Gilead Sciences (GILD) 25 Apr 242024 Q1 Earnings call transcript

Good afternoon, everyone, and welcome to Gilead's First Quarter 2024 Earnings Conference Call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. [Operator Instructions] I'll now hand the call over to Jacquie Ross, VP, Investor Relations and Corporate Strategic Finance.

Thank you, Rebecca.

today, the a first closed earnings release market for results quarter after we press issued with Just of XXXX. slides of gilead.com. release, the press and are data The available Investors section our at website supplementary on Chief The speakers will Medical Johanna Daniel call Officer, on Officer, Officer, Merdad our Commercial our our Executive Chief Andrew Chairman Chief Financial be O'Day; Mercier; Officer, our today's and Chief Parsey; and Dickinson. President Poretti, of where the team be the we'll Executive that, Cindy Vice open Q&A After Kite. joined will by

get Slide we remind uncertainties that the Before materially. that let started, you differ statements. and to statements we me forward-looking making could Please will results cause relating risks X be to forward-looking refer actual to regarding

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

I to billion, rates across X% Gilead which thanking sales, Thank Total of grew the to million. want a commercial higher COVID-XX excluding Veklury you, in Jacquie, and hospitalization with liver teams execution. delivering quarter, first total demand start and oncology the and for HIV, you strong XXX see performance and $X.X continue product Veklury track a our everyone. ] [ afternoon, disease. clinical for by reached our year-over-year sales to good of driven by

metastatic is Once which portfolio, well again, diversity driven established sales breast product therapies. for the grew and triple-negative reflected X% Oncology cancer transformative Trodelvy, of cell quarter as HIV regimen the sales growth the our year-over-year. sales by XX%, second-line for product were by our #X up

in indications in and our more such expand areas capacity we double move we market build in next-generation products. our have disease therapy, Maryland, at manufacturing into exciting as analyst leadership to recent networks on than the with new event community As plans and clear into U.S., outlined the cell

EPS this been by an which $X.X would the to of diluted quarter, The [indiscernible] reflect disease. above Sema is driven per $X.XX EPS R&D which of brings share. acquisition for have charge registrational incurred of results the need an significant perspective, first address charge, us or has liver Bay potential $X.XX billion an in with important quarter seladelpar, sales. expectations, product an acquisition higher close non-GAAP medicine, IP From expense the unmet first CymaBay the

We approval a RDC, in decision biliary EMA, with of regulatory have regulatory filed for FDA and for primary as TA expect treatment seladelpar both an cholangitis, we and August.

we PBC people a industry-leading approved, seladelpar to commercial expertise and liver therapy potentially benefit. our will leverage infrastructure who long-standing with in to disease transformative might If bring

momentum at regimen was our Moving XX reflected III to on initiated bictegravir programs Gap] data Phase novel and advance our which for weekly the to stength plan once-daily our oral oral data, with in once clinical HIV pleased we've [Audio pipeline, execution. trials in lenacapavir very abstracts We're CROI. and Based of

year, host event of landscape innovative this Later of prevention share details wave further therapies. we next options how to analyst an we the will and HIV with HIV including will the treatment, long-acting for shape

milestones Slide Before briefly I to Johanna, our will pass on I X. recap XXXX it

ARTISTRY-X trials, and inhibitor. first oral once-daily Phase with as as for our evaluating bictegravir [indiscernible] evaluating in SWIFT well patient We the alpha-X-beta-X first Phase have in achieved already lenacapavir in for III GS-XXXX, patient combination II

III on milestones, updates our and track including from for Phase also are for We Trodelvy upcoming X trials lenacapavir. clinical

Gilead. this a is focused Looking XXXX, time ahead of of rest the for to execution

the the expiration quarter will near-term their [Audio organization of for thanks diverse ongoing to growth, great Gap] clinical no both opportunities programs portfolio disciplined approach, and we on Gilead execution for lot see With therapies. many have My we this lot work our progress to of tension the deliver. the patent in a and agile and and a for across focus again and teams major in XX longer-term plan. will decade We play, and our

Good after noon, everyone.

on [indiscernible] quarter business, Veklury, up were total seasonal excluding product base strong ninth our to the teams we X, were HIV, $X.X up delivered first can our continue product With Veklury, growth oncology XXXX, establishing Including first liver reflecting the year. of year-over-year. first a $X.X quarter Beginning our start build consecutive solid quarter billion for year-one growth the this firm on businesses. which and sales, navigating disease to of the Slide quarter, year-over-year for sales X% a and base billion, marking dynamics total X%

dynamics not on by billion, Quarter-over-quarter driven the are were we the were Sales up Slide offset quarter demand first year, seasonality repeat. to as sales year-over-year of by X. primarily by the higher down demand. in pricing X% Moving HIV typical partially expected experienced $X.X that to to Europe driven well favorable in higher as X%,

year a in following is, evident generally is of in average As price patient of in co-pays general, deductibles occurs variable prior drawdown that indicative of year, less the the first shifts growth more the lowers full HIV build every with and reminder, in than towards inventory quarter. trends every year overall and first of together the end mix and happens where typically the a year. start This realized channel quarterly quarter and

As always, normalize quarterly pricing we inventory typically as year. progress and we throughout these see dynamics the

leading as on the line XXXX. year-over-year up $X.X remains expect to Slide starts outlook, sales to with for switching shown continue HIV new for strong Biktarvy treatment regimens markets our X% well for Supporting sales expectations, demand. as market as with approximately treatment XX% reflecting XX. for those across regimen billion, major the that HIV in We grew growth

