GILD - Earnings call transcript Q2 2018

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

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Gilead Sciences Second Quarter 2018 Earnings Conference Call. My name is Candice and I'll be your conference operator today. At this time all participants are in listen-only mode, and as a reminder this conference call is being recorded. I would now like to turn the call over to Sung Lee, Vice President of Investor Relations. Please go ahead.

Sung Lee

good and Candice, you, afternoon, everyone. Thank

and market regarding our after the the quarter press Investor close available of earnings earnings today, releases press second releases The XXXX. Gilead two Relations issued of slides CEO on for on are we results Just detailed the John website. section and Milligan

product show Executive speakers will Robin President; Chief the McHutchison, change and sales John Officer Washington, products release. press the on grouped that notice Milligan, better to and HIV Financial product you Development. and now be President The Scientific You understand Officer; Head Vice and of Previously, Executive together Chief and Chief Chief HBV Vice sales. alone so today's antiviral the Executive Cheng, under will Officer; John in HIV this how we We President we can present Research call and of Andrew category. and Officer Medical performance

uncertainties our recent me products, product Before statements, the actual expectations press that involves to respect begin these be releases. of remind from and with risks our assumptions, could be beyond found all including cause can risks certain financial and statements. A and plans comments, projections forward-looking SEC capital, latest will we with use results documents candidates, and making we disclosure which control that and you prepared of materially differ of to are these description in our let

company's well help are the any financial the underlying the over will the GAAP will press statements provided during Non-GAAP now made website. I not on understand measures performance. reconciliations turn does release call forward-looking earnings non-GAAP The undertake to this used Gilead obligation as Gilead in to John. business to addition, any as update to In be call. you

John F. Milligan, PhD

and you, Sung, everyone. afternoon, Thank good

the been to future, an release, it entire the from for good here a of career company honor saw and It's my over our now press and agreed Gilead the at time that board a to the down professional the solid I'll footing end to reigns turn new and this leader. CEO stepping I for departing work have is year. on is you be As as

seen from the results the You've strong quarter. second

numbers, and in tremendous Gilead progress I these believe When Beyond CEO were we the behalf position a stepped is I'm number of role with pleased I into wanted strength. on very the a the have to there company things of of accomplish I of made.

well-deserved working a pipeline industry-leading well different to what decades, of will faith have and does our three mission change the inflammation also move transactions further on external strengthen and continue and of internal that our this or to I'm cell Board We I full and in and for support the of years, as late-stage NASH. and the company forward partnerships our and proud extremely I'm unrelenting new opportunities. not execute as direction our while and and therapy for We've fast growing HIV to looking and nearly a program me accomplished, will franchise pace been at many has of and a with Directors want emphasize company business. pursue that programs to we strategic pipeline this break and

conduct new a growth. the until chance will end to the its As role for search CEO board our to Gilead lead its next staying my a I the press release has described, in wave while of into be of year

at results the hand, the business past over and would So great to from let's I this call quarter turn like Robin. to the get now to

Robin L. Washington

everyone. afternoon, good and John, you, Thank

I I've a quarter, contributions the Personally, well commitment support, appreciated John to Gilead the in provide and I'd Before future moment and like thank take over endeavors. on many leadership, years. your you to to for wish your I an friendship, update his

$X.X to will comments by review a settlement stabilization HIV which product I'll performance. This of very $X.XX sales of strong quarter updates performance the business effective a and to the the quarter year-over-year XX% the results HIV the billion, regimen HCV factors. The $X.X share for Non-GAAP per continued $X.XX Biktarvy quarter for in financial strong rate We was due following of pipeline. Starting portfolio, due the for on examination the was increase of led our to tax non-GAAP year-over-year same non-GAAP and contribution earnings primarily revenues billion uptake launch. share and with were about the revenue per period Andrew billion the benefited our our XX% tax quarter a share the commercial with to XX.X%. earnings quarter, Yescarta make HIV, very for increase from U.S. Sequentially an second for and up for McHutchison sequentially. provide the per few will the of quarter Turning the franchise last of contributed delivered the primarily earnings from with with further and Total second results share Descovy-based and a the $X.X progress were of per a then diluted of $X.XX. compares in year. John and

first observed the $XXX recur quarter. which First, million in for the draw-down second than in quarter, accounted seasonal not and U.S. did inventory more the

of mix XX% rapid Second, We private second by segments. second the is benefited between this U.S. quarter. and quarter pay split pay Biktarvy the about the private in and XX% government, approximately And, in the that million. estimate was government typically approximately $XXX which equally second continued payer quarter uptake but third,

year-over-year continues the normalize anticipate growth sales to Descovy-based among regimen treatment switch business prescription million the during Biktarvy one Biktarvy's increase these to its community, including the single XX% updated risk, the include for risk-reduction U.S. The have current young came and the the and than These treatment-naïve We tablet the Truvada support came XX exited one HIV Biktarvy from as quarter on $XXX the statistics since Biktarvy strong increased Centers underlying total published from awareness full older trajectory, be risk switches. International with at we conversations non-branded XX% which with men extended came Drug revenue who dolutegravir. quarter the become percentage in growth quarter we Based advocacy regimen. who will prescriptions Genvoya and also educate from educational includes of for In at-risk as XX% ongoing will years. the branded overtake Administration to of in hope to year-over-year Descovy-based the indication strategies an history. U.S. XX% those these Genvoya Biktarvy commercial. growth, comprised containing the which launched will approximately infections recommended More successful for to demand most May patients to about In came for the balance two and we regimen Disease serve providers television for the Prevention. another guidelines prescription a Biktarvy launch treatment from individuals, the the number Also regimens campaigns, the this continued Of quarter. switches, the adolescents of in for XX% Gilead the over comprised estimated living was that across in adolescents. of The coming sex from PrEP a of earlier disease adults Journal Truvada HIV HIV regimens. February, organization, our grow initial week Gilead's regimens, XX,XXX Panel, destigmatize the the new reflects and PrEP men, patients XXX,XXX efforts Services youth a aged about Food reach was HIV to prevention in AIDS multi-tablet and in March, and of major anticipate Truvada Truvada highest regimens. U.S. strong this healthcare a delivering taking HIV campaigns, initiatives Society-USA U.S. efforts in that anti-retroviral with as of of program We end from for for Control them. became for approval to driver, with approximately those quarter. and to delivered this and the HIV their Medical as single two regimens. Association and first for and U.S. volume Health infections the of its in to with demonstrate particularly continue PrEP. now community's American XXXX, together agents XX Truvada PrEP To further for the the need HIV U.S., to unaware a Department new guidelines Human for added according In encouragement U.S. number at-risk individuals HIV Our use recommended and one

