ABBV - Earnings call transcript Q3 2019

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Operator

Good morning and thank you for standing by. Welcome to the AbbVie Third Quarter 2019 Earnings Conference Call. All participants will be able to listen-only until the question-and-answer portion. [Operator Instructions]

I would now like to introduce, Ms. of President Vice Shea, Investor Relations. Liz

Liz Shea

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

Chairman, for Legal Officer Chief the the Joining Affairs, portion us call is Corporate Secretary. External of Q&A Laura Schumacher, Vice and

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

included these XXXX our other Additional risks our on XX-K is uncertainties and and in Form about SEC in Report Annual information filings.

in by financial measures measures filings as which today's understand earnings undertakes reconciled conference can website. forward-looking our statements help non-GAAP to business AbbVie except AbbVie's comparable be GAAP as with on regulatory found past, our are in update release these investors ongoing obligation from performance. law. On no and be used the These required measures today, non-GAAP to call, financial will financial

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

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

Rick Gonzalez

the our the more update as as Rob joining provide I'll discuss again then recent detail. programs today. well us our on raising quarter. year Liz. you, in discuss for we Mike performance and morning will advancements Good and quarter you Thank across will and this guidance an are highlights, quarter thank everyone third R&D which full

we'll take your Following our remarks, questions.

of performance hematological share representing for ahead with billion guidance continued our X% strong outstanding driven our was $X.X the quarter adjusted oncology of midpoint also by in year and earnings quarter immunology. nearly another exceeding Total delivered of $X.XX. of by the $X.XX, revenue per versus last of growth and AbbVie expectations

with continues our in business, an multiple nearly and delivered XX% hem/onc market share position of has than across global operational strong remains CLL. quarter. of the which perform IMBRUVICA sales in well to more start with across last growth IMBRUVICA the all a indications year. billion increase of leader I’ll exceptionally $X.X the quarter of XX.X% clear in lines versus therapy revenue

and the are recent frontline inflection the of driven especially treatment guidelines. body setting growing with augmentation pleased by update in We clinical evidence, IMBRUVICA’s to label

$XXX substantial CLL in in segment also Relapsed from to million are expand VENCLEXTA continues with good recent and approvals very of contribution new AML. for VENCLEXTA seeing frontline the patient our quarter. progress making we more are Refractory We a total share and with CLL than revenue broad the

best-in-class creating of further improve care. new turning Now the our leadership therapies, we where a immunology to introduction of position patient portfolio well SKYRIZI therapies two and broad RINVOQ, with strengthened positioned to

in the We that quarter. see with of recent remain launch SKYRIZI, continue psoriasis continue with launch the well category. million to well The analogs $XX total is prescription extremely to excellent approximately from going trends in above performance revenue

share. leader SKYRIZI X,XXX six access bridge those This have first And the in SKYRIZI with and new the prescribing this already patients. program. as Through both in-play the patients, in months treated for including our psoriasis more its we includes market, short patients switching and X,XXX already approximately than on timeframe, established position physicians has patient

access than commercial addition, for a product more to XX%, now In best-in-class SKYRIZI its testament profile. is

growth plan. significant our over expect SKYRIZI long-range to drive to continue We

and arthritis. moderate patients severe approval also treatment to In years the and our quarter, announced major we rheumatoid This for the the known leadership major adult the who U.S. our commitment as a upadacitinib, product another indication last of to RINVOQ new approval the XXth in for the immunology, approval milestone for yet in had of in five marks demonstrate AbbVie, the continues

offers trials, from over a commercial prescribing products highly we been across very a registrational physicians demonstrated to has or on launch organization meaningful Feedback advantages the the for profile a positive benefit strong in risk development and arthritis. strong trajectory. With experienced rheumatoid have RINVOQ market immunology support today

highlight for and prescriptions for early both second are received RINVOQ was prescriptions full recent on and within month trends month paid those The In RA more our were October, market, RINVOQ XXXX in bridge the including estimate has been the ahead segment. we datapoints analogs program. of encouraging than the who of filled you. highly tracking performance the comparable few I’ll a access

of level in-play this on RINVOQ’s patient other currently volume, is less share several After patients. RINVOQ and on in-play of the than Enbrel. Based approaching REMICADE products surpassed the and has in-play in rapidly market, X% prescription RA days capturing share is approximately established for XX

our to of RINVOQ expands expect very are significantly expect early market cannibalization months. expectations. the share next in XX% several Commercial increase We and we strongly ramping low have prescription access seeing above and with January, we this HUMIRA also as access over paid far. By to line is commercial volume thus

seeing. the pleased by So feedback while we received we are are the we certainly physicians, from still that we launch, the early trends from demand in robust are and field

and by across U.S. Now gastro. driven HUMIRA all derm, the turning grew three HUMIRA. to segments, strong rheum, this quarter continued growth X.X% volume in