HIV HIV. the [ or after demand approval populations resistance, Biktarvy suspected regimens Biktarvy's share see was recently, with in virologically branded other Quarter-over-quarter, people gain was a market in again extend suppressed to into common XX% points with treatment known year-over-year discussed. by initials to sales benefit continues for launch, seasonal of X the that all Biktarvy percentage U.S. up broader Moreover, Notable MXXX typical granted resistance. approximately to and factors share years for X were once continue of as we Most down X% higher treatment. FDA ] the outpacing use form offset

lower year-over-year to by by discussed X% channel ]%, [ demand. Descovy earlier, partially $XXX down average XX dynamics Turning demand. offset sales reflecting higher offset by due were driven to million, down seasonal the Sequentially, partially mix, higher sales price to were realized prevention.

next with market XX% While [ temporarily over volumes the the recovered cyberattack first yearly and unchanged maintaining in $X.XX the February were [indiscernible] as potentially as to March. subcutaneous option. readily we in the as growth ] only despite first prep solid demonstrate market setup availability is launch disrupted volumes robust share continued year prevention Healthcare, over a the of Overall, to twice by including up in quarter, look as the early late This U.S. generics. Descovy [indiscernible], in market lenacapavir

long-acting strong orals, evolving Gilead's well and and long-acting treatment we rolls to marketplace commercial leadership in Given look are to positioned across we daily prevention, HIV the foundation injectable. maintain as

timing to up across for favorable Moving demand higher XX. X%, of the for Sequentially, the dynamics Slide of timing liver of X% purchases HDV on our and purchases. Department HCV as HBV the disease primarily the were primarily driven by quarter first as by were products Sales HCV, up $XXX sales from well and inventory year-over-year, million, HCV Corrections

Gilead commercial overall remained and to viral expertise global hepatitis pending in globally to adults that XXX,XXX U.S. PBC, performance. To RECONNECT strength Europe. approximately our for diseases. people the end, liver in to XXX,XXX portfolio and the bring treatment of treatment the excited approval with a meaningful of patients footprint continues underpinned and fewer stable This impacting be in Despite HCV has our year-over-year, is is seladelpar people starts about contributor certain

almost XX% cut to at year. for the the sales PBC, With seladelpar of prescriber half in of second base to patients that the readily we make force expect this U.S. available approval

best-in-class pruritus. existing potential and be Seladelpar clinical therapies, to with the the emerging on to of differentiated a has disease, key a demonstrated particularly symptom profile

to meaningfully XXXX Following contribute we and to beyond. in modestly its XXXX, and sales launch more in seladelpar expect

Turning other peaking to the well quarter wave patients expected winter over with Europe the in U.S. standard continues be the than Japan. the with to regions in such as for lower COVID-related COVID-XX, the hospitalizations market treated with Veklury compared XX% States. care United as Slide earlier are of and hospitalized first XX. antiviral were in to

overall to and million. Veklury $XXX a year-over-year As sequentially sales X% down XX% result, on were

more on world. patients therapies and to XX,XXX patients XX% firmly $XXX $X to year-over-year and look a are to treated the million types we Having future XX. oncology of above now to to up over Slide of rate. date, across Sales around bringing medicines were and tumor many lines billion Shifting portfolio forward annual run our treatments

Moving to year-over-year, XX% reflecting $XXX for quarter demand. sales exceeded Slide XX. million, the continued up first Trodelvy

patients. cancer, the And the triple inventory adoption, dynamics zero has In metastatic first. reflects that the saw Sequentially, as offset pricing well negative leading the X%, notably primarily repeat. demonstrated where dynamics X Overall, U.S. the pretreated This its U.S. by Trodelvy's partially in share demand U.S. awareness second-line by outside providers sales strong the amongst IHC were unfavorable HERX-negative setting, breast a of continued quarter fourth as Trodelvy was market Trodelvy drawdown HR-positive with breast in regimen share approximately Europe cancer metastatic most remains driven did not up in and in we setting. in the

look with lung the across reach survival We many meaningful to forward already settings and Trodelvy's ahead, years treated particularly profile tumor with are patients patients to breast confident in extending its potentially Trodelvy cancer, types over itself bladder safety cancer We XX,XXX cancer. date. differentiate continues clinically earlier-line more benefits and to in to

first of XX. sales Slide in the were Cindy year-over-year. and cell quarter, $XXX on team, Kite behalf up X% million to therapy Turning And the

In in and Tecartus authorized growth line other to as date. we ment new up. Europe from U.S. to seen to progress across We're increased good in Essentially, updates, of share see both while of with Japan, growing community for referrals driving and markets existing and for brand opportunity our expanding setting. flat with the to network treatment sales of satellites recent centers guidance demand the and our Yescarta number also X%, over up the our such see expanding geographies were through authorized XX affiliated in centers and pleased and consistent continued we've in where slightly

example, in established community proud collaboration once the to with flagship For Tennessee we're quarter. have first our

onboarding identified community new cell and more time. refine efficient we therapy We've for partner with become oncology can critical we at that continue effectively will on this over so centers blueprint practices many learnings we to how

populations by start forward through the had quarter. each seeing We year, look primarily a driven to to new following Gilead across to we businesses towards the We and up and partners impacting this momentum XXXX. year-over-year. to people Kite seladelpar the of the the thank expand start end later cross carrying the from our their across therapies strong diligently this And market core to teams world. execution I'd approval. like Wrapping impact of year, for bring positively expect XXXX. as to demand as this we first strong our more higher over We initiative all commercial

