GILD - Earnings call transcript Q3 2021

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Daniel O’day

To the significant reduction in the risk of hospitalizations after a three-day IV treatment of Veklury and the outpatient setting. In order to meet additional treatment needs, we also continued to advance our oral programs to develop a novel best-in-class therapy.

Turning to HIV performance, we saw positive gains in the treatment market for the second quarter in a row, and reported record revenue for Biktarvy.

While treatment prescription volumes remained below pre -pandemic levels, we maintained total U.S. and EU treatment market share and we grew Biktarvy share sequentially in both geographies. to despite our generic continues is market market steady holding entry. PrEP recover PrEP in share The Overall, our and third the clearly HIV quarter Giliead results give is highlights from us recovering the market pandemic strong our share market market position. confidence that

of deliver result we quarter, the at we close and to strong full-year [Indiscernible] now the have guidance. expected the per twice share the That our year. start look revenue a As increased earnings set of to revenue

been full affected expected resilience. $X.XX clearly COVID, revenue While it midpoint, year. shown our has than at base be also by At the of we has business we to start higher billion are year guidance the the now expecting total

on therapy across in with of prevention, we our next risk efforts generation Our work, prevention. of trials and living the evaluating progress Lenacapavir at treatment available to HIV in confidence longevity part-based of developing HIV HIV. the is X of people clinical or and our to that options and the Lenacapavir have extend cornerstone the our in business highlighting is

granted was FDA review heavily treatment for Lenacapavir experienced population. quarter, This the priority

HIV oral and with long-acting therapy Eslatrivir an combination acting X signed start for this As the agreement subcutaneous acting a evaluating, HIV. be as with if Phase earlier lenacapavir, of the Merck people for acting as Separately, in first as multi-drug we long eslatrir, study this explore have breakthrough treatment. you Lenacapavir a we of approved, know, available announced to treatment. week, reminder, year living would and combinations long Mark designation, Earlier X-month long resistance, Lenacapavir has with well who first treatment the injection treatment

options infrequent long be shaped heard shown visits injections has living stronger even continue potential options and to Lenacapavir and office or oral subcutaneous is and HIV. or subcutaneous our while that taken both you greater welcome injections would by adherence approach The at We've convenience, progress privacy. people weekly promising on coincide these include could routine much advance potential that oral updating of will acting both for in advantages with Our that to they with throughout. very home.

significant broad stakeholders. also diverse While extending executing oncology transformational the portfolio. leadership and HIV, in potential that bring our in This we're on value benefits and with people potential our for has our could cancer for

highlights X adult solid myeloid additional of quarter tumor XXXX. from unfit, initiation Third The basket - and cancer multi approved in leukemia cell III our acute fourth in We is an approval in to or study. the of and early head study magrolimab, Tecartus first-line a refractory trials initiate plan acute include lymphoblastic FDA neck or tumor indication AML for relapsed leukemia therapy. and ALL, Phase

in and Trodelvy be for an metastatic And positive which this would approved, first for Commission tripling Additionally, Yescarta we breast second-line in decision be year. if CHMP this has expect And European CAR approval in SBLA earlier from the Trodelvy the cancer for the XXXX. potentially our triple-negative Xth month, team breast second-line filed line T a later in an could of opinion setting. therapy Kite cancer LBCL, this earlier approval

for the and clinical antibody said a immunomedics with would trial of combinations that combination and Additionally, metastatic with supply use When tumor we cancer. breast the types, and first-line pursue a across treatment Merck's conjugate collaboration we to would year, that last wide triple-negative with Merck we Trodelvy explore both Trodelvy Gilead's internal external new anti-PD-X acquired of range molecules. we the announced for agreement we've just evaluate drug -X KEYTRUDA of TROP of therapy

out this approach. early an as of example this now see with to can partnership You start our play Merck

for we the delivered X, Slide pleased on target note that milestones quarter. I'm X our to Next on of

of as January you in You'll But are first the oncology, updates timeline the to expect We Magrolimab for of February. XXXX. the on the Phase in First will also have the sharing in adjustments for this timelines to touch the event-driven PFS normal readout Merdad trials the later and Ib late the Quarter for especially modest also Ib readout forward early know, that look have call. TROPiCS-XX as Magrolimab note now like in these quarter TROPiCS-XX. quite in XXXX. we or these Phase TROPiCS-XX And shifted topline

now Taken most of in field some the the as portfolio a whole, today. stands our promising oncology targets

adenosine to addition TIGIT, In for many therapy. others. include These and TROP-X, Trodelvy cell CDXX and

across quarters. The momentum taking quarter the to our are in in in by momentum the overall forward sharing look encouraged confidence gives much and very great more are we us of positive progress. pace these programs the the and coming We direction the third

the That we well market portfolio. when update I'll employees much commitment there is to Johanna, on in to making plans around And the a pandemic commercial the potential health. highly who want world kind and are our excellence, possible HIV well-placed the are with With Gilead in to evolve. global on significant way the bounces back. the scientific that, while their We an performance hand more our in of for sustain who leadership share glory on for to HIV. third the quarter. the this impact our to over to are oncology, I their to promising we've all passion in with begun And making will already thank all as is execute public continues come

