GH - Earnings call transcript Q1 2024

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Operator

Good afternoon, and thank you for joining the Guardant Health Q1 2024 Earnings Call. My name is Kate, and I will be the moderator for today's call. [Operator Instructions]

I would now like to turn the call over to [ Zaric ] with Guardant Health.

You may proceed.

Unknown Executive

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

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

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

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

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

Helmy Eltoukhy

afternoon, quarter you and ]. joining our for first Thanks, Zaric [ XXXX Good call. earnings thank

lives our X. With Starting the comprehensive pipeline selection continuum with suite of biopsy tests, is a across Guardant on screening. leader of Slide are robust and of MRD opportunities liquid a for patient transforming cancer therapy care. in we tissue-free

front We us. are is we believe a massive just the of opportunity in what scratching surface of

cancer. the on our bold more story our our to every admission, serving action and to time In mission patients. impact fulfilling of I'd with give Guardant, a fueled like to have by everyone share line test dedication At is free from patients

his and Stage same cell for an day, he back, biopsy oncologists distress with IV In test XX was March cancer Within bedside GuardantXXX diagnosed visited came at he tissue later hospital a his rearrangement. test. the lung CDx his and gastrointestinal days, identifying up the pain. non-small the ALK-genomic That back hospital after male with results GuardantXXX a liquid given followed is in XXXX, test very CDx

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reimbursement tailwinds had X. in and Turning driven XX% volumes. revenue, XX% $XXX.X to line significant to the We as was start performance very oncology million This supported top year revenue growing in GuardantXXX Slide which as by the a growth quarter, fantastic first to on of with the precision clinical increased XXXX. quarter strong strong by well in total biopharma

from broader for and and Turning depth ahead driver nicely We growth management to TissueNext tests. number of ordering. achieved despite XX,XXX a such volume for Clinical primary quarter continued grew average year-over-year, of of both breadth newer volume increasing XX% the Response. in as Slide to X. GuardantXXX volumes clinical first test tests record driven reaching continues to contributions our of products reimbursement. also grow of continued Reveal growth oncologists, with continued be the by

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for biopharma a newest leading of tests. demand This for We see indicator lot to platform. excitement an offering, for GuardantINFINITY, our smart powered continue future is clinical important our liquid by biopsy our

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in improve field. free of all cancer. more This data us based time and years, scientific cutting-edge to outcomes to and technology largest ever the deliberately give tests in impact investments ultimately, most impactful and incredible to on our of develop from has patients proud we both demonstrates breadth made the patient in Over the be community the performed our conducted have studies to and we have some science, are order

evidence reimbursement drive and physician improve ASPs. our supports generating coverage, turn on that payer real-world volume and in which impact to will committed are to patient technology and our we We impact of outcomes. continue favorable as expand demand increase will This the its

pilot The England much to integrating cell liquid lung It identification new our progress is international concurrent non-small with launched new CT advanced at cell routine on is testing national allows look Royal diagnostic to so Slide service recently in subsequent treatment non-small may earlier closer NHS benefit and blood biopsy We lung GuardantXXX. cancer with a patients taking in England partnership This journey. our that they Marsden X. supporting receive test a even test targeted biomarker scan, patients using Now into at with a cancer ctDNA patient's suspected treatment. earlier from a care

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adverse liquid of are events enable therapy, data from the heart in physicians platform including will heart patients applications Just profound bar new biopsy can we smart for failure. months partner. detectability These prior risk predict testing to that will what as and exciting, the our handful a expect in directed cardiac that setting just we drug-induced their damage a of presented showing HERX

MRD. colon II the III has to is a share review peer excited CRC with publication looking at journal. leader review Now in our Stage Reveal tissue-free been study COSMOS shifting where X, and and our we manuscript on patients from under data to for Slide submitted COSMOS are at I'm gears that

to a potential ahead for to year, the coverage of additional remainder the anticipate Looking we colon breast Medicare support submissions publication cancers. and will in that

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

the seeing the than by in we by XX fueled but today. segment, are we than this that clear out such market, enormous survivors tissue-free We market MRD in market. more the million are solutions, as market be are this A fact from surgery. cancer to X greater are years option the excited only said, Reveal, addressing leader the significant will not only tissue-free MRD in key That the demand

year. states several it starting at bills margin deck Even important believe with this is we volumes we to this with burn passed the excitement, ahead are now biomarker for to is bills, gross improvements our enactment ASPs. Reveal of time see minimize have closely additional hence, Reveal of very impact the reimbursement and possible positive. until XX cash with on Medicare Despite other biomarker manage states

tests. are some of for to well We bode our future still see commercial of the will process that tailwinds in early starting coverage

initiatives in also are Reveal. progress our We reduction for making very the COGS good

lower term, expansion. COGS margin improved confident accelerate MRD us As volume an and milestone MRD for a gross margins that the be minimizing in we to in achieve in result, are greater burn significant making ASPs, important XX% with This gross positive long business. we with will XXXX. and than will enable be over expect greatly Furthermore, Reveal our cash