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

a first will with Thank year. of you, quarter busy continue of Johanna. at had that We've rest throughout the readouts the clinical the Gilead cadence

X ARTISTRX CROI regimens. at we of and which to seladelpar III bladder has anticipated on combination with presence of suppression data our benefit the X cancer data-rich the breast people pipeline, robust HIV FDA to cancer. HIV portion regulatory following our novel across bictegravir Starting This Phase stat We prevention, momentum potential Slide continue from II decision This with Phase we March. and virology lenacapavir biologic Importantly, oral is in XX. building the combination on included a complex trial. an from updates progress industry-leading on

X experienced have treatment suppressed since combination, of trials individuals. and suppressed in Phase one in another We started individuals this virologically III virologically

expect XXXX. complete We first enrollment of half to in the

programs. have oral X also We once-weekly

combination of III with into islatravir virologically First, expected to suppressed with people this NRT lenacapavir year. a Merck's advance and later HIV TI Phase

integrase to Second, capsid Phase working inhibitor GS this a into advance oral with our the combination combination novel of II XXXX, study. a We're inhibitor.

an HIV, important program regimen has first the insti clinicians regimens. option an continue second for standard for and treatment insty-based of Insti to oral treatment The to prefer be the agent. once-weekly the and potential care containing who are

in program from with people and for half data our the Ib to neutralizing data this second of antibodies yearly Phase the Phase our presented two broadly from share twice of we we and year. Finally, lenacapavir study parenteral plus II intend CRO, HIV

to from adherence filing terms would of of could convenient trial purpose subcutaneous support prevention. Moving together second only to purpose in X, Phase plan our expected HIV regimens. to This PrEP. not from update the an Data the first for in from transformative schedule offer year. with this of I dosing We III a prevention lenacapavir One, data half purpose prep share also be the to HIV twice as regimen, option yearly but is

XX. Slide to Turning

start phase breast, and range continues in oncology metastatic presentations Abstract upcoming currently for of be evaluated ASCO Trodelvy lung across to cancer III non-small just with cancers. yesterday meeting, X a across Phase underway to trials have cell the solid tumors With the to titles Our endometrial pleased trial [indiscernible] bladder a dozen we're later and year. were this this year. over released plans

III We AVOCO-X. lung Celine our data will late-breaking cancer from be non-small trial presenting Phase cell metastatic

from PD-LX data first-line subjects EVOCO-X in pembro in at also half the updates A all-comers chemotherapy Trades Phase Updated of of Cohort PD-LX high this be evaluating Congress second on from shared. will in in II plan trial cohorts We the CMD providing year. Medical

Depending survival submission the on the the anticipate the more highlighted. II this and U.S. this Phase expect enable Trodelvy. share demonstrated trial overall in III Phase approval significant full Phase TNBC, In Ricardelvi only studies from cancer confirmatory III regulatory edge study, update bladder both gastric Trodelvy's PD-LX event first-line overall second-line addition, presentations our improvement in we accruals, Phase the statistically patients survival year ASCENT-XX data ARC-X for for and to we II ex-U.S. negative Phase be of III setting, -- have year. updates that These timing later in in two an vial Tropic ADC could is will to the for filings. on support include in the

team development presented approach to investor therapies of last to therapy. Cindy at the event. on to pleased that month's cell and share Moving cell novel I'm the Kite's

you to the innovative see Yescarta constructs. paving we leader next-generation and in as plan Slide cell leadership Kite a therapy, way this As on XX, established multiple into extend can and for while Tecartus potentially also myeloma

median second at ASH at presented survival a of median in encouraging progression-free the in On This net-sell yet no highly and trial in the to this year. demonstrated II update half where the not IMAGINE-X data year, last later-line Phase [indiscernible] met myeloma, responses cell trial. months of cases multiple expect Phase we durable follows observed symptoms provide follow-up with Parkinsonian I XX.X the update

are providing next-generation optimized potency. which For and Phase I we therapy constructs trials, bicistronic aimed assets, in megasons, responses manufacturing improving overcoming deeper product our have more and potentially and at cell sustained resistance

the into tumors multiple as vivo range car Beyond and of with have that, disease netco we early plans solid allogeneic and diseases. to expand other research in in areas a autoimmune myeloma with

clinical on Slide XX. recently of inflammation to to CymaBay improvement seladelpar, Phase our PVC. to related demonstrated in progression markers an significant completed agonist of acquisition our We the portfolio. added cholestasis, Moving seladelpar both and III and of investigational PPAR delta trials, risk for In pruritus

filings accepted of our patients. the management PBC previously FDA As regulatory announced, certain seladelpar for adult in for

by decision decision early We a anticipate XX, regulatory and regulators an FDA year. from next August European

TPLX we seladelpar rest and on inflammation for progressed several pipeline, have with We II at a our alpha-X-beta-X inhibitor. global our Phase reach oral IRAKX an continue Further, look of Slide trials, that oral we potentially as the have the work to anti-integrin to potentially PBC regulatory of authorities phase Wrapping expand patients. best-in-class first-in-class XX. inhibitor including up assets oral into early