Johanna Mercier

Thanks, Dan. good And everyone. afternoon

XX% $X.X As year-over-year, on see you primarily by can driven product of Slide grew total X, sales Veklury. billion

impact billion Trodelvy. and and Excluding expect such Offset to the the of growth XX% COVID a have continued X.X hospitalized XXX% were Veklury, we and since. due Delta the by in up end the with year-over-year, primarily been X% of Over reflected demand to contributions strong Truvada declining in U.S. Veklury and COVID ever $X.X sequentially, cases, track with sales Veklury, billion consistent to sales the and the new sales can our see X, Biktarvy you patients were variant. LOEs. -XX On medicines Atripla surge down in of Slide product from continue total these of Veklury at hospitalizations, August with which recent the peaked including U.S. as

of toward billion Biktarvy, Moving X, on by sequentially by and grew X% for continuation HIV favorable Slide offset X.X mix. revenue trends partially demand payer driven to net favorable of pricing the the less strong

impact strong, revenues of Our pandemic-related inventory, down primarily total sequential HIV trends the -Atripla in year. and by X% Truvada lower given prior LOEs year-over-year, were the driven channel were stocking

LOEs, U.S. grew HIV the treatment. pickup revenues in the from sequentially, about suggesting in The treatment HIV the HIV a trends recovery of up Overall, X% X% the were QX. market year-over-year. encouraged by Excluding started impact improving modest that we're

HIV and a U.S. to XX%. reflecting driven billion. net continues revenue demand XX% at Our the treatment to inventory, steer lower flat revenues by market Descovy And increased hold grew and modest pandemic sequentially $XXX recovery XX% at Biktarvy offset approximately by gain, the steady record share year-over-year, quarter-over-quarter, and overall price. of strong was $X.X million

of We around continue Descovy market to shareholding PRAC Truvada. our see to the recovery despite and of year-to-date with study encouraged generic versions multi-source availability quarter-over-quarter, growing XX%, the see XX%

stats. in Biktarvy. the On of the Slide We're capturing sequentially XX, million that on and sequential revenue growth see XX% to of U.S. to proud and total XX a on in the down primarily due market in X.X% sizable HCV more Department of with did to leading share. the especially Sequentially, basis. EUX, Quarter see the revenue XX% We're favorable by prior [Indiscernible] quarterly HIV particularly Biktarvy Third of quarter XXXX in market and Department the of year-over-year, Corrections of X% X% a uptake continued Biktarvy's U.S. the the of than treatment Fewer Slide declined not people purchase with starting including treatment given XX% inventory starts on repeat. gain pleased living now by in of share Next XXX timing relative EUX. of settlement fewer year-over-year, and of and market to patient Biktarvy US in the continues was Corrections driven U.S. purchases both dynamics, outside patients’ the

stats testing we seasonality. in -- declines Europe, in some the and continued normal on to pandemic-related addition geographies in impact saw year-over-year, volumes Although driven by additional patient lower and in improved sequential U.S. visits,

to market the holding just is share around and XX% we steady EUX. pleased continue U.S. in HPD be the that Gilead about However, XX% in

HDV revenue France, sales now $XXX wrap of XX, driven revenues demand XX% in million was to Greece. million our Austria, addition Moving Vemlidy HBV portfolio. $XX and markets of Hepcludex Germany, and the reflecting for Hepcludex in by year-over-year, Slide international and to QX

full working are in government We authorities in major reimbursement with to market actively secure XXXX. European a

to in of share in second-line. are quarter-over-quarter, XX% in second-line revenue metastatic XX, to of a TNBC part April. $XXX to line estimate across continued receiving the still, treatment third was cancer And for due adoption bladder the estimate on expansion by growth Slide setting, setting, we patients in or cancer, U.S. Trodelvy. Moving for third TNBC million a driven approximately on In In approved that third receiving quarter Trodelvy. TNBC And already line or later are in of metastatic in second-line increased second-line Trodelvy. four Trodelvy settings. about Trodelvy patients metastatic grew least that both XX% later at patients opportunity with one and there's we urothelial third with the start

community physician remain We so settings. far are focused awareness pleased and in with the uptake broadening on

is Trodelvy metastatic included Following adoption. expect and a will cancer, second-line now further in drive in preferred clinical updates. this as guidelines. guideline TNBC recent NCCN, both regimen And we breast ASMO

of Australia, the are in we We following Switzerland. are preparing the first from positive commercial and TNBC a decision Canada, European from Great the this recent metastatic from Trodelvy And later year, opinion expecting the Britain, CHMP. Commission launches

XX% XX, lymphoma, million. therapy in slide than of launches impact driven entrants year-over-year mantle both by $XXX Kite new demand U.S. and strong Christy more behalf offsetting on products the cell grew the follicular LBCL. lymphoma team, and LBCL expected our and Next, and cell in was to of This on

indications, support online our Maryland addition to XX% mid-XXXX, which many our our expected and reduce of facility are MCL FL processes the of within reliability costs. working particularly To growth, operations rate. manual automate have manufacturing and proud maintained we in will With we we best-in-class that our new bring new our are

team patients highlight would it This also us Kristy which first supplemental more available only Kite and therapy and therapy We updates. during LBCL, the to in the potentially T a Tecartus over Merdad with carrying I has one questions that, BLA the cell on eligible filed Makes Car these U.S. with to ALL. also take is hand team want to adults And for bring here to approval pipeline step even for Tecartus patients. Q&A. closer second-line available the now to The in Yescarta recent FDA of in the

Merdad Parsey

Jyna. you Thank

a for more the As to pipeline view you always, most today the of refer focus appendix our comprehensive our presentation and updates the of on important programs. earnings

First in of who getting gender with in infection. transgender, on the for XX X,XXX-plus Phase prevention young in prevention, cisgender evaluate PURPOSE-X are HIV III adolescent we've who the HIV and X,XXX the to We're girls risk also prevention initiated Slide over for for women have trials, stages Purpose-X, men, men. Lenacapavir non-binary initial of recruiting Lenacapavir sex and