International on in remain international The dynamics basis, expectations. XX% our competition trends biosimilar were down and international of Europe the operational reflecting markets. consistent with an impact and HUMIRA biosimilar approximately other sales direct

again full XX.X% group. our on at per strong expect midpoint, the of adjusted reflecting Based $X.XX at to momentum now earnings EPS top are XXXX growth the of remains our the our which We business guidance. continued share of quarter progress $X.XX the of the year and once we tier in year-to-date, raising peer

of extremely I business. our am performance with pleased underlying the

aesthetics platforms Additionally, CNS. acquisition will on-market positions new highly and medical growth with the significant we with Allergan, in leadership attractive planned across adding including valuable assets be of additional segments growth

substantial shareholder the in transaction the of approved The We completion the have proceeding and proposed acquisition expected Allergan reviews remain regulatory XXXX. quarter who planning on is progress. advancing Integration underway and as the for globe. the track closing made with is of first around vote well we recent also successful

transaction Allergan will the performance. AbbVie generate new deliver significant The tier flow merit R&D to earnings to has poised debt. rapidly financial a strong significant growing our and cash and dividend down Combined, pay platform, is top we support and strategic enhance innovative and

we XXX%. dividend cash $X.XX announcing grown have beginning our our noted XXXX. from with February quarterly XX.X% press increase inception, our the to As we in today, per in Since are payable per dividend $X.XX share in dividend release a by our quarterly share

to launches and progress am portfolio I with that pleased momentum our our advancement. we the summary, making execution across continue demonstrate are extremely recent in the pipeline product and we strong with new So including the

have growth of assembled impressive the an strong. assets outlook and We business for set our remains

remain long-term The us lives. improving and achieving more Allergan the We vision diversified. focused transaction value our performance on stronger even while company shareholder for delivering industry-leading strategic patients’ make will and outstanding

turn to With programs. Mike additional our call that, for R&D on comments Mike? over I’ll the

Michael Severino

Thank you, Rick.

notable We earnings continue number since stages all medical our a to several pipeline well make great as with progress last pipeline of meetings. presentations as at data significant of call, across milestones our

U.S. of major another the indication arthritis. milestone immunology, we rheumatoid its initial with and the RINVOQ our achieved and of to approval In portfolio expand continued

and the risk label, We comprehensive strong profile benefit large program. are across reflects our very registrational pleased with demonstrated the which

developed option medical important in represents at the in internally RA new, which therapeutic launch and highly discovered AbbVie RINVOQ, was very physicians from an underway providing the community patients. U.S. their of feedback with the and The advancement a treatment differentiated for been positive. has is

an with We expected Europe received for in decision recently also a positive RINVOQ next months. approval few opinion the CHMP in

In addition, quarter. in approval first we the Japan expect in

for good making other mediated well. are the RINVOQ immune as development conditions We progress in with programs

placebo announced who key first secondary arthritis, of inadequate to an in this doses met evaluated PSA primary in trials RINVOQ or We of and endpoints. both which biologic X from compared results study. the psoriatic recently patients, arthritis all more response DMARDs, registrational study, RINVOQ our had SELECT one In the psoriatic to

ACR refractory to both as detailed at and skin encouraged strong scores next We of well in responses forward very are biologic a population. the activity minimal meeting measurements, year. presenting on PASI as the pretreated results We response and endpoints, disease medical by joint look heavily including levels

from see in second half year to mid-XXXX stage will X Meeting and anticipated commercialization SELECT XXXX. in be next study for diseases the ACR our we later trial, from expect of including first PSA registrational in expected the abstracts presenting in two RINVOQ We At rheumatic results data submissions spondylitis. ankylosing our with in month, XX this regulatory

endpoints this function primary and and RINVOQ as to a placebo. and demonstrating as imaging compared endpoints significantly improvements In met key physical well signs study, in symptoms, secondary greater

will that segment Both our areas and in study important for our immunology X plan within We large portfolio. coming Spondyloarthritis indication position a in Phase Spondyloarthritis, and strengthen to months, psoriatic focus the an expansion rheumatology in AbbVie’s of the begin markets rheumatology. RINVOQ’s arthritis Axial and key Axial further

In of to first first in of half XXXX. from in segment, registrational the the we see the RINVOQ’s expect results Dermatology atopic dermatitis trials

with quarterly make in patients. extremely the its launch and its psoriasis going profile administration progress well. approved We in first well is and differentiated continue great was the to physicians with as SKYRIZI, with both resonating indication second SKYRIZI and quarter

efficacy continues after as its feature treatment, is at important X.X to data of complete achieving long-term that the strong PASI response. EADV showing One demonstrated by high presented on XX% of levels patients XXX recently provide clearance. profile skin durability SKYRIZI of or We SKYRIZI’s Congress of years

the developed indications. colitis The very a significant are and SKYRIZI in Similar both and particular, is registrational well. opportunity disease several ulcerative in being to crohn's for programs in SKYRIZI represents additional segment RINVOQ, Gastro progressing

to data Phase XXXX. next from crohn’s colitis Xb and are from study Phase We in disease see in expected ulcerative X expect the data studies in a year

significant year Moving received advancing Gazyva and combination now our which IMBRUVICA data in and update VENCLEXTA. include data this good frontline programs make progress the to We oncology, we for CLL. where frontline We’ve label of the hematologic CLL evaluated progress in with ILLUMINATE study, breadth setting. continue made a expanding IMBRUVICA to in IMBRUVICA from with to

updated include CLL program. important our the guidelines NCCN addition, were in In from three to data frontline studies

wait positive submit young in patients. plan study reported for X the watch data from and X Phase the ECOG year, first-line fit and in population later and also regulatory to we We Phase this data approval

use VENCLEXTA. element our strategy An ongoing IMBRUVICA clinical of combination important and our program hem/onc of evaluating is

expect refractory we the lymphoma, of In SYMPATICO mantle see combination with non-Hodgkin's year, X VENCLEXTA in to cell evaluating trial IMBRUVICA the a in results next Phase study area lymphoma. from relapsed

in also progress good program combination are with making We the CLL.

