Gilead Sciences (GILD) 28 Oct 222022 Q3 Earnings call transcript

Ladies and gentlemen, thank you for your patience, and thank you for attending today’s Third Quarter 2022 Gilead Sciences Earnings Conference Call. My name is Amber, and I will be your operator for today’s call. [Operator Instructions] It is now my pleasure to hand the conference over to our host, Jacquie Ross, VP of Investor Relations. Jacquie, please proceed.

Thank you, operator, and good afternoon everyone.

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

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

call the over turn I’ll to Dan. Now,

Thank and afternoon, good everybody. you, Jacquie,

you Total in but the excluding from year. of foreign XX% Veklury $XXX were sales of momentum strong the teams, impressive share Veklury and momentum execution, Thanks growth excluding Atripla fluctuations a to share The of this impact We’re Veklury build. execution The for sales today and details, pleased increase quarter HIV, from $X details over a another commercial total and for continued has great third and sequentially The very $X.X another Veklury. was quarter. product million commercial for continues product of team cell quarter XX% connect our of by for including: loss the the we all Trodelvy, the therapy, and the came grew of billion. positive for to Truvada strong will total in of XX% billion, year‐over‐year. currency to growing X% clinical growing majority of including Biktarvy, HIV with last for to oncology. share by exclude sales quarter exclusivity driven quarter was and If more been this the gains strong tail‐end

also We this quarter. momentum saw continued clinical

capsid lenacapavir heavily‐treatment dosing it people six‐month schedule experienced a received in therapy Europe. its Lymphoma, the and first Marketed for B‐Cell and with with multi‐drug HIV it the resistant adult virology, Some for first Yescarta relapsed the Trodelvy as HIV, Lymphoma, regulatory Tecartus line priority is approved to living Lymphoblastic granted the in approvals HR-positive/HERX-negative review of include: Sunlenca, in approval, for refractory approved and line metastatic for first for cancer, treatment. breast and second making the FDA highlights inhibitor EU late Acute Large

to treatment, investigating months; HIV ongoing expanding Merck’s BTLA agonist combination many This for in a X bispecific MiroBio two now our prevention; multiple long‐acting from our lenacapavir. We ambitious program, the our adding MacroGenics. and program for and of portfolio, be oral we important we resume antibody active, our a in we to an a for extensive start phase one X pipeline, trials of from with strengthen are lung clinical are our trial to and to our oncology, advance taking islatravir early‐stage continue more will to coming for steps plan including: oncology studies once‐weekly further in inflammation combination addition have for and we planned option

EVOKE‐XX clinical slide first cell to for line remaining our ZUMA‐XX Moving for cancer X goals we’re on to trials, non‐small line X risk on Phase LBCL. start lung XXXX track X, and the first namely high for

quarter ARC‐X strong strong readout been in before has for very cancer Gilead. line interim first a another continue cell end Overall, to We the for the of very X year lung this non‐small study expect in year. another Phase the

We’re share for Trodelvy. seeing demand therapy continued an impressive cell growing Biktarvy, for performance growth of with gains and our excellent base for business

across the breast cancer in inflammation. clinical the franchise. and first our is foundational virology, the the for asset of a on executing development we’ve HR-positive/HERX-negative priority approval extensive lenacapavir, future Trodelvy oncology under On had for side, and review program now HIV for an we’re U.S.

and I’ll the with to along expected Gilead building that, key on the settlement share beyond. the exclusivity This an the very consistent through to year execution. commercial teams recent take momentum and of update Johanna Finally, on outstanding portfolio third Kite performance. to invite in is I’d of clinical some components franchise this their significantly and we With TAF and rest to has our HIV terrific like look robust opportunity thank to quarter forward our the the of extend commercial execution strategy, U.S. of progress led for our that XXXX a in to

Dan, Thanks good afternoon, and everyone.

acknowledging for wanted to I Before by quarter. results for commercial into jump quarter, the teams another exceptional third the our I begin

of in virology oncology. important continuing in market and build our ensuring while the also to presence sustainability of expertise our strength and goals We’re franchise, progress our making

and areas, billion, franchise excluding core quarter Turning growth of excluding FX LOEs to in Growth year‐over‐year. of with oncology. we the HCV, XX% total and residual slide X, X, and HIV X%. sales Veklury the by year‐over‐year, slide $X.X billion very On HIV or X% excluding impact were the product XX% impact strength of HIV notable excluding strong up each HIV, oncology. X%, was up sales a had $X.X with FX and product Veklury sales driven of Sequentially, in LOEs, and our total grew

dynamics, Excluding the HIV and average both by primarily HIV quarter, higher Europe this higher grew average and due mix realized to favorable by by year‐over‐year, mix continue price, sales FX in channel represent up year‐over‐year. last LOEs, was to approximately realized including leading government impact demand. to X%, was shifts revenue U.S. HIV channel our of price, in of higher quarter‐over‐quarter demand. driven low‐XXs. U.S., HIV plans XX% prescriptions, similarly XX% while as demand. by Similar in higher to offset the the the utilization to were the part U.S. in dynamics, as addition Overall, Quarter‐over‐quarter, despite well growth down and less treatment pricing driven Medicare was inventory revenue driven FX government

pre‐COVID seeing The the X% care of year‐over‐year HIV activity people returned XXXX, market of we quarters. market the both trends. grew bring our for in at encouraged to In that work we the a pandemic. to year-over-year basis, U.S. reflects This we U.S. market broadly, more following suggests Europe third treatment has into Turning with have the are five and risk market on and grown the HIV to people growth partners are the been the has with the living consecutive that and quarter across back Europe. HIV doing

to treatment the stable $XXX continue and growth and X% entrants. forward, million, and generic other sequentially, in Looking annual Descovy up remains PrEP range. year‐over‐year we expect market sales despite to market X% XX% were X% share

demand market to PrEP sequentially. Onto the PrEP the and largely continues quarter, growing PrEP the For the robust Overall, demonstrate driven slide XX% market and pre‐pandemic grew well‐above levels. by awareness X. year‐over‐year for growth, X%

