GH - Earnings call transcript Q2 2022

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Operator

Hello and welcome to today's Guardant Health Second Quarter 2022 Financial Results. My name is Bailey, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions-and-answers at the end. [Operator Instructions] I would now like to pass the conference over to our host, Alex Kleban. Alex, please go ahead.

Alex Kleban

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

in regarding the issued entitled these in risks press information appears the uncertainties Additional Statements section and Forward-Looking release today. Guardant

otherwise. is live that, or call events in Commission. Except whether Guardant Helmy. as to information see more Risk annual a complete for XX, For turn or list Form of to be financial as X, I'd other call a broadcast Reconciliation required and the not in on section This the that are of XXXX. conference to to include company's and also future GAAP the description, time-sensitive please filings revise certain may the and comparable like in projections ended statements the accurate information, today's December contains because XXXX SEC. the directly measures or financial August of Exchange accordance GAAP. obligation any new This law, discussion any calculated intention forward-looking disclaims submitted will year by of earnings found XX-K update Factors to only or With measures report its with the call Securities with A financial release over and most

Helmy Eltoukhy

to are upcoming a Mike LVT I the screening. XXXX line, Eclipse the update you the then and will time trends, blood data product and look progress over thank oncology live powerful launch on more provided helping call at and financials the detailed across patients for our including Good finally, will the longer call provide we stages cancer lives guidance quarter XXXX. all and Shield with healthier from our will At today dedicated patient tests. update was afternoon Thanks to Guardant, for a for I XXXX, of advanced off joining In an and in begin our her reimbursement commitment, start AmirAli an like cancer. I would across quarterly this our providing call. multi-cancer to on turn diagnosed a Alex. story. earnings In with line launches. with second rectal woman stage with And XXs

decided following to a Reveal CT she experience a to is as the Perplexed PET Because spreads were hip. oncologists received at tests in malignancy confirmed our bone. of therapy which scan This the three cancer of detected rarely Guardant scans, bone. it than and lesion bone a small, pain surgery of result scan, adjuvant three directed About rectal and scan for less to the the reception receiving millimeters bone was she years radiation recurrence. years blood from the accessing size uncommon and lesion initial of as The ctDNA, hip so can the how after full pain-free chemotherapy great test is now results her precaution of a is a diagnosis, the life. number ctDNA This colonoscopy, is hip order treatment. is very urology Guardant living cause detect can be when patient back tissue a patient Reveal. an led normal. her and including radiation, indicated her order difficult. detected example Reveal began a story and cancer-free. She Guardant something diagnosis, a oncologist ran them All to well work bone workup. and to risk Reveal increased in Following and search to Her her chemotherapy responded in new some

ended We Precision X. thanks slide of X,XXX, a on performance grew continued year Oncology our Within biopharma million, prior to quarter by XX% the with XX% year-over-year with up and XX,XXX on second XX% quarter. reached the up $XXX volume traction this, all over revenue record Clinical reached to volume tests, XX% up turning Now oncologists. basis.

X. slide to on Moving

Our when effects nicely, periods we team our stable recovery original as biopsy Diving to And navigate was from a macro below throughout growth other our started commitment leadership of quarter. quarter throughout dynamics, the stronger customer tests high-performance there positive during for We similar takeaways we May a indicators for we continues and monitor. the extend QX anticipated liquid strong of service. but to headwinds. That softness that to continue we but June had bit in forecast of sector saw QX the accelerating growth very into were underlying through bode and our remainder said lingering year. the across see expected disruptions. a COVID-related well the growth Put we simply, number volume

number both record year. a ordering in These and of number oncologists tests we are increase as Guardant Guardant in versus last average about breadth more continues time again business this last the also year gain we oncologists large Our depth, a strength of XX% ordering ordering on Since oncologists. multiple products. to reached saw

with products in including to In customers. and lead to of And terms continue TissueNext strong industry of finally, the is voice addition share in driven this our Reveal, by GuardantXXX, we growth very Response. new

X us Turning what to our help half. accelerate second clinical volumes in should and slide the

in nicely early July back up have seen in weeks. pick far volume So the we

pleased MRD, reimbursement by that are very impact that the we MolDX. Guardant announce Reveal tailwinds for of have to excited number In an in addition, for we are have Starting of critical start the received remainder to will a we year. with

Medicare We blood-only patients it an in be earlier disclosed X, gain we for stronger to be volume tailwind this colorectal momentum half. MRD the assay the As by reimbursed excellent or will believe first us Stage gives with, X week, this even second to cancer.

cancers. make Reveal lunch, for available in addition lung, will also advanced breast, our which to We in Reveal the are of and for preparing stages use colorectal multi-cancer in

are great launch. We a and have targeting progress half been second making

on important business should an of catalyst we the EMR this our a track our variety completing Finally are announced as of year in our serve for half integration for Epic second products. which across

on slide XXX delivered growth companies, to base. quarter, biopharma on partnered than grow we evident have the in in with to second X, liquid more early our was use. assay our To-date the XX% This we Guardant access launched facilitated continue of full pleased year-over-year. representing biopsy customer X,XXX we successfully are as research customer the Moving biopharma engagement. we smart diversify tests we and and ASCO where Furthermore, have power for strong announce Platform to

make focus is of into agreements d'Hebron samples with back of QX. in business. notably EMEA, of scale for a Venture. achieving strong quarter, open now our believe In large healthy this With customer biopsy, States the discussions at slide planned in half partner We the for we progress have to our we strategy outside we in pipeline lab signed markets. On the AMEA processing we year. started a Joint end global core setup Guardant the a our of Health of on X, Most United number of including of Spain for a Vall continue to in Europe liquid and the have heading purchase completed smart

partnership year. Japan, GuardantXXX offer companies of approval signed on to biopharma to And a earlier expect China, Adicon China strategic received lab year the we customers. with we this later of in CGP CDx largest receive and regulatory in one Focusing this in reimbursement to

over the All to will call of our to closer us provide now update globe I turn takes across this step the cancer patients program. another an on to to screening technology. all ensuring access our receive AmirAli

