GILD - Earnings call transcript Q2 2024

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Operator

Good afternoon, everyone, and welcome to Gilead's Second Quarter 2024 Earnings Conference Call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin with our PrEPared remarks followed by our Q&A session. [Operator Instructions] I'll now hand the call over to Jacquie Ross, Vice President of Investor Relations and Corporate Strategic Finance.

Jacquie Ross

Thank you, Rebecca.

today, the a second 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. the joined Executive call to President Q&A the by we'll Cindy that, be Perettie, open the Kite. After Vice team of where will

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

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

Daniel O'Day

good this therapy and everyone. share up treatment commercial and to X% disease HIV, of quarter HIV Trodelvy afternoon, was XX% XX%. strong with oncology. was pleased that cell growth execution across was was year-over-year. and up liver I'm Thank you, for another Biktarvy Jacquie, up

In our and line leverage delivered the operating growth, highlighting addition, exceptional in expense management demonstrate continue model. bottom we business disciplined to

Given for non-GAAP raising full EPS operating and of for guidance first year, our we income year. the the the results are the half

people with X considerable virology This infections evaluating important is and PURPOSE to key such prevention Moving allow zero is set purpose for milestone cisgender AIDS in could a of with highlight which who designed and Latino updates. The lenacapavir program, groups, of results clinical individuals inflammation broader a The time twice-yearly PrEP men benefit expected -- for of have new X,XXX HIV in including results HIV population its in XXXX for young efficacy and XX wide prevention. to outcome. Lenacapavir, bar therapeutic to with positive reached transgender countries and we're a of showed quarter cisgender excitement efficacy the in XXX% generated reach of trial, over more The an our was Black at regimen. these a from a III is women. delighted of this to Munich prevention presentation Phase women, our much the prevention dosing being range adults. HIV highlight participants A to areas. than women, HIV could the include and readout

year We expect next year this an as a late as for commercial with or update late XXXX. X PURPOSE early launch early

of and of in several that The ADE updates strength innovation the PURPOSE highlight treatment. Gilead's part prevention both for data were XXXX at HIV

extend of Phase pivotal and which regimens. complex data into Our daily and HIV has at III people the our on oral HIV, AIDS for trials late well including bictegravir to our those the leadership with XXXXs is now lenacapavir, included promise pipeline beyond. combination Updates from XXXX in

with recently team a We biliary program, new also primary PBC study long-acting about from This, combination II orals once-weekly evidence Phase promising treatment The the Assured to or our the of plan could continues most GS-XXXX Phase before including of opportunity for seladelpar shared clinical evaluating our grow, end the shared year. the in behind bring to of Gilead data and EASL. at GS-XXXX. We the the who body treatment addition the the seladelpar cholangitis, to in excited patients III to data benefit. is start and broad to these

ASCO, to T. showed lung the the trial of efficacy Phase II broader to data to reach Phase best-in-class with Moving patients expected care, of compared meaningful manufacture from cancer. are of underway. The evaluating first-line EVOKE-XX standard III currently in metastatic our pembro cell we myeloma program, a line historical with supporting CAR EVOQOX set combination fourth Trodelvy At to our results BCMA ready in non-small new shared we to oncology -- potentially second multiple

We and cancer EVOKE-OX this lung following readout and continue path bladder year. the earlier metastatic to in the cancer cell Trodelvy TopixX non-small for matastatic second-line assess

In the first the care served only the remain highlight meantime, this on and market second-line an date, TROPiCS-XX-directed patients treatment approved for we cancer cancer. quarter cancer Trodelvy will ADC is the remains triple-negative I'd Trodelvy the and results option. that in be XX,XXX where to To breast standard confident breast strong important of over metastatic have commercial and continue

in has edge cancers. that supports shared completed results GI gastric showed for These Phase compelling Phase zimbrlumab plus data chemotherapy II the enrollment. III XXX at program, also We ASCO which first-line domfanilumab and efficacy upper STAR

forward milestones on XXXX trial our III Phase cancer Phase event-driven ASCENT-OX look an and evaluating TRODELVY metastatic is trial upcoming Moving updates PD-LX first-line Slide We trial the breast III triple-negative patients. X. key to negative in to ASCENT-XX from the iMMagine-X

disciplined the progression-free for in clinical results impact survival solid of global seladelpar. it cost and positive initiatives support would into Johanna. With -- hand remarkable A HIV, moving growth potentially Trodelvy imminent our -- that, outcome to filings, across planning therapeutic management tangible some areas, I'll launch from over revenue

Johanna Mercier

very second like afternoon, to the Gilead thank pleased momentum and the we team who quarter execution. and continued strong to saw to of would everyone. I'm report Dan, quarter contributed Thanks, good another in the

excluding Veklury, X% oncology. sales, shown HIV, up were driven liver Sales realized $X.X up Including sales As billion, product lower X, price prevention, second with total Slide by X% with across year-over-year. HIV and were on across the offset year-over-year to were demand of on due treatment total $X.X $X.X Veklury, quarter, by in up mix. strong average partially growth and year-over-year disease product Starting X% X. billion Slide billion

Quarter-over-quarter, following as and as higher dynamics sales the inventory well pricing reflecting demand. quarter up build first favorable typical X%, were

we growth on full of to HIV approximately track year, sales Looking X%. to remain deliver the

