Guardant Health (GH) 22 Feb 242023 Q4 Earnings call transcript

Good afternoon. Thank you for attending the Guardant Health Q4 2024 Earnings Call. My name is Victoria, and I'll be your moderator today. [Operator Instructions] I would now like to pass the conference over to your host, Carrie Mendivil. Thank you.

Carrie. proceed may You

today, year released ended Earlier the results quarter and December Guardant you. financial Health for Thank XX, XXXX.

from and Financial today AmirAli me Garden Eltoukhy, Helmy Joining Co-CEO Talasaz, Co-CEO; Mike Officer. Chief Bell, are and

those Before materially of this forward-looking management This during discussion you cause anticipated. call uncertainties laws. securities results I'd differ These we events the material will actual to meaning that measures, also risks like and exclude begin, will within remind include that items. non-GAAP to specified of statements from which federal make to statements adjusted or are call involve certain could a financial

events the statements, as in only and with SEC. the of new the material regarding intention XX-K to financial comparable measures information filings Guardant disclaims press live most as in Additional and any future issued other projections directly otherwise. in financial obligation release as today our to and revise is whether as broadcast. Guardant uncertainties accurate because conference Form or call well as well or update GAAP The forward-looking reconciliation available of or risks information, this information are

to I'd turn over that, call like With Helmy. to the

progress for turn will at Quarter and on detail look provide call more and XXXX more for thank screening. our Carrie. I will Thanks, afternoon, and in Good Mike then to financials the finally, Year joining a and our AmirAli go XXXX start our selection I MRD. an outlook our over And you across over for update an therapy call XXXX. on providing update Fourth off Full into will Call. Earnings today by detailed

infrastructure, million at our the very breakeven substantial pleased X. now of XXXX. therapy reimbursement our area end each reached Starting therapy the This wins years selection follows marking that series regarded. in of business We a insurers Slide have all for We commercial lives. major the with progress flow achievement in on U.S. after selection cash coverage surpassing a pivotal health year, Starting I'm throughout covered investing XXX year. of made from throughout of major GuardantXXX,

surpassed Medicare GuardantXXX Guardant lives covered for received Response. Japan received million and also for national reimbursement reimbursement for in We XXX TissueNext,

We of EMR prior integrated accounts XXX also outpacing our exceeded year-end, as targets.

to in on at of upgraded platform the share excited MRD. Reveal over the performance. I'm year, better strong Moving smart the year full enabling to of a with growth biopsy volumes XX%. that came even end Reveal to liquid we

following reimbursement We continue also for received CRC Medicare additional performance. and across and in CRC to high in produce XXXX compelling Reveal commercial Reveal data cancer coverage for demonstrating clinical breast

finally, a screening, submission screening. completed with for made CRC FDA steady PMA published adherence and with Shield blood-based progress the we our demonstrating with Shield improved And first CRC, for paper review

bold While pushing Shield we with of possible believe data CLVX, sensitivity boundaries for bar at mission we clinical the improved deliver have FDA when from meets continue our cancer. to of the to year. Day with platform, our team I'm to our we proud so everyone compared the free CLVX Investor of our presented demonstrated on approval, performance what's as time give more for already last upgraded

positive additional came our and Reveal settings of now treatment. was this diagnosed Reveal to lower she highlights effectively left in be Reveal with for lung. weeks discovery, underwent can deliver Oman triple-negative the a line like ctDNA treatment schedule ordered in better second back a series admission, This is after a XXXX, tests on further early cancer of undergoing part used surveillance as physician program, then how of share patients. patient need and outcomes. physician The test scans I'd XX and surgery. In the story has Her patient to impact for growing nodule In for the test surveillance found with surgery. our additional which With identify had breast her the story

Turning finish the in growing $XXX XX% in revenue for slightly had the with strong to fourth range quarter to performance prenounced Slide XX% the year to on XXXX a year $XXX X. top our We and above full January. coming to in million million line provided

the the periods. XXXX, driver reached from of Turning has XX,XXX Clinical to clinical such TissueNext up been GuardantXXX full respectively, Response. for the we year newer products with growth XX% to customer experience X. and quarter to enhance and the Slide and contributions test increasing fourth continue the prior volume year tests tests XXX,XXX XX%, primary volume as in compared as

on of on fourth to reached quarter a biopharma the and increasing and become year in has has driver X,XXX testing the X. year XX%, to in the compared our the test XXXX, for our more biopharma tests volume liquid up tests of represents Slide and period. now which respectively, been major XX,XXX for this our business. XX% XX% Moving A volume full interest Biopharma growth biopsy smart major prior biopharma than platform, differentiator GuardantInfinity

especially backlog drive of will our us exploring our for with continued positions the leaders forward, active in diagnostic for deals in more epigenomics companion pipeline, Looking growth services. even robust and biopharma XXXX. our We engagement demand of coupled with potential a for strategic products believe one, partnerships,

selection some great the over at our within on few last closely improving business for of We in the strides more therapy GuardantXXX recent quarters. X. highlights Slide ASPs looking made Now

year, X is on in LVT coverage play finalized tailwind wins Medicare November, ASP GuardantXXX price also impact of took LVT Medicare to believe to a and that from price crosswalked GuardantXXX will increasing positive price We're in $X,XXX. from the the see $X,XXX continue this Specifically, of to the GuardantXXX commercial from the the to This that year. for starting payer be GuardantXXX CDx. coming for to this proposal its effect out January

increase to GuardantXXX in be range to will result, that of of ASP As we XXXX. expect a the $XX.XX quarter first in the The $X,XXX.