Lenacapavir XXXX, when XX% will FDA is of once granted compelling PDUFA provide XXth months heavily for people This with enrollment expected been updated in the has an priority action review And living HIV CAPELLA for This HIV and injection development become In part background our viral the if head combination date suppression treatment Lenacapavir achieved with demonstrated trial, the timelines available enrollment on The treatment, X Gilliat antiretrovirals. for that clinical experienced Phase collaborative the with clinical long-acting oral for HIV combined have set optimized based to long regimen. with is along. Merck this resistance approved, is to Phase living a Lenacapavir of that flexible the first We leading is work February developed further X with week, multi-drug other for pill. individuals treatment for more who of is in data started would Earlier is HIV. of oral this was August trials enter acting to and next we that Eslatrivir. combination once-weekly injectable options for develop subcutaneous the work Lenacapavir for announced oral clinical for work the treatment year. X Merck people combination. the leading

outpatient primary presented XX% based of breaker reduction all-cause demonstrated There outcome Veklury Phase were day XX at mark study PINETREE hospitalization the statistically related endpoint also Veklury XX. the data the the the on intravenous significantly month patients. XXX April last the Slide of study significant XX, with -XX at an those Again, IDWeek compared significant the analysis landscape importance by efficacy at hospitalizations deaths of highly in to a data, for blinded the of that In the patients in placebo. The emphasizes by of three-day reduced COVID collected Moving of were with we demonstrated risk COVID study high-risk composite and or XXXX halfway either Veklury. patients time. stopped remains arm meaningful. Upon X the -XX due the with treatment early late statistically risk no demonstrating results particular, and trees a enrolled -XX. a COVID treatment. mortality the therapies. But of conference in It We and clinically of antiviral on of results pine enrollment day evaluating the Veklury to course -XX COVID as Veklury

an submitted approval these Veklury for oral discussions for agencies work novel setting. to federal our filing, outpatient with COVID our to have SNDA to as in treatment IV develop FDA We're of -XX. and also continuing antivirals We explore the regulatory an data the

continue which overexpressed is to in as Slide many a XX, to Moving Trodelvy cells. pipeline tumor targets view Trodelvy interproduct. TROP-X, solid we

that a on a So, - range wide impact can meaningful Trodelvy of cancers. we believe have

and today. X the -negative randomized HR-positive anticipating eagerly trial in that cancer. approved In readout Phase all breast Phase X TROPiCS-XX a addition the to study, TNBC from the second-line bladder metastatic metastatic second-line in indications We're HERX are

yet we event-driven number a achieved disease As events. an have evaluating of this is progression. reminder, target the trial not And

have potential data deliver we the readout To of We remain line early the clinically February. cancer. clear, achieve only benefit metastatic late will a meaningful to As announcements HR-positive or Trodelvy top number the with in data, now X-negative or expect we January breast begin such, to to be once confident events. patients for required

advance do for to registrational indications. continue other also into We studies Trodelvy

risk, X we to to the program. forward for cancer clinicaltrials.gov, other example, cell updates sharing as initiate on For as and in non-small recently we lung plan the to at line posted second Phase trial third tumors solid look expand

we'll first-line half the initiate mentioned, Merck's and in trial start to looking XXXX. with York Trodelvy KEYTRUDA study also the clinical combination metastatic work Dan first in As TNBC with New to plan Merck of on at for the

a [Indiscernible] of onto we Moving benefit Slide in safety patients believe could synergistic the and XX, that to hematologic with potential to its tumors. continue observed with date profile variety solid

and our initial know, you As MDS focus has been AML.

to trial While recent landscape. these evolve in remains enrolling on patients X The in ongoing and the commitment well. Magrolimab of is to we clinical our continue our context unchanged, programs enhanced in higher-risk development the evaluating MDS therapeutic the MDS track Phase

discuss Phase top before year. and plans Ib the expect end of the continues share with development the to We mature. XXXX. Quarter now trial FDA regulatory in our our Meanwhile, path of will We to line First the data data from forward

the X,XXX first-line Looking TPXX ongoing, Magrolimab beyond patients option in nearly trial therapeutic in for enhanced MDS, from mutant new U.S. the targeting is our X AML

in In AML. diagnosed U.S. treated and unfit the addition, an are estimated annually X,XXX with patients

efforts expanding next AML for year. to trial first-line unfit our by initiate a Phase development early So, one III we're --

head from One urothelial the X study we've Over cancer, patients tumor lung months, cancer, a cell neck for few solid past trials and initiated with separate and Magrolimab. cancer, non-small tumor small lung solid cell cancer. and basket in

for broad to and to [Indiscernible] updates tumors, an more plan to initiate also therapy forward TNBC. be for effective solid a as bimagrumab available. metastatic expression Based in they on third sharing CD-XX study become We potential look

to recent There's slide behalf highlight the with Tecartus Next, ALL team, an adults in refractory of Christy or most also Kite available XX% approvals relapsing wanted and from incredibly which on XX. based on currently on I data with relapsed for unmet patients need ZUMA-X, who was achieved XX% for The remission. patients approval on demonstrated of of adult high treatment. patients these complete the

a event-free filed P-value expect We the of survival and next study reviewing X.XXX and dash a care a of to Additionally, medium entire potential as for status. the for endpoint of follow-up representing update with the standard a ratio an hazard second-line LBCL. Johanna mentioned years, look With earlier, patients. in significant on has less approval met of Kite primary X.XXXX, year a than forward dataset advance Yescarta the LBCL and X sBLA the of

moving expands promising remain Lastly, our excited XX, oncology whose in new Slide to we partners about works very pathways oncology. many

a partners that our receptor but has and example, promote adenosine at candidates tumor immune and includes Arcus growth. pipeline For only not anti-TIGIT also inhibitors CDXX to responses inhibit

later data. the trigger ' to of more year Arcus for continue this domvanalimab review or next opt-in early expect mature We likely year, the to pending period review