LBTs. the final planned April related FDA to the its rule On oversight issued XX, of

tests team as The New work to is to rule, fact exemption New we us tests York the approved, outlined we regulatory our the largely consistent our exemption now. that state State, rule the our from through premarket by While review with to are continue operate approved expect this it expectations. for do given key to allow details York would continues an of

biopsy a CGP first across As reminder, tumors. FDA-approved solid CDx the GuardantXXX liquid for was test

to Our positions rule. aspects We to continue proven FDA of tests into guidance the numerous effect. with the look final arguments offer when to to high-quality rule clarify help us final goes track follow-on the the FDA forward record

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

AmirAli Talasaz

Helmy. Thanks,

way the Shield within test significant our with line with strides And best-in-class blood market. Shield category see our of a remarkable at any continues to do making blood the competitor we the CRC as lead screening establishing we first-mover in in time, credible advantage. are sight. We test not this new be

the was the Medicine, publication world's XX. of Turning quality This call, data positioning the leading ECLIPSE Medicare of us endorsement our for blood reimbursement, to reimbursed a from Medicare milestone study reviewed major the was strong of clinical published potentially Shield England benchmark journal. for FDA-approved pivotal a in Since become and our Journal to CRC peer New This earnings meets last test. data the data. first the Slide screening medical the

Turning to XX. Slide

a media, consumer excited interest and from the evident. this in close a such others, NPR, Following recognize gap. it providing of such and brings New the Journal screening outlets advocacy England the step attention leaders. the groups blood publication publication value to we to many in helping Many and this patients The choice New York test an With Associated for Times, to of is from us new the of one as see were response potential as closer opinion significance Press, Cancer very enthusiastic Medicine, and Colon Coalition

Moving on to Slide XX.

May continues review next progress. will review panel and The collaborative process to interactive and we take Advisory FDA will steady be of meeting continue XX. make with Committee the and milestone positive, on the be Our place process to

hard get prepared Our team incredibly ready, well panel this to we has for worked are meeting. and

from broadly the operations, years parallel, prepare of Networks. in we including after to this seamless approval. launch years have experience enhancement are so LDT, Phlebotomy Armed to customer ordering FDA we to Shield of XXXX test fine-tuned experience with eagerly available. In of it's National and make exciting access research After digital Shield development, and anticipating expected of X our shortly IVD commercial

this XXX best paradigm. to for million the the average-risk having positioned unscreened deaths screening evidence is includes which important XX, broad Turning that unscreened occur with XX. Approximately the blood XX% unscreened this There test stool-based believe the to individuals is within million CRC-related a Slide to group XX the individuals. of And age that opportunity of menu population. are available is CRC between of this clearly decade. We a most transform real-world shows capture reaching opportunity. And over to modality XX

XX majority National that and blood the This months into test test blood million XX% annual last unscreened on population a draws, by from XX% on Interestingly, people, an care of a findings the in health with We CRC been blood their fact, had have has us during believe screening their above last XX Health Interview getting of screening system is months. these XX care. the doctor draw because addressable tells in of based that existing individuals Survey. the making blood-based XX age nearly group an the engaged is, obvious fit a routinely seeing

with our importantly, More tests the Shield do, ordering years, complete they past confirms over LDT test. real-world PCPs when this are over X patients experience for that the XX,XXX test. And enthusiastically

Shield than to of continue rate an see incredibly XX% for more We strong adherence LDT.

to alongside participants test had results other showed from of to choice Kaiser improvement X,XXX second Moving care option CRC Permanente a individuals, was when or colonoscopy screening previously modalities. outreach unscreened of standard FIT X of were Shield. in on groups. than Slide added was group perspective Shield given Through and the participants telephone rates One into a A offered significant randomized more the randomized XX. study group

that shows increase that expectations. even levels increased screening of menu study was include exceeded blood has the rate dramatically demonstrated threefold, This while options screening the at to blood compliance by the opportunity tests. that initial This our nearly expanded to the screening significantly

be eventually Shield tumor Shield to screening broader address of for excited paradigm our We assay. with the very landscape continue screening the near-term more CRC the to to about addition opportunity cancer the types transform to and

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

Michael Bell

AmirAli. Thanks,

results XX. rates otherwise unless provided Turning reviewing to QX year-over-year XXXX. a for will I'll Slide financial start All our by growth on be basis, noted.