Andy. And progress track continue the remaining now milestones. readout clinical year, in the we on have the on for data We to we our hand and for to quarter, had and over and remain first X our [indiscernible] call completed milestones in patients I'll

HIV, sales and $X.X in it achieved Thank liver disease up strong with oncology total base with good year-over-year offset to X% growth X% [ up the you, XXXX The Merdad, decline solid of business billion. Veklury product ], year-over-year. and our Beginning a year was afternoon, everyone. across

quarter-over-quarter, dynamics and business primarily down pricing was base in inventory As seasonal HIV. by driven expected, our

items our Moving the significantly beyond performance Slide EPS impacted quarter, results. revenue in XX. our shown on Two first as

IP our and results the billion quarterly share R&D of GAAP non-GAAP First, with $X.X close the associated included per CymaBay or charge $X.XX acquisition. the in of

quarter. first result, our expensed fully effective tax and transaction an impacted expense acquisition, in this nondeductible a a As as was was asset the item rate. This

higher $X.XX above our non-GAAP driven quarter EPS expectations, sales. by expense, have this Excluding primarily first for would been the

the impairment that excluded is side our on our GAAP shown and item results. Second non-GAAP included is an from results right-hand charge in

of and relates Immunomedics. R&D As this a IP assets value tenant to the acquired live reminder, from the intangible carrying

value of billion, the lung the cancer. At associated all with XXXX, carrying end cell $X.X was non-small

non-small EVOQ-XX competitive in could of activity. metastatic and second-line plus result a and launch serve that As timing the to This cancer associated cell the readout in addressable primarily have lung January, expected late market value reassessed we the Trodelvy patients, remaining among a delay $X.X reduced billion. reflects smaller

portfolio with year, share. opportunities EPS now some the the GAAP in and deal a remain including impacted program a therapy on see a IP our you as by meantime, per Gap] in lines billion In new well goal We [Audio earlier initial model. strong first indications as $X sales that shots can of exceeding multiple $X.XX not development impairment quarter

the results to rest our Moving on Slide XX. of non-GAAP

the the down For XX.X% management. disciplined on of on expense gross modestly primarily to quarter SG&A declines focus consecutive due X% reflecting continued product mix. second to and down the margin is was our This each operating expense year-over-year were a year-over-year, R&D quarter, basis, first

negative IP the XX%, R&D Our of tax was CymaBay rate acquired charge. in reflecting the quarter effective first the a nondeductibility

same revenue earnings a period share $X.XX Slide to a Switching year acquisition. XXXX CymaBay diluted time. the change positive our to this XX. $X.XX was related expectations negative compared no to year, share expense per full $X.XX is last reflecting There the on our for Overall, to at guidance for primarily the per

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

of Veklury no billion year. for $X.X is to guidance approximately our there change the full Additionally,

As expect quarter we infections. last our do until Veklury discussed to clear very in trend quarter, earnings update call, our not COVID-XX third a absent guidance

other expenses of margin of P&L to the the in range non-GAAP end the mid-single-digit range the We basis. There of now guidance, continue is CymaBay change gross no XX% to the higher at on R&D product growth with to to where low expect incremental our we gross parts the reflecting a margin to previous Shifting XX%. our to for XXXX acquisition. grow associated expect

relative a We expenses continue to to expect percentage SG&A XXXX. to mid-single-digit decline

is expected our basis, a higher we SG&A On be as CymaBay expenses. incorporate SG&A dollar expectations to previous than modestly

can within the is now as acquired window this guidance. to billion manage to operating as we transaction of However, approximately rest issued IP of the year. the the anticipated milestones the R&D $X.X previously be expense due expected throughout CymaBay well

is reflecting to to acquired in expenses guidance the billion, range and the R&D billion expected operating now income Operating the to IP $X.X modest be $X the CymaBay associated of increase transaction. with updated

rate tax $X.XX. impact CymaBay nondeductible diluted the charge the be is expected This of of CymaBay. $X.XX effective approximately acquisition, Given negative in in a acquisition therefore, EPS range includes of We, XXXX now to for the onetime to the of the approximately the from expect XX%. for XX%

As that quarter Slide XX, of shown updated first on transactions this has in reflect the the been to closed were XXXX. only

are EPS you range the in the these $X.XX in of and year that $X.XX. see can a shared to be guidance we back GAAP Excluding of February. full expect XXXX basis, range comfortably early On charges, we diluted EPS the within we

XX. Slide to Moving

sufficient unchanged Our with our allocation remain capital sheet. flexibility in priorities balance

increase a we $X.X shareholders. quarter, announced as in billion returned to the our dividend demonstrated and Specifically, quarterly X.X% first to approximately

disciplined and will acquired sizable M&A our we to Gilead in near to addition, that while it Overall, seladelpar in And capital. In the we unlikely $X.X engaging flexible to any is transactions portfolio. opportunistic, will we'll be in of continue be our use be continue term. for adding billion, CymaBay