Slide to Turning X.

commercial growth of experience our digital end, continue serve in customer EMR that with increasing make believe a we streamlining rapid with the on oncology infrastructure. will investing per largest account progress catalyst and adoption. to excellent as We three systems year. these throughout the depth focused integrations ordering for integrating To are We the

critical biomarker at adoption where testing only bottoms growth increasing but setting Another is position of group down especially level, up driver reside. large practice level the the not the community top most patients at in

the X,XXX more across X.X to providers to oncology sites oncology patients U.S. who pathways we a specific the would target practices and recently leading Notably, oncology million benefit testing announced XXX the community with identify Accordingly, cancer treating U.S. therapies of over increase use biomarker that from collaboration network than annually. network has patients

to see continue expand globally. We offering we our strong momentum testing as

of quarter, across laboratory cell interest the Last test to England. the advanced awarded non-small an our by was powered cancer Marsden expression NHS to accessible patients, patients potentially lung Royal Guardant technology making

in future We pipeline solid already providing Lifetime biopharma and use growth. partnerships a also have exceed over China GuardantXXX of foundation XXX partnerships. XX launched generated for a for strong global biopharma

shifting Slide X. to gears review Now on

to active broad As biopsy from had we this tumor-informed alterations mutations technology, Reveal mentioned to tracking XX hundreds assays. thousands compared platform of achieve liquid we major to can by year-end. earlier, a our high XX per patient With performance to milestone of one-wide upgrading as methyl by smart

samples. accuracy low applying by maximize thousands Our to ultrahigh clinical leads machine methylation specificity of learning background chemistry and overall to we

to track quantify with cancers tumor will fraction based MRD the types test other be high able our the physicians is to expanded epigenomics technology. precision Importantly, and tumor breast will in be Reveal to for and lung available use time. CRC, using setting over currently and

Moving on to XX. Slide

biopsy surveillance liquid Stage We generated colon our breast XX% to and for This presented some data surveillance previously and GI ASCO have in in with specificity. XX% sensitivity from our at looking achieved included with already for was the and data promising at smart Medicare Starting data platform January our indication. submission Reveal Cosmos on cancers. shared X patients, the CRC will MRD be study symposium our X

specificity our combined liquid a assay Moving This in this XX% breast, clinical very we We is cohort. on recurrence X XX% with now for biopsy. on have to to with details Medicare Reveal to sensitivity look cohorts as performance data our sizable if this year. in smart This other in surveillance in exciting achieved and space. distant the blended where data indication. breast more data included for not forward our submission to favorable, this We be approaches is about sharing assessed will line this

Moving Slide XX. on to

As have for for we we cohorts many a have shared, strong pipeline clinical data utility establishing and with validity Reveal.

our are has from building influence samples XX,XXX of tumors XX,XXX rich we in running. will the that study trials across efforts guidelines. instrumental but changes in to to almost pipeline expand biobank solid have supports practice We only reimbursement not compelling and a patients evidence be variety also potential from This

submissions to support anticipate year, additional publications for This will coverage. that we Medicare potential

lung clinical pancreatic year, cancers studies Next will for reimbursement. additional important and as that gastric advancement support we validity have of such additional

turn AmirAli will update an call on business. I screening that, the now to With to over our provide

Helmy. Thanks,

Turning our to be available. Shield it's research horizon. test number launch of this test achieved IVD for to a key approval. we very business After exciting XXXX of pending for on and are There Slide CRC our the screening year still years make a broadly will XX. prepare prepare to were as development, exciting milestones FDA near-term to

data. the of our top-tier pivotal a quality been publication and in validating study has accepted First, ECLIPSE strength data from clinical the the

in the coming We expect to published see months. it

FDA review. continuing are we Additionally, make with progress steady to

review take advisory recent remaining meeting the to they next the attractive positive. of that continues in has The will FDA the now Committee panel. the milestone Advisory fill place process. the process late and on In to discussions, review likely FDA with to QX meeting collaborative Our as us informed vacant receipts be continue will be work date panel our

to of confirmation to Register. the to are the the The continue XXXX. That and meeting and in receive said, date Federal we FDA publication approval subject in expect FDA details by

working this is for is prepare Our meeting up commercial hard scale the team operations post preparing approval. parallel to in to and FDA panel

XX. Slide to Turning

expressed only has we and are overwhelming in systems. highly for PCPs a Shield the by been While by health enthusiasm short market encouraged time,

compliance Shield In of witnessing modalities. XX%, cancer the with to test, are evidence is adherence higher which XX,XXX screening. current and drive in potential to rate much of first XX% effectiveness We order the the XX% real-world completing was range its the than unparalleled

impact and individuals took screening completed the had The patients of increased Shield XX% not over Guard. Shield. screening X papers those demonstrated who of in by published at of screening overall at JPMorgan rate. setting health to X,XXX the study and introducing a a to Shield results evaluate new Permanente was shared a were the system Notably, was the X plus offered when been patient readout that Xx. CRC improve FIT This study screened in for more than were as conducted rate This randomized positive in option Kaiser study test we who As hadn't before.

