Guardant Health (GH) 9 May 232023 Q1 Earnings call transcript

Hello, and welcome to the Guardant Health First Quarter 2023 Financial Results Call. My name is Lauren and I will be coordinating your call today. [Operator Instructions] I will now hand you over to your host Alex Kleban, Vice President of Investor Relations to begin. Alex, please go ahead.

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

from Helmy Craig Guardant Talasaz, today for me Joining are Mike Medical will Chief Q&A. Chief Co-CEO; Eltoukhy Bell, Financial Guardant's Officer. Eagle, Officer join and AmirAli Co-CEO;

begin, laws. you during materially Before that material and These management statements I'd this meaning the could to anticipated. statements those results from uncertainties to forward-looking involve differ make within like or cause of call, remind we that will federal events actual securities risks

call also measures certain This will of include non-GAAP are specified a financial discussion exclude adjusted to items.

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

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

over to detail I provide an look therapy progress will in and our joining call on Thanks, detailed and outlook afternoon, for selection and the thank earnings MRD. AmirAli our at for call then you on so far on off today progress finally, our go start more first will screening. I update a Mike Alex. more And quarter and XXXX. XXXX for call. financials turn into for providing Good update will today's our an XXXX in

the with believe screening. we and are MRD of in at built platforms technology selection the have cancer to forefront in innovators the fuel is diagnostics, we Today, what coupled exciting fastest-growing leader in market therapy growth. industry the Guardant, in the pipeline long-term one we most of At

cancer, help live lives. to stages patients longer us at of healthier all enables this of All and

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she testing modalities X tumor ALK with Stage and tests from negative additional was other for Further was indicated adenocarcinoma. lung Following ROSX. that diagnosed EGFR

somatic a revealed However, entrectinib. targeted GuardantXXX therapy for a fusion, liquid candidate biopsy making including several her ROSX mutations the

of therapy, indicating to Following treatment ordered for to was which she back therapy. she responding in illustrates well confirm oncologist A doctors combined GuardantXXX response ordered mass inconclusive. an she decisions making better crucial nodules. do year the or and to was in was One tumor regimen into to story ctDNA whether reduction no detected complete to imaging not test with over power of resolution other deliver these patient treatment primary Guardant testing to XX% responding outcomes. assist the came and the Response continues Her

from Reveal with $XXX.X contributions Slide to revenue be growth X. and off year to quarter the TissueNext.. continues growing XX% the We driver with main to our strong million. Turning first GuardantXXX started increasing

notable service. to driving conditions, is and continues expansion team stable quarter the All a operations market Our delivering and focus in and market we execution, superior backdrop growth all, our by customer accelerated on of competitors. in retrenchments

X. Turning to Slide

the program followed a a representing patients. treatment monitoring, response GuardantXXX consist time is received frame. in reimbursement. for overall biopsy, are first by blood-only initiation in It Guardant our Medicare Medicare assay response the test The of for reimbursement mid-April, test we is We to receive report pleased This to for will forward immunotherapy the step major fifth that Response. testing liquid appropriate

increase and finalized pathway the for term, ADLT this test which been has we should response for medium are in further. an rate at Our $X,XXX exploring pricing

which significantly our in quarter, to Turning grow want therapy to take share, core we market continued business. spotlight to another to Slide selection moment After record we a X.

built foundation we first in the is on comprehensive oncology FDA-approved the believe have strongest of diagnostics. years, create liquid the the platform Over what biopsy, we to

Our XXX million over commercial we entire reimbursed with portfolio is include by now reach selection Medicare, therapy when covered to lives payers.

ourselves and greater customers XXX hundreds We market oncologies, a leaders, team have publications. commercial with of than established supported biopharma, ordering more clinical across over by and than as clinical and patents technology biopharma XXX-person XX,XXX all

is long-term not vision, doorstep. a at Achieving but scale our

margins revenue, reach to gross than greater expect in of XX% XX%, million breakeven generate more months. to XX% than therapy nine than this revenue selection, For of flow sales year, and total cash $XXX growth more we which six above clinical represents our with in

ESRX Slide on quarter, with XX,XXX the a mutations up Clinical prior XX% be quarter. the tests continued test growth the to driver first reached significant GuardantXXX uptake the to quarter. over continues in in approval Moving in main CDx compared for to X. lung following breast early year with our volume cancer, cancer, strong in

AI-powered, added patients growth, to we TissueNext in rapidly offering. and recent our by Reveal MRD share onboarded tissue Galaxy launch the market gained Guardant also of and Guardant the as driven

more systems. We past test to integration, in Guardant leverage, gaining are large execute quarter. processes again in ordering building continue we and on the to This investments the is in from part account oncologists depth, with due more EMR

our from GuardantXXX payers. We mix positive and ASPs, commercial supported momentum nice upward in a saw move by

