GILD - Earnings call transcript Q1 2022

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Operator

Thank you for standing by and welcome to the Gilead Sciences First Quarter 2022 Earnings Conference Call. [Operator Instructions]. I will now like to hand the call over to your host for today's program, Jacquie Ross, Vice President, Investor Relations. Please go ahead.

Jacquie Ross

Thank you, Jonathan, and good afternoon, everyone.

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

are as Gilead forward-looking we operations, started, products, currently will to of sheet the to description results of website. statements understand A provided in data business, reconciliations including to used Before get you on Gilead's let that The to be in statements. are release, the and impact earnings be those found operations, certain from our All be to as our me differ press assumptions, on disclosure Non-GAAP supplementary we release control you GAAP the financial plans to and the the risks the update beyond company's and remind non-GAAP help measures based on any information condition corporate and statements, can will such performance. underlying COVID-XX business XXXX and and statements. of well in Gilead pandemic making actual press expectations latest business and projections forward-looking forward-looking obligation these Gilead, SEC could these and financial assumes capital, respect are earnings to no related documents. candidates, available the risks with involve guidance, materially of strategy, all which cause our financial and financial uncertainties that of use product results

Now I'll to call Dan. the over turn

Daniel O'Day

the and oncology want good last appreciate you Jacquie, over We virology deep you thank afternoon, and and also those more to them. view the These in-depth the provided a X I time who our events past, and Gilead joined of number had a dives with everybody. a patients today, unmet few Thank months. of growing taking strategy you, to broader in shared to We clinical teams diverse much potential therapies range our for new its address our a portfolio, deliver highlighting behind across of conditions. needs of pipeline than the we view of

primarily turn I For and hope more virology confident so becomes the quarter, deeper joined, you I'll our of to guidance, a and revenue with of off it share on line last oncology this year those therapy, growing with is as shown impact strong year-over-year, driven and sense to pleased of start X% from XXXX. which you share was Veklury, revenue growth quarter given product USD Truvada LOE. more by XX%, HIV was X.X grew of Total the compared quarter X% Sequentially, our driving X% a notable HIV Trodelvy This up grew seasonality. market in to of now why revenue sustaining XXXX. of than the got who that cell down in our primarily billion, leadership and our of performance to reported first XX%, as total to X. result first I'm we're growth. that our X/X year Biktarvy, than Slide is in HIV a

expectations the support which the the expected compared quarter therapy capacity in FDA over cell of of strong to for XXXX. will end cell portfolio XXXX portfolio therapy the therapy therapies new of several approval following is marketed Yescarta of oncology another of to the first of expanded also with approval and FDA facility delivering quarter next relapsed Trodelvy and by performed our LBCL. The part growth. of second-line cancer growth our recently the We facility pleased Maryland, highlight refractory increase growing new XX% Our years. our I'm well, in doubling our manufacturing cell revenue

the the with in physician's statistically progression-free the its to that TROPiCS-XX pipeline. in primary met Moving choice We shared in study a Phase readout significant line improvement top endpoint survival showing March III versus chemotherapy. from

Additionally, first of of key the secondary a demonstrated the endpoint analysis trend overall in improvement. interim survival

X the As be to details The results the deep including across for oncology therapy, we types lines regulatory to potential shared trials are initiate June. Trodelvy for in approval more authorities through and at study Trodelvy plans later-stage you know, ASCO dive exploring Trodelvy highlighted earlier this of XXXX. broad XX the will patients. month, with multiple with pathways potential more of we XXXX, in tumor to bring these At

X. Turning Slide to

we the As we're the shared we're In and of due to with some from TROPiCS-XX NDA added and itself. timing are change. know, the is as disclosed January. remaining in the on that, lenacapavir for confident with Other subject deep are the slide. biocompatibility CAPELLA, than fully you for the this milestones that this decision working on we trials resolve, our case CAPELLA to of to targeted oncology in We've issue you dive track newly well

on pleased the more ENHANCE MDS, lifted. I'm the interim partial of there's no share for to trials, pleased the the share slide hold, call. first the note later of hold in magrolimab clinical will half that in the despite to for Merdad including first-line pivotal free high-risk for we're unfit readout NL also to have we first-line expect ENHANCE Additionally, the that shown pipeline first which details for XXXX. timing change been the

to thank a their of to delivering putting behind just teams who today work the Before that I with a our the of all are to It's want pass future. Kite and take XX,XXX that full diseases I over way to it seeing. thanks for across diverse expertise, the you're new this were and advancing patients therapies pipeline employees innovative conditions and world commitment for and passion to the Gilead moment Johanna,

we're capabilities that place level and innovation in the some have given gold we ambitions confident and have the achieving today. We coming of years, them for in

I'll invite our Johanna share first update Johanna. Now performance. you, on to commercial Over quarter an to

Johanna Mercier

everyone. afternoon, Thanks, Dan, good and

in solid to USD We start year-over-year Trodelvy offset primarily X. a billion with sales, cell as by a result that XX% Veklury, given can and business. of year X, total product year, quarter-over-quarter had the HIV sales, year. our first the billion, Slide product Veklury, the were every to Quarter-over-quarter, driven see with experienced and the HIV X% first HIV, X up guidance, quarter of we seasonality sales Slide quarter So were part by the in seasonality consistent you XX% turning $X.X we quarter, HCV see in our typically excluding down for of therapy, of total On the in excluding the down dynamics. to customarily pricing

build associated sequential inventories of then with quarter First, during drawdown. decline their and the dollar them over fourth inventory down the draw QX. was On the channels the majority basis, a