AmirAli Talasaz

started put biobank and making on to will in a to cases our of update In an build than and the where in lab timing ensure us we have good depending exact the from progress for few with account study. to since and enrollment May, of further control in in pathology we just months, continued rate ECLIPSE already position our expect are confirmation of With the CRC also ECLIPSE samples for are sometime with CRC year Starting development. ECLIPSE the range identification the enough more on XX% earnings call, we will central now have are this un-blind Based process last parallel, future and ECLIPSE in we review last slide X, data. with research readout running study of in on more we we few of progress timing to CRCs. XX% for find target away the our good to when last and Helmy. the generating PMA the Thanks we on which today, one early our continue made We've our blood fourth CRC quarter CRCs.

and with progress good making deliverables PMA also our are required other studies submission. for analytical We

review. already have and has FDA to modules submission modular the to our a which started agency pursuing are We submitted earlier

quarter by the track As are eclipse submission readout a believe end the year. to fourth result, even of we we with PMA complete the our on

Assuming successful favorable PAMA and and process then review secure depends confident pricing the and we market-based pricing. approval by rate. list charge are actually we a Medicare well-established FDA status based can and is initially ADLT on a ADLT on the

$XXX can the payers. overall we across Over long ASP term, all of believe achieve over we an

colorectal expect states payers we ACS state guidelines. are requirement The followed for FDA due Society ACS a be the number the by tests. or to screening American cover Following recommendations of to in included by recommended ACS approval, level Cancer to

XX states to follow be with estimate milestone that our best XX% that about would of favorable test Our in about ACS for could population. XX% there are covering the USPSTF A guidelines major is grading. guidelines, inclusion

the and of former we five-year lead our research cycle Under the USPSTF task rapid as we gets in process XXXX. structure, as hard matching known new FDA current level opinions modality a Shield. developments We biomedical current worked test adoption understand is performance FIT in guideline such at new of behind even established long processing on based in have the technologies as from to approval, technologies to USPSTF, can not force guidance tests, blood include screening. a and screening the cancer test really USPSTF We the is It for and colon recommendation expect lag expert members. decisions USPSTF new significant our as believe update

pleased by topic both process report urges and in new USPSTF technologies House approval. its upon to early inclusion that update utilize appropriations of language Senate are the We and screening FDA review bills

recent Marshal and Human raised are letters this which interest the we to Energy Department Leaders important issue. and United Services USPSTF from appropriators, by encouraged in of process this addition Health questions In to Democratic congressional and also about Commerce from demonstrate States Blackburn the momentum Santo addressing

I'm Turning ahead our of and to original Market to that LDT our launch of feedback great Shield is uptick a our expectations. off share Slide are Shield start. excited to LDT. initial nine the and

significantly contribute users boosting a higher the in and is XX% Our rate core testing samples, years. over first that, compliance is number tests. still-based drive real-world will XX XX% than in to colonoscopies ordered a observed blood-based of next by lab the In simple and we received rate. overall screening our compliance X,XXX reported testing physicians. over tests is rate still this much than our of for blood in adherence tests higher of Simply This to ordered the ratio numbers number adherence

We favorable clinical for evidence this for some studies systems screening. clinical CRC to are health with also year blood-based adherence launching rate generate additional

Another advantage converting our for efficiency cases. and relative order rate has enhance higher test billable margins operating by tests. this of in higher to seen marketing is significant what adherence been of commercial sales We stool-based historically for channels higher believe the efficiencies will to increase fraction

for forecasted long-term The minimum the XX. from the on readout our study. sensitivity ranging test which CRC We is slide studied XX%, about for to ECLIPSE of Medicare sensitivity required XX%, sensitivities to sensitivity adoption depends adoption from blood NCD coverage. Turning by Cologuard

robust very adoption a with around for assay sensitivity expect We XX%. an even

seen in of for sensitivities forecasting at still opportunities are such We Even there opportunity about per with year million over annual well XX CRC tests. over is tests XX%, any screening such current market. at scenario XX assay opportunity In a $X per $X significant XX the billion. revenue Under we years PCP of out, years advance research, profitable blood-based to with for billion. we are CRC year notable tests about in sensitivity have dependency an million adenoma to annual four our million forecasting about not three

studies control in As XXs a in low to cohorts. early-stage from CRC XXs reminder, previously our high case reported CRC sensitivities detecting ranged

