GILD - Earnings call transcript Q2 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day and thank you for standing by. Welcome to Gilead Sciences Second Quarter 2022 Earnings Conference Call. All lines have been placed on mute to prevent background noises. After today’s remarks, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's call is being recorded. to of conference Investor like Ross, to now President Vice Relations. would hand over the Jacquie I Please go ahead.

Jacquie Ross

Thank you, operator, and good afternoon, everyone.

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

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

Dan. the I'll turn to call over Now

Daniel O'Day

forward Thanks, This our of Jacquie, quarter appreciate our which really US$X.X look strong results, was to sharing everybody. of execution. today. We and revenue quarter very delivering a afternoon, and for second quarter clinical a good business, We billion. strong commercial you joining highlighted

grew second total Veklury, and we actually also quarter, business If was sales the product the LOEs currency the X% impact look growth year-over-year. headwinds Excluding and at of the in the XX%. exclude HIV underlying

demand prevention to Our and HIV higher by deliver, record and from a quarter exception market recovery. the Yescarta for cell awareness the second-line demand benefit. Yescarta has and by through Yescarta's performance patients also curative manufacturing the for standout of by relapsed/refractory April. B-cell lymphoma portfolio and with PrEP. with sales this lines in Kite potentially oncology XX% for later the was the second-line therapies. continues go billion see for effectively our therapy, not time strong and market for to continued treatment those ongoing This our was FDA first a treatment Trodelvy a expect business. needs of meet we to and scaled no contribution Biktarvy is grew both with and large treatment. for topped approved was growth quarter uniquely but a year-over-year, Revenues and for This increased $X.X in only patients

progress. to clinical Turning our

with a therapy for dosing be and the will lenacapavir Our with December. If by decision treatment-experienced the HIV, expecting lenacapavir we late for the FDA first approved in NDA submission now for been has HIV X-month treatment. living first schedule are heavily cased and accepted the people inhibitor approved,

to Moving Trodelvy.

late-stage things patients, will hormone-receptor-positive/HERX-negative FDA update We regulatory are potential in as we discussions you with a regarding for progress. the and pathway

new Phase in dosed earlier begun screening patients We interim cell triple-negative study the triple-negative Trodelvy evaluating for combination this our in breast dosed And in study than a in Trodelvy evaluating new ASCENT-X no ongoing the We in first-line X cancer metastatic our our early are in Trodelvy month, patients. EVOKE‐XX. in MDS. magrolimab have also an lung and first analysis non-small ASCENT-X targeting cancer, X patient breast ENHANCE, the later from first-line, Phase cancer first XXXX we arm high-risk magrolimab, study. we patient Also

we magrolimab ENHANCE-X, first-line for dosed Additionally, X for AML. the Phase first a patient study unfit

this combination studies to additional a for Later to Slide X. we an and X mix of Trodelvy studies. expect Moving in initiate year, monotherapy

ambitious enrolling and Kite update on our momentum in second commercial continue our the want thank share We for lay our patients therapy extent domvanalimab execution trials. also this the of across planned teams Gilead's for success. combination program. scale I'll the continued really in to existing highlights With three a the start trials take to The I to and studies cell plan of programs to critical invite Gilead commercial that, an oncology to and of two for future and clinical opportunity groundwork Johanna terrific performance. to quarter quarter

Johanna Mercier

Thanks, Dan, and everyone. good afternoon,

higher and with X% Slide year, in both leading On mix higher every to portfolio. associated lower well as demand year-over-year, as pricing we our offset utilization, Turning had to $X.X a HCV. total product Sequentially, sales well a were billion, by our channel coming product HIV to HIV, second by business, driven of realized up of in with year-over-year out sales by strong part primarily up price Slide as quarter by average X, $X.X driven as cell PrEP. total and driven across Veklury X% for Veklury billion, the total and therapy very excluding were inventory We X. treatment primarily sales the of XX%, government demand see quarter HIV first dynamics up higher Trodelvy seasonal excluding and

exclusivity of largely Year‐over‐year, price seasonal and but, Europe Excluding to as HIV XX%, the over sequentially in higher channel X% Truvada the average Quarter‐over‐quarter, relative and HIV U.S., in treatment that and grew we to and the in first. second of mix grew see sales the HIV were market loss well X% U.S. X% over in inventory typically demand realized of impact flat XX%. was to the in due the increased Europe. quarter the Atripla, as up sales leading dynamics favorable the

to year‐over‐year encouraged growth to quarter sales and, market market to second $XXX the in up see X% range. We’re in on X% basis, the million, continue expect and sequentially. were Descovy annual treatment X% a the XX% year‐over‐year recovering

to pleased growth are with see PrEP that awareness levels. volumes market market We continued are above and pre‐pandemic well broader

both was other holding percent mid‐XX and PrEP market in quarter, the generic up recovery is market and sequentially, share robust growth adoption For X% of in growing highlighting PrEP. overall the and Despite year‐over‐year, Descovy XX% participants, range. the

driven the -- channel those continue XXXX, expands, share preventative in role quarter margin QX to Descovy market look in growing. mix. acting year a by in as -- grew and last an to adding to the and important Slide treatment strong care, the we seeking of lenacapavir by expect primarily leading be and Biktarvy a and to second market XX% XXXX. early the play $X.X as As awareness fastest continues Biktarvy’s from alternative well as to demand grew as HIV, U.S. X, in year‐over‐year grow PrEP, really as continues wide long‐ of billion, Onto to XX% to overall XX% potential for for the forward

failure in five differentiated reinforced safety first efficacy as once this the cases Biktarvy’s in increased X‐year trial of dynamics people AIDS Notably, years, seasonal quarter duration sequentially, of past International from to growth to had for addition to is a mix treatment contributing demonstrating inventory of profile Share regimen. sustained channel earlier. unprecedented at up resistance well zero in living XX% and due X% clinical we weekend Montreal. again Biktarvy with revenue referenced profile also zero the this quarter-over-quarter cases as Conference the an Biktarvy was HIV and resistance, the In At fact, XXXX, in HIV. demonstrated

