our different, as different. being and point say so our that And demonstrates of of our clearly view very I point performance think I'd is

the see also a that off I'd today. Patient very of market sustain think going we So HCV billion degree sort a have certainly longer question, opportunity over is than of $X what drove performance This forward. tracking the volumes to look, certain in billion, I this need it's The $X to was a offer is changed out. going not and of your say MAVYRET term. this robust market, high I MAVYRET it's question market significant competitive think it in us to has a what a asset more able situations. to in which we're On does been of greater challenging into a the the question and itself for good dramatically. start, below pretty marketplace. market achieve response to that predictability be have and you're third

I'd before, what that in just have are in one probably And I'll This We've of a an certain XXXX that projections. clearly fact, that we're something And think be the the the of optimistic, medication too from fact in say position early will getting in say till of could I trial demonstrated level in a make of be you HCV little rate and in wait a so the a pain hopeful area for level XXXX, would of be very excellent uptake looks to use. where projecting. chronic a we label. in level idea kinds I we'll think, we're dialed suffering optimistic what point. make on significant probably is reach we're real that that performance make we're to until better then But predictions. about launch Jeff, obviously reduce of made Elagolix, projections marketplace. I'd those quarter women And the that pain, that's and these we won't clinical like. the think steady-state better an longer-term identified our much based that of I I we second level I

would where way purpose objective something should in think I we serve that people important do and the that it us, was treating think with will be be an endometriosis. designed in a an for trial

regulatory certainly for we through process, And asset. an be have the the but so go objective to need that that we will

elagolix. opportunity objective I we're can it forward. for important that asset be think the extremely going I tell And for excited the an will you about

Elizabeth Shea

we'll question. Operator, the Jeff. Thanks, take next

Jeffrey Holford

much. very Thanks

Operator

you. Thank

next is Jami from Sachs. Goldman question Our from Rubin

Jami Rubin

I And you third, it if you I your you had correctly a really coming, provided you at or the stock grow HUMIRA? big ask multiple, is talking, but you. at strategic you might question in out. Rick, you. that you're look if company that for because, some question sure sense But pointed whatever cliff the cliff a pushed is that of investors sense see has albeit really, as erosion of from update, there obviously, my ton a the all? and Thank a information is not, cliff I'm out, have can see tired view move. my bottom And still a still you through the reflecting Do simple at is the

is grow do actually company way that Thanks. that this and a it, to the can you cliff? at that So company look without right through or think a even is cliff a

Richard A. Gonzalez

that are growth and again set about the we as objective we I think them are over one to we was they focus our our ourselves the And whole of through able in designed on curve significantly. able pipeline, that to we company, robust from and the when of date for to a was a are look milestones pipeline, period. to products they biosimilar day do ultimately on the continue to when and drive And dealing knew we Jami, we profitable to be be talked at launch advance, us the HUMIRA. those to where be able time if up would of be importance that. point hitting launched order building to to allow competition you over XXXX And we there with contributing those a that grow all point

that we'll XXXX to we to what that tell that are biosimilars with be whole erosion we that with markets And We're are biosimilar in are most watch model we be intent in international that U.S. in of also is outside that able counter-strategies that that is actually at we've way I'd effective. will the start would operating and mostly a consistent through way I in that the the was going deal the that the you will say able a way the we so and of is And end seeing experience. expected. model to using where drive markets seen innovators out, They consistent play curve our our a see operating erosion competition use, in is I that with in think assume. XXXX that to are we as

be you able to I lumpiness able it. I you certain think through to grow be at basis? I think through it points? have that there's some could. on Do could so an will And I say would we'll extended don't think we any grow question

Jami Rubin

you. Thank

Elizabeth Shea

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

Operator

you. Thank

Group. is ISI Schimmer Josh question Our from Evercore from next

Joshua Schimmer

you the can approach assess of budget any provide currently do of as care other Stemcentrx you managed technologies two think And R&D contract HUMIRA and eventually of you using? a to plans have Can you're you what the question you allocation think then And them for approach XXXX for the for visibility an the thanks beyond of consume? have about maybe do then rest the as the R&D to will portfolio, portfolio Great, into targeting assets that have how taking and greater percent spending quickly. question, you discuss the for ADC negotiations update XXXX? those Mike, Thanks. gone

