Earnings call transcript Q1 2023

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Operator

Hello, everyone, and welcome to the First Quarter 2023 Gilead Sciences Earnings Conference Call. My name is Nadia, and I'll be coordinating the call today. [Operator Instruction]

I will now hand over to your host, Jacquie Ross, Vice President, Investor Relations to begin. Jacquie, please go ahead.

Jacquie Ross

good and operator, you, afternoon, everyone. Thank

Executive available market with earnings after The at release, data closed our section Johanna and quarter speakers The today, Mercier; Andrew Medical Merdad Parsey; release press press Chief our Chief call O'Day; Financial our Dickinson. are our Chairman supplemental will and a Chief gilead.com. issued Daniel slides be Chief the our Officer, today's and results website on XXXX. Officer, Commercial Officer, Investors of we of Just on for first Officer, the

Before from to candidates, financial latest that plans no including found operations, we based and A making earnings certain currently are guidance, documents. strategy, financial operations, corporate XXXX condition, get the those started, involve assumptions, will statements, risks, of product let results can and information could me business of be and release expectations financial materially remind in and that beyond forward-looking statements forward-looking assumes All Gilead, of disclosure capital, risks available on description and obligation our business, and forward-looking and differ Gilead and control we all projections, you with related to respect uncertainties any use which Gilead's to press of update products, be such and to our these actual these SEC the cause are statements. results statements. to

as in you earnings well sheet, be Gilead help to business used understand will our reconciliation The measures to in the on supplementary press non-GAAP the company's financial provided website. the GAAP Non-GAAP as performance. release, is data underlying

call over that, With turn to Dan. the I'll

Daniel O'Day

and quarter team The good and strong track-record everyone. the of first Thank in of execution you, Gilead continued clinical its XXXX. Jacquie, afternoon, commercial

of product $X.X increase basis, a sales the base grew by driven reflecting third and total two-thirds across the our we're the HIV oncology. driven Veklury, our business. seeing and On roughly million were in at diversification XX% billion, our was sales the tangible by business year-over-year portfolio. outperformance impact of successful business Once of base transformation, with Our other of excluding again, the $XXX

growth HIV which includes HCV, XX%. Trodelvy up therapy disease, a X%, up therapies up in XX%, and XX% cell saw HDV and up We year-over-year HBV for liver

expected, to lower of As COVID-XX rates Veklury continued revenues track hospitalizations.

result, a from was $XXX revenue first of of As last million the down quarter year. XX%

in as This pretreated our in commercial very received population, On effectiveness another Trodelvy critical FDA cancer. metastatic for the was early the Trodelvy far. HER-X late-stage breast negative been as but for Trodelvy approval the in has U.S. early latest the further that we Its a indication, so strong oncology commercial side, February. of addressing launch highlights need this well patient this is team. HR approval clinical for a This positive third days,

continue We HR half this Trodelvy's to metastatic HER-X negative Europe for year. breast positive pretreated approval cancer the in second of in prepare in

of Another treatment initial this or first ASCO. in key is lymphoma milestone setting. year's the XX treatment years versus standard-of-care will X for and quarter survival patients from announcement relapsed results historical data Yescarta primary only overall at in curative presented Large improvement in survival to overall the study. ZUMA-X of the Phase now the for landmark nearly the was significant Full statistically be refractory a show B-cell a

part progress eight one so on are of is, far. of and the the Turning pleased CROI, this course, evidence of bNAb for just that bNAb of continue with lenacapavir data The team clinical At shared lenacapavir's we're exploring Phase options we combination combination. Xb year's six-month the we for to in lenacapavir long-acting body therapy. combination progress to add investigational the and subcutaneous to virology, positive a as effectiveness our

strong people and lenacapavir engagement living approval treatment. following are experienced interested are seeing prevention for heavily first for meantime, HIV, treatment from of as potential physicians in full our the KOLs and of Sunlenca the lenacapavir who we In with

a first and approval We working in potential significant for forward people, available know, making to available broadly we the soon see the have and look as to available in most approval yet small lenacapavir with the HIV to to a this XXXX who beginning you limited the unmet make as prevention them. As it to forward others with potential possible. living timeframe. having promising number need And very end to efforts options addresses with many lenacapavir of HIV, ongoing more looking the as epidemic, we're people

quarter Johanna first commercial for of performance. a With review to that, hand Johanna? our I'll over

Johanna Mercier

afternoon, the XXXX, to momentum in to a Thanks, foundation firm organization growth everyone. good Dan, execution in a commercial delivered year to and build continued we saw continued set start The XXXX. and the for very and strong on

year-over-year. $X.X on were each our As billion, X, and X% HIV hospitalizations. driven associated Including product and total results oncology, delivered COVID-XX by sales sales show our by excluding core franchises led billion, XX% year-over-year lower Slide fewer Veklury of sales totaled Veklury, $X.X product growth Veklury down up with total

XX% billion, sales inventory quarter. demand HIV driven Quarter-over-quarter, experience in were sales with drawdowns. were favorable the pricing $X.X lower X, up year-over-year and XX%, down normal Slide typically first to we higher by seasonality On associated dynamics,

growth. reminder, reset, patient on at start had market deductibles year, co-pays realized impact and prices average and which a the As an the of

the these And in followed quarter, drawdowns to of quarter. through by meaningful also the year. the remainder a pricing normalize expect We fourth the first inventory in inventory buildup see impacts in we typically

year-over-year of user end a this on quarter-over-quarter pleased we're impact matching Following our better demand. with an effort less and have see a goal historically dynamic, product manage better we highlighting of delivery focused to basis, to both than

business, a stable as in We quarter-over-quarter more contribute efforts compared expect growth these HIV our to prior to years. to

Turning to Sunlenca.