Phase XX, Very X out spans promising many in four, industry-leading X pipeline combination our excited therapeutic inflammation of our various committed focused still and our and And best-in-class pipeline build and [Indiscernible] it's advance days and three slide teams our remain Alpha to across our on invested Beta areas. opt-in in inflammation and are action, include to and across types most could mechanisms with opt-in which immunosuppressive agonist, -X pipeline. committed potential actively the such our partners, continuing virology targets executing while on Xb as have cell IND Additionally, will the expanded permissive And to which programs to Other modulate antibodies [Indiscernible] which checkpoint access Phase through received combination [Indiscernible] study. a which we our later recently Pioneers, be and X are including several initiated clearance tumor inhibitor, CD-XXX CCR be Inhibitor, in this candidates In patients, partnerships, from trial last partners help that pathways, that to X, HLAGE closing across of in quarter. evaluated trials and Tippl our in enrolling year. portfolio is our portfolio for early focus expected Genesis oncology Johnson franchise.

to it Andy. over hand Now

Andrew Dickinson

everyone. Merdad. you good Thank afternoon, And

our in highlighting and new partially Third Quarter total HIV heard triple total a sales by Trodelvy. This Truvada demand in Europe Sequentially, contributions XX, in our in year-over-year, excluding to the of you've part loss impacted Slide with exclusivity in excluding by from offset HCV total sales was pandemic. performance Biktarvy continued product driven for last fell up were be ongoing such product and X% by U.S. starts PrEP. sales was treatment recovery and year, financial product medicines as role X%, pandemic. by the pandemic as the where strong, the to overall Johanna, late new their the Veklury's offset continued Veklury both from XX% in the Year-over-year, to sales continued up Moving due Veklury, following

lower promotional realized for Veklury in clinical offset nine Trodelvy. rate. and for primarily Trodelvy remdesivir of Turning exceeded year Slide tax first to part of XX%, activities interest down higher and non-GAAP XX.X% was reserve, tax gross for the benefit. margin was to prior-year the the $X.XX in net guidance Non-GAAP non-GAAP our in period revenues increased see was can sales diluted and X% expenses, higher per $X.X inflammation-related billion royalty Non-GAAP year-over-year, income the lower a increased higher increase same Veklury our in rest has X% of expense and the a P&L, year-over-year, up a share points total Magrolimab. mix. up the gross primarily reflecting you reflecting was billion tax, geographies third margin by of for the effective recorded higher year-over-year X.X On rate discrete a as billion the lower On tax with well product investment our all effective basis already last months. of that quarter, quarter basis XXX prior across higher $XXX million by earnings reversal year. driven reflects change points The and SG&A compared a to by as marketing year-over-year, year-over-year, previously $X.XX R&D $X.X product offset for SG&A litigation we're and product primarily XX Overall, due XX, we

our at pandemic share we shown as for Slide months, and and recent the infections are the rest result, guidance past respectively, with X% the As earnings mid-point year. per in the of revenue expectations our we wave we the business, XX% for full-year for a and the After of believe peak have by on hospitalizations increasing modestly of moved the XX. and updated

We of play role important continue to COVID the treatment with globally. expect patients that in -XX an Veklury will

significantly assuming However, expect the in experience surge, we step we not fourth revenue to down Veklury do quarter. another

are the to to XX previous range As full-year year-to-date billion of in prior now performance. X.X a Veklury billion. our to Veklury billion billion XX to full-year sales XX.X our billion, outlook X.X raising in We be compared range to of the X.X result, billion expect results we range product billion of XX.X of total our X.X billion revenues from up reflecting in to

to hospitalizations. billion, expect prior billion track We approximately to in sales We will the -XX to COVID continue Veklury related year-to-date XX.X expect Veklury range full-year total to now continued XX.X product performance our related billion that of reflecting sales pandemic excluding of be XX.X compared impact.

we primarily rest the be approximately strong previously, of XX% our non-GAAP expect third to for As to the margin quarter. to compared XX% our XX% in margin gross reflecting P&L, product gross the

expenses, we XXXX levels, percentage prior operating R&D to low decline. to expect mid-single-digit to our of compared to expectations as percentage mid-single-digit For compared non-GAAP decline now

still versus On tax expected XX% We expect is compared to effective percentage dollar expectations to on to rate a this be XXXX to our approximately year. low be single-digit prior flat non-GAAP flat decline. of SG&A basis

$X.XX Finally, operating $X.XX. EPS non-GAAP expect be priorities to the On margin we and and not between and with the our diluted And expenses, EPS capital product updates to $X.XX to gross be our now $X.XX changed. year. between full allocation, our for GAAP diluted have revenue

to invest third at we've the in and time, quarter repurchases. our billion dividends returned and to both year-to-date $X $X.X share shareholders continue We billion and through over business the in same our

of this earlier $X repay notes X-bondholders ability our billion our the would exercise we notified X in we billion year. today, that $X.XX non-call debt We early. have also repaid And to

least Operator $X.XX the exceeding down we year, invite Q&A. debt down now $X billion. I'll to expect With significantly Taken of this that, pay to at together, the pay our prior begin billion to guidance

Operator

instructions] line to be that will We ask X Then [Operator question. yourself muted. your limit please you. you Thank

If re-queue. follow-up, please you have a

Matthew Harrison Morgan comes first Our from with Stanley. question

Your line is open.

Matthew Harrison

make the my Good comment little Great. Merdad, of Probably Thanks the that afternoon. for can more terms Merdad. rate you tracking for tracking and the detail bit taking caused previously else made were assumptions watching in unsurprisingly, on you not question's and a the maybe this or especially that were anything change question. TROPiCS-XX you how around trial? just in in event they blinded to you Thanks.