physicians. Additionally, and XXX% of survey patients

We are is what do optimistic for blood-based a when about the a impact this blood can offering test visit. accessible health screening being added publications highlight test into the These incorporated routine option CRC screening. CRC of idea of and new care a as significant Shield

on over detail that, turn With Mike will our now the more financials. to I for call

revenue growth for the million to totaled biopharma revenue quarter year-over-year was for clinical predominantly year with across Precision the test Thanks, in year of of quarter. fourth testing GuardantXXX our Total clinical $XXX.X precision Total the from main AmirAli. strong same to XX,XXX, revenue XX% year quarter clinical both $XXX.X oncology revenue as million XX% Fourth year-over-year million, the the prior U.K. million compared quarter. the was the $XXX.X increasing and grew in continues to well increase compared an in quarter fourth for quarter. growth on XX% Starting driven of fourth was all tests XXXX from Slide in volume period the prior U.S. in financial be in $XXX.X quarter. This volume quarter the with million contribution prior volume driver up cancers XX% from million, oncology volumes. by the and results prior year. to the increase from XX. the fourth $XX.X as strong $XXX.X Japan

from which $X,XXX quarter, driven saw by a GuardantXXX pull-through the GuardantXXX Medicare from $X,XXX This on increased commercial fourth was capital received from in also rate interim X. October the for the in rise $X,XXX We which and to earlier coverage QX. ASP approximately approximately to increased continued $X,XXX the in expanded year in LDT, from the sequential the

QX expect in rate LDT be of X, January ASP a GuardantXXX the which the again blended to XXXX. to the we XXXX, clinical $X,XXX new the $X,XXX in fourth first Medicare As the XXXX. to range on clinical $X,XXX $X,XXX GuardantXXX the similar rate was reminder, for increase increased approximately ASP of quarter, which Blended of quarter $X,XXX ASP in the will was to

Biopharma offsetting million in fourth products from GuardantXXX quarter of increase biopharma geographies. million revenue quarter. $XX.X totaled tests impact in in tests, up XXXX. the prior the totaling year the different oncology for approximately the $X,XXX quarter. prior year strong in up $XX.X test Precision XX% and X,XXX approximately from the XX% quarter, fourth mix was With ASP, volume Biopharma of quarter the fourth the was from ASP

other million year to million year quarter. $XX.X the and in totaled to the XX% compared $XX.X compared Services revenue in Development margin prior fourth the Total prior in gross was XX% quarter. quarter

XX% in XXXX of fourth compared in the For XXXX. of Precision Oncology, the to gross fourth quarter margin was XX% quarter

and and in the gross to margin in XX% XX% tests, mix margin overall improvements tests. for the ASP. saw Oncology mix quarter Services biopharma margin The and of slightly and U.S. the changes compared clinical gross mix due we GuardantXXX fourth increase international in gross and Precision While the test in to of XXXX. clinical due was the of tests to of in Reveal other QX GuardantXXX, Development XXXX the TissueNext declined

G&A and In the million of compared reduction liability in for million onetime operating samples, $XX.X this the the expense motions LDT Net currently we charge $XXX.X $XXX.X for compared year-over-year related for research recorded judgment. sales increased result of Shield quarter fourth booking file which $X.XX due in jury's or other loss of volume revenue. XXXX XXXX. margin per a which seek of development, infringement in a a fourth a per to to we or and were in cost Total share patent the XXXX. $X.XX plan and recent nonrecurring lawsuit. charge, was million are quarter a minimal change to verdict to and $XXX.X The Notwithstanding to new share verdict, jewelry was expenses QX $XX.X QX marketing of fourth of and amend million processing and/or the to trial also quarter the we primarily XXXX, to a in million, operating XXXX overturn

full XX% growth testing $XXX.X The GuardantInfinity was TissueNext primarily volume $X,XXX revenue year. to types, in $X,XXX cancer XXXX million. revenue increased XX% XX% all $XXX.X up which across strong biopharma than driven year. by million, which in by in which driven volume $XXX.X testing was oncology also a Reveal, by million in grew improved GuardantXXX grew which $XXX.X XX% testing increased the revenue XX% Biopharma Precision of uptake compared over grew year-over-year. was $XXX.X year-over-year, approximately Turning the from XX%. was driven more Total led to and XX% of to million, million, Biopharma prior growth volume. increase Clinical an which clinical year-over-year, increased revenue XXXX. to the ASP XX% with

variable line in well was $XX.X to related as year-over-year Development to the XXXX. third as progress timing, Services Total with gross declined projects royalty was due of in million XXXX reduction and compared milestones and with other the our to parties revenue XXXX. XX% XX% reduction at revenue. in in margin XX% the to start guidance primarily This and

mix. gross been XX% quarter, oncology, offset in XXXX changes have in slight in to is by with Precision the where XXXX. was in compared product change decline XX% For in more fourth ASP The we consistent year-over-year the saw than increases margin

The revenue sales in Net Total to which services million G&A until share loss In XXXX. of operating other million, to Shield due and and $X.XX XXXX samples compared $XX.X changing of million material. expenses not marketing booked XXXX to a for $XXX.X to QX $XXX.X compared and and as Services was QX and in marketing and costs in per were Development cost LDT both onwards. XX% other research XXXX. margin was XXXX, gross from processing in sales LDT booked full $X.XX to in the the was XXXX. and development margin XXXX primarily a compared million development, the loss Shield compared XXXX and end XXXX was Net was XXXX as year to in $XXX.X XX% XXXX was expense of which XXXX. was decrease

on to margin Slide Most we the gross onwards, non-GAAP provide related will of screening From Moving margin our measures we the revenue. business. XX. performing in test this measure, financial provide which measures performance which on gross non-GAAP to generate non-GAAP clarity better quarter importantly, minimal a report on excludes costs the will to currently lab,