Turning XX. to slide

tests our been screening indication. a indication, detection that but early CRC always brand. stool-based not for will build well indication. CRC, vision as test We anchor the just to detect go selected Our multi-cancer blood-based strategically lead and only beyond single this can Unlike has

our resulting in blood indications. lung high-risk We adding lung broad test to new XXXX. a our blood a Previously, be panel will individuals our year reported of of are also our early-stage cancers the indications midterm, Shield blood-based test a in we gain test planning large have case-control to test in LDT that to screen XX% multi-cancer can operate to for upgraded with cancer improve. further screening life In screening, study. By test, detect should

multi-cancer strategy about Guardant, then exciting our to accessible screening, blood-based to approval and outlook multi-cancer our for Mike with call With will compliance. tests. at while are access to data, working get further confident These in expanding I waiting building in our high building sensitive, We ECLIPSE see test highly screening for wide on patient us XXXX. over times detail our for parallel more and financials the to are test FDA now that, turn to widely

Mike Bell

Thank you, AmirAli.

million, XX% cash the XX% Total growth with of from second representing true-up, driven year million tests exceeded quarter. $XX.X clinical in the in the precision XX% tests This was to Total $X.X previously up in the total the true-up for second $XX.X Because in Note that second revenue million received million, year million of ability and the recognized. the oncology clinical million, received of from prior tests Precision included increase XXXX testing year cash compared quarter. to performed both year-over-year $XXX.X been $XX.X up quarter $XX.X volumes. by from those prior relating prior of the was where cash for a to XX. quarter XXXX, included growth revenue prior quarter. oncology biopharma for period revenue slide total revenue the sample revenue clinical only revenue was had Turning has $XX.X to million periods, that XXXX prior tests. was for quarter in $X.X million estimate improved, quarter in second our

was this the XX%. growth underlying recognition cash-based impact, revenue Excluding clinical revenue

well volume the growth an growth the prior the products GuardantXXX of reveal test XX,XXX our and new of year, again which as was clinical to quarter XX% response from is as Second period same contributed increase the next tissue for strong quarter.

the both and For momentum from as MolDX. of TissueNext reimbursement growth have now volume we coverage year, expect Reveal gain received the remainder to

revenue $X,XXX $X,XXX the for will to is blended the as the ASP was the $XX.X volume to mix the which last clinical of For products. new strong. quarter. the for XXXX, clinical biopharma second the by the approximately both quarter second quarters million quarter GaurdantXXX $X,XXX was Biopharma range year the few ASP new $XX.X be products from reimbursement consistent continue GuardantXXX test in million, was for as oncology and in the Precision prior volume blended well totaled with up XX% from ASP influenced

from approximately Biopharma was year quarter. from XX% The up totaled second X,XXX, samples second up $X,XXX, sample XX% prior in ASP which quarter year quarter was the the the period prior prior and quarter from Development quarter. the year due revenue similar Services XX% totaled was $XX.X in other mix. million prior the line with the to in second quarter product down a

impact which profit Gross were the ramp take the expect and the than see signed to prior diagnostic quarter gross Gross compared of partnership second services year. of profit while will the we milestone to revenue $XX.X be positive and XXXX half period XX% continue per XX% of the million quarter of $XX.X our for XXXX. of time continue to approximately a of in projects we services, the had successfully demand XX% $XX.X for loss to continues compared second a projects $XX.X XXXX. for we in up. year margin XX% companion second $X.XX XXXX, was the of the our quarter of new a million prior second second quarter. XXXX, to our same of of prior purchase the EMEA that second in revenue own. Adicon share XXXX be to $XXX.X to completed share increase the was of quarter million development million several in we compared million, for related not the includes the to we or second to lab quarter strong did an related in one-off Net quarter the the joint in $XXX.X loss Guardant million, And to in expenses other will lower the were that be Although, second per XXXX or development venture still year from XXXX. Operating $XXX.X quarter for compared the XXXX mid-XXs $X.XX million Health charge of percentage of Net

Health held and interest As in affiliates. XXXX, acquire a Guardant reminder, SoftBank paid $XXX.X to June by we million equity its EMEA the

million we million. result, which on price line of liability statement, the liability a sheet the balance incurred income the $XX.X a $XXX.X carrying represents the the purchase difference of final we interest million charge between of and to in the As $XX.X non-controlling were

or infrastructure progressing as primarily well operating to the on data and related generating and and both second a million PMA net the adjusted tax, the non-GAAP compared quarter development XX% employer loss payments the submission continue or investment prior oncology EBITDA per loss Non-GAAP past on million a commercialization XX Shield $X.XX the $XX.X XXXX. XXXX, data. of completing from the depreciation, to screening over our and million quarter we expense. to of test. a across Throughout for as quarter $X months, measures expenses, define investments our $XXX.X their quarter. for of were product made share for clinical pipeline our $XX.X be financial on strong of This expenses share per income Moving quarter adjusted increase Non-GAAP test, for our our second million, LDT clinical and our screening of the of the as support XXXX, was development continued to compared $XX.X to data interest, non-GAAP expenses compensation of the in and businesses Non-GAAP XXXX quarter intangibles, the and and screening EBITDA net in reimbursement. pipeline second in invest payroll continued of in of the operating oncology commercial contingent Adjusted device Eclipse $XXX.X second will other slide our products million from second acquisition-related CRC The for million XX. the consideration. in of XXXX. was multi-cancer year loss We loss readout in XXXX amortization tax focused was the excludes by amortization increase income driven $XXX.X will stock-based

balance We ended cash, quarter Turning XXXX cash equivalents to the second of approximately sheet. securities. and the billion $X.X marketable with in

on to guidance, like taken of to to At current on our Slide would have Guardant, moving measured a the path and Before our capital on I a XX. to year been approach investments discuss focused our have liquidity bit and take we profitability. to ultimately always time allocation

