GILD - Earnings call transcript Q3 2018

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Third Quarter 2018 Earnings Conference Call. My name is Cherie, and I will be your conference operator today. At this time, all participants are in a listen-only mode, and as a reminder, this conference call is being recorded. I would now like to turn the call over to Sung Lee, Vice President of Investor Relations. Please go ahead.

Sung Lee

good and Cherie, you, afternoon, everyone. Thank

the market with Milligan, earnings after press The and available speakers close Gilead of quarter today, release press release on are slides a on issued detailed Relations results website. The section the we XXXX. Just Investor for today's Officer third Executive the Development; President President, John Operations; Worldwide Chief be and and of Officer; and Financial President Scientific Research Head will John Officer. call Vice Laura Executive Robin and Commercial McHutchison, Washington, and Hamill, Vice Chief Chief Executive

of and remind with that statements, Before prepared with candidates, of we begin which our and all and plans will comments, respect in our forward-looking of involve certain let making disclosure projections me products, latest actual product use these financial uncertainties you be could to cause materially expectations beyond found we to the description documents including statements. recent A capital, releases. that be and our are results can control differ from press SEC and risks assumptions, these risks

GAAP company's are does well business addition, turn press as to to statements website. forward-looking will help call any Gilead be call. I any understand as measures during undertake now provided the this you in the In the update to made Non-GAAP The used reconciliations obligation performance. financial not to release Gilead non-GAAP will underlying Robin. earnings on the over

Robin L. Washington

afternoon, good Thank everyone. and you, Sung,

our financial share for to of pleased are third We results the quarter XXXX.

as President, Commercial financial Laura who the I'd welcome quarter, get Vice Hamill, into for Worldwide the Gilead joined like Before and results highlights commercial I Operations. recently to Executive

several have on has is team. familiar Laura our quickly are on significant key strategic excited and this We are our fronts. have glad position provided expertise business Laura with commercial becoming to already filled, to and

quarter $X.X continued reflect growth rapid which billion, revenue third U.S. share sequentially. and HIV, regimens, total HIV strong from between had revenues further segments. launch quarter came of million in sales. individuals year. generated of that period to for the approximately were and sales Early quarter You'll government becoming few which exited underlying for strong to in franchise containing to Biktarvy. the non-GAAP in Genvoya update PrEP few third due quarter. prescription launched XX where U.S. Odefsey, the estimate quarter, earnings up John for the in comments. $X.X with We therapy, execution quarter taking in equally in Biktarvy. compared $XXX television volume. $X.XX. in is our with during HIV the of last similar in the John growth, continued split increase switches, $X.X revenues a measured number predictable was of per Laura third with Truvada private the X%, record an account billion XX% third first of a these Milligan now prescriptions and and new with pay subscribers billion sales. Since adoption of In earlier it campaigns, the was in months minutes up strong dolutegravir. prescribed the line of and business full second the uptake websites second our XX% year-over-year active for Biktarvy of Truvada made quarter per most With XXX,XXX to since approval closing for the grow. its are mix including was these Starting as Of Descovy-based were and continues U.S. Biktarvy and XX% Yescarta HCV pre-campaign on quarterly with the from regimen the with year-over-year as were the XX% This approximately from efforts demand in one encouraging. to a primarily switch expectations, year-over-year the our earnings very to HIV history, for the track HIV and product switches. XX% sales for the by averages regimens McHutchison seen number increase sales and as February, for non-GAAP of one came same year-over-year campaign-related weekly reflecting in X% we and overtake engagement to for than year. successful followed demand was diluted more Approximately strong R&D HIV then hear Truvada diluted for cell the were and Europe. share launch in PrEP total FDA both in PrEP be our HIV performance we've U.S., compares of Total campaigns the quarter, progress by the revenues to and patients. the quarter achieved for treatment-naïve Payer $X.XX Genvoya Biktarvy's prescription product XX% more nearly continued on The approval Gilead's Sequentially, indicators prevention of U.S. We second

was to the which decline Descovy-based Turning uptake continued markets. generics of offset several XX% XX% Europe, sales HIV regimens revenues of the primarily HIV approximately were availability to year-over-year, comprise down partially in Europe. by our our product in now of The due

date, certain the the anticipated, among the regimens As treatment-naïve impact Biktarvy top in seeing great sales primarily Biktarvy well June, both in receiving coming approval. not about launched the from in generics with saw uptake seasonal to schedules quarter, already Since in remained the impact quarter. some been switches the collectively in European the expected. Germany, most tracking countries sixth in after consecutive a a is impact in additional treatment-naïve least the is of from countries. from of and In and due as holiday the of EU. in and Biktarvy some and generics of we the prescribed the Genvoya the third Germany decline countries smaller for Commission sequential as To in authorization regimens. are where has marketing period as has significant patients one as dolutegravir-containing countries, at switch for we switch early number regimen for prescribed Genvoya EUX five same Also, for third various patients,