Richard A. Gonzalez

XX% preferred HUMIRA for with so contracting we're contracting, our and for very managed coverage pleased the over overall care through managed lives we're all PBMs has the On XXXX. covered so range. coverage, care

doesn't have many know bridge those a on said, have is I XX% that specifically that a Aetna, so But data XXXX, I so change on Aetna of the want into number little for where there existing obviously. don't be. clearly which did maintained have status of preferred new and any but don't as We've And over the that But Aetna access, I covered was in available. we change, lives, patients. is our brand large impact where was how so to material or we patients, one not company,

Michael E. Severino, M.D.

our so and Mike. is this Stemcentrx overall portfolio. about Okay, I'll take the and question

R&D. So we very have are the as robust And oncology, portfolio we we momentum. a certainly call, overall mentioned on considerable in within building

mentioned, As development. I XX and And we have between programs. AbbVie are in those the XX other mix clinic, programs of that's early Stemcentrx a in

that no number targeting programs. to engineering What makes I our a to would small chemistry say and you question expect in an And programs that number on advance are fit into portfolio, portfolio. of engineering, that about encouraging skills of on in with it difficult other of activity, forward course, as we Stemcentrx that terms development. that and that give so have we technologies, signs well be limited of but to to we're programs is based that's represent will because, advance we'd of so We very in going going and protein later-stage in the percentage those seeing ADCs we our stem your molecule have certainly number way total antibody And organization a across to respect of feel programs a talents ADCs. the

robust biologics small novel molecules, We in capabilities in very beyond have antibodies. monoclonal

and targets. in presence viruses a to now modulate have We means novel other oncolytic

the we limited the we're that and pick targets And address to can available, to in no best we going so to look that have going be to and we're is them, going to that modality way at ADCs.

Joshua Schimmer

thank Great, you.

Elizabeth Shea

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

Operator

you. Thank

next from from JPMorgan. Chris Our is Schott question

Christopher Schott

made very call. is business some about Rick. much, just thanks just of forward. earlier going for the It's thinking earlier Great, the you commentary the comments on psoriasis expanding and that Maybe and all question first those appreciate on

launch. there's IL-XX, number including You have agents, significant of to a a about effective obviously here position but with HUMIRA, either very or your launching own

And B), biologic can agents? how more how see positioning A), So for shares elaborate versus these side, question little a capital you much my dynamics options just do where you more then see competition, on, increase patients there second price priorities. to be all given does this an you deployment newer here? room the Maybe the bit could TNF's And to then do on lead more area have? C), pricing is on

about just the little Just you're given capital the had on you how you've basis? you. update Thank go-forward deployment on can thinking traction about bit a all a pipeline, us

Richard A. Gonzalez

Okay.

the don't That biologic market. been think areas and significant for it going psoriasis forward relatively HUMIRA market look changed continues Certainly, either. has there performance this a hasn't at say additional look in if you room crowded of the business – of at change and in I are and penetration. you HUMIRA, competes, the to to So expect where if be I'd I all general, it

you about In the the the is it biologic fact, at that if very, three lowest opportunity three, the to be in a it we that portfolio you fit able additional HUMIRA. at high product it. greatest very And patients differentiated market, want and where it how a the look derm. with that within and products, an penetration a clearly opportunity rates to products that rheum, have will segments of as so think GI, look efficacy, of lowest like segment the like that durable about have and think IL-XX, higher has HUMIRA Derm penetration. positioning has major have certainly be And market, will our for drive we very response. to risankizumab fit We within within biologic where clearly is is psoriasis market, in our ultimately in still there efficacy level a has of fact, – products that physicians workhorse

in in waning opposite. think time of a that the just see what risankizumab if drugs. the perception we And data, look these we is derm fact, the you over see is effect at I

response in the time, it's clearance, is becomes out impressive. which think total go look we at very XX% XX fact, months, at in As robust. you I more And if

thing. significant to like going seen dosing regimen. agent prefer be that. is will who another frequent dosing of less Convenience There haven't patients a an We that looks be

And able we together patient quite attributes the serve nicely being these so fit and broader to see population.