percentage XX% favorable demand most capturing both another favorable seeking were in to driven to pricing were the U.S. the Once by position again, with Biktarvy $X.X record to XX% regimen and up in inventory dynamics. XX continues higher remains for command well pricing every Sequentially, share in new the up switch starts and new higher the Europe, the demand to Third X%, the a Biktarvy medicine treatment dynamics. in a X the medicine of those another and and U.S. up quarter in well prescribed U.S., to sales for U.S. quarter as leading due sales HIV, year‐over‐year, billion, year‐over‐year. Europe, treatment starting Moreover, those market growing U.S. leading Biktarvy as person notably, X both as points in as

to Looking to like fourth I’d points. call the out quarter, a few

inventory management product in significant down draw focus delivery quarter, an historic given timing by First, renewing in the the with align inventory fourth quarter effort trend first the we build to our inventory the better of demand. on followed are towards end‐user in a

treatment the shifts you channel that of share we and performance a impact addition gains will in to realized on third in continue and we both been growth second in while market Second, had that to for prevention by driven favorable have strong solid average has remind Biktarvy price. our some quarter mix markets, see

over favorable observed do Given mix trends the the quarter. the more be last the stable in we to expect two we channel quarters fourth

year XXXX and the also built basis, and factors to that further for and a or be XXXX excited LOEs FX proud these X%, in way quarter we extremely therefore fourth year expect sequential allowing on full we’re HIV expected have growth of FX be to With to the in mind, noting we the beyond. is flat summary, roughly impact, and approximately positioned HIV In is Gilead X% headwinds about for date. excluding portfolio HIV sales

the prevention treatment subcutaneous the important HIV now options, option evidenced for the continues treatment share its for is most to other Descovy people and approval has profile rate HIV believe sets multi‐drug six treatment and is generic annual and lenacapavir’s And get by entrants. great $XX ongoing, competition even regimens. is planned opportunity a recently in with revenue Sunlenca with a for HIV maintained stage over clinical heavily living group lenacapavir‐based We resistant in that well therapy. few rates growth for more EU. our as impress, excess community of familiar this XX% run and Biktarvy’s monthly, market though physicians billion. experienced to despite This for a PrEP, an Specifically, strong

now Descovy XXXXs, into of recent projected impact treatment markets combined XXXX TAF of showing settlement the the for and of with, and extending Atripla early exclusivity of to solid patent prevention and the All U.S. us; in LOEs the behind recovery; this, Odefsey Truvada and Genvoya’s U.S. loss the the and

truly our leadership this and of market. well‐positioned for confidence HIV in underpins the is that growth continued Gilead All

quarter general third slide the Now there third HCV that were prior in in were sales primarily expect a in the and fewer the consistent sequentially, of and benefits, with patients in trend other than the you dynamics share due year XX. market year‐over‐year and U.S. quarter claim trend our for resolution we’re basis. Europe, forward. $XXX expectations and quarter U.S. HCV U.S. favorable patient the the Despite Europe, pleased onto rebate up the both pricing both and starts the in XX% Europe million, starts, for of increased HCV favorable these XX% XX% to a Offsetting and share on year‐over‐year going should maintain to both more in

and quarter‐over‐quarter, HDV sales primarily HBV X% favorable driven by were XX% XX, slide and on For year‐over‐year up dynamics. inventory

XX, quarter on million. Moving were slide third to $XXX revenues Veklury

fight for seen benefit continues European Nonetheless, expected, of to the be sales with are to continues in based pandemic who Veklury Agency, to authorities the that being the Veklury treated patients the same Health start health patients increase hospitalized including recognized Veklury’s and COVID. are the the compared the U.S. World And U.S., U.S., of the Organization of by is in Medicines hospitalizations outside three‐day part COVID‐XX. path the play which setting. the continue were utilization against a it demonstrated clear As significant year. treatment it’s outpatient year, XX% given year‐over‐year the predict. IV to risk is a in the in on the Indeed, where Veklury at support of data used These difficult last remains needed. reduction factors PINETREE after though hospitalization peak approximately to period down of we’re sequential lower hospitalizations to the as role the in below proud In the

clinicians to grew reimbursed Europe, to million year‐ meaningful and $XXX we Since and and significant with infrastructure Reinforcing and Moving and on late this elsewhere shortly. the approval the overall markets additional to Review survival data Europe also pretreated XX world work continue XX. and over‐year around February come clinically in in of we with in on unmet quarter, TROPiCS‐XX line TNBC on We’ve in Sales payers U.S., in Oncology, Biologics beginning the as work potential the slide cancer. to breast is a decision launch X second Priority line to year next Trodelvy with look its outside broaden countries XX% of now XX% quarter‐over metastatic begun expected year. HR-positive/HERX-negative FDA the study, and establishing last metastatic Trodelvy access. to License in right our the population, Phase demonstrated need a in Application accepted into has supplemental regulators, support

We’re more excited for benefit many by potential to Trodelvy. patients the from

continues manufacturing to in to Kite’s customer meet XX, slide ability ensure quarter Kite that viral team, and lymphoma to sequentially. Therapy large its Kite and supply and the on geographic our results FDA‐approved execute pleased were expansion. in the of demand. sales remains These onto reliably share clinical commercial by Christi third continued $XXX B‐cell recently up strong Now it with Cell availability well‐positioned up vector to Together million, XX% and on year‐over‐year X% while facility growth Oceanside, and behalf were driven in I’m

quarter, quarter‐over‐ launch For million second‐line in up were X% a Europe. by headwinds U.S. in by quarter, of and sales the partially LBCL XX% Yescarta offset FX in continued driven $XXX year‐over‐year the successful and