price in in fewer Moving leading of the Europe. to by share Slide were quarter to was XX. to HCV, in average due higher the patient XX% mix the to patient partially as to we timing start. maintained year-over-year volume HCV Overall XX% higher HCV a lower in realized by sales of down Europe. driven XX% U.S. starts, as Eastern large market the both order addition and XX%, well steady Sequentially, offset up channel in

on updates $XXX growth in volume HDV driven the associated and flat with volume-based regions. quarter-over-quarter by adjustments quarter demand year-over-year, Slide shown other XX. million, in were sales China were procurement on and in and revenues and HBV year-over-year second For roughly all offset recent unfavorable XX, Slide Veklury higher by the as

in declined As expected, year-over-year as and most rates quarter-over-quarter both geographies. sales hospitalization declined

drawdown U.S. in reflected inventory revenue the quarter. Additionally, second

U.S. been Veklury. COVID-XX hospitalized most hospitalized COVID-XX the XX% being is treated recent the less although patients in are that severe contributed still While receiving subvariants of roughly pure prevalent, are to patients, have and

enables European of to Last globally. COVID‐XX Agreement continue be our participating to purchase patients Joint the for signed with up Veklury months. committed that second countries with period a Procurement supporting to to we We month, XX Commission

We're it's global need Additionally, conditional Committee look and guidance receive increased Human XXXX, readiness the and appropriate a full the our for with COVID‐XX. to patient patients reflect European European or recommending year maintain of for marketing needed record Veklury Medicines Medicinal will Products the have builds anticipated clear demand track since treatment year. the authorization, and meeting Veklury decision This proud our of Agency’s CHMP, half. second full where the of Commission the supply later Use, fall forward this by in of opinion a positive our adopted final for authorization to on for prior, to we the

over‐year the Turning growth strong and U.S., to the of Trodelvy sales offset Germany grew and Oncology, awareness due XX% France year‐ in XX% increased quarter‐over‐quarter. was X% Sequential with unfavorable to dynamics. grew U.S. volume by XX, Slide X% adoption. with Trodelvy $XXX Sequentially, on particularly outside pricing and in growth beginning million and

continued of as sales as U.S. reimbursement We the EU. the see growth in well the second by expect half, force driven our to the impact in approvals in expanded

the Trodelvy committed to broadening with are payers continue and for access around regulators work world. to and We

recognizing building to and number significant first We’re pleased for decisions demonstrate with clinically Trodelvy’s Technology to decisions use add Phase Assessments statistically clinical the meaningful X population. in the based in Trodelvy countries. the of survival a U.S. Health breast with positive support in significant ADC benefit patients the other patient overall the in NICE in both trial. UK, the These triple‐negative is on cancer benefit mTNBC recent Trodelvy following NCCN ASCENT and metastatic this by the of

NCCN fact, later guidelines second‐line Category recommendation a recommendation to highest mTNBC, available. elevated its In X for and the Trodelvy

for Trodelvy while FDA by for in advanced with that a recommendation the XA NCCN patients disease. Trodelvy’s issued not Category is we these the Additionally, use HR-positive/HERX‐negative for setting, approved use pleased has are

XX% and I'm sales Kite team. in were incredibly for driven second the a and of continued and U.S. some Yescarta million, XX. our which third-line plus to up XX% therapy or to share year-over-year strong quarter Turning Cell Christi the in LBCL, growth launch Slide sequentially, strong pleased behalf second-line exceeded on results for Yescarta. by strong refractory expectations relapsed very $XXX

and data impressive strong high a reminder, authorized approval, an NCCN familiarity treatment a early large CAR therapies. predated recommendation, our with As in uptake, especially with drive T the which centers volume helped second-line

second-line ahead on of approval. in large program in LBCL through this other approval expected is access Yescarta two LBCL through and available in The early fall. decision markets: second-line is decisions Additionally, the Yescarta Germany in already Europe later France reimbursement

our meeting plus overall awareness U.S. year's use at and of American presentation the Hematology year-over-year, approval follows sequentially recently, in growing Society of Yescarta. increased of Third-line data also confidence This more last LBCL reflecting in ZUMA-X the deliveries X-year the second-line and and

cell up XX% Kite's the source meet reliable We're and our effectiveness our of For in Yescarta ability demand QX. sequentially. year-over-year further strength therapies. deliveries cell sales the proud XX% reputation Of therapies increased was Yescarta consistent Kite's and that of were a $XXX to XX% our overall, differentiates manufacturing note, year-over-year sequentially, million for of XX% quarter and for and of deliveries continued strategy demonstrating expansion and

of as strong While early first in second-line we usage normalize XXXX, QX we the saw expand towards and very beyond to referrals. more expect the in demand half community adopters growth this

up later sequentially, geographies new million, Sales for as Q&A driven a adult Tecartus. in and expansion In commercial to into entire and organization. uptake by available lymphoma as the quarter this strong summary, well leukemia was lymphoblastic for $XX mental continued and Kite the cell year-over-year in XX% demand for XX% U.S. call. relapsed/refractory Gilead were the for acute Turning the Christi is really quarter on