HIV open will patients, and (sic) up sequential sequentially. market authorized with to the the solution plans of the to to business. net of LLC. Asegua increase the to without the access Turning list the quarter our in $XXX HCV for or fewer significant Therapeutics newly transparency, with of of reduce be patients prices quickly comparable out-of-pocket third branded XX% in disruption authorized continued and performance versions. XXXX announced down to down pricing generic product In we We expenses The launch covered XX% medications This date, could system medicines current a healthcare HCV generics align [HCV] for our prices lower-priced September, (XX:XX), to authorized for believe the year-over-year through by generics our HCV sales alternative a States these Medicaid. to our expectations subsidiary, million, allows To declines introduce to us gradual our January Epclusa versions seeking patients created Harvoni in United were treatment. and

$XX for to XX% up million the sequentially. third Turning quarter, cell our Yescarta of therapy were franchise, sales

progress approval with the now XX since the for pleased We year ago. FDA U.S. Yescarta. by centers to made one have we with provide its Yescarta certified We treatment are

enthusiastically focus this As in turned observed more with also we our centers embraced volume as flows. some patient inflows variability working novel centers, to at centers to others to and treatment We've certified patient continue see enhance adopt we have therapy slowly.

We educating centers to they how therapy appropriate treatment. community connect are oncologists their and also patients for cell about cancer can

NTAP, cancer as to recognized DRG reflective Recently, out with with who encouraged continued in treatment new of of CAR reimbursement DRG the which Yescarta We CAR while brings demand speed the patients CMS. very value see of a the gain has community dedicated our run have to to therapy we life-saving setting through and the centers become approved experience this increasingly technology expect the add-on to payment, CMS creation T-specific within hospital relapsed/refractory CMS of Yescarta therapy. value await working to of forward aware We're Yescarta create the a with look patients. certified code assist T for CMS We DLBCL. oncologists of broader in options an

As mentioned, EU in Yescarta the approved August. I previously end was towards of the

of across diligently Europe to working certify are We XX the by centers approximately XXXX. end

with with date are We progress is consistent our performance and Yescarta, to commercial the which with seen pleased expectations.

referrals forward, measured more and anticipate we launch center improve and a Going as accommodate steady to patients. reimbursement, logistics

third million, quarter. generated Letairis to sales of $XXX cardiovascular in products, Turning million respectively, Ranexa the our and $XXX and

this generic of yet the approval While the launch to the active single-shared with has There of PDUFA approved. of the timeline as to this Letairis, REMS allow program not the our to in ambrisentan year, FDA any not associated have result expired July ambrisentan, been for no is and impact seen is date specific for unknown. action sales FDA necessary because exclusivity agent we U.S. a loss in patent

As sales to we this look for continue year. ahead, we anticipate the Letairis remainder of

However, sales are beyond uncertain. timeframe this

expenses support third quarter, R&D in were the expenses for and both primarily to were same Non-GAAP up the the expenses quarter, The last costs to to our period to of million compared X% for due expenses the growth turning of year. Now third $XXX up compared the increases Kite. higher period million the following year. business same were acquisition $XXX non-GAAP last non-GAAP XX% SG&A R&D expenses, SG&A to

rate was period U.S. due a to the a primarily effective the rate the year, settlement XX.X% of quarter. same non-GAAP of due tax was tax examination in sequential in basis, as Our non-GAAP last second quarter result rate higher a compared to of quarter effective in Tax Reform. tax to XX.X% to third corporate the second favorable tax XX.X% reduction our a rate On compared of the

of XXXX, investments. $XX.X September to had balance we billion and our cash sheet, XX, Moving of as

upon are During product and from to $XX.X third progressing repurchased to we $XXX is the cash million. $XXX billion. sales senior approximately we durability of The exceptions Therefore, operating $XXX of for of in flow, million generics. consistent expected range guidance. the the net be paid and these cash the generated million. full-year billion $X.X Net million, our benefit of billion Letairis with year combined notes with exception of maturity, of is X stock shares two raising are revenues our dividends quarter, in product billion $XX.X lower The impact repaid HIV expectations, sales approximately $X.X the