Just forward refractory was ahead. look the In year‐over‐year Tecartus the grew in launching we to was leukemia. to in $XX second‐line Tecartus by driven approved European LBCL ALL in in million the Marketing XX% deliver growth Yescarta last sales, for acute or EU granted. Authorization September, and early week, adult in relapsed lymphoblastic for months there

geographic and expansion expansion, Authorized continue existing by well cell and our applications Singapore, as our Brazil, through regulatory broaden Arabia. in access Treatment awareness demonstrated to as Saudi We Center recent through as therapies indication markets to most and in

with oncology XXXX, Christi hints last represents incredibly billion on $X.X that, XX% rate almost move million our Overall, our on with quarter from of the Q&A ahead later and the for call This oncology, revenue was into and I’ll hand up Merdad commercial the always, year. we at goals. strong As we this $XXX months of as available for run from last possibilities is the XX% call. update as pipeline. clinical annual for continue on last and an execute quarter an few to to over And an Gilead

Johanna. you, Thank

sBLA the partners spanning execution with area of that’s Before external to study initiations, internal start, I’d of strong like broad I across a recognize that and the all approval cell two therapeutic diversified activities EU. milestones our milestones. across team range first and stage approvals XX, you the submission therapy, progress lot made EC a year, our far Trodelvy, for we’ve in and On our slide for lenacapavir of see this can in so clinical nearly meeting

BLA Regarding of our about we the Letter concerns a received for FDA, from citing and filing Hepcludex. manufacture Hepcludex, delivery Response Complete

as update We the regulatory that will with efficacy and pathway when the take resubmit the agency can on clinical can. or share with confident and but We possible in living digest an HDV, were the remain fully trials to bulevirtide people to we it the on plan to CRL, will bring potential by note safety path work forward. We benefits new U.S. the will the FDA. time requested quickly and as no

HIV Moving on onto slide XX.

people lenacapavir living Sunlenca much‐needed its with subcutaneous with thrilled and is people authorization treatment from other a received We’re HIV, option those antiretrovirals. limited the and with European for in Sunlenca as is first‐in‐class first for combination alternatives. living twice‐yearly, with first marketing adds only a multi‐drug HIV capsid resistant HIV inhibitor. the It that Commission

important programs. decision other In is on we continue NDA of treatment and validation meantime, our late to EC regulatory first FDA progress We December from continue our the to this lenacapavir‐based prevention expect a approval while from this lenacapavir the for in year. an

investigational treatment, lower dose review. development NRTTI, a HIV moving FDA islatravir, is of Merck’s after plan allowing new forward clinical a For

we to are resume combination. and Phase investigating the trial oral, an such, once‐weekly lenacapavir X planning As islatravir

to the and Our trials in‐process development to at internal for four progress evaluating six‐month lenacapavir. share clinical continues antibodies, clinical from bNAbs, combination Phase ongoing, lenacapavir programs data we study two every our and Xb expect In with HIV. are also broadly‐neutralizing subcutaneous prevention, next or proof‐of‐concept year planned or directed

updated be Moving COVID‐XX, to for the standard recognized care Organization. continues slide World Health patients Veklury severe with XX, Veklury for to of guidelines with a as from

a Additionally, of treatment Veklury use the CHMP of for with opinion COVID‐XX. the on issued positive patients the pediatric

have the development need new effective and of convenient medicines. am oral for and pleased just Designation, novel outlook, a Fast patients. to to options Although treatment vaccinations continued there treatments share FDA novel has COVID‐XX that expedite aims improved is I our for oral nucleoside, GS‐XXXX, the promising which granted Track

either results next the discussions the we that cancer we Phase metastatic XX, start who active statistically significant late be and was FDA chemotherapy have that benefit. on the other TROPiCS‐XX in outside cancer show Phase including overall patients therapies potential and in have options. demonstrated breaking study the progressed to HR-positive/HERX-negative with X HR-positive/HERX-negative clinically X Trodelvy to presentation global On continue pathways months, metastatic several meaningful at within in limited X.X‐month and expect We globally a slide September. a regulators breast survival with endocrine‐based a on U.S. with clinical ESMO or breast Patients

As with of inhibitors. TROPiCS‐XX chemotherapy were in a CDKX/X addition median in heavily a to enrolled patients pre‐treated reminder, three prior the regimens prior

granted recently FDA the for our Review. set is cancer XXXX. metastatic currently Trodelvy Priority HR-positive/HERX-negative sBLA breast The for Importantly, February it and date PDUFA a in accepted

medicine work to regulatory the continue outside with eligible this We available U.S. patients. agencies potentially to to make

we bridging months X Additionally, from rights trial following data development mid‐XXXX. from Phase in China Phase acquisition our the metastatic expect metastatic and in Trodelvy’s study our next the X and few cancer breast Everest of HR-positive/HERX-negative Asian Medicines, TNBC commercialization Asian

Eight the non‐small in programs X to own and can well Moving line we X already including Trodelvy, as etruma, including in have second X in actionable lung see study durvalumab, cell first to by XX, you are cell active on third of and XXXX, expect cell study AstraZeneca’s least cancer as cancer to lung that the zimberelimab, mutations. non‐small domvanalimab EVOKE‐XX Phase trials slide end magrolimab. trials with non‐small Keytruda, with lung Phase underway, lung and Merck’s cancer X EVOKE‐XX our clinical our without cancer at line

with partner levels to first‐line later Our year Trodelvy Keytruda lung to initiate cancer express Merck of this study Phase tumors and cell also combination high the patients PD‐LX. evaluate in the plans of X whose EVOKE‐XX non‐small

to in comprehensive studies, to forward evaluating updates MOAs for expected the and ongoing in EDGE‐lung that lung forward ARC‐X treatment explore STAR‐XXX additional initiated are a cancer, of partner could our patient Phase zim and years. PD‐LX‐high to in is Lung with the seeking need cancer need, X evaluation promising ARC‐X the Phase significant from which the our area Phase new before platform multiple dom end interim and to we options two high To cancer, lung to support analysis these the signal in. unmet have have we’re the we opportunities, Arcus, looking trial months. to in and bring including the combinations X VELOCITY look potential year. assets Data help a initiate first with the coming address Additionally, studies in Arcus‐led plan patients. in of fourth of dom‐based and non‐small sharing cell just Overall, believe lung coming cancer we portfolio achieved we disease the X our unmet combinations