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

Merdad Parsey

pleased on we clinical to are our you, made updates Slide Thank portfolios. Johanna. second From and a wealth NDA positive we PDUFA were published very based from data CHMP for Journal indication, a of for end X/X in trial New from our U.S., XX, a oncology Infections this CAPELLA with now treatment have with treat that the with week, date XX‐XX% and quarter, HIV solid XX. the lenacapavir very in population, at set this in data earlier England progress suppression Outside Week of Retroviruses December. perspective, the Starting share updated, of this the X‐year, HIV including and Medicine the virology sustaining those spanning submission data accepted XX we lenacapavir In people experienced May difficult at on with trial. Opportunistic opinion achieved on for a living presented this treated Phase data was received heavily to X‐year Conference for achieved we the Week of virologic at rates the year. last

the this European later decision We Commission from continue expect to year. a

We Looking applicability the triple-negative broad at across of choice Slide types. quality-of-life to cancer. XX. breast new Trodelvy's in data tumor increases ASCO reinforced in metastatic Trodelvy's on range potential study a ASCENT These with that from over physician's survival treatment Phase data confidence X shared health-related patients benefit Trodelvy and positive of our

in We of our metastatic or had a demonstrating data cancer, three reduction in quality-of-life with study, also Phase TROPiCS-XX HR-positive/HERX-negative the endocrine-resistant breast highlighted statistically clinically light-line, meaningful received significant progression X PFS patients The in median patients. disease and a and death data, of coupled risk from treatment a therapy. who of positive Trodelvy's treatment survival first also This the the having TROPiCS-XX metastatic as prior demonstrated positive a failed interim at HR-positive/HERX-negative analysis. the support option NCCN trend lines with recommendation, hormone study after setting late-line for potential in overall XX%

negative for regulatory are As to ongoing continue FDA program. TNBC. the patients we'll Dan the as patients followed who ASCENT-XX planned mentioned, path, well TNBC on our meantime, study subsequent patients clinical when began in patients the being ASCENT-XX, with potential have In PD-LX update screening tumors We Separately, discussions continues Trodelvy analyses. metastatic OS our valuing with the Trodelvy for PD-LX expand metastatic first-line TROPiCS-XX positive you we and in in first-line evaluating with as can. we

expansion cancer, trial for cancer. is Pending accelerated with ongoing designed from data patients the our Trodelvy of registration confirmatory TROPHY‐UXX TROPiCS‐XX results Phase line enable to two Phase line In in the second Moving bladder advanced the U.S. with encouraging the quarter Keytruda X in actionable study metastatic cell Phase cohorts TROPHY‐UXX in X evaluating This urothelial X first cancer combination plan our mutations. in initiated to supporting Trodelvy with approval non‐small study of Trodelvy mUC. we study, X follows program, genomic Merck‘s or the from patients locally global we study in Trodelvy mUC. in to Phase open for studies the front without Trodelvy EVOKE‐XX the lung patients in lung our

first‐line KEYNOTE‐DXX with year, this expect enrolling in half study X Looking to expression the at or Merck. Phase in our EVOKE‐XX cancer with begin than equal PD‐LX second level forward XX%, the greater for cell non‐small collaboration of partners of patients to we to lung

we Additionally, later in initiate castrate‐resistant Trodelvy expect prostate combinations, cancer. including several other this year Trodelvy to evaluating

Moving divisions requiring to on protocol have changes. We're the both have that FDA magrolimab programs now All without of the patients XX. magrolimab magrolimab. partial any resumed pleased clinical Slide enrolling hold lifted additional on FDA

of is response durable shared in magrolimab Xb profile At MDS Phase alone. with rates historical to and complete unchanged. efficacy data XX% MDS compared from of rate continues and AML our safety Our in the high-risk with magrolimab's high when potential response confidence azacitadine and ASCO, encouraging demonstrate rates we study

with of line Notably, with XX%. X front analysis interim than Phase XX% of in patients enrolling later promising MDS, is and observed also study AML CR expect TPXX XXXX. efficacy no an ENHANCE, and our a ORR nicely We HR mutant in we early the

therapies and a from Yescarta in improvement therapy race cell behalf X we data on Event in clinically body gratifying exploration ZUMA‐X Free demonstrated and patients more settings. of patients it further ethnicity. to a Yescarta median efficacy of And meaningful safety safety, are and establish in Building of quality see on relapsed outcomes and consistent the over XX, for regardless Kite growing for data, patients clinical sub‐analysis times the survival that and XX, with our real‐world Moving and profile presented team, evidence. These benefiting greater LBCL, life. than ZUMA‐X the of ASCO ongoing at cell that more Slide is demonstrated Yescarta on of Survival of data or more to Christi support given refractory of and

evaluate line our patient second as this study first to Phase second patients We a evaluate in Phase study as expect year. X LBCL first to outpatient of high‐risk for ZUMA‐XX, LBCL an ZUMA‐XX, in half Yescarta well in line, enroll a the X to in setting, Yescarta

a evaluating Yescarta line Additionally, HR year. this new of we expect Phase follicular first-patient-in trial ZUMA‐XX, X in the use lymphoma in later patients, second

to Now XX. Slide

we six data the Dan of clinical data X as domvanalimab; steady regulatory our cell ARC‐X well potential therapy from focus several spanning update Tecartus; well milestones and the ARC‐X’s for Phase X expect on for decisions, trial Phase our a to Trodelvy updates an for data continue the as as initiations for have The we Yescarta, study late from year X also HR-positive/HERX‐negative as partner As at include: Later to data lenacapavir, least Trodelvy, in number the key US; ARC‐X. patients Phase with Arcus, regulatory the half this interim quemli. more and mentioned, in including execution. discussions year, etruma half first and for in progress made of on including clinical line second

investigational for in our GS‐XXXX, for COVID‐XX. novel data development X Phase treatment of early with the oral encouraged are We nucleoside

move regulatory planning discussing are and are the to clinic. agencies with We into early these data

Tizona our as to Pionyr, such stage pipeline see continue earlier to with pleased are We partners, advance nicely. and our also

For robust external mid‐XXXX. Tizona’s pipeline in its we will and over portfolio our program treatments and cohorts need. expects that, call many confident enrolling data to Tizona HLA‐G to our patients internal to across is partners, oncology, inflammation example, interim the expansion life‐changing and deliver Andy. currently I’ll those virology, dose With help share are With hand