As and long-term and we look the will develop future oncology screening needed at the we business to business to ahead growth both support investments business. how the significant opportunities, the look

strong as operational test and built our by currently well out as have commercial fueled sizable margins infrastructure. core we GuardantXXX oncology, in very For volume is gross and mid-XXs growth which have new good the a products,

drive we believe as sustainable areas forward, smart continue support biopsy that and utilization to in clinical reimbursement. growth will to long-term data will liquid the MRD, such developing Going and invest we

two business of oncology we investment expect business approach, in breakeven and cash years. strength our reach the our the approximately flow will Given current

believe in are of and a Underpinning this our by launch amount be investment screening phase USPSTF Shields operations. infrastructure underway to these into all after reach have our ramp-up we one with necessary years we cash development dynamics, currently heavy investment breakeven Taking in efforts. two For screening, is fair the multi-cancer milestone-driven Shield followed commercial for flow screening. inclusion we guidelines that with can a that we CRC account scale a we as to LDT

allocation for to fortunate position will foreseeable profitability. cash continue the on capital to we future sufficient our in goal with and balance are long-term a the manage business We to have fund to our a actively sheet

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

grow guidance to half growth sample expect We between of is at the be continue parts now XX% Reflecting unchanged million, million with XX% to overall expect midpoint. by and , and the moving clinical of reimbursement grow expect we volume continue compared lines. $XXX with representing XX% over for to some we we XX% volume least oncology revision first as real the approximately precision Despite XXXX our grow by over to XXXX XX%. approximately and our continued performance to prior the the but $XXX between This tailwinds the previous expect of to we the from growth clinical expect to half approximately second testing by oncology business. volume biopharma year the strength over Medicare biopharma expectations, at revenue

Finally, at and $XX our note, LDT we screening this we least year. services by highly that from encouraged to expecting continue strong are XXXX. in to test, not revenue reception million of the it be revenue expect Please the development contribution are significant while other will launch we

to Moving Slide XX.

new products, LDT We our continuing for obtaining great and cancer Shield market. our into are expanding reimbursement our strides portfolio with product our the across our make test broadening screening business reach to

up will this are aggressively we opportunities the are a now cancer We will confident continuum. we we to ahead At open it point, questions. be the across that best in leader and pursuing

Operator

today [Operator the Instructions] ahead. Securities. SVB first of from Please comes line question go Souda The Puneet from

now Your open. line is

Puneet Souda

the Thanks AmirAli. question. Great. Okay. Thanks, for taking

now just first you in can is MRD couple in So time one one the on Maybe fourth if expected for said I AmirAli, line But squeeze quarter. Eclipse. a well. as

September, wondering that could still talked give about initially. part hit. you if of you So timing can know if October I October view is a that you

you XXs. or And bit maybe or could talk little think XX, a order to in this XX to wanted enough let's that say power And CRC then, lastly resolved even do targets the the So study, on of sort are pathology just the maybe for you to good and services at the all reach need point? about challenges Eclipse, is you confirm interval. low

question. I think that's major a

would get FDA, a you if the what much. the and when adenoma for commercial maintained covered Thank And there? would be could payers pricing is performance on advanced is under potentially if of then I confidence it that and interval impact gives Reveal by so MRD that there any you be great. from three-year Sort Helmy,

AmirAli Talasaz

for Puneet. Okay. questions, Thank you your

one-by-one. go maybe So, through that

readout of is our call terms timing, half, would story earnings last team content is October, continue a in September In the a has very mentioned be the still second high have the or October we What that in is likely the these, possibility. quarter good we a -- to timing before we is very fourth in of be the function still basically the October of lower confidence end the timing a would year the for exact and sure Really finding of possibility. events. number

test. Our high-sensitivity studies powered a already are for

we the are tests test target Our for blood other into study. raise effectively it There some decision for multiple about want the control to is and study the when we for of blood-based factors to down the of probability clicking skies terms bar --effectively is full in the bottom in content unblind goes the are bar really unblinding road. and

So, the have weeks these about. we balance to are it's we going these matter good that would and decision. -- talking make of But where are, a we when we a kind finding of CRCs are stuff we are all the

full the to we be readouts quarter in to it. we have the going it's going over have So are control fourth

$X.XX belief. has our -- to That's that. we do nothing is test one ADOT we three interval prices Medicare which are well-established pricing reason interval a at to sell as is process, that's used for going years. recommendation In and the over our set pricing. be And --through terms is and little to of price blood Framework cash paid be a after test our every manufacturer with testing, our testing. these to

about strategy with we and are pricing So, negotiations through to pricing? to confidence with ADLT going are and go that the MRD the we have FDA post have going negotiation status. we a CMS, About that the process very not approval getting post our good CMS,

Helmy Eltoukhy

announce disclose And and it's be we'll as we'll then, we're to Nothing Yes. also status coming at through, well I'm ADLT this sure time, able something quarters. soon. pursue the in working to it but

is that's So to still very that route open a us. much

Puneet Souda

Thanks, guys.