clinical therapy based as earlier we on Moving more are moving survival benefit the we highlighting Kite Tecartus growing of new XX, as lines indications. expanding We Tecartus to bring opportunities to on still Yescarta Christi cell and the and are on the Yescarta believe our that are build pipeline adoption momentum patients. of as into to delivering there by team, well and slide patients and significant and to behalf

several study a Phase an plus including have As you second in lymphoma. outpatient follicular study patients Yescarta line enrolled X in and Phase Yescarta see, studies, we to LBCL, ZUMA‐XX, evaluate setting for line can for a recently X in second high‐risk ZUMA‐XX,

demonstrated to of HR LBCL from a initiate XX% ORR where patients decision the line on Yescarta Yescarta the QX. in CR. We in The also first ZUMA‐XX, to encouraging XX% and screening was study expect for Phase ZUMA‐XX trial X based begin data

of a plus post‐CDXX that’s KITE‐XXX bicistronic T evaluating evaluation Tecartus CAR LBCL. rare in studies Additional include B‐cell malignancies, an and CDXX/XX third line in

We therapies the efficacy and are AML. and the our internal committed turn external XX, both highlight cell hematology MDS and our to through safety breadth pipeline we of partnerships. and programs slide of to On continuously across improving

MDS we in Phase For our study of fully schedule. magrolimab, ENHANCE X enrolled ahead

with two and additional expect a data Our collaboration work and and programs. and in exclusive and the option are bispecific few patients weeks that as develop continue, clinical to research furthers we ENHANCE‐X Moreover, CDXXX in announced FDA discussions with in binds well AML regulators an outcomes therapies update the MDS. into oncology license XXXX. to to we trials, XXXX. includes This for ‐X, antibody A we as MGDXXX, topline Phase could our our ago, This explore we currently that antibodies. X, is early underway the other and bispecific and as share to for translate targeting MacroGenics CDX, well complements magrolimab, X better enrollment AML with

to were the we KITE‐XXX first T the September. XX, FDA welcome designation acquisition enrolling Gilead. wanted orphan drug Phase including a pleased to of RA slide end proprietary systemic X bring targeted few platform moment take discovery the and MiroBio family, a to Gilead a currently completed I team indications. study. IBD, We and inhibitory at in in MiroBio ago complements This CLL‐X and to the patients the granted our weeks On is other inflammatory to receptor and to It’s research CAR lupus disease and opens are immune portfolio. opportunities and cornerstones our pleased agonists acquisition their add Finally,

getting our to spanning that, induce started clinical exploring inflammation. I’ll programs are possibilities up, XXXX, accomplished We Andy? at and in tolerance to across of by explore a now really the Wrapping just virology, broad a believe signaling lot in offered and indications oncology portfolio. Gilead, in antibody here range these underway and the immunosuppressive yet which With XX We’ve autoimmunity. we’re that note excited feel agonists, restore to we continue and potential have develop we have

and everyone. you, Merdad, good Thank afternoon

quarter in across strong business. results, another share to franchise pleased of core with sequential and year‐over‐year every our We’re growth

a slide of on XX% Veklury, previous HIV sales to addition $XXX shown If FX impact, this grew total was headwind underlying FX. despite LOEs, million from As XX, the year‐over‐year, we impact product exclude XX%. growth excluding year‐over‐year sales, in

XX, Veklury of hedges, see was as although higher quarter. that quarter than note of it expected, expected, than litigation at with product to XXX approximately $XXX the on impact year-over-year, reserve. Non‐GAAP down that second on million U.S. basis last can year. was primarily you compared the basis slide net recorded dollar, the points down, to total third strengthening more the the a revenue, gross the reversal doubled I’ll sequential FX from third to Moving quarter year, of continued last previously XX%, was of due XXXX a margin from

product in by XX% margin investments was and excluding Biktarvy‐related IPR&D payments Non‐ tax COVID up R&D due due excluding effective basis year‐over‐year. IPR&D Veklury improved up the $XXX sales. upfront Non‐GAAP the sequentially year‐over‐year was expenses points expense quarter and and product up million investments acquisition. the Acquired reflecting higher partially X% acquired billion, and acquired in GAAP R&D, by Veklury XX%, by expenses. XXX higher gross milestones includes for due our the year. $X.XX XX.X%, for was due third quarter Oncology. acquisitions, of in Non‐GAAP product $X.XX operating normal Non‐GAAP upfront non‐GAAP primarily XXXX, diluted earnings MiroBio higher share margin than Acquired payment. by non‐GAAP the same the Of per guidance was to of last the note, compared shared third a back Overall, period in the non‐deductibility we MiroBio share, $X.XX August. impacted On we take EPS this our not XX, post‐tax primarily Sequentially, transaction look reflected MiroBio quick in a $XXX related year to slide and by at the in X% gross expense IPR&D full the to year, was sales. quarter down billion, of addition same billion, period X% Non‐GAAP approximately operating was Sequentially, to higher Veklury increased higher exclude driven the Veklury expenses performance impact of is million treatments XX%. IPR&D $XXX HIV was the shows product SG&A LOEs, $X.X $XX.X expected, this impacted stage to as higher and of expenses to total HIV up royalty of in margin year‐to‐date, million and lower If the IPR&D, was and HIV as highlighting the offset compared underlying year‐over‐year, acquired for Veklury, margin pandemic. excluding which Veklury is the Additionally, lower demand Oncology FX sales, sales. the year‐to‐date, year‐to‐date treatments. year‐to‐date non‐GAAP we $X.X of lower last driven headwinds growth was to down in sales COVID‐XX to year‐over‐year. and

our our expectations XX, we year reflect and to of sales results Moving slide including to guidance full FX. are year‐to‐date increasing our for QX, our view latest