Shield income the of QX line screening in recorded from reminder, a providing tests As the have in cost our XXXX, development we and statement. services LDT other

non-GAAP was margin quarter. operating to earlier, and a million XX%, compared report going fourth the nonrecurring of year to expenses, the forward. gross we'll this for gross the the XXXX. year was The $XXX.X exclude screening, continue Again, both metric charge quarter were margin, quarter $XX.X fourth During which and full XXXX, the mentioned excluding important XX%. prior non-GAAP Non-GAAP reduction million

full XXXX. previously non-GAAP the year, achieved we in reduce operating For XXXX stated would to expenses guidance compared that we our

to $XXX.X non-GAAP loss million XXXX. XXXX million fourth the of compared the XXXX net quarter $X.XX XXXX. $XXX.X compared $XX.X fourth quarter per Non-GAAP to million full was expenses of $X.XX or in share share per According for for year or operating were $XXX.X million to the

XXXX, $XXX.X share was compared share million $XXX.X for per net full loss per non-GAAP or $X.XX million to the XXXX. For of year $X.XX

Adjusted EBITDA $XXX.X was the quarter XXXX. quarter to loss of in XXXX compared in of fourth fourth $XX.X million loss million a the of

compared million in loss EBITDA XXXX, was loss was Free million million XXXX. to in in fourth to million quarter $XXX.X the a million adjusted XXXX, a XXXX. of QX negative which $XX.X of cash $XXX.X of for a a year flow negative represents full the $XX.X $XXX.X compared XXXX For reduction

burn we high achieved negative of guidance to XXXX. of year previously in million stated our $XXX flow that XXXX below for from was the negative cash XXXX. negative reduce in free our full a the $XXX million $XXX XXXX, would For Accordingly, cash we year full million

at and on than more successfully our XXXX. significant the breakeven end and screening. therapy lowered fourth quarter cash short-term of securities of with billion both XXXX of of our position grow We and investments $X.X flow of marketable as cash less we while debt to business equivalents our closely in selection our mentioned, ended to and cash, reaching made achieved cash target therapy $XXX continuing Looking cash With selection target Slide in XX. of Helmy MRD burn the our approximately million

annually so look we flow burn next the X that cash to generate can which As therapy driving to profitability reach that year in to we positive approximately to XXXX, carefully the the starting with spending to we selection, of cash ahead years, X breakeven, next from managing billion. the for confident are continue years. time our cash business each by be MRD $XXX We our million flow screening will our is lower cash current achievable $X.X balance by and

and XX. Now full for turning on to our outlook Slide year assumptions the XXXX

year approval to in of contribution coverage. screening approximately growth be expect XX% FDA to from to on range timing million XX% $XXX full and $XXX representing guidance Medicare of compared which XXXX reimbursement Shield the to of include revenue does dependent not We revenue million the are XXXX. any This

to revenue when We include revenue will update appropriate. our screening guidance

to be For screening, expect XX% guidance in of XXXX, which range also on gross are XX%. we to non-GAAP we margin, our providing the excluding

million, to as Shield and a development operating commercialization representing screening FDA efforts. to $XXX well the year-over-year. expenses, on as primarily expenses of This research to million screening which the X% following approval range in be X% focused be guidance We expected expect includes continued increase $XXX and operating launch non-GAAP will of

additional in assumes million the during of XXXX. expect the net which flow $XXX for of approval FDA depending screening, cash the in adjust outcome outflow we maximum range million XXXX. cash cash free burn $XXX to guidance a color for on negative million This be To our process. $XXX on could Finally, to provide year timing some and the downwards

purchase increase by launch expect by partially used reduction ramp up to This in of we million a in $XX of approximately the for Shield. planned XXXX. $XX compared We capital equipment approximately capacity will reduce million lab activities cash offset preparation as to operating the for be of

Finally, Slide turning to review XX catalysts. our to

therapy to we Shield number questions. data launch. GuardantXXX smart ahead catalysts we volume and and As of With the of will beyond, call each for we a liquid business and in selection, approval have look MRD including for to biopsy expansion our publication that, now XXXX FDA areas open upgrade upcoming across

of [Operator Mark Instructions] Our BTIG. Massaro first question comes from line with the

Can in about the maybe nature. is largely logistical one first My it Is of meeting. for you little just ASCO provide the context more pushout a AmirAli.

said late You QX.

of label filling you the of really discussion to I should So June? And who then my around of if guess the if in request confirm question a second lot there's about attend pencil just from you're we it's can And an meeting. matter kind curious FDA? will guys -- a advanced planning AA been adenomas. is

Yes. Thanks, Mark, for your question.