the Turning generics. Partially preference results approved robust strong the the XXXX continue the and sales the was U.S. nearly of EUX Biktarvy. of and take reimbursement switch countries. toward make the we driven and quarter. up to in in year HIV the June pricing expect of which and reflecting XX our collectively half our broadly, similar markets. in launched offset for half the European a the by XX% down The significant product for consecutive to are of for comprise immediately business first Europe availability remained prescription Europe, second performance Germany across half revenues number will of will contributions strong EU year-over-year now patients HIV in very the the our of to worldwide generics over year-over-year and HIV growth believe was regimen regimens in slightly physician regimens. HIV second revenues and Descovy-based and few Descovy-containing uptake market to of one revenue naïve were other for end Biktarvy can once deliver months. Biktarvy Genvoya to of The We achieved uptake the several patient year. fifth by the continued strong of These regimens due

QX, mix look QX the in our similar payer could Given we HIV to QX. experienced U.S. dynamic revenues

Europe schedules compared to due could quarter to impact is impact on also there seasonal QX. note in countries holiday various revenues a QX in it important Additionally that typically third revenues is our that to

also in We see European countries. certain to generics impact expect from additional some

into All of these guidance. assumptions have been factored our

were year-over-year and down X% Turning the for down quarter XX% billion, second sequentially. HCV, to $X sales product

the more quarter. As further to steady we starts reflected of stabilization anticipated, decline and Patient and continues performance is a expect be slow sequential for the we moving predictable, in seeing still which our market, forward. are

in HCV that revenues is the forward, market declining rates. is going will contribute to and belief durable our a meaningful way Our at albeit

the will for segments daily to geographies focus We increased share single-tablet promotional pan-fibrotic, market pan-genotypic, behind Epclusa, efforts and continue and once market our across compete with regimen.

of best and Turning performance with million, their delivered $XXX ever to quarterly respectively. cardiovascular and Ranexa Letairis products, million sales $XXX

Letairis will to of in near As Letairis a reminder, we second and agent the month for sales expect ambrisentan, end expire impact this the U.S. the half patent of our the active the this year. in

sales million. Moving of $XX to therapy, on were cell Yescarta

We to healthcare by response life-saving from and the provider encouraged patient be Yescarta. communities of the for potential continue the

approximately the the in completed patients Yescarta-eligible centers authorization cancer United have States. We more which XX% of the than of XX cover

While therapy and connect how focus we additional Furthermore, to are continue to cancer working work treatment. with on to oncologists to we now they turns patient can flows. appropriate patients our cell educating centers community for their authorizing centers enhance centers, about

in expectations. Yescarta United at insurance of commercial The PPS-exempt In treated mix centers. with payer by the access treated been States, with covered patients terms of the consistent or has were majority

We XXXX Centers to as rule-making announce that Medicare. to prospective more that on continue that EU, the establish the B month large upcoming Medicare large code opinion and October Services fiscal rates diffuse to or CHMP Marketing create is to therapy of positive for the a adults that expected patients. year Medicaid system refractory of to CMS primary better August to comments cell Application beginning with final for two the fiscal systemic Last DRG of relapsed in-patient announced access work in adopted payment a is X. We process rule reflective therapy. year provided value patients payment provides for the lymphoma part provide in-patient or & on of as for this a in lines B-cell the Yescarta after the year will lymphoma we the Authorization for treatment

launch Authorization France. Marketing and grant quarter and to the underway. plan centers efforts this to the by of of are preparations on We XXXX complete in launch for with year authorization more Commission European focused end the initial third than XX expect of EU the in the primarily our our We Germany

Voucher our in Now, turning purchase year, same a Review Non-GAAP of quarter, R&D investments million to the in up to were Priority the expenses. $XXX compared XX% to second for due period and primarily expenses second higher to last program. the year, quarter, up support $XXX of our primarily Kite. the compared therapy for business the acquisition growth period Non-GAAP were second to of the due X% cell to our SG&A same expenses following last million costs the quarter

Our the non-GAAP effective due lower was rate in quarter first to XX.X% compared this second of in to favorable quarter examination. rate XX.X% the a a second tax settlement the of was quarter The year. tax in

As lowering XX% in to effective to be our we a are range result tax this impact, year guidance of of favorable XX%. non-GAAP the full

Moving to our sheet. balance

As of June of billion we had cash investments. $XX.X XX, and

which of GAAP to the During consistent million results no increased second of payments been address cash prices our to six repurchased increases impact of and like rate, of months. we the found implement non-GAAP and progressing least of operating did have expectations, million before reiterating of in with share. on any non-GAAP from And for Also, billion adjustment EPS a of for our can U.S. billion. tax lowered. flow per earnings is to we tax plans so diluted be quarter, at I'd area $X.XX to $XXX on the the One products also has generated slide exception $X.XX share pricing. to in Details is XX year $X.XX $X.X $X.X range We presentation. dividends our do guidance with midyear to X.X full been $X.XX are closing, paid not stock including we and has effective per The our $XXX cash shares guidance of year the million.