an with number $X have quarter our option living have in-line any, million people of for if the other options. resistance is and who First much small important sales was with expectations. of HIV Sunlenca developed very few,

to treatment. treatment market and engage and with X% in XX% year-over-year potential And prevention, tracking in for approximately X% expectations providers awareness to to the the in in year-over-year. the Overall, over in-line community Europe, the X%. prevention HIV lenacapavir's PrEP of almost leveraging We launch U.S., with the ahead grow up grew continues are and annual US X% with market of our growth launches

a up itself people X. XX% pricing U.S., Slide of growth major billion as driven as markets, dynamics. to US. market-share $X.X sales in Biktarvy leading across markets, its the in including HIV, therapy Biktarvy switches has year-over-year, across favorable and as the XX% a by living inventory U.S., the regimens. Biktarvy up Moreover, now most Moving as rate and cement and year-over-year, position X% were Europe treatment choice of existing higher of other continues that demand, to well well with capturing treatment impressively for maintained new and starts the new representing outpaced has major for as

year-over-year. our for PrEP other of generics, we resilience On including for PrEP. Descovy, at foundation greater Demand Descovy remained sales availability XX% despite options, XX% provides of were as year-over-year. and the solid PrEP continued $XXX million the for once prevention of quarter, make launch for lenacapavir a market its again strong in business potential maintained PrEP towards The approval Descovy up share. XX% than progress

up hepatitis were $XXX was timing HCV, HDV the of Moving disease Gilead continuing slide to Corrections. favorable XX% of portfolio purchases by viral year-over-year, $XXX portfolio. outside year-over-year, pricing and patients X% to HBV Department of million, we're contribution down medicines to The sales $XXX year-over-year and by dynamics up primarily the pricing the of the U.S. sales due dynamics driven million, X% million, our Liver XX. to and highlighting In

with continue all some We trend HDV. start over to the and expect portfolio. In from of offset HBV and across observe given solid HCV our we the Liver pleased time, meantime, nature of shares to market therapy, are down stable curative to

below XX, we were expected, peak infections severe and $XXX of and and less sequentially, Slide hospitalizations to as as levels. On sales became Veklury year-over-year, COVID-related down million remain

occurred earlier expected, As a the in quarter fourth beginning beginning the we the of only winter reminder, and had lasting QX. through than surge

sales backed evidence treated clinical and modestly, of for the path As the and its rates that highly States. United XX% surges and the and well patients clinical Veklury in COVID-XX to data real-world Veklury's grew are share subject hospitalization, lower over it's use hospitalization profile quarter, maintaining the share Veklury's reinforces by is the in overall volatile despite of hospitalized pandemic. tracks

to Slide of and on growth Sales by driven U.S. sequentially, in $XXX XX% with and year-over-year beginning and XX. Moving strong the Trodelvy XX% million oncology were both up Europe.

expected moved year. to a HER-X setting. as to We patients Following HR later extending strong forward U.S. approval start make patients in some breast to early-February, this where this cancer, a quickly with we're in decision in these available Trodelvy's reach new Europe, for pretreated off clinicians negative this in is to Trodelvy metastatic option look positive

force of tumor of across number learnings and but successes meaningful From types, regardless Of efforts breast last course, metastatic negative just HER-X of a by negative recognizing is with also in expansion positive are body triple-negative the a strong here TNBC, in breast field Trodelvy's not cancer year status. overall survival HR our data of TNBC. metastatic underpinned are and metastatic our in benefit. more cancer This physicians clinically HER-X recognition the

were continued growth and Year-over-year slide up the with $XXX first XX% X% Cell XX% $XXX to the Now on sales in million, of with XX. We're therapy year-over-year demand lymphoma. quarter sales quarter-over-quarter. were or to pleased up refractory by driven up and sales for the by in relapsed dynamics, strong million, X%, primarily in primarily favorable and both Europe. pricing second driven in-part growth setting B-cell third-line large Sequentially, Yescarta,

sequentially, were Sales and relapsed year-over-year or demand up for cell lymphoblastic $XX refractory X% Tecartus. driven XX% mantle leukemia. million, and lymphoma both growing adult acute to Turning by

continue increase of in therapy in peer ZUMA-X's adoption time. compelling to recent over we overall believe awareness will addition results, survival including Looking to raise share. to and cell that data cell We the ahead, space positive dataset work broader therapies support cost

to through performance. medicines, look maintaining portfolio to been oncology In of the and rest with year the delivering beyond. forward our summary, start strong the of this momentum current a it's and positive virology year product We

pipeline. I'll with for our And that, to Merdad? update the Merdad an on call hand over

Merdad Parsey

you, Thank Johanna.

strong for XXXX year pipeline metastatic patients clinical in trials studies. brings a XX breast U.S. approval of ongoing so an programs. first initiated negative to our the cancer certain positive HR to including and far additional Phase This Trodelvy with in this our start the X HER-X regulatory XX four off are year, clinical We for

Seattle in February, abstracts CROI presented expertise Viral with late-breaking Starting and across continued on we virology XX Gilead's XX, leadership highlighting COVID-XX. Hepatitis in and among data at HIV, Slide

preclinical based programs confer first in In once and validation In model. shared our data every several from can injection believe we development presented further a a has lenacapavir animal the protection HIV, prevention. long-acting potential treatment. subcutaneous six prevention, in the an for HIV readouts lenacapavir month be lenacapavir as of We providing single-agent we in-vivo data prevention to that option

trials. are We PURPOSE in this Phase currently our pivotal testing X

twice on with investigational two XX% lenacapavir At data of proof-of-concept Xb with week-XX, suppression. virologic generally Phase shared yearly in participants we neutralizing well antibodies. maintained was treatment, receiving In trial Further, investigational the tolerated. broadly combination combination this regimen treatment

all evaluating slide trials now X patients obeldesivir, high XX, also both at from highlights the rates Moving of with oral of enrolling. Phase real-world two investigational first to that shared the among we side Veklury of are CROI. that COVID-XX COVID-XX. readmission in right of patients risk nucleoside patients positive Slide Veklury death admission, our on The showed These days GS-XXXX and within in analysis hand of and three hospital standard or COVID our analysis risk initiation data oral retrospective reduced hospital

time regards epidemiology to COVID-XX, to in enroll with could cautious uncertainties take it of to trials. the Given of we global the fully length continue these be

on build as portfolio. momentum Slide solid the continues cornerstone of tumor Trodelvy Moving our XX. to to

breast We've on based the Commission of filing, this the seen expect in acceptance adults additional expected, continue This and who European received therapies trial. Phase year. to HR endocrine-based therapy is in the overall approved X is a the cancer, the Trodelvy for regulatory our second third HER-X approval disease. As metastatic Trodelvy least FDA European and previously in its benefit received at metastatic TROPiCS-XX from two survival FDA with negative positive decision for of indication. now approved systemic already half