We commercial from that expected addition others are discussions. Humana advanced coverage QX, in Aetna, in major the payers given the US, for during in are United and all on QX closing of GuardantXXX

ESRX been Our a helping driver and has us remaining address major CDx, to limitations. is coverage

tailwind a this of All providing ASP. is for

biopharma solid another had up We growth, with X. Slide quarter volumes XX%. of to Turning

XX% have CDx. our continue of to our also panel converted or of we to GuardantINFINITY, see epigenomic and than continue smart liquid partnerships strong biopsy-based rise more utilization mix to now and Our GuardantXXX

on XXXX. announced ramp sales in to In and later addition, we ESRX seeing target start another are up collaboration China

Between CDx with our ESR and an ER-positive cases mutation, focus a of XX% or would capabilities. ESRX breast in up breast where therapy. can for demonstrating qualifies Turning of after of tissue our develop mutation. the ER biopsy to estrogen in need patients that this cancer XX% months or receptor will With leverage With programs partners years highlight for liquid women six I a already can mutations HERX targeted a which and quarter initial have potential real testing. CDx cancer class for partnerships strongest negative biopsy on liquid positive and Slide X. that to our to cancer, yet are new Guardant emerge can key regulatory develop breast ESRX will or them an focused biopharma technical for XX% like transformational be area ESRX

development moment led team value worked our who ensure to to our have that done we Star. of get At one from to more Everything we take patient we live efficiently up fulfill a to the tirelessly how mission we our transformative like to delivery North Guardant our most is by put platforms the thank in built first. do about I'd most important patients. primary of work extensively to and diagnostics think through we helping

our quickly. that line to improve we to In our made an to our innovate to while goal effectively in with recently ability leadership balancing need effort some operate additions team further key

we including scale brings to as more diagnostics joined leverage operate running of our labs Guardant bring per experience, further way and overseeing millions year. Officer. a than two operations will efficiency, Operating as Dahne-Steuber of the tests decades her for Chief Ines Ines we new company. leadership broad Under

platform was products and allow Chudova bringing created and to us With and across leverage promoted research and Officer. single Darya Chief are newly role efforts for a together this our oncology Technology we scale our quickly to to more development screening efficiently.

and products strategic to and to leadership proud opportunities continue look team the look scale forward exciting their our chapter to our I ahead. I'm to very of help this contributions and next for forward Guardant journey. of our

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

Thank you Helmy.

XX. to Turning slide

business in as in to preferred continue new spearhead screening we patient make the good category We a progress screening market. our

PMA for for filed is FDA the Our review of screening first its process now underway. and clinical with is CRC indication Shield

in XX% Medicare but success where the from performance believe XX%. ECLIPSE also guideline screening performance, for and XX% to approval. ranges the approval meets specific and recommended demonstrated for XX% CRC a post tests this FDA commercial in requirement range above is with only sensitivity Shield FDA noninvasive other not robust coverage trial bar test the We

customer of incorporating In value feedback validates ordering LDT screening Shield real-world from our continue addition the expectations test the and physicians into menus. to our exceed

XX. Moving to slide

details Just at additional this morning Digestive our the Disease investigators and insights study ECLIPSE study. pivotal presented Week, from

cancer are trial and screening experts call with We investigators results. on their other to share these perspective host to fortunate a the

screening at XX% post-treatment. parameter. an is CRCs a Stage of survival years rate in with The of surviving high performance I/II/III detecting CRCs early-stage five have with XX% to test very patients important

XX%. The XX%. only to For IV in advanced rate Stage was Shield is CRC's detecting III I survival X-year of Stage sensitivity

spread sensitivity was be For would beyond Shield the localized wall XX%. cured of CRCs meaning which ball no procedures through sign surgical likely

distant For sensitivity nearby cancers, body, XXX%. of cancer the was distance Shield to part regional and notes length or spreads where to

of Taking of Stage Stage a II, with and detected one stage CRCs III and by CRCs detect XXX% IV. Stage Based years on a closer Shield cancer that nearly all with every curable Shield as we CRCs. of lives. look longitudinal three screening Stage XX% I with stage XXX% will many a of CRC CRCs believe will test this all performance, XXX% at save

could Three not CRCs few were a staged. be take to a and lost want to I moment details. follow-up to clinical highlight notable

a excluded they from staging of result, analysis. CRCs. As three were the Shield out detected excluded the two

their malignant staging. had procedure further the treated by and excited have five during doctor considered TX study polyps addition, hence they fully small colonoscopy no were In which

staging as they Shield. was these For by analysis, the the I. were considered one purpose detected Of of all Stage

performance. back going Now the overall to

step creating of commercially save any drive are performance This live the Medicare the detection for critical change CRC. blood-based major the confident a category. for XX% dose first requirement the screening screening successful test is patient-preferred approval first FDA a major We XX% two hair exceeds everything for coverage, needed specificity has this at for Shield new to victory test. of in our We and be believe generation and