competitive As have substantial increasingly in by discounts. responded providing market you payers HCV we the evolving, to with know,

grow our value system. that trough and Gilead believe for confident healthcare are can is which for on competitive In we continue We future. net XXXX is broader pricing the is delivering to we and patients closing, year that the in a

therapy future and in the growing areas of and inflammation our in equips Andrew. led sheet, our I strong momentum now us business and to emerging is long-term launch turn NASH which the HIV business, call over create future opportunities in the to invest increasing R&D healthy of in Our in a confidence balance cell U.S., supported Biktarvy by by the shareholder value. will to progress

Andrew Cheng, MD, PhD

Administration. trial with Among Descovy-based, a program. is had important analysis regimen the this inhibitor, largest health and treatment, resistance first data commercially It's by to the clinical timely help epidemic. seen further place Biktarvy data XX where venue cell on RNA Biktarvy microliter. the single-tablet prevention generated baseline to patients per see I the milliliter a at that we we Gilead's pooled the copies to conference consume become will Biktarvy available in I'd partner build The below Drug researchers, position. evaluated single-tablet Robin. field. in SYMTUZA to represents any protease count last who achieved Amsterdam the International emergent intend two has and This needs in the and like patients sustained and remaining baseline and world containing RNA virologic or AIDS taking to our the our on that demonstrate mill. you, leadership tablets both resistance than Conference the on context per Janssen some where across what copies HIV – a as this suppression Thank and previously unmet of an results evidence-based I'd cure, the some the highlights of an approval in presented known SYMTUZA exciting per week from also patients groups XX% that U.S. World than with of efficacy Amsterdam. more congratulate Food response week option among AIDS the XX as each HIV International CDX Conference, for XX lack summarize global how this week in presented provide sub with day. of provide and greater is AIDS like HIV sustain to issue fourth Conference analysis collaborative vision policymakers, of to XXX,XXX the we a advocates high treatment drive less weeks and no of XXX for HIV regimen the

For is are needs. to a in we resistance HIV, Phase life already living in GS-XXXX HIV this some resistant studded to nucleotide being forward inhibitor people who are sharing is study of on a the also with their novel nucleosides updates fact meet reverse we currently transcriptase and advancing in people look drug X future. trial molecules with living a and to

some results recognize in after days. potent for in dose have daily days and moved inhibitor once regimens pleased to or can single the clinic we volunteers for XX subcutaneous than therapeutically XX or concentrations than novel a for also living healthy of our similar dosing molecule active we update infection. inhibitor. share formulation Although subcutaneous be have data This the a even and our blood ever most HIV for is with we pre-clinical clinical formulation relevant single-tablet once-daily a the standard on impractical therapeutically Since into I'm capsid that levels HIV in anti-HIV lasting time, at people species. set inhibitor greater to the a GS-XXXX, capsid in have risk greater single current long-acting of recorded an convenience, results established that challenging animal that injection

States. infections, United collaboration In with could compelling data public from conference Our correlating to and a took by importance XXXX through week now are use daily the HIV to option the for PrEP in Control HIV conducted the for every use Gilead, Prevention and to as while in Truvada the people University, states underscore declines self-administered PrEP significant highest ongoing states important that in state-level declines in for to an an the We Truvada have Truvada effective new infection. of an week. stage with three for an infections. this that of the effective the at conference Disease and in reported of presented the goal infections health evidence showed adhere data Centers Prevention at new new of Emory subcutaneous PrEP new lowest analysis utilization states the decrease the is which months, – also HIV who product this center for regimens. number the oral be efforts These with provide of number increases can for XXXX intervention significant unable efforts

cure. our efforts. is certain immune GS-XXXX agonist investigational cure X cells. eliminating HIV that can In for are toll-like agent HIV remains to summary, investigational infected compound. studies agent Turning important deeply studies neutralizing our which Combination from antibody that One following cells. broadly anti-HIV spectrum an care completion A innovating leading committed kill activates to to prevention, each for the GS-XXXX, are receptor HIV planned and in of infected cells treatment, to envelope dose-ranging the second across is of Gilead

sex make infections. We Truvada progress of means with a are new continuing to HIV as in practices safer significant preventing with combination

medicines living people We of with regimens. single-tablet HIV, needs six including have available multiple the address to

for are in of We prevention new on cure pursuing could one lead working that to focused to address And a remaining discovery HIV. treatment. needs day remain and both research we

for to John to HIV people the now at a the threat to the We the call years in have like and of McHutchison. worldwide. been intend health to for I would of remain HIV as these is as efforts long over forefront leader many turn

John G. McHutchison, AO, MD

Andrew, everyone, for Thank and thank joining us today. you, you,

As we pipeline candidates you the are across of infection. patients HIV Andrew, with for care continuum heard advancing from

areas, additional minutes a and key from forward half, this second of in year, half the in also milestones cell to few are well therapeutic I'd as making look as progress accomplishments starting first We spend to highlighting with to therapy. the like other

need be regulatory steps manufacturing anticipate who manufacture Netherlands. anticipate in therapies people XXXX the cell by Yescarta turn-around cell European As shortening for worldwide leasing who taking new new will fully such of care. them, in potentially proximity we for to patients receive Europe, approval capacity this capabilities establish we're facility the a the with operational urgently manufacturing personalized to to the in closer facility to in therapy time therefore We geographic