Trodelvy for lung second ongoing. The Phase line cancer non-small potential cell in EVOKE-XX trial X evaluating the is

pembrolizumab the also Additionally, line KEYNOTE-DXX. study Phase cell cancer. in led EVOKE-XX recently first is trial for non-small as by X Merck with lung This evaluate high FPI being to Trodelvy PD-LX combination had we known in

including of accepted in including the programs been this presentation over data to we're do ARCX XX data updated breast, Additionally, abstracts and oral have announce year. abstracts, portfolio. Trodelvy an only that investigational therapy insights targets, trial cell bladder elements of highlight new and on of promising these Not at our ASCO lung many the cancers, excited our include our dombinilumab

an to treatment pleased from Recently, survival the These adults I'm relapsed ZUMA-X XX, data new of the in Slide the initial within lymphoma. only late-breaker the kind will statistically on or oral large highlighted X Yescarta overall Phase first ASCO. refractory years. B-cell discuss as clinical therapy therapy. versus for and standard-of-care to made which, at almost with benefit cell of presented data significant be Speaking any show Yescarta trial is evaluating progress overall survival we've of we XX

As within our leadership cell out in therapy current earlier we we're work to stage our programs. building extend also portfolio, our

tumors. preclinical As mentioned Arcellx's we pipeline closed myeloma. or clinical earnings patients our Community call, our and blood with our of in closed CART-ddBCMA Therapeutics to acquisition treatment in relapsed co-develop of in cancers solid refractory co-commercialize for agreement last the Also, our extending multiple and February, and we

our Community pipeline. to integrate currently broader into are We innovation asset team with their working the

sharing Wrapping you spans that oncology, which can key updates journey. Gilead pipeline the well-diversified up are highlights and its XX, approvals are readouts, we this The in programs we as stage. FPI's, updated Overall, inflammation. see clinical and across the indications transformation made on across milestones virology on that and XXXX, that XX has Slide progress regulatory data expect

to you I'd have of to to has as progress portfolio. through that We updating the forward progress tirelessly thank team look the We we Gilead like program, clinical and ambitious XXXX. and our accelerate worked an execute

over And with to Andy. hand that, the I'll Andy? call

Andrew Dickinson

billion, up the families, year-over-year and despite Merdad, growth first base base $XXX total basis in with negatively sales, a by to quarter product lower quarter FX XXX Slide growth first XX% approximately everyone. points sales, demonstrated you, strong X% start in commercial XX, $X.X million, HIV. sales oncology, growth. FX excluding total product Veklury, almost afternoon, down growth our XX% our each and headwinds. to business. Thank continued in Overall, the was XX% on Starting our of in product Total business Veklury offset due by were partially sales good of product year, impacted representing including growth

points partially Turning in was percentage to product and offset quarter due timing Non-GAAP of gross from margin of Slide things, royalty Biktarvy product last X.X the other benefits. by initiation among year, the mix, XXXX XX. down first the XX.X%, to, inventory

due expenses clinical $XX higher OpEx, billion, we R&D higher anticipated the due to pressures. well to was $X.X and including items. acceleration in of up Moving as expenses, investments one-time R&D XX% quarter than in million inflationary first year-over-year, were about Non-GAAP late-stage studies, to the as certain

including Merdad total XX, Phase As the trials mentioned, XX growth. X making are four certain started brings expected, we to new X new the lenacapavir trial with for was Phase have we This of ongoing so future and far investment this notable studies ongoing number enrollment year, number a of programs. in Gilead's we trials a in trials in example, Trodelvy for and lenacapavir faster than March. acceleration, Clinical highlighting

as programs patients been we has bring see expenses this team as impact clinical are hard trials, to close and Our higher fast to believe includes the options the working some to and therapeutic first the R&D advance although that rapidly can. working acceleration we peers we gap our our new to studies these of efforts in quarter. certain in in contribute did starting have to This

past impact ongoing of manage programs expenses continue with and based the process prioritizing to potential practice, Consistent carefully, we data. will on including

now build to our last the well areas. the robust trials Gilead's XXX most taken clinical several three years have with and pipeline in targeted We across history, therapeutic diverse over

$XXX data acquisition up driven over the be the business, a inflation. of Non-GAAP related Community, impacted to collaborations. to years. number was readouts corporate R&D to with and upfront oncology fee and million, and excited SG&A and commercial associated drug acquired was primarily Nurix by to investments next by expansion $X.X many the building payments as Non-GAAP Arcellx billion, IP to continue these year-over-year, well expenses in primarily in that with later-stage milestone our branded prescription higher programs higher our are as so of XX% due trials expenses expense momentum We see of several addition in

first driven quarter non-GAAP than $X.XX was compared earnings same our operating Overall, last gross period lower in for Moving higher tax recorded expenses discrete share reflecting in product XXXX lower quarter. to benefits expected the diluted the our XX.X%, $X.XX was in rate non-GAAP the quarter to first first tax, tax year, by of effective the per and margin.

guidance. move is I'll to for year Slide guidance the now on to our XXXX revenue full There change no XX.

billion of billion, Veklury the for of range base to of product sales $XX.X in expect growth sales $XX representing billion continue we billion $XX.X We year-over-year. business X% and range the X% excluding total continue product expect to in our $XX to to to total

what On year, billion from volatile some guidance full related first in quarter the this are as and and below COVID-XX know our unchanged the an year we internal leaving pending assumes sales We from we increase points was our expectations later at year. Veklury, guidance move dissimilar modestly saw data XXXX. not our point through infections additional experience in that are $X extremely

Moving to the the rest of P&L.

