Guardant Health (GH) 24 Feb 222021 Q4 Earnings call transcript

Hello and welcome to today’s Guardant Health Q4 2021 Earnings Call. My name is Elliot and I will be coordinating your call today. [Operator Instructions] I would now like to hand over to our host, Carrie Mendivil, Investor Relations. Please go ahead.

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

If you the have if please you not an received this like send be news to added to to e-mail company’s list would distribution investors@guardanthealth.com. release or

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

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

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

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

for position you to oncology will our thank we our call our continue the year AmirAli I more will earnings strong our at a on study in full Slide XXXX XXXX cancer turn Starting off screening, afternoon over quarter surpassed of significant joining XXX new our year Mike as future our start as X, second the program. detailed highlighting technology We liquid a grade progress call. to was will for Thanks, outlook Carrie. across as I and a Guardant. leader. on our XXXX. for screening fourth and financials for finally, number prepare ECLIPSE target continue then reached organization and advance build on started today’s biopharma enrolling study, scaled significantly growth. registrational look and for Good update by to launched a platform the call products, And enrollment partners, an biopsy for our we provide lung

to Guardant is of driving commitment first. conquer putting Our work is patients care. and to transform our cancer ultimately cancer force The with mission at data our

are to providing bringing clinically the We to best continue dedicated to information care. products patient absolute actionable will market that inform

surgery. a began with chemotherapy. an Before off But patient progress, diagnosed rectal I spread soon underwent He cancer. a start on provide to the update man cancer patient I surgery, The to was discovered node. X would XXXX, had story. In Stage like a oncologist quickly after his lymph immediately already our XX-year-old with

transitioned a was CEA feeling great to Fortunately, periodic still was cancer-free was was he past His considered normal. to within be care. normal limits. for scan well was CT responded checkup. to This he His treatment and follow-up summer, and long-term due

X His a scan oncologist scheduled CEA months residual So, be for the and back positive test, ordered performed also colonoscopy, to Guardant the Reveal oncologist including later. which tests, disease. follow-up CT came

recurrence had The as to bring can and order nodule, is continues to which critical been catching CT the remove the to a before detected rectal information and an small spread. cancer a treat it a scan. well. lung oncologists in PET ordered surgery story was patients, how visible This on cancer. that a second Reveal Guardant confirmed early recovering tumor nodule to highlights After cancer immediately oncologist his results, these not patient biopsy, isolated the had metastatic With scan

X, $XXX Now, over turning to ended prior with million, we over This $XXX revenue quarter. XX% revenue year of our for up total record QX quarter up performance XXXX on Slide of XX% XXXX. another the brought to million,

now on the a continued XXX test volume that XX,XXX is quarter, prior Slide tests, to increase fourth quarter. to year second more commercial than for focused on to we during the build year, individuals of we team strong They X, the Moving believe our organization reaching an clinical of none. from delivered oncology, XX%

is evidence, clinical test in Over continuing product I takes are be technology. continuing our a very twice market XX,XXX environment approvals, just the fit to takes tests, and inroads from impacts where make commercial Notably, channel. regulatory products above up commercial community today It of have volumes COVID, this to are the in a achieving are growing reached academic well their we and accounts, and how and executing terms team of league in as fast The growth. amazing course reimbursement year-over-year. robust we of as centers. than for continue of experience. proud all, strong own the market performance, oncology clinical the in the XX% more market in large year, Penetrating we despite customer

setting, came are setting becoming remaining our the team’s XX% from community in while oncologists virtual. with reside. same of we quarter the to majority of face-to-face are grow academic weighted were Today, patients XX% our roughly our half, XX% compared community year. in interactions the the centers, the period cancer of increasingly last is mix to volume Approximately, continuing where While towards the in volume

tools Guardant excellent products the have whole ordering as equipped virtual are tests additions. needed seeing are with more and physician precision board, and to of Across oncology team the oncologists to and drive our with We our we more a both oncologists existing seeing continue traction More in-person new interactions. adoption through platform.