With computing now for tests. Shield, performance the Guardant screening bar has future set the blood-based

market. to generation bring of Shield to We excited the are first

We a commercialization first cost-effective preferred time result activities relative blood-based will to clear screening. in advantage post And in approval. this in competitors have category advantage FDA new this our patient mover

to upgrades By win significant gain already ECLIPSE competitors, future on can The running technology able have platform the second we our innovation from our of our our provided ahead lead incorporate well samples. and of we first generations is pivotal we have completing Shield. been major further that study advantage mover learnings a by into

screening Stage of PMA cohorts missed blood. Since in and our were we more predominantly made analyzing data cohorts. have pleased our more well not and we powered relevant last captured both Shield signals commercial locking colonoscopy platform have cancers excise our level were testing with progress ECLIPSE, in and in already For insights. additional represented the year, malignant I'm by that I through this during the procedures development upgrading polyps performance lower very LDT with data device technology

this has set developing Guardant on aim is on the compete very moving. early are to the we'll bar and future of with already improving progress, test sensitivity. that need Based the we that with second-generation bar stage working Shield for

lead Just to new performance with will we like category. GuardantXXX, patient-preferred continue improve test to this

a of sensitivity rates Turning of Shield. to experience we effective over adherence sensitivity the completed. XX% LDT demonstrated test XX%. screening test with for and patient is of last gets clinical the XX. function real-world slide and the In rate. median unmet adherence clinical XX% than the to test continue practice rate adherence show Blood The XX of our CRC have that is a The months, tests an more both to

we to at and CRCs more XX% detecting XX% adherence, with stage. many together, a contribute are Shield confident will Taken curable that

to slide XX. Turning

making to of Shield lung path FDA-approved beyond first our Shield potentially the blood the SHIELD the are screening with we trial. will in Going first be LUNG cancer good multi-cancer CRC, screening pave progress indication platform test. for

million make our operating anticipate for take will Now, the contributing level loss pipeline this for we be FDA We on launch investment, ready ongoing talk and our next moment than successful and investments that less would milestones. FDA performance be IBD With XX expansion progress I the screening milestone-driven receiving would with by indication significant commercial for lung better on generation revenue second of to approval, will of months. from like be to and to Shield Future our upon program. Shield approval then and investments a $XXX screening deliver the cancer. contingent gated allocation about research success even early-stage

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

AmirAli. Thanks,

$XXX.X first the year our oncology revenue testing increasing XX% for to compared $XXX.X Turning in million, first year-over-year XXXX financial to biopharma XX the grew clinical to Total year our prior slide results. XX% compared across to This the in the businesses. quarter to Total of million quarter. growth for review was precision and quarter. quarter prior $XX.X driven strong increase was by both million million, $XX.X revenue

Precision from up the quarter. for million, tests $XX.X quarter totaled $XX.X revenue first oncology million clinical in XX% the prior from year

First clinical increase period XX,XXX, was the X% volume QX from of from an of of or quarter test the and increase year same an X,XXX XX% prior XXXX. tests

While GuardantXXX significant and we continues uptick with be than volume driver cancer XXX% lung and TissueNext. growth the revenue also both more Reveal strong to saw growth continued a cancer, year-over-year in in main breast in

was Blended payers. $X,XXX which ASP towards $X,XXX, in was end above supported ASP to and ASP blended by approximately GuardantXXX quarter First was QX top XXXX. momentum range expected $X,XXX slightly our commercial of mix positive the the clinical from of

ASP both from Response tests mix XX% the influenced mix the GuardantXXX to reminder U.S. and quarter. a million as the between $XX.X revenue lended As for quarter first between million by volume up prior clinical clinical year Indiscernible the Reveal well and of be as overall will totaled from in biopharma international. volume Precision TissueNext $XX.X continue

first test XX% first the was $X,XXX tests with expectations. in our strong primarily XXXX. agreements million was million approximately quarter was totaled XX% quarter in up quarter which higher volume first and with services the Development $X.X approximately up for from the Biopharma by the quarter. of totaling revenue year other quarter prior Biopharma partnership first line prior $XX.X X,XXX year in revenues in the ASP quarter, from driven or

a same prior in year was XXXX in change year. of margin factors. The profit Gross XX% XX% quarter of first prior margin the driven profit period compared to of the for Gross compared million of the gross was number $XX.X to by million the the was gross $XX.X quarter. in

biopharma volume than compared Response. increased This oncology, the For Reveal XX% due between due revenue to XX% QX changing as the and the faster revenue $X,XXX in in was in proportion precision margin as gross clinical XXXX. growing to first clinical was mix coming blended the biopharma and to $X,XXX quarter clinical from revenue reduction from the well year-over-year TissueNext ASP to change of with