Andrew Dickinson

you, everyone. good Merdad, and Thank afternoon,

on results R&D, everyone I or this to measures R&D to now IP discuss the financial would reported in-process upfront development following our our are SEC earlier acquired R&D. business payments guidance acquired that quarter Slide year, transactions, similar IP in peers, starting I included non-GAAP and remind like and our including second Before expenses under XX, for

payment reminder, a million announced reflected the in XXXX included collaboration our in but our full was the $XXX As May associated prior in with guidance. year not Dragonfly QX is results

Additionally, this we this There a and this that R&D. see acquire shifted slide touch P&L. smaller reflects again guidance presentation incurred on R&D the few opt-in $XXX relative I'll R&D total believe this given the IP XXXX moved, payment payments XXXX fourth are the you'll milestone in and Arcus impacts in reported we period note changes the we been that now XXXX to our notable last highlights is change made IP payments further million in our R&D I'll reflected results. prior because to R&D The to from guidance have quarter that costs that is other our call. later that We our projects. of have opt-in acquired to better example most year.

notable both our XX. second Slide our contribution HIV our on quarter oncology with from results, Moving and quarter to businesses. strong a was a This starting very

quarter. reflecting As up were year-over-year. in were the COVID substantially rates product hospitalization X% sales, Veklury, and sales lower sequentially expected, year-over-year, Veklury lower excluding Total the

If the as total impacted year-over-year by LOEs, impact hedges. the this excluding Foreign second the HIV impact sales, underlying was as $XX quarter in Veklury, of growth XX% well of quarter. sales net we approximately exclude currency million

and to Johanna the you FX Back the half first Slide sales total X%. took Veklury the excluding first on gross for Non-GAAP XX. due payments, $XXX Non-GAAP Non-GAAP quarter to R&D growth SG&A activities, through there. increased For primarily as timing of was Acquired expenses activities, for XX%, and was operating margin reported X%. was investments quarter year-over-year, $X.X margin second XX.X% our X% following to including the results milestones the product of was XX marketing as was corporate higher IT R&D the and IP $XXX Dragonfly points R&D million, HIV half, and expenses, impact including primarily promotional the was excluding for was business. Dragonfly product and the grants. due up down billion, oncology the up year. reflecting for Non-GAAP increased XX% Also underlying revenue growth upfront acquired clinical the well $X.X IP our collaboration. results upfront development excluding the LOEs, our year-over-year, million Trodelvy higher due settlement investment and and of related Biktarvy-related to including billion, year-over-year, expenses, the basis as in royalty to this first in quarter, such for operating trial primarily primarily payment. drivers

the operating for was margin quarter. Excluding the payment, XX.X% non-GAAP Dragonfly

Moving was effective to the tax, XX.X%. rate our non‐GAAP second in tax quarter

was therapy, Trodelvy, note, XX, of growth $X.XX impacted the had compared half sales quarter with HCV. on last same Overall, the cell first hedges, earnings diluted $X.XX Slide non‐GAAP a by the per half share as total basis, first for well on represented $X.XX and product per net as Of strong XXXX, which half million, offset Dragonfly approximately share of the XXXX. a of to as royalty. compared $XXX across reflecting HIV, year, currency first payment, shown in by we the of headwinds Biktarvy‐related part period in with the post‐tax Our year, second

Moving year‐to‐date second to guidance Slide expectations reflect for full to are we sales results year including for XX, expectations our our and half, our our FX. the increasing

quarter. $XX.X $XX year, we we half, of initial rest product in February total revenues, expect billion. second to billion the for sales strong billion broader therapy and reflects strong product in sequential third For quarter, it the $XX.X the approximately in range our to and billion the million compared we in growth compared keeping of QX. to third the And expect modest experienced In impacting revenue $XXX cell we HIV, continued previous notably second therapy, in we first in This modestly performance HIV, higher expectations to incorporates total cell environment. our mind quarter now of to flat by compared the the very guidance also our $XX.X in the FX expect headwinds macro sales impact the to year-to-date, half, expect in the strength to in addition In growth the

Following demand the launch experienced we bolus second stabilize. we orders the to in of quarter, expect

with And to of the Veklury. $X $X.X to half approximately almost first revenue Moving billion, billion we're expectations increasing our year. the for

inventory no second expect from the in guidance the assumes hospitalization to quarter, we States significant that Following rates hospitalization continue sales rates. increase to and track levels. QX in sequentially our United Veklury in drawdown increase to Note

Veklury, compared we representing product $XX.X be $XX.X to X% total our to to expect of and $XX.X X% growth to billion of Excluding sales prior range billion, our year-over-year $XX to billion billion.

fees. and With will no as milestones from include we These margin year As the of IP product reported our have change, gross R&D, million expense change payments guidance earlier, moved R&D. of the no acquired R&D acquired with longer along be XX%. R&D to rest as P&L, non-GAAP payments. to this range upfront of XX% BD-related will XXXX to IP is opt-in full $XXX as there for described such

full expect percentage compared this the by a $X.X change, a billion. year new mid-single-digit increase to to expense now result XXXX baseline R&D we of of As

from acquired R&D including the reflects unchanged items, the of guidance largely year, remained and start XXXX. in expense R&D IP of previously recasting R&D only year Arcus, full reported the for this in expectations revision Our

acquired R&D. to Moving IP

during issuing we have reflect what IP What we'll for EPS We guidance full are here year-to-date did included with we this activity guidance year needed update any our acquired the quarterly and quarter, as similar to Dragonfly quarter. amounts. not to the the relevant the is deal R&D