HIV position, share Biktarvy treatment billion Biktarvy leadership due our to favorable to in than the Turning and typical sales Total pricing the X% quarter of the the dynamics. inventory up over U.S. meaningful almost consecutive XX%, XXth more market a sales quarter the up choice, firmly remains higher was particularly represents up were for regimens major XX% other other largely treatment, as lead across Biktarvy starting Slide This second market as well our switching in year-over-year, treatment quarter those year-over-year, or regimens XX. gain X% year-over-year primarily branded markets. share demand. with were $X.X first following for U.S. of Highlighting all Sequentially, of reflecting HIV of share

to market annually. of Overall, continues treatment the X% HIV expectations grow with our line to in X%

offset sales Turning of higher price second million X% quarter. to sales in Descovy, due demand than demand to lower continue average as were to with we realized more Year-over-year, mix. $XXX growth by channel was the down see

will their to ongoing realized average in -- people need continue impact to the who ensure access reminder, or addition our price have to prevention a mix PrEP choice. of As channel regimen to efforts in want

results Sequentially, thrilled in -- total quarter unprecedented XX% with than the the beginning is With transgender are mind, and larger This where young which or program, volumes and to women, just in those the with women, or year. our adults. second lactating. XXXX of more last purpose today Black pivotal individuals we're populations to in as and communities includes our landmark including and same that cisgender PrEP the such up seen access men multiple of women, compared period underutilized more pregnant Latino difficult is who

or will option subcutaneous and who with only prevention need we expect the regimen of dosing. long-acting lenacapavir Overall, as the choice yearly twice as emerge first for want those

potential early for late are XXXX. We as PrEParing launch as

U.S. the channel to Sales on Moving up and mix due XX% average portfolio the demand driven liver year-over-year sequentially, higher XX. Slide in and to XX% were higher disease price by realized

with continues differentiate -- disease year-over-year, and together share liver Our HDV. fewer to despite with HBV itself in demand growing HCV in HCV starts leading

As U.S. date for to you know, is PDUFA we next ready week, our stand in laterally seladelpar the and

leverage commercial European who footprint the diseases quickly people PrEParations decisions U.S., PBC XX. in the in turning upon We were seladelpar these progressed XXXX. well after by and we continue Slide treatment. to many bring look liver building the to of initial in underway, able commercial impacted U.S. early regulatory the relationships existing are to to to and forward Outside XXX,XXX our

an includes has to well XX% COVID the part for patients setting. U.S. be infections recognized COVID-XX. Veklury severity as share the care While variable, remain maintained of Veklury hospitalized appertization over for treated of this rates in This continues where important of standard

For year-over-year XX% down and as expected. sales sequentially Veklury quarter, XX% second were down the

on over XX,XXX types. Slide With were $XXX up treated proud the Moving of patients our made XX. to multiple Sales year-over-year oncology XX% cancer or million. across to quarter-over-quarter Kite and impact the Gilead oncology X% date, have with we're up medicines positive to therapy

increasing available in ADC remained cancers. U.S. benefits Slide metastatic metastatic pretreated for across in cancer and cancer cancer year-over-year XX% types X% were approved awareness Trodelvy with amongst and to higher more triple-negative its on the is the sequentially, HERX-negative setting. driven by indication. and COX the the second-line has physicians, $XXX and HR-positive, breast in directed of in X survival with million, detail the metastatic quarter Trodelvy breast primarily clinically demonstrate second at breast only the U.S. XX. leading Sales Trodelvy Looking up adoption up Europe Europe meaningful metastatic demand for growing across breast regimen And

the Trodelvy be date as FDA. well we At the we an available Trodelvy's and We to with tumor treated existing planning -- approval of the plus in types patients to look cancer, across are under further markets advanced are or for beyond In expand multiple U.S. the metastatic as indications. to bladder second-line new for working as to XX,XXX-plus discuss accelerated results to reach steps time, next and bladder new this continues cancer.

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

In focused efforts, further see up therapies. from competition Despite comp as of sales out-of-cost the in providers centers headwind including sequentially remain and educating our a momentum patients our we've the cell the the these at begun on were to XX% near-term efforts curative U.S. authorized treatment and potential in U.S.,

reach payers end towards the with of XXXX. the we community as making key to national we're with reminder, commercial impact these working reimbursement. cell And including extend broader from of As unlock important practices, expect a therapy, inroads initiatives

second geographies the blueprint to progress to encouraged and quarter time. patients was portfolio X work our strong -- by in market. the as other it the our more we're are for bring commercial therapies Outside we and newly for solid international Saudi onboard and continue potential the new Europe and to refine Overall, Japan teams strong. remain U.S., across over to We'll energized transformational this markets and a centers by launched Arabia. as such demand

with and prevention for to then I'll that, next as HIV early Merdad. call with seladelpar the for hand lenacapavir as And next over late First, year. PBC week

Merdad Parsey

Thank you, Joanna.

the was We the of HIV Phase Medicine exciting a important infection New England Journal I yearly readout are of X evaluating our III in our second twice very quarter of lenacapavir with pleased cisgender up trial, Purpose prevention and for to number women. portfolio. recross of wrap subcutaneous publications Most the

this can first to XXX% trial see XX, III Phase the prevention you As HIV efficacy. Slide was ever on achieve