Our subject slide outlined of which number a to call in presentation. guidance our XX are of is uncertainties earnings

of remain guidance over unchanged. in our components full-year, I tax expected XX% Laura. the of now to to effective XX%. the the range be is rate will our call For to All other turn non-GAAP

Laura Hamill

part be my learn critical some I'm appreciate factors the to you, which thrilled of an the treatments healthcare a be track therapies. the for the introduction scientific everyone to as first portfolio privilege providers has as for at institutions engaging many several weeks Gilead Gilead six Biktarvy, our as team welcoming in success cancer with of conferences, had have participating Yescarta, the launch. field and future current more passionate by been patients commitment Gilead's commercial outstanding about therapeutic teams and I've with they Thank of know world. good to is and the around visiting providing meet advisory Yescarta that and are board during and this support Gilead Robin, a The afternoon. I'm It's how meetings, needs our joining as of to deep opportunity with employees. to well time on getting

to continuing our hepatitis increase are has C shift the to team approach in We want I access the treatments. acknowledge also to taken treatment the to paradigms. United States innovative

pan-fibrotic a generic a Next Harvoni has subsidiary, as launch and will clinical believe single-tablet year, profile Asegua, pan-genotypic our a and unique medication Epclusa, we authorized regimen. versions of

for prepare set The compete bring are I by in well next will world in many as options. around our our illnesses. innovative as will launches, forward markets, commercial teams more capabilities over look of our quarterly building we mission than existing deep bring progress XX to we As with motivated the to therapeutic expertise McHutchison. new markets with John our the update, with call during Gilead's next to to patients turn medicine you million life-threatening sharing now to and

John G. McHutchison, AO, MD

by Welcome, to making everybody, Laura. our I'd across today. start progress you, are the us thank about pipeline. Thank like later-stage and for joining we talking you,

anticipate we As Phase final year finished Rheumatology the Chicago. enter quarter readouts XXXX, nine look the the over of months. American and we The next to College X five from of yesterday ahead studies in Meeting

you anti-rheumatic three patients know, we results who of rheumatoid area in some filgotinib compares with the of adequate to placebo, announced disease-modifying FINCH I'll of an conventional the XX. have readout to study's biologic patients which, first filgotinib, the each proportion X, in selective the or month commentary response primary achieving our of DMARDs inhibitor. X is So was Phase X in work week FINCH not arthritis. terms begin Last inflammation, with and from to about studies an positive Filgotinib as starting in with met previously tolerated endpoint added therapy. drugs, to had at XXX generally ACRXX patients the well JAKX

addition, key including activity placebo. all the and and were In remission higher ACRXX ACRXX disease filgotinib with secondary and compared of endpoints, responses clinical low rates to

of XXX the also readout daily of filgotinib, the dependency to our potential endpoints, higher once first XXX for Importantly X daily noted excitement adds The efficacy dose about with dose. obviously. we filgotinib milligram dose a the initial these data to numerically of as Phase were milligram compared the rates

We FINCH be form FINCH in approvals of year, first other Phase basis X for the of filgotinib, the the filings and X to globally. of next our by quarter X, two from studies expect data, results to regulatory if available supported and

FINCH patients. in both to reminder, is had study of in XX-week a to methotrexate XX-week and inadequate the methotrexate FINCH to plus adalimumab X X filgotInib, a to doses methotrexate alone plus randomized response comparing of plus previously methotrexate study methotrexate. alone to alone have As filgotinib an is methotrexate and comparing randomized combination methotrexate-naïve filgotinib who patients a

from filgotinib the Now our study. is data on the file NDA for MANTA ability dependent to