$X.XX $XX by our For our basis, billion non-GAAP we from $X compared $X.XX grow earnings continued per GAAP range our now inflation, and for we expectations costs for to compared to be net XXXX. $XX.X expect losses previously, between SG&A result of share diluted share the investments. $X.XX SG&A, earnings to to organization a a compared $XX.X equity we with to full range and low income between to to a Similarly, billion higher expect previously. unrealized expect now $X.XX to our percentage expect billion $X.XX commercial expenses $X.XX, we operating as investment Altogether, single-digit from On and year to up per to primarily $X.XX billion $XX.X across reflecting strategic previously. to diluted

a guidance million As expectations reminder, included associated payment well as our reflects Dragonfly this which May, in EPS the previous upfront not $XXX with was our we and in as guidance revised FX announced collaboration the in operating expenses for to the announce guidance licensing second of that half. or the third course business does related additional we The upfront normal or might fourth payments share today not deals include partnerships quarters.

any update to closed in reflect transactions development needed our the new business As we quarter. the guidance of impact to continue will discussed prior as previously,

pleased level payments. can have billion Q&A. of we $XXX no open that to the our we $X In XX, we including With returned the of $X.X capital to share repaid this shareholders, the the prior of I'll is the repay to the dividend July Finally, quarter, X, million almost returned to you after our I'm we Immunomedics close billion that, change debt quarter, $X to of And just billion to on acquisition. operator commitment there priorities. invite to year. the Slide fulfilling see debt, were allocation same as debt at in

Operator

RBC Abrahams from Capital. comes first of with Brian the question line [Operator Our Instructions]

Brian Abrahams

to the discussions talk things to HR-positive/HERX-negative with you on about if I perspective. that ongoing. the subpopulations key that towards the But broadly gear there Trodelvy the expect commercial from quarter. population labeling if a you'll either regards Congratulations you certain in on recognize are or can around I'm data might be and focusing speaking, are just wondering,

Merdad Parsey

guess I'll with Merdad. that. is start I Brian, this

our the forward as For with us I with discussions the trial. those we how as on, over we forward. the in we see I study, will think data think our time, continue right focus use now, evolve go And course, as we we'll of go that evolution regulators of OS

subpopulations, part additional course, of that you. terms of on therapy, and eye line in of prior of at consistent an the the or we've original things of analysis. all But or which terms -- of duration shown whether shared number subpopulations we'll of with keep In we've and were with those what those sorts it's a of already were it's data presented ASCO therapy

will we've be it what already consistent So with shown.

Operator

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

Geoffrey Meacham

driven quarter, guys label? meaningfully? trying mean, demand of total market overall or I'm cell it by is figure therapy for the therapy. you huge reimbursement reached mostly I'm out point think sustainable? I second-line do Johanna the in curious the much end you a out called cell did was the new Or had to a Christi, tipping which guess whether segment we just how access expand I

Daniel O'Day

Geoff. over to you, Thanks, Christi, please.

Christi Shaw

question. Thanks, the I'll with second start Yes. Geoff, for reimbursement. the piece,

really Our good. is reimbursement

less access, group. that's for Medicare XX% have the have second-line quarter, one and across and Even paid commercial. Medicaid, XX% three we in had with than We already launch, already the we --

second-line that line. are are that stem your your referred in seen the of terms to to uptake, of first question, are first transplant we've Yescarta. instead due the point is seen the that cell transplants launch since We've the of for ones patients reimburse that getting going second So uptake primarily

So our both. initial that is

year this But of expect we dependent half what a community. and had expect forward to bolus, on normalize growth we So do we from XX% the quarter-over-quarter. rates going that the historical that to the referrals this is XX% growth, believe we the more growth as that that is we've -- becomes second expect year-over-year

patients of do rest really in expect second in the the that the believe that good we the exist the be we growth, line for and a it So a ADCs of to year. still is this but bolus

will growth Just to return growth to that reiterate that, historic more rates.

Operator

Our Buren Cowen. Tyler question comes next from Van with

Tyler Van Buren

guys Biktarvy Can you please on significant the the life? and the impact and have product latest provide HIV patent potential regarding longer could sales drug concentration of business Gilead's pricing in to reform given your particular that its thoughts perhaps

Daniel O'Day

patients. patient as an and industry, issue the as company, important Tyler. Thanks, U.S., everybody of And the it's costs. very an very think This is current Dan. part particular, that is I think in start. legislation dangerous on fundamental of think terms the Yes. of potentially a -- the in short I reducing the mean really I I that. reducing which different are on call note proposal focused in the a is to out-of-pocket do a innovation. mean, there for precedent real we, are of upon Unfortunately, to lots making ways I'll impact And forward negotiation falls I

impact to know, very full think of discussion -- as I impact. much of several first Tyler, it's some bill costs. our very all, the area is, have in and still out-of-pocket difficult D from of years business first reform, that the could in terms it's how away, Part on impact. say And also of the you patient the now, right would determine What is course, the in I help but

it and its how I could that is think aspect think about negotiation still, think, premature think when terms exactly decade to one the of in the bill, it's affect, in about impact. the of starts to later I too

let's patient-oriented I we'll tremendous be things on So clarity actively portfolio going the supporting our more And think, even see the overall, mean what benefits months, we'll able step you new we emphasize impact a have legislation, that might of the I would just we strong. and Washington. here pipeline. program. over and are of time, the one happens to coming current out -- think But the in first then where it weeks to on business. discussions give goes to our strength we that once is innovations how the and what see with are in adjustments Rest I at involved take assured coming

beyond. cycle think very in is Gilead I and at business innovation the HIV We growth have And continued sound. our

Operator

comes question Fitzgerald. Our Brayer next Olivia from with Cantor

Olivia Brayer

Are guys you're you guidance from of the monkeypox the seeing this at into second impact a headwind point for HIV Is half any year? business? that factoring on

Johanna Mercier

Sure, Olivia. It's Johanna.

one that take me Let on.

number actually our Speaking the of the also the our prevention but men. percentage there with business the is rising general And seen they a because both with with treatment of of have across HIV men are a monkeypox sex are in that with lot having higher Europe, percentage, experiencing specialists monkeypox. but folks correlation obviously U.S. also

overlap. that's obviously, the so And

association. of are our business. that seeing impact and we're So and coming not seeing on diagnosis the HIV in more close an screening that light because actually to We're contrary, in, of that