X potential chemotherapy of range at comparing about in and of the could work a our ZUMA-X, cell All and excitement share second-line B-cell the stem lines future. therapies wider The Gilead with an complications. day us the large launch this therapy standard for that of about by to care Yescarta study having of autologous care and its of Yescarta Yescarta Kite both current done use patients spare cell successful, being cell with study concomitant new ongoing advance patients stem of one salvage lymphoma. to standard in often diffuse would treatment I'm of could difficulties enthusiastic of in to these particularly all help Phase the followed attendant receive support transplantation is If earlier transplant. and people from to patients or

we it partnerships rapidly that therapy, partnerships just respond malignancies and that As tumors. an the bring have tolerated, safer treat people acquired programs of investments And beginning. gained believe we through the we and make reality. hematological that efforts In acquisitions, to sooner. our therapy. a significant represents, forth Kite, even broader greater percentage an so but also pipeline technology of the with advance I we as augment initiated and months treat is that to Yescarta more treatment cellular patients becomes solid It's critical, can XX can also seven since have of or a better this range we the recent even

collaboration immunotherapies a focuses development receptors. a announced strategic gamma based we Lastly, Gadeta privately-held of on discovery cancer T company delta that the with and on novel cell

targeting broaden therapies solid tumor potentially unique and person cancers additional also capabilities quarter, to tumors. to in on and tumors. developing mutations effective and therapies for manufacturing, for Cooperative the announced particularly the of that found Agreement, realm cancer of of Neoantigens cells potential Research the patient-specific antitumor National the Development surface they Together, approach the CRADA, are types develop activity or adoptive more targeted solid these new Institute we including with Cancer and add research their the research to to each offering cell neoantigens. our tumor, During cell our in are collaborations

Moving to liver disease now.

If NDA on for selonsertib STELLAR which and showed Phase STELLAR fully first were these after Our believe of the first development X, with earlier the product severe capabilities a data two the to selonsertib, the also year, selonsertib we necessary expect approval enrolled from and approved to of position for Phase FX the or file with hepatitis FX combination this treatment perspective, bridging and patients could be we XXXX. cirrhosis, of in evaluating benefit X half inhibitor study X studies of and alcoholic this this ASKX timeline, should of in primary our market. fibrosis patients endpoint a be all ongoing be efficacy in or in is first with teams selonsertib positive, trial. the lack our discontinued the available a develop in Under to of NASH. building new From prednisolone X a are for commercial we the mortality, mid-XXXX. Separately, currently trials,

any have have to disease. functions patients for most that preserved clinical disease very who alcoholic severe NASH dysfunction they important it's NASH diseases. distinct two patients in of are is different Patients high and in decompensated advanced hepatitis from therapy. with This completely severe compensated with XX-day independent hepatic general studies hepatitis with Now, a note have and alcoholic mortality, liver and and NASH

scientific year. later upcoming conference data this Additional shared at study the from be an will

Turning inflammation. to

achieved XX% and to of filgotinib results compared the of and improvement psoriatic signs for in arm study XX% potential also an These College as endpoint arthritis, significant that a a be on unmet Rheumatology by week medical The symptoms the to announced X there adults of to filgotinib Phase of XX primary of have assessed psoriatic need. for its In May, Galapagos EQUATOR our condition about enthusiastic in symptoms of is continue severe psoriatic score. the We with achieved effect high filgotinib. at arthritis the arm. which arthritis American response and indicated signs the improvement Gilead XX% placebo ACRXX moderate filgotinib has to

naive that the Phase futility XXX inadequate portion FINCH We are also In conventional patients an disease-modifying the biologic in a named announced Data X DMC added analysis rheumatoid ulcerative X into interim who Monitoring to filgotinib Committee Xb/X recommended that both independent filgotinib of have response biologic conducted drugs biologics. The study colitis proceed placebo in to X, study Phase each experience and SELECTION. or planned patients. as an planned arthritis compared three enrolled. antirheumatic X studies, fully had FINCH and X DMARD to the

We study from the year. expect results later this

know to each the at is study filgotinib from as as you which also currently an establishing ability dose being As file the is adequate database on the dependent drug MANTA safety NDA of our studied, for well data enrolling.

inadequate growing our the across months. therapy and I cell alone to XX-week combination focus, therapeutic a to the to methotrexate filgotinib excited the hard half from their pipeline next we first want data readouts this franchise, HCV XX business generate robust over within the a And take Gilead's alone methotrexate-naïve and year. of revenues, FINCH will also our In study the that methotrexate methotrexate, expect led had thank execution in comparing dynamics and employees plus comparing FINCH We multiple of filgotinib for year. to to stabilizing study half first by plus results of in work HIV John to methotrexate. plus in filgotinib randomized XX,XXX an X X, randomized summary, XX-week from nearly in about adalimumab to areas a response a opportunity performance and methotrexate patients and methotrexate are very alone incredible patients X next have Phase who

Operator? questions. call the open now Let's for

Operator

our Thank first comes from of Barclays. And question you. Meacham Geoff

now is line open. Your

Geoff Meacham

John, Hi, to work it's so with I Thanks much. say been want pleasure a Great. just you. real to

really missed in going You're be industry. the to

John F. Milligan, PhD

I that. thank Well, Geoff. you, appreciate

Geoff Meacham

payback I'm activist about letter. worried a little our from

John F. Milligan, PhD

to letters I to promise Barclays. write not any

Geoff Meacham

all you'll bet I miss sure. questions, the And I'm M&A

John F. Milligan, PhD

It's this. chance guys, pester one a call, my always miss really you'll years. this with is the you me. been will not I pleasure so work know, to to last You I and And have it more over enjoyed

Geoff Meacham

All right.

this say, hep XXXX? Gilead get it to backdrop, positive Or more the is a or to back growing, is of to C and is think maybe late trends either rapid So Do on at deployment stable, look look more is you or could in nice you Kite – time get platform. therapy aggressive? NASH? deals definitely year at when you happy be even just obviously, in HIV when thinking cell investments, I'm growth

John F. Milligan, PhD

overall a question, I message strategy. It's that very here confident mean, our is send we're out Geoff. trying today in we're that good the to

We our are transactions fair We're always think try we'll satisfied that. further and going we to with business, really continue can do where it's to very active at continue seeking to to we're to are. and be do faster, which looking I more, say very, to never

so we a team. development active business very have And

You'll things they coming the us slow has of us to go-ahead half The our today going not the see down, given the meet announcement year. to in many second if move is this these with fruition to transactions and board criteria.

forward. So the will satisfied in move is continue I'm satisfied, not we my confident to baseline. I team and know never and I'm

And so our that's message.