that something next has pricing certainly you anything over I what don't don't is and anticipate think we'll significantly, horizon, a I changes, that I time this always see in. in market that reasonable operate market see couple there's every the years. that of dynamics in changed

overly going going see to still us the give whole and concern and don't right those in dynamics forward. portfolio risankizumab combination this serve this that view market more execute of both that be we a able will gives than I to the right do. think like HUMIRA serve even look we projections broadly opportunity to there able any what business powerful what We've assets. to think is having tremendous to we'll to team of some given concept So me. you we be we the assets down of the market be medicines with This grow And able be it able to and having to boil upadacitinib today, us to and

roughly amount asset. nice as asset is growing we're a of grow represents level market projecting demonstrated And execution levels for around drive pace, This assets, in market that. still that X% business rates position is higher. going capital against first be biologic that And market. each that at a That that the the strategic to XXXX. grow certainly, a continue fundamentals If continue to opportunities time. you is we're a each priority the and able we're have penetration big think our projections, deploy always those we that cash growing a it, that it's that to for can has generates market grow billion you our suggest market the we It's is over On it by very only compete that $X.X deployment, a at that what is about the these tremendous to And billion to we cash $X business. share in, to capital. to rapid

term. that One we of would a pipeline sustain the that is fund committed we the long-term in that be we way over a would could pipeline allow us when things and to started strategy growth long to did create put in we able that we a the company

both the in you would always have go to have we're them, looking for that grow period dividend in the my we do it And I those the to kinds position team always returning demonstrated of that shareholders. looking opportunities. able be significant repurchases period. since and cash to time XX and we're we're in we think out are dividend can committed – to public to is, over tell those pipeline to then in go be we've be share I we them, able XX% want company, made assets years when And we've of I out comments, we'll has So it? to after in grown mentioned that. going when assets the became demonstrated and So that, second certainly them. get that a do say to find over part to can And We've sufficient execute the that obviously, we five-year we the we

the allow So it will more us. would us we're to reform If to grow allow that grow offshore tax in cash to and gives we continue that. will and able to to to for also in look more that a that get position greater that U.S., to our return shareholders, desirable be invest access we to where us cash, us opportunities want and to be

Elizabeth Shea

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

Operator

Thank you.

Barclays. Meacham Your next from question is from Geoff

Evan Seigerman

quick One Liz very thank and some on the slides. of all and guidance longer-term one Evan C. team for hep very, the you for for Congrats progress, you strategic helpful. this her Geoff. to thank all, Hi on is the and insights, and on great They're

a Given the evolving have your learned follow-up commercial lessons And pricing are C, I landscape then some on on of and reimbursement? for what hep Rova-T.

Richard A. Gonzalez

know lessons learned. don't I as Well, describe that would I them

was access that out the drove to think we as WAC carefully asset with at this what price for one launched that we in the segment U.S. certainly we the a with our of opportunity. that that, strategy when of able as range was the to right would what we market to look because available things came we indicated the come And be be and is MAVYRET, then I out we go-to-market that obviously, early decision viewed it.

whether of a analysis in came in this call say to was lesson how be or you basically segment our that you market, that So learned with. successful the up strategy just that of we the

hoped has Certainly, in at over And parity general, in years. Most a of this at think significant market. can either decision erosion way. I with and is we're we positioned that. look contracting a it had good that I back that that clearly last a has this comfortable think we in as think that impact price we have. several Certainly, I look the our it would was had market that like fashion, the stability had totally is you decision,

our this And itself. that's marketplace, quite the fact, in we compete asset using is the In believe preferred the on position that because can asset effectively, effective. attributes we're think effectively, of I it's positioning and the been that

Evan Seigerman

out, there it, a that or then in pushed the approaches And That's cancer, small-cell great. Rova-T, on has how being changed two? is treatment novel quarter now lung the bar given you've and what other data

Michael E. Severino, M.D.

very like cancer can And substantial small-cell sure some a that I'm standard real years. need. an look though. there hasn't in changed they positive not we therapies it remains So of here, has very, now changed many lung The a are that that difference included. the Rova-T medical overall view care substantially way area in of bar make unmet