XXXX, it on the wrap launch with year. in transaction earlier, closed. Slide this before Before CymaBay now Pending contribution highlighted note approval, U.S. on XX, I a our a up, as the the Joanna expectations quick end to expected regulatory that modest revenue expect we of has seladelpar

be as incremental we Additionally, year as launch which we to of to to to support R&D will to to is and efforts, the shared issued the within investments Q&A. we that while And guidance. we I'll look our onwards. window invite of this have breakeven the ahead, other in now add expense dilutive we XXXX XXXX able operating expected And all significantly the transaction EPS expect the to deal the are make Rebecca be expenses this the transaction manage well to as accretive previously begin year, as earnings operating in

[Operator Instructions]

first Chris from comes JPMorgan. at question Our Schott

on this from and conversations. thinking question the headwind. franchise. broadly, redesign expansion think year I talk your from you're about XXXX, a Can we how and about just margin more is despite more impact more as coming directionally HIV about had the Just little maybe the -- franchise about for to know And line and you just still this that a we impact bit think can top Gilead next growth Medicare

color any can you So provide be there appreciated. would

Welcome, Thank This cover Chris. Dan. I'm question. Great, have going this Joanna everybody. you. to is

Thanks, Chris, for the question.

towards our in do offset we be redesign impact to D growth impact. weighted the So be to Part of expect our and HIV Part the business. an XXXX HIV redesign D by expect

impact in our as beyond. top in a we to the our beyond we and be and grow said So to right, roughly designed we 'XX year-on-year in business of D HIV expect line, despite -- the total the momentum XXXX overall, XXXX, [indiscernible] building that, flat Part with expect having XXXX -- sales result,

the we Part of expect of growth demand offset the will HIV in So impact 'XX, do HIV but our D. business,

Andy. on it's take margin Chris, the question I'll expansion.

true that more guidance just what know, beyond XXXX That is we historically, underscored it very I've in don't we disciplined are you have is and today. focused mentioned. would specific said As on expense be as we What Joanna -- provide management. XXXX for

in last quarters. You've that X the seen

a this if continue operating you our operating that time. improvement see our in you the if [indiscernible] strip transaction, to I at quarter, margin, think basis and over expect non-GAAP on an look margin out for we you

the and to you see expect continued improve disciplined growth So for line expense broadly the our we over top time operating management. as margin do

the year More at for specifically. course, provided question. provide we details, next of to thanks when early our XXXX be guidance So

Dana Our comes Partners. next from Leerink at question Graybosch

myeloma accelerated FDA's of for relevance second in recommend MRD thinking about meetings Abema. and you're and recently Kite. myeloma. death relation from was to as risk ODAC with there. dealt multiple of in the design. CAR-T One, a both an ODAC It's And for line the approval had I early important X these to intermediate needle endpoint in for how And multiple your wonder trial earlier cell Cavity

we'll Cindy Thank you. We've Dana. Thanks, Perettie to go right over her. here, got so

Thanks, Dana.

if I intervals So of I shown is the everybody. it's disease-free from CAR start in think What they believe that people off that. disease. the Ts this with they the we that ODAC, get -- early recognize line having value positive for is value their earlier

very were that. we So happy

I were as as see additional a residual an to excited disease as around equally second secondary ODAC the MRD, minimal endpoint. think we

need faster so how around I to in ODAC And to that patients. really bring that understanding think agency and this sell can a the surrogate to for of to to piece potentially program market door and with application that be come the now MRD the endpoint we're is the encouraged us the going our the right on regulatory for front. of more we're process used up decision is open

Our Raffat next Umer of ISI. from question comes Evercore

spend CymaBay. quick I second a thought I'll on

as deploy during as adjudication. dose well did the pathology be diligence liver safety would in independent is, the didn't did from paired Given you the process, pathologists "possible cases CymaBay trial, the question the need My very liver I'd would of evaluate ever you if recent previously at the that where think NASH it PBC the that. to Gilead deal. data guys biopsy curious and trial that publish lower how happened

I'll him here is let Merdad answer. so

Umer. Thanks,

a one much bring think a near-term -- didn't in synergize lot really thorough our saying the other whether what overall. CymaBay. seladelpar that will work the review do not of of pathology. of our benefit We I by our doing think was around and in disease independent and that. and seladelpar start question medicines approach to that did portfolio with me will that we obviously of and -- many we We is Let We of diligence third some we're we your -- in do an liver think of patients to those did the expansion liver did other third-party

and did diligence confident means for data what a of on over outcome the we and time. their itself outcomes. around the patients we However, the lot are And it

our the following Obviously, the in of optimistic the PDUFA that And in. and which we EMA, file items upcoming and the also we're waiting we're -- date about. all questions right are now sorts those

So an we're providing to those proceed. as filings looking forward on that update

Our Buren at TD next Tyler comes question from Van Cowen.

hoping and X presentations ASCO. could the Avoca [ help ] for was I at expectations you OX

For AVOCOX, the is breaker tag interesting.

voco So OVOCOX is in next -- that for year. confident what to PD-X more? X-month us do related readout A to the in be hope X, the could data we see refractory Or the something patients? Cohort And we expecting OS we benefit should leave or to with the

Merdad again here. it's Tyler, Thanks,

share and our that are upcoming, which think to of number think of for about presentations I the were we updates So we I of fill released, and see lot under embargo X, for a details pipeline and a options a because build we both there we're a bring the too can as once now in ASCO it's those. oncology our challenging overall in real pipeline ASCO little And us have our because for real our can't we evolution happy new pipeline obviously, many talk patients. blanks to data IVECO and of are for change ability a

you the point. I as for could I PFS, session of well more late the on breaker give on overall you as this survival response at wish profile, data course, safety include can't will of -- ORR part we mentioned, and As of Avoka, as and details, I but duration

] I non-small And of say, updates you forward data talk study looking but population. those cancer broader our Cohort at conducting cell X that underway especially be details there, implications again, the with with for are can't the sharing will we is frontline A and talking everyone. that [ right about really -- providing the the including to the And EVOCO-X Merck. at high lung lung looking it's our debt, partners As PD-LX [indiscernible] about results also of are now other those we we cancer

of comes next at line the question Geoff Bank Our Meacham from of America.