-- puzzle important and So the prevention to think a monkeypox try are do prevent people piece actually really to same and the in. of The treating. I is with piece forward moving the getting vaccines

positive what do trying business on and we're that's right how So the now. HIV definitely to that, our can more ever of front support we

Operator

from comes question with Evercore. next Raffat Umer Our

Umer Raffat

question a on clarification. a had I

question. First, maybe the

whether are will viral I early implied on ECXX well benefit with And say expecting data. on ARC-X discussing but trough. you you load because I'm data Phase slides above TIGIT much how clarification oral if quarter any today's saw -- C you then data as curious you think, Phase Remdesivir data or FDA. as in Merdad, we're the the only was tracks PFS -- ECXX hinted, slides be second X last half, PFS X the the

clarify data PFS could be part if update. there's of you chance the if maybe could So still a

Merdad Parsey

the Yes. Thanks questions. for

the as study in far as for volunteers. X is goes, program oral So Phase COVID-XX healthy the new

far expect don't other from I that in tolerability that see we can trial say gone and so well than safety standpoint. things And very with think a an is both So anything PK all and I to exposure have study.

So we'll now proof-of-concept we're where we with clinical and very And into are. move the development stage. happy

-- guess the data no don't ARC-X think And overreading. data, then So in load I I to of would viral share. not suggest I terms

not later the out, will on will we working sharing But and data data to be and with have. really with data are data show now. data right we ARC-X are We study year. that -- will what this like the that going be We're as will this detailing assured those them later we look we'll work year and the Arcus, Arcus, sharing from be to roll data we

Operator

with question next Matthew from comes Morgan Stanley. Harrison Our

Matthew Harrison

demand hoping just little a in could about U.S. talk was Trodelvy bit the I you

of you've there a that sequential mostly here. need reflection the quarters Is last that growth label Or you factors there are significantly growth? and triple-negative that in a expansion couple from market other slowed standpoint? growth Sort of pretty sequentially, over has penetrated most the of

Johanna Mercier

Matthew. Johanna. Thanks, It's

a you context. to me little give more bit Let try

some Europe, from Trodelvy you referring but also in of the across as board. namely So really lot growth for strong Germany, had real from sure a A you're increase global as on. growth, been we early a awareness and standpoint, there's a France we where of to that launches the learnings making saw market to, that comes bolus as of bit

We we growth about saw Unfortunately, strong at And see actually did standpoint, it dynamics. got impacted it a demand so from onetime X%. quarter-over-quarter. unfavorable U.S. by pricing

that's our Trodelvy. you actually so we are definitely in see end do a the from And up where haven't concerns revenues No momentum see we X%. maximized standpoint, and share our opportunity net because only the on continuing

having cancer really last Let shut But that said four our the data awareness. awareness over this down me the and survival is real to tell data the that's we've little shown and patient piece. months to the offices that, there's us population, opportunity we've expanded with era down. overall were got tracking quite think in you, really COVID footprint. slowed overall quite that that the picked through something up because That's that nicely incredible I a and increase survival centers three educate and a only for closely We been just

to you close as footprint of As tripled time recall, April-May may frame. our we

seeing as shouldn't from as and start HTA or as as you've expect have come those through come first additional should would but takes I love month. shouldn't months usually results it, we seen the in those that through decisions and as in well launching countries through, fall the getting so about of see some reimbursement well. results, Europe six you to you're you obviously, that, know, when do Now expect you not It -- the within you

to opportunity that opportunity. sure make and to we track on definitely more that, So but capture forward definitely ahead looking

Operator

Our next SVB David Securities. question comes of Risinger from

David Risinger

Congrats on the results.

on net are to for a drug molecule you the comment from percentage could Medicare we law, that which but controls possibility more potential legislation be price of Biktarvy XXXX? of revenue against Part small unfortunate in light sense obviously into government be may currently in in the innovation we particular, broadly. situation in just have could the the that the working So exposure D, in comes so signed Biktarvy innovation And

Daniel O'Day

Do you Dave. to Johanna? want Thanks, with that, start

Johanna Mercier

Yes.

start with me Let that.

So your thanks, David, for question.

about we on a XX% the commercial. XX%, different that, commercial a Having think split touched pieces, I it's of impact. around some versus the about depending at on government to, potential said business, guess, bit you're from a little I looking around -- XX%

well of that your kind kind that's playing I'm and that out Medicaid/Medicare as of So what as -- your including XXXB. your -- in business, more is what's to

think it's the the of think you don't should I looking business. -- it I at at more So -- percentage look really just

forward. business diversity will close in probably looking we But and nothing of our I see also some help all be really going really the that incredible to quite geographical think is total look diversity to and which also go you that government the when plays from impact would we're the plays I XX% really out at growing going because portfolio our setting. these as pressures as of interesting are it's some of us how to mitigate time. well, think to suggest year-on-year government this out I it's just it is for a we business,

Operator

Sachs. with Our next Goldman question Salveen comes from Richter

Salveen Richter

year-end? could programs? you give pre-pandemic and you'd and On with the on below keeping a diagnosis you quick what's separately, HIV, where just a screening whether us [long-acting] on could expect update stand full And by you comment levels recovery

Johanna Mercier

you of What's the last part? Can the that last part repeat question?

Salveen Richter

stand long-acting when see with the you we Where programs positive might data?