development services QX the XXXX margins of for margin a of currently processing market in other onetime in of margin to samples XXXX. of Roughly in first for of the our the partnership LDT to X/X is the are margins the continue Shield more incurred of XX% the Development cost QX approximately year. as gross in to part one XX% overall influencing to related the still with and our many we we our the Despite expect gross quarter to gross agreements XX% remainder decline factors XXXX compared booking which activities to of revenue. be due remainder cost decline due

in was quarter $XXX.X QX XXXX Operating first or $XXX.X million of expenses or first $X.XX first $XXX.X share per the XX% the per increasing $XXX.X to $X.XX Net in were XXXX. million of to of the compared for quarter XXXX. XXXX share for compared million million quarter loss

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

a related the non-GAAP measures nonmarketable payments equity exclude payroll and gains compensation and As realized amortization expenses, securities employee our equity reminder securities. and acquisition-related intangible impairment on stock-based assets financial marketable contingent of of consideration, tax

income first loss $XX.X the increase loss of a $XX.X for of the million $XXX.X $X.XX We for first XXXX. the net quarter prior for per the of of were the per million $XXX.X compared of XXXX million XX% expenses quarter $X.XX income was was amortization the quarter EBITDA, XXXX operating or Non-GAAP quarter $XXX.X million expense. from loss quarter first loss for to a in million depreciation, to million in define other net tax, first Non-GAAP compared non-GAAP first share or EBITDA as adjusted Adjusted XXXX. interest, adjusted and in $XXX.X of quarter. XXXX, year and share

Taking for made cash year XX. respect reducing Slide expenses progress operating cash We've operating target a expenses, full at very our burn, the with good to closer our our and both XXXX. on meeting and burn look of

As the mentioned, costs, XXXX related first operating million and expenses non-GAAP severance million approximately include to workforce reduction. recent the quarter of $XXX were of $X in onetime

of our Excluding million in reduction $XX a severance operating this QX versus costs, expenses approximately represents non-GAAP XXXX.

well quarter last cash XXXX quarter few as outflow workforce XXXX. reduction, declined we've over the including first efficiency built Our were QX years. our the as in also the implemented driven to by was infrastructure, the in of free million, $XX first which ability in the to leverage These comparison decreases by measures,

throughout levels the full and $XXX full fluctuate our expenses, under our on year. expenses While of cash activities outflows, to down and and continue certain year, to burn million compared the goal up cash the operating with both spend could operating lowering year we outflow diligently cash will depending reducing our of XXXX the timing for manage and free to

Turning XX. to Slide

As just recent demonstrated investments cash a million and ended and the cash, marketable $XXX and workforce prior securities. in made with years result mentioned, QX I reduction, quarter equivalents infrastructure in debt from leverage we in as the

As we the nine to and months. will look progress the investing to will At six continue maximize breakeven ahead, are which we targeting selection the in towards we opportunities to we achieve large time same we balance, to this market serves next core In our principle. our continue milestones. to scaling actively align selection a our key fulfill investments with manage decade's worth stewardship, capital in investments order where leveraging we our and achieve to growth therapy commitment of are platform, in

thanks material our therapy volume coverage and pay in selection leverage gaining expansion. also rapid are growth We to

driven be by our cash in breakeven growth reaches screening. MRD two business opportunities core our in will As therapy major our flow selection

clinical technical on penetration spend continue coverage. to support will reimbursement focused our upgrades and be increasing market platform XXXX developing MRD data In to

than managing over ahead million we approval. anticipate our We XX-month next screening are period. from will the for operating screening that mentioned, the spend AmirAli very our less of As pipeline, loss closely be FDA $XXX

level early-stage the approval, performance. be contingent this approval revenue ongoing and We this ready Shield the milestones. of With will better of by beyond to made be even Shield receiving commercial successful generation on Investments will engage next for on it investment, FDA and deliver significant expansion lung IVD cancer. success launch we upon progress indication with FDA

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

to million guidance, revenue XXXX. to XX% to million revenue full to We compared compares our XXXX a healthy approximately $XXX of of our growth of our representing be This clinical expect $XXX reflects market dynamics first to continued the now are XX% raising million our previous $XXX of strong range competitive in year strength. the expectation This $XXX and and very confidence in our million. quarter update business performance to in

$XXX Finally, be million years. following below in improve and free approximately be XXXX as we flow expenses operating discussed, to full XXXX previously the XXXX consistently in improve negative to year expect to and cash to

will a us is goals. priority for approvals cash key commercial regulatory stewardship triggers in clinical milestones Capital as and top such achievement of line and and with R&D deploy we

turning is on to cutting-edge XX, transform to are vision our long-term slide and finally, execution. consistent And focused cancer technology diagnostics opportunities high-impact through

we up will call point, questions. this the At to now open

ahead. from question [Operator Dan Instructions] Our from Thank please you. Stifel. comes Arias go first Dan,