net medicines to access we lower discounts plans the exclusivity expected X%. in quarter second of that is often in impact, growth and by excluding X% market to were continued starting due rest realized and to up dynamic for sales in levels recovery to this impact both of our be market patients' seen as treatment of this the quarter, and Year-over-year, reset. in we for diagnosis by year. the part of affordability market Part year. HIV PrEP, the support, of of QX minimal Truvada HIV Second, prices the impact and in we're encouraged driven by This increased D in XXXX. LOE throughout efforts And sales The to the this HIV still treatment HIV Overall, growth copay year-over-year lost expect LOE on is due customary signs surge this QX. rates normalize the the part screening insurance maintain despite impact below increased and prepandemic other Omicron a

first basis, treatment $XXX as markets positioned up such sequential slightly both year-over-year were virology continued and result, sales engage European catalyzed who have February, million, little partially market basis. by hold market a and the was dive market And in and X%. U.S. over the treatment as quarter Gilead switches deep ensure by in and year-over-year, grew driven flat, PrEP down to a benefit European Biktarvy. Notably, the to XXXX, HIV by as by PrEP U.S. regimens to well of a approximately sequentially. payers launch continue continues generic regimen. competition double offset during lenacapavir. their year-over-year to On medicines As a such those the and Descovy to PrEP. remains Descovy X% roughly We were our the market preferred the believe The XX% expect we in grew access highlighted PrEP from market growth long-acting in newer with to XX% X% share, we'll market on

growth, and $X.X in U.S. XX% of sales driven were switches Biktarvy Europe. remains share notably, and year-over-year first gains for continued new Biktarvy in U.S. Europe. X. by and regimen in Slide to in U.S. the starts quarter the and Turning new leading starts market the billion in up the both

next of fact, representing year-over-year in the the highest for medicine U.S., X.X% share the HIV. to almost is XX% than complete promoted larger any In share regimen leading Biktarvy up share Xx treatment the and of

to primarily on year-over-year by by starts maintained has be dynamics. X% France $XX XX established. and Sequentially, impacting was Moving decline declined sales steady HBV HBV Vemlidy, namely quarter, Asia. sales pricing X%, market primarily Slide the were by XX% been reflecting while patient HIV. inventory pricing HDV the and and driven up in for dynamics year-over-year HCV. Hepcludex new the overall the driven was XX demand for Slide full We Germany the HDV market HCV were same in and to higher due pandemic. million share, to Sequentially, XX% where unfavorable and impacted in reimbursement HBV seasonal and up continue

with There's of and week, receive Omicron in now in billion, patients. Health the U.S. COVID-XX look ongoing the support the this this to approval clear treatment World later lower in in Veklury guidelines. treatment there hospitalization XX. and therefore, as We're to are potential overall, of nonhospitalized the that year surges, no very can. surge Our days Organization's countries U.S. FDA year. earlier of revenues will another optimistic at shown extend And other The not risk second this of commitment patients Veklury we the be ongoing. first old, was with values least received Veklury the quarter regulatory at approval quarter. U.S. certain highest $X.X reach and forward nonsevere that of were higher pediatric timing And in where for pleased to of across in our globally. course, These Slide half the XX Europe utilization to after and change in the but we on discussions we Europe hospitalized to for patients due rates, for Asia tracks of And January COVID-XX the will guidelines our patients revised hospitalization. commitment our were highlighting recommend Veklury regard, to COVID-XX we And conditionally maintain the in readiness the to

to globally. reach force expansion indications physicians oncology. encouraged Trodelvy's support by we support across Now are to shown right in sales and France, Trodelvy XX% with sequentially, of adoption to and and but completed to approved extend the not patients all to up to Europe available on We're make we our to benefit turning health from Germany Trodelvy soon. both our those access and and U.S., could to prescribing starting field X authorities XXX% Trodelvy's today. now notably, as as by progress XX. it more throughout We're on those and With strong work and the Trodelvy April, in U.S. We were today reimbursement from the at Trodelvy believe updates the patients, Slide We've scale continue footprint impact year-over-year forward U.S. TNBC just patients and have and sharing reaching are to the patients to second-line the believe X extremely will who field uptake physician in expect expanded we're in about who year. than in feedback look it. the more physicians metastatic who we excited bodies benefit

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

of lymphoma. driven For highlights refractory December's the by quarter, sequentially sales durable as in demand XX% follicular $XXX global Society million long-term growing or Yescarta of were survival as of in benefit relapsed well showcased XX% recognition Meeting. the up B-cell at continued lymphoma large This the American last year-over-year and Hematology

lymphoblastic to sales this XXX% of the leukemia of FDA's million to improvements month XX% October, week. manufacturing cell U.S. refractory approval growth our due just well site the relapsed new Tecartus, year-over-year which our second-line sequential cell approval acute announced $XX lymphoma. LBCL capacity CAR-T manufacturing or pleased XXXX. the strong facility XX,XXX-plus in portfolio our in to early seen aspiration new with addition as uptake to as demand Maryland strong manufacturing to with strong For of therapy in we relapsed increase earlier were the a mantle adult Yescarta in We're last XX% and The our refractory across we've in cumulative approval the Through Maryland the end up existing up continued for serve following by to last for our momentum contributed Tecartus. across by site, expect capacity in-house support or patients

for to provide see FDA patients. been approval started immediate and ever Second-line It have we heartening is help since. orders coming after can truly the the steady day in the

second-line guidelines is the is the to for LBCL questions data, in standard take care available robust Q&A. Given of to during inclusion NCCN and with and the we cell expect patients. Christi therapy the our paradigm Yescarta any clinical Yescarta the team in shift here on

that, will pipeline. clinical our over the so update Merdad for I an And call on hand to with

Merdad Parsey

expect ensure leverage such trials to is and our activity Johanna, broad execution clinical and we inflammation. fully helpful XXXX, its is you, on more deep firmly oncology of of I the and hope virology oncology, the end than underway hi, Gilead, to portfolio. portfolio, here potential. virology and we full our at breadth have and and of By XX were focus innovation the that across a With Thank depth everyone. dives clinical highlighting in XXXX

heavily to on reporting HIV. with XX. the people February, from Slide shared treatment-experienced X-year multidrug-resistant Moving data HIV We and living CROI at virologic trials exciting in CAPELLA suppression XX%

we Given planning prior this we're NDA designated review lenacapavir the and the complete significant by response NDA need and the unmet as clinical patient resubmit as the of hold resolve FDA, was population, to the soon letter.