in very driven which oncology testing revenue precision revenue. due XX% growth tests both in were oncology expectations. significant increased XX% our with XX,XXX to Total $XXX.X biopharma XX% to pleased grew by from quarter revenue, first Precision very line We and grew clinical to million. for $XXX.X million, revenue clinical to tests, which to XX% clinical test strong $XXX.X million our you, increased with

year-over-year across the from solid as a U.S. contribution saw U.K. well all as Japan we volume GuardantXXX, in and For growth the cancers volume

volume from quarter particularly Precision strong for biopharma which XX%, million, tests, We we first revenue reflects and both in also saw continued Biopharma year with. up strong volume $XX.X Reveal strong, was oncology tests the entered up pipeline TissueNext. totaled X,XXX test growth XX%. the totaling the

in well We with continue to the expect revenue biopharma environment. to low full and year change our macro the biopharma adverse business the conservatively teens for potential forecast to grow to biopharma perform XXXX, upside assuming no

development line our Finally, revenue in and $XX.X services other and with totaled expectations was million.

Slide XX. and clinical incredibly had reimbursement to an to year. mid-XXXX, to the we've consistent start strong and Since improvements seen Turning ASPs

] increased X, rate [ January on LDT year. the Firstly, to $X,XXX Medicare review crosswalk our following CMS process last GuardantXXX

XXXX. impact the coverage commercial seeing the had we now we're Secondly, of GuardantXXX in wins

in million significantly higher QX In previously XXXX, revenue an last $X for year in upside approximate cash performed was resulted had quarter. the which accrued, than collected test we

improved in QX range forecasted In we $X,XXX our to is the trend, be increased to $X,XXX than for higher addition, of $X,XXX, to reimbursement the due commercial GuardantXXX to range which ASP of $X,XXX. this

the year GuardantXXX We will be this the range. for in ASP new full higher expect

Finally, we for XXXX. first Reveal, received in better-than-expected also TissueNext Response quarter commercial and of reimbursement the

quarters. future more upside to received While we see these points tests, potential ASP a consistent QX in still need reimbursement for in reimbursement the to trends

target long-term top feel hit ASP Although earlier ] reach breakeven. flow still anticipated. as our our line cash bring it's on our achieve track time as well company-wide targets Day line [ early at This than are potentially was out Investor to we to days, we presented achieved originally the forward we

non-GAAP on measures Slide XX. on Moving financial to

reflects XX% businesses, excluding and margin, in to was gross screening, an in MRD of first selection which XXXX. the Our our quarter improvement therapy compared XXXX, non-GAAP XX% QX

XXXX, reimbursement and we managing gross quarter the of XXXX a we XXXX. to Reveal a proportion Even ASPs mentioned, by margin GuardantXXX broad with volume to able are in QX were to we received negative Helmy non-GAAP compared carefully driven it Reveal carries gross QX test As first improve of strong ahead in our larger margin. of currently as tests reimbursement

$XXX.X margins increased the This by prior operating QX Non-GAAP improved million, primarily significantly $XXX.X expenses reduction of a to was year. lower decrease from of $XX.X loss in last study our loss expenses, operating were costs completion ECLIPSE adjusted of revenue, XXXX gross driven QX With improved QX of lower million and in million the quarter. EBITDA million to XXXX. a following in enrollment year $XX.X compared clinical a

to cash of and XXXX. on million negative cash QX negative $XX XX first million, $XX which improved the compared burn. XXXX Moving in flow year-over-year Free Slide significantly to was for quarter

have you've range has guidance compared improvement we for seen of full XXXX. been cash revised in $XX slide, the As flow year of to which from million million, $XXX represents million negative which million to XXXX, $XX an our free the $XXX the to

The key improved drivers we the of GuardantXXX a reduction for guidance receiving are XXXX this screening commercial revised spend. reimbursement in and are

by mentioned FDA we be next approval. before, major milestones, As being times spend many our gated screening the have milestone will

While we delay previously and lower a plan, of than launch XXXX, stated now continue Advisory panel Committee maximum and cash revised to year that to screening expect $XXX the million, the Shield $XXX result, commercial our burn FDA operating in be we as meeting this million. have to our expect means approval

screening. a On the provide to screening breakdown of burn are additional for this we year slide, of investments we in included on have color also level the full XXXX cash making

making multi-cancer study, are early incurring in to LUNG well coverage, and and during we make continuing costs can research development, and a improvements prior reimbursement SHIELD and including you detection to Shield automation spend, progress we're and invest our in technology development. see, clinical screening gross As loss Medicare as to as continuing SG&A test

change gross This reimbursement per a for operations in to become LUNG the screening commercial of profile reduce as gross following enrollment enable million study us once will maximum while clinical our We year. expect loss profit burn SHIELD to investment increase will net the screening a $XXX completed. the significantly and our XXXX cash not burn will exceeding is ADLT expense in