Merdad Parsey

will Matthew. when Sure. in our Look, but into to. would Hi, hit trials at you the That's variable of importantly, by, this Happy able the frame. we as We year, event-driven now inherently gone terms this think has And occur time how and we we're to I events share know, best said, come initially to mark point. events that right the year. that are as thought we hit time mid-January projections those probably results next database. to when had mid-February those tracking I mark events are think as we'll the be

Johanna Mercier

call. ready Katherine, next we're I our for think

Operator

Our next Tyler question Van from comes Cowen. with Buren

Your line is open.

Tyler Van Buren

the Thanks clinically Can of what be afternoon. people at seem for have feel another months. remind set or you X us A lot a is terms question. of in taking good benefit on expectations I guys, you Hey, help meaningful PFS? it TROPiCS-XX. to taking just around on one

would let's you X.X would you. you how data? the sub If two-month still do or a ahead or and that benefit, Thank say, file X.X, guys you go PFS reach view

Daniel O’day

Merdad? Yes, Thanks, Tyler.

Merdad Parsey

consensus meaningful. have would've threshold we clinically d is the think that that months do X I for seen thanks. that folks Tyler, Yes, agreed

we to fall if to of difficult expectations. that, short were the we look our is totality happen, But if and think not the speculate would of to I that were place we want which provide a to if the We'd look see we at to areas would could before totality of the do. we benefit patients, data deciding and where and other what ed at there's data. look

Operator

Thank you.

Our from Evercore. Umer with next Raffat question comes

line open. is Your

Umer Raffat

me call. [Indiscernible] around a and Hi. the third I'm reporting on for to U.S. based Maybe materially just hospitalizations better, I'll for that’s on And different as XX% drug artifact little to U.S. [Indiscernible] understand spare would COVID number re-express remdesivir price near the Is know my the thousand if you I'm subsequent focus just on to billion in XX% U.S. Ramdevsivir the third the estimates? in maybe imply quick question quarter, understand a in it's the a U.S. was the why XXX trying reported in our five which it let XXX,XXX Merdad patients on penetration we second. quarter were to just total than trying this historically right had. well. TROPiCS point

Merdad Parsey

Thanks, Umer. Johanna. ahead, Go

You hit one. that want to

Johanna Mercier

coming different what Umer, so total Sure. -- a what obviously a Dan referring is to $X.X you little So that right? referred think I year, that's U.S. most the The billion the the of mix earlier $X sales million of really over the bit asked, billion, of than you're out to. actually the $X.X the and patient population.

U.S. the less and math se, patient just would just to top per of I would say greatest, if you price my the population, head. do but than a XXX, that five-day about the therapy that on the get off was track math is Ramdesivir average for I your can't So, it what doing near on you

little a just lower higher it's and than other think of parts of because in points. bit the world that probably I price

Merdad Parsey

of color also And the the -- market on patients Johanna the the maybe patient the hospital. [Indiscernible] current share in for

Johanna Mercier

take out see saw both Yeah, and with Obviously, I different play specifically. hospitalization. -- to at used as that and share Demethazone a to. well that north products. we we've we're anti-inflammatory that out from but that XX%, Veklury close obviously in share the days of bit usage to you're do in seen products U.S. and of up we've a looking of early obviously inflame September, increase of other databases, seen often the in XX% But the we XX% We've little the itself with protocol referring standpoint thought August probably the surge in seen

Umer Raffat

Thanks, Johanna.

Operator

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

Your open. line is

Brian Abrahams

Hey guys. question. more COVID, taking Thanks with Sticking learn my for curious to about.

these direct-acting cocktails. potential COVID Your the color that at outlook if beginning and develop us evolve inhibitors, Thanks. looking a When [Indiscernible] year to could derivatives bit for are on into learn beyond. the little at antivirals those? spoke oral protease I'm treatment curious you're you how might we give combination efforts around and next more will you COVID call, about primarily about more to

Daniel O’day

Thanks, Brian.

there's I because, and think to to the not between team to a going always the about have I'm been comment. connection no sort of direct continue comment What let little from to use be Merdad Umer we've anything [Indiscernible] think, that and we've right that see on Ramdev's all outbreak. previous correlation is proven that. I how back members I will the is cushion shy cash predicting other will to evolve bit I'll say doubt a we

outpatient that And Brian, market also hospitalized play to and Johanna and a there's role get important we around Ramdesivir as patients, continue for that So although point world to continues. the your have future our any We're pandemic maybe really we injectable share, welcome the the doubt, on now satisfied to of says yet, the continues no the to to and forecast to. work, have to continue we science to obviously the in endemic, want want not put to you're setting. data, if and you Merdad,

Merdad Parsey

with you. Dan. I Thank No, No, agree no.

of it is have in -- combination of types, of think on starting changes to eye we'll it how an anticipating think over I or it'll see predict various I outside a vaccines, difficult virus what believe goes. therapeutics and incredibly it's all course, we're keep to time, the to be

[Indiscernible]. have of outcome shown We that's think date none any a to to Importantly, so resistance the positive far. variance

begin Veklury as setting is what IV in hospitalized particular, They're a outpatient treatment haven't going are as are moving remaining outpatient setting. certainly disclosed share data quickly the in hope to we really as -- the that oral compounds be. But they we'll yet to those stalwart in and possible provide the an mature. molecules those them forward potentially, alternative the and, with our option, We

Andrew Dickinson

And just remdesivir. we I I versions to continue think say to would it's oral that Brian, add, fair work on of obviously

and to and standpoint, before viral to opportunity -- resistance. to We look future the at COVID have your said also point from in the oral anticipate medicines therapy a scientific combination past, for

those themes are those medicines and the Merdad, you move continue to of So all forward. updating to as then course,

Daniel O’day

Brian. Thanks,

Operator

you. Thank

America. of Bank with Meacham Geoff from comes question next Our

is Your open. line

Geoff Meacham

question. Afternoon, for guys. much so Thanks the

well I was pandemic, Just in to when When picture had business, single-digits grown. we you we growth a the has back bigger last Thank help quarter, generics the much think question long-term I high year oncology and growth great but rate the higher and your much. core affected just you'll look and and you the of in go with market, that. really has pandemic very look know and -- and pipeline long-term remdesivir quite rate long-term at to this think a this you the HIV But lower maybe it's is, on drivers question has even year HIV you do the used done HIV. have us know

Daniel O’day

Geoff. Thank you,

So, Johanna.