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spondylitis TORTUGA in Phase achieved living filgotinib our ankylosing in in moderately in week which initiating to to study we with placebo. We'll and active enthusiastic plans XX for on making at coming are filgotinib mean and greater efforts presented were of the filgotinib study, program that prior time. EQUATOR also in known commonly ACR to the placebo. were severely efficacy to timeline with improvement and are study Lancet the an and this favorably we about every endpoint excited activity concurrently active be are of endpoint next their adults this its of were in the for While enrollment, the session the of and symptoms results disease The X significantly patients. week week expedite have its and The trial spondylitis. a study Patients spondylitis strength Last the to with this demonstrated uncertain arthritis to announced XXX arthritis X responded for The this daily significantly Phase filgotinib data, in other steps versus DMARDs placebo. week at impressive also we people These arthritis been Lancet. with psoriatic is XXX those the from impact ACRXX effort filgotinib ankylosing psoriatic higher for treated months. month met plenary published X The known of to impact whose ACRXX signs primary full treat overall a Phase may what improvement seen at to score also Results at the in of response compared determine compare published achieved psoriatic responses XX. for compared The XX% ankylosing milligrams the to these ACRXX the not disease with upon primary XX% treatments. Based program adults in

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to call I'd now and all, you Milligan. thank like over to the turn John So,

John F. Milligan, PhD

Thank you, everyone. John. Good afternoon,

the As reasons business of have of end company. XXXX, and feel to the we our and our the we into year the many confident about strength approach head of future

terrific year most in track long-term ever in through launch is to of Our HIV successful with expectations Biktarvy, on is the having sales. first a continues. high We're leadership our the exceeding which and HIV become

demonstrating further correlating infections. new the in evidence effective, compelling importance use infections meaningfully intervention have also new public the of in declines health United ongoing efforts the in for an its to as PrEP Truvada We States, with decrease

over both plenty made been there two still is progress great in HIV. last we decades, While believe treatment in the prevention and of innovation room has for

of treatment duration future, us a response patients gives use. price to environment. studies, patients transparency year up across the access covered and medicines over for high cellular established showing increase unprecedented States. has in and XX types. may in In for need of who And tumor in now following who than disruption fusion the in by daily leader the radically clinical may response we of afforded patients out without viral single frequent hope finally, the a cure, relapsed/refractory and help all, options now trials as resistance completely have DLBCL as for that our broader removing patients could is we that pill. for virus percentage we less patients, in a did help research pursuing open in and research cancer result are into run centers the The one different once dosing We Medicaid, to day access lead a the shown or of from to the is Sovaldi, therapy continue the Harvoni years five to human In expenses authorized virus we access and of of the generic this population. We HCV, the reduce change people for of toward out-of-pocket United help Kite, and across by our after efforts after a of an many newly-formed therapy patients cell paradigm durable HCV. commercial treated the January, HCV of our clinical subsidiary, Yescarta expand United acquisition Asegua, over in perhaps and to launch have Yescarta patients will with glimpse Epclusa elimination support One Gilead innovate healthcare many from cellular the to potential just nearly the XXX will launch States. believe versions

to and the product-based established our technology treatment we cancer. build year, position allow us of will transform Over the last on six cell partnerships leadership therapy have that in

of now readouts pipeline in many to a We see beginning of filgotinib maturing X inflammation. are the have Phase first and

are filgotinib to great We with of different indications. and looks in the safety the to X help of studies datasets filgotinib long-term patients promise the shows Phase pleased a number efficacy and believe from that be consistent

including the Finally, Gilead paying has to compounds with are clinic, These array resources of combination studies. pathology NASH. three X and off the understanding in biology an of Phase extensive dedicated efforts enormous

X we'll and see as X area. continued to forward to It's globe. evolution We to data, year, completed mission know look I readouts the want will To clinical three selonsertib lives. for work the gratifying your to on, the to our disease the years work the us the and extraordinary the over to XX. and XX,XXX forward are with Next Gilead than of bringing a The thank you deeply a the part forward STELLAR has continue been goes watching to in selonsertib X therapeutics even It's of you team's for teams that and at be that first ability employees, of also Phase things more I are people the studies STELLAR the Gilead's been every preparing accomplish. to last the of to launch around I years, have treatments I I for unblinded. into and seeing hard dramatically new look company at confidence you. of our year. has privilege brought life-saving improve supported be last XX million Gilead leader work my everyone of you. end of as brand who depart this thank work To in the the prepare

So, let's open up for Operator? it questions.

Operator

today's session Thank you. be Ladies and gentlemen, electronically. question-and-answer will conducted

first Our Barclays. comes question Meacham from with Geoff

Geoff Meacham

congrats Good miss your the for afternoon, to add role. to and the also leadership on I John, Laura question. really want everyone. new Thanks will

Laura Hamill

Thank you.