Merdad, a question you. for

you've real the this XX. On usually big. year, kind But think, I wasn't the a you is only this stuff, the list, car in assets cell next-gen therapy have sure the no. which have pick will cell but next-gen priority what on space, among be on update pretty that, front, lot a Slide of I are to the that fat scale Anita had beyond of the if you cartooned competition that players and priority of you There's was later got guys could move sort you

This Geoff. answer Perettie have question, that We're Dan. if don't mind. going Thanks, to you Cindy is

to Cindy over So you.

products b we and X are So right trials. have in constructs Phase are clinical that now Ia

The first XXBB one has is and CDXX that CDXX, a CDXX. bicistronic

second one construct like is X-day other one is that a Yescarta X-day The the with manufacturing. manufacturing. And manufacturing, same fast CDXX with

of those into advance the with all winner goal that looking we're So X our of pivotal picking in to parallel rapidly at the trials.

up well. as coming Obviously, a shared that's So we've next. what's antisell lot around

quickly. answers hear Kite a it as expect fact next-generation earlier have X year. relates move the to research, we create lymphoma have early the question. can plays With this about to into the quickly with plan And we you'll scale at the as that that more as assets lines that that We have the as we well we but and integrated we later vector the Hopefully, [indiscernible] well to advance NetAcell, as would in-house. obviously, of readout, in IMAGINE construct our do number your

Our Jefferies. Yee next from Michael question comes at

enthusiasm better have your ASCO on second of Evoke Trodelvy why will strategy or least that as that first-line you your chemo at of us, you frontline your and combo line is you're do at if top and data -- than Astra, b, excited -- just for -- are about remind a is a, data the at therapy or believe you be just PD-X. and in coming can triple that whole up competitive is frontline you on Following

again. Michael. This Thanks, Merdad is

authorities data with motivated X talked once as give in discussions cancer options, we forward something in the show We'll provided data population with to those will the second be look even data. think speak that to we able us line so with you is full I noted, and VOO and having follow-up And this to forward data. discussions we've is great, health once unmet discuss ASCO at to directly share As set conducting we are more The regulators. and the go us can deeper the discussions lung -- and be need ASCO and about, and those trials. in at including data data the

have it update data, your I'm But more. share -- Trodelvy sorry, combinations. And a confidence question last question we're and be frontline the the then to where talk to I second EVOCO-X of the combinations. from once on Again, of And of around data, intra-portfolio those are YUVOCO-X part about the trial see we get on was sorts able allow we to in to of combination efficacy about can think to does for part line. we [indiscernible]. do continue and and able your example, the think front around additional combinations looking if think a the our we'll dambinelumab other our We us

look we our do portfolio. for our at combinations putting needle from with continuously with look portfolio opportunities for the So within and

Salveen from Goldman Richter comes Sachs. question next of Our

$X thinking is now have there the post So meaningful deal levels. I&I in leverage and about Prometic about acquisition? any And noted preference oncology. cash billion and back are between How or to you bolt-on virology, is you CymaBay currently

In it's Salveen, near with don't one. I'll expect start Andy. in remarks, we M&A. the that sizable that I term, highlighted our Maybe

a us. we ahead of execution So have of lot

Calabar. portfolio, including of deep lot a growth drivers, a have We

ordinary short clearly that we So the in we're term, will do to standard business continue deals. highlighting the course very development, licensing

You and deals working couple every that's a are those the whether or more for and X average unlikely that saw that also a that said that's the we near a like first historically park. cycle on CymaBay that should over any pall regular general term. pursue quarter. exactly or less do M&A deals basis the in of We've it's But meaningful in we'd like

So saw in I we first lot it highlighting the -- generate quarter. a think you're that you flow appropriately have we again of

don't time. we continue the to short our cash over invest expect the pipeline. in to We will short meaningful We're least going M&A run. run, at in But rebuild any in the

So.

Dan. is this Salveen, And

question. when to of always both first these. urology answer mean I building of we're a all, and the portfolios therapeutically robust I agnostic your approach portfolio and end we around got Just inflammation. mean, we've oncology in

and channel. Seladelpar a that's our portfolio an But hand use most that franchise across So the work opportunity synergies for have on. within think as or we now approach. look, said, equally, for We makes we'll to opportunities a Andy therapeutic look finding in and look through And liberties And able and to complement those We be example we areas. is science. to that frankly, spectrums. of execute our sense. great attractive that our lot across our