Operator

comes from you. Thank Jack today of Please the line ahead. question go next Meehan The Research. from Nephron

now open. Your line is

Jack Meehan

Wanted second you. category a a strategy Guardant to in comes been notably, you're afternoon. Thank Reveal for category of debate overall. when Good with you're first pursue bit around MRD on whether Guardant whether it blood little for to there's or in can ADLT focus status Reveal, whether reimbursement

if any indication your Just ADLT status Medicare? was around eligibility curious, you've gotten for for

AmirAli Talasaz

Yes. That's a Jack. great question,

As This in there's open XX a from don't kind that true available liquid it's that of -- route indications some its have certain is even get. very even tissue, ones first significant to us. that difficult space to test anywhere the have biopsy only tissue and to the

field So test. terms for the It's this moment for. open a disbursement of status is a breakthrough watershed in the and ADLT is wide a

Jack Meehan

how test a So a additional provide be this resection. to reimburse around can any test? will was time? Medicare the one will three-month test, after there for of there what is bundle reference of the color logistics then of And also then, And you Awesome. window period it

chosen? Just comment like how is that

Helmy Eltoukhy

for initial a we in on setting. This -- be dossier reimbursed. in the question. Yes, that It's bundle the is is tests is really based a will that submitted the data this great of

So, it setting. for be would post that monitoring essentially serial in

So, the string large the a of essentially within first interval time follow has three to for they would that have be performed time. of test any when months within a

Jack Meehan

Thank you Helmy.

Operator

from The line ahead. Thank go the today BTIG. comes next Mark of Please you. from Massaro question

Mark Massaro

on progress. Maybe questions. and Thank guys. questions much two the congrats for you very Hey the

and adjuvant the reimbursement confusion patient the as time there test it just Can setting ADLT both then you points? the to about you then journey wanted is, And came Medicare in question LDT that was my monitoring used screening apply of status call the clarify, the you window, are planning MRD for recurrence FDA for CRC just to second after first if in. clarify an as are you The pursuing first six some for that or repeat well I be the get that also months in can approval?

Helmy Eltoukhy

great Yes, MRD question. one. it's I'll a start with

years period multiple of But a continuing initial those are Medicare a that from CRC to for those of indications that the -- have after intervention, patients setting extend adjuvant pursue away out data considerable of for the over. can for to amount additional some is discussions with outside intervention time let's for we're say this that period time. well yes, as as obviously monitoring for So additions,

AmirAli Talasaz

to CRC, plan for and obviously before status criteria abilities for status ADLT and LDT Shield you ADLT CMS wait that and apply have in requirements. based ADLT have current need then Regarding to FDA approved apply coverage approval CDF we our our the for first, from secure you Cat test Medicare is for on coverage

Our it plan sequence coverage is in then approval go through ADLT CMS we for and practice quickly FDA that tests. current of to

Mark Massaro

you. Perfect. Thank

Operator

Thank The Brian of the from Weinstein ahead. today question William Please go comes you. from Blair. line next

is line now Your open.

Brian Weinstein

Thanks core for the to guys. the want a taking I talk just business question. little here. Hey about bit

forecast. was volume the growth mentioned You below

it reiterate new an You talked of obviously May and bit And through just Was it And on Thanks. kind market, There's the a there doesn't June competitive that being Can look what about thought headwinds just part weaker. competitive some products what third some July? was early the but you are little weaker? of was thing? in in were what like quarter? we're the guess, that on? you August that first going I industry when does again going count was out specifically,

Helmy Eltoukhy

new business strong the XXX products in We question. with very both regardless growth as obviously well. saw and Yes. Great core

remaining. on. strong full the would depth new we fact, from in on some had And macro the a seeing week And in competitive we've we increase breadth – very front mentioned that the can strong we as that half be of terms us. and of fixed a and in robust. worry we terms been gap field anything a based things in a what think we shortages close to of lingering the so of We're June. we hospitals progress essentially we're and and and in in and continuing very metrics of year And May the very confident seen we underlying mentioned mentioned pressure has space. staff think there's overall saw with then the in I general April effects the lot not So, as But COVID had

Brian Weinstein

you expect that Okay. precedent based product you've with off off had or with with that conversations you Cologuard? ACS guidelines, that already we ACS that is you expect of that And the CRC guidelines. saw then Is said based of that

AmirAli Talasaz

guideline some on that is even you history. there strong based seeing good of recommendation favorable But is recommend before that we outcome a with a approval a again of that FDA is far some so coming expected based expectation highlight out for the of of based kind of some testing. some very there confidence shows data conversation on readout study really such frequency, the we when blood-based FDA engage make. There American if But potential post us there on would is level Society with be changes They what our tests That's as probability stakeholders on approval. I a that Cancer to. ECLIPSE heard assuming . they by pivotal a even some would

Brian Weinstein

Okay. That makes Thank sense. you.

Operator

comes from the go you. question today from Please Thank Mikson Canaccord. Kyle line The ahead. of next

line now Your is open.