Geoff Meacham

you. Thank Okay.

Operator

Yee our you. question Jefferies. of comes Michael Thank And next from

now line is open. Your

Michael J. Yee

stuff echo all Oh, hey, thanks. our Good afternoon going the and us, all I think done with appreciation John. you've to and we're

Gilead should that could deal perhaps of you going I given so Is Thanks that ask, do is, either some change? uncertainty extent, a investors into do you in other you or different? Is think certainly And I so think areas? making? of that be strategy think next to do a terms that much. I into would guess What what period what new or leadership more think what would anticipate

John F. Milligan, PhD

You a know, Michael. good it's question,

my we're less new think time, of and start-up into been seen the other, to should who opportunities expertise, next scientific, into for grow, how NASH who people to or compete such products for really the the example, today, the market a somebody commercial a launched markets private background to I know brings for are who've If But us experience. company time history, long area, was and limited cap oncology people where I've as been I've my new have you in doing leader so here or a be billion company the I've pretty and $XXX about exposure, we think from my growth. lot I in

think we company and ideas, don't and leader I the who and and the will bring the looking for we patients serve. experiences forward from take baton a are me new one we who move will so history for it new previous And for have,

And somebody for that. I would like so look

Operator

Abrahams Thank our question from Brian next you. comes Markets. And Capital of RBC

Your is line now open.

Brian Abrahams

Thanks Hi. my on well and there congrats your John, quarter. you taking Congrats to accomplishments. on almost decades all for as my question. three And the

inventory have on the particularly out what, dual in HIV your Europe overall quarter? if of then any HIV the housekeeping in And from could saw as to coming revenues wondering On front, any just IAS, share? any, pricing, impact potentially expectations restocking front, on if market and/or Thanks. favorable impact regimens wondering just you this

Robin L. Washington

say, I'd Andrew last QX, QX, turn and I'll IAS, was and commensurate remained the with maybe demand-driven then and on No, Brian. in it start inventory the with stable, to question, right? consistent over inventory So demand. about between Wholesaler was to again, talk hand was QX performance days

Andrew Cheng, MD, PhD

the And XX from analysis. differences from we've all I the seen when understanding given methodological it's of of presentation, virologic the who remain were in of regimen, some have meeting resistance yesterday's coming I the patients a that in still out had failure may we at Brian, before look think the better results GEMINI Yeah, two-drug the that we and Andrew. seeing we're data Amsterdam think profile excluded interested week

dolutegravir the lamivudine, that of by and XX. JULUCA the highlighted two-drug the picture I long-term think some are data as is the when what profile recent interested development past about of resistance week regimens, looking we in for particular highlighted resistance we at think big in understanding

the the continuing to in in its focus regimen, on GEMINI world and to in studies. which one load work interested understand very two-drug be real are regimens how – limitations we'll potency viral So has especially clinical a

Operator

Leerink. Thank next from comes Porges you. And Geoffrey question our of

line now open. Your is

Geoffrey C. Porges

before. teach the you very And prepare to that the one next a the congratulations, prepared I'd path over how never a to I like Thanks resume six it's to help be to much. volunteer since echo John. months you've first

John F. Milligan, PhD

worry. to me set to daughter she's going My LinkedIn teach me Don't profile. up told how a

Geoffrey C. Porges

with stunning. It's full much and circle. very a come just look out that. really the guess it's much to HIV now and It business I but broader focused in portfolio. now through really forward product HIV really on started is I remarkable

the rate to or the so. about growth hear XXXX for you least business, So what sustainable is I'd HIV through comment at like

what sustainable combinations. going price You're thinking contribution the be over legacy about and rate both from TAF-based combinations of it that mix, fabulously in then this the doing the and transition to currently and well, for from to shift sort we how the growth forward? Biktarvy is and exactly should just occurs. for it's difficult the business But us volume, model

John F. Milligan, PhD

and XXXX, I as backbone see very don't the patients. the patients. great There and the of be will aren't large why across think We to treat mean all out treated in United under but TAF-based for expand be well mentioned opportunities Biktarvy very, we think choice can start XXXX. continue will United number the are with still We we that of think see this? a with product, we beyond the States will number a I patients you to areas Geoff, of treatment, regimens for who States. that be patients growing successful more we a who franchise the this simplification,

our we're long-acting progress mentioned, products. great making Andrew in As

States would of an us opportunity there's I We're seeing pharmaco-kinetic treated higher It for patients a think molecule. the treated significant choose who interesting very XXX,XXX the much to very, United we're a for a patients every-three-month by to in who beyond encouraged this segment the option. field very the aren't today is grow number. data

Robin range of And over extend to that. so great the and her for turn I'll thoughts. expand us it And I for to opportunities see

Robin L. Washington

to the And, covered XX% it's surge XX% relative U.S., I in seen, as said, continue LOEs. this and and development, with ability John even long-term our very Andrew new so through continuing in to go and innovation we're to grow products been it, very forth Descovy-based conversion with franchise as think very, to of you've EU and, new the John. good over confident Geoff, are you've the in team

HIV I we I at. to think stay is excel true will that'll Gilead, of always, innovation what and think,