Johanna Mercier

just market the Sure. are specifically asking you generally? or Geoff,

Geoff Meacham

for For maybe guys, [Indiscernible] you the market.

Johanna Mercier

Okay.

out I exactly second was what quarter what's in think we playing today. the said

what were in bit negative of little back prior We to a we QX, and have We're that. so seen much What -- take a little accelerate about little COVID. at a from where growth, we're we quarters standpoint QX. to get from a into recovery we're lower this point back and bit we're going we're to the that a were recovery and We're X it's just we're base, QX X% continue, bit is, of to about going a seeing time. in actually, before actually, -- X% market starting at assuming

you come as and standpoint, market think the course, assuming That's standpoint. well. no of that I basis Biktarvy get to we product through. When out, about quarterly will our at obviously, a think about growth assumption a as year-on-year on will you is double-digit other from then and major play growth help from you XX%, that of think a see surges which, XXXX,

demand We dynamics Obviously, going we're so on. different year. about strong, is full still share a over that. with last quite pleased grew in quarter, have over X% We X.X% the

because at. a had leader. on we're market we're pricing that larger our as So, on But much some looking the we different obviously dynamics related going to mix also are well base that we've are

has directly by something that's the that impacted pandemic. So

bit you quarters. other over commercial grow As any and versus more seen PHS rapidly your than segment last a think about mix, the couple channels we've government little specifically of

double-digit basic So look that in dealing you with. those dynamics at But very growth. demand, are if strong the we're the

Andrew Dickinson

years right. you're to of market of They years again, difference introduction incredibly as there. get in market strong market. worth PrEP it's the to going see it's the couple the just the you think -- a PrEP the ago couple take lot probably treatment Lenacapavir growth a of that Jac, to will of that also by driven a it's referring was market well. Remember We exactly that again, the just Andy, and that's touch treatment the probably in a highlighting joined base on

and Johanna seen So, market what building market, in in terms to base years constant coming should the dynamic see will back a couple we've treatment it's relatively continue I PrEP in off And grow as is historically, bigger dynamic of a driving think then additional and you of the the just we're with growth. said. the

Daniel O’day

Thanks Geoff.

Operator

Thank you.

comes line Yee your open. from with Michael next Our Jefferies, is question

Michael Yee

the to be Obviously, [Indiscernible] question. Merdad in what you Hey, of suggests get think for good later to afternoon. ask Thanks on it's OS. and would I do the it which wanted could immature TROPiCS-XX go important. importance crush But was Mark, OS TFS that still maybe I and for I think over sitting have around, OS it and you 'XX. confident result? the how a that do impacts if just that confident a are Thank on wouldn't comment around you. and okay you X bit. benefit other impede be months, his

Merdad Parsey

early modified had we this stage, you Happy to that trial. behind modifying we the sample make recall, I think when reasons the Michael. go sure We the part of the sample the purpose we the to. could endpoint. the Look, as modified with was changed of back size important hit OS assumptions year, one main the And the to Sure, it's you size in that trial. we expanded think we I the and

are So, we be control, like that crossover right if hit I the you able caveats things that think feel reasonably with to to OS. said that hit should difficult we we all around that and PFS, confident

available. here really central to around outcome that the And to think this things investigator the all that that's we'll I think are have that But as events, the a important. led overrides when progression means delay about. we're So, that those I moved the data we think of talking delay gets slight I are issue to the from other stronger underlying

Daniel O’day

we just been the about to when us Merdad the event-driven oncology questions space all maybe on to to there's uncommon had it's trials certainly a but what not because complement risk trials said. have of several of have slight the you And anticipated When would adjustments we we're would I And just we lot now of that experience, the think in have OX those know just point we mid-January the about in data coming for of think to timelines. December in Merdad's out talking middle of and point protocol I And with this have that year adjustments initially did in that the to data this year. all about mid-February.

timeline minor. changes terms So, in and the changed has really design, to TROPiCS-XX. of for And the are nothing very our conduct trial in regards confidence

So, wanted chance a sure Mike. make Thanks, to I to I had that. also just say

Operator

Cory from JPMorgan. comes question with Kasimov next Our

open. is line Your

Cory Kasimov

make which get about my the this question. for program asset I to afternoon, guys. ask Arcus taking Good expect to the to in on regard data TIGIT added you to Thanks you wanted basically you or on the go-no-go more would for it opt-in. to just more to what just decision. see you're looking it you there to for take patients Thank going latest Is thoughts durability your just

Daniel O’day

to want you take Merdad, this?