Johanna Mercier

Yes. Thanks.

out You little Apologies. bit. cut a

the then the for So me Merdad it part over to that question, first throw long-acting. and I'll let get of

very standpoint, of pre-pandemic what line pre-XXXX. seeing screening in HIV From so much an kind were standpoint, from about is we're X% a diagnosis with where you're So we below levels, past, diagnosis or the about XX% so that's but COVID-XX, in XX% the decline seen rate normal. a of to year-over-year. prior below that of pre-pandemic, seeing even we've What kind we're

your years, And you think about XX%. that's so about three if

a market news, So from -- from good is above thinking What to this not levels HIV evolution. on, standpoint. about growth focus PrEP market you its treatment surprise is are and a though, there the you're right, I standpoint, we huge pre-pandemic fact like that a and how would as

confident it's we actually, And market so than in actually recovered. And been more recovered. ever the before. than has it's very It's feel PrEP, that higher

the an of it's actually market. expansion So

time treatment. I a think of honestly good that is in patients. QX, is for taken it's and great So think can But really I little it more news bit for much we're very better in which shape, place, as a I say

Merdad Parsey

wood, efforts highly started. And a end PDUFA approval, remember After lenacapavir, we be the that from treatment experience, and just then knock that the the long-acting in of the reiterate multiple at that, with have lenacapavir ongoing. standpoint, think I for date think us for first year I'd will gets I

through for And coming efforts. long-acting. have you partner own that pipeline -- have subcutaneous purpose are have a PrEP few years little there, we We're have studies. would there, years, molecules we as number are And then that lenacapavir we there, underway. that well we studies for on lenacapavir. the on studies, a work treatment the of Merck so are are with out. longer studies our prevention longer-term bit are a our because shots as with least islatravir. a long-acting regimen they'll those include And potential they're full couple we number take And we lenacapavir treatment a to -- for on at read noticed could continue that at we have combinations may be of Those with side, the goal looking On the to side, both partnered of oral

a So we'll lot of as and work you options along, a And further lot of different progress keep ongoing. that's updated. those

Operator

comes Michael Our next from question with Jefferies. Yee

Michael Yee

any would was write-downs just And have was And question parts. this? don't soon potential us, hear you if further there? opportunity. not the One is to that Or back at I if filing? But FDA it met you've the On different what's maybe Trodelvy, a you so Andy there. case. could how be the holdup be cancer write-down to two remind on or And then a actually but filed, that soon be already on lung taken think comment I there'll think with maybe Merdad, scenario

know EGS as think there you lung X I be would well. and cancer Phase in I say year, read slide, year next in that data your next out

understand just lung that to wanted and your confidence cancer. in So level

Merdad Parsey

questions. the Thanks, Michael. Thanks for

go think discussions yes, agency. the said that and filing. to to continue on we optimistic cautiously go with for I forward, we'll continue them potential course. are discuss So the things think in TROPiCS-XX has about with changed we update We're excited we should well, to will in if be that, generate having in ongoing And from able I and that data Trodelvy, we be what the nothing that able to you are earlier due

think actually earlier that lung, we're our primary generated X out. we'll Phase that But the then address of studies Phase some reading with referenced in be the additional In will data -- trials Merck to terms initiation doing, do of the the you focus in trials is Andy, on write-downs? lung be us be I over of those that the time. some should coming the for And have want it's in combination be focus lung. X other we will combinations I or Whether will line maybe, that

Andrew Dickinson

the thanks I'd Sure. Yes, Michael, happy. for be question.

the looked took forward. we at write-down we recall, earlier you the took to path conservative we this as potential year As that a approach

sheet on in to had the lung on we as continue we will progress quarterly cancer and breast hormone-receptor-positive/HERX-negative the know. historically R&D, have basis cancer, IP program which and you We value monitor as a and on the both of we as in should caring both balance

confident monitor discussions program where at our as discussions with And you. as it update like the that regulatory is we the FDA or program the major you going, we'll value. event, remain approvals, soon regulatory continue over it's overall, whether in we'll or and we time. Thank filings each to we'll and agencies. Again, potential on So can other look

Operator

Our Seedhouse James. from Raymond comes next Steve with question

Steven Seedhouse

or strong of opportunity second potential the on up those just for line outpatients here one opportunities, you're sort and view versus another ZUMA-XX of how if I high-risk, about legs some the similar upcoming peak was you had overall I could size wondering how the Yescarta second populations first-line opportunity and thinking be or given in just the line launch. market -XX and Yescarta?

Daniel O'Day

Christi, over Thanks. Great. to you.

Christi Shaw

for more seeing only Steve. importantly, is the great used, It's patients we're really now. right you news grow. the being class Thank for but question, Not Yescarta

second-line use survival, therapy receiving product data patients of Yescarta overall of April. the And the X XX means at X-year you our ZUMA-X Also So the cell really in Category are. impetus of line. was NCCN ASH growing, was really therapy, only second guidelines, ZUMA-X two out being that for all which that data -- second-line NCCN more X-year the the of the that of for instead cell ZUMA -- data saw approved with overall is approval

curative is So this to momentum safer starting we grave do in that is happen, disease physicians only have that see this where it potential patients. the

risk Vanderbilt. the outpatient their we're that with regulatory authorities trials. get we treatment as negotiations setting, So authorized define data frontline outpatient which Yescarta centers as at And patients closer on through utilization now the on clinical trying this of are our for trial. in we to the the we're look to have And exactly we in setting, that we very the also some look setting, already high doing we're to future, in how optimistic right i.e. of published do

authorized pent-up who centers, stem believe, continue. I'll bolus, the to will realize treatment that -- we're transplant. with though, treating this So that the second-line curative starting This will in patients. cell is I are immune I of reiterate bolus I potential a this think what we the finally of therapy this I say, said this before. do And is for demand launch think [HCC] patients to

heavy is the lifting over. So

do ensure We the to centers community timely in have a to a physicians patients lot referring treatment to of work educate fashion. they're to at that

work education, have as do in -- we also countries launch we that's multiple globe. and included community to in across the in the So do and the

see So next steady we come. continuing quarters growth a to for the do and years

Operator

comes Barclays. Our question with from Gould next Carter

Carter Gould

one guess I clarification. question, one

weighted think about to guess the year? And sort in to First of of out supply could of business, extent sort manufacturing the that year-end? you about I might don't Medicare I manufacturing also CAR phasing really of this just the on we that, that. hear And side the XX% sort T the can ramp the Johanna, on comments the that just you talk on the a of EU answering much if help clarification Should of we incoming been on getting there? But that. It's out, lot for government could side, spell sort then Medicaid versus on guess, address Biktarvy. on piece, appreciate you I the