need call they to members identify and so panel, is device panel through for empty So additional notified I in us as they the and remarks, to mentioned half the panel specific go fact the added of at terms go that because that mainly that was forth. vetting our prepared that to going FDA ASCO, time of the scheduling in the process be some the the and to

get somehow now as confirmed result, going it's it the scheduling kind late date, to So it's going of register know appropriate they the a at to for federal Once be are too. in we QX. communicated time,

we we kind at delay. time. So FDA believe of XXXX. other want that There that's line shale FDA about in to behind of the reasons impacting time all review get had for know approval is not the we kind the line sometime I is this time and no from expectation decision the beginning reiterate But ASCO we that the that this this

benefit review this typically be the label discussion topic I in terms AA, ECLIPSE device the in for the innings in didn't our going in performance very of get external population in this process. from the feedback to potentially interesting that late some Regarding to hot discussed the is to get to risk we've an agency. of sensitivity, patient intended continues sent think But use the seen and field get It discussion in of agency. outcome happens the we label that CRC of with opinion

of the with comes The from question Partners. Souda next Puneet line Leerink

two into wrap my I'll of one. questions

First better have guide, one Anything now for advisory side look work conservatism if that the the X,XXX just for before we the maybe Can you on at I publication level shield, be year? When this a need on what accounting reimbursement GXXX MRD just committee? driving you volume GXXX. to the business, is a maybe remind core of seems lack is note LDT, sort on And just, to require that could you elaborate FDA that? maybe then of AmirAli, the of us paper of the the for will good.

net. Yes,

the I in On looking the we a traction for -- year GuardantXXX. you XXXX I GuardantXXX. we're U.S. still mentioned in guide, of XXXX. good think being at mean, had got We've growth strong

with can lot to think that's that I that to that continue. customer-focused the we we're I are work a across expect we doing and growth think cancer And continue. still so expect of And all sites activities, that

we're now U.K. especially U.S. traction outside and Japan good And the in and also, seeing

should growth. that to lead volume also So good

LDT get an from ASP we'll X,XXX well moving the GuardantXXX now right, X,XXX. You're from with as to uplift

gross to that currently additional manage still saw an something It's want expecting though. we're perspective, Reveal We're really growth, get We that's or still a want reimbursement. last growth margin XX% negative MRD we in positive. From over to again, like growth XXXX. test us. for year. -- So with

us can we brakes and until a costs every and foot manage we so drive to And off we really it take run the the So test that. volume reimbursement. get that then time incremental we want

the questions guide. So hopefully, the that answers yes, on

FDA the Shield on the with that paper, we data the their publication. so progress through very about have and that at gone own dependent detailed paper extensive They process quickly process far. and and review at look not FDA is And do pleased

not. review they they their a got don't So evaluation, or in publication have it peer through go look published own you at

from line with comes The next question of Dan Leonard the UBS.

that the the that I last AmirAli, further on Or you an follow-up could you one Is timing can a ECLIPSE actually I was point had on in color occur there that at XXXX. of elaborate any imminent? just share? think publication expectation point. would

Yes.

that our actually, goal. was So

to think, I impacted went that we are was, process, that journal. think some pleased of the we review update that which journal the top I very picked kind tier, tier of but we

that We now embargo with are -- journal. under right

of So cannot tell I a unfortunately, lot details.

is the So based they the issue journal and scheduling on -- publication have. the planning that

So -- as the I few prepared remarks. but be it next should within months, mentioned, the

from The next with question comes Stanley. of Tejas Morgan line Savant the

that in could you, guide, you Japan what see and I the or in on a MRD. Maybe Hikma U.K. year? Biopharma addition recently then Is factoring contributions follow-up one for it you that have the OUS Mike, Mike, announced? this of In just are start to largely in, partnership we terms and traction and all to some from China

is Helmy MRD the indication, and than a on in terms guide then you setting? CRC much Cosmos at the you talked GI then remarks of publication. the of for And that of for what are you obviously ASCO adjuvant in which opportunity about revenue surveillance in where the one side in from your bigger And terms prepared things, the you, are CMS assuming reimbursement data

of Japan on international in the half to of Yes, back start the U.S., clinical year. geographies. I we and second by Tejas. not the can Japan take the the the we'll the be reimbursement obviously, breaking revenue U.K. got the drivers on we're Outside see real But side, side. last and volumes Yes, different out,

very year. So is launch online going with really to we And QX that of come then started well. last [ in Romain ]

In the traction we with the revenue to and and there, seeing that we're they'll to again, Hikma. think good region contribute Middle So the in East, start volume XXXX.

and think I Japan less contribution there. see is in to really, U.K. but looking biopharma could of China there, some the an we still But the at then line. start probably And we're opportunity

with And assuming really think to we've potentially We're good a with that, in have in online with contribute of that that lot working pipeline again, we're partners we China. a country. recently, came Adicon working I just got starts that the lab --

that's revenue during yes, contribute to so And ] XXXX our [ biopharma to going

Yes.

up the to I Very that terms once as And CRC something think we dossier I published, into of CRC surveillance we're make terms nothing, for the In year we're going and preparing push MRD, sort guide yes, But that speak. baked surveillance. think almost it's as there's data, of out can. bulk fast we with Cosmos I this hopefully, the gets don't the the of happy of it our indication. publication in think, for can as

upside all that's now. right So

of Arias comes question with line from the Stifel. next Dan The

Yes, here. you just on Helmy, thanks us for portfolio. the liquid maybe can the biopsy within questions orient smart

to half I trials terms for should want upgrade clinical assay door lastly, I mind? if that year, the just of when to in be in through tests we then I specific all wondering more within first to may, the any out are been then the second the keeping you that that are versus smart said it's I'm On if upgraded? confirm assay the and we there ongoing made be be changes half to expect and going know need that are can this Reveal, GXXX just and