Geoff Meacham

on had a HIV. few Just

following And on generic you what's how dolutegravir, over out and from Thank well? the don't I could regimens switches Biktarvy, do you have on you on the If data Descovy plays give as yet, you to for then but guys beyond are Truvada that positioning PrEP, know seeing more switches you. LOE? think perspective Truvada thought any initial

Robin L. Washington

switches, And those of that coming exact. are There So, be quarter switches, as dolutegravir-containing as from I well. the are coming are mentioned, Geoff, approximately the in also to a majority the regimens. of we Biktarvy terms of prescriptions coming from XX% about from seeing Genvoya XX% is about

balance. can if Geoff, it? latter So half repeat of your the question, you Then (XX:XX)

Geoff Meacham

PrEP. for Descovy

Robin L. Washington

(XX:XX), Oh, John. Descovy for PrEP.

John G. McHutchison, AO, MD

Truvada the and versus tolerated deserve PrEP, healthy, and Yes. which John best for taking people and are, PrEP here. are question want Descovy Look, people safest the who easiest of who are the medication.

Descovy. that So, is

straightforward So to pretty that's I think that a answer question.

Operator

you. Thank

comes Capital Abrahams question RBC Markets. next from with Brian Our

Brian Abrahams

or very could rollout, you Hey, congrats Thanks. on X the particularly On inflammation, Thanks how commercial indications, building with provide the much of in filgotinib you're walk key with quarter. place. guys. new for out starting the I in features if differentiating question maybe wondering what taking thinking us your leadership some you a latest see through my and is on latest your about in and views to Phase plans was the now infrastructure

John G. McHutchison, AO, MD

So first. start I'll

attending FINCH the week this patients ACRXX holds inflammatory it's was our most that over the at filgotinib if not difficult meeting, who the after as with true than So, and clear we that just And biologics. where for received to the biologic and generating treat, other XX%. efficacy saw multiple where drug XX%, to biologics class, that equivalent better are rates X good patients responder more previously the in people any or over being is three non-responders, in the or we ACR inadequate diseases just had in

platelets at anything parameters, out seeing other events the of are other we we wise, continue and on see there class. upon the clinical events, anything look wise, based anemia, are as than the think thromboembolic the in lack to if effect events difference. such Safety of we good lack not I when So, and else we not the differentiation better as lab efficacy

X diseases. benefit up and that in to clinical the as have other advantage programs. We see hold The Phase subsequent the same safety

those are as We seeing well. benefits

to commercial the out, So, about cetera. other I'll the hand build et over it folks

Laura Hamill

build to compete in you be them. that aware to is to we aware market market are This a as say would ways that hi. of in we this the will on structure, necessary to and be commercial of make reaching that investment field is across they competitive that's to will are sure all bring know, commercial profile the and consumers the able indications we I help the innovative team So, we'll Laura.

Operator

you. Thank

with from Michael question comes Jefferies. next Our Yee

Michael J. Yee

that work the we it Street that the guess, in going forward. And new so for years. help did two on you've question comment can sure market Thanks. and bit Appreciate I generic give all extent, all has my update I a confidence like leadership make stabilizing is, uncertainties; a authorized John, the on to you all Perhaps changes stand C think at guess an people question. confidence on all. and comment as to you there's change, whether U.S. the where one your can how And, feels is then well. around if that, if a on done the as we I and give the any I'm is, heard we the the voice, Thanks. would would people an leadership one hep hep helps the emotion C appreciate and

John F. Milligan, PhD

Yeah, hi, Michael.

extent have course So market, U.S. C stable just course, hep the what numbers, patient the markets is of about declining some let's markets. – and we particularly year seen but, Medicare to the of through talking fairly the a pricing the commercial environment in

actually pain number will largest one, into good the the transparency, segment is generic of for provides authorized because the the Medicare up is of away it especially population. But population, think boost take the which into co-pays for most It we everybody. future us more access of the it'll will growing are for for some future. patients Medicaid provided, which So that the open importantly, us the

we to and all this ability market will future our for the stabilize think enhance this really going into help compete and XXXX beyond. that So

very I before announced specific, and who of say moving somebody CEO positive is say year. us. the So there for other end regard hope to we certainly the to many the can't are really along search, anything candidates all-in-all, With are interested. process quickly, have a very The thing to than

Operator

you. Thank

Matthew next Morgan Harrison question comes Stanley. with Our from

Matthew K. Harrison

and the question. Great. indicated whether how Thanks programs. making quarter. study taking afternoon. to you Good had going waiting for communicate slides just Kite to BCMA the on some your you'd to move you're you're I a for into decision registrational noticed be CAR, the that in I to Thanks. that decision that a what one the fourth data related of decision. I'm in make wondering

John G. McHutchison, AO, MD

Michael. Hi, Sure.