Medicare to afternoon got Good monitoring I decision. Thanks wanted the ask overall and Helmy, the about the that Response resistance you've now assay guys. for questions.

a of we couple contribution Can contributions down revenue you ramps. think but also and quarters maybe volume road should the as the the the about near about just that term assay talk

like treatment going some does for GXXX there's see then to impactful get being you And XXX as that the for off-label seem response. usage trajectory? Response It adoption do

And guide? just forward? respond maybe Mike think So, then your if to there you meaningful going Thanks. is curious in revenue anything that's

we It's you can as for is Medicare important question. need. pleased classes for in the very the this difficult immunotherapy in the is where I Response. of tumors indication terms an to recent We're Thanks And use the terms of assess. think the solid of all cases with Yes. oncology to be Response really largest of therapeutics for got really fill going for approval major which know one

strongly Response Medicare we that in have ahead of that hand, a reimbursement. to is lot we're now that pushing pushing aggressively. test we've be But more not very going been reimbursement a

nice certain I GuardantXXX initial test say of that of a acquisition an There's sort It's attachment rate. kiosk it's really would single a forum. a test.

is attempting And in another. so hand we'll collect with increasing really go the more and just the hand data. beginning, two this be to one And

We show test across have this -- targeted types. publications that there works. for out targeted therapies And multiple tumor

payers terms with working more and continue to further. trying we'll of Dx this so expand with certainly And in

be of move also well. as the in up pursuing to We'll trying ADLT terms status price

have both of we Mike think those ahead I'll levers I the let tailwinds us. So, financials. about of and talk And

we now guide. that of didn't the for just Response, we've At remainder of year year. Yes, guided, got when the revenue in have the the the the on start we Medicare but reimbursement anything for

added to that guidance, sort very low of the very millions. We've it's but single-digit

we're year this small amount contribution guidance. I for looking revised minimal So a this at in yes, think XXXX. But

Okay. Thanks guys.

you. Thank

next Souda from comes Puneet Puneet, question from Our ahead. please go Securities. SVB

Yes. the questions. for Hi, taking Amir, Helmy. Thanks

delivering a was talk two to do you X you have XX%. Shield is What four good a Stage at you least could What next potentially at that do next-generation So Stage for there? the to to that's from Then steps? are which need it XXX% be -- a submitted could When to about CRC? Obviously test FDA? bit the was little see.

us bringing Thank to time X Stage what's you. talk maybe and sort on to improving and market? the advanced this line adenoma just test So of of ultimately improvement both that

Thanks Puneet.

very also is are above the way CMS coverage generation reported clear needed we actually We of actually. that believe and what's this commercial of FDA we for first performance this So success pleased brand. Shield, is approval.

get the Having of to it. market it approval always going go we're by finish to take FDA improvement first have with this continuous this that, powered said and generation the we philosophy Guardant data. So to to for line --

testing that can additional first the last is another we be that the through and process. liquid blood ECLIPSE, be this best now to And be with and showcase of not samples Shield going what going running of biopsy to done generation the is

soft I detecting the are capable is class out specific team cases. cases And very a figured these technology mentioned, early-stage of of As that missing. more core our we of potentially

they were just represented It's before. development very in cohort nicely our not

we too sure the shortly finish it's SPMA mention with to pleased progress line take time first to claims. are we the are but this it we a early want generation are So, and make Still are line specific we we to excited to made. potential going and the upgrade we with this after, to going device to upgrade agency routes upgrade to work we through

In terms think clear. of I the routes it's

As a a we terms continued. -- that that you know at that in samples of That we have. move biobank bunch additional upgradability, have we strategic ECLIPSE was took Guardant

cohort. We many first our from more samples leftover freezers have in the CRCs many more

So process about to generation we and But first us line progress samples. the generation. second just the need and we then finish take make more let talk to can those this

much. Got And first quick an annual Thanks question. one expect super it. with Do so the generation? current it test you to be

-- biology of one actually of from app like when think for to and rate some CRC takes I based see a you're or minority of become look the X it next even terms in going when the really the how like actually at long at years Stage like the literature in a terms three looking you're of I to No, of that advance go late-stage of very there. kind stage modeling, on to it's -- think for CRC you stage

with performance. curable this as getting almost for that as you're this of excited is long again, the continue to here would believe better. you high intervals We is to CRC. to looking device it's age. worse. CRCs mean what test only cannot this I going be test. you compliance, better. that would at It way over That's the doesn't it done last into and every at this we bet all need detect band why with But very So are make get it better The really three time, just when run this years potential And get