in to we targeting clinical portfolio low investment percentage continue this believe compared of an double-digit a for revenue low with overall XX%, margin XXXX. We now total a investment full sustainable XX's of the revenue. opportunities expect and non-GAAP broad more is to that This non-GAAP as as a target of a full attractive appropriate year approximately company to the discussed, resulted product for a is R&D level year late-stage growth. in R&D percentage We expenses increase XXXX gross

include course expected of transactions non-GAAP million, as R&D we additional over approximately announced Similar prior acquired committed year. we $XXX the amounts. expenses to the IP IP R&D will R&D to be to to acquired continue IP reflecting acquired We previously quarters, continue expect

to declined digit year our full XXXX. where no guidance, we a a to non-GAAP expect by to change SG&A, Moving percentage compared prior there is low-single

plan we no this $XX.X to there operating look billion. to Although partially continue is R&D offset investments, range income higher year. the will of to for billion now change expectations $XX to we Overall, non-GAAP opportunities for in for the our

continue no and we is tax-rate tax target there Additionally, to non-GAAP XX%. to change guidance, our a approximately effective of

our And expect you continue first, allowed the $X.XX finally, broad in the And guidance of range shared are prioritize expect and per that second, diluted we we initial in share, for a to revenue to XXXX. with that in EPS GAAP to finding range R&D committed and choosing $X a expense early-February range reflecting, EPS $X.XX. the in On basis, scenarios. we $X.XX room non-GAAP we're investments to of in higher absorb P&L be overall to of diluted model to potential we that the

Slide $X.X priorities. our there shareholders billion quarter to and the returned allocation you in to can Moving no through dividend see of change first We repurchase XX, is capital our to shares.

in with Finally, growth enable to development, or or acquired built, we can in to of us the continue we've quality our to breadth expect the business the business. mind, the access acquisitions that no of on comfortable and years. are partnered to it change partnerships and through make is there will in With very opportunistically smaller quality high you assets that the philosophy, pipeline coming course the normal

I'll remarks. for it And some over Dan now, hand to closing

Daniel O'Day

Thanks, Andy.

prepared transformation. for Q&A of our is open noting just summarize by we another quarter Before where we continued remarks impact this the demonstrated I'll that our

thanks maintaining the portfolio, and to With to of committed track to positive building record the execution in momentum, recent on our dedication on world. quarters, financial are and clinical strong this Kite look-forward while Gilead discipline. teams, the delivering we we've that we Going-forward, commercial shown around to

I'll operator the to invite open that, the Q&A. With

Operator

Yee question Michael line Jefferies. Michael, Instructions] [Operator first open. of you. your go Thank goes please to Our is ahead, today

Dennis Ding

for two, for about how progress And of maybe the competitor? you clinic then yet? would you the Ding Hi, inhibitors in look would are just and can Mike. talk competitor Thanks they expectations HIV. perhaps this PFS us, for you from differentiate? your see what Dennis the like at oral your And could taking Thank you. imminently? number you questions. long-acting like What number one. that's integrase for the data Are your And Trop-X is Two on coming to

Daniel O'Day

the Thanks questions. for

of little already it's really yet. breast data, us we across to We're haven't comfortable data in led the the with certainly OS So data for terms think I shown we've competitor in doing seen to benefit. and Trop-X a early have cancer approvals be with comparisons

market data where we're the cancer see Trodelvy can you breast impact are. has OS for being and we So, and approved of having uptake patients the in with from that had those an comfortable very

on and emerging keep Of we'll course, an those they data every available, become indication. as eye

have [lenacapavir] available. as oral several and data terms number clinic of for we and, oral then of and Very well programs our long-acting parenteral an to you to of we've the orals, to formulation. remain be our And injectable, oral about into become excited know, to as both go they about profile sharing long-acting long-acting portfolio, the including a in both long-acting really we them, moved excited the in that. -- and long-acting as portfolio clinic we'll committed (ph) as do those That leverage portfolio into program

develop, stay-tuned data share. those as gladly So we'll

Jacquie Ross

may Thanks, question, one remind as we so next possible. the callers all that in themselves have to question we to Nadia. many queue I our to folks can as get And our please. limit please Nadia,

Operator

Brian of ahead, Abrahams line your is The go you. to goes next Brian, please RBC. question Thank open.

Brian Abrahams

much Hey, and my so for taking good afternoon question. thanks

and meaningful to ASCENT-XX about support what's expansion? potential earlier thoughts optimize your negative little post Thanks. to trial could I wondering optimizing approval? lines its talk in use Trodelvy, regards population moving commercial to of patient across you of terms seeing for if those -- expedite different you the you're this bit And latest HR indication, the this about Regarding positive right design with what guess lines I HER-X trial was along enrollment therapy think on to a the in as lines

Daniel O'Day

and to O'Day Brian, much. of your answer Dan Thank Johanna Merdad the first you. the part so question here. going have I'm Thanks then second

Johanna Mercier

Thanks, Dan.

in think And uptake, HER-X strong far line what seeing in is plus pleased really launch with that we've But earlier think lines the with up positive that's with we line. fourth I negative. we've some data us even important basically And seen third initial the basically, moving HR addition in so for helped, early had really think share shown, we've that So been as about I results trials really even the we awareness, done survival of survival of we’ve has the in we've overall because work the overall to community in strong also metastatic in obviously, TNBC that Trodelvy showing as that well as in extended year that really team last academic helped HR field launch negative. work the make centers, we we of the positive HER-X did and solidified us has sure therapy.

So patients couple only on and can we and have still right really a the of for this months track of But physicians what definitely bring we're Merdad? the early, their benefits seeing setting. understand in they in. Trodelvy

Merdad Parsey

And you move this in year. lines second getting and looking ASCENT-XX. population. know, that of do half started of we're study in earlier Yeah. that be the as as design into in anticipate the we terms Look, of going to we therapy study, then chemo-naive at And

excited moving The very about design really So be out. things program. will rolled that are final along of we and nicely, are terms in details

I in final of right think crossing now that the we're terms protocol. [indiscernible]

short posted that see you'll So available and in order.