and XX XX expect months. X in frontline from next Phase the expected Meeting We at CLL present the are from upcoming ASH data program additional to Phase to X data the a study in

our to continue hem/onc We advance programs portfolio. other in

be will from patients early-stage presenting data next frontline X at who evaluating very confirmatory encouraging two Phase data myelofibrosis a are study upcoming failed year Meeting, see Jakafi. And Phase where studies in from we AML. results will in X have we data several the including from evaluating in We programs ASH seeing VENCLEXTA Navitoclax

High to the Jak-Stat are fibrotic is symptoms a marrow marrow hematologic in risk tissue not signaling function. myelofibrosis attenuate Current through disease which by disease therapies bone interfering with replaced serious modifying. is bone but pathway address

we offering Navitoclax, approach unique the BCL-xL to the are for targeting course a the With apoptosis cells and through clonal disease and causing restore modify the reverse myelofibrosis fibrosis hematopoiesis. potential mutated of BcL-X pathways,

in an also myelofibrosis our next with representing in a important we regulator through option quarter, approval the second Elagolix to developed decision thus submitted have application act Navitoclax resensitize that for treatment for year. Jakafi, may uterine expected quarter cells Also of resistance in fibroids the patients. potentially

drugs, And to ABBV-XXX its for with DUOPA-like is for the demonstrating ABBV-XXX subcutaneous delivery presented approach treatment invasive method. a patients non-surgical potential Parkinson’s our advanced potential innovative data delivery provide as to disease a option treating efficacy neuroscience, a an we system new disease. less motor pro in fluctuations Parkinson’s in for Levodopa/Carbidopa recently with with

current represent potential would ABBV-XXX with broaden to population the DUOPA successful, improvement today. significantly patient to If the treatments treated a addressable with beyond those transformational

as program program X ABBV-XXX look underway is progresses. you updating to The the Phase forward for and we

pipeline forward until to to accelerating months programs continued XXXX. year progress good more and advancing important in we in have the coming milestones many make we look this and So, summary, very our

I our over third quarter to performance. turn With will comments that, the Rob for Rob? call additional on

Rob Michael

newly reported our $X.XX year Thank midpoint. you, adjusted another We Mike. We strong to above launched a X.X% share revenues from exchange. from compared key earnings growth the were excluding foreign competition. of impact Strong $X.XX, prior had reflecting basis, X.X% operational up quarter per several unfavorable on and Net guidance offset X.X% biosimilar and international growth impact performance. of products of an assets of

impact growth down X.X volume in year were HUMIRA favorable a across line in biosimilar quarter. XX% sales operationally, U.S. compared HUMIRA reflecting of remained approximately and sales X.X% were below expectations. other with price billion, a with X%. and $X international Wholesaler and $X.X billion, competition of to International levels the month up Europe markets X.X% prior inventory our

continues with million $XX the SKYRIZI uptake strong quarter to of following in sales in launch the first demonstrate full April.

the Rick are and partial the quarter million. with pleased launch we As – mentioned, Sales were RINVOQ. $XX in

Hematologic in global both driven $X.X nearly CLL. the and share were revenues an than IMBRUVICA net of XX.X% by VENCLEXTA. in oncology sales operational growth up lines all strong basis, billion, by IMBRUVICA $X.X billion, driven on of therapy strong continued were more global

VENCLEXTA continued all approved by share indications. $XXX driven revenues million across were gains

Medicaid in operational international by million, XX% markets on Global HCV select within treated U.S. segment. basis, competition managed roughly $XXX revenues an were increased down patient approximately and driven volumes lower the

in and it the next AbbVie year, performance impacting decade. leader cash HCV dynamics generate into the to Mavyret flow durable therapy global for remains expect the we well Despite this

also sales growth operational Duodopa. for and continued strong Creon We saw

the was gross the to to basis prior quarter, P&L now Turning year, a of profile up XXX basis XX% point benefit third points the sales, XX for including adjusted margin areas. related XX.X% of our accounting. sales other investment impact expiration programs on oncology, pipeline partnership R&D the of was to of supporting offset by immunology royalties, partially the HUMIRA Adjusted and compared

tax SG&A and XX.X% ratio assets. newly The and of X.X%. prior expense was an was expense points adjusted continued sales, investment year. the basis versus products interest in of margin XXX million $XXX the our rate Adjusted operating launched was adjusted net sales, reflecting of Adjusted XX.X% improvement on-market was

our In we net per impact results. been after-tax part a consideration The related the This adjustment of the intangible has EPS the share the assets this to and to impairment charge acquired charge was acquisition. impairment from of quarter, net $XXX $X.XX of contingent related as recorded excluded Stemcentrx million. liabilities net adjusted of

at strong our from continued performance Excluded is adjusted of year-to-date, items. amortization $X.XX reflecting specified year guidance this intangible our share per full the raising $X.XX, guidance growth are between on XX.X% to Based to we earnings $X.XX known of midpoint. and

also to impact rates, exchange increasing for to our have reported now foreign on full are growth. expect year At approximately year guidance of basis. we We X.X% unfavorable approximately growth sales an continue and revenue expect operational on the full current X%

forecast of This full following approximately HUMIRA assumptions. now sales growth year the X.X%. We comprehends updated expect U.S.