Thanks, question. Dan. great No, Yes.

trials think, smart now the are to on So to transitioned, we've possible Reveal -- -- nearly the that tests on that of smart biopsies. I were yes, we biopsy, where liquid all liquid all

I there. think spot traction. good a So we're really good seeing in We're

as that assay. side a as performance think in side both the the terms of of well of lot on the excitement, biopharma I clinical

I are and transition sort of a GuardantXXX. want in view. of that think place regulatory we properly that of a around sure We make to of from view in reimbursement point we point transition the terms good

now items liquid are biopsy. see is right going major smart the XXX those tell at gating that excitement, centers So a business But catalyst major, there I academic transition. lot can around terms of and as that a when the to you out. especially that in comes for that our of We be

more the on us. panel will well mention And larger that's for didn't this to thing -- has prepared remarks, features. year upgraded the same product doing also we be been a And some tissue that and the a but in then

upside further are the year, this think, where go in volume of I think that of clinical of these A we a lot of year. of end terms could from happen sort by will transitions I later sort

Sykes comes question line of Goldman Sachs. next from The Matt the with

for one you, Mike. Maybe

hit flow individual segment. a could for sort year, in operating last of us give Just selection therapy given cash leverage maybe you in sense breakeven that you the

just trying can get spend might in a the sense this growth the around so how need Just of can selection and see that kind and assume color they in doing? grow expect you flow some areas. year grow as of you much course give of not over as for cash to of to you there I'm 'XX. kind some I time therapy profitability can of spend offset of how you're that for year. over any given Is of into flow Shield can the other is kind cash the this sort

area the huge infrastructure a selection, other Matt, I leverage Yes, now infrastructure From it think and and a it's mean, to forward. building spend. in really on the and from we've only It's and and that That's therapy on relatively that development, we're we as incremental we to quite question. marketing be Probably good going lines think, I now we've the for really the focus that increase to and marketing to look selection. research out, get steady sales really, they're elements the G&A the we consistently experience going EMR can customer only across going where be I spend laid built. that business, sales slightly XXXX, across integration. be therapy going

gross dollar additional of little on to sort therapy a dropping the to every million. bottom $XXX color maybe down million to less give is $XXX just of of burn guided or And cash overall in line the bit that more we've profit to selection. So of

been at an terms. look Roughly the MRD that can investment screening. $XXX is We've million clear different in $XXX that. More very million be to is side. still going You about than on

of There's marketing running the test, the data, of clinical the cost the cost there's generating sales efforts. and the

as still in to going And we automation, and we're So increase capacity XXXX. MRD making continue CapEx to the on million perspective, $XX side. investments a around CapEx then spend we're probably heavy on from

than flow free that So burn the cash that overall covers we've about. more cash spoken

so selection. see XXXX we therapy to will cash And from in positive start

start that bottom going revenue down I again, yes, the is a to to of lot think to drop the line. grows, as

over next So we'll that significant to start the few business cash from generate some years.

from Bernstein question next The comes Research. [ the line ] with Bersin of

Shield. on Two

and the cancer a modeled in lot you've The that chloratal and you importance the you first about the adherence study of talked that showed And benefit is, quantifying of you've screening. highlighted better today, have adherence.

and have versus aren't modalities, other still if sensitivity even best-in-class could Shield impact. quite has best-in-class that you So specificity

that the screening assume the has However, USPSTF adherence for models XXX% all used in modalities. rate past,

score class. in will some fundamentally to the to methodology used that USPSTF change the they've to for extent, well So Shield have

USPSTF? you So or laid question or share you've Are FDA for by gated second-line give on data points confidence happen and Shield. had then those first that for of for you AB force what investment any the a recommendation quick approval conversations this and follow-up that out field that will or therapy you getting have can

a Yes, Thanks. is sure. question. great This

generate modality, cancer So adherence experience of value the the or XX% rate have pleasant which the definite have patient date issue we If up would population adherence having we that screen people is are to on We not coming million test. not patient-friendly of is unscreened complete XX patients. a who from with screening. then didn't would debt have to

impact, So in awareness is high. terms of pretty the the

Director lack issue frankly, is now. kind test. are And this that of adherence, in CRC a we we've has not in former stage with sense common the USPSTF said looks the can't some field members, having We are been not touch vocal when at but very the in conversation with completing that Scientific of USPSTF advisers, of that, it screening people have been the

mind outcome of perspective when You on gains in need evaluating year terms benefits. in that you're this have life to test

we and let context what of million build in screening, Out brand, is $XX cancer put Regarding good order this and by eligible right? for are second-line very second me we a for believe you. the line getting colon through first people are getting for million are need are million line some for but U.S. There first tests. in a actually XXX in screening multibillion-dollar us. stool that this option screened general, $XXX line, is better, Obviously, colonoscopy And is $XX million, to in FDA Shield. approval

screen about So population. on million patient XX have we

are the although is indication being reduce the first-line colonoscopy not for but versus the rate colonoscopy reality all the opportunities, complementary. going Effectively, of million, $XXX and these to tests replace commercial