and we generate balance with to cash by look is to to we flow therapy driving earlier, the As next that cash can XXXX investment burn ahead from current we our continuing that lower cash reach years, screening, each our achievable selection, billion. managing potentially $X.X year the breakeven by flow continue or few profitability positive so MRD which cash of to we're into confident carefully

of Now to to to compared to Slide we increase primarily XX. XXXX expect we representing turning range the million, of XX% assumptions across XX% $XXX to able make all pleased and full increase GuardantXXX the to upside year. our expect the on revenue improvements the of be the had in be million outlook that full remainder XXXX year growth for This approximately in quarter $XXX commercial to for year the due We and guidance is now first metrics. reimbursement the ASPs We're in XXXX. to

this FDA reminder, revenue a guidance dependent contribution any and approval screening from on our update revenue when the revenue Shield screening, coverage. appropriate. timing are guidance to to doesn't As include which We'll include Medicare reimbursement

our XX% to gross XX%. improvement due non-GAAP is be excluding improved XX%, in to to screening, the of to margin, range from reimbursement. of this expect commercial clinical We XX% Again, previous guidance an

the is be due to flat screening outlined. $XXX a decline. X% million operating in We've expenses, million, This the to decrease reduction I operating $XXX of in lowered representing to expenses to non-GAAP as range our just year-over-year

to mentioned, million previously $XXX $XXX as range to Finally, free be the of XXXX. negative in in million expect flow cash we

our Slide turning review to XX Finally, to catalyst.

the to selection, Shield business have GuardantXXX each FDA of therapy submission Biopsy ahead we in MolDX in including MRD publications launch. upcoming beyond, of for and key Liquid of rest and a Smart look number and areas, data upgrade our we As the for approval XXXX milestones and

that, With the we'll to now open questions. call

Operator

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

Mark Massaro

we're myself one away from weeks raise. beat X strong question, obviously, to limit the AdCom. the on Congratulations FDA and To

or expecting benefits think are in on you you of conversation of some the a not I safety of the the the that adherence. of for there about people of questions But thinking like are much as other how of as some this labeling whether the conversation patient think focus Shield efficacy a the I have and community of sense topic tone think be adenomas. well Do to lot compliance investor a patient and are the on you guys ahead? label and advanced the questions will focus setup meeting? a are the or focusing And

AmirAli Talasaz

Mark. you, Thank Yes.

We point to are excited this to of review process. the get

measures In weeks away to the a couple topic terms get is to meeting, agency we just the those by are and of it. going all of actually published days from X agenda, prior and

question. of reported we excited we materials those it working and conversation the detailed been get confidence go. when And and performance about get provide are hopefully, registry meeting we of at with to to going team they how in federal quality to study high see about to of the quality that some that So to hard ready public, has that put the very this are we've would more become kind and insight device panel, published that the go done, to and this our your point

Operator

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

Jack Meehan

focus have on to GXXX X I questions. wanted I here.

on The first ASP. is

$X,XXX. to So $X,XXX

drivers I was or it start were the you Were stood that guiding. volume peel kind back side, stood right that about if any could indications just curious everything was durability you're you the think cancer about to $XX the of I anything And And feeling there of on than better there if out? then was growth? was that way. of out some tracking I the was there how year? if the wondering

Michael Bell

I Mike. It's commercial quarter. can really reimbursement I had think the strong Yes, start and Jack. the on in ASP we Yes, ASP,

of get from but were the payers, also all and just X,XXX We for portfolio. the LDT. payments we we commercial GuardantXXX, But reimbursement really we're that. uplift going Medicare for with pleased increase the also from really So GuardantXXX knew not saw across to that to strong

Yes, said expected the on in positive our now So we increased that range $X,XXX. the ASP. to impact prepared we've really GuardantXXX to remarks, to our $X,XXX a as ASP had

it's So per $XX test a you're about right, increase.

We the quarter. performed upside $X we was That received prepared also that million and remarks, out it so approximately of QX, said really test period, to commercial reimbursement was had in But $X last you of ASP second out, we really rest strip if the half for that the of GuardantXXX that performance flow million an even will in year. increase was year. we the still think in related the strong that, now in through that the for in

Helmy Eltoukhy

of in just And with saw fantastic in we a really I volume, bigger very how remarks, obviously, all is, some right I the to we the quarter. growth essentially are really getting in be given it XXX. terms widespread initiatives for really think across half and percentage the and bodes said growth But And terms the the been well, it in breadth say, saw way. start is. would growth we've of was that taking both started prepared obviously as of was our look GXXX indications depth, We depth I for a think of the year, pleased off especially of second

up. volumes International are picking

have depth accounts with then been we've We're doing all EMR We really lung the think, the started. start NHS of And increase those patients. in just sort with EMR seeing, our in cancer work engaged XX,XXX considerable getting as they is getting I the integrations. engagement

driver of the And going think couple a be that. I so it's And growth years. of next some to nice up picking we're for pace of really the