Super. Got Thanks guys. it.

you. Thank

Jack, from Nephron comes Research. from ahead. question Meehan next please Our Jack go

afternoon. you. is My Thank ASP. on the Good first GXXX question

acceleration had payer So of the in range. of and covered the high $X,XXX $X,XXX end Recently you've to big wins. a lives terms

with talk you you what year? Just GXXX ASP? Can to guidance for the range claims in players it's some experience about new think better get the remainder possible assumes these curious do as outperform you of terms of of that

driver is Jack, and Yes, can Mike one. quarter I I this really improved main is from first mean, on between -- Medicare better here. of it's the the the CDx And this of test. mix at versions Yes. I the LDT ASP CDx CDx ASP the version. $X,XXX, LDTs think the this take the reimbursed

that by being or And over by driven getting that's the -- been being that towards of is some of approvals the year some mix we've FDA CDx so. driven the last

I can that positively. think So continue

that momentum going tailwinds, payer from $X,XXX. than as the to I it to then lead come And yes, start think we'll could positive higher see there claims and we see the through hopefully,

the moment just at assumes $X,XXX this guidance Our that level.

again, positive But last really see. we'll the news so had months. over And we've few

the really that well for the bodes so remainder And year. of

Great.

with on sticking Reveal just guidance. then oncology And with and Okay.

double-digit how building just And low to updates I talk about are you for would Thank think previously be how Can tracking that? to volumes the you were million Any targeting sales. helpful. you're Reveal? you. relative a contribution

been sort let focus I of Mike. I'll lot we Helmy. volume we've has mean, you as It's working a strategy that products. our of know well. the reimbursed on been extremely such And engineering overall that

we've seen with are so And reimbursed. best categories that growth products those in

being Reveal. That in very we growth see to said, strong continue

year-over-year. mentioned XXX% I think over it we was

Mike, track. very do have I to anything think add? And you yes, much And on so we're

Yes. No, we're on track.

number I the guide. in that's mains. still we double-digit mentioned think and current assumed that low We're that of still on for track

Thank you.

ahead. comes go with question next from Kyle Kyle, Our Mikson please Canaccord.

questions. don't where Thanks. rate be you Medicare reimbursement Reveal have a you you well my for monitoring Reveal and commercial well. tests the want or that right I And also other on in in [indiscernible]? as as on Congrats Hey more a to has Thanks shift And Maybe with been taking how sticky help start me if recurrent the comment Guys. on for now? setting could payers would quarter. of helpful. seeing performed Are private timing

Yeah.

We've reimbursed I what So seeing. we've very -- on been focusing more seeing we're a a mix to similar been lot think volumes.

So indication it's and adjuvant setting. the CRC the

if So of the seen existing sort kind -- we've strong. the utilization -- indications of anything the to in be continue

published making setting hopeful for of have sets. they're be on still the that, year. We're those once terms we'll of in CRC. clinical And those the surveillance data submit and some additional that positive excellent for progress to released we'll additional gets later in track cancer breast in We're assuming,

then, And thanks that. from for this included AmirAli for data X In call the staged guys. one completely in morning of Thanks five USPSTF perfect. That's Okay. the doing just CRCs. earlier Stage Sensitivity kind DDW that those the on on

were can I out know a but move cancers. into X, USPSTF would you're and those take really nuance Stage of more up would I advanced kind here that have FDA more If into account those picked you conservative guess, because.

Sensitivity those Stage much overall Sensitivity would be back you out higher. X -- If

So of I'm curious, aspect? just treat sort they that would how

early done. staging the required. treatment Hey. I looks they let there not step like I'd just the so are additional patients to are ask malignant provide it provide the but malignant details. say a like details. next and are few that stage polyps through [Indiscernible] All of more the things in they've terms I'll words even Craig Those to CRCs, Craig going

It's AmirAli. Thanks Craig.

get it's One about different of on cases. perspective things when everyone's these data, through have a to you think going to the the and assessing to

with HCC a around malignant polyps then transparency they're the histological more the FDA how they use were staged to or the we're staged not and others going managed were And and criteria that. traditional to and basis. what how How providing deal is to

have to were there's protocol staged work how them FDA to clear about in That's they quite we'll But the to are want no things way something we're see with pans just it's going and these that talk to on differences talk out. them and about. and doubt will obviously different that

Got it.