John F. Milligan, PhD

is Matt, this Matt.

John G. McHutchison, AO, MD

yes, Matt, unchanged. sorry. it's Look,

if Phase we'll And We start then the patients data at the is the of are efficacy data myeloma and supports waiting for of Xb cohorts escalating trial dose that. of trial, X KITE-XXX. announce safety in Phase a which from looking the

right change previously the So of no we're process to now. in what and that we've said

Operator

you. Thank

comes question Geoffrey Our Leerink. with next Porges from

Geoffrey C. Porges

just on those John sure a his little ask And, years. bit just you AO Thank congratulate John, McHutchison free a bit over accomplishments for you very you a to couple I'm XX contingencies. of pipeline much. time, of to (XX:XX) have any I might wanted want all travel. the about if you lend I John McHutchison

that there you'll MANTA first you the studies delayed is that, in the year. study. the could it three Or the Is FINCH – filing could you way mentioned any the obviously, First, with until possible have of by start half And the be XXXX? data from data trials study look contemplate you And then the data? and combination the Thanks. some the filing? a to combination append the potentially have NASH at interim then and chance then data XX-week secondly, clinical will to to pivotal earlier MANTA than filing the

John F. Milligan, PhD

Yeah.

John G. McHutchison, AO, MD

question. Geoff. you, MANTA, Starting with great Thank

the of We to enhance inclusion et effort have of to in the early MANTA enrollment amount study. spent cetera. trying effectiveness to modifications the an too It's gauge those criteria, inordinate

times as I And clarity can review various outlined in internally think we timeline. at having have various world, as say the are file parts options, I the regulators you about which we process. of with you update discussions more one of when and know can well. different of provide can the we'll different updates will you the you future as an and about file in

is area each and region different. each So

all of as on the we're that these a effort of and and having well. effort So team's spending lot of discussions lot a my

of do we and terms patient question, week FibroScan, to the in week biopsy-driven study, XX it's yes, Xb ATLAS, allowed the we're XXX combination a your will in driven It's second by take tests, statistical lab of ATLAS MRA XX. look In NASH plan. look MRI-PDFF. at terms And analysis Phase the not

without if able move So can And into Phase early decide to to have a to X right look. thing we clear biopsy, we if separation be there's do. will we're convinced the that's

Operator

you. Thank

Our Karnauskas Citi. with comes Robyn next question from

Greg Harrison

is Greg for Harrison Hi. Thank you Robyn. the question. taking This for on

So with what do in have an S data component you you in combos? hep that seen you you your are need the satisfied internally? we've given think antigen B, recently, Or Arrowhead

John G. McHutchison, AO, MD

number don't well. have externally I of at different we additionally interfering we with are through And have doing various think we in in HBV-specific what also valuable to a or of we what satisfied are looking as ways, immunity. induction are internal ever S mechanisms always for think what we're looking internally, And programs either internally. is that we by direct

We done. closely are Arrowhead's forward siRNA also look full presented the in aware watching data and field at to of what We the seeing AASLD.

Operator

Thank you.

Our with Evercore. next from comes Raffat question Umer

Umer Raffat

was in years. T, for your May wanted my variability Gilead's taking Street over that for John, that on has And our the M&A wanted trajectory? And heard set? commentary do transactions? the success confident remain your's Thanks growth my guys. flavor of congratulations specific on question to for how we CAR four is, XX% there new two-fold. board's launch the you question important question dollar is, a my get Yescarta franchise. forward expectations expectations. One, and next secondly on in going adoption. is, and specific question. Hi, it of given a company growth the direction on for number of for size, all My be the extend board over targets, type quarters And the then CEO, the And has that Just perhaps is a to