Operator

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

Daniel Arias

of then up to that? important ASP it use you out holding especially as back safeguarding COGS this point test you're at have possible becomes Mike, as cost the that there? to that on a you MRD, Reveal or a improvement which get since some And on come target what the the extent of you're sounds for where help headwinds revenue it opening because me can getting as XXXX? point for like at and do maybe making talk to Reveal bit least the Is COGS, you spigot the and

Michael Bell

low last expect XXXX. to can revenue. we're we out I was not sort We revenue obviously, it breaking on start year Yes. the of year. for MRD said Reveal the that millions. And for that in this grow Dan, double-digit

growing and seeing are with are nice ASP. volume, We the traction the we

think different that but you we particularly revenue revenue by the products. So to... grow, breaking I if Helmy, the out I want to will don't all don't want be of know,

Helmy Eltoukhy

see, Yes. I I tremendous volume out there. mean think I No. think, we

As I remarks, are cancer years surgery. prepared survivors are there XX said in the out that million X from

ASPs And really seeing them an are untapped really really population. are kind especially And there, We're sort volume out suitable Really, has major that are latent the tests population. so no is. demand where today. there getting the that the in of there sort to for impediment and that much are of so where of been COGS

these surveillance And once we're and all of initiatives. that through CRC the will of reduction get some likely COGS be much, we much improved indication once

to in nice very the good we of putting yes, of feel volume. so we'll gross ] that we're and we terms be terms our positioning really off the see margin positive, are. once our really, and taking terms beyond. in of looking gross the But [ volumes And And governor now in profile pedal metal really where in 'XX margin the

right necessarily so now, see And cash. don't burn a we to need more

Operator

The next Donnelly question of comes with the from line Citi. Patrick

Patrick Donnelly

you are at moment. they're bit, same holding just volume you Helmy, time just there, expectations nice taking way the on quarter. I at terms XX% about impact. not Certainly back curious Can the while some know volume given you MRD the our growth talk of in year? the clinical what volumes following through seeing in little work you're maybe the the the one up there, a guys profitable volumes

if great year. just the that saw the be away as clinical So the what and in would work it through we MRD outlook just again, balance you through quarter could volume, and the you talk

Helmy Eltoukhy

of I with mean, year We're we're Yes. across lines. all all types, the the No, tumor very our clinical in start volumes of board. terms across growth pleased product the seeing

we're where going. that's with very so And pleased

Reveal those just getting nice sense mix for of of the think some volumes. us I the in is managing

of EMR I so for is I as have, integration, growth And initiatives I some the the which think think are, we us some of said, thing major the stuff. international

excited half a liquid of And I very biopsy year I smart what think then is this think, we're about, second transition.

sensitivity, We need of that, is what and still market. are a that well seeing patients' are that. Obviously, best-in-class from we're lives. but that there's Even we're really in do competition have the and save major saying terms biopsies flows, turnaround that differentiator liquid ebbs the really before time, current a products in the really we to doing from to

start are profiling doing and of tumor smart from all test liquid we've really had and really sort new difficult that going to as colorectal. breast, the that transitioning hasn't overdrive of the do the from of whereas the in we been strong what pharma types, think raise the in tissue, expect data of market, biopsy, to that really with especially conversations outside as into is demand in and we that us useful capabilities that smart in going really the epigenomics exciting we're AACR bar at that been biopsy, But considerably of from around terms once things physicians out and in their some has terms seen comprehensive we've put liquid I to call, highlighted in lung even the sort is of to genomic of

innings. is think its and in there volume epigenomics we catalyze will lot that a liquid biopsy sort of of out so early that And still still and smart

Operator

question The with comes Ji from line Sung the next Scotiabank. Nam of

Corey Rosenbaum

on This is for Sung Ji. Rosenbaum Corey

FDA a to that come there mentioned Would Shield for the your commercial timing materially timing additional into your delay is of And XXXX. following strategy likely one you that? update in have insight USPSTF So approval? peers impact yesterday with in more