volume robust segments. all We leadership maintain continue to and across a a strong see growth position

operational expect For international HUMIRA, at billion $X.X of sales current exchange rates, decline to approximately XX%. approach we an representing now

expect continued now million revenues of SKYRIZI We global $XXX approximately reflecting launch momentum.

IMBRUVICA growth and For sales million. our approximately revenues hem/onc $X.X global U.S. franchise, $XXX approaching with we XX% approximately for now now of of we expect VENCLEXTA, sales billion expect

forecasting now HCV billion. are sales approaching global We $X

now margin the operating to on XX.X% of just margin gross remain sales P&L, XX% approximately And adjusted we and adjusted of sales. of above forecast

year tax full non-GAAP XXXX. below our unchanged. a remain expect now we assumptions in rate Finally, other year All full just rate guidance XXXX

other specified we earnings and amortization $X.XX approximately between non-cash expect $X.XX, quarter, items. share For the fourth adjusted excluding $X.XX of and per

approaching anticipate foreign growth expect exchange we impact. a At unfavorable rates, modest current We fourth sales quarter X%. operational

XX.X% significant earlier, a mentioned cash in will and AbbVie dividend the to dividend rapidly we a quarterly the Rick today in reduce generate with strong support us growing cash in February increase debt. As earnings with and allow of flows XXXX. combination our payable dividend beginning and Allergan The announced

by of XXXX. to the a debt-to-EBITDA continue to achieve end net times combined expect ratio We X.X the company of

deleveraging are through We XXXX. further

outstanding and performance financial with we in with of to In and deliver closing, positioned well has track performance business, once record, AbbVie again beyond. delivered momentum our the combined remain XXXX strong our top-tier

turn With over call the will back Liz. that, I to

Liz Shea

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

Operator

question Instructions] And Navin Jacob today [Operator UBS. our you. Thank from is from first

Navin Jacob

Number arthritis couple to think A SKYRIZI. the want those we please. how should question. And how RINVOQ for relative one, basis, just relative the guess for taking be? for big psoriatic understand could market RA. I Thanks morning. a about Good to Same opportunities on

some ASH. thinking to with They're there at landscape? some then going regards the Calquence. Wondering questions data how are four, be about And been IMBRUVICA, reporting AstraZeneca’s competitive you to around has updated

an you the or questions about finally, your brazikumab. of on we is on versus the when assets. There update some hear around just divestment transaction, then And should SKYRIZI update have some Allergan do an of

helpful. clarity be any So Thank would you.

Rick Gonzalez

Rick. Okay. Hi, this is

you I’ll question status the I am of going PSA and walk Michael? about through the then, bit for Laura have think I’ll Calquence have I and little Mike talk reviews cover the regulatory to products. Allergan’s a

Michael Severino

as This often overall other axial but segment that Okay. and PSA I I’ll spondyloarthritis, is part large of important equate an it’s Mike. makes as the take meaningful referred spa PSA a the question. The it to. is RA segments. contribution,

announced that which the had Those in area we we were this very in delivered as study expectations. this and at two components revenue with – strong meaningful line completely in week we arthritis our earlier psoriatic provide results

on both measures a activity, We and are with and both which impact very on measures, the show of substantial very joint joint the ACR a disease getting measures, proportion patients high control. composite had that on we skin strong and skin measures, on of of look level across minimal

So we RINVOQ for long-term. think substantial it’s a in opportunity very, the very

market a to We going But do a put contributor dollar be haven’t the RINVOQ yet. very that we think important profile. on overall to it’s

of very well its SKYRIZI psoriasis. is initial doing indication and

a We show important That’s have the in psoriatic it’s of psoriatic benefit arthritis SKYRIZI a We not think arthritis to underway. setting. as program advanced.

But setting Phase as yet. expect in readouts well we to perform well data those on have based don’t X. We would it that

the portfolio in market. think really important So have we strong the two of very we’ll that between segment a