HTE these of agency vials not to the basis Separately, of of you time, As and FDA an actions course. at compatibility due progress in you lenacapavir early additional was of ongoing an discovery the that forward highlighted the updating that dive approval track shared in MAA half on virology treatment Europe of At and internal candidates for we're We're with could shown itself. know, the use year. in deep partner XX. X second our the lenacapavir February, in consider we a look with assets with lenacapavir for details or on the in Slide the vial the alternative to development dialogue

give and that to unprecedented In single-tablet the in assets XX% XXXXs duration treatment beyond. addition showed Phase the Biktarvy. biologic very note, us programs, regimen. X-year in analysis we to X the failure III immediate to of an suppression is regimen term, for HIV above the in X trials. PrEP resistance cases to CROI, high Of due for or MA components of sustain X-year a we HIV at and data our this continue of will any degree Gilead leadership generate through strong these confidence At In its

XX. Moving for antiviral is against role Veklury the in use patients. and nonhospitalized to both the COVID-XX fight hospitalized and important an Slide only in is approved playing

to old Just moderate to severe high with in least patients for days who days, the approved considered the few or risk XX COVID-XX are with FDA an mild past treatment for hospitalized at COVID-XX either the pediatric of and progression and Veklury sNDA COVID-XX. for

investigational a way study Veklury, Results that COVID-XX In trial. lead Phase metabolized ongoing once from trial have as nucleoside remdesivir. this addition GS-XXXX, could registrational works same we in to to the I an our oral

behind ensure patients COVID-XX of that available many are continue will as worst we possible. to while even to is to this hope us, therapies work we So as pandemic the

and on Moving ASCO study June. specifically Slide more to TROPiCS-XX share data oncology, XX, Trodelvy, in we'll detailed at the from

in regulatory in the we're study minutes the meantime, chemotherapy Trodelvy And improvement I/II statistically the with As unmet we're choice and a first on interim explore endpoint consistent final timing high Phase of pathways events. with arm OS targeting In Immunomedics-XXX-XX the significant PFS given a reminder, engaging need. we a showed late-line the versus announced the that at potential that of trended XXXX, OS the now are to physician's with results analysis, trial. in authorities depending analysis primary patients.

population targeted data best XX. clinical challenging a patients. encouraging The in TROPiCS-XX As patient we've advanced excitement reminder, a strengthened in more breast than more this has group earlier-stage knee seen patient our exploring

more pivotal As and ago, due study patients, HR-positive/HERX-negative we for course. we'll X we're in shared planning share a weeks information frontline

In X cancer. of number TROPiCS-XX non-small half to the addition we're PD-LX-positive half a and front-line for for this non-small FPI the FPI, targeting and this of trials Phase TNBC. lung PD-LX-negative cell urothelial In carcinoma year. new EVOQUE III cell and includes frame. the XXXX, a metastatic TROPiCS-XX, Trodelvy second patient or anticipate first is the the cancer studies XXXX, first-line we're first targeting ongoing, for in for time lung XXXX in, trial metastatic year, for In we readout of

for you shared the we to highlight we're studying first bring of behalf cancer. deep on on time and the need for the III earliest my of and studies. our XX or oncology initial see dive combination, to lymphoma As based receiving This B-cell trial NCCN's with of alive stages standard earlier that the could also Kite patients was progression without additional approved treatment this more X I'm Yescarta of month, treatment for total, versus can relapsed Trodelvy, or showed treatment Phase initial combination or were cancer second-line Yescarta added these data alone colleagues in in or treatment this people therapy XX relapsed either including the first treatment. are earlier XX, month. refractory Slide On B-cell the large X.Xx FDA within of X this pleased at was for cell that than to patients. months for the Yescarta approval more refractory lymphoma slide, of is by combinations, guidelines options approval evaluating new of ZUMA-X in disease The how In FDA care. the on years LBCL

and clinical resumed on very studies. clinical myeloma hold be magrolimab working at the time the being for resolve we're MDS partial multiple are the of high-risk holds remaining trial new have lifted multiple the initiated. holds potential by possible. for first that the patients XX. pivotal we're the MDS XX and and the X quickly the the years completed partial and just Overall, magrolimab's the patient in excited DLBCL of already holds FDA division to myeloma clinical had to that We're first treatment the early enrollment since ASCO actively trials, our our these forward longer to reviewed Slide Ib patients we as interim expect the note as high-risk the trial partial for remaining them for and in in our on data enrollment more I'll XXXX. In was DLBCL MDS meantime, in a TPXX and share analysis to AML and and to Moving partial follow-up FDA, by Phase different of that meantime, June. with is pleased impact AML at trial we first-line fully In look sharing first-line enrolled limited we from

the added for to and evaluating shared data have to subject targeting in NDA with with combination there no the targeted the XX you With cell malignancies. non-small we're upper lung front-line of GI partner, updates January. in new the number evaluate milestones hand potential noting the decision TROPiCS-XX zimberelimab for the our submission Slide CAPELLA in of call a With readouts that and second Arcus, change, and cancer of same R-XX trials, and on are timing to Finally, to combination that, for half STAR-XXX, of dominilumab I'll Andy. including over the chemotherapy some are year