AmirAli Talasaz

heard about [ tried to find that we ]. a We we actually would can see confirmation. so if Actually, Yes. fine

no has In process think delay that USPSTF to their sometime intending and CRC come should are draft out this for indication given year. fact, screening plan, they continue to research their

on talked weeks, in website field But website. if couple of plans of are fact, research look going research during a their the -- road got you the In to at last published draft their terms about. the map that [indiscernible] new we we draft few actually

milestones look milestones the getting to of and some we 'XX going guidelines. the one at actually our of the some of In expansions before USPSTF to are terms go the of for is expansion, through we

also American this to cover good bunch [ sometime to you screening states announce in opportunity, adoption a CRC in XXXX. test would ACS. mandates and the the hopefully want also some That state-level field, of importance in to Society guideline that by recommended a be stories are of of this I saw open reimbursement ] maybe that they Cancer expecting catalyst take we ASP tests have

Operator

Subbu question The from is Guggenheim. line next with the of Nambi

Unknown Attendee

] Subbu. Hong Brandon for on is This [

GuardantINFINITY? therapy anticipate of immunohistochemistry of with level PD-LX. that terms Do approach to we protein there. general a the you are kind other or comments combination markers offering for offering selection, some of feedback NGS around this competitors IHC, kind any In And some got at just besides addition in capabilities combined the of outlook

Helmy Eltoukhy

what about is the INFINITY think is difficult to Yes. to if exciting something that not is that thing the I works thing that requested. I And add mean I do in a it even menu it's tissue, we're can see test. of Obviously, INFINITY do the applications seeing terms difficult And of are to frankly. with blood. in the in some tissue we

can what it. But added We're we've like the -- we're and the in tissue what anyone the do about so just platform. can adding some that things base is layers, Guardant do. market when of commodity things that breakthrough only in can terms we if those PD-LX, that's And talking we're add world about you're needs talking to of

exercise. simple fairly So

Operator

with of from Mikson comes the Genuity. Kyle question Canaccord next The line

Alexander Vukasin

This Kyle question. One is for Alex quick Mikson. Vukasin on

released multi-cancer a single cancer, extensive and you over proof believe wider between how is, screening are yourself point a one a time. growth in multicenter you that build test point going be could could I in historical to Galleri discuss, here, different scale? So besides of you different revenue information -- way, just -- also, do saw the Grail, that Shield? obviously, on Form Form And fact, [ XX, successful pretty regarding kind guess could, blood-based XX versus they a in the these their obvious, ] recently

AmirAli Talasaz

Okay.

setup to make pathway those other population up on those believe you wide terms filing. of we have a sure what can but for XX-Q and you hard So be of a technologically But really do general, multi-cancer it's scientifically, kind do to simple screening is blood accessible would comment need in the companies to test, detection, innovation early with open in to markets. landscape,

lung study, our a our like some a indication -- CRC and colon, making of review over pillar point lead detection force cancer screening going into to we then to of transcend about accessible. think with market kind pathways cancer reimbursement, for other from pathways is more start applications. and I you working expand And cancer confident you're like But and are the and really for this single multi-cancer that time, that getting are doing got just types the early strategy to on really lung for cancer approval, task pathways test be Medicare

I would [ time over there pan we'll MSAT that other FDA and reimbursement, path barriers, for tests, out. think many, ] many how strategy are see

Operator

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

Yuko Oku

call regulation compliance for expects for Tejas. review affect is certain with effectiveness safety basic may are The test and that currently there that LDT marketed profile. FDA Yuko the premarket notes This on modifications recently LDTs finalized generally if

a Given into headwind as tests as would go gross be time, development, medium-term under changes test rules bps role? like assume improving the it algo finalized you this effect? to multiple would go follow-up, versions, And constitute modification performance quick over to a XXX XXX future think margin in also, then GXXX fair about through or

Helmy Eltoukhy

CDx think usually out borrower telegraphed. I was maybe than something have framework. GuardantXXX the sort under sort FDA the think that the largely is is little under that of if anything, software we a multiple the FDA. what which are I expected. rules that done we framework bit FDA of came has upgrades GuardantXXX from is is And CDx, been to lower We've of upgrades, Where

And very that. have so operated under we familiar with We've capabilities. those successfully We're it.

so way impact. has our It really a of change almost business. in yes, not in very minimal any this is And terms

Operator

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

Daniel Brennan

strong quarter. Could clinical on said you overall, had bit we felt just a in conservative Maybe the give just bar. moment. you volumes after zeroing a us like a reasonably on like last growth Congrats and our came my little GuardantXXX year, really above expectations, a guys clinical in sense, for a

color quarter you're wondering, of Just how and the you can in the kind how of marketplace kind the GuardantXXX throughout speak seeing the rest year? we on volumes and progression of any in think what to clinical did about the

Michael Bell

the in the with overall with volume we true in line our of for Yes. XX% talk I expectations. the our about the for is same cost, I The said overall -- came -- clinical can volumes mean GuardantXXX.

came in immediate approval, we and comps. QX, nicely. more it very difficult for GuardantXXX. So to even the saw have an in year, for volume February last we're of for difficult was a know And an comp breast QX because the us had ESRX we we uptick going

growth half with GXXX in back is So harder I don't volume at continued Yes, how think going GXXX we're I year. of be Helmy... we for came volume were know, sequential in higher And to really the first the pleased still think looking we're the I QX we going growth. comp, but year-over-year to see the a think quarter.