And very so keep high. bar we'll the

Bank. Our next question at Deutsche comes from James Shin

X share in is ask have going also trials? play Destiny and I will you with Destiny you landscape two wanted similar Can HERX to on X HR-positive to how [indiscernible]. [indiscernible] soon pretty sort to out negative. this like Trodelvy's data seen, have efforts Breast these versus you and think of sounds

for -- Well, learned from Thanks keep to James. the prognostication. it's away question, to I've try

are the And harder is of trials it in breast we for continue patients. in number do. role that way TROPX in do [indiscernible], is approved, to important breast the proud have want cancer. the maybe plays that's look, with that, by footprint other push we and to right our a along now is put to ADC to only would the I cancer ongoing of So that expand by Trodelvy is Trodelvy fact -- that we that the driven part still large We

leading right we think TNBC, I regimen. are the in now

continuing are HERX-negative we our in in population. to particular, HR-positive as And the and advance

we in our think filings randomized regulatory there. approvals. the I benefit shown around place for a confident We've been there, and remain our that's and trials basis clinical

data looking coming that's the Ascent [indiscernible] coming So assume to I have can -- up. what We'll think But the are. into forward with see success. we don't

breast information that provide additional will us I think cancer. to further in expand our potential

Joanne maybe add. And can

cycling add have the better. that, women of would also through HR-positive have chemotherapies, Maybe more say these earlier just of the in to to instead these that options in therapy lines patients I

it than X the for because important up it DBO and Trodelvy earlier, the results of more label. and of actually with OX allows a that profile to a is also compound population potentially So play bigger Tropic moving today

we also the so and do And move [indiscernible] up on versus marketplace effect believe ADCs only that other safety there's itself profile, efficacy. differentiate this this not in opportunities profile depends for to

foothold zero of we that in IHC HERX-negative, these really therapy And our of studies being HR-positive, of continue, will whether or the lines setting strong play light later believe so in in that's lines earlier out.

at from Wells Fargo. question Next comes Mohit Bansal

LOE. about do question, picture mean, think I longer because, not limited low single an is you mean, big HIV again, oncology, dropped mean, I you I a this medium yes, [indiscernible] term if seem mean, it all ports point. digits. I growth somewhere around Maybe at But to expense have the And

is probably an So thinking low just like How us do Saba you addition. more to to growth understand kind term, single people for long you medium how trying a high of single-digit company about from are this missing? definitely it which are to turn like overall digit

have then start I'll Mohit, and add. others maybe

and just cell therapy. X thinking significant and all, I than outside over doubling back the portfolio HIV past oncology size and advances think that more built portfolio of the now the we've about our in with of years of with First the stepping and

prep mean, we'll just ourselves have a dimensionalized. say treatment to the about of that the little market the side market moving the on analyst a is [indiscernible] we've the long-acting half So program update treatment have this others more event, first that kind of to potential with I I an growth confine for we you addition on, very as and we towards that in on and second and the bit robust think we of year of would got the forward, business, all,

is I time opportunity is that significant end which your frame, growth you decade. when And until think that the which the of -- about you provides think mentioned,

That it and oncology portfolio. then as HIV have think of accelerated about think So -- top I total entirety the we decade. the half on towards we allows the head of second treatment that, the us of growth to prevention

as And And of Phase out this are a half of cell the -- this lymphoma B-cell of I'll large second you, PDUFA over again, in decade. other importantly, the then the seladelpar within therapy myeloma in [indiscernible] we've and agents multiple got TRODELVY III oncology cell that area XX well potentially top added to then those as robust including August. both has just portfolio will with the with that the the course read novel lenacapavir a in year, very Trodelvy both on X to X we've close remind So and needle that, III, which entry readouts. readouts this Phase year, mix of date for of

needle finally, the as to cell then opportunity end year well. you the And just the at update on of the

it next course But substantial expense complementing over So we'll our decade outside. business by produce continue have what a I'll company in we to investors. really addition where growth management we with portfolio, company well but to we returns today, in the to of for on the within to entirety at the think the mention be our good providing more of the takes have just as drive look within focus as we today, the needed guidance way, the from the

Our next from comes Atlantic. question at Baker Simon Redburn

around launch Ipsen a [indiscernible] in June. One at If launch on plan, all seladelpar, really August in if And the according dynamics launch. and of to competitive I question may. goes your out will

was I So that wondering makes if really any just difference.

disease situation. else the market You've the in paradoxically awareness early and too greater obviously help Ipsen. Or March? got Is having actually somebody to thus steal on PBC than infrastructure them promoting far it raise for

launch So around be dynamics would any that color very the helpful.

Simon. Thanks, Johanna. It's

think right. that take And me one. I absolutely Let you're

no differentiated and around the there the as you well is the is when namely [ of in ALP for trial clinical in about really meaningful fact that improvement incredibly PBC think be said today, effective pruritus there significant and that III Having hitting fact to we a cellular normalization options is PDC awareness with the well the that, I feel increasing patients. key as market that available. potentially we've seen for patients disease impact impact disease. delpar also best clinically in ] is clinical one great I antibot symptom the there than Phase around more jet the think the which competitor are disease And is confident have true

we the together, of U.S. all just footprint, we X referring It medical don't were difference. already incredibly well And addition that is disease. months a profile believe about differentiated PBC prescribers. commercial covers both to those make put And that in to fact XX% comes liver of so all and when strong I it that our with established think to,

launch look and think seladelpar we date. PDUFA with for really best-in-class forward about that our that potential it's I

next Baird. comes Skorney Brian of Brian. from Our question

This on for is Brian. Charlie

something So seladelpar. about again, ask to

wondering there's at potentially you pruritus Just lot any if have the as you your considering may portfolio? any there need looking well label as be a of for potential synergies future, considering line for ambitions of unmet with in remainder with a the first liver