number the the oncologists to in double share closest with compared We of of competitor. the have our CGP interactions largest market, nearly voice

and an oncologists. Looking success opportunity Reveal consuming detect the of end months. early presented greater of Guardant January, with of channel monitoring existing XX% that Guardant surgery intent observational a prior our lead than to high ASCO are shows for while cancer X/X growing Cancer curative we At Guardant recurrence when the a average recurrence Reveal, at time interest study to X colorectal after sensitivity of can and MRD disease at used ahead, vast lead integrates leveraging Stage longitudinal test early-stage epigenomic can on that cancer. tumor to which An biopsies recurrence disease Gastrointestinal of detect all a of for in The analysis to treatment. signatures demonstrated Symposium heavily Cosmos, more complications, on and Slide from tissue. colorectal in and data Tissue difficult are the genomic Reveal encouraged we new patient’s to invest need without closely continuing be in delay the large prospective for obtain, detection X, time can by performance interim the

can of to blood-based decisions Our care. overcome and barriers fast these continuum information test provide and the treatment help across guide actionable

approaches setting of TAM as $XX monitoring that utilization of for favorable be the well billion $XX today frequency less the dependent or X, Turning to blood-only surveillance challenges billion half resection. access opportunity, from logistical of only for to than would of the tissue, given Slide curative informed date recurrence approaches. a Tissue this many surveillance years some of especially potentially is to due out billion landscape. noted increasing more reimbursement as $XX accessing has from tests It over grown such the opportunity this of in setting, should the

Turning making particularly the X, of great to United States, we outside Slide in are progress, Japan.

for is near future. CDx in regulatory and running there expect and lab to up the receive Our we GuardantXXX approval

patients we the our by reimbursement similar rates and compared a with XXXX. focus public about CGP. large opportunity, approval, of XXX,XXX turn Following will to very in XXX,XXX reimbursement end market the U.S. Japan for securing represents to late-stage

We in and Royal are with currently are and at Vall UK. in Spain in partners another investing the two d'Hebron also one Marsden Europe the labs, building our

national of opportunity. be laboratories by building and most plan months. with the to centers research for providing leading of patients global These key services labs to is the their for will the academic self-paying care, in service expect the over for clinical next industry become expansion sequencing next-generation clinical network operational patients private XX with partnering the this available international a future unlock We strategy believe UK. We effective to health way and

samples, on Moving a volume in biopharma the we third from healthy XX% saw XX% our to up business, year-over-year. on rebound quarter up biopharma X,XXX and of Slide with X,

our indications, also the including using just breast. with are partners setting bladder and lung, seeing biopharma interest Reveal CRC beyond in We adjuvant for growing

the in tissue-agnostic blood-only forward significant of partners look approach biopharma Reveal usage and see our to we setting. Our growing benefit with

to In our addition active ended the served number target XXXX biopharma to XXX grow. customers reached than sample increasing we year We the of and partnerships. volumes, with more continues

a have leadership pipeline We breadth attractive service offering, clinical of us the our discussions healthy market and strong makes partner. customer our and product an of

We the number others two new to grow. continue We with customers recently of to contracts signed expect discussion. a of CDx number in

or see several to project and While continue been line the this in demand are of to milestones. we we some strong completed services, be soon revenue expect projects lumpiness overall near-term given have recently development completed timing for

breast data to liquid as the to new recently to from survival, cancers. soon PATA colorectal and for of Excitingly, presented world the utility this clinical and Breast via advanced In response cancer GuardantINFORM emerged. at effective world utility biopsy. therapy XXXX breast clinical products, both as continuing switch our X the presenting more from are monitoring the the study, progression-free demonstrating doubled demonstrate a real We data approach San patients to using of we in resistance therapeutic Symposium, clinical Cancer outcomes option of demonstrating platform Antonio GardantXXX benefits the December, evidence treatment with help real

for can a was which potentially biopsy, tissue difficult treatment. need to there consuming, delaying Importantly, no time time and be

that ASCO our to a cancers MSI-high frequency to project immunotherapy. Additionally, GuardantXXX high testing. the clinical new status demonstrated gastrointestinal detects presented advanced with biomarker that utility to patients instability test microsatellite GI, response important an at tissue-based at in similar is we data used