We plenary session. where the have was society data AIDS -- shared at the International our a meeting presentation in of July highlight since

published data England in Journal The Medicine. were simultaneously the of New

Our early second for lenacapavir registrational or XXXX. -- trial

data bringing goal of data positive prevention X, we Assuming to at trials people based from plan on file XXXX. the early of as to from transformative HIV both late as HIV risk purpose with

diverse to registrational populations people commitment U.S., X, X X our who in from Phase evaluate that purpose These generating lenacapavir II including trials, Beyond inject key U.K. France, and trials drugs. the we reflect across could data are benefit. the trials our populations across and

patients, also geographies prevention affected are to studies been options not physicians and greater including drive These awareness amongst have where intended historically.

our HIV pipeline. HIV options. addition next-generation on of we comprehensive HIV Slide intensely are, course, highlights In And XX treatment treatment focused prevention, to

viral at updates was lenacapavir AID bictegravir longer-term in II recent maintaining oral combination effective data our from showed meeting the highly the Our Society of Phase that once-daily included and regimen suppression.

our further HIV, those in Phase complex with regimens. people ongoing studies on These III support results including

evaluating oral our bioavailability the We expected also combination XXXX, once-weekly long-acting this Initiation a X is oral regimen GS-XXXX integrase of for year. II lenacapavir and Phase as these and Xx prodrug data of oral agents oral PK the reported designed both to greater safety trial inhibitor. later GS provide and to

combination Additionally, option. we to Phase with This in initiate regimen once-weekly is lenacapavir our expected ISLEND-X oral are evaluating and the to Merck's first ISLEND-X III be on islatravir. track treatment trials once-weekly

duration longer treatments. at Looking our

across and our We every programs Phase from the I and every integrase inflammatory I for the initiate conference to inhibitors highlighting expect at diseases our Phase provide studies EASL injectable to continued updates potentially leadership. X-month viral our in X-month both June liver

were III interim as form the Importantly, filings. for of open-label the shown consistent study of from that the Phase PBC, global regulatory the seladelpar of our slide, with basis the on ASURE response right new study results pivotal

to an from data III FDA of early as support know, XXX These a European week we EASL. shortly viral monotherapy decision continue volebretide XXXX. the shared chronic with hepatitis, a results in trial you regulators In milligrams final regulatory decision Gilead expect As treatment Phase at MIRR-XXX for HDV. to follow X

Phase treatment highest in promising a presented the simultaneously response XX evaluating alpha Journal with England New Medicine. post XA we IIB the Additionally, were interferon posted Volebretide as in The ever published finite HDV regimen. were milligrams and rates data of

on with KOLs ASCO frontline quickly Phase and survival of possible. We belevertide a patients trial We're to the we with FDA, at shared the encouraged plus and XX. data continue with our pembro, from are oncology progression-free mid- health A authorities, the by setting, mature XX.X bring and Slide be we our progress including to across the cohort as EVOKE-OX late-stage as pleased work data Trodelvy to demonstrating months. engaged Switching to II median programs. In to as

the exceeded non-small monotherapy performance evaluating enrollment well. data PD-LX all-comer cancer is an our non-small lung high study STAR ongoing is trial, cell These cancer population, historical and our EVOKE-OX Phase cell III going support of III ongoing. where in Phase lung first-line In ZIM DOMs XXX PD-X

and ZIM TIGIT-based in with The Dom this Our the upper updated at completed first would chemo data of regimen Phase be patients. GI edge chemo If evaluating enrollment. for Zim Phase study upper Dom the GI XXX supported combination. use gastric ASCO III STAR plus cancer cancers successful, and presented II has

In settings in several including Phase evaluating earlier breast in have breast underway addition, of triple-negative Trodelvy programs ASCENT-XX cancer. we metastatic III cancer, PD-LX-negative

second Turning to our line programs.

We're this cancer in and metastatic We no EVOKE-XX as have alone. assessing for cell with non-small immediate currently on discussed setting. lung EVOKE-OX in based the of have path next steps results regulatory expected, is confirmed regulators, there Trodelvy

at our discussions provide will bladder future and a also conference We updates results program, scientific the including after cancer FDA on KOLs. full trial with

to of Yescarta of we Hematology relapsed data ASCO, Cindy from Yescarta overall pilot in high apparent no demonstrated in Meeting. nervous survival XX. no greater Tecartus refractory Yescarta system And to on collaboration than we Institute. European a expand new unmet shared need. months in team, lymphoma shared on toxicities and adverse Cancer study the encouraging with Moving include the reported we Slide events secondary with the patients. the XX these at or these Association behalf with central these ASCO of XX both Based Dana Kite for treatment-limiting Farber and Yescarta with and updates primary At median use are patients additional to regulators or efficacy and of risk patients results, engaging with

further Phase B-cell trial preliminary and II with that survival Tecartus adult in overall resulted in the refractory XX% overall leukemia. XX acute lymphoblastic almost in prophylactic and of reinforces the from median experience Additionally, we treatment or for a strategies. rate. pivotal rate Yescarta large steroids survival manufacturing months the trial, ZUMA-X refractory with supporting lymphoma we early large success shared X-year Yescarta use of XX analysis ZUMA EHA, third-line relapsed B-cell reported and of XX%. At Real-world or strong in relapsed our intervention outpatient B-cell lymphoma other second of manufacturing of use

earlier we that clinical cell, of trial partnership I Aneto include or our patients. for our our Further, a we myeloma shared Arcellx. III a refractory potential will set relapsed multiple promising best-in-class with CAR-T design that XX, on will Slide development line in developing BCMA Phase program broader for highlight study are iMMagine-III Notably,