Andrew Cheng, MD, PhD

And living Andrew. with one form XXX,XXX yet factor would Geoff, just HIV, that rate, its about growth add not therapy. to thinks only really know receiving when the they're any are Americans to XXX,XXX has that one I who of the anti-retroviral

for this its as about that. reasons I the we're many one of life But not very in are control, is there But anti-retroviral capsid is them oral work that, something highlighted, very, may given so for point. the HIV we therapies the and at without know, profile. excited And where progresses as so they are their

us In we adding addition, I to its well-tolerated closed think think Biktarvy just been therapeutic physicians that their well or as color for five inhibitors look for for resistance also years And enter Multiple that tablets drug than more we've seen. date of doctors really difference is the this daily with integrase to about institutions of institutions in Biktarvy, with has to haven't when no exceptions to create profile. we and Biktarvy, few open because as we've we've have a practices what compound. that interactions, seen once small – examples plus profile doors made we some unboosted at patients really how that Biktarvy that, seen seen we've that seen us with

Operator

Stanley. our And Matthew next you. from question comes Morgan Harrison of Thank

now is line open. Your

Matthew K. Harrison

Hey, great. afternoon. Good

their some did in I is that but congratulations to comment testing And John, maybe well-deserved there for lack if like on you break. can So ask they And the occurring? mutants method if employed they've key and to seeing you to as sort product-specific in a so. Andrew, that how differences a take I'd are were of luck you that in of sort your this could, good just of any may resistant resistance have you studies question, if studies? versus led

Andrew Cheng, MD, PhD

I good began It's when we very call resistant thank a very quite come Matthew, inhibitor into came the at analysis a it population, what down patients they've them require viral samples population. load so of one, to but discontinue for resistance they not rapidly. we suppressed – with analysis looking integrase We resistant think to X. be XX greater resistance technical put samples, week at for our And after you on to did So, we than question. anyone a with an

that second So get and we whether looked used the send a than we sample proceed then because greater had for at to analysis. come XX not – first to we'd would second in, confirmatory viral quantify they the them, off patient the load, or and sample

John F. Milligan, PhD

to rigorous is very say sure think resistance. make it's that analysis that I Andrew, really fair to a it's very, there no

Andrew Cheng, MD, PhD

John. Right, No.

you data and very Biktarvy. XX-week very in right, know, conference. resistance the scientific presenting we're profile comfortable close I that's think as upcoming think And with I we're strong of to

Operator

from you. Citi. Thank And Karnauskas our Robyn with question comes next

open. now is line Your

Robyn Karnauskas

a that it's you're how M&A. be to, think launch, you – adding market you again. sense you're what and how and with of data to people the thinking of the about from And you the you And with over NASH and as a market has what your you into around data since Do you're enough the for question, I about just lot pipeline is want what a can there's you Maybe it's think doctors in from the there see on thinking then else as to hearing what market John, the to have you drugs about you. have next drugs question said. on would out us Thank going and not taking learning development? pleasure gone year? evolve It's learning massive really I about well? is from you're want hiring I my of market oh, this its been a part because space? It's some echo developing? think to everyone Or the coming a And Thanks. guess it'll phase working NASH. would a now give other in

John F. Milligan, PhD

thought wasn't and for NASH Robyn, I'm words you, a that not thank market. those kind all, ever of First I sure

are will done we've work-around development digging. of the think diagnostic doctors, likely early into necessary the to kinds of market, establish the right a we the scores, different best NASH. trying across the the a think I be fibrosis we're launched really this as market lot medical tests first lot be to to because NASH, going doing the understanding of I into to is We've drug understand that to have populations, what area way get been

got we've of think good the I pretty a patients. So understanding

field the populations, big through us, market think good FX pretty a opportunities so think the FX pretty potential for the it we're have considerable differing I be area. We a that so understanding for to for and a I and of in confident has

in NASH. with to like You in innovate and have asked which any is enough that why our look we molecules? in we we'll why make things do for say feel never we continue or molecules we have to sense adjacent combination continue I to two HIV enough than portfolio M&A, in decades about would for more area,

So kind of relentless in area. that we're

Operator

our And Thank from question Evercore. next of you. comes Umer Raffat

is now line Your open.

Umer Raffat

you on Hi, One, guys. much there I things. is we Thanks X two NASH testicular so a focus my be studies, Thank an is much. to blinded from tox the ongoing aware sorts secondly, Phase that for there for basis then have interim of before the first? of final should And readouts, filgotinib on we learned taking wanted anything very question. studies? the ongoing

John G. McHutchison, AO, MD

Okay.

five in years. endpoint data of interim biopsy. in for the NASH, D&C, We X subpart all a course, that and looks interim there The of at the endpoint one no John is approval is H, I'll the continues the analysis. for Phase which terms do the regularly. The So analyses address the is speaking, week interim actually of – XX and have the is safety trials it's study analysis STELLAR

either obvious their of So in X we've change if and would terms risk/benefit in those change, any studies know signal Phase so far there recommendations safety not had to any that, the we was conduct. about of

terms the and comes evaluate study the pre-clinical to above believe the that as in. it abnormalities adequate something have enrolling the minor filgotinib and We safety our we in that data we're is beyond we're histological In address. models male and seeing it's we'll study, margin the of

Operator

Thank from Wells you, next Birchenough and comes our with Fargo. question Jim

open. Your now line is

Nick Abbott

Gadeta you adding or you as afternoon. CAR you a Good standalone as to here Nick over you're cell the to or will Is see additional you. for your this I going specific to candor the delta bi-specific, in have receptors deal It's Thank for John, Jim thanking my to very you gamma a T question that be your comments did that week. to, do sure in sort TCRs I'm product? concept relating transparency echo T Jim and and, or years. give of the an last

John F. Milligan, PhD

your that's name. a question. it Yeah, was caught great we Nick, I if think

individually that's approach answer on. both them and terms a and will So in to the explore is cell of to We be will advantages we hamartiological will into very short that a alphabeta both cells believe that complex allow TCR our it but believe so malignancy of initial we'll standalone. collaborate engineered T the of which is have initial very also that both, or all that data question solid the gamma that us constructed properties those program of the of

Operator

Nadeau from of Thank comes Phil question our & you. Company. Cowen next And

Your now line is open.