XX the to So second market seeing line as the a maybe it result, people. what we and is years. overall interesting first-line to for right we in are tests. these the people, with to note, what rescreening pretty and would rate say, marketplace XX% would about low, rate now be like all that thing after just rates XX the at look stool-based size size Other be low Cologuard years market million fit be happening XX%. rates over after for X Restraining adherence is is with that's for, let's testing They million for also would are expecting all are these

to it fact, we are consumer want survey again. X the stool-based matching who've showed testing, In these of XX done people don't that do that findings out they before

on to screen stool and really not is grow opportunity XX for the sticky. patient test So test a this is limited, their to population pretty million

blood-based can a patient-friendly be is enabled believe opportunity completed this in office done screening a As huge there for modality. that by the even and result, we a

we the approval. we for Shield be for line second opportunity So a a that's us as FDA context indication can huge of think even get why long as

TD line of Dan with comes question the next Cowen. The from Brennan

for Thanks Great. questions. the

just you're So ASPs back to up. there, XX%. revenue are growth going and have coming the XX% XX% your a the know on first off guide one you I is

that Reveal. what not you're in there? So and the indications of for then just breast. you just maybe you the you color, kind just 'XX can Maybe MolDX provide on in said modest for I what you provide wondering during getting one us volumes timing towards or range? in new on of baking Are can if you And those was just overall some and end CRC in second you clinical? baking in give get two conservatism But or pharma bottom could color any that the XX? would real any anything for know of very confidence approvals kind color were

relatively Yes, a maybe be the the breakdown the take Services, Development around for gross. little we different a -- swings can just flat it's expect a start XXXX. bit give that's quite the to lines. But line of guide very against a I year, to with across I'll lot. lumpy color more Yes, on On going

to line, precision did XX% around on expect, Yes, maybe sort testing, the grow we growth sort of year, at clinical we to that going is biopharma, biopharma. implies further. of the oncology see and so And which that that's midpoint the in as that some double-digit biopharma breaking last that's year-over-year. And low

we a into We have -- year strong with we've finished very a very strong the strong pipeline. gone XXXX

on I think we being a We just be of conservative companies spend. line. want to continually see biopharma impacted that by other lot

And sort this the where we're so think I of conservative side. expectation double-digit low on

those of clinical least sort revenue all it XX%. growth if at implies you And together, of put

come cadence still on that thing on of other that growth. at plenty look very could one with that we the upside And just the of So be clinical as strong revenue maybe growth.

know always of end where the the to QX, the QX. at revenue our that through that very seasonality always we as biopharma biopharma customers have know important -- that we revenue it's have in think is push I strong we in And companies year. budgets sequentially always then the and lower

we'll And GXXX So sort each an revenue QX QX have we QX, even we of of uplift it ASP overall be in throughout in the expect to XXXX. then sequentially the though grow expect of versus year, sequentially lower quarter. still to

color given on guide. So additional And hopefully, some Helmy? that that's

Yes.

with at sort get the as preparing of And MRD, least of is getting soon MolDX at terms the breast least In in those forth as publication going and that terms can. to we published time the then item submitting as really, speak and out publications and to in we'll we of submitted and CRC data. back be gating we're

that in get in months Obviously, this we XX the also last additional the a built, much catalysts to this in over terms the We I say very sort reimbursement of baked good upside if feel manage year would would really is haven't say, lot certainly of we I quickly. through unit potential general. there into that we business. think the I business about core of

of practices U.S. TissueNext. that, I to upgrades we transition, of group upside the integration, have Oncology, like in think, lot liquid smart of are. We partnerships is biopsy the large a AMR with terms potential some And the where

that's the good, feel competitive very including we So landscape there. around

The line next the question Research. from of with Nephron Jack Meehan comes

had a I afternoon. Good Thanks. gross couple margin questions. of

either Helmy, And First for for margins dilution any for Shield the Shield, what you COGS NovaX for could ] you just changes something make or volume was assume there from the are the growth gross year planning lab, the sequencing any talk to drive side? if help on is embedded? to guide savings I Mike, if for and you're [ include Or strategy? the in with wondering about implications your

again, minimal on we Yes, the Jeff, very X want we Shield LDT side, be business, focus percentage on point In where going the screening. think And like really running to gross are gross the to we overall those. a revenue I for excluding XXXX, the margins saw margin from impact tests. get something

And gross so XX% far, for of XX%. of without margins XXXX, the we've screening to the given guidance

going without really be can to understand screening. us performance what the is to people XXXX then It's volume. it's difficult to business for on the It's throughout going to going it's the screening. timing initial be volume at. on when going impact of rate start say Obviously, hopefully, dependent be the depend and FDA So to we going the then rate to also on be. that on depend is and Medicare that to and to is launch what going to going ramp be of approval the get And get what

I really manage And want think we with to that it's because mix we level. our XX% the excluding -- is all on screening least core to we gross feel it's of business that across just at that with to screening again, can measure. I margins. gross the why comfortable that's be focus So think impacts difficult But aim, margin to

Yes.

in sort And pursuing pretty would and of ] over the be In as we're think, terms others of around and going think couple we're with of making general, going some, to, of dividends that our program opportunities pay to next really say, running [ lower good COGS NovaSeq production. we especially on of years, have sequencing some as a of the I I oncology sequencing, investments terms just I And there's in overall robust tests. COGS think, I certainly is side that of such the lower some the our infrastructure instruments there the cost well. may Shield