Andrew Dickinson

and Merdad, you, everyone. afternoon, good Thank

guidance QX is results EPS assets QX our acquired a billion $X.X the and impact update, on in GAAP on get no QX on year non-GAAP to our in I XXXX. year. to wanted GAAP EPS Before full non-GAAP impairment touch I related impact $X.XX EPS the share our This and from review the the guidance. our to partial for into to or R&D in-process guidance Immunomedics P&L had There per full

have With acquired. reassessed the in we assets readout the TROPiCS-XX value the data March, of

regulatory as these HR-positive/HERX-negative States with the potential reflect for pembrolizumab. Prior and incremental that final extended have United assign indications, a pending reduced $XX.X are at Trodelvy's prostate, we as IP of as the and combinations in well authorities, have a bladder as potential venelumab a tumors we the the $XX and given cancer carrying the data, endometrial launch third-line-plus intangible that competitive Trodelvy update, emerging solid in values Recall no cancer. in indefinite-lived impairment patients reflected such of Immunomedics. PD-Xs that not billion was we the value breast of potential did the cancer Gilead While to decisions in been carrying value result with to made $X.X indications as cell time, exploring acquisition, a late-line the cancer today's knew assets breast Trodelvy of billion. now billion At accounting the that beyond and X these of purposes with other time delayed at opportunities non-small taken hormone the magrolimab, and likelihood as discussions like receptor-positive/HERX-negative progress market Europe This triple-negative landscape. of cancer, possibility share breast acquired well but for for R&D assets lung for

opportunities. As XX you are through oncology incremental targeted including number of Trodelvy earlier deep this a programs dive our saw at for XXXX, initiation month, there

return shareholders As a time. an will we our result, confident remain Trodelvy deliver over attractive to

Slide to Moving XX.

points billion, XXX first hedges, offset sequential $X $XXX that in strong cell as the QX by product up in improved billion. were sales X% of start Total growth. basis, and HIV, X% addition first throughout $X.X and by sales. were excluding the in Trodelvy in quarter burn up HIV, our a to quarter of lower following growth Veklury In a sales, HIV part expected on we stronger-than-expected were build associated inventory with first quarter net with seasonality typical to year business million, Veklury, the was the XXXX approximately headwinds impacted, from revenue normal a expected, seasonality by basis despite FX in pricing the year. impacted of was HCV note, to gross lower the year-over-year, The observed therapy, us, first quarter behind Non-GAAP Veklury, QX representing of Total Of in adjustment. almost sequential the negatively year-over-year, revenue. basis for now up rest year. reserve to XX XX.X% With throughout we expect the rest the growth primarily margin was product due inventory HIV QX, of QX points product

expenses the we non-GAAP with up as were primarily costs was consistent business. SG&A Trodelvy. largely And quarter First of non-GAAP our XX% up Non-GAAP due our billion, year-over-year. with was oncology expectations $X.X billion, X% R&D expansion year-over-year, $X.X both operating support higher to associated

Moving tax. to

were reflecting non-GAAP our revenue the effective earnings compared Overall, per impacted billion quarter gross last XX.X%. non-GAAP was impairment. share higher to the and the earnings the higher XXXX quarter the by per a operating our in GAAP first for effective tax period year, rate by On in diluted $X.XX margin, rate part share of $X.XX were in same Our expenses. first offset higher $X.X tax and basis,

fortunately, now our so in far. to to We into middle year, impact range the impairment start also, earlier. year the quarter evaluate demand quarter that on strong Slide will we per our before the second and With GAAP reflect during full the discussed $X.XX can to the EPS, U.S. the $X.XX. excited only share share up. in We significant we note see primarily you $X.XX expect of of to GAAP XX, monitor $X the are outlook from hospitalizations second about the $X.XX the start year. is of we year. the to revision but to and the as Veklury, the wrap item strong drop-off EPS One guidance On revenue in mind, And our to the housekeeping quarter the in through first

many guidance in Prior from supplementary and in in-process measures. recent longer R&D data the the Gilead quarter Relations to on financial from period new of expenses our have Following and to are peers, first results SEC, website. beginning no posted will our reflect methodology this acquired shared exclude non-GAAP the been Investor updated similar

include or to As the year not partnerships our a any licensing reminder, future payments full impact of normal deals. business of the related guidance course does upfront

to guidance basis Going on prior quarter. reflect forward, the in a we impact the plan corporate transactions new quarterly closed update our to any development of

Moving to Slide XX.

to debt. You can repaid is we our first in million there no capital the priorities. allocation In quarter, $XXX see change

and $X.X our returned shares. billion we through Additionally, to shareholders dividend repurchase of

Finally, on either. M&A, there our is no change to philosophy here

We smaller and that the make comfortable continue course operator of to normal invite the to with growth partnered, pipeline or or assets are built, enable have quality open the the to of the the very acquired high-quality in it mind, breadth partnerships that, business. expect years. access acquisitions through will us I'll and we in in you that With the can coming the With that opportunistically Q&A.

Operator

[Operator Instructions].

of line the from Michael comes Jefferies. question first Yee Our from

Michael Yee

ask potential the Maybe I planned could or Trodelvy filing. about

you it's and describe OS just think a that talk PFS modest trend a would Maybe you that what attractive could note magnitude combination it of of And and that OS conversation the think green filing. trend? Is a is a with is you about there to bit a Maybe drive filing? will change. FDA. little subject and to what light a be allow just You

Daniel O'Day

remind Merdad anything We see discussing coming coming more to we this that regulatory at I'll in I'll in and that second, just at with a be up but... authorities but discuss to over if the path Thanks, will to Michael. the forward. the early months ASCO it turn just further add data the forward June. folks look to engaging on Merdad stage, I'll data has there in

Merdad Parsey

always a the think data agency them. I discuss -- filing with that have of the data Michael, and as we'll of normal Yes. business, totality the the a to conversation course with prior

was As primary endpoint significant. statistically the we've said,

to come at a we with will we And looking based them have so conclusion the conversation on all and data get. feedback that the

Daniel O'Day

continue to at in up and and therapy therapy move hormone And of results to given as Right. trials well lines those TROPiCS-XX receptor-positive. earlier in lines we we saw of plan look the

Michael, lot, for a thanks So that.

Operator

comes question from next from Our the Matthew line of Morgan Harrison Stanley.