Kyle Mikson

Thanks guys. Congrats the the quarter. question. Hey, on for

question about parts. I multi So one guess I have

over adherence So AmirAli impressive the in XX% onsales. that the first for X,XXX me is at samples

So delayed reacting the do for on of congrats at And test similarly you it the Could recently? the not confident who was that months. reimbursement. going leaders private about guess, took then Helmy, maybe of why any group, so is And you're long early obviously by talk indications the Thanks. why then review least I future trended are like to curious that reimbursement six payers and just commercial that for like be how in adherence age by has way? they're

AmirAli Talasaz

of high blood and Yes. -- confirmation would kind weeks kind test blood seeing really tests of look of that we're adherence across patients question Thank prefer almost using ordering now like for be steady few physicians in samples, so you that adherence very week-to-week. X,XXX stuff your over hundreds

to continuing a this get But it's time quoting, accounts adherence. skis our that show obviously are based adherence too adopters the very seeing, are seeing I to targeting the think I'm fact on off stay. really stage. The at too we lot trend even our excited. that are from And quickly we we cash are don't get is want in are So but and much that we higher

adherence a programs it. to patient of see at strong really investment adherence about physician, patients make the happening sure what's symmetrix excited monitor This to are and samples. to very kind there and really again, to is navigation are about the significant Guardant, that of going the it the amount talking submit have we the reality of So happen. what's as like on matrix that a we continue huge is we going don't note patient Please

Helmy Eltoukhy

Yes.

test really delays and in forth. back some so terms space is like In MRD, this a definitely what's new of there's with the very and is existed novel

could education recurrence I required detect of tissue. how without learning and you possibly the -- diving think terms in work and into having really

we've I getting gotten mostly to space. there's that of we're just data confident we the think come understand over confidence will that have out by that be good So -- validity into limited a clinical -- where could now place in speed publication And and now very works. the

Kyle Mikson

guys. Thanks

Operator

from Thank today Sykes Please line The of next from the Matt question you. go Goldman Sachs. comes ahead.

line now open. Your is

Matt Sykes

taking have number for my of questions. my questions asked. Thanks been A

just maybe it to I'll high and keep it one level. make So pretty

the funding view? terms that private Just the years with think it I could terms given your on actually what of on the environment funding you're potential in you impact are figures ago, biopsy at look all field of environment focused there you're, in coming have guys crowded how like liquid potentially of in back that funding the biopsy the How a just the overall goals, achieving know in a competitive a this the out was as X.X environment? environment. I view about in space of changes your competitive competitive we liquid for thinking obviously, number becoming was given but landscape companies and looking landscape,

AmirAli Talasaz

I a last that's There we're have few see of really that to say be that in driving to money continues That obviously, interesting been the be invested. dollars of this the continue space. that, to to developments. hot space. It's continues would be some the quarters said, kind monitoring raised over

terms very going so how to business to in always of necessarily been metal And the the of disciplined the in terms pedal we've -- least programs. terms internal our operate we of always in at we're taking continue and to to so in take doing. be this environment. not we're slow of -- things going we're But down going work the we're not we're We're

there's mean very be So few the what and in things the well-positioned quarters progress technologies, feel as but in And to consolidation. next it's -- biopsy general. space think some we liquid going and well as for could well-poised terms opportunities of I

Matt Sykes

Thank you very much.

Operator

Thank today next you. from Morgan question from line ahead. Stanley. of go The the comes Please Tejas Savant

Your line is now open.

Unidentified Analyst

quick just Hey, Tejas. I ones. a this have [ph] Neal two for is on

early ownership So now full Spain that the fully in EMEA on color operational updates lab investments with know, thinking I then year-end. we Japan? how anticipate extra is should for traction we venture, to that joint But by And see about operational. Any the in here? scale-up of the when in there? any you expect on color planned mentioned you reimbursement could Japan some be

Helmy Eltoukhy

we're the very We're about making Yeah, excited no, question. progress internationally. great no,

Spain, the in excited. a really access a and early first there. certainly too laboratory probably to that's literally so to out. super It's say going our kind They're think two more to Europe lot give of just I its in and first they're getting samples technology

work in done about have the excited that. and UK We being similar we're

terms of on connections have joint size, have a market patients, we in number upcoming they cancer clinical great lot that is with great reimbursement that rates there. studies very Japan extraordinary of catalysts side, the acquired, venture the the In we're we hospitals terms of there. bullish of an about

could years in reimbursement, we think – be once fully there in terms the we're so there. potentially come some to And upside

the a the well, that a is really have I obviously unified announced kind to think of signed pharma opportunity of and us taking partnership and a in companies in making on very just really, as have China control investing opportunity for really in of we us rail terms future, with us. allows global big we presence which market

I that region. justify we're think to it's investment so the And going in making

Unidentified Analyst

you. Thank

Operator

you. of next today from Thank Stifel. line the Dan Please from Arias The ahead. go question comes

Your line is now open.

Daniel Macek

on Macek Arias. This Dan is guys. Hi, for Daniel

is What then again. also with cancer. it Helmy, lastly, bear so Palmetto the come current timing reviewed cover for their tumor me. on then questions, first specific over mean, done solid So that might able expect just Thanks. to studies for today the you coverage might comprehensive that umbrella we initially testing come under MRD will are of MRD And to this decision, provide then it effective? to to is And Reveal sorry initially, does serial few decision? the a the language you that? for then, But the And coverage the come And you've colorectal. or it time? to repeat within be when or LCD is studies on when I any within reimbursement see

AmirAli Talasaz

Yeah.

So what kind Yes. just let me of give of overview an that.