Philip Nadeau

be likely you payer that mix in the on What the program, to decision Good a afternoon. in Definitely HIV past. that's add the than going to year? the the in normal says X in Phase questions, that pipeline to played payer for HIV mix and Gilead that mentioned the my the the HCB. of revert and in likely Thanks. drove career different question. treatment a John, think you me briefly, and on would to an question a a pivotal go/no-go go entry the decision we're to back and some fantastic idea taking study. And of we're if and Two done. strides of part give a in – congratulations success let of KITE-XXX also of could have the Robin, the moving data just there's commercial, hurdle your what to a data I it half slides on job was Thanks in well first second in QX that half the big on my sneak pivotals? Can I what see us the is on year

John F. Milligan, PhD

Okay.

dose with program know X, is John, refractory Phil, about people I So Phase which talk in and in the KITE-XXX its first relapse myeloma. will installation, you as

other on see slides compared will we on where So right we that's the it, refractory of determine of from other we've whether we into will said then forward decision half products patients and the But and we exploring are Phase we data in now. a second data to the take in X relapsed value course. this similar BCMA data will the it myeloma, that's and out the with looks make year depending see how as in come

looking we from renal of have also as community people We impairment and have so low lot cohorts of at fragment we we have impairment, variable people Many is renal humanized about important. have as also that be a well, a with support the will single-chain with which these fully and registrational we'll have trial. activity see so where make we'll this year in a expressing well more is we targets data and the know moving Phase have BCMA you wait X decision on to that's to later as as the well

Operator

from our and you Thank comes - next question

Robin L. Washington

be payer In we commercial when was tilt you think about some equal, to always reimbursements it's remakes mix approximately quantified ADAPs, it, quarter-ends XX% if think that cautious fairly wanted of that's XX-XX, a just it to and HIV. me and after XX% what relative to about typically you government. typically just that I you're so QX operator, than sequential that think shifts into that sure regarding to asked mix slightly to and we've is we Phil that an larger be we much payer franchise past. government finish, U.S. estimating, that so the slight QX normally normalizes, between little could messaging it it's for but and we're the i.e., to what I that Overall, again, in but on mix a is factored always just we saw a Let specific want see question you typically be HIV It's seen growth really driven be more – our to it's based headwind there's mix address. there, year-on-year, Phil, mix robust simply if if half by for always think quarters, been one because a to the more relative I it's be back in, know, the come overall typically recall million. in consistent, in the very be about that you you transparent to but our about guidance slanted tough right, variability second growth of $XXX adjustment exact HIV And I and

Operator

Thank you and Piper of our Jaffray. next Van Tyler comes Buren from question

now is line open. Your

Tyler M. Van Buren

the to Hi, progress to therapy that the receiving so the I late? some provide good afternoon, pretty just and logistics opposed It guys and some I prior in improvements the and of get late. not as like center, question. have you to an like has as adequately on-demand sounds penetrated thanks. thanks things freezing for the debate And on of your beneficial product paying the taking you business and It the of a been to are the there's to curious know as been that sounds like, thoughts, ask whether upfront made or some over of question and want is made could cellular on having pay of that update some product so

Robin L. Washington

That was Jim?

John F. Milligan, PhD

Tyler.

Robin L. Washington

chime very start, Hi Yeah, Yescarta progress to overall but in. launch. Tyler, mean, relative think we maybe can of I the all are I we I'll our excited

on manufacturing confident I'd coverage. have to and our nice, I good we're slow that seen being good being in on our Our online. studies, turnaround about just and focused about consistent on to my sure this overall what has we steady And us what that generally really focused performance are flows and bringing been are launch. centers additional process say track with mentioned, on focused times. centers, talked talked you continuing so said improving ZUMA-X similar progress; remember we're patient very our centers the relative We're we've as commercial focused I our in remarks the we've to on a be reimbursement. making prepared excellent

issues to over very a very good it talk to the mentioned. some and good tracking about Maybe expectations. turn to overall launch John you relative other of I'll So

John F. Milligan, PhD

who process how more think of we greater have has exceptional I thinking and spend improved scientists efficacy, – product forth. and it an the time of don't so Tyler, can about lot so manufacturing safer a group active be the

specification as I'll ZUMA-X of said clinical are Robin as in not reiterate, in out lot mean I is we've what what a we So issues, practice just seen seeing and well et of we're cetera. having

collected of distance for if this. to terms that's really in need cells freezing be sent that's products shipped remote. to not So an be not can somebody and freezing products a or frozen long the and very issue Products

That frozen. would take day Our be additional do. an product to could

Andrew Cheng, MD, PhD

good will for quite That's is John, States our Perfect. the send we example, certainly in our not so patients of it's a but in, doing experience that. point, the them and for European it cells freeze bit have possible United we a and practice

patient about cells, that take that charge payment I we I the we them think on the on-demand, just reiterate those you manufacture cells. patient and to said something only if want we gets

interim, no example, to is for something then if the charge expires happens the in patient family. there So the

Operator

Kasimov JPMorgan. next our of from Thank Cory you. And question comes

Your line is now open.