Thanks Okay. Craig. guys. Thanks

please ahead. comes Our from J.P. Morgan. next question Julia from Qin Julia, go

Hi. Good afternoon.

sense could the then test the loan next and next-generation months and expansion what's give under spend including So the a on R&D $XXX Shield AmirAli, development. over between you regarding commercial XX the million of rough us

that assume is within especially sales role marketing I you how efficiency XX-month investment FDA a million important know the adoption?Thanks… investment characterize step-up And pretty include in window? which this next does driving plays in in commercial receive we given And potential that that would $XXX the budget and you once approval

Yeah. Thank you.

adequately kind S&M activities number. more to the with And So definitely are would successful the to are we to progress and It's to actually in in that really the going so our some that R&D going and have of would embedded we kind our level be taper a of increase actually launch sales we all how investment marketing product. resources that significantly down right of on we studies side after that of make spend believe this it's that includes terms actually of not it's until IVD this forth. resourced add launch around

we really low to to samples so are of split are of building that with of based So $XXX the in that of the we R&D some about improvements infrastructure terms million are the the and that the still and I be heavy just that able side forth. doing on trials to talked on be handle technology the cost at scale able we some

enough it's really product. have is and marketing, heavy, there launch amount for actually FDA that this adequate but of So are a believe to R&D successful amounts still reasonable we very reasonable sales

ASP And the the the on as kind getting revenue we actually make we and volumes of with coming more and expect. we that meet milestones revenues increasing the

are expense. We our to going manage operating

calls, a competing as for on with would what mind mentioned Frankly are in that category. we other in seeing new the have in screening efficiency much new a completely us test are the based this players S&M not that Keep we I we we it's category, you especially LDT. believe mover blood-based first higher can running in prior be for

with first-mover this advantage going based going to have the that that that launch are FDA -- We of terms approval to level confident feel shaped earlier. we bit in are and that that the penetration in we investment have are a accounts little market on of mentioned we post market a actually successful already I we

Thank you.

ahead. comes next Sachs. Dave, Dave please Our go from question from Delahunt Golden

marketing. Hey us bit color and earlier Julia more you the sales the guys for and give color on on my guys, a part data the question additional thanks force and little of actually could And the on if sales today, ramp took in and and across its about these to the country get patients? thinking all there out PCPs -- type gets campaigns the calling media the strategy or you're it for with of anything get on touch PCPs if other Shield any there

Yeah. Again a of the even approval actually FDA few quarters time at and approval. after FDA shortly for that after

people. we lines, a as national have commercial like need going expecting the end very I of getting XXX terms time we potentially sales not about said in it we are to our large We going XXX, talked for to are team coverage. about what before to have force be that to USPS At as are was

going But and in market that of based cancer be what it's FDA we believe and after timing quarters are screening. of the seeing in that launch in time fraction blood-based that I on at to mentioned. strategy now the right number the our And few depth ordering of the for we seeing a we the actually a are

frankly. approval it it going But show team. ramp possible. the are look look milestones when leaky we confidence efficiently. than higher we will It's don't so of So do that process of test a we get people versus have and more in mind definitely, This because and the OpEx, hundreds hundreds get that of can in terms very we modalities. that actually depth and we in to efficiency really FDA need gives when at for very up commercial ordering, this not case that that execute available to a XX% selling we you go you converted in us to revenue significantly. to it's of of adherence will We to patient meet order And is the other would at our

are loss to We milestone-driven I our would earlier. the contributing seeing going the mentioned our milestones. and close very revenues we will manage to investment justified that are we meet accordingly we by number operating revenue And some step-by-step increase

Great.

Mark, Mark BTIG. from Massaro from comes question next Our please go ahead.

leader Hey, Helmy. think are on strong the the you guys. is selection portfolio obviously Thanks first therapy When question for market in taking the for we strong about you My question blood. of congrats quarter. the guys and

To gaining onto tests? then do a XXX the traction other ballpark and some XXX perhaps you Reveal. moving Guardant get platform the you to wanted of what other is you're through between assays - extent start bundling? TissueNext of think you with Response a I additional As attachment competitive then what rate And by can and some have and the sense if

manage it ecosystem and much can between from liquid the precision the where will powerful move interaction lot we with now, fall tests a of of complete has platform, into pieces the point data oncology of make biopsy their essentially place And further, where have increase the we will connection sort this So an utility. a really that the this view oncologist of smart more as really we to to different patients.

for now patients. But this we're call we're they that push essentially can that testing and seeing already in workflow this where evolution. Guardant place Complete going right button of a get through their physician sort a We one really request

be and put seamlessly immunotherapy with a they if response all now. reflex if after patients that on managed the the they can of want to want liquid so And start issue, test

of well the the those tests. we've our connectivity turning so we've as as really GuardantXXX seen very blood lot our in I tissue test strong, we're features test, but say, Response don't on. rates, out think initial broken and test between attachment I And would a of terms

market We're And is believe market growing, just actually or one itself, we strongest business taking points companies. first working. function that of is that very, taking it's is that test but our So we the get why else other It's leverage which rapidly. fact GuardantXXX the point. attached from to time initial everything not share a very have share growing that is I think connected

an good us. it's forward feeling going for time very and it's exciting So we're –

maybe we sensitivity And Great. at just is To and a XX% X Stage the FIT be get at surgically Obviously, at Stage for the in XX%, – obviously, I excellent one – X where were uptake sense but certainly exceeds light AmirAli. X X test test. through stages the the And to extent sensitivity should through wanted resectable. XXX%. wonder will what X, the incredible of of what the it look at

numbers give us think overall? sense Just for a about how to the

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necessarily is that's here of terms the why I think in most kind adoption. of factor comparative don't numbers important like So