Merdad Parsey

decision that that study. I patients make really this remain interested in to that I do study. patients longer per enrolled that been I that data in of think observation things. move And year. well arm, are we think as as about Corey. the able feel I mature, We is enthusiastic Thanks likely time anticipate the be we'll And think thinking. a the for what We as said, More Sure. and it's that's we've that Yeah. our combination will opt-in

So, continue In I decide think larger, we're dataset those believe data. a see expect headed robust we we that to to where do total, that's to with on. more

Andrew Dickinson

And agent as of looking looking from that doublet is in upside as we single the the for for said before, XX% we're the would well, for in doublet and ORR hopefully an of separation us. clear over triplet we're what and be

Johanna Mercier

we're ready Katherine, the for caller, please. next

Operator

Research. Garlow comes with Andrew question Wolfe next from Our

is line open. Your

Andrew Garlow

question Hi. and Thanks have my for just on one taking HIV I pipeline. the

on with space One [Indiscernible] combo? of So, Merck care integration standard inhibitor. include that a an given lenacapavir competitors and needs your you're claim to frontline in collaborating this as of

be you So, or agree that with not needed to [Indiscernible] first-line always likely given setting. in integrates experience your do a Inhibitor as

Merdad Parsey

don't We are. pursuing that make. It's we That's approach that. combination Thanks Yes. for why obviously question. the believe an statement interesting to we're the

that approach right the We're combination get that think we in data I the with tell So, confident now. taking long the the pretty there will we're can story run.

Daniel O’day

Thanks, Andrew.

Johanna Mercier

Katherine our next caller.

Operator

Porges Our Leerink. SVB Geoffrey next comes from question with

open. is line Your

Geoffrey Porges

very could question. Why stats I much the you it's back to your HCV but question for plan those to core guidance, then don't to developed And impairment QX, Thank Perhaps and XXXX? you've QX HIV in obviously you early we expect grow [Indiscernible] sense us go in for taking the a for you of give business? the XXXX. for already. your compared secondarily, know do businesses where

COVID be businesses. Just about core on see how impact thinking those helpful you're to

Daniel O’day

QX? I QX, meant you Can just clarify

Geoffrey Porges

were And categories I'm sense therapeutic trying a in in in you to hospitalizations of number pretty of -- QX and in now. clearly recovering really QX. we're No, different showed get decline the

are where wondering today to QX we really So, XXXX. compared

Daniel O’day

Got you. Johanna.

Johanna Mercier

Sure.

with start I'll onto that Let move HBV and me Geoff then HIV.

So, at and about HBV lot with we year-over-year. that has timing an of being under X% to standpoint A adjustments. where about pricing talked do

So, not it's per se. patient

about pretty directly QX. they in because to flat did actually X% down see declined are We much market is pandemic, QX diagnosis, positive. again the we and related though screening were starts What in year-over-year, less that's

to that seeing because we're an should it that the say back typically see would patient pick starts but be be less quarter. there's believe say up. as will that to we patients I in so I time able it we the that quickly wouldn't will what cure, go HDV increase. you But flat over as hold need because just so, decline much And not

assume So, are - pre pick we -- bit a than so COVID the will of tempered we diagnosis up. puzzle, piece screenings do back -XX. in It's The decline would little think HIV we XXXX. seeing and less still that more

diagnosis, there's XX% XXXX And XXXX. versus down still XX% screenings about below levels. seeing we're So,

assumed, we're still much excited be. seeing we're the as recovery to line that because that's we're not we needs levels that, in back and we're what quarter-over-quarter, with So had as to about

levels from and therefore, it are HIV come I would so quarter and it's assumption lower where just take get now in of we're in to quarters right and would is to we'll bit going to and the market is base talked bit base what just a a helps growing to little but of was of to couple your we XXXX, a believe a a a the from growing longer, there. get us standpoint give the it's And perspective. that that typical say dynamic about little Hopefully take back a lower going from do couple small we growth back, in market very single-digit you last

Geoffrey Porges

That helps a you. lot. Thank

Daniel O’day

Thank you.

Operator

[Indiscernible] next Robyn Securities. Karnauskas question comes Our from

Your open. line is

Robyn Karnauskas

Hi guys. question. Thanks taking for my

are that that the long-term TROPiCS-XX for business future your are Just growth. want on data -- how long-term see to your Company. picture important from Trodelvy Trodelvy is of thinking the to Thanks. your growing a think about seems of And market initial on questions here of you the that have to HIV you big changed growth. as thinking see acquisition? business? Obviously, you strategy opportunity like Because your don't two your going Can it there long-term are expectations if you from core for about talk the core lot and areas how about very the

Daniel O’day

Right, thanks Robin.

ask. of start certainly and Andy All here,

Andrew Dickinson

Look, Thanks number the has about number Robyn, want Hey, think of for growth just been If you question. there as to think Johanna we a a growth when are may step well. back, in there long-term And I drivers. weigh questions. of

clinic and the Trodelvy, of In mentioned, long-term think We we the did that see number we HIV the programs significantly 'XX perspective. specific continue of turn our get Company see lot expected from a lot driving. that are Just our potentially to and much our hopefully growth specifically, don't overall. were in I a growth say growth we've short for of programs, the or profile done where Magrolimab, is reach programs. Similar bullish see including On promising 'XX, the the said guidance. a and We other a long-term prospects number profile we've we'll more we provide to long-acting Trodelvy growth transaction. a the the continue did are is drivers to again, expected growth. the to currently you think to the now When that again, picture profile inflection Trodelvy commercialization, we've number these in Trodelvy, programs paint very on than historically. the Therapy, to are we that said of to we be there including a an as you drive collaboration the when that Arcus we improving Cell run, around we business, What the

the other just hormone-receptor about So, Immunomedics. studies. of you'll Trodelvy remember, that excited of lung areas. and was those we're work cancer we we highlighted study with doing when a win number we're Obviously, to positive there acquired in The ways are one

expect much give overall. that. plan give a today that to greater clinical then The Merck the appreciates Trodelvy we market today. going sense for you will with That there's example probably where of is earlier a announcement So, and you broader much of a we're development of fully sense good a

So, say I macro changed. Johanna a think comment, at for level not I I'd Trodelvy ask have our before expectations to

of lots get us enthusiastic We different be going continue there's over are there to to for where and very about we're time. where we and ways