Rick Gonzalez

about me CLL environment it maybe and the the competitive more IMBRUVICA VENCLEXTA little to a are So, got about – broadly, little talk around the bit talk in setting. let a we and

certainly would surprised positive if have we first-line. will BTK, we expect will a didn't being Calquence at look in data it and that we that frankly positive data as certainly, have be think, it I

a data IMBRUVICA comprehensive will data and very have and large certainly impressive the I mean, competitive dynamics. play into and that obviously,

in from does if perspectives. what’s about think sort the the What about competitive the against to you I competition that you two today? field, like competition? think think this And dynamics it experience need been looks

able compete and now. And for it like in an what competitor CLL be going to looks am market talking way to way forward then, specifically I a this in effective

think plus now been years. of has in has proved differentiation. get It has market it’s to able label that a indication So, about I real and any been MCL It has share. second-line really not for, Calquence a the today about XX% two

between time. for XX% had XX% quite It some and

area quite VENCLEXTA. CLL which time. X% use some is gives behind of about view current it’s of about vacillated that on in IMBRUVICA physicians idea plus, an you almost in third-line being for and So, think guidelines and Its despite since that kind XXXX, X% all of in is it I how treatment

and approval think in market or today. anybody If when compete they remember is, is I marketplace it how important to first-line, in the to get this operates

treated of look and you that share IMBRUVICA’s who share of today. If patients patients currently active under I treated XX%. are is what by at is, treatment mean first-line patients IMBRUVICA’s

half treatment under patients that are of IMBRUVICA. the are today utilizing roughly So,

Second-line XX%. plus is about

three else. treatment under are patients right to IMBRUVICA of anything IMBRUVICA. now is switching don’t taking progression well-maintained see who and off using are or So, therapy. patients physicians of Calquence IMBRUVICA quarters the them I to treated

duration of we’d increasing. we is if that, be And we seeing not. the down, It’s indeed therapy to it’s something slightly stable track, but going were which

the market to and you have for limited into will for patients got competing only have share you to areas comes patients. this by be compete compete failure where in new that or anyone So will share

VENCLEXTA know, first-line. going in case are And have this recently compete or you to approved also in is market. against as of patients, to in VENCLEXTA patients the failure they And new been

We about post three approval. that months are

X% patient it’s it’s If in capture XX% second-line, you third-line, look and new at in it’s In XX%. first-line, share already. VENCLEXTA’s

fundamentally I I VENCLEXTA best intervals assets believe believe provide think disease-free being that IMBRUVICA. the able So, is, think and reality have long and with and to between many CLL physicians we durations patients we two them of for the treat

in gets approval a that share. first-line some CLL, So, certainly if Calquence gets

feel assets I confident and But this you in on based that have. on the that performance, highly I our we based would marketplace our in tell position

Laura? So,

Laura Schumacher

regulatory the With respect Okay. is well. proceeding the process to overall regulatory process,

filed FTC, working to was September, in second With approval major which We not all specifically the and a for unexpected with respect we the have at through end are jurisdictions. we of FTC. those received information request requests the for

We’ve an and also about IL-XX brazikumab, today the our assets. notified other is intent them two of Zenpep. One which

process have closing. think with now I divestiture ongoing parties. remain several a robust right XXXX earlier, as we interested a of And Rick optimistic quarter We said first

Liz Shea

Thanks, Navin. Operator, next please? question

Operator

you. Thank

Flynn Goldman is Our question next from from Sachs. Terence

Terence Flynn

coming Hi, good give wondering any start the strong Maybe with Thanks taking to SKYRIZI, where I respect you on U.S. Congrats progress. was to question. and me. launch similar morning. or in two from Wondering the color from terms just launch? versus different can to the anything off looks a there. more be ex-U.S. all for sales of us are

had And as U.S. earlier then, curious to we how some this week, comments should about HUMIRA well. your next Thank pricing Rick, hear you. think Amgen be we’d year? thoughts but

Rick Gonzalez

think relatively I reimbursement in that an on we have that really you a to reimbursement countries today. is reimbursement of pricing process But process, international ongoing. number SKYRIZI, only small remember, have

it’s and countries. next you reimbursement going of can that’s well markets we that course to in as So it doing months over in. get pricing additional XX in But the significantly is the the expand extremely expect

SKYRIZI in western and are markets. European in seeing to expect certainly reasonably what would perform I we the with consistently the U.S.

I there that a there and opportunity about are we good So, think, excited is opportunity.

be different of change going view or significantly we’ve far through all I’d I don’t we of XXXX. in we any Certainly, contracting what obviously as process care are from pricing XXXX. managed into in in significant pricing it are in dynamics to that process the our around relates seen XXXX. It for the and HUMIRA pricing, HUMIRA would say, that

Liz Shea

Operator, Thanks, next please? question Terrence.

Operator

Thank you.

Scala question from Steve next Our is from Cowen

Steve Scala

delivering pressure still So, the regions there quarter. well How and where HUMIRA are patents quarters Despite are that’s all row. force? AbbVie has apprehension, the is biosimilars despite in in a and beaten on a question. very Congratulations foreign you. Thank the first investor regions? that between Were just executed is three success

might And early QX, had release implies the be the closing then, of thought, saying than Allergan like kind in seems generally earlier which second, the been XXXX but it January. company it says

So, earlier earlier what been allow to Thank for have closing? key steps expected than achieved that you.

Rick Gonzalez

you guidance fourth at Steve. you our Rick. of if back year, the to XX%. look so, guided about go is in correct, to Yes, are overall at quarter OUS if – On last HUMIRA, we This you erosion

in As his our now erosion that will Rob forecast in is XX%. at said comments, that about come

than you’ve So, we seen in that each slightly lower expect the of and what quarters.

As you indicated, we’ve overachieved.