Helmy Eltoukhy

have, a are Smart just EMR Biopsy initiatives to look, I second we're bit seeing of said, I terms Yes. international for as excited I the think we're half stick think, we in No, and Liquid of, I little going mean, transition. integration, because

off, going good general. a So year in be expected. better I think, than And we yes, started to we it's I think

Operator

Research. line The of next question Eve the comes with from Burstein Bernstein

Salvatore Alberto Buccellato

on question. is long-term ask I Eve. to of Buccellato wanted more This Alberto a for

in have already have and billion some debt companies other convertible in than penalized. You seen being XXXX, we due $X more

So cash you before that -- raise We're assuming that that. will Investor for plan need 'XX. shared be Day, that you you positive to flow in to money your don't

And this more discussion of that? about profile ahead expense options thinking you the are you're what So reducing your considering? are of now? Are having you

Michael Bell

that I at thing in with is cash next The the down we've that sufficient years, is to our first been that the cash the get traction I Yes. think we've that to we every of -- us now. to seeing year we've our got ASPs over just consistent that reduction the that would come cash And end going say pretty fact, just with $X.X level over is of the and the than saying was in and to this sort billion. get year XXXX. breakeven down quarter for burn mean, there. balance think cash few full we're in And burn I brought more in actually,

the potentially for get I earlier that think company than to potential there's we can breakeven that XXXX. level

focused really profitability. we're drive can quickly to how So on we

mean, X% convertible, of aware end the a XXXX. I as maturities it's yes, we're far it's that. the moment, As At of got coupon, well

time that know with people. having to are. think what it something the at our and we're continually the we at side. decision address comfortable right We're make I at we'll it's point and future. need you've relatively we're in on our lot the advantage want to sure balance feeling we're looking We sheet But some so to of And of options make right aware talking what moment. a do the on got that thing. But of, yes, we the But the

Operator

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

Puneet Souda

the for question. thanks Guys,

change wondering, if that your end coming to well of Shield? the maybe that on your how maybe an positioned -- would then not just with are consideration view looking there? in any this Does the of you're this terms on change will And you're seen much have a but across There progressing larger Does competitively as at the Shield is I know commercial Committee, in thinking a assay So some as has providing all competitively how Advisory asset competitor frequency is some presence readouts that that frequency be down readouts. is a the later year. later we there the expected landscape, are introducing year? marketplace, just

AmirAli Talasaz

Puneet. Yes,

the confident final to potential released a really like So very that the target, gets meeting any we days there of terms time couple AdCom, then. by before in of and and in going meeting like by are final the could happen are of And terms agency changes that kind of agenda excited. it

very are right from we literally have to going So X that AdCom just now. base the soon. all weeks We're information away final

the not is at any Shield kind now performance. we best-in-class the I'm frankly, further blood advantage. have a competitor time. if this best-in-class sure seeing we extended actually are data, first-mover of terms credible test time And And technology, In of competing like

But to inning late this FDA have at performance anybody is continue we monitor with advantage the of field. and very we have and approval, going the are anything feel with are else day. end in the of where this we we time So see we'll comfortable if to to very that here going competitively,

now even right are we excited even few opportunity a about the ago. than So more quarters

Operator

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

Casey Woodring

Casey is for Rachel. on Woodring This

a had XX%. Test were biopharma up So strong volumes quarter.

a I quarter perspective. think was funding a XQ from strong was biopharma XX%. obviously up revenue

guide? forecast the So for for to can were or there your low And hold much relative number at current through funding be rationale initiated that maybe just walk even if levels XXXX revenue improve growth? when here there reiterating us were continue levels to you to would teens the how upside where funding you to

Michael Bell

us We strong for take coming a in first the biopharma incredibly quarter. Yes, came this. can I pipeline Yes, had in strongly the year. into

And still through. now very strong. And so it's came looking at pipeline, our that

our guide maintaining biopharma. in the for we're we sort said overall prepared remarks, I think of

We half to to the we the funding ensure of really, back there's sort the potential no environment to be want adverse just impact that macro of conservative. in the that biopharma year. might Just a want cause reduction

us upside there's that half on biopharma. definitely, To in of difficult. the for the is quantify year back So

guiding our you back if think in of half we're year-over-year almost flat of sort into of sort sort year. guide, back to I the of the

pipeline So I us term. near But the have strong again, in think, looking quantify, that can there. feel the hopeful it's difficult but we to for upside yes, we is