Jacquie Ross

have question, may we Nadia, please. next our

Operator

Chris go ahead, please The JP you. next is open. Morgan. to Schott of line question Chris, Thank your goes

Chris Schott

you year. little this double-digit R&D obviously are programs just bit for in operating some had Gilead's can question. R&D so we've accelerating OpEx, how a I one got should step-up the about be Great. Thanks much sounds thinking talk like you about this costs and we forward? going on It just

margin I think we maybe can about of think for to investment can guess of or the about margin operating or year going Thank levels, do company? about about kind expansion we going As we dynamics you. of the expansion think forward. margin start need another to two think we before XXXX off forward,

Andrew Dickinson

Thanks Maybe it's and back, stepping for the significant the in us portfolio that Dickinson. long-run. Chris, we've a just short-term great that as That's Hey, large again, Andy for built diverse question. positions really both highlight the and well in as a growth, reinforce question.

some and clinical we're pay really that, to in investing to an which our significant into is leading heard development, remarks, you had kind As our focused dividends. starting accelerate accelerated prepared efforts we -- of of

in validation and the our this Johanna strength our approach that the of seeing across results also highlighted You're base commercial business.

revenue your in already frankly we're that, for reasonably is are X of to be greater my year, year to we highlighted years of are But more believe We R&D investment. line that Phase XX's percentage think our company, comments trials we that good kind significantly a we we that's I will XX underway, point, targeting which as a have healthy this this the have of So level, actually I think historically. low now than I point the a on And what it's years over kind expenses targeting. have there that's peers when be. with and long-run, lower. place over cycle, than we're It's

what healthy comparisons of Again, with question start. operating great and operating your So we we still know. there's our we is above the do you you've as margin, oranges on IP which see R&D new very rules. a a the Phase margin as then months, to have to we expect over already margin, maybe have we get -- and X operating But growth time, drives again strengthened beyond to think XX and in this bolus last underway that seen and trials through off that apples

your come, good to our more little going it, time but to from perspective. to point, get take we're So to a in more through spot a it's very

Jacquie Ross

question, Nadia, may our we have please. next

Operator

go Thank your line you. question of open. please Richter ahead, is Salveen goes Salveen you next Sachs. Goldman The

Unidentified Participant

is it through XQ. question for data, OS at And for update? you now Thanks the do on anticipate front? which [indiscernible] data TIGIT this read combo our view much Roche incremental? then more on How is this that just ASCO. taking Thank afternoon, Salveen. on you. Good you just Is on How expected the in do

Daniel O'Day

will we an we said Yeah, more recent think have updated What I a cut. have is, we're planning dataset from thanks. and what

So there'll with about presented, data ASCO the be was what talked compared additional what we year plenary. at last

there so, population. patient data a with should be mature And more larger

our confidence. that help And should so reinforce

it's data, terms In think the Roche of a I great question.

the own benefit in we've Certainly, will to our rates in the are of dataset is other in that adding expectation bringing case. response those demonstrate data, And of -- other think, in in data well we PD-LX as I benefit data out our PD-X terms Roche so our public TIGIT PFS TIGIT inhibitors, terms there seen inhibitors their believe parameters. benefit. certainly TIGIT that as, all Look, continue -- and to

So out all to should and help seeing antibodies confidence I be the there. will data to think provide those looking TIGIT we forward to OS that additional

Jacquie Ross

Nadia, next question, please.

Operator

Bank go Thank is you. The of ahead, next please Meacham Geoff, America. Geoff your open. of question goes line to

Geoff Meacham

appetite same what's towards think you guys. afternoon, so what much why look has leveraging leukemia, your the indications been and successful non-oncology is pipeline I at at guess, liquid you maybe I cetera? tumors? Thanks like do steps targets in tumors. you it Good or the question. like expertise the Kite field have of to rare guys diseases next wanted for ask to is, the logical for lymphoma, you. Thank looks and Great. with the solid commercially mostly evaluated some terms very Merdad, And et myeloma,

Merdad Parsey

really T-Cells reasonable a I brief Thanks, tolerability complicated great to think try for I'll question. answer. population. engineered Geoff. hematology Very and that the give that in patient far very has profile so demonstrated Look, leveraging a efficacy

index. therapeutic I about all think it's

you As broader options start is state go the different are indications different. into treatment to disease where and

index. I are considerations different think for they therapeutic

antagonizing appropriate close different whether broader or on oncology lupus question. outside a a therapeutic about related populations, of keep we that maybe the eye your to look into From perspective our perspective, you're index we're for patient, going else anything talking given to the I agonizing immune as believe So, system going blockade very outcomes whether patients. targeted hematologic talking and do believe and lead we we to you're better or for in the better getting that about better that, disorders, immune be more that is will to do offer would to in-patients, is modulating

about in And our have cell in we and seen modality the I BTLA from therapy so, not we there like that's you've antibody is and we're -- we've our to portfolio and play have our deals not perspective rest inflammation. our done, only of that, we portfolio is the restricted, what think

outcome and of best of be cell the for patients going modality regardless are So those. certainly, pursuing we therapy one to will be

Jacquie Ross

question please. next Nadia,

Operator

please Terrence you. open. Stanley. Flynn next ahead, is to go goes The of Morgan your Thank line question Terrence,

Terence Flynn

question. so the taking thanks Hi, much for

Thank right Just on from of seeing breakdown you between us give color you color supply out you. any that's want momentum. footprint, patients CAR-T versus longer-term issue any in third-line terms Yescarta. wondering maybe understand I the of to been if for second-line just Obviously, year. some me other now. terms nice supply was Obviously, on therapies there, total the just of some can an And there number of can manufacturing dynamics. then, kind of you're in one but more the in a

Johanna Mercier

Sure.

start me the then touch maybe can let of So manufacturing on the puzzle. and piece Andy

question, the Terrence. So thanks for

only really growth we've help that ASCO the coming and be little but differentiated in as second-line, slower really seeing from ZUMA-X presented obviously, what second-line data continue strong will through, the into I seen and I think a we think will that that are current is at and versus across OS well second-line standard-of-care. third-line, momentum coming and nice

-- second-line from well And importance actually last today for as in the that of just has seeing nicely in Yescarta. have to actually reimbursement is and is markets of patients, one NICE just example both second-line year, therapy lot because happy of getting we're reimbursement, recent Europe accelerating coming Europe the with a a late for for approval growth we and it approval of as, picked-up in what actually with U.S., really the got data quite you're say we and that seen although but really

very a understand make that overall so second-line. opportunity growth the And that sure to the sure physicians benefits about still obviously, in patients. going. And team are and working well-educated for excited survival make is really is lot this long-term the diligently to they we're There's where of these over

So for over more Andy to with that, come turn it that. manufacturing. I'll on And to