in -- year. completed a half we first note our overall. committed for half with second are this one of of occurring first patient purpose start all program pleased our ahead We're of and for We milestones half this to readout the good with to have second expect that of the the pleased line. time execution We're our trial in to the off

updates, seladelpar myeloma negative in the iMMagine-X pivotal on Phase Phase pipeline inflammation decision FDA from bowel an inhibitor multiple relapsed week next alpha-X-beta-X II to addition with study and TPLX cancer. over programs an in as triple-negative to and later-line as forward -- disease. these or such oral trial in PD-LX II pivotal in a several III Andy. And well an now integrin inhibitor update the the I'll first-line for have Phase breast we metastatic Along look includes for as We a maturing that oral update inflammatory hand call the PBC once-daily ASCEN-XX refractory to

Andrew Dickinson

Thank afternoon, an HIV, you, and the offset expected our sales oncology good up across Product billion. Veklury than decline liver business total with on year-over-year. X% The sales team and to excellent everyone. with growth more Slide year-over-year base X% Starting Merdad, $X.X quarter up product in disease XX. delivered

our Product to basis to was X% certain expenses X%, down Moving recent gross points from magrolimab and following data XX the wind down margin last due severe and updates. down R&D trade XX. Slide results non-GAAP studies -- year. on of regulatory primarily were year-over-year,

was to clinical new down in the meaningful and quarter. towards most opportunities. reflecting IP savings X%, partially in R&D of the million, and XXXX disciplined manufacturing These initiation R&D XX% Acquired $XXX to XXXX. primarily settlement the studies. did timing the reflect management of payments by due R&D Sequentially, down collaboration that was in year-over-year, of the million $XX SG&A offset legal second activities, due resources primarily was ongoing not new repeat

seladelpar. our third second this margin of highlighting XXXX, margin commercial investments up we the the and XX% SG&A operating the quarter of the our leverage since ahead have was launch of Operating business includes strongest quarter Excluding payment, for X% year-over-year model. in was

tax. Turning to

On per tax from non-GAAP a XX% with diluted authority year-over-year grew to reported settlement reflecting $X.XX share. XX%, approximately second rate in quarter. our EPS $X.XX tax basis, effective a Our the

$XXX XXXX. in of representing share we the million per quarter second legal earlier, $X.XX of the did not mentioned had repeat in a XXXX that settlement, As second quarter

expenses, product IP Excluding EPS R&D grew expenses. reflecting sales lower higher acquired this settlement, and including XX% year-over-year,

Slide base of highlighted business guidance of full Switching XXXX to growth As each performance on across the of driving in for our the of X, a oncology, to on virology core franchises which year our of first our X% expectations we half XX. strong X% at upper end year Slide with had solid year-over-year, is and X%.

sales, in total expect to excluding range the continue to $XX.X billion $XX.X in $XX.X million the million product billion. total sales product Veklury, range We to of of $XX.X and

experienced are not stated this the Given updating as guidance previously, variability Veklury our and we historically at time. inherent

about year, half the the As we continuing are think to of the second that of factors are here some monitor. we

First, we always have continue price channel to our expect realized business average variability in experienced HIV we normal relative the that with associated to quarter-to-quarter mix.

variability therapy continued to expect we cell due Second, out-of-class quarterly and in competition. in-class

And is there finally, revenue year. there of headwinds the second of in represents Trodelvy sales half uncertainty associated Trodelvy than Tropics-XX FX a incremental of Third, possibility -- some bladder reminder, as is following today. a with XX% bladder less the total

the deliver growth. assuming volume incremental XXXX, rest contributor strong an to For areas revenue all across expect and growth we to seladelpar as approval, to therapeutic of continue

and volume disciplined consistent and growth, on approximately revenue continued management. X% to HIV by product Continued year grow operating with sales expense our HIV full expectation focus

margin absorbing the and despite the non-GAAP than XX%. range mid-single-digit reflecting change previously guidance. R&D, Moving by now seladelpar compared in late-stage to low a There percentage R&D no to expense to XX% expenses to XXXX, increase of program. to gross we XXXX R&D for expected lower to total non-GAAP expect is our

For CymaBay change prior the associated have we able guidance SG&A, the our expectations absorb to to pointing last incremental been mid-single-digit to transaction. quarter, with to Consistent no XXXX. compared decline a with there expenses our is

year $XXX from to IP expenses to seladelpar now billion $X.X global quarter out we transaction of last acquired buy For up $X.X a million the billion, Janssen reflect full with royalty. R&D, expect

our expense quarter will results. This third be included in

expense, second are Finally, acquired million billion new increase our expense or strong despite the income EPS royalty quarters $X.X buyout expense Slide non-GAAP operating we pay billion this This $X.XX. associated absorbs approximately of and and per sales. operational in guidance guidance Gilead's our with demonstrated diluted of control the from increasing our royalty to the $XXX Janssen. with seladelpar increasing the guidance highlights that IP to to both to fully X% $X.X first million R&D obligation EPS $X.XX XX to to the $X.XX transaction share seladelpar and $XXX removes the

our of with tax $X.XX to on on associated priorities. Rebecca -- Excluding now the execute is we notes billion federal Tax remaining scheduled repaid for billion positioned we $X.X second part and our paid returned and April be tax we the the quarter, is Overall, and of billion $X.X XXXX. The Cuts transition to this expense Act capital of begin allocation commitments. management Jobs transaction growth and billion $X.X In well on the and of discipline of that transition shareholders, senior payment to focused Q&A. I'll continue long-term near to believe XXXX. execution, to invite for strategic Gilead delivering commercial And as