Conference platform, a believe to shared a velocity of XX, a liquid always our by the vision I biopsy quantum the motivated we January, for JPMorgan be Slide at at for forward Moving on will Star early biopsies. in liquid rapid Guardant, have we which leap Care. smart Patient At moved North

about genomic that greater chapter capabilities. genomics, AmirAli other smartphones enabling analysis many We advance smart identification immunooncology upended an comprehensive We platform Our diverse GuardantXXX to next CDx first-generation more deep even profoundly of products. Investor signatures way screening. have tumor planned years countless others. XX biopsy of genomic, liquid close to the platform footprint tumor look nearly now for this will therapeutic update first the product this of from biopsy rich will hundreds interrogation many a Drawing capabilities of liquid in from the cell offer biopsies, of experience year. this at a an and of ranging microenvironment, phones monitoring, will forward our of and sensitivity signatures prognostic research our larger I of smart much Day believe ecosystem over to to this provide provide and current sensitive analysis on than sharing platform liquid among new applications, liquid of more immune complex oncology more are by applications turn include the our call that will fall of on epigenomic and XXXx from rich than biopsies and same new thousands

Thanks, Helmy.

simple, straining guard the likely much cancer. against Slide to make compliance progress is has need screening we health to great expand blood-based the during system are is At integrate to have communities across the believed reduces underserved continuing wellness our improve screening patient and Guardant, screening to easier test us XX, checkups workflows, program. the to Blood-based that Turning follow-through, into accessibility to potential for we would tests. always

to reimbursement must early a patients to blood-based access and at save For in broad save detecting care objective the scale, value-based inclusion In requires screening finally, alignment and approval. such with stages. we screening at order to into a test strategy tests, sensitivity for testing offer need FDA lives guidelines, lives, ensuring cancers health with systems, access its pathway that the and of the high

FDA of limited screening colorectal recommend great The in screening screening the due benefit age For pathway. well-established of blood-based individuals guidelines of The been of and XX. efforts. is compliance many has lack Days screening compliance. of Medicare majority use potential an of over blood increasing cancer, vast of CD the test to the for despite and utility established holds CRC and has approval

have we this to ago, middle years of in year. X our that almost out XX, started study expect pivotal Slide we to Turning the registrational ECLIPSE read

time. be at registrational a the this all study, Given that is same underlined data grade will

Although our we timeline. due as clinical expect resurgence in we COVID, have our study during last a do well the impact time, as few weeks this experienced site internal material some slowdown productivity at a to activities of not to

also successful in of expect FDA review to the to agency. We pending submit latter PMA receive and this expect our package XXXX, year approval the in to by part

on commercial the approximately launch team. track version this LDT in year of called and Guardant XXX are the already onboarded to first this PCP member of assay have half We an SHIELD

We is commercial our included which in USPSTF XXX in members our team by XXXX. expand are time test to planning expect over gradually to guidelines, we the

SHIELD in post to year approval. this is that of strategy engage accelerate commercial will activities FDA Guardant development Our adoption

CRC primary care to increase blood-based started We of target physicians key to and awareness have screening. stakeholders engage

pleased impact in the screening improving need is high a modality with We are CRC adoption drive sensitivity. be compliance Guardant It high for the that of with a increasingly we will believe early rates, and interest screening. test. that CRC clear its confirmation instrumental are We significant feedback potential clinical compliance in blood-based long-term experience the is successful SHIELD to the with hearing there unmet early a and of we high for

cause lives. lung known opportunity with screening for XX, on is lives beyond CRC be our save Lung related multi-cancer cancers lung to for screening develop is of leading not individuals. test annual regard to a States. advanced to high-risk our do In with where already death blood-based focus Looking can is stage. evidence-based to multiple appear screen CRC, cancer until screening at cancer Symptoms saved. the United the cancer Slide the of typically is cancer cancer disease guidelines screening in The recommend lung an