In as revenue headwind headwinds. from reflects broader will, billion the QX including up total billion. and range FX in launch $XX.X basis. demand and line to billion, sequential $XX.X Johanna HIV to therapy, our HIV, This expectations roughly once the HIV, fourth on Veklury, we previous FX be performance environment, macro cell In quarter. notably the therapy, to incorporates to expect year‐to‐date, second following billion very of discussed, expect our strong in expect slower of basis, $XX.X flat growth now we growth product which LBCL the stabilizing again, a a we primarily cell Revenues, and be in sales due For a strong on sequential $XX.X for

competitive with both mitigated peers of to current to be which shortage our we improve cautious regards and view quarter, as to landscape their a Additionally, partially later expect we fludarabine the taking fourth are reliability. manufacturing the in the

$X.X of and track the continue to assumes expectations hospitalization billion for our revenue that expect the billion, third guidance significant we rates rates Veklury, increase to in and Veklury approximately year‐to‐date our to are year. quarter $X.X with sales to Moving we from Note full hospitalization levels. no increasing

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

expected our compared to for $X.X P&L, is gross expect baseline the range, There billion. XX% where prior our increase the R&D be of percentage As in guidance, change full expense compared margin no now approximately of to a rest XX%. is XX% the by XXXX we product guidance of to non‐GAAP the to to to to year mid‐single-digit R&D XX%

what the IPR&D here amount, to share deals issuing needed not for guidance including include Moving to and update business any we today to normal with we MacroGenics relevant year guidance activity of is the the last not quarter. might this quarter the year‐to‐date acquired that our that payments related does quarterly EPS did with per week. during full IPR&D, What guidance in acquired reflect are we’ll as included to fourth partnerships have The any MiroBio quarter. we or similar upfront associated course we the approximately licensing close shared $X.XX collaboration we announced

of previously. to share a as an anticipated with rates. digit $X.X expected dollars XXXX. For we the in billion by result headwinds FX core through diluted across non‐GAAP investment to low revenue, than of $XX.X percentage $XX to $X.XX to we expect now billion organization, from XXXX X% And end continue On we and for decline EPS to operating billion is share, $XX.X strength from a and per which half to $X.XX year, previously. as continued $XX.X a compared share SG•&A, grow to our a to range non‐GAAP our $X.XX to $X.XX in earnings our expect highlights GAAP in $X.XX results, $X.XX and the range earnings EPS of billion share, up is basis, guidance expect compared for X% compared between single to billion despite be per total This between now and commercial up to in Veklury billion to share expenses per range finally, per expected approaching the costs our higher expect more XXXX. our full‐year, business, per previously. range This diluted $X.XX grow expectations Altogether, SG&A we XXXX our the $X.XX to income inflation, the to

capital our billion is payments can $XXX allocation $XXX there dividend the priorities. million In and see repurchases. you million no on returned shareholders, to Finally, including quarter, share slide that we change over to XX, in in $X.X

previously, repaid that, to the returned third the same in at the acquisition. we to the Q&A. invite With early the Q&A. debt I’ll the that, have and we debt of announced operator invite Immunomedics we were open to the As billion open With to operator $X prior quarter I’ll level

question Chris from comes Schott first Our Instructions] with JPM. [Operator

question My lenacapavir treatment. in on and was

number with more serve is segments to going the combos see other that of with an in, anchor with these that a becomes we you’re Biktarvy? asset different to the likely internal it guess, lenacapavir to end from a maybe up programs? clinical a is bit like in the of How different I resulting of want combos or see market, of part I treatment. lift portfolio a first, relative interesting picture partnered And hold. the islatravir just second So, you then bigger about, the that, as talk that and really of type asset one your and the Do separates one little

is Hi Merdad. Chris, this

Let new population. that treatment-experienced who options, the lenacapavir them. a start this people for new about are opportunity we a in for by of have recent -- Obviously, lenacapavir think me as first highly and really limited approval in class I that’s provides a saying the group excited

in islatravir, that is In development. we terms islatravir about of its what is it like fairly late

long-acting treatment us is to given be think I I terms with the that. think way. long-acting said And launch able that. opportunity provides X near-term time in could in months the X a be before, lenacapavir a relatively frame. that’s Phase it or for are parenteral to a partner where important that our we’ve in And option ability in optimistic what longer We really providing goal about going to we’re terms of And is a that of, as longer do and market our in than is in

options So our are we really there. for providing pipeline have internal that assets that, our

there, using our that oral program. options an programs For of weekly potentially get people that provide to a other part now that oral islatravir, And and right -- is number us, we is have in level. to And do certainly a lenacapavir. that we option of treatment islatravir pipeline get potential think could for terms of our that’s oral opportunities options we for in have

a will of make just can in our that we with if able answer will and there one always different look partner, or longer way extend as the to we achieve therapy provide or partner therapy we go get different forward, do be being And a I improvements to that it, try partner molecule that to oral, think could So, partner whether lenacapavir be therapeutic last directly that than we’ll goals that’s probably potentially your a different formulation, to we will and to lenacapavir the at even in longer the duration question, exposure. six-month a there parenteral.

and I So us to continue try to over time, innovate move to expect forward.

light the market understand add was just to to point, market, within will treatment in always preferred. that, more in maybe is for done we’ve prevention. the oral market, has standard to then the will Merdad are in oral, have a really of that be we set setting, daily there. to, that also market the there really your the patient Chris, believe research which weekly that a lot the oral treatment, quite to but long-acting referring clear what And different specifically with to it just of others And Biktarvy which you So is segments

be or Some subQ they every at have, want want don’t something all. potentially And some very or the will reminded the that X you that make obviously, HIV. taking months be to to to months have lenacapavir injectables don’t that want people every they’re day. every X just to single combinations even Others be reminded with sure appealing then

we’re the those out. are to trying segments of so kind And play

of a long think seen more So, be there we’ve in as daily than split I the segment do a oral. acting, will

please? ready next you the Amber, for question,

Goldman next comes Sachs. Salveen from Richter with Our question

the it monotherapy. at ORR you On on see clear this least data on already interim come? TIGIT we benefit the likelihood And the like seem don’t, could based on program, point? And when that then what does PFS if have updates, the versus that is we’ll at doublet arm