Unidentified Analyst

Young is on Charlie Matthew. for This [ph],

So Veklury is, being And China the can there? is like look then guess economics in from actually what talk currently COVID case, over there? and -- benefit that's if about I maybe you question being outbreak my the the used

Daniel O'Day

Thanks to We'll for question. Johanna. the go right

Johanna Mercier

question. your for Thanks

have being that as we And help those at China XX with still has million been over with China, authorities light patients which trends to less less And What in discussions continuing I just do in time. of though, WHO treatments. your point hospitalizations, the hospitalized pandemic, really updated also health and recently are patients severe Specific disease, China in Veklury the obviously. those we're on X what's impressive. fact this it's less approval don't with to used also out guidelines well. of in going question discussions the to So now therefore, think the is seeing, going but is in worldwide, U.S. X most of is we think I

Thank in currently at time in So more you. but play not on this China. to come in point that,

Operator

of Abrahams from Our line Markets. next question Brian Capital RBC comes from the

Brian Abrahams

that increases success? Sticking of COVID to seeing expedite X potentially Anything And theme. there asset? for that with any ways X development knew of level confidence X are that you're potential future that the X in your

Daniel O'Day

to Merdad. over you, Brian. I'll hand Thanks,

Merdad Parsey

Nothing to Brian. great new a report, Yes. question. It's

others We've are the partnership to fast forward in really Phase agency to I our we are II/III along agency really count. really that's a as program And design and expeditiously. study the as possible. continue and moving well Phase moving ready got and to great a with We working with move

so So so right far, good. now,

Operator

Simon Our from the next line of question from Redburn. Baker comes

Simon Baker

to you a I are alluded us On seeing if Johanna, year. dynamics. compared wondered rates you update on impact also how HIV, launch if from diagnosis any initial are the and of could market [indiscernible] now And us color bit just you give more little CABENUVA.

Johanna Mercier

Sure.

for CABENUVA. question. Thanks, So both and market your Simon,

So market. let the me start with

still look definitely if they're and levels, somewhat up. below they're So prepandemic, at the you diagnosis catching but screening

and and the market was well. What impacts, flat we the in need started X.X% HIV to close think this overall really XX% continue get that's and Year-on-year up change, we really make picking I quarter-over-quarter much -- to though, and Europe saw obviously U.S. 'XX think end last back as surge we I that pretty the a despite responsibility Gilead first of sure this a depressed and total diagnosis think it's we we the And we saw in since half growth. have up in of that's that it's has market, of share in I what screening pandemic. for saw QX QX part the our signal -- And to to year year. that focus Omicron watch ensure really market what and of QX we on.

you've and taking of recent the come that activities that screened there's we've So but so lot which, past, get more we in the we a people have that, on on full-fledge seen team that to in ensure cases don't is seen to anecdotally. unfortunately, and back [indiscernible],

market, market every single time surge. a prevention it's seen faster the different. pandemic, little bit time back again that bounces and after this post we've and lot a Prevention On

So what a the quarter-over-quarter we've U.S. prevention. seen growth was X% in about for

Omicron of growth, little in modest slightly Year-over-year, growth was the surge a but bit, the which January. because that's So XX%. declined

how faster your been consistent think in I post is sense kind that's telling bounces we've around surges. I guess, question And CABENUVA. that's year-on-year CABENUVA., X.X%. share of so these specific in seen really different, as And treatment to back the of it variants. the On CABENUVA., much

no, into What new see market. we the an coming So haven't is we impact. seen entrants

a switching normal. standpoint, that long-acting, going this is see seeing higher-than-usual CABENUVA is so the it we're drop-off is back. always little to going well. And patient [indiscernible] which an do share think also with a is Biktarvy from exciting. lot that on, What bit first is I a of there's a You as of rate

time the interesting I very watch. So to HIV point share in questions. to impact think Gilead. more on the do the And that the I one but it's market definitely limited for for your at think Thanks market, agents this better,

Operator

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

Geoffrey Meacham

I for Dan. question had or an HIV Merdad even maybe

know important you an is long-acting the [indiscernible]. Gilead. I getting very to So And broad strategically increasingly right around built pipeline

lena? candidate would is the trial is, And a it bottleneck main to for question with of far? there a Is go so an you the lenacapavir? what's the So matching that been PK/PD may up larger optimal if matter scale a make wait doublet into

Daniel O'Day

turn a Geoff. look day, the be right did didn't truly goal Thanks, in to entirety of portfolio certainly is Yes. dive and chance deep on to the... to have that that and meat Merdad the in spend we Appreciate you the molecule at along clinic. want remind just going have time little -- a shots over to to I'm find unique many to many Merdad, here. a But But lot it will it. opportunities challenges we virology exactly really a maybe second the more you lenacapavir. those presents progressing of give to the for the and But with the of have Lenacapavir partner. we

Merdad Parsey

Once start Yes. the really, And for a partner PrEP to clinical or long-acting to the wait molecule hopefully, treatment oral back In then resolving X the getting our Sure. a could be agent. possible a I of think than studies trying for I trials gets with in to as at about for molecule. us we'll I'll this on And and don't we'll months. go by you're And again, resolved, a to get done. maybe with saying parenteral, looking the mean side, we the are filing longer with numerous completed oral, as weekly mix issues portfolio mode. need lenacapavir obviously point, you're we in to long-acting hold. where PrEP for approaches fast that's we've absolutely oral built get business at, it's parenteral and right. for treatment, provide an And move the And or have combine right, long-acting thereabouts. to we're we options that

characteristics lenacapavir sorts replication. special us unique I'll the is that. to inhibit you properties to the formulation characteristics of enables do have candidates right, It's we and site including that And those they have they the which about do that that just that have properties tolerability? that is more the ability it's And to show oral right allow right less undertaking. for to it an therapy. -- progressing molecule molecule challenge said get like say a are us essentially, So to number So and reactions the of we're that things agent? a injection the HIV from and long-acting parenterally, has a again do standpoint PK/PD us about is very molecule Finding another

Operator

Our Sandler. next of from Do Piper the question comes line from Kim

Guyn Kim

your launch I matching LBCL. could and hoping wanted to the first is there impressions whether Was of ask expectations. the Yescarta about you demand sense second-line with launch of the your and out in provide some

Daniel O'Day

Christi Yes. to Thanks, delighted have Do. us. We're with here

we'll hear Christi. here. Over source it to from So you, the

Christi Shaw

Thanks, Do.