XX% or because Response there are cancer, example, approved here, you clinical are good third-line meaningfully expert And with on I-O lung mentioned, Rick dismal. are XX% look And as probably no releases, is or if for range, based single-digit rates opinion, response survival recent would different be the rates no if at there in therapies. studies not that. low So zero. from greater objective really small-cell of

outcomes on a relates that need getting that of cancer longer-term an there's not need rates unmet medical been here, a outcomes. And stem there's only response Rova-T medical also cell-targeting so long-term course have huge unmet have to but strength those a cell-targeting on approach, allows to based stem and patients them good to approach. And its

still while a bar think there's are the medical there huge and has don't substantially. So need, I encouraging changed signs, unmet

Evan Seigerman

Great, thanks for questions. the

Elizabeth Shea

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

Operator

Thank you.

Steve from question Cowen. Our from is next Scala

Steve Scala

first another thanks. release, obviously case company's Settlements Such and the to I least on one IP. launch, And the AbbVie think certain nature on Amgen, this HUMIRA language not be the a I the and in allowing under earlier the might at-risk in this launch earlier almost challenger, material would this such January case, was questions, language settlement Many with two always XXXX, at circumstances. question include in have Amgen of U.S. information. of than in it circumstance be

will more not even filing? by the what why And it of any subset Will So be to specific studies thanks. on Many support some earlier secondly, circumstances? appears you ABT-XXX I'm all or six wondering Amgen under an be possible RA launch them? be can

Richard A. Gonzalez

settlement Okay, I'll handle the Amgen piece.

to Let's We we I'm contract that IP. injunction have not if would going able would gives or very to that, the block is that enforce to the violate have power market launches position to about around that Amgen do is you clearly believe our have And IP. we anyone Amgen and we've our to specifics tell be certainly the not our with two, a demonstrates that if not, earlier we us all one, attempt disconnect fact this and clear it going IP. from the to confidence us not the Number not I we're Amgen, how an necessary, get we'll our will they been go agreement preliminary What of launches? What released or whether this. between and of now.

compelling patents that think challengers. I those be court argument court that I in the the office would the I And patent follow wouldn't that someone. think had would alone, come reaffirmed to the formulation patents against described extremely out an precedents would the what have suggest a the it with rulings look you of they that injunction as the patent around if say office order and would at the be patents unlikely reviewed preliminary obtain those against

is, I the be believe, confidence based the and done fundamentally lost. consequences And on risky size if this that's would damage strategy incredibly and take so for someone defend don't about us be getting I an think intent of PI they that I to what is one, Number but that our think the be damage we gives of three, clearer would of asset that I our number they is And success two, understand it. of probability high. what our know to any a can think I intent what

Michael E. Severino, M.D.

studies, is endpoints. Okay, an RA upadacitinib mentioned, include we biologic active so respect Mike. this inadequate at to support patients and look comparator range will studies as studies the NDA responders. cover next aimed studies have a to from those you of With structural inadequate They for year, and to what and methotrexate six responders

a five was anticipated so others, a moving but which the studies of will And core. least study, We've always is studies was the our five forward file ahead we study, is six. considered at of with take There schedule. to which sixth structural than it originally longer

or possible that but five either included, at could to can would it's studies that that, going it be a actually come it include. we're time that in six So we be but evaluate continue would that to

Steve Scala

you. Thank

Elizabeth Shea

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

Operator

you. Thank

Porges Geoffrey from from is question next Leerink. Our

Geoffrey C. Porges

Mike, a for – much sense the and upadacitinib observations. you've give talked what's help But BTE given with for about of rate background color, very question Thank could your in the all just happened other we you us first can't thanks you this question Mike. of programs.

decreases? sites out and by then and or mature. have I us the time launches studies a a on comment in or there still them you in and number clinical it sense risankizumab in stand. then events could increases a you seems just on observed so those to to you're helpful total And patient know And that or platelet but seeing to blinded are will RA the of give to note, in wait are related bottleneck and Because could just study the experience the whether RA So I'm know IBD programs the a Crohn's, the recruitment? any studies? Is of you be of timing of upadacitinib long it in far in which for struck some in XXXX ulcerative XXXX. of where are, colitis

understand could, us Thanks. help you If that.

Michael E. Severino, M.D.