Cory W. Kasimov

great for to add good me question, Hey, congratulations my Thanks let on afternoon, John also guys. taking run. a my

or setting the obviously specifically what to saw curious rates receipt launch. or changed experience CRS of neurotox been at I'm you appreciably real-world of trials. commercial in Want relative in follow although chemotherapy. the in seeing any in the that be And comments can whether have it's bridging about more different on based patients T to the Curious rates or the these of front, safety, on all the clinical for in up missed. color CAR you You'll on you're terms definitely very provide kind early

John G. McHutchison, AO, MD

asked Cory, advisory as development them here, a seeing Kite different board here this all whether it's specific we so docs actually of have this products the with I forth talking commercial there difference. John and and question McHutchison we scientific isn't were and they're and actually and were anything about our to

Operator

comes And next Blair & of question William you. Xu Thank Katherine Company. our from

now line open. is Your

Yu Katherine Xu

also the Hi, Gilead HCV congratulations well best you as to side. the good of quick I afternoon. at phase And very the on great for and on a career/life. question achievements next my all you John, to have

the sales where from I how international B going. been growth the the as grand come has just growing. on also you. is HBV Thank strategy in there? to China want and in what So understand front, boy, is that Gilead's launch And have

Robin L. Washington

question. the I'll take So maybe, Yeah. HCV Katherine,

was You we're know, Epclusa excited. in recently approved China.

and We've in the international also early Canada, U.S. think countries I as have well Europe country, to done sales fluctuations got in outside we there the think several it's ourselves possibilities those Asia in in similar while Japan, and are quarterly markets, from still and very there, country Australia, overall but as excited about we're we to what U.S. of to the days I Europe. continue establish

HCV pan more and you guidance, think predictability, and Epclusa, with to well which (XX:XX:XX) type be right, I think I with only as see, portfolio poised products So can regimen on is our product single-tablet out stability with track we're overall of there, pan-genotypic successful we're franchise. globally our the with our

John G. McHutchison, AO, MD

question, one the hepatitis just again, before Epclusa to and simplest said. John strategy to I answer as it's Robin, use. regimen from Katherine, B follow up the Yeah. It's Robin duration, is

a biopsy, don't genotype. a don't liver You need you need

there, of So the simpler. the as is far out the efficacy some of products others, as the know. in And same all it's terms you

So there's no compromise there.

terms of to think augment want for to able notes. We be I of we be want it's to In hepatitis attack replication, viral the specific and to strategy mechanisms able grand immunity. different B, similar HBV to your multiple

the also two the clinic. one stages in capsid, our molecule. One have in clinic. the programs new is the TLRX And is We in early that's other

TAF. one have with in Phase with tenofovir one – now and two trials, Bank SBXX XXXX X collaboration We Spring

both Vemlidy, with which any approved have bone you more course in We of have of programs is as at and many issues other also action axises. mechanisms or doesn't clinical than we looking know, those have XX kidneys, And free of countries. in

trying So it's and B we're largest of cure research around our people, world. many the hepatitis for one the millions to finite create with about of passionate internal many programs a people

Operator

final our of of comes Lynch. And America Huang of Ying Bank the line Thank you. question from Merrill

line Your now is open.

Ying Huang

questions. for Robin. taking for my maybe Thanks One Hi.

the before for until then a decent that FDA is. more until did filing but guidance to total you that year. you why wait that to of revenue enrollment trial half whole had very increase of QX increase for mean and in compared least you not we want complete year Thank to mentioned for NDA drill XQ, saw to McHutchison, can study filgotinib filgotinib? on next the And you finish wait UC application Does product the John actually secondly, the the safety in which won't for at for until you. the You down XXXX. first second sales for I half have maybe file

Robin L. Washington

Sure, Ying.

half I think to do call, cylinders. our when Again, well deliver the be franchise firing extremely different. second So all But with And we guidance we and again, on comfortable mentioned I on growth. HIV to reiterated dynamics positioned I'll I slightly start. it. the guidance, on It's as as about feel mentioned is call, our anticipate I very long-term think on

than have those payer new know, HIV we some purposes to that, may for that but of shift of we And mix as you more said dynamics, So kind then, did U.S. those from what for in other want very modeling some for understood you the occurs. ensure July, there's U.S., about I the components. anticipate nothing that end U.S. of do to the in But the have Letairis do the that, patent in we at so product there. are good generics things We which for normally expires impact

Turning steady generics starts. of as we to to additional as the do are And we expect HCV normal related Europe well patient countries. available, Europe, few become quarter HIV the have also our impacts available decline and we franchise. in them both holidays, our slow, seasonality third HCV and a in to have that summer And

we of because and a our at growth guidance that revenue I about that do want growth and still healthy we to very, very emphasize year continue our So prescription year-on-year the beginning expect U.S. factors those HIV talked but on to remain. basis reiterating robust, that all be we're the

John G. McHutchison, AO, MD

obviously time, of can. points. Ying, expeditiously me for let make question we the filgotinib filing terms in second But of as three just part file as we'll the the

and from Phase that be three randomized efficacy all, to of data has safety trials First supportive. we need and X

range Secondly, today safety which we in said need on studies to a I And, each exposure as data need submit need, we time. the of an male do. stage terms safety to study, both we are is prepared know, And you adequate and from database of thirdly, the predetermined these at tough enrolling. comments, for

they You've six got have drug men months colitis sperm to have be to with collections. on ulcerative multiple for have and the and

doing we filing will enhance we the the announce in enrollment when it's of and we're terms So details time. everything appropriate can to

Operator

for concludes that conference Lee for remarks. like Sung turn our And any back you. closing over the I'd question-and-answer to session Thank today. to

Sung Lee

for Thank you, you to We joining interest you appreciate looks providing us with on updates Candice, today. the Gilead, your our progress. team thank here and future continued in all and forward

Operator

day. you Ladies today's participating in This thank have great may all for Everyone, gentlemen, conclude and the conference. disconnect. does and you program, a

Gilead Sciences (GILD) 25 Jul 182018 Q2 Earnings call transcript