Operator

Go ahead. Instructions] [Operator

is line open. Your

Evan Seigerman

updates BMO been had Seigerman Roche touch This lot Capital ASA TIGIT. space. discontinued the a kebab in study cancer. is lung Markets. wanted and their recently, on update, most small of the know Evan cell Merck in from I I to TIGIT There's

could safety in And and program? terms efficacy would you just think like you walk much. Thank for opportunity STAR of So, so the for XXX you TIGIT? look both with what through how about good us you the maybe

Merdad Parsey

Yes. for Evan, Thanks, question. the

to I we've including as as And And today. that molecule event approach, adverse a we demonstrating note that updates somewhat said differentiated -- along, gets have the past in noted, TIGIT you from we've off, competition molecule think over of were is there is an which and have that, data profile, the active Fc have Fc a an I a that that highlighted lot our the I competition of in difference molecule so. that that or would first on think known been think terms I relative silent is has. to our that, months we differentiated X the

areas of where we best stay there believe focused the in is Additionally, I activity. try chance think we've to that

example, forward cancer for cell. non-small have in have any small And on capitalizing not look so initiated cancer. both trials we seen to gastric We the data and with we far, so cell lung

As you completed have the an provided on as and the ASCO I that. we the enrollment know, gastric that III of trial in call, study noted we edge Phase of update at of

about doing continue a and cautiously data-driven so it we in are optimistic data trials be in way to on So TIGIT based our generated the we far. have

Operator

Our next comes Morgan Flynn question Terence from Stanley. at

Terence Flynn

parts Two Great. me. for

Just if to this help frame for trial, Purpose I. given a the Purpose II is Merdad, expectations just wondering you can slightly relative different population

we So for ahead that just as then think and setting part about second of data, there level the Johanna. is

that guys PrEP really is But are other So high the use still what you still in way a help you payer obviously, given branded take as company to steps noted that market the alleviate of growth some you've can roadblocks the which seen maybe PrEP use. generic of the recently, of Truvada encouraging. level

Merdad Parsey

and you said. question Thanks, Joanna, sure as and with us it I'll a start that make good thing It's hand remembers. great Terence. off then a to everyone I'll for

Purpose our Our non-binary I in assist and women was and people. was as noted, is X in trial that and the men cisgender transgender ongoing women, study and gender gender Purpose game I the

similar to Purpose. lenacapavir is the as a be to study Purpose rates. I, is filing. for to trial One evaluate secondary like would will be Truvada That's background And necessary secondary endpoint endpoint. is of superiority second endpoint. primary II that superior the HIV designed the It Now And ongoing. that's against the Purpose

demonstrate a result II. if in positive we -- we hopefully, once So Purpose

for Purpose filing to We quickly move I those will lenacapavir with combine as as data PrEP. to those data and possible

Johanna Mercier

Great.

the lies despite blocks referring you to maybe second PrEP to. payroll So the were just in what of complete opportunity some the and part the around ahead that that growth of question

a PrEP of on the year-on-year. points Just at One so market for or is about today, couple that. growing is XX%

covered couple consistent is over all are of growth we've the Descovy that last coverage from an nice of XX% years. over access standpoint. seen lives So

daily So an standpoint. today, the concerns any not have access do from orals

as and versus that payer a medical that more we've to we benefits potentially competitors. create you're a maybe I from the about our some with think is benefit, seen what access pharmacy think headwinds little of already referring standpoint, might bit

seeing most lenacapavir about the users size in with we as think And growth is growth As profile just also just over much as market whole. opportunities. to the redefine the a XXX,XXX purpose think offers twice we allows X data sub the growth, with see us really major it third I in one around the not X recently as and other yearly we're only around One, PrEP adherence. it that market the on of maybe U.S., but One share a today, is is light really market

right, revenues transgender So out and if those users I women, more States. about break United we coming so young growth reaching thinking of reaching and as the well men little than just just down PrEP MSN around a market now, women, are are cisgender primarily as Latino settings over is bit, countries, size right adults, time, reaching because beyond more the different more in prescribers well today, white Black really individuals

better the XX% standpoint. be will and least obviously, yearly has subcu administration. a to of greater that than When where it presence twice oral is believe X has From and with outcomes. we not over from today. And in today And and prevention higher frequency -- together, than is are the be a market the adherence we higher none oral think you and lenacapavir of with long-acting a share growth divested daily but #X HIV the standpoint, daily believe much share, do will between also Gilead we about leading last Descovy brand just

the obviously focused opportunity for but the as So only Descovy, future on with we what all an with together is of not potentially. those corner are pieces lenacapavir prevention around

a we how from their in benefit drug, reimbursement others And CMS support PrEP but when from high-touch basically we medical facing we B I access impact greater who that going is from Part or we gets very to think even wants to the think how and they PrEP challenges about do thinking ahead also think a making work access a is are it standpoint, access prescriber about doing how have ensure an that as everyone for to this of sure through we're make needs standpoint, to choice. here. that approach a and both do been thinking drug