has screening growth up-to-date lung can the ability of in screening. demonstrate of screening studies can compliance early easily as with cases cancer it compliance are We improve and be simple test treated screening the around the for believe to only a detect people recommendations. XX% However, underutilization, to eligible blood when stages majority most also

undergo screening a multi-cancer shared as evidence to our new using in to of XX called the assay risk in a cohort, registrational cancer accuracy screening for regulatory LUNG. lung the Moving CT the on LUNG individuals All the designed SHIELD validate study have screening lung standard for XX, between is Slide LUNG of to SHIELD care in to assay of prospective of subjects cancer our last scanning. high performance low-dose lung year, next-generation SHIELD grade we Guardant cancer. we ages designed SHIELD XX who enrolled be will for provide

for prove of the developed expertise We enrolled registrational nearly ECLIPSE, already us. our expect and are large at believe a patient targeting this We this first months. year I XX individuals. invaluable of within the complete screening competencies beginning will had to running we announced XX,XXX enrollment enrollment has team study, and that our Through core

performance are throughout screening this in test types of XXXX. expecting We multi-cancer to several present cancer the

now line addressable for XX, promise types, screening The for quickly be of our up and developing to confident our cancer brighter for population market cancer of I a test open high-performance the screening readout the FDA up is we trial other about we will and the SHIELD with of will health. future Mike reality believe blood-based with millions approval. open path cancer have paving believe in to future over billion. strategy I in more screening see towards the cancer screening a opportunities coverage $XX that, outlook Medicare detail the call billion colorectal ECLIPSE becoming and Turning our to by successful we life-saving aligned opportunity by I than additional of test and can will the total market. LUNG, humanity blood-based Slide blood-based screening more $XX in to With studies, for blood-based financials test first people. of turn to bringing cancer screening XXXX. am improving

AmirAli. Thanks,

prior with testing Total $XXX.X compared quarter. the by Slide in XXXX, Precision of increase sample was the tests from The million is period line year XX% clinical consistent from biopharma starting last the which was to $XX.X was blended $X,XXX $XX.X Fourth increase prior XX% total test quarter quarter oncology Turning from of couple fourth XXXX $X,XXX quarters. between with to precision in was with was million volume clinical of million, approximately fourth quarter million revenue revenue clinical up $XX.X quarter was volumes. the ASP the XX, million XX% GuardantXXX from for fourth revenue in up This and prior XX% strong of $XX.X the $X,XXX and expectations. clinical growth for year the driven year. our in prior XX,XXX, growth ASP million, $XX.X for the of year oncology with the quarter. same of both an quarter. was

rate $X,XXX $X,XXX at which XXXX XXXX Medicare the set of been CDx for Importantly, for has was same initially April rate in ADLT the maintained and XXXX. GuardantXXX reimbursement

we a to of continue the expect $X,XXX the for during GuardantXXX result, range to As be to the in course of $X,XXX ASP XXXX.

products We seeing clinical products: for the increase traction Next we throughout Reveal, expect Response. year. our are from Tissue continue and solid And to to volume these new

X% in $XX.X totaled oncology will up up prior to prior the revenue quarter fourth strong year prior impacted Precision year new from quarter. period, be was biopharma but million, will private volume XXXX, to year in be contribute products a However, Development payer Therefore, was quarter down start new significantly from prior we the to expect from reimbursement. ASP XXXX sample receive until line with Biopharma don’t to clinical to in blended ramp approximately ASP from $X,XXX GuardantXXX time quarter. the in XX% totaled year quarter the the similar we to $XX.X stable the up totaled with expect million, products product other approximately and the mix. tests samples for revenue these Medicare the quarter in whilst the XX% take million $XX.X as $X,XXX, Biopharma we from revenue third fourth due reimbursement services X,XXX, XX% quarter in up. and of of fourth ASP fourth quarter.

the came quarter, that services settlement to end other approximately the with revenue of of Foundation agreement finalized XXXX. and related royalties and Medicine development the half During at the from licensing was

starting royalties was represented revenue in we this last was full end XXXX legal Specifically, May the that December guidance shared and anticipated of the through settlement to the reached in when year. year for