So we're very encouraged.

NCCN before guidelines know, now X and First, for put standard changed the as approval, of LBCL that category you the use identify as which, providers physicians and may care. second-line to Yescarta

in site the happened that Maryland. our month manufacturing is approval, with And these times. approval a approved which the So after before was in approval, then right -- unusual

this all we So patients. really cylinders to important really hitting of like in we're bringing therapy on feel terms

Friday at orders the come a X approved so to second-line And Saturday, on p.m. about started in. And on launch was

Maryland we're our already facility. product manufacturing in So site the in commercial

it's out as in the up, orders think, really as when I we building data December, at early to came the starting obviously, see ASH soon days, was the definitely, So come but in demand approval. get and we're

Operator

comes question of Cory next JPMorgan. Kasimov line the from from Our

Gavin Scott

Gavin, on It's Cory. for

and in sharing that these any cohorts? of evidence year? there label going in expansion looks utilize of we're on inhibitors like then opportunities you if, there's multiple with to study. It biomarker are cancer, is you PD-X the cohorts any of Just in lung curious synergy EVOQUE-XX with just one, Trodelvy this plan And the study. particular, two, and on a And Trop-X

Daniel O'Day

Thanks the cover Merdad, that? for why you don't question.

Merdad Parsey

Sure. Yes.

On we to impact of on the we cancer not a so of And as evaluate responsiveness. our experience we role expression continue the side, Trop-X breast in for study the actually, Trop-X seeing expression are far, responses. biomarker big discussed, in

we're patterns looking So we to And than seeing. different. but we'll cancer expect may we'll behave keep lung because do be -- expression differently what

a So in maybe type. there'll different tumor be different a cutoff

seen. be to remains that So

synergy, I'm think with And we'll studies. of I that's the add. terms to term -- using clinical that the coming the we nature larger careful additive going about tumors in In see we We need at where X always trials. with think different the do benefit, the to of conduct are that order the we're synergy. approaches,

approach. different a implies I think that mechanistic

patients agents, expect will components. of what that feel that PD-X, we think the I have inhibitors, do bring over of additional we patients. to Trodelvy treatment those immuno-oncology and bring additivity above PD-LX the do should benefit we the So yes, additivity X And to

Operator

line Our next the Karnauskas from Truist of question comes Robyn from Securities.

Robyn Karnauskas

way. Yescarta the on Congrats by data, the

around want I M&A. [indiscernible] So just little to your a on bit comments

we're I did out. that have in good And that investors but all you believe highlighting think the going them you these some read job see great day. oncology to think programs, not I a

gap How you you open magro your and growth you near-term start a acquiring to out? as are you would -- to Trodelvy are about a about growth, like for reading that some thinking near-term provide would trials that something So be company? trials thinking of before lot your

Daniel O'Day

I'll add. I start and can appreciate that you up. bringing then Thanks, But Robyn, and Andy maybe

for of pan-tumor the combinations molecules, you acquired lines the when the in really organization at the on in to history has of over purposeful the been naturally, large almost potential a cell phone the us of taken strategic whatever X I a beyond medicine that oncology a build potential that particularly we've these time portfolio acquires and and of potential that I'd in and remind think approach now to late which years folks is really last And thoughtful acquisition that addition X our therapy, is alone and with earlier for capability -- extending years. process just it's the begin organization, size past lines, trials in terms obviously combinations.

that of earlier congratulations think this going X years lines that therapy back like number actually, But pursuing the now started will the magrolimab, up terrific can with I combination post a with that the -- of we and Kite which with the the cell a Robyn, of patients, exactly process. of Arcus albeit curative of kind of obviously, example by are bringing Kite that into the leadership on out the took we impact Yescarta. acquisition, and to in earlier technology then right potential you a with therapy for assets, and see therapy bit course, is on playbook and that, Trodelvy, potentially I you is with appreciate, be now a --

time So the and which I M&A. frame have think one we of the remember to evaluates always success

including that, of we years The just you say and bandwidth possibilities the any bar on are higher ago we is other mean was of number we're also for company like of course, the a because have it with the Trodelvy. study lot constantly now and than one I opportunities several can thing Gilead see is complement the do, other operationalizing, would a who side, ours with much companies, in but folks that fact, that. bandwidth Merck of to looking doing I are collaborations

just we the that we spends inflammation that early on constantly our Gilead. at there's this. I'll I and here of thinking So lot Andy's additional add know Andy about at creating think, I'd a different types looking as different thoughts be will oncology work time -- to this are program those to I on opportunities love ways, our the virology, growth to story But well. there complement our out of bandwidth.