Operator

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

Unknown Analyst

on like raise [ probably sounds Meyer see Great It a big to year. moving was higher of And But expectations your ASP to start Matt. are what gross drivers you're margin is or the some for us give gross there. pieces any the you the seeing? Wilhelm color This year? for phasing margin driver on can rest more the for the ] on other

Michael Bell

the were caused The the ASP margin. driver we pleased No, was gross on this Yes. impact. really real

ASP expectation our of we as in remarks, year. raised the And so we said remainder prepared the for of the GuardantXXX for

good saw reimbursement Reveal and also We as well. commercial TissueNext on

there year, do continue there's to potential mix. the think the margin, to gross So through bit offset we a that upside on little want of sort if the by that was I

higher we the manage. impact. Reveal pleased. we ASPs line off Reveal, the there's margins. were try a to gross We an really that to But our if improving. and as impacts volume margins brake other of to foot mix that we're mix And sight different overall, have see take potentially managing We're on could well Gross even are higher

So well I the very we from perspective. year started up that think

Operator

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

Douglas Schenkel

talk ahead. range On Shield X-year then you've interval is recognizing this and two I for that think things. is really as spend this later month? about and testing is prioritization of want asking what Two, consistently the you AdCom we Shield, do is different a outcomes way, earlier a One you product. R&D look believe said realistic X to maybe an question

is we being and to work? out If seemingly little And commentary wrong, about here And as X-year timing economics test, for is ask every pushed R&D that USPSTF I'll what you in then today? this this is second. from There's then in back a others do a been some be your happen sit the come bit. expectation and

AmirAli Talasaz

Yes.

have questions in several of here ]. terms [ combined AdCom, So

is with the in But to published good performance the that done benefit-risk vote we've reported that AdCom to the kind looking discussed that are So But in study reported questions. of as and of are going terms how we those data it. on in the we confident terms all very of terms want of the and of see panel of outcomes on of our and about there. that in efficacy they terms very of have be we profile We AdCom, kind kind to safety, everything data device probably goes. range a same at typical on presented advisers performance decide the what the question of feel in and the to we'll

-- frequent interval X-year of becomes this every even the terms I testing, years. if and more before, the In mentioned than Shield X interval test for

upside an fact, it's us. to for be going In

going in an Every So diagnostic would ADLT a pricing done, test, get FDA is annual to was but we've is terms in overutilization We process. even to believe get set, That's based set, a upside, upside not one testing the of frankly, what? year testing, an P&L. last pricing that is The on be approved land Medicare modeling Shield, downside. of an our that going it's it.

Operator

with Mason from Stephens. the come will question of Carrico final The line

Mason Carrico

been if jumping this Sorry, tonight. I'm between a has discussed. few

second Shield, your how you've a expectations a still of about is for terms in label big opportunity. So talked

in screening your to with to of continues long it opportunity. expectations as Your commitment as line the fall

their you realistic first what assuming may after position second-line look where approval. guys label, XXX,XXX than we commercially you're So better Exacted can they are year get guys? fall? a as into not. framework were ] for a I Maybe next you hurdle time, But or we maybe there is believe, in a at hurdle any [ in of next give test, that sort year, adoption you FDA for Cologuard expectations year volumes is

AmirAli Talasaz

we finish for if get of to general, expectation follow-on the take FDA conversation is approval, in Shield after going our Yes, would that what approve to be very of success but AdCom to to definition to cannot It is line and FDA and the with see the the we'll have of failure the perspective in huge And the our happens. steps. from obviously be opportunity if Shield convince a front unexpected, us. would is FDA

and the that there out open the million In which biggest population, in is blood-based second general, opportunity, market a unscreened opportunity line, for are second-line right segment terms completely this CRC indication. screening is now. patient of CRC we XX for noninvasive get And screening for

with we go why with Shield even excited the that's market indication. So continue second-line to to be to

said Having have that, we milestones.

this assumption as volume exciting we commercial is to have the is contribution. right time, of market revenue terms graph and if and think monitor we We are as going in the it execution what some And still now.

other about for the we it a approval next we I'm In future sometime factors. talk pretty of depends right at specific the time. the XXXX. in talk in FDA would year, on guidance terms of setting it sure It timing would and some about

Operator

turn that you. I over for the questions That for call the Thank today. we will any final all concluding have back time is remarks.

AmirAli Talasaz

you Have day much night. Thank good and so for a everybody's interest.

Operator

call. for Thank your all That concludes today's and now participation, disconnect lines. may you your you

Guardant Health (GH) 9 May 242024 Q1 Earnings call transcript