Operator

next Leerink from Partners. Instructions] comes [Operator question Our Dave

Daina Graybosch

and process a to confirm just wonder thus, iMMagine-X then and is your it cell, is want observed data be of enrollment? we a to I net the higher that to on can what so of if enrollment soon as can ASH expect trials competitor in back. you wonder have kind X-part accepted the X what at deeper iMMagine-X. avoid should bridging a whether a One after follow-up approach debt you I was I and the time therapy imagine completed in question risk in ask on

Geoffrey Meacham

got Pretty her here. Daina So over We'll Thanks, we've to answer turn that. it to Cindy

Cindy Perettie

Thank you for the question.

about best-in-class met. be been with its sell really to continue We has excited profile. enrollment And net potential the X IMAGINE our target with for the

of of obviously, I is did we're And abstracts, cut an follow-up what a process in for at second to think we data. think ASH? the question the we second the the you initial -- see do sharing asked the final type cut, expect would I of we'll

question but we up therapy. have second So the exact with iMMagine-X have that -- I to follow look time, your around bridging once can you don't follow-up we certainly was and

production as we now, to from able our heard weren't you Dan the tech moving we into Right will complete facility. so -- be transfer, Maryland

the to therapy our bridging get lot to learnings market of time have iMMagine-X as with in we existing of supplying those the it able to our on relates out upfront to expect today. having do and be So we facility, therapy. nets Maryland a that a we apply be to will and patients back products

the necessary bridging do option the if with therapy today, we design for to have However, protocol patients. do

Operator

from question Evercore next Raffat Umer of comes Our at ISI.

Umer Raffat

I'm low-dose well. bictegravir heading lenacapavir combination of as to regimen intrigued some you have just thinking possibly about to into very alternate that Dovato nuke second And back rather Or your experiences plus well as of a just meaningful trial to a -- the I'm could trying Phase this would some replace Biktarvy understand III. extent? sort I'm as a in

Johanna Mercier

that take I'll maybe So Umer. one,

can a studies a both treatment that a integrase really X capsid. doing is we that Phase X step. broader we complex that to kind really which first indication and we go And suppressed. include regimen single virologically combination of -- looked So first we get the all III, as believe we best-in-class that inhibitor the label into with was the are also are regimen, Phase The a first-in-class at combines

as complex optionality we opportunity switch an viral provides the of it's think for segment also simplified the in that about FTR we regimen, decrease opportunity, that's So optimized, for but the marketplace. suppress an think

that's perspective, that as believe portfolio we as in think standpoint, segment. it of care is Biktarvy opportunity will still we a the remain the standard we a and also today, oral daily as an tariff So the standard about think but from of switch

in space Biktarvy's So bigger a biggest switch because and from the to such share, a piece, for market probably growth. piece right? naive segment, big the offers switch a large us play is for in a another that we HIV. have us So obviously, opportunity

Operator

Barclays. Our Gould at next is question from Carter

Carter L. Gould

Great. one. another X Maybe purpose on

the very efficacy impressive. So again, was

However, those long-term as see setting, potential nature months? the guess those have were XX. its out did of that in I that profile grade modules, north think nodules X and And sort see demand Johanna, you X, how to of for then of XX% only week this back and the go influencing they but about patients did after do recognizing impacting we get retreated or profile, for you the of patients that

Johanna Mercier

it's a nodules and the just actually drug palpable, due discontinuation but but if is number time. bit, all, So are palpable, over a sometimes very that. sometimes That's the X Sure. seen not we've right? nodule because explain purpose one. generally to little Two, depot, And not gets are Carter, in little nodules smaller visible actually to the What speaking.

been places, And we that those believe I in -- injections the have think because so where play inside. well to and out some will in when different actually as studied flexibility we just as not they've stomach

to people little be be bit think opportunity a well their will I flexible they as that more so And an get for injections. to where as

really, on Purpose we're from data I learn So the you have II. we're data hopefully, at as from actually. taking all, we're that concerned not overly we'll And there similar getting and it Purpose

Operator

Yee at from Jefferies. next Our comes question Mike

Michael Yee

a month, changer. long-acting specifically potential X a HIV have think the game question QX could I be We for which on

you Because X on or safe good HIV follow confidence if X have of me pretty generally a you barrel load in you know slide think have Can development, your it's your I level I/II. that Phase on there? what them if tell are advancing. and significant spot they you -- you're you and reduction in

Merdad Parsey

from looking right -- raised clinical. Merdad. new we're be at have the the cautious we reactions nodules you site long-acting human it's that get transition for don't whenever -- to injection site about the We the you other the predict just might then long-acting to that severe we're the Michael, preclinical not but pharmacokinetics. which lenacapavir, We talking about always in question, were Yes, from the I long-actings agents, is and Thanks. more think injection particular. to able reactions

going out So And I those we forward. play multiple that's us see to need into to why move think allow agents you to Phase I.