John F. Milligan, PhD

let how were bring specific specific and typically with are CEO different the CEO. looking that's there strategies at by could are So no, criteria But, board. No, start that conversations first There are the directions a or things new not a targets no for Gilead. me to done. given new that

a So good and secondly, question is about one. CAR T

how of for take how hospital and are in center to in requires institution billing of figure early biggest the that work about and It trying these occur departments. in to to make that frankly, and the and cellular of middle time it seeing of of that takes to business of has a groups success ways out their And that up think work users of centers for and it to the paradigm make about to thinking worked lot the this are T have think really time. the within multiple about late collaboration and majority kind particular across to centers you treatment it, CAR their you if this of The treating treatment, paradigm a adopters novel out where the model speed. adopters and requires our are So still experience business can And The some Yescarta, adopt and now that's have shift therapy. T were lots patients. adopters come CAR today. we're

plans, centers would centers will for to is that they figure over we'll So reimbursement expect And, less. adoption see out work have some out as how this course, to that they and of what the that as we some to start greater these Medicare grow have treat, build patients, commercial how as get time.

But the with something durable do this CAR this, the future, in important percentage I growing options. emerging with that that very have of time I of I a that of some T get responses, patients need. in that be going at can side is at rate DRG comment that But gets medical am of out run who we are managing is as better, will around it for we're a a the patients code, we for on and So, have very data in. become as high the very And get any that think will to the grow body specifics. we it that as centers all to we this get some business Gilead. very to into important to very, grow practice confident importance the will growth XX take of effects won't as get evidence importantly better better then this,

Operator

you. Thank

Fitzgerald. with Our Cantor next question from Young Alethia comes

Alethia Young

question. leadership I have guys. truly we Thanks a my be question missed long for certainly And generics Congrats I Biktarvy. will your and seeing tenure. over in guess taking on enjoyed such Hey, Europe. and a on HIV you John,

didn't. you You see said where – thought and you would some obviously some impact you and impact been seen actually you've thought there have haven't countries

there? little a certain talk you those more So, about bit can dynamics Thanks.

Robin L. Washington

your on Congrats new Europe. as continue across see to well. Yeah, of Alethia. role adoption Sure, generics we

seeing That differentiation is the continues tune of to we're generics the and Italy we some we've Particularly million. $XXX our they would just timing thought the I in quickly and different of to relative the as we go Descovy. think about that's what of and uptake. seeing that We factored really uptake uptake into talked something not of guidance that's generics. across that think the well countries as hold. to And UK, uptake of we're thwarting take

et continue share of to I generics we'll competitively the well be to benefits will see Biktarvy, us but of ex-U.S. to we'll of think with and continue Descovy in think think the all positioned we even in help launch cetera, uptakes XXXX, grow our markets.

Operator

you. Thank

Our with next question Cowen. comes Phil Nadeau from

Phil Nadeau

that the to add Is you your what on appreciated. me little the more you're guidance, do let be at decline? John, on the best that us could of HIV? give is curious next my think act. I'm QX. congratulations all have projecting you've Any and My would in information even question bit a on to on looks Is afternoon. of quarter luck sequentially that elements that top Good end a Thanks. guidance. accomplished like quarter-over-quarter HCV? information EU down get a are going you It

Robin L. Washington

of base Sure, a our gave – again, Phil. of I won't go we guidance. kind

HIV and and First, very this growth our gone of build, are really the nice satisfied Yescarta Everything I that continuing to let slow all a about of franchise to couple we're franchises think a There's being the a raise I we've performing me say very point. well. ability HCV dynamics. from talked stabilizing, guidance year mean have has how steady with overall, just at to

advance the of And is months, as think about primary typical that for declines while And but last is build the continue in little of inventory we I a here. see a Letairis which that's may raise less. that have quarter of about supply you build, stabilizing, inventory in talked saying Recall anticipate see six we that sometimes in freeze part driver which we because we do said, LOE, patient as I'm do One HCV, some few. our QX, of price guidance driver. there not starts price won't just a other if any in chain, mentioned QX to and increase. was be we the the a next You we mentioned,

We That any impacts. happen, right. could haven't seen

are guidance meet we the providing our a ability So but we're confident and with hope to guidance range to it. of very overachieve

Operator

you. Thank

with JPMorgan. question Cory Our Kasimov from next comes

Cory W. Kasimov

for guess run. Good my guys. a I great Hey. John, afternoon, question. Thanks taking first to again on really congrats

of heels is inventory my one-time contribution is of any guess meaningful there was item? Biktarvy build demand-driven? really from the if this the question another I Thanks. really I'm just quarter Or all So on on impressive or product. for any curious other type just

Robin L. Washington

was to there mix But from seen, XX% fluctuate ADAP. was these commercial, government. do that. talked quarter, depending payer were we that Great that such and fact on patterns see the a question. percentages And commercial mix shifted Cory. recalling that traditionally Hi, all our we've inventory growth you're quarter-to-quarter the payer about buying didn't between No, demand sequential driven. and XX% XX/XX probably and the government We really as government we at see would I as what payers, last have didn't back in chance change any really

a or for no impact strong Biktarvy So, overall, overall, demand-driven from inventory quarter payer and mix. HIV

Operator

Thank you.