especially the the a background the for and a patients to potential is the given going course benefit But of earlier is pruritus really Frontline a Charlie. of -- lot as bring Thanks, challenge to given of lot in we is their This care. getting that you currently will to know, important for be Merdad. is what standard us. seladelpar think patients,

in of starts and recall been And superpos. course the early or people frontline moving making get the that registrational any up anticipate long second-line to on profile patients moving I before therapy, and other see fact frontline therapy how frontline is are moved relatively haven't potentially so to making their the to formally actually respond for the recall, therapies think line. efficacy think that we second how the of seladelpar trials one treatment in presence the options, could thing there about to second-line the the the market therapy And to to given

label see things. the our So we'll sorts think that plays I we those of out And all see how and in once market.

that. able be update we'll So more to after

Our at Markets. next question Capital comes from Abrams RBC Brian

an obviously readout. is X Purpose upcoming

to may So out potential that wanted I individuals HIV control control you who the are versus how for then infection making unique to when design, differences serving assessing of And accurately some project rate? intrinsic have trial. infection sensitivity of behavior screened the what's group occurred into -- the elements the specifically its the control clarify as risk do in

Brian, thanks, long could it's I talk this And about time. a for again. Merdad

Let second risk and with comparing a screening, HIV, assay in of they at after time me -- anyone very been been this happens and to -- the the that's that's sense, answer. incidence studied think therapy. for thoroughly, the then before create that -- infected design, to compare that the The people to the recently for after recently it And behaviors potentially relates question key as can start concise a of that that at your looking time screening part. on in we we'll give be profile counterfactual of were developed time I'll part a try to we what based randomization a and has at how the and very infected. diagnosis need who's at And don't, in of HIV overall HIV I

the elements regulators necessary think I the the the X get adoption. provide and the those we're to So that all information experts and for us had in the will we've field, and between discussions design to confident with approval in

Our next Flynn question comes from Terence at Stanley. Morgan

Great. the on franchise. Two parts CAR-T

the then curious So in if it's meaning second wondering, industry. to -- a respect your other lot developing it level, number immunology. [indiscernible] so focus is, to of amongst Obviously, less there a for cell of was the proved And progress comment here companies just your the a high is CAR-T where with stands parkinsonism, differentiated. part

on on So thoughts the Gilead's floor. curious just

for Thanks, question. the Terence,

-- it feel both we Parkinson's on the and commitment relates efficacy. -- differentiated metal, absolutely safety that on potentially we're to So to as we're

could then it, we noted but are have As we have we'll the observed, efficacy about early we think rate constructs signals equivalent be will the the observed now. continue or other of profile, And the on neurotox we class. earlier, that not and some monitor right be to profile feel we

soon. bringing the looking forward behind XXX% we're [indiscernible],and we're data So those to

space. The second around question autoimmune

autoimmune And So will to others and monitor space. we Andy play before, the in from we space. continue as you've that heard

take look our -- to a today. have space taking are other the we'll we don't in time update have and that in what's any portfolio, versus what be than I We at

Our comes from last question Carter at Barclays. Gould

hit just as of the persisting the But your I Tennessee on Any meaningful saw a Maybe cell dynamics same the sort things that hear of been of as return appreciated. far of that in growth that of therapy, mentioned of level constraints U.S. flagged reference. some clearly, more have focus. second be didn't ATVs. -- the to together, all there would of I round commentary half you you the I in the guess just that's also to kind that out any the and year. the point putting confidence

in the we No, we of we're second confident year, Yes. return going half feel as the very that growth to stated. to

just think And that that X. shared in be flat quarter was had is as X, guidance part I we'd to we slightly the our in quarter of restructure. down to due

out into are We are we we taking approach having team confident So now the And strategy almost feel the looking we're and hard. play. in about working stales putting back at a our very U.S. fully

well dynamics. talk a the think about that as as market to we I need piece

what we've constraints, a the observing. in. competition about the the we're working that confident ATCs really seeing We're constraints lot past this feel observing spoken But we're half So of through those ATC is and about of the and things coming myeloma are the bispecifics, multiple year. in based the with hospitals second on out-of-class constructs we

is This Dan. Thank you, Cindy.

II joining. expiries are Gilead I the appreciate programs, to no a end track the for long-term lenacapavir. Phase plans. PDUFA opportunities we updates for execution we the of of year. disciplined decade, variety the patent in in X for summary seladelpar more all as a and We've growth update [indiscernible] any agile that, the management major you got I through near-term on of the we've are where bit highlights, approach just at and the On just III to clinical of very from our at lot you of active on stay Trodelvy, deliver. a focused know update the with top the August, statement. of all continue want end trials to XX Maybe Phase clinical So a got We'll date on and

So have, on that, for I'll opportunities hand the and that closing more to lot rest over we With many we firmly deliver. to are Jacquie focused we comments. have a assured potential

on close, share Thank second arise [indiscernible] to we quarter note you, August and housekeeping I just X. this to Please our could and changed release Dan. that earnings tentatively item. be XXXX [indiscernible] conflicts can then. To in planning X are is scheduling results that now accommodate that

second As confirmed will quarter. we'll you on for We call forward close the With to that, and today. our interest progress appreciate always, date you. our the updating quarter. Gilead in your our we throughout look announce following continued close the of Thank