So patients essentially serial of it's cancer stage Stage that tests for adjuvant in X bundle X reimbursement colorectal setting. a and monitoring of

after discussions three surgery in terms now think up that. is could we're individual in that of period first that in in either in time is, look the that's The treatment and be -- first still back when testing extend can months, subsequent I billing then and after or opportunity. terms perspective effect test reimbursement And a that can

would And it think milestone. that it's big time indication so continued think I say I bodes is well for for something And expansion a please. I

I think that most answers of your questions.

Daniel Macek

to did. you like be MRD Is it of same yeah, in Yeah, under general? the going LCD testing

AmirAli Talasaz

LCD is The general. Yeah. a

Daniel Macek

then, because Okay. I'll gears Thanks. has lot maybe change And covered. just been a

you. up lung reimbursement. adding in FDA actually logistics test the the launching and data could an terms AmirAli, Thank to then give of you in to the what like just might XXXX, For the approval idea that of all shield us way on look

AmirAli Talasaz

Yeah.

we think to are even We blood really about the a actually and takes excited the feature like that's that testing is. next very that there level

value is I field the which CRC, how other when I adding the significant. blood you think Type lot X, cancer conversation completely. of And have just of in add you some think a can much start

or just you're take go you stool that to very one going just stuff. would test test do So a that simple and can relevant sensibly compliant thing

done studies. terms to to these a in are XXXX. We've in of since look XXXX sample be shown in case We've validation control cancer. kind studies collection study going of upgrade We data at to already able

are We're of had year this had it's we doing as study going January FDA registrational going for study getting more So January and it's our LDT really study of to and a study. to for year Shield that touch in as take we've the the get we parallel we us. -- path label. time to this lung enrollment been part of started the And actually study the upgrade a five-year finish run done for and we grade that some

Daniel Macek

guys. you, Thank

Operator

Piper next you. Thank question The today ahead. go Please line the Sandler. from of Westenberg comes from David

now line Your open. is

David Westenberg

Thank Hi. my taking question. you for

about test talk the MRD Reveal, metrics mean in in So and of actually characteristics. specificity I Guardant sensitivity can we some

of context checks interesting mount the things that we specificity have multiple just point that of of about like at we team that things to we a found from in this testing overtime. people or is discussed. metrics And in as our of the One kind ASCO lot testing sort to found of serial tend think

of need we're kind really success So specificity when with oncologists, commercial we're have to what thinking do about and you think at? you what numbers

Helmy Eltoukhy

of if I to been close high specificity. shown the in XXs not XXX% think is we've terms data all the

assay. that of seeing assay. Yes both such seen specificity. to sort We're blood the really don't to there and a confident tissue performance if case very but seems balancing just confident -- you we're logistical get the the ending you very of the of be beauty that's sensitivity and misperception not to And but find a of it about performance approach the on can't information, have to trying specificity. down. haven't we're of be performance high is tissues somehow the of So, we and good the act simpler And

David Westenberg

That's you. been this if sure today. been Perfect. calls jumping around not asked. I've And very three has I'm helpful. No, thank

has and compelling of just frankly is proposition CGP any have in the marketing threats you of think ago, believe under-penetration of the that that of terms weeks to liquid of are environment haven't of past, mean stop fairly I seen fact in particularly then really there kind under-penetration just they or in seen and you spend in same any a be really Are different we I an the competitive I'll incoming that it liquid course. a competitors money one an of space. on -- private a the the entered couple -- So, the I CGP generally? you of seeing continue And biopsy there's biopsy given lot

Helmy Eltoukhy

we No, mean haven't Yes. seen I anything. really

test a competitors and or Some say a out lot trying this we would poster of than competitors. has of these brother This publication of there's been from I there's space come just to a difficult their a -- Frankly, build there putting in more everyone normal brand, almost these asset, there's a haven't it's even lot assay. data. us performance, seen

business. I publications think in XXX over we're the technology now Guardant

we So, it yes, for -- really changed hasn't quarter. the

David Westenberg

Thank you.

Operator

go Thank America. you. Bruin The Bank next of your line De now is from open. Derik question line today ahead, the of Please from comes

Derik De Bruin

afternoon. my Thanks question. taking good for Hello,

got I've two. So,

give to XXXX bit as sort clarity look you are inclusion? how you commercial bit us to for think to Just terms the to of meter could some the about of have have your sort on little on do into in clarity to of you. higher particularly more more have little Are a guideline ramp, to what OpEx of out going ahead infrastructure you're this see blended year? with do next Shield the ramp But is next rolling as And is Reveal $X,XXX you're it one you get but first you we how -- I base sort of number as you've ASP look out $X,XXX you as a XXXX. I for appreciate of like also ASP have and for at -- that Tissue talking The also a to realize I mean about particularly But salespeople? build ramp? going Shield. up year? in coming Thank sort got good of that into we you a going

Mike Bell

last pretty the it's Reveal base very Yes point the to is got Derik, this it's reimbursement an perspective a then to private that's to got now GuardantXXX We've Mike start CGP the with mean respect terms $X,XXX and From ASP it we if clear Medicare. of go news covering same. $X,XXX case up larger quarters here. investment as say remain the I'll from GuardantXXX. on could ASP potential good now for to Yes. of few had one the of probably next take view, Medicare. year consistently from for yes thing that. We've get payers I for news from we've blended and of will in going overall And some we good

us. that's So, positive a for

mix depend Response, to between the and GuardantXXX, on Reveal going Non-Americas. I depend think then it's Tissue, Medica on volume

-- out the later good potential year in commercial year So, oncology team. marketing going and think, the sales and probably very the invested there which OpEx starting is earlier perspective a are movements a last we on last sales I side -- point, And then from then out sorry, heavily well. from screening that. built And front, but force really is commercial sales built the we $X,XXX

on forward out milestone Going screening, a for the we'll build really basis. that

-- we so look but on track reimbursement And we'll -- to -- I think launch. when we're for commercial then

we're on going taking it's and it -- to markets. So depend those

Derik De Bruin

Thank you.