Johanna Mercier

would betting a where are as with opportunities in lines breast Yeah. well lot No, going I triple-negative earlier Trodelvy across cancer. specifically just the pleased of the in we we're that We with cancer, think Andy. growth still -- short-term. both there's bladder I as setting believe today thanks, I add,

seeing we're so, opportunities those out. play And

but standpoint, believe to on and HIV what Andy -positive not we even the the only coming TAR our going I still add the think oncology for looking studies positive opportunities. future should a [Indiscernible] to are opportunity from also our in setup just expand more foundational us The would front, we I that - help you was such alone success, HIV opportunities, is just mentioned, let are set market guidelines that is also up to pipeline for HR VIR as so. at saying as way thing an hopefully. through, HIV

to that of Merdad course, In addition Lenacapavir too earlier. spoke

we're have So, going what on as excited about there well. we

Daniel O’day

Robyn. you, Thank

Operator

your question Gal comes next Our line with is Ronny open. Bernstein, from

Ronny Gal

cancer And can thank questions. the of of afternoon Good ask agreement. Trodelvy, Trodelvy might economics non-small was in you as then can exclusive bit cell steps TROP-X Keytruda. peers about And piece signed a a and is, your about those taking of you a are little cancer, This well. of cancer. an on -- and agreements that my may one the I them little negative that agreement ADC elements have about get wondering, bit wanted in lung they with for triple you combination the breast talk with a of Merck between to another agreement partner lung I and

Andrew Dickinson

other other ability the not straightforward, area agents, And any KEYTRUDA. added with collaboration TROP-X antibodies. the design sorry, inhibitors the they've They of To be their Yes. as do Trodelvy economics Hi we on exclusive. And Trodelvy. hopefully will ability They for are breast have Ronny. they result have to It's the do And providing it's including input do of course, the studies on in had well. studies simple thank to these studies but triple-negative you I'm enjoy started with a in on PD-X benefits have as same other cancer. is not other end. to Andy. studied, we this question. straightforward, study relatively study, Thank KEYTRUDA the is you. obviously clinical KEYTRUDA. a Merck They

there's do to that course look cancer. they at lung will that area going well. an another another study with we're highlighting That of You're in that TROP-X inhibitor is as

expect that straightforward, collaborations. vanilla these are plain simple, but clinical relatively I come, So, more there's to

Daniel O’day

of And the opportunity to us Trodelvy. because I the promise But from and expand multi beginning could potential in like Ronny, ourselves. more opportunity with you'll to strategy, tumor scale as we the do this we see can ourselves. given partnerships And look it's Trodelvy frankly, allows there's much what expand to we than for really the think of - its engaging part right of our things many Trodelvy,

Johanna Mercier

X have more Katherine, time maybe I for we questions. think

Operator

Okay.

Our next one comes Skorney from with Baird. Brian

Your line is open.

Brian Skorney

months, assume Good your Thank transformative guess of of Hey. taking a my the data into ASH. in in - TXX market how Lymphoma the we'll potential own guess couple does in afternoon, seeing be everyone. in you bunch move given the the for at success, I B-cell opportunity I your to and potentially data, on Telerik addition to a Large thoughts change well? frontline just CAR I actually question. think success of... for about setting, you upwards second-line for Thanks. do the view as

Daniel O’day

That's please. fine. Christy,

Christi Shaw

very said, about for ASH, first September be year. the only expect at right our from of the But T we're back the Sure. the next second-line and now. data and will of FDA status Yes, potential half you on we're presenting end excited hear to at really submission seeing as CAR is we cure

[Indiscernible]. a been therapy will to typically So, with And class this don't see hope huge agents delay second-line will to impact what exact but has cell of be patients. be for to when It to we moving we'll you now the look our those marketplace. have it out at a out, coming We that new in the and frontline. study duration successful, projections see

with well. Second-line actually completed, patients US. combined data allows That us see you'll we'll frontline play that is which the can about ZUMA-XX as XX to basically our ASH which also be in, at thousand we double that presenting in market was the

not for and up, projections specific and pretty that it second-line of are, really see see the trial. stack frontline, will how we We're cell brands. future our it doesn't may You head-to-head for where they're on or our although confident therapy in change

Johanna Mercier

our just maybe question, Katherine, last please.

Operator

Carter with comes Our last question Barclays. from Gould

open. is line Your

Carter Gould

the get just on Great. Trodelvy. Thanks that's for later in. squeezing afternoon. one study to going long Good started Maybe for me year this

study. You've basket we but that study data? study, that characterized the and the data assumption, you. Thank time could basket Is see risk, insight presumably by TROPiCS-XX a we fair some had at see from that you've from maybe

Merdad Parsey

Thanks. question. Great

just the data, data the that It's the of approach we're at looking in data of the accumulated, totality have we and the that's Our we're the TROPiCS-XX taking. not really -- at we have. we're looking totality line

for do will it's but not We risk those point, data your I time and the plan seen. -- those we to bigger be on take data would I given sharing we time. too, us expect So, over arguably around of the data not -- we've the that sharing tropics,

for share terms in what Trodelvy time, definitely excited [Indiscernible] those we'll data in seen So, over but performance pretty the it by we've now, we're of

Daniel O’day

[Indiscernible]

Operator

I'd call time That's like all we questions. closing the Ross to for for remarks. to back have Jacquie turn the

Jacquie Ross

today. Thank you, you all continued Katherine. Gilead and us on We our your look in you joining forward And progress. thank interest to appreciate for updating

Operator

This concludes today's conference participating. Thank for you call.

You now disconnect. may

Gilead Sciences (GILD) 29 Oct 212021 Q3 Earnings call transcript