Andrew Dickinson

just at perspective. Even, our for question. impact just confidence strong start are business. And this the in today. the Look, it's of really for reasonably of results, our FX, Dan. market think maybe quarter fundamentally, from Robyn, profile And I we and back to growth beginning adjust that growth with the in have our is look underappreciates a thank we Thanks, when Robyn, go say to And would the lot you, our the if in there's especially you LOE I you growth. first fair where

can of the of going. where sense but gives question, our confidence you much on work at team management growth why when not we in a are the today, business, HIV next profile was that to to there as better describing. as we're have Dan couple the so are oncology matures do about we years that your where things strength that get hopefully, portfolio And our way we're meaningfully the the we in profile. should that a But always only of what you in seeing the we look growth So business, recognize,

expensive, So while all everything our including genuinely you growth know, we're far we assets, company in and we have need signs few right where and are that looking as of not will a them the team. a more Many take today a really commercial leading we that's is. really are look at and definitely things, those believe between. focus time. the But to to as that seeing be management are sector, for just little it's going We we

is So The you opportunistic. Again, assets maybe acquisitions. should large to not clear. commercial Thank that's expect commercial we'll be course ordinary But or is smaller partnerships, chasing going It's you. we're very today. out deals. our focus not guidance go where that

Daniel O'Day

And of saw choices And making the really representation decisions addition at time is make into because -- to the any say virology we're team days that company really move right in you really portfolios to dive the the it's and bringing leadership we the the we're just that right molecules And Andy. some to as getting all thing forward. that's last teams oncology as Gilead deep -- is expertise worked medicines, and that. together critical in in hopefully, I'd that on we've sure at right the both the none. some the the of and second Thanks,

So a we're we're pleased really us, and the big progress focus with really there. for making that's

Operator

of the from Evercore. from Raffat comes It Umer line

Umer Raffat

to it just trial to materially at it take, question feels slower I the Dan, than of of amount program prior the Merdad, on a like moved. start expand [indiscernible] pivotal line and pace and the how is moving which Paxlovid it forward remdesivir. wanted time feels on And time sort and this the will

about expedited even established which emergency my the pace to given pathways XXX(b)(X) at talking active right are are given maybe what path the fast now. infections FDA? when Because non-inferiority is Paxlovid So not question the thinking and/or a comparator are relatively unreasonable I guys an versus trial guess presumably, you is, public health happening

that a where this wrap could summer. this view? in all accelerated path Is too up So there's your

Daniel O'Day

Umer, I'll Yes. hand and it to I'll start, over Merdad. then

antiviral I fastest have everybody course, Remdesivir with an of for the the development to all, in on essentially this the from focus still approval was reinforce we speed. message an standing within first I United States. mean, phone, So our great mean, arguably of of tremendous to ever occurred absolutely lessons organization. that's and moving are just And we

got we've this being those to that, world, both So pandemic for developed path. somewhat Merdad wants has implications at it experience turn maybe a a very he at recruit to -- X around working groups trials, those And I details that, to to perspective X of and the pandemic with put in lessons with regulatory you take. that the pursuing on I'll certainly terms of a accelerating learnings And particularly our both the other different the as lot over of FDA with add. stage And clinical on from stage. Having know, and therefore, raining to use we're, from now also any of a say path regulatory ability in said trials, are and course, X. property X around want just unique we'll

Merdad Parsey

very without approach is not issues. asked I past. to think in It's Yes. very than quickly. add Phase moving about I nicely the the I study I Umer, much XXX(b)(X) any other mean know, you've our moving

As explored. can are all -- we've that about the avenues those and you you've are avenues thought imagine, all mentioned

to move the the nature of agency. will we fastest the with so with that's having and the us, And available we're pathway discussions

Operator

BMO next Our Seigerman Capital Markets. line question from Evan of from the comes

Evan Seigerman

Andy be a might It one and combo for Merdad.

behind can some impairment? had. the just based of magnitude to we've updates may Maybe data some some square the how the the of the now of through So have you've data trying -- how from $X.X walk billion of write-down? August changed inform the to you I'm assumptions me math on seen that XXXX your

Andrew Dickinson

before to back an is to up, simple. a it's accounting It's we question. it's Andy. for discussions Evan, with value regulatory that this construct reassess relatively the the even just authorities. Look, are Thanks remember, required And question. we the have the great

was a of when So I expected The was came just what was that when is want said There within strong it because specifically when after reiterate put data required the we at the out. to of together study back up we we but This asset intangible had modeled deal. outcomes schedule wasn't range This the the point indefinite-lived we the to range we acquisition. that are did outcomes, data. positive. we and the

So it's a simple very model, too.

discussions have the analysis again, of But where by on you combination could balance FDA It's when which we'll valuation months and the are course. attributed key, change flow non-small at in lung And that expect, way, the consistent to have you'd probability your assets look simple. relatively the is the the continue any the our hormone to approval. to So look coming with valuation at sheet, still cell is of cancer the the breast we over cancer probability-weighted coming valuation as years, cash receptor-positive/HERX-negative the with business standard discounted transaction. of it's sitting

know that data approach, We this and PFS the at there that's you. and conservative key this for will the we are is we the assume more months. assuming, survival, on we're need not path overall Evan certain -- based and not though took we were We coming for in that looking even and that is wait a forward I the think to case a

accounting to the and the X.X. a that we for had we made, that's that call, call -- purposes for So and make the treatment, leads to

is IP R&D of add billion would at end I little approved, we're was cancer. thing had to or the indications $X.X cancer. already receptor-positive/HERX-negative finite-lived the that already remainder lung assets. -- XXXX, of in non-small hormone other Trodelvy-related we And cell $XX.X of now billion Those breast it other The are half that are related The over a we're again, that. amortizing of

explicitly hopefully, now And line have as you combinations our as on we model of little bottoms that to -- we which did explore There and were the cash indication. hormone we that other is need from positive when that going gives this we bit not earlier said the billion expected flows from again, is we of deal $X.X build deal what originally, part receptor So reiterate plus well to highlighted I'd up. were we relating no them into did acquisition, a model. But tumor breast when color. to third cancer the the types call, the line

this. more for forward accounting the patients many, back, believe continue there are to outside for step that shareholders a you when of So and importantly, of value lot paths with we construct, many our to create

happy off-line to you more if I'm give helpful So take to it color. it's

Daniel O'Day

combinations, potential Yes. treatment accounting think somewhat a Evan, of an absence is several Thanks indications, to And a of having this know, a bottom I regulatory so value reflective to far. the as you the of approach took Andy's for thing in the of evaluation conservative mean, of which, initial years lot, I it. Andy. We is again, I later the thought mean, prudent was Trodelvy terms the that, the we the course, transaction, is it line do. in of point, the never, time discussions in at

with and press well. there to So hopefully, happy of than our release in it more up there's in take plenty information you as

for So that. thanks, Evan,

Operator

question Van Our line comes Buren next Tyler the Cowen. from of from

Tyler Van Buren

later Can the year? the readout interested And for when related you than we II primary a latest please upcoming other to the outcome seeing are PFS the most get the data us for Roche what the trial Phase your in in thoughts you regarding results, endpoint? [indiscernible] successful give

Daniel O'Day

a lot, Tyler. Thanks

So to Merdad, over please.