We've a move forward. moving aggressive leadership treatment molecules. our prophylaxis. HIV have maintain and them pretty order in in forward number We We to been of long-acting generated in them

go once so see those forward. we us data where in want decide that will those to we both And molecules help I, I and between start Phase think choosing to

moving Remember, as we're program data study is with forward, well. bNAbs, will II that most our from expect which we Plus which Phase our also program long-acting get to lenacapavir and be we -- BNAP -- advanced should our

be for take So we'll programs, to which the shots. usual And it's quickly. we those is able advance multiple of and one hopefully, why risks them early

Operator

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

Brian Abrahams

how GLP-X the portfolio, Or interested to Are in planning you landscape about other may thinking metabolic and are are it to oral pursuing? you that participating? adjacencies obesity forward? your You as have move you preclinical diversify GS-XXXX an in there you more be pipeline. potentially the And guys continue and guys areas

Merdad Parsey

it for obesity proceed best-in-class and just diseases. in and those from weight we molecule, NASH best will profile. initial program. Once for generate are which preclinical of our came XXXX for have to data-driven Phase some XXXX, data, is something will Yes, study and want you that as best-in-class the that agonists, both in that we'll I so allows if decide planning how interest a other internally on our data management, have GLP-X plays Brian. data a sure we an shared the out We evaluate developed far, make preclinical out. oral there. a we to to note, us way it's Thanks, metabolic And and And on see help we based how dealt we

we'll are update the more generated. as So . data

Operator

Our Schott question next JPMorgan. at comes from Chris

Christopher Schott

My was questions the U.S. were a -- CAR-T just question just franchise. on

Just from get to on about be sequential of can wanted we with community as here? that, just that -- update and of indicators an seeing part CAR-Ts guide your how the thinking leading growth any some And these some kind you're should on your physician engagement get the latest maybe could view maybe help from or that seeing efforts of we the impact there the can we U.S. of the when start efforts in

Unknown Executive

Thanks, Chris.

our is this with our therapy really this parcel strategy. growth part pleased really cell U.S. quarter. strong And and are to We refresh

and quarters our as on what excellent ready sure We've also of in go. referrals to specialists. restructured performance part CAR-T really our So authorized year. had sales between got the team we trained you're part the the the within for And at that centers, that we sales seeing that's treatment strategy, as making team couple specialists a those end this And and occur the place as of reminder, next the of of quarter. lymphoma new to we focused last

hospitals And we'll in up within I'd continue and -- educating those practices, referrals and to HEC. the potential CAR-T to spending their that also payers. that those there, progress focus community really to community on practices building both the national We're therapy parallel the making deliver into time and including they're the say, this it's really bring and why the offering with about we're of curative a lot institutions good And important patients. work regional of

as are facing despite -- and from earlier it's a this, dynamic But Dan you market. both all heard we Johanna,

some cautious remaining of in-class half headwinds, year. the competitive are see for as to both this we second We continue competition.

capturing said, time physician our new we have that we of working the the and we'll bispecific. are share out early year. continue that so seeing also with initially. the frame, which focused indications with competition to potential the in awareness institutions do this of June But execution are raise physicians And of mind CAR-T to in half for curative and So we're all with on and late came May, out-of-class second

them a that great us learning community fully it up making last quarter relates way. we're As as taking it's progress relates longer lot operating, and a little to bit had than expected along that shared it get the we and to practices, I but to

centers. So continuing to blueprint we as our we're onboard refine new

Operator

Our comes next at from question Steven James. Seedhouse Raymond

Steven Seedhouse

target? Are outlook. long-term of about of mix to could comment newer more that a the the with X/X seladelpar, tailwinds is of expecting moving When updated obviously, of oncology of lenacapavir, Or well. Just that combine some redefine so still given and you Just the oncology? the of on view be revenue the market hoping then which indicated PrEP XXXX as pipeline. outside oncology you you could you just course,

Daniel O'Day

question. for Stephen, the Thanks, Yes.

keep with that you, the in is without today which of remind adjusted have sales probability indications I'll the we So in are additional XX%. target BD. remains X/X and achievable portfolio many of that target our around that we just believe and are them mind

you'd to So that and puts set in takes see pipeline that expected We target. when we expect certainly that evolution.

to short expectations for allows pay obviously it So support succeed others some all to and of or that fall goal. programs initial achieving

they're nicely. XX% of the today just there. I growing oncology already than would X/X In X XXXX, of quarter are about way product that the total note sales more sales

this the progress we're overall So on goal. making highlighting it's

our our is very problem the ambition. lines well well our point more to in even to we also the as you ambition I as tailwinds with strategy. of think as as grows, the to committed stretch put to we're in seladelpar. Obviously, and virology, good -- you're it, and business think right data It's firmly have the business puts metocapavir our that out as a that much base progress I along as But solidifying and have. virology that diversifying

Operator

Wolfe at Research. Tim from . comes next Anderson question Our

Timothy Anderson

a question on the have I space. Trop-X

year-end, which thought will also get first-line from those the III will Phase best benefit. But Breast we'll And trials trial Tropics probably or drug allow And likely a with guessing safety prediction and for do how thus sure readout the less you getting before your lot. design metrics OX. how far be What's you've your X think Astra's we'll ASCENT-XX sometime compare? quite your the So those this comparison will around results efficacy you'll show other? triple-negative TRODELVY Astra's. similar, are for side-by-side ILD of each I'm I'm about of other is against versus up and stack

Merdad Parsey

I Merdad. you Maybe the look, hit think -- highlights. is This Sure.

triple-negative Trodelvy is aren't our and predictable our and well, definitely Trip remain, for doing -- has efficacy Where programs care. profile standard very mentioned, I the space. we demonstrated ADC Trodelvy in are in as largely Trodelvy, adverse breast to differentiated. of remained becomes very -- you where And manageable. negative great has triple is this that think, cancer and We only approved space And event

been physicians. neutropenia as their think which mostly part Trodelvy, and for and the comfortable in I certainly we have -- very manifestations both stomatitis different to mentioned when clinicians very we the diarrhea, managing our KOL. speak with certainly On of you as well been gotten have ILD it's