I would of say, a of better in is would the than earlier the came majority areas by better impacting the in There market. well. at those it portion we bulk stabilization it, market slightly that performance of that is the the a markets a pricing driven as is of are expected. little But biosimilars performance level where that’s have other in

the it. as is the were think how concerned, interpreted we earlier I far trying As closing an don’t if to that’s market telegraph date,

well. closing. extremely are Allergan good the activities going Integration on We are progress making

are We very managing tightly. that obviously

processes As are Laura regulatory indicated a few ago, advancing. minutes the

like done. the like But stay the and it get to guidance rapidly with a is this pursuing and quarter change was. Obviously, we’d we we’d that can that But to are want had as that activity at that we’ve wouldn’t original point, to we close what first I as close. to current guidance

That interpreted. was it how that’s not our intent. was So,

Steve Scala

Thank you.

Liz Shea

next Operator, please? Steve. question Thanks,

Operator

Thank you.

next Andrew from Baum Citi. from Our is question

Andrew Baum

you. Thank please. Couple questions of

there fund the both out-of-pocket a proposal Finance the and than from periods to Senate’s Committee First, Within obviously, but pharma coverage dynamic, catastrophic the cap that, most. through proposal has on well planned spend legs probably funding Washington, more is of as very as the sponsors. it’s

adherence thinking about how payers both in negative of due but of the also volumes against revenues, hit the off hit side competitors, direct net Thinking of including compliance playing order versus balance Calquence you indirect IMBRUVICA, increased claw to that? impact am do a back I positive to economics. the you to on the from

is arthritis. on rheumatic The second question

are your Novartis versus your enable both Lilly year failed to trial, in do that show to RINVOQ that? given next So date waiting will improvements for HUMIRA you front-line ACR-XX confident you and have to setting

from comparisons in provide what it’s know am I I making necessary in interested dangerous significant today presented doesn’t second-line But cross-trial reassurance. the that. you

then infection on that the placebo? you with rates you could versus thanks. comment trial And psoriatic milligram arthritis the in the RINVOQ finally, of Many XX saw

Rick Gonzalez

I’ll Rick. Mike first dynamic. cover as is have the you this two. Andrew, the pretty still the cover and indicated, situation will one other Certainly, I is

Although, affordability, it’s up last But access to the a of open or to activity They lot I’d a at lighter to try been month and in going is two. I little of look still summer. think had continue lot the over say, interest to population. the still there particularly that’s ways across a and Medicare

to And I to IMBRUVICA we HUMIRA or where think affordable patients. in medicines on a tell today like example. company The therapy like a would make as even direction that’s Finance and from Part-D appropriate believe goes We you, they that. we I a down a think more it’s as helpful. support and It therapy costs I Senate takes do need those are an out-of-pocket Bill

The in would It takes average say, $X,XXX It’s about Medicare believe them patients. significantly still an cost. high most fundamentally too that’s to try fairly I government our out-of-pocket down of patient Medicare has affairs We or neighborhood to $X,XXX. for we are position. it $X,XXX. people $X,XXX and the more to needs of below think an be income articulate working something to that

issue loaded with is there other year. in is, The the still it front-end

patient the that has two most these months, three have don't standpoint, come in months flow of typically cash up cash a of with flow. and the individuals to kind from first $X,XXX So the first that

patients’ be that a full allow year allow will with across to to up approach be affordability. it would certainly the coming So, structure spread reasonable those a more

in to can these But to I access, trying for AbbVie. funding you to and speak to relates And the that. industry. make certainly, speak has certainly, look patients can't for As I entire someone catastrophic more broader the and the area, it have for if affordable pay drugs

I at and testified step-up that I said the of we Committee, said to have are cost. Senate We Finance more cover willing and

more that direction, structured of to a needs have of although say, far, to companies that and the they be that more or well. in I pay it piece year. more to the cost the actually plans costly and government so innovative it to punitive way will per as pay cost it moves where companies Healthcare have the obviously more It is have would below benefit drugs who total certain therapies a gives $X,XXX

that doubt I seriously. a intent, They any give the were to benefit specific don't was trying I think to company.

where right I'd to modification base important at would that But of is and really direction. this the say, be catastrophic So, looking is something the percentage it bill. an in overall threshold that in the moves aspect

about to your volume, be cost. some you answer across tell there move do entire the to the it Net-net, will we just carefully isn't We offset portfolio. overall increase. volume the have up not can believe volume Specifically, I question looked our enough

think the some But to this, scheme grand think have is reasonable I with on to the the want approach potentially where a meaningful debate this could a and impact go think modifications, with of in I put we issue and I you rest.

that So, it. something it's of am with modifications I supportive

Michael Severino

response patients pretty had biologic of joint where heavily of at pre-treated ACR-XX and was in And Mike. in just question drove levels IR that a that's Thanks. DMARDs higher keep the This is is a three prior the in arthritis. population. very fact, in we or psoriatic population important the endpoints. that levels failed the it to I'll study high released bio on despite mind bio One thing is take we on IR number that two at a level

with you entirely expectations. they subtracted look the are placebo our at if line in And differences,

comparison, hit in our structural our the the would the endpoint. and which not but our So, the in to data second only program marks study includes overall these increase confidence head-to-head also ability

and The very that because a endpoint. that structural second add second I study a is robust it large has would study thing that is

to effects powered it's So very show the see. to expect we would that well

and So we arthritis remain confident psoriatic overall program. in the head-to-head our in