Merdad Parsey

Sure. Yes.

durability be responses, that only to for. thinking would ORR. that going the in factors agent those will of for. the not But right? response looking would the the as and we the your hoping that rate add to be of And been a what addition to are we'll is for that, responses So depth TIGIT be the to looking overall I be it's we has dominolumab think our point,

is for. they've see will Obviously, there when is out We to a overall we'll sort like tolerability of ASCO when if and see -- are the But comes profile. data seen to looks at the looking factors you Roche as going be be the well will. they those what also looking be what to in various it benchmark,

Operator

question Wells next of the Mohit from Fargo. from line Our comes Bansal

Mohit Bansal

FX. regarding Andy for question a Maybe

And U.S. has been So mean, the you $XXX XQ, you Andy, about a I decline. U.S. provided euro strong, there that guidance, million mentioned to was in dollar then European impact. -- since X% dollar

which strength absorbing stronger to are if From now. my the So help you this you business is plus. this really are is understand could you understand that is you us $XXX I'm FX where anticipated, impact how it guidance just much means could in this than math, what of right million base But maintaining be coming trying that from.

Andrew Dickinson

great that exchange And right. April, take you're absolutely even rates And or seen question, to I'm the impacts a the Sure. from of it's which look, That's it. Mohit. revenues we've in a relatively The strengthening happy -- continued coming European simple. of deterioration dollar, business. our

There change to how very the of the for lead Johanna carefully. also, your watching of the there's the the maintaining part the expenses $XXX to payments budget from in yes, are in-process year-over-year accounting this there guidance that, weren't and additional QX. impact reported R&D, of rates earnings. And -- impact will is clear, are was exchange I headwinds. part non-GAAP in are FX which to be also million treatment previously question, instance that QX to of comparison related confidence a upfront So we

you there seen business side, we've far. so are flip strength of the of On think Veklury outperforming. of that the our are parts Again, that

the for could of also the in things the EPS things at think over team There middle the year, non-GAAP provide more But that puts of and update. changed that the will key offset some GAAP I a the and is impact and have and EPS. Johanna So are rest additional we look our to that I that management year thoughtful will the we'll negatively couple recognizing takes strength have this that will the course and of of expect you of the extent.

later that helps. And very are we Hopefully, in guidance so today. our comfortable year, but the we're give we'll where additional you color maintaining

Operator

question of UBS. next line comes Colin Bristow the from Our from

Colin Bristow

about doublet one, you're -- just just there's thinking enthused market you following TIGIT and on what Can The about me is strategically? -- and I are but asset. concern on, wanted through see really understand quick Is really PD-X absolutely that how the a timing? Just most some you're the it TIGIT excited the that? Or adenosine to about it value, just your where about you you data? and the this triplet just help

Daniel O'Day

ahead. go Colin. Thanks, Merdad,

Merdad Parsey

at combination and something broadly. as make And is could least lung that other agents way potential likely Sure. to then which be is Look, to I think great assets. for add looking across our treatment benchmark to are a that across TIGIT/PD-X going hope I that have basis bring all cancer sure or to better we is responsiveness. such, sort of seeing would potentially the have all the we combination data we're to obviously the even we there Maybe say can the the more in to the us it be

our TIGIT/PD-X that's to are Trodelvy becomes to else in the belief seeing options think our being of the we But raised for -- that I something whether need we're those baseline or I for. So that and combination would aim is floor us or all sort consider. is say pipeline, adenosine

Daniel O'Day

conceptual Thanks. there. nice Very

the question. So question, we'll one out can last please? take Jonathan, time, of we have respect last for everybody's

Operator

Certainly.

of for Goldman line Sachs. from today Our final Richter from question Salveen comes the

Unidentified Analyst

for [indiscernible] Salveen. is This

quick. Just real to go back to TIGIT

have Arcus importantly, seems on that might than months KEYTRUDA previously PFS. see most want ORR maybe OS an noted on XX-plus be XX%, and, you'd like a to and It see for given greater You OS? and would year to plus mono what sufficient you like data but PFS

be hear this. on would Just to thoughts great your

Merdad Parsey

the milestones those time take is I that being And And out. there. data agree at right? with got that months, milestones say mature from decision. -- remember going would that Well, we able what are have bets would XX milestones you've it's I set those look will which play to We're to less make a without to to important going make to to our OS for

tolerability sense, and maturity it. you'll say will as a actions So will look a rate driver underway, and will would that be of all depth at watch that, The the benefit garner the seeing response that that data there, those should can getting that of I far you're we confidence looking see will you be sense be we'll And overall give as a and our of in at and is benefits set the in the things. in at we duration because to when our look be, studies absolutely concerned we the have again, be response right assets. for we from those just

Daniel O'Day

attention deep want for it With progress the We forward really comments. with dives you turn I today and that, for the I'll to to for year. appreciate to that, of we've everybody. I had. updated just on the with keep thank final over beyond our you chatting look at to ASCO And couple Jacquie some

Jacquie Ross

rest and continued forward day. joining Gilead as you Thank in to the We great interest your year, look us your do you of Dan all a for updating today. throughout Have appreciate said.

Operator

Thank you, does conference. today's the This program. participation your gentlemen, in ladies and conclude for

You may now disconnect. Good day.

Gilead Sciences (GILD) 29 Apr 222022 Q1 Earnings call transcript