Operator

the comes line from of today Please question Julia next Qin go JPMorgan. The from ahead.

Your line open. is now

Unidentified Analyst

Thank Julie. is on taking question. you This Hi. Amy my for

pricing have I and specifics coverage. review on So the two

any cost you the see review? additional like one curious for missed could on clarity can like that? I to is can update expect it The potential one we some second you indications outside is, -- little for we see first could you. expand CRC? on Thank bit The when to coverage have a I'm when And of on maybe

AmirAli Talasaz

the something question targeting half you. launch out coming it, in and the we in gross collecting on further every and product that year as we publish to we reimbursement XX-plus terms of on to reveal percent quarters that – get that some we're hopefully margins have basis announced breast second more confident We for range. validation And that data we data the released scale. of working on but lung going terms terms Cause publication. I those data data of of for private very indications of operational other just -- would this in and we're typically Yes. can care so would is be of in we studies high a like are our the the --- we get we're say really

Unidentified Analyst

Okay. Thank you.

Just the response? quick give follow-up. reimbursement Can little you the on us update for GXXX bit a

AmirAli Talasaz

there's no update. discussion. They Yes, still in are

Unidentified Analyst

All you. right. Thank

Operator

from Max Please Co. the line Thank from you. go The next of today ahead. Cowen & comes question Masucci

open. Your line is now

Unidentified Analyst

Hi. feedback for liquid launch plans touch my is the one from Stephanie access you've some Max. quick that This the on from broader taking you Thanks of been for on early Could launch with seeing smart commercial for along me. your platform? A biopsy of early question. a platform your

AmirAli Talasaz

Super.

think I the of -- in think be saying they scaling studies in potentially interest market kind speaking could with generating has I product terms what in We're our our terms able right a of Guardant with make we posted new -- fit. partners of progress it's a think And demand do of terms lot of we're lot on lot it's we we throughput development the products good it. think imagination be -- really platform, really that. of the to on of to that right schedule that we'll target for a terms oncology in as more here but right to what of future think and And at -- really going handle of the of you our keep side. of product. And it's I

Unidentified Analyst

signed partnership helpful. Got How think about should biopharma testing a Aecon China. in follow-up And quick you it. the impact going we in Thanks. strategic forward? on agreement That's the volumes

AmirAli Talasaz

from companies. China, largest quickly of opportunity of A becoming partners lot do be the our lot it side. biopharma which global helpful. in is should are Yeah, a They work the second

of the platform it's so And the partners really give excited to about Guardant platform the testing a going one ability unify very to that so we're lot for us across opportunity. our

building pipeline of of already the laboratory. that large ahead a launch have We

going it's very So we know be to positive us. for

Unidentified Analyst

Got it. the taking for Thanks questions.

Operator

Please today Citi. The ahead. line you. from go from Patrick final of question Thank comes the Donnelly

Your is now open. line

Patrick Donnelly

kind see study confidence guys. USPSTF taking the big just on can I is still? and material are? we of about that or about again where the you. have talk that maybe update? do confidence could in of you far. level then enough level is -- And inflection the mentioned have that contribution know quick amount guys Eclipse, for think the XXXX. of in we secondarily, you you you volumes, can Thanks enrollment AmirAli, the the number Can view you potential questions. as size Hey, that? of the Thank right terms And correct you have Do you of point ones two before kind cancers. you so Any cancers talk just

AmirAli Talasaz

Yeah.

a mature what by based you're get material CMS more material CMS believe CMS next In we approval seeing line. to are right be the so contribution, contribution you but -- coverage, volume after terms had end the of of actually we have opportunity on revenue projects just after we we coverage of post sometime top expect today coverage, I'm -- And next year maybe would that NCD. getting more going year contribution -- really and so

different USPSTF, growth. before to catalyst kind our but way us be of volume milestone lead definitely for it's USPSTF catalyst and a is So a event take a major a

away as to are terms we and CRCs just unblind the of what's study study number already going I Regarding studies And monitor to to happening. XX that earlier not XX it's one powered. when are just we in mentioned from right our CRC are the of

review. setting are We other their for at precedent definitely also of consider to terms a tests their in approvability going

to be have fourth we database we out. in actually confidence the a that results going good consider in are and is going full free very the we we terms believe control get to But which and when we So quarter. it it unlined have of and over basically press to bottom going are

Patrick Donnelly

Thank you. Understood.

Operator

no There you. Thank questions more registered. currently are

today's Thank concludes all conference you that So participation. call. your for

now may lines. disconnect your You

Guardant Health (GH) 5 Aug 222022 Q2 Earnings call transcript