And That's the did in then, third of with released part infections on just the to XX immunomodulator rates question therapeutic and infections rates, the higher uncommon arthritis, we psoriatic data in class. a dose. infection see that not respect serious of numerically in your in we milligram

first This study. our is

respect make with parameters, most based to dose joints how that safety to have to going doses the dataset a that that to also as out, did with and forward endpoints to are we carry RA. we in determination respect we'll across complete of study not We on plays see other dose do the or not see only appropriate see the and on the response second but

Liz Shea

Operator, next please. Andrew. Thanks, question

Operator

you. Thank

next Porges is SVB Geoffrey Our from from Leerink. question

Geoff Porges

you much questions. results. very and strong may. questions if the I the appreciate I Thank Congratulations on Two

you First, of regimen? be thinking in a how of give you treated really a sense could us potentially could the be whether setting, you XX duration could really think CLL with non-chemo, And VENCLEXTA on volume and VENCLEXTA about because transformational? that significant patients non-CD IMBRUVICA, it are of

could Rick, the relief about you then, that talk went am allocation? just And dividend there up. sure there out a is some bit capital little I

you getting Now close confident you to and about of feel talk Thanks. the increases? about ability dividend your outlook how the are to long record for you closing transaction. dividend Could Allergan continue the the

Michael Severino

mean, combination patients we it's in used This I'll first very Mike. and and CLL. from co-morbidities. is that you and there When I ranges a CLL question is look group who IMBRUVICA a opportunity VENCLEXTA of CLL in on later meaningful think number develop there. do life at heterogeneous a take have the population, the your of part

progression to receive rich therapy patients with tend Those IMBRUVICA. today

those patients, We are and who less strongly responses. life, But co-morbid in as had earlier patients treatment who who very, are very very there are that seeing IMBRUVICA data. we've in deep getting shift CLL intensification patients released illness, interested other developed

is the be will patients expect compelling treatment intervals translate that We'd it's see and the an We very that we important think data disease-free And responses. option. deep on that think particular, long a and to therapy based for generated I those into VENCLEXTA combination, to-date. we've in IMBRUVICA very

to to specific to be duration, respect the going based on data tailored combination settings. the do that's those tend duration therapy. individual to have fixed With But regimens

Rick Gonzalez

I'll allocation is Rick. this capital Hi, Okay. question. the take

Let start about maybe more with broadly me allocation. capital

and priorities allocation. continue us. growing want three invest to a down strong priorities we and we And basically to have when the at want look in want capital pay to dividend debt. for We the are to those business. We drive We

comments that we drive place pay that’s towards. will in his put be have formal that have We that down will the a Rob debt we absolutely objectives consistent something and plan indicated that in with

cash very, in we and flow are a Allergan in flow. fortunate tremendous the amount combination generate are we cash of significant Now business very that generates of that will together a AbbVie

have we do now we the so, would dividend are if going we luxury double-digit not that able certainly our both. to that about concerns we And increased And have had any forward.

able So, we ability dividend the to I are committed have and to to be can committed do a to strong debt and both. tell paying we you growing we are down and

think confidence increase announcing of flow is reflection we a the are I dividend that cash in generation. And our today that

Geoff Porges

Thank you.

Liz Shea

question next Geoffrey. Thanks Operator, please.

Operator

you. Thank

Wolfe from is question Next Research. Anderson Tim from

Tim Anderson

Thank you.

in does to to to back Astra's And Going that that next that side-by-side safety? is that to or year, product or if able where what on Is come? your be product either reports come? does likely analysis differentiation form head-to-head the on Calquence, out that efficacy show

products be? the commercial I the And to in terms what these sidelines, that clinical would it were keep them with be where still dynamics might like data of understand on next-gen the shows better, but Calquence, if

And on Botox. then, competition the a send is the you of Wondering of obviously question durability your your planning past. give if can view time period long-range assumptions, some it indication extended an second off well lead asset of over in product’s us and Allergan, the

market decade There for now, is planning range the rate is example? about Is assume? your growth at next certain on continued obviously new positive what long it through the threats same

Rick Gonzalez

Mike? Okay,

Michael Severino

me-toos the really like BTK the forward. we of look efficacy on when We said. has put have inhibitors the see look take on our first safety, data, Rick they look follow-on to is based We So But part I'll Mike. the that some at or on at as wouldn't the this expect that differentiation positioning Calquence. data. understand

second-line have like-for-like at publicly Phase is for data only our example, data. the look indication line you they against you which X where X If in up that and data CLL, Phase available

that's look we prior of you had had very, look at despite three median response assorted number therapies that one similar. therapies. fact they prior a of number they study of median at And very the the measures, and a in If prior therapy

patient population more a results. heavily same So, yet and efficacy the much treated

that So action. based expect of likely our a on indicative mind that's It's wouldn't mechanism in of you inhibitor. and not BTK differentiation

story look see showing no and larger scale about, clinical similar you as evolved corresponding trials, that go started as study to time label talked It events rates both they same and in of well. pretty safety, no if that their we you in at that well. has off bleeding are at now you points. when as actually And see up afib those those that And because looks back you comparison fit look that I if their

really mean, important over differentiation labels time. So we it's in don't keep see I that there evolve to either. mind

get has look post-marketing you time. and evolved, things label trials multiple unblinded over have at how product's Phase If extensive that's natural a to the also and label your we our experience, III large lifecycle accumulated as course added of