I at. coverage. going Number get we to two, look should actually what are what are look to FDA approval, Medicare get of data – in we terms going which data at we level

this We performance those it, test generic for it, what like to all numbers our mainland for those eligible reported we've is are going are know We access who And requirements. clear. you test. know patients over are way is

When into who have face symptom. not numbers you're mentality. like if half getting with to have of early data they X exciting X X. in from the these we Stage keep smaller at just in look and I associated think it's at the cut patients any just say Stage are we don't variation see detecting are go scientific some stage, screened mind, value, let's Stage to for cancers it to there all pieces you you at when But statistical And

look What you after. Stage fraction missed of three it's X going at years When the are minority. Stage to X become a it

believe that which test a many patient applicable performance test kind for modalities. why would value. stage is exciting and test CRCs at nearly take do It's longitudinal to, and of all This that's not a curable in it adhere other lives. interface of kind and So we save would to

you. Thank Excellent.

you. Thank

from from go Derik, please America. De of ahead. question next Bank Our comes Bruin Derik

Derik. for on John is This afternoon. Good

your you were biopharma, Has order And strong you spoke some seeing their in selling any obviously there headwinds clients decisions. guys been quarter last with some So book. of improvement?

conversations balancing that So order I of going in in with that's Japan, in getting terms are out reimbursement wondering And how of how your terms was the book. finally.

No, Yeah. for are we side, think I the headwinds. when biopharma on think I some potential there that mentioned

are obviously said seen the what We considerably. do as think We're biopharma necessarily where we're haven't we terms in someone lot some will looks the we resolve of of across pipeline of this that encouraging half of multiple second happy affect with very like. resolve that doing things happy business we having with will and conversations programs. companies we're And uncertainty a volume. We're And of budgets our them that extremely are. pharma have well seeing We some year. around

continue we to business. an think important growth going to driver be this is our So for

as And similarly a big going. making conversations we're In us that business us. having reimbursement track there. and that And in also I'll well. China we good good once we're think just think think add there gets for for -- will I progress strong this yeah, business be a will still for terms a Japan, on of have And we year be we're that to

Thank you.

you. Thank

comes final Stanley. from please ahead. Tejas, Savant from question go Morgan Our Tejas

mean that patient wants tests? or fashion relatively how of the time example, in rare evening course via of look measuring your for discontinued do points out lay is that thanks bit if I versus in the tracking later, treatment period continued, response now? physician over are of guys. here. the it like on viral the Can little mind that One follow-up time an a for decision assay use over advantages protocol. a a you work you think two Helmy just those would and time Hey, longer right just for what the at Good multiple Guardant to testing you to

lot there. amongst all point other A Yeah. initiation. I utility the mean, if the you it from really out clinical time almost literature that post-treatment the of look initial at of including are tests derives

And so benefit. that's really the

If so and start relying on. then approaches, wait longer imaging -- radiographic essentially other out on you can you you're

that's there focusing the what where where So loss -- as make it's decision. using cases utility that may out be really missing clinical think any or the it's is monitoring. sort value. time know you of don't be in future utility that where of that just you're And may help the we mean monitoring almost a much kind That don't and point. of sort going by nice to in with can it's on is. in Obviously, a extensive But But the that field we -- use beneficial. see shows test doesn't fact data single

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statements make So, few to chime I Craig maybe then ask in a I here.

diagnosed when patients. of look public in like on you databases the fact, distribution So, CRC recently at staging

getting patients close. Stage patients XX. X cohort So, are right the Like it's actually recall X, I in at think Stage XX about of diagnosed XX% and pretty for in had I if this we

So, it's to kind want add? Craig of But do close. pretty you

time a a trials I small number our difference mean talking across talked collected might diverse Also trials and those US we're Yes, add. population. I you about about compare numbers study when you one. for

time. from to you at can really in to different XXXX between XXXX population get theories XXXX the about XXXX. And that into point to versus what's start it's So,

where COVID people would spot at databases one obviously things other actual screening the on talk thing mentioned, actually when a you the from as look make things. nice about breakdown, AmirAli And in But pretty in expect story delay X and much the Stage is that it's and to population. other would

Thanks helpful. That’s Got time. the Appreciate it. guys.

today. call. That you. joining concludes session Q&A us and today's for this everyone is of you Thank end Thank the

now… may You