Andrew Dickinson

I you Johanna. Thanks to And for On Terrence, hey nice is, manufacturing, Yeah. a us. strength to say competitive again. area of talk for what that’s would Kite real

approved manufacturing globally, two each one the the three have and then we centers in in know, coast, on one United you As Netherlands. States, the

operational, automation outstanding to Maryland of off and an we fully start we're in are which our team. just them process, facility to a have moving of our All already great is partial manufacturing

not on the either So had on manufacturing cells of the we constraints, vectors. capacity the have viral or

California an made our outsourced internal Oceanside, we and So -- viral remember, both own viral an vector supply, have facility. our on we biologics vector vector a

but serve think, specifically our don't have manufacturing I to adequate capacity So footprint, capacity shared we we've the today. Terence, assured, of rest the market

Our team We're change. ahead of don't we to a two great job steps that does one and always forecasting market where the expect going. is or

an standpoint, just has the really job. outstanding manufacturing done team a Kite from So

Jacquie Ross

next we may have please. Nadia, question, our

Operator

Research. go you. of is Thank Anderson Wolfe goes next to please your ahead, line open. question The Tim Tim,

Unidentified Participant

accounts my of We IRA Tim. targeted Hi, the the volume negotiation. Adam question. think that Also beyond by it Biktarvy, impact possible thanks are is are IRA of it to and exclusivity the that on portion need next is doesn't decade, discounting No extends you the possible, aspect done. know but before This that gets investors commercial limited to the taking [indiscernible] pricing Thanks. patients? it's over the on for Biktarvy’s behalf other

Johanna Mercier

one, that take I'll Adam.

have do believe IRA will that the on So we an yes, impact Biktarvy.

Although happen could do decade. how and obviously, between is a this probably so. and, earliest play-out, things be negotiations Medicare there going of It absolutely again, The exactly said It's pricing will that including lot we it business later in what XXXX can -- early then. that or it's still the is happen. the now to understanding our believe only be true. is And you on will

to in channels. within manage effect populations patient in that We spillover specific higher been commercial other to those had discounts channels we've channels, mentioned. that have we the the able obviously, today, As situations, that and believe you where to our we've

And and here, believe we so We're you different again is our with about combinations we have spillover. managing of be lenacapavir of much think convention expanding able that so XXXX going to with standard-of-care -- do continue mitigate And think for to so, obviously the I addition that the also what the in work. we're and think really to that to orals. portfolio where I we that as as daily that out Biktarvy our as yes, we're be kind portfolio will risk and our in fact treatment

on but of the couple of a we're the and out situation think that, years IRA. prepared to I within more more the to have some different So than to dynamics come manage more figure

Jacquie Ross

we our May question, please. have next

Operator

question to next of you. go-ahead, line Thank Umer please goes your Evercore. The Umer, Raffat is open.

Umer Raffat

Hi now guys, thanks your Daiichi, in on up in in HERX-low I number Trodelvy saying competitor, TNBC growing. quick light for terms prescription to in in trends of especially share patient taking real question. one are tracking the have of they want how particular, touch and my

So got out, this new I'm just curious a because how shaking indication you've that's I know quarter.

relates HUMIRA, maybe $XXX,XXX. and each CAR-T, dose interest And times of I least secondly as therapy But points, But the of especially conversely, also, there's it that to $XXX,XXX. as cell I immunology will be think in X a would immunology. lot be renewed so at would imagine price

So how about head you Thank much. potentially you into do think immunology very economics indications? you as

Johanna Mercier

the I'll specific MDC. take and Umer, in metastatic TNBC seeing what that to first part and of Trodelvy we're

OS the that The the data and to TNBC what piece is right? our field in Trodelvy, TNBC that we've do the data So seen expansion through, of for lot but comes a growth really one puzzle. also continued has in of actually stores, continued is with

in The that other HR-positive. the is OS piece we've also shown obviously

the breast space. cancer understanding community that better really So, Trodelvy in

the market really split the population. and physicians between HERX-low have neither this at point haven't of split market We kind

seeing HR-positive/HERX-negative. that. the is Trodelvy of plus established to is look of that indication, in therapy we're and as what do metastatic TNBC And in the So lines itself standard setting, second really TNBC each this and is care it in at continues we line what

TNBC, IHC IHC X the and X is So XX-XX. I between do think, and X remembering just split in

we spectrum, across think -- our maybe really competitors. I So important a of some much is remember. more that, which by represented represented to so less work Having said

Trodelvy the right TNBC. metastatic dynamics in that's now So

Daniel O'Day

Umer. Great, O'Day is This too. Dan

I can in patients the benefit the I a is on to of dovetail second lymphoma one. large The I'll just disease, up survival benefit system line fact of CAR-T from and the late-stage pharmaeconomic imagine the that, five index. about B-cell let before Merdad I before lymphoma. the in think price to large But point appreciate them current therapeutic said curve, XX% tremendous what years B-cell now articulate you we the standpoint. that mortality a of -- of on me very both cost have from providing essentially a your and question perspective a do importance flat that surviving

that, those brings I would think that to other price point patients. upon based any areas in therapeutic particular benefit be clinical the

segments across And brings, be the the use we therapeutic it where wouldn't important. and of necessarily at Of benefit more those broad-scale a for accordingly, types course, index patient price then all level understand of we of There will different patients, to patients. health course. care to patient both the the be look this that and system that is would

disease that seeing take at in this But So to would I the think hypothetical same it's given other we're the stage. we states. approach benefit cancer,

Jacquie Ross

on our many as to another a to to one possible. please like reminder, the hoping limit get as folks yourself We move do to ask have next just we to question As question. still XX call, question and we'd

next So our question, have that we with please. may Nadia,

Operator

goes Tyler Cowen, is go-ahead, question line Please Tyler. your of next Van the open. course, to Of Buren

Tyler Van Buren

figured line in I tremendous the opportunity leak Great, thank differentiate guess I line, the I taking program. in for setting that thoughts latest that you very much and Arcellx with second your question. ask on given data for you plan top Legend's how the would to

Andrew Dickinson

potentially Obviously, Hey, question And behalf full Tyler, I'll we team. read. you've get Kite interesting data Legend it's very par or be potential on We area continue want product. now see the the than of and the Andy releases the have the competitive to very better take Dickinson. that and to that to on Kite program read set. believe we others the J&J same Arcellx has a to in that that

benefit that across a the therapy to of where of disease becoming and earlier, in the potential potentially cell us And patients over increases the exciting to second-line opportunity doesn't that as time, for course, in delivering magnitude which, of go Arcellx cell terms Kite care standard Dan size may as team. the BCMA see come of of to it's is it surprise And said different therapy areas.

like forward data, with the great to fantastic a patients. to look more and carrying team seeing over forward our time. certainly, to and it Arcellx So you for But on look forward set updating data together looks program

Jacquie Ross

Thanks, Nadia.