If you compared their point, to label IMBRUVICA's look at they similar. label a look pretty at corresponding today, time

to our like see to and we So, differentiation. these me-toos eyes, expect look wouldn't that

Rick Gonzalez

Okay. backdrop to research we This in the did acquisition. And the Botox. of we answer second it leading market getting about to the question that it is the the Tim, your did work relates I'll answer acquisition, Rick. that up I as am

for of important and carefully So we It's product an Botox. at Allergan. Botox the durability look

has which come job you thus branded at the I potentially One, experienced look and two far tell is toxins. expect think forms an two more outstanding And it other see other or done forms. competition, we branded Botox. comes you if in organization I in toxins, to would it But they've Allergan what with can

patients I they in research practices Botox, name. door, offering told the is And market when without channels walk operate that it is it us what that in equity brand is tell Botox strong so by extremely for the that for difficult you clearly of operate that they the the ask would to those because many

have well. so of because extremely dynamics quite asset a has to manage around the competitive been that being bundling that, able effective And they and this program

And we a this for the our did number fairly across in built and we've a every that We've model times. and fact, I built we’ve virtually Allergan we would model say single of said conservative product. as built transaction,

it is forecast. longer range is more so, project But what growth Allergan certainly And more than conservative and model their performance does than going conservative the for still our forward. Botox it’s current

performance the fact and was well. of very, the quarterly was I impact, speculation. Botox a competition would big there despite soon. say here a to lot going We'll see last have very The performed quarter we've performance watched Botox that their

would I expect continue that perform Botox will to well. But very

lot way of and have the continued way I to so, they for quite the And the deserves brand this credit a think handled they competition grow well. that organization

or to talked look of to we've to see bit second for in not have at are going a relates as around Botox The here. whether quite investors it is biosimilars aspect and as you detail Botox you any to

would that's this at biosimilar the with we lot particular But very uniqueness the and is, we outside short feel answer be have to a looked you, we version create very confident come extremely the expertise this based would extensively on Botox case. tell that to I and a of of the difficult there molecule, conclusion of

So, in as confidence. Botox. Botox good ability that about to aesthetics about all therapeutic continue area, able of was think be a to good We thus far And both we our the to say I long feel supports the area. data feel further answer to the well grow our to you, basically only as

Tim Anderson

you. Thank

Liz Shea

Tim. Operator, please. Thanks, question next

Operator

Stanley. you. next our Thank Risinger And from is question Dave Morgan from

David Risinger

much. you Thank very

results just So quite were on question obviously I impressive. had a gross margin. the the

on AbbVie's down So the you Could comment slightly that to was XX.X%. sequentially gross for And margin? outlook just that?

in-play to patient with Rick, was percentage wondering capturing you you in-play respect Second, is RINVOQ well. comment X% the SKYRIZI I if earlier, you psoriasis as a patients. of have that made said RA

Thank article with on IMBRUVICA, there on finally, talk that? then recent And a that? bit Blood was to a hypertension. comment the how link little managing respect just are Could you. you product's with you And about

Rob Michael

David.

first take your I'll Rob. is this So question.

we The margin have key keep profile. the more in I year. within XX.X%. mix So profile, you to are gross approximately be for if XX.X% pronounced guidance quarter, year-to-date thing a margin at given you more will at look impact particular on gross have can pronounced and our sales and it of mind

seasonal the in well also as products from we impact Synagis. IMBRUVICA that IMBRUVICA with stronger partnered and But VENCLEXTA. of share like In partners as we mind QX, for VENCLEXTA, expenses our saw keep and sales

gross impact profile. was that in margin So expense our offset

quarter. you result, exceeded a the on that operating this our profile as see margin can guidance So we've

an XX.X%. all-time high achieved at just We

you gross to about as margin, opposed to focused on just it's important So be really think margin. when partnered those operating products really

Rick Gonzalez

then Rick. SKYRIZI is pretty and in-place for share right is XX%, SKYRIZI, psoriasis rapidly. the And growing now David, this On over

Michael Severino

is I'll this And Mike. IMBRUVICA hypertension. question regarding the take

it's our think with important seen it then clinical practice clinical we believe and very and uses pay in trial been to And effectively in in both to safety effectively. has inhibitors other clinical hypertension managed managed and is programs. patient close it be needs we that So obviously, to and IMBRUVICA BTK attention

at look If risk overall strong. the very you benefit profile, it’s

clearly released of data wide have very all and of across data. I that number We from settings X comes, a of our risk in think a range Phase benefit profile studies

very we in overall we So confident are think hypertension are of managing molecule the and effectively. I profile quite the

David Risinger

you. thank Great,

Liz Shea

have one for time final we Operator, David. Thanks, question.

Operator

at questions further am I And no showing time. this

Liz Shea

conference That concludes a call. Okay, thanks lot. today's

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

Operator

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

at You may this disconnect time.

AbbVie (ABBV) 1 Nov 192019 Q3 Earnings call transcript