X possible readout? Phase love would just the if through outcome you there’s initiated could the So, this could studies. see that us scenarios And to with walk any recently impact data if

really I’ll make nothing terms Salveen, and enrollment again. Merdad we’re of has by where for is that X analysis maybe interim was And the changed going reminder summer. Yes, is and in to start the ARC-X really, the fourth this that saying completed the the only over be this study is study headed. recently ongoing Phase

already, data it we our look bolster the to just that to program, when our Based in confidence combination the to doublet that. context, right, your so, support think seen and ORR in TIGIT consistency and look we dom Phase ongoing a about combination. the continue and continue X for zim if And as on you the point, this should to we’ve to that, underline at dom in in

In going I PFS allude terms enrollment fairly to, is I given fact the recently, is that until went of as likelihood the to going tried is be PFS, to think that PFS -- be. immature we informative. on but is it’s informative, fairly be there well, triplet the and may think And be may not certainly, PFS it as to about that when unlikely

partners And is medical sharing sure our it’s exactly Phase making a we’ll we’ve lead our what have moving with we we’re into about And so, how with. the year. at in that, the the Arcus certainly, confidence we the TIGIT to and it. programs And and -- moving conference approach your that data plan data next before, point, really and the as already that said to with and then confirming look at decide with data we X are evaluate at our

So, I hope that question. answers your

Abrahams Our comes with from question Brian RBC. next

Trodelvy. for A question Congrats on taking the my thanks question. quarter. on And

views might Trodelvy updates latest With landscape, to on curious strategy who how Thanks. population. in HR-positive/HERX-negative expectations latest commercial used, it the in, your maturing and patients align be receive with survival your Any on data TROPiCS-XX HERX curious on that? may see post And research how first? could the on effective fitting overall the in market competitive on evolving it be your I’m where certain also in that you

Johanna. Brian, question. Thanks for Hi it’s the

let been quarter So by with strong. saying really for Trodelvy, the has start performance basically, me the

of basically. We’re And seeing playing quarter-over-quarter. markets seeing out. in XX% reimbursement And XX% week kind year-on-year every growth, we’re add

XX We have over that countries U.S. have gotten now ex reimbursement.

France, right in So, speaking. coming and Germany really we’re now we’re strong seeing markets launches namely other as

So, foundations there. strong

different ourselves, across helps with having in you bit think of I treated population with data as the right, really breast position triple-negative well we’re TROPiCS-XX, competitors. helps for foundation when really specific both heavily-treated cancer so we question our therapy, a this some kind of the think where as previously now your cancer. little population, TROPiCS-XX To of -- HR-positive/HERX-negative, patient lines about obviously, in breast than patient in but OS Trodelvy around do

patients very we’re actually so, options. And because excited these have limited

in now with these overall there And real Trodelvy, is so, patients. for late-line a potential survival

in we the build we the we’re very as in cancer thus and our will on think that success well in feel we’ve positioned far we’ll confident as So, seen how research, breast that playing as do marketplace, Trodelvy be we’re market triple-negative we’re very out, well that it out. doing that playing

previous in triple-negative what we business. what footprint, specifically we of of not do in how have the to expanded U.S. one base our to might in need the do for So, also mentioned continued expect in our And I in before the both calls, momentum expansion but only cancer, prepare need we HR-positive. we’ve breast to

ready sure successful. And date up we’re so sure in we’re we’re well make for to PDUFA coming make that poised that to February that

to Maybe maybe And I’ll Merdad. is -- this add that.

getting who certainly, I are We’re data think, And far, I much in particular, types. not to them So across may about been highlighted, patients there’s who that’s where, decide respond a believe those an right? who may to those we’re there. tumor -- of think We that be adequately of right? don’t done, have certainly, not late-line opportunity Johanna that there positive on data Trodelvy seen patients how may lines, do excited kind later to be so some to those in as we’ve but achieve for you’ve beforehand. will HERX and in the potential And able now therapy, with sequencing, there’s treat HERX consistent I

really sorry, -- then the would HERX really the important remember. in distinction I breast in triple-negative population. we’ve think including I to HERX breast, data And a cancer, HR-positive And The that very that’s strong important thing that zero and certainly is cancer other including to triple got based we’ve types. benefit there’s far move in as an tumor clinical in negative, we’ve on other us opportunity we lines and HR-positive therapy breast well what and finally, for earlier seen the in so believe in brought, to add of

of earlier into I lines tumor our always strategy been types, broad has excitement to think as the go to advance and ability about into always positive therapy Trodelvy generate that’s our data. -- been we has

comes with Michael from Yee Jefferies. question next Our

that a even I would cancer lung in Congrats lung also great that was think opportunity cancer I you an observing you’ve data which if study there? you you had commented update to breast EVOKE-XX on you you EVOKE-XX to there’s Immunomedics. is is to based is think Trodelvy year. big versus basket trying this replace I would Merdad think wondering on if on wanted ongoing. more you bigger and question mean EVOKE-XX confirm rates I understand think And EVOKE-XX, next then in I give line. think some been update chemo. I response next cancer. Can to when I first early you you on on the you pretty acquired just would which And about that’s more would that opportunity we on quarter. and than a docetaxel? know ask second-line how wanted year confidence

and maybe Thank on comment EVOKE-XX you. EVOKE-XX. So

the question. Yes, Michael, thanks for Merdad,

I third-line our early -- and both question studies. across in in as referencing seen we early And to great follow-on line Phase think look we’ve around going our know, tumor what And then to you initiated a just and you’re now we prior very in to into and To to follow and at setting our enroll as think from ability cancer. and your in frontline well well lung starting continue point, looking cancer particular, earlier Xb I on, setting. and data, the the confidence we’ve second- studies as those study is lines. it’s types the lung really

which think trial you in a PD-X [ph] population, with us combination for high and EVOKE-XX to the As study PD-LX is doing on. important the know, I proceed with we’re an really

the the Michael, timing is So, I to think is difficult would of what I that say always predict. data,

a to we’re to have the and need. bring very excited with days. how high study it’s unmet really meaningful We a about a the group enrollment therapy to But see early goes, opportunity