For XXXX, royalty revenue to to basis total quarterly recognize be we we expect a to revenue start the anticipate similar on full to XXXX. year recognized in and royalty

quarter an communicated or third the to in payroll payments, fourth of adjusted XXXX. tax $X.XX per for of Non-GAAP define to up. we tax of $X.XX such, demand of changes continue quarter quarter. compared throughout fourth other fourth attributable in for of positively fourth primarily As the expenses depreciation, XXXX expect successfully several XX% to expenses, and of $X.XX fourth expenses Medicine. we net Other by recently was Operating while development $XX million Non-GAAP for the of will per Health to value services, was non-GAAP as related last and to for was quarter XXXX. year Non-GAAP XXXX quarter new million and the we the development for consideration. Health quarter lower to acquisition-related quarter share fourth Gross million of were $XXX.X compared booked Net $XX.X quarter share $XXX.X employee the compared million And of $XX.X of fourth for of operating quarter or or XXXX the loss quarter, year XX% was million as time from of million in XXXX take period, income same Adjusted quarter. the operating were fair $X.XX million the the million completed. projects in in million strong quarter increase to in of loss the intangible XXXX fourth was expense. XXXX assets settlement we net million, $X.X period been XX% prior impacted fourth contingent common a million for diagnostic amortization Foundation QX or revenue quarter the to quarter in for EBITDA our $XX.X of $XXX.X Guardant which to XX%, income for in to prior quarter gross prior the a $XX.X as up Guardant the profit corresponding from XXXX compared of XXXX, of margin XXXX million, projects of compared net stock-based year exclude the stockholders Gross in due expense XX% share to million services from per quarter $XX.X XXXX. increase fourth $XX.X in that share loss expenses year. $XX.X $XX.X interest, income have was increased attributable for prior million see in adjusted We the and our royalty XXXX. loss of the per be fourth compensation $XX.X compared and fourth revenue amortization a companion ramp the the EBITDA other and profit to and the loss $XX.X million

year compared as from increase clinical two reimbursement. of XX% XXXX as of an expanded completion the diagnostic from programs future out was we the quarter. to XXXX team the for several Development in a data $XXX.X XX% of Foundation we and to grew with successful significant we royalty full as clinical year test oncology XX% in impact build volume XXXX. consistent XX,XXX $XXX.X Clinical compared blended XX,XXX, testing product XXXX support year down in million, margin up investment year. with in in testing from our well the XXXX, million X% screening revenue clinical year pipeline the biopharma X% revenue to products well of XX% agreement of tests to services in started for from XX% $XX.X $XXX.X the the grew volumes generating year-over-year tests. signed XX% Overall testing performed year to licensing the will sample clinical ASP and of Biopharma ASP, XXXX, million, to XX,XXX from year-over-year was which in as and $X,XXX, partnership for for year million, prior approximately In as XXXX. expenses in for increase the to grew approximately XX% business. $XXX.X revenue their and year companion due mix. our $X,XXX year-over-year the of Operating increased year support prior million reflecting as Medicine. $XXX.X the during products which XX% launched of was $XX.X was full was true-ups full Gross XX, with new approximately $XXX.X the million, million million $XXX.X of XX% revenue in Biopharma Precision and blended the to ASP period, increased year was year-over-year. in was revenue to to commercial to was expenses revenue comprised the changes during the oncology tests. were progressing the oncology prior XXXX, cash year increased our million, our $XXX.X infrastructure Slide XXXX. up including continue million in year prior full we full Turning total invest XXXX in strong other to Non-GAAP operating XX% which a $X,XXX for