I go and So those of breast. triple-negative we'll for think be in our think looking look Trodelvy in and particular, for can our a we really where solidify data. We'll continuation position and it's data

Johanna Mercier

just just differentiator I of and the that points. a . market line, cancer the the emphasize Merdad think as think is in what well we I today triple-negative said big Yes, data these think of care ones standard the fact about are I so would that we some second established #X that, as do breast on

Operator

at Richter Our Salveen comes question Sachs. Goldman from next

Salveen Richter

HIV more pet the able and these haven't different to to patient With Purpose to could specific about populations? speak patients differences X? these in regard could the And expand regarding X are typically you program, you strategies already? potential from read-through in why speak been to responses the drugs there to to market, here And whether long-acting reach strategy you Purpose any

Daniel O'Day

maybe a X-part have add Johanna Thanks, Merdad as and It's kind so have start Salveen. of I'll well.

Merdad Parsey

patients is get oral to bring that diversity to PrEP the Yes, Salveen, broad a development. that we our different, on of can patient program purpose in right The early program populations really are you're did ensure are different. early in a awareness, why a and populations patient the PrEP for different levels have we to of We're of our population, absolutely different those variety women which talking populations relative different agents. to And X otherwise, PrEP our example, the of expectation levels population. with of cisgender is that populations purpose the use is their compliance

infection for the cisgender I women, data have in in occurring think if outcome protected degree very expect to X, purpose -- population, that, protection on of powerful. of a lot that strength the the are really the so us confident people infections and with X rate who remain the in essentially are some variability that fact I with in despite will And maintain able months Purpose the be that confidence that would the background far, think, we no you we I give of

Johanna Mercier

that, part on Maybe the to second up pick of Salveen.

the have So when in needle moved we to it's you to think a important the think about market. just penetration back, understand step take how much the actually I prevention

Just if of a couple standpoint that. penetration of years you ago, it you CDC X/X were -- from estimate, XX% we're a you about consider when now over

it. expanded really have market we and So grown this

definitely a -- is this individuals has one been where not treatment. sick. not that is think it's I market these of typical not market are It a you that the are HIV challenges --

nothing. They they have no have Obviously, asymptomatic. --

therefore, very XX% or a Descovy think market, is about about daily a you you think pill, so which share pill and single challenging incredibly oral the And of over whether when total taking today, current is every day challenging. generics it's

in think that, we use do I demand many on and white So see PrEP population and there's actually -- MSM. are that biggest the

that a and here, people of market something individuals future. we the can the lenacapavir subcu truly real the opportunity there's to has that could believe from a of for commercial that high prevention a with -- that yearly much profile very reach the expand we twice So truly benefit

kind that's so of the And steps.

that growth I think been an we've ongoing it's So seeing.

as future do of have change a we step about think think here I we to the prevention.

about have people really differently I lenacapavir all offer and think think what these to of epidemic. could we HIV dent completely a this in make

Operator

Brayer question comes last Cantor at from Olivier Fitzgerald. Our

Shin Our question Deutsche comes at James next from Bank.

James Shin

the for thanks question. Guys,

Part PrEP, for And is the mostly B move to For to a... is PrEP, expect do a remain net the positive when by approved -- to you access? eventually market

Johanna Mercier

one. that I'll take Sure.

is perhaps or So move, that do CMS think the it's on, the I positive. working NCD

that potentially providing I access services greater it. think it's really with the also go and around providing

is despite BXB small actually very market. So of be move could prevention total the today, piece nice that fact a a the Medicare

think As about I will we both. lenacapavir, think it be

well it the think medical a benefit I be as a buy opportunities bill. for there's as be and pharmacy both probably benefit and to

need just buy to prevention, that bill current in familiar something of very is this they're differently we think I and users because think not the with. And

for to I an up do have but planning the option if And we're what think so to is about today this do think tomorrow of make is they do want for that's understand something don't we thinking kind And of they that it. they this we're about it, setting lenacapavir. future as they really system want if to that how sure to

Operator

I'll for questions. time That share have remarks? we invite that completes Dan any to the closing

Daniel O'Day

line summarize We growth that bottom our model. very follows. in Thank leverage would revenue of the you, a closing, had strong here the and everybody. quarter impressive quarter to In we like growth team the as highlights

the to HIV promise the comments. this late all continue for Secondly, from XXXX thanks really to on Gilead commercial portfolio remarkable positioned you HIV focus half imminent will for it to to teams want for of we clinical, the the seladelpar into data some to when including My And I of quarter financial execution. should after of well enable us leadership and Ross and across second and made on in Jacquie of leaves the over oncology. strong in with U.S. beyond. quarter all we to well joining in final of to progress today. and the trial future, The purpose X extend the progress build the that and that from us our growth XXXXs continued launch hand

Jacquie Ross

date today. provisional for and you, between us now One I Dan, results quarter share tentatively our that thank earnings then. all scheduling XXXX we final item. arise that accommodate to be X. changed on this conflicts Thursday, Please joining you that can could Thank and third is housekeeping November release to are note planning and

we We always, close updating third and announce progress the you throughout appreciate continued of confirmed on date following your Gilead -- the the will quarter. As on our look forward our quarter.

Gilead Sciences (GILD) 8 Aug 242024 Q2 Earnings call transcript