Our next Baird. with question comes Brian Skorney from

what a wondering us Phase the you happened sort threshold, just missing bictegravir entity insight Maybe slides, to of nice kind is XXXX the has PK there? been Thanks. known have could on like confidence any have gives to perhaps been give removed Merdad, it that in XXXX just the long-acting a jumping was Obviously, from with noticed X the you’re more combo. seeing maybe for the I the long-acting off pipeline it in or of something HIV would bictegravir bictegravir there? pipeline. Is you discussion. it or part I the of that

just Happy has question. is lot And patients. the to expand an of we done on to thinking in for and one is for looked look, addition at the opportunities molecule as that Thanks give we reactions. a amazing injection that. Yes. to happened Yes, terms really, subcu about issues bictegravir if bictegravir for long-acting of long-acting given oral what is was tolerability could had we in site And see subcutaneous. molecule it a

So, the it’s itself. about not molecule

is subcutaneous of One of long-acting therapies challenges tolerability. developing the

to and studies a every and are like continues to your are where to mentioned part make moving of standpoint, about long-acting come -- along molecules us. oral to PrEP from that opportunities lenacapavir maybe think underway, different it’s standpoint, parenteral. And to be want huge for nicely. number a the earlier, an long-acting, at And therapy I day. long-acting lenacapavir, so, we the those back agent And prep And want clear part don’t we lenacapavir then think is along to backbone as point, a get our a now, we way of I maybe is huge bictegravir step way are that treatment for I to of go. From long-acting sure as just about to it, that it’s oral a looking

we in think longer, gives development competition the the for. molecules get a preclinical on to get a what at up the or and chemistry every expertise subcutaneous looking We are for us that number have really to molecules. we’re which that of is -- of world-class a that’s even to and We number to the three-month need Johanna get looking that to will those or laid dosing leg out,

next Our Matthew from comes Morgan question with Stanley. Harrison

to a about you of little bit what wanted terms XXXX. to Can sort set earlier have Phase given that the commercially, just data kind you then, some range pills on of where a thinking the in just see And X as about Thanks. ask same you compete to of developed be a fact sort what might just data look just need possibilities it in you the might might I be pandemic? of of that were may those the of like? question talk hard

Hey Matthew, Dan O’Day here.

the question, first we’ll second. take part feed So Merdad and your have of then the Johanna can into

Matthew. Yes. Thanks, Dan. Yes. Thanks,

-- a you going the are now I XXXX vaccination, those know, Phase giving you as has I started this well. So, looking make And may as challenge point And in right you a options. an high-risk other is in at now, we pandemic changed earlier patients Things as trials know, a get who high-risk lot. at patients challenge looking think hospitalized year. right treatment that excellent has

what’s to what to regulators your Those other unpredictable the the that’s how into need for with has down I for. as pick but having we might best that pandemic trials whether start important demonstrate exactly its for discussion agents, prepared is that been part, we the -- are as up once clinical forward think agents, and is resistance that may rates. how new the hospitalization heaven does combination we think we’re be it. increase should us come And things the way move that to to move about forbid, we XXXX and see to tool, with an our road, benefit have really as XXXX. a the efficacy point, all again, we that anticipate establish the So of the And the which internally population variants

combinations new So surge. resistance and or treating both a

Yes.

is Johanna. So what just Matthew, add in saying. line to I Merdad with would it’s that,

I as So we’ve rebound think we’re to look marketed addition antiviral what is so, at plus commercial is activity. a the from the real right effects -- a have standpoint, now in have going a here as to we’re it and issue, that thinking agent as current boosting well that fact the doesn’t seen products with fact that

kind So I those think thinking are pieces about. what of we’re

interactions you as drug-drug bit know, well a well current with has agents been some of As the an issue today. of

up this So we very opportunity seen with pandemic. and I will as really I this hospitalizations options little more and -- potentially to seen a bit think not little benefit. of here boosting to And go patient just that open But a if of we’re for pandemic, most increase think a seen still the it’s more you broader curve population We’ve over. of agent, those there’s We’ve an we’ve we with bit closely without because make sure that Veklury. recently, tracking believe hospitalizations, down. course, for do that up

things across particularly in, the rebound this And I’ll other and in thirdly, interested the Dan to that antivirals; boosting government, to to number to Matthew, conversations O’Day. was my designation the is lack variance continues as lack Fast recent issue. too. and they’re major the applied Merdad Track mutate; is made, U.S. one two, that one just our addition in there’s add which this is virus the oral of and with both X Johanna working DDI, points of more colleagues, GS-XXXX, thing then Number that

a the the think COVID way think there with of work to recognition pandemic/endemic, I as is closely call And options. that we U.S. it in the to government it’s want for to expressed a that’s need So, fact this for whatever continue wants I us you additional ongoing develop the with program.

Tyler Van comes question with Buren Cowen. from next Our

results. I Congratulations follow-up, had a Biktarvy. question on Great on a quarter. high-level the

So, like it of around the be to will year. and it continues see product uptake, this XX% looks HIV product revenues impressive very

of peak over to years? several a next percentage product HIV the sales the expect you out do as where So,

the really the momentum it’s globe. performance, Thanks in of would for I that increased around And just U.S., question. proud I that say say but really we’re we’re the is would Biktarvy this even the Tyler, Joanna. is this not the seeing.