Our please. question, next

Operator

your is Please go-ahead, Co. Hartaj Our open. to of next Singh question line Oppenheimer goes & Hartaj.

Hartaj Singh

Great, two XX know EVOKE-XX cancer. lung But question. cell non-small years year and still can lung a scientific little on opine Trodelvy bit just remind of I a non-small trials for on in the Thank quick cancer are thank Trodelvy guys, or you. just and out. rationale Thanks about the those just I in the had reading cell trials? from just us to you question behind you. a

Merdad Parsey

non-small cancer. the non-small things terms think Sure. several dissimilar us lot we I give forward there Hartaj. not of of from of confidence cell moving distribution lung cell breast in Trop-X expression broad in in cancer, a demonstrated -- lung are that Yes, cancer. too Certainly, has

those efficacy think so cells. in by those tumors is us of And the I us that lot give Trop-X delivering believe a to incentive to that expression gives the payload going to of

Trop-X cancer. data ADCs directed to Secondly, and cell we've seen external of support internal that non-small both Trop-X bringing conjugate lung targeted value antibody drug for the

it. about been has we're which very approach, broad and our So excited

going in cancer, going I and are, you we line second non-small very is as well know, that cell into lung well. is really is study going EVOKE-XX think,

we we'll is second-line start high. at cell. And are to cancer that that Trodelvy Trodelvy see first, those believe our for in to We And combinations we'll very in start potential go. from would on that tumors in as continue then in trials looking tumors and well non-small you looking PD-Xs to those We we build in out studies think front-line lung as with the data those as then other of roll our imagine.

Jacquie Ross

next May have please. you. question, we Thank our

Operator

open. Baird. question is next goes line Brian, your RW ahead, Brian please of you Skorney Our go

Charlie More

Charlie right, for for about question. All is More taking on thanks my a had question lenacapavir. This I Brian.

like viral the data it out of case one experienced XX with seemed So BmAb, with to recent regards the rebound. a

HIV? kind you. So same inform line, for of have I along that thinking was market in forward you that Thank size And you of of combinations which are expectations how overcoming wondering what kind with do the regarding the might long-acting about resistance. moving

Merdad Parsey

new in Look, Yes. terms for Very treating of are important I associated And HIV. we're important approaches people not the it's in look that's think many right? of taking. resistance, with that, to lenacapavir keep clinical options that tools BmAbs one mind. breakthrough for, was relatively to really And

both has been foray that Our into true tried that to again, complement to will bring rates people used, opportunity provide orally should we treatment and low HIV that broader options or efficacy. that move with living approach portfolio associated and of with to BmAbs, parenterally, with where an us have long-acting mechanisms high to a early believe the be molecules small resistance with we

we're what that's testing out. So

I ideal we partners, the will that intentionally, plural use and moving find As be the forward. we

-- And long-acting those so, I with for people at would first a an as the treatment living HIV. look approach BmAb data early to -- early

Mercier Johanna - A

part question the And maybe size second the around the of market. Charlie, to your just cover, of

do out. long-acting it split about the market will When or to you look this think of going about end a I'm the by market, so. probably believe We decade, So we standpoint, treatment think the think that there to XX-XX from really what about us to looking they to that next-generation for. definitely have and reminded are they're long-acting that out patients are HIV there that bring be for an to opportunity patients looking not the

I at need think kind in this medical the space in this of point last that's the unmet time.

daily the something single a HIV. every there's put I bay that want take oral be their to standard actually medicine they're also in of lot still to do day make to at that where think their taking the sure continue that care patients they to know Biktarvy will of market,

wanted on the our very a standpoint, PrEP in view. -- different just the expansion prevention touch from to market, Just I

some very And market expansion are the HIV, that different, at but and here of seeing different. partners also what discussions had people risk is split we've the with is community probably we're is

is So assume. go decade what XX-XX the towards the of end split we probably going to by is this

take they patients, That a risk, don't a something are fact the want don't have. and they that not day at these people lot do necessarily to a pill are these for to has with

of sense. a And lot so makes that

So this scenario in an something every six months aligned with physician ideal setting. visits could be

talked an And know, about expansion lot. this as all we've then you standpoint, from a

number those only captured that that that And people at kind under at that XX% U.S., at about CDC XX% not still are the folks the of you assumptions If we've there's the risk medication. risk. around and are unfortunately, are of currently look in of are

incredible so sure months, to really And together expand an and there's epidemic. end to this truly every with especially something that opportunity, marketplace six we work this make in

years, the treatment in as a to hopefully, just partners two the we'll next approvals in after with lenacapavir times that out then was mentioning. very and and Merdad come. bit that exciting data different So, have reads And prevention within

So very exciting time.

Jacquie Ross

please, our to Super. We’ll move Nadia. question next

Operator

next open. goes you. please Steve Thank Raymond your of Steve, question line ahead, go is The to James. Seedhouse

Ryan Deschner

is Deschner there, Seedhouse. Ryan Hi question. this Thanks for on for Steve the

current clinical the the versus amount the successful? And anticipate do usage in large usage potential of nonhospitalized split its nonhospitalized with development Just Veklury. a for hospitalized cannibalization you is coming if from curious remdesivir Thanks.

Johanna Mercier

Thanks.