Daniel O'Day

start Great. the…. you to Christi, move do want to then and we'll

Christi Shaw

to. Happy

But proud things one we're consistently, all do the of EU, to for well. particularly of they're Segundo, Amsterdam into to supplying probably as is Yescarta, the that and in started So to the now our starting supply Europe of your standards. reliably ability with El And both California. is Tecartus point, patients high-quality

of we the expect all year. so of European move end for site to to patients by And this the the Amsterdam manufacturing

In first just opened we'll addition, we site, which time is the automation. the Maryland have actually

site to Maryland allowed has increase one of patients that our us running and in One is by And of of modules our for up slots that XX%. -- -- two actually had number automation Maryland. of

that provide very vector I'll we what ensure of we that about that in at ramp-up years have supply future we what we the and confident capacity can today, Oceanside, X.X, decision last future made continue for ago So in we high-quality to but and only not the have we a feel patients California. supply the have plenty The on piece to have viral for standards. three say bring to is we

you vector of and ups of the at whim supply. not if we're downs, So will, viral

So can not to disrupted. keep we and have both ensure ability for patients internal we and that external be that continuity

Daniel O'Day

to you, Over Christi. Thanks, Johanna.

Johanna Mercier

Yes. Thanks.

the allowing by not bit Carter, all maybe we I but of So we're talking opportunity, numbers thanks on me get about. government, be what little a clarify, insight for just and to numbers might the those gave reform you to reform full think this impacted more and give obviously, the question. or that

And it's less so Medicaid total than from XX% our of standpoint, business. a

later add? potential impact. want did in so about this you And on we And really Dan, anytime really happen what that decade. focus as impact It's again, think should doesn't that's for to soon. we

Daniel O'Day

I'll of I there's here, a lot moving Thanks, of things. know Carter. add. to a kind of I so just reinforce couple just want parts

a to catastrophic three it half there know, are occurs D in reform. the of XX% mean here, phase. the I potentially goes difference is, from It aspects [decade]. today, course, of you is in second phase, major As And of the the instead in the bill. Part XX% different of one what catastrophic

I quite manageable. think we our as something -- at from business look our perspective, that is

negotiations. There's exposure The the I low second thing to. have X want a is we to negotiation. inflation I on one which be And third think rebate, is just lot it of not would to moving And then clear parts of government affect government negotiation. point, and a contracted is already Johanna's the does business. the to the business here. of entirety Much under

associated how about decade. be most really so passed and there's discussions that. of measure think lot And sure be find and the legislation later bit a extraordinarily this when. compressed of -- And in And It impact. products details also this it's that ambiguity to about I what's that a quite companies difficult and the I'm with you'll there'll with should

got do underlying as also and here I much to the for as I these right the impacts this very robust again, term at that short business believe stage. that is believe industry, So this a not not we've thing are

to just So, yes. that's... on be that XX% And clear, figure

Johanna Mercier

Medicaid. Medicare,

Daniel O'Day

Sorry?

Johanna Mercier

Medicaid, Medicare.

Daniel O'Day

Right.

Jacquie Ross

we minutes. couple have Andrea, a still of

one please. Andrea question will So we take last

Operator

question last Wells with comes Our Mohit Fargo. Bansal from

Mohit Bansal

COVID little can the PrEP talk So maybe, in market. about bit a you Johanna, if trends

of decline market I So you price a years, of to last maintain share. bit just took know couple little

pricing? do the stabilized stand share in Has of Truvada point? where versus stand where market the this on So this market And Descovy this you at it at does point?

Johanna Mercier

Sure.

about market from so right for point we've incredible basically lost share PrEP, generic generics. -- about pretty a at X% Mohit. over all in a we're think The is you we -- or of maybe So basically let think facing. pretty than the that There's less new year, Truvada as been I if standpoint, one, share market is of Descovy entrants The about marketplace. think you now much that so market balance last competition the take think we XX% aptitude if me about you share which but that the Truvada, in

the in people because we Descovy a And it's risk at trying we what now. past PrEP pricing something. there's stabilized, ensure are physicians are choice you when were than higher really to is So -- the need for well just doing standpoint, although the that -- The genericization. really a choice Descovy what Truvada of has from as referring to, as a mix rebates were it for definitely

make want option that we and we an that so think best renal you that's profile the about marketplace to and for And -- that on bone can sure Descovy if offer. have the them with sure making the safety

why we've specifically commercial been in playing come So on the really the field, bit it's that's fund, rebate why on that front. more -- put that's it's a of pressure and little

growth good is a to so And leveraging new that's negotiations, market playing also out. shape. XXXX. think as in the And come I for that's but prevention we go year so as stabilizing, year XXXX, every incredible enter been into we more But for we're we're

in very positive prevention for at risk. people Descovy as are So all as for the things things well

Daniel O'Day

Great.

want quarter So today. thanks a I you I really reinforce would was say, thank team and so just joining significant momentum, what thank this much for to our strong again. I just business. to for the in want

You on and delivering where for the this stand saw comments. it our I'll of closing We're both that, and Jacquie where right we committed quarter quarter first turn commercial excited really quarter heading. to about over quarter. to side now or With pipeline on second some we're after execution the

Jacquie Ross

free look progress throughout for in Relations feel We continued the your today. you thank you. quarter. follow-up to have you year. if Please and Gilead any questions to reach Thanks, our Dan, and all do us you the out on Investor on updating interest to Thank forward appreciate joining

Operator

call. conference today's concludes That

bye. may Good You disconnect. now

Gilead Sciences (GILD) 2 Aug 222022 Q2 Earnings call transcript