$XX looking And just now, about at run X% We’ve in rate And XX% excess we’re seen share share annual so, market about an of Biktarvy. we’re billion. with year-on-year. gain

is naïve so well about the at very I of the both -- right And for So, standard Biktarvy, really the we’re obviously, switch share already coming future. bit share poised you you just -- and to HIV. obviously for little because do patients share, new now you’re The that XX% Biktarvy with obviously, the think on switch we’re share, can’t lower can looking a under if setting Biktarvy. switch into

is closely an for we’re issues or just there’s because come from therefore, profile So standpoint. but that does tracking to efficacy as older making that really well, a on when patients from opportunity, either very standpoint drugs have been when it safety some really and Biktarvy there to sure

both would growth goes. levels We’ve where little where Biktarvy right, to about on Europe. in seen the at actually I around market well, that note pre-pandemic add also year-on-year, And Biktarvy do goes, market the helps, the the continued also a we stabilization back just goes, so well in as of agenda. or X% market as U.S. and believe goes growing and a the So, Biktarvy which as because market is bit with

get into that from very worked sure to care, and diagnosis lot Biktarvy both teams efforts. standpoint. helps also with and screening so, And partners really in groups driving back closely The of momentum and that we back patients advocacy our have that a a into physicians and continue of our make well, as clinics, community standpoint course, is

Now you to -- those really that numbers and pre-pandemic. back we’re see

the So in future I by to forward continue leadership moving HIV this for Biktarvy. in we’re well think and place driven good poised

caller. to squeeze in we’ll two go more, Maybe Amber, the please. just next

next comes with Raffat from Umer question Our Evercore.

slightly really And I wanted tenofovir a of to second Biktarvy today, very settlement? to And ongoing. a is topic on plaintiffs you the for unusual of part, Andy, to would on that my in are sort significant litigation charge you’ve this prominent to the Because different show and Dan take up that handles been you curious, amount and litigation have open has more brings past. of something a it to guys every was final case. a taken there’s And much been And you this something this question Andy. more touch on to have I then be doing I’m a to that’s judgment, how me a guess I aggregated litigation that there or legal in indications happen two-part to up? I and the the looking date? up is for accounting a the in I on charge is because other question differently. ask company know And

So, Thank you. I curious. just was

Thanks, Umer.

do Andy your more Andy question with in me to And say, just start to want hand in I’ll confidence in patent it any I Let it don’t to overall the some portfolio litigation, we obviously, to ongoing that, before general. I of well. comment hand emphasize answer specifics we’re to we of with over maybe litigation on -- any level over have as detail. our

Dan. to know, you as we’ve Thanks, the for This with a questions litigation. base this. on that Umer, been thanks the getting Zantac lot touch Hi question. is Happy Yes. topic, a of on

can So and some context. a background number of provide things I that

So first you know. litigation different baseless. of all, routinely perspective, U.S., managing those companies, or of we as a matters, from in are meritless of are like our lot most the Many anyone operating

over the the or say on IP of ViiV material shareholders, that typically usually know, is specific you X companies. our terms favorable matters litigation or the a around I material back won -- resolved practice, the to can TAF stepping past is litigation the litigation, and third X -- year, litigation Company What litigation or IP on the have that comment As matter that generic litigation we we don’t bictegravir, were to then Juno as Kite with was the cases.

specific the have outstanding on question, the And the liability your maybe an externally. complete then to both have I We case. ongoing confidence internally merits in product and legal mean, defense we of team,

different Zantac litigation it is the than case. So, very

plantiffs. TDF-based think transform on the hand -- your side in piece mean, to in well care really slightly in there. that the label labels ours. day known, the were side effects it. sorry, patients our but potential the for There products were for number of there different just labels HIV. cases, the U.S. And question and in remember the I life-saving are is from in disclosed So our well here, were of were correctly The the These I’m Europe effects. the key XX,XXX plaintiffs, products if were instance, And an important I Zantac that’s at were case I of XXX,XXX But difference products that issues the one.

market as very it’s the case. Zantac, reformulated. was and correctly off I a remember different taken So,

drawing the that team on of things, would last thing, We take to California Zantac have about are And last great said, This saw all you I many careful do that briefs this the is in some as The seriously. litigation affected be that been take working number two that a read. with filed. Umer, it. very by you state seriously. I’d I publicly between and available. of Those it it the that have there parallels what we a litigation. So encourage don’t were we amicus companies mean too in are That maybe doesn’t that’s

you over not said, look is different our what about have that how of X we no, of cause expect would action we are the the X months taken case. amicus And strongly and I a proceeding merits years. coming And typically really the forward there charge, speak with litigation and feel or in very relative to as this charge. case think the see I a briefs finally, on to to then to

you. Thank So good question.

may go last to question, Amber, our please? we

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

integrase you’ve seen I few nuke there to to that that that long-acting want more either of have but to up non-nuke, something that Thank profile follow I or it’s if Merdad, HIV. lenacapavir, would like wasn’t a better mechanism you. you versus in-house to looks tricky a has comparable category? is long-acting? a a sure develop questions been straightforward develop on be on you’ve know that I HIV gotten in it’s than that doublet

is Thanks, our do chemistry Yes, getting long-acting inhibitors. a Merdad. at a have INSTIs for a better I shot Geoff. and that class capsid we favor to where virology This believe we’re our team the -- the partner as think we

looking bit where think a our and likely into are people there. goal. fair to mention effort we a this of did our may more program will at remind that for do say under variety potentially from I you, standpoint but at of the where achieve would does long-acting -- going those. just us to I I and is looking are are to we have there. mechanisms open But at the INSTIs provide get We we’re bnAb. another that every six the script a it in have we radar, option gone the looking months the So,

achieve So, will to are open that pretty committed goals. the and partner our finding we right

of how right is wanted quarter putting continues demonstrates that exciting the more you and And believe our more, time years, -- want that tangible strategy. the to further reach I we’re With emphasize and Terrific. thank seeing over communities we just positive all now realize the our potential third foundation the the performance just the on Dan. our for for this of After to delivering we help I joining today. we to three to do to build. momentum past It’s place as Company serve. an patients to in impact

out to and all So, Kite in thank any you additional Relations please want as the questions, usual, to to I And you for Investor again just of opportunity joining colleagues team. to our if take interest all this reach at Gilead. Gilead have your thank

know, today. joining to you help. happy thank they’re than more And you As for

Conference XXXX Sciences participation. your Earnings Gilead Third today’s Quarter This you concludes Call. Thank for

You line. may now disconnect your