So Ryan, I'll take that question.

so what last of of somewhat hospitalizations as the a obviously, standpoint, have lessening from well. So we the and seen is severity less infections, of hospitalization in or a year therefore,

So different we've seen a of things. couple

more as know, hospitalizations numbers non very seen late, in that because we've much the tracks closely Veklury to you obviously, obviously So well and hospitalization. that of

guidelines, showing delivering mortality keeps Veklury that strength of hospitalization. and has of hospitalizations do fact up. that usage reduction data that's the our in real-world lot updates of is, that's of come for And super versus the readmissions Veklury in a gone out what has And of strength the to have to interesting. the the seen despite continuously come in our data And down reduction data, we've with the QX, that expectations around actual

very our Having the quite with single in growing. powerful digit a -- But it's is but is setting definitely that still in so. the is of play bit really approved it small, a hospitalized only outpatient use data, is COVID-XX. So there. This Veklury that, said antiviral or for

so drive. that to continues And

make COVID I sure at think really setting, I think they we in setting and setting if patients our risk do the to think which that are that think I get portfolio in what about need would nonhospitalized thinking hospitalized infected. both have more program, we they we nonhospitalized what have nicely then our as oral the works the complement

Jacquie Ross

next our have please. we may Nadia, caller,

Operator

Yes. The Olivia to line next is of goes ahead, Brayer Cantor open. Olivia go question Fitzgerald. please your

Olivia Brayer

for for transfusion And afternoon for you especially can the Have when drive thank adoption in magrolimab, help you through to guidelines initial question. initial setting is started rollout you a and you strategy think that look guys beyond specifically? to Hey, there -- community academic centers? commercial anything good the of do

Johanna Mercier

I'll So Olivia. that one, take

sure. are waiting about think We're for excited, obviously. we model are read the thinking excited, about magro, out. we As we we data our to commercial and have for started But

a couple pieces of one. think that I to

One the what of Kite we like, the strength making brings play kind the that in community well. looks as strength sure understand and of also this that but is

also been standpoint to learnings So very that we're through. -- of sure starting can overlap going not we colleagues to there's of with We apply there that partner that we've a lot are our from make from think physician a lot we that scratch, working Kite closely a I and right?

lot pieces a play. So of those are in

support And and that standpoint. and execution that basis make on sometimes and thinking, in fact will when piece we the as making would are our our also little not just to trying well see a to add an regular commercial better the game with and diseases smarter physicians sure understand and where a the right? timing that from I last bit the and get do being how commercial model we has model we're understanding, to also of the say, These to the do approach that sure community ahead that

are pieces play. only But as not coming for data. obviously, be So, but the ready the we're for are we we all those well. and But anxious the into approvals sure that data, will excited

Jacquie Ross

here. just more a few Naida, try and will squeeze in

Operator

of Of goes course, Colin line please UBS. to question Colin, Bristow open. your is the next go ahead,

Unidentified Participant

question. for [Ting] (ph) Hi, this Thanks on is Colin. for our taking

also, can of just arm And CR back magrolimab, in you control and the your for how update? the what's expectation trial? chatters the the and more high-level what's of planned the expectation ENHANCE for year, total overall the were or outperformed other survival there -- some -- interim disclosure for the azacitidine a actual many will half data specify intensive trial, update Tekada's regimen. of around dosing be III were on a used your side arm? There they where And interims in So Phase for

Thank what's you. So this? over thought your

Merdad Parsey

Sure. the question. Thanks for

that So analysis, the for is of reminder -- study interim in it's analysis. a the powered final the terms good the

for we've analysis interim which And to we final analysis, guided that any the occurring our expectation year. so study has next think that is I run to

is occurs, that will to When the an just not we data that. nothing analysis won't Generally, there since will share generally either we to happens continue we if seen the and share If data. tell us because we DSMB it. to see -- share that or interim discontinue, continue have continue, it's the But we'd would other potentially what trial, discontinue. don't have any be will than we obviously,

than would trial. So of is the end earlier be run our that, the that. certainly something expectation saw we if to It we upside

you're of And the then right. expectations, absolutely I think in terms

of are efficacy at wary that looked to the population. has performing everyone data Takeda think in I the azacitidine and as patient in

of going end the at see we're to so have to like trial. wait what the that and And looks

it a very have I'm we treatment But that are more assessment. that's to buttressed to by told guess, fact bit us I a effect. the indirect that going has the confidence we a -- gives DSMB me -- trial, of continue see little the

see. we're So how But to trial. for we've assumptions terms powered the in we are some power to -- we have going of made

to able detect difference between be we'll hopefully, two. So the the

Jacquie Ross

may question please. time just Nadia, for be last one

Operator

you. Thank

your Mohit final guys Mohit. ahead, Please Fargo. Our line go open. is Wells Bansal of question

Mohit Bansal

tuck-in. about back? this could has an BD anything position you thinking with But Great. point. Thank changed urgency on growth question this there, a no about you you at at maybe there that good in for point Is and in BD? the you know a thought how updated you're past, about thinking there? coming mean, now I be talked taking I the my And there's are question.

Andrew Dickinson

think bring mean We Andy. new and it's exciting products that I to recent is question. and of over changed for stop. don't to going the we puzzle for important from BD into Nothing's our Mohit, Thank expect to innovation It's us continue you the part time. our updates. important that portfolio an forward.

extraordinary made proud That progress and point, have said, last that years four we the of. to we're your really over

active. breadth and recently our expect still four will But be that And do -- should depth we will And three last do given less did or said licensing years pipeline, will ordinary we what reinforce so the breadth course and we've over of than the the the is you deals. I'd that years. over coming we we

We've will it which I point, point. way would growth, drive we Obviously, to think at time and is you expect we excited last can, to about deals saw look great about will always to to if a excited opportunities that very year. Bio Merrell the what deal, the that's to that's Community we're small about going a your patients shareholders. and do We're acquisitions. of in in for about. benefit talked this and spot. then it, we But our add think But And the to Arcellx to from portfolio, do our all thoughtful we very way time

Operator

time That's questions the I'll any to today. have Dan back closing comments. we hand you. now for all for Thank

Daniel O'Day

we continued so is to foundation just XXXX. line want XXXX. had And on have believe a strong very you Kite Gilead a you building interest I and we've and momentum in we year joining firm collectively from Thank the Look, strong continued much. to the growth your for for thank for all bottom today very Gilead. in at start

you. happy to to Thank more and IR very support and Jacquie be or team, your to didn't please follow-up for than questions, out As questions additional joining. get much usual, if you reach you the we we'd have

Operator

you concludes This call. joining. so much Thank you. today's now for Thank

disconnect now You lines. may your

Gilead Sciences (GILD) 27 Apr 232023 Q1 Earnings call transcript