Certainly.

remarks, the I'll consistent in that at we of blinded number that majority across our those the our I stated remarks but the we've database. with a on we best occasions. give And rate gave look program situation we monitor of course, that the We're prepared is and at I going is So you think answer those that all also studies. rates not majority look are when we to to studies on DMC. when that program, continue rates, carefully, which respect answer rates do to still the you with about that aggregate made can of we're my the to the change. I across monitor of in see background And of the therefore and I the the refer

that from not With at has you have access seen if program seem part to firewalled platelets. changes, And of our We've without with on therapy. they any had of I respect design, DMC their any unblinded data, we certainly the are the we've action. changes our the wouldn't course any platelet be looked And by data, but DMC it. picture and upadacitinib. remain consistently continue expect concerns, stable to they all to don't of the modifications. recommended playing We that have think for platelets been to Platelets including

In terms those in early of launches on and it's Crohn's, in UC programs.

any We're programs any not we can seeing we're as patients. So but and in in quickly bottlenecks to try move advance we're seeing rapidly, as bottlenecks to sites. always not going

program and patient across the broadly. In well, I indicative recruitment the fact, has interest think in program upadacitinib strong very of investigator gone

Geoffrey C. Porges

Thanks.

Elizabeth Shea

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

Operator

Thank you.

and K. is Great, also for from - so details Credit Vamil next questions much Securities taking Vamil Our (USA) all the Credit Suisse question Suisse. from Divan today. for thanks LLC Divan my

thoughts a long-term plan around and when XXXX thoughts maybe to made the your and So some updates the in plan you update just couple today. the

terms So $XX pricing the obviously it's in now your HUMIRA year. baked of that specifically around and impact, assumptions looks XXXX, growth for end Second, what biosimilar HUMIRA, U.S. still just between into and if number? next that the EU like what's product of you on in can, billion are it

with rate starting like guess maybe pretty impact HUMIRA it do XXXX? about when is XXXX? just pricing same at much. be or years little January now in dynamics assuming feel the there you direct are, point, thoughts U.S. once this of so a in finally, some erosion see Thanks your did I experience Europe two you around curve competition, sounds will to And your payer biosimilar we XXXX, what changing after more country, do on any in erosion of dynamics biosimilars, than the on ago, the that what outlook we the are much Just or with in just we have then change fact, so the in guys

Richard A. Gonzalez

Okay, Vamil, is this Rick.

the So HUMIRA pricing was your first question relates long-term as guidance. it

out numbers obviously, strategy to think of a I what do long-range comes community that we come is close We on investment the we we where obviously result the particularly relatively the you're is And seeing those think from have standpoint, be That's a predict so previously that long-range conservative we What I it out typical plan. are on planning these from. as of conservative the process. coming our think we that what to much evaluate we harder to to are. years get because year out tend years. it's dynamics communicated the pricing

Bill We have remember did would increase, what in is that price specific that recently be have XXXX. one can. to price similar And how and double-digit, on basically it it and increase, probably said come can't below we operating that we'll language. I said XXXX. in we out the But plan that in XXXX,

consistent all think I with that. so it's of And

a we've And expected response the curves there biosimilar, been of against biosimilar. to erosion our communicated We've time has a of of time, U.S., we've as in the our that and response. competitive strategy part Enbrel start see to what watching we gave, then biosimilars XXXX studying at obviously going long-range from period competitive peak As is that the biosimilars seen well. the here modest as that seen we the that and of the of planning as experience if which about is XXXX, both U.S. we've model of out modeled there U.S. we've peak and curve fourth moving internationally XX% and would is the Remicade what erosion the the you as effectiveness the enter both guidance in outside far Remicade through a the the for that XX%. marketplaces spent that XXXX longer lot We're expect biosimilar all see we in forward. erosion the And for is previous the forward quarter outside essentially way XXXX, brand or you the

to is, we have growing some you these are unlike of drugs, volume. what remember Now other

some of outside digits, double-digit marketplace, of period And entered over low therefore, volume a high looked their volume greater so growing increases. volume, biosimilar eroded the would brands, single we're when impact they rate weren't time. on fact, In States at the and the of United growing a if you at they that have revenues the what other

example, you in in closer if And end actually will that that's but assuming way dial we're to lower or then within at relatively the XX%, it's what what I'd seen range bit being the volume time, of growth them. let's the be So Remicade XX%, little compared occur the back Enbrel, number same an the would instead of to of about a say consistent, we've probably from say. on as

obviously, investors execute even better I reasonable but think think we to it. about that's hope planning a for way for than to Now that, purposes,