Doug comes question next the of Research. from Schenkel with Wolfe line The

want kind ask relates a to Shield. question high-level to I follow-up and it then related as a of

things and of cetera, to say studies, medical community So And the is. or there we post to et VX of stock about there's think you case-controlled time where see clearly I out a not, it's lines, investor Guardant moving this this describe it in fair like is complexity questions is reason design, there. price VX. your from in is big level how why attenuation managing how is trial The

what what things scenario and a for scenarios, There's taking good how new really consider Even follow-up in is that off Shield CMS viewed program think USPSTF, Shield. What that How Under to payers. how go very expensive how is or a FDA, stock? you year the viewed exist that by private knew with premium go time a of you're screening. terms set can management resolutions. this do you back to on in long spinning And guidelines. discontinuing get things in folks outcomes better used then a with steps you're I the by with runway. And better? would of my do are for the you range you

Doug. question, good very Actually, Yes.

a question, out bunch and right, you're accept that, think it's a frankly. I are So there people I right. of fair

] [ ] over are with [ we show come approval hopefully, execution commercial is FDA and the status ADLT would would going performance successful that that think focus this think going I launch and and is reality I to come on common time, a VX really we've about the guys that just with huge about. talking to generate more these with performances that betting what confidence guy blood-based is screening has even becomes this on CRC talking reality of versus that seen hey, potential, when was

bars CRC are data a to big, dollar terms the be I up very bar in we seen screening would and some successful middle. of that that the in delta -- the multibillion make versus And feedback Definitely, of that there we've was was frontlining somewhere the of were a some kind accept there ended brand. what database

I can So a a different that much in management think more be done expectation in way.

that our because in that here would believe the waste doing So that I accept to like we that going I money you, would will burning that. the is commercial we you, tell terms brand don't have this no something of out to if we life Shield it with I'm I optionality the tell have bearing just not believe figure not are impact have. Shield, commitment we of be Shield. we would money. our There

always have gateways. So and mentioned we milestones we that

first is the FDA us That's first. this approval. this approval The one just and for getting FDA

in by second business proper The is we and a one trying that showing generate can way forth. this commercial sites so

years milestones that going would continue we we line dollar in meet we and add would are opportunity So those. generate as to have meet and come. P&L all the multibillion to these to Shield Guardant

pure playing So are time to not or our here. with here time Shield just waste we

We have do things life, in to better frankly.

strong a Are here. strong have very very We potential very, SPX

line the of from Rachel comes question Vatnsdal JPMorgan. next with The

is This for on Casey Rachel.

through Can And front? now those course you you of maybe year. total year. eligible accounts or how contextualize was that of for noted accounts total Just XXX the goal, number can which percentage see over XXX walk up a the volumes then scaling as the integrated, accounts were guys above us accounts on integration? end about your You the you integration talk EMR where to stand XXX things that

mean significant percentage our percentage it of we're to out of volume, but a I number break going is sort of now. right Yes. sort volume of the of

back. when and get a can much test essentially account level. to just EMR they I So retraining, where accounts we're order the a they simpler lot and are. is existing think, of on. happens lot that turn those There seeing system at we it of we're of use very What significant in a in uplift so just as pleased engagement makes terms really, life is the the results their broker

dividends there slower a we're increasing terms of Epic and on level. fast the the with the I'm this upside But the, team we their seeing sort it's of really of the we've the last end next. very terms we think in off the to progress And accounts. we're done significant in still think, pay we're accounts that good jump of made. a accounts. we as pleased pleased drivers is of so to that at And making so progress process where and very sort got those one And see also of I over pipeline at potential with of go ordering of the our of But We're to it something volume think, certainly be It's this we've days. progress made, sort rest each I in hospitals year. one can very year. the turned rates work of year has We're is that has early going as possible. and of

from comes question Cooper final with of Our Andrew Raymond line the James

Maybe and just one data disclosed the preparation on more in there. MRD breast you

I out think or see others, the about up? of How terms would or a subset of lower was we that sort some about of given of XX% in your of shedding numbers we the Just kind some stack the ctDNA. context subsets that XX% that thoughts think how certain population and subsets not? think And we love sort do sensitivity it it's of cancer of how in whether X% different there, -- from in specificity breast when

there need that current be to data included you lastly, of kind data submission. additional Is then before for any the to Or going need we you you published? And is just studies say submit CMS eventual just you in coverage? to do your see think

start question. the maybe I'll second thanks with one. Yes, for the

sufficient think does of believe I in cancer publications and very as at negative of we've this different from right, a the diversity Medicare we data there. a have subtypes, perspective, of is have on, breast validity breakdown fairly number there so much cancer, Now a or terms clinical than sort cohort, we other subtypes good well and different seen time different or we've than it breast negative points of terms larger and more good when performance for two cancer, looked levels very sort good has it's in and positive shedding to seen across triple of sizable of types you're

solves subtype performance. CRC metastases, rates. So by type. really level, on factor of sort the It's no method in of site of industry-leading biology side, same terms tumor of thing of even just think, subtype different on And really that. see, the a depending I we the kind on shedding there's the the That's

And these the results subtype subtypes typically so of potentially biology different solve But lower fact other performs sort hold at detecting that's way in alterations more you're in the detecting of X well of that's team. levels. of a those the the performs to that right levels, alterations just now, not shedding why well there's because the factor or

and your Thank you Thank for you the That today's your for enjoy concludes day. call. of question. participation, your rest