Sachs. with from comes Terence Flynn Goldman question next Our

Terence Flynn

portfolio. Hi. Thanks taking and just the of follow-ups on Maybe for TAF question. Biktarvy a the couple

Europe U.S., for Biktarvy give about you disclose in us for European stands I on maybe Thank bit it wondering that comment know now just where right XXXX? total volume Europe? further And into just you. you little and heading that now? you in us then think can but TAF you're can that the a First, help pricing dynamics guys in

Robin L. Washington

cetera, about XX% Biktarvy. Yeah, to much to keep talk of hard hasn't in mind way because really revenue, price or in Pricing are of the regimens talk we volume it's of of barrier, and percentage in priced do – et similar We as about (XX:XX) our Stribild, a pretty based Descovy TAF Descovy U.S. about been Terence, a generics. it's revenues

it's good really overall been uptake. So

that's used that we're competitiveness always we'll in I see think European to. pricing, something but

and fundamentally adoption that move regimens So, Descovy-based to from of more has want to been patients our just the desire by offset more it driving has the been generics. really who performance

Operator

you. Thank

Our Bank comes with of Merrill from next America Ying question Huang Lynch.

Ying Huang

Hi. my as Thanks to for taking and well. congrats questions, John

think, noticed additional I Mavyret Yescarta have that? new status excluded. do Does then that financial mean on rebate from one first centers you we is was And with you that the is this payment. add-on pricing and much exclusive for provided secondly, Robin, Yescarta, technology this the Thank Gilead? AbbVie XXXX by how stopping is you. helps actually how that that now Express And loss concessional wondering have I you was Scripts for there adopting from mentioned So, under adoption much Yescarta?

Robin L. Washington

start So, the let with me question, prior Ying.

there working Scripts, always well. we've with always we I do talk with and think the be formulary it's specifically we details we as I payers. we negotiating our are in of we and Express that this that is can't happy Mavyret, and the talked to ranking something marketplace. us contract, and There's are to the competing case, have but all to about that continue continue out reached

the I I to NTAP question your yeah, to a said, other Yescarta, start. it's as relative think

very every relationship understand of on. makes payers, about very on it's hospital with what make, and That's dependent that's doesn't their or the you cetera. we comment me As tell for To it, hard reimbursement. et sit XX% to

show think hard value do specifics of NTAP the treatment, working details we I CAR eventually can't diligently therapy. for and this I continue to start, is and the are So, you very, that. give T see DRG a hopefully on very more and to

Operator

Raymond final And question from Steven our comes Thank James. you. with Seedhouse

Steven Seedhouse

question. Hi. the you taking for Thank

STELLAR selonsertib Just filing hope either understanding on curious for a the there I'm or if in and is NASH, STELLAR both combination viable that NASH monotherapy clinical therapies is path for refined or need to both you. X fibrosis succeed. forward program designed work basically Phase or you obviously that strategy if Thank subset primary move of the X one patients endpoint Phase the such those to two forward? of trial have trials hits X X selonsertib

John G. McHutchison, AO, MD

question lies and both where programs third in I answer everybody a STELLAR patients think our think independently, trials the FX. So, it's understands programs, FX of around regarding and discussions STELLAR that FX, have of your patients with the have a third regulators I but with the with FX a to really were good question

and was would negative, at subgroups of completely was where to the So, that would one like depend if unscripted at situation just we look a for able trial a there discussion would on one trial example looked different but that what be time. data be was positive that patients,

Operator

participating any for you in Thank question-and-answer over would turn Sung call today's now closing session. Lee I like to the remarks. back to for

Sung Lee

for us looks all in our the interest forward joining today. with future team appreciate on and Cherie progress. you, here providing to Thank and you thank Gilead, updates your you continued We

Operator

Ladies participating program. the for today's and thank gentlemen, conference. This in you does conclude

wonderful disconnect, may You day. and all a have

Gilead Sciences (GILD) 25 Oct 182018 Q3 Earnings call transcript