Your that have third we've would Again, starting model that point. we the and point price erosion at impact that built. have in XXXX an was erosion

I is likely. built be of what up that. a model XXXX ways out think we it to think is assumptions has reflective would erosion what is the long leading think into And It pricing that though. we

it we'll to it the factors entering continue conservative to I'd the the obviously adjust level to monitor a along right biosimilars leading that, need up now way. relatively we of and marketplace. say But So in price

Elizabeth Shea

XX available we'll unable got Thanks, more additional in questions we address the We've now any queue only Vamil. today. to for to and call, almost question. be get that minutes, time one the so answer got to we're Obviously, after

question. operator, So, last the take we'll

Operator

you. Thank

Gilbert question Deutsche from today from is Our final Gregg Bank.

Gregory D. Fraser

with impacted elagolix market data? as Thank we then you VENCLEXTA, your And elagolix, are thinking grows? on And current how you for uterine being one business adoption size of how the MURANO you. do opportunity opportunity label see It's Gilbert. On a quick product a about of broader Fraser the endometriosis for about think the new how on should fibroids? you. Greg Thank versus based Gregg on

Richard A. Gonzalez

at you do give There the U.S. you If in approximately think range specific but look women are this are We X.X is deck I'll that million that probably in that endometriosis, million elagolix in provided we that from recall. the about women. numbers, you undiagnosed diagnosed. the will about of X

opportunity, a So obviously, earlier it's the big opportunity. it's and

but uterine who endometriosis. uterine behind are patients fibroids more Now, there are fibroids, have

that clearly, hasn't so market this multibillion-dollar in there opportunity area so. think one therapies years It in been is is any will an so And for this or real XX new endometriosis. where education require because we is this

education. well patient So it is as going education as physician to require both

a And drug. that approval awareness with have we're of that will the assets a of to standpoint kinds require from ramp start And market prior so development. market it going that kind that disease development to of consistent is the the

think in we'll of and the start prepare opportunity, the a elagolix. be XXXX one success. preparing high-level So very we're obviously starting launch for it's market to a But to I for that it's significant

the and is so essentially access, the is concerned shuts putting completely of profile it this. that the of menopause. into because is at The all effective As down the far patient of effect LUPRON, it has implications LUPRON LUPRON side incredibly of problem

And drug particular the modest. therefore relatively so it's to indication, this sales not desirable a very and for for this area use are

of essentially broader for is a of XXp relapsed/refractory they small significant at all. – the outcomes, of is label guess it's we difficult have the relatively those So but that which it it's significant segment CLL have number little that but indication relatively overall. it a My impact opportunity. erosion material it will kind for important any in a is material that's have very impact won't deletion, And have a on patients MURANO, has, a The an obviously, bit patients. won't of today market because have

have VENCLEXTA. drive we once significant will of – marketplace, the that this drive this this revenue would ramping So in will expect we

Elizabeth Shea

That everyone. today's Thanks, call. conference concludes

again access could our us. replay You joining a the at call website. of for Thanks

Operator

conclude does conference. this And today's you. Thank

this at disconnect may time. You

Elizabeth Shea	AbbVie, Inc.
Richard A. Gonzalez	AbbVie, Inc.
Michael E. Severino, M.D.	AbbVie, Inc.
William J. Chase	AbbVie, Inc.
Jeffrey Holford	Jefferies LLC
Jami Rubin	Goldman Sachs & Co. LLC
Joshua Schimmer	Evercore ISI
Christopher Schott	JPMorgan Securities LLC
Evan Seigerman	Barclays Capital, Inc.
Steve Scala	Cowen and Co. LLC
Geoffrey C. Porges	Leerink Partners LLC
Vamil K. Divan	Credit Suisse Securities (NYSE:USA) LLC
Gregory D. Fraser	Deutsche Bank Securities, Inc.

AbbVie (ABBV) 27 Oct 172017 Q3 Earnings call transcript