$X.XX million be Guardant and will to Health to from investment in common period. focused in on attributable loss of loss XXXX. as prior XXXX. was prior development XXXX loss $XX.X compared Net the the million share $XXX.X attributable a ECLIPSE, corresponding stockholders completing share SHIELD in of test. Guardant XXXX per to $X.XX loss for EBITDA the Non-GAAP $X as per XXXX Net net to in $XXX.X compared million Guardant commercial common Non-GAAP stockholders XXXX $XX.X the continued compared corresponding for year in XXXX. XXXX loss our screening, the Adjusted for screening net year million was as launch multi-cancer of in XXXX submission $XXX.X an for readout the period. $X.XX to compared was million data CRC $XXX.X was loss million to For PMA for compared Health device to was LDT,

decision right to a EMEA quarter that We our the we we end As expect currently We transaction previously coal joint this second shared Guardant XX% purchase the do to the of Health venture of reminder, XXXX. before our the exercise complete to shares not of own. still our XXXX a flexibility cash robust in feel our in continue We marketable securities. with to future billion and can the and cash, cash which equivalents that ended $X.X for have strong foreseeable operations we us balance to invest support business ongoing growth. to gives drive future

to the Slide and range over $XXX XX, in million $XXX assumptions. approximately on full XXXX this the at are we be between Now turning few growth million, key year revenue expect Included for of our revenue outlook representing XXXX XX% to a midpoint.

grow biopharma least clinical XX%. by oncology sample and XXXX, to we compared expect to at than to Firstly, by XXXX volume XX% volume grow for more

As over to grow a testing oncology revenue more prior the result, expect than XX% precision we year.

development take Secondly, as strong although we partnership a services pipeline, time earlier, mentioned these projects have to up. will ramp

such, As revenue approximately expect we and for XXXX. development million to other $XX be services

SHIELD we year. this expecting contributions Finally, launch are LDT, of it significant we upcoming excited are not the while Guardant from revenue about

our into product great we oncology expand cancer portfolio Moving our on market. Slide to to we and reach XX, as continue the screening broaden XXXX in strides made

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

Instructions] Our Thank Please from comes first you. Peterson JPMorgan. go ahead. [Operator from Tycho question

kind a the was maybe all decline down to? in else Response and Thanks, clarify you or of quarter guys. that that of the just weighing first would ASP average to point the just function And something numbers, was the on Reveal there there

you Mike? that, take Do to want

to it’s similar that as it quarters I reimbursement, $X,XXX, blended. right. $X,XXX that’s Eltoukhy. Yes, previous Yes, that range. Yes, expected bringing that, lower came take And products with was overall down ASP just new down we this can in GXXX

expected. We through that was continue So probably that XXXX. to expect

guidance about coming first despite below in in foundation UK COVID the Street can And tad is uncertainties? high embedded just anything lab reflecting the contribution you the And in clinical And then quarter? the trends royalties, also the lingering end, at the that you’re guidance? really volume say is

No, Mike start, in. Yes. can Yes, clinical we for bullish about and I’ll feel volumes XXXX. maybe catch very

strong from did year-over-year, some said, limited. impact and access XX% part Omicron which very physician excellent see quarter, see. being I think, certainly is, was first in we of growth We’re projecting first to That

that resolve to seeing We’re very nicely. begin

hopeful we’re the so we from that of And that really more COVID. will away the trends impact of start some of seeing in negative positive terms moving year throughout

In lab, its terms days. that’s still early in of I think the UK

say samples. we’re oncology So the in pharma precision this both would it’s contributor to a year. not growth business, in volume clinical very significant samples I that projecting and strong

the One challenges has been development services of just the revenue.

of large else don’t up know trough We’re have in projects if sort two and Mike between terms ramping add? down want a stages. anything just – low, there you new is and we’re those ramping we in in a large to really, of I projects

Okay.

I is and me, think that there No. else I covered think don’t all. anything you for

Okay.

liquid Okay. you ahead just Reveal, the on talk biopsy, about about Helmy, just And fine-tune talk smart updates needs on and launch? And time reimbursement lastly, you then able to of of pipeline, there on can happen then, what to similarly, there? lines kind are

Yes.

shortly how But and we we’re that platform, around we in and And biopsy, think the that typical, will year, more initially. and Investor biopharma very some information [indiscernible]. excited have we present lot new – share will launch that. clinical back Day to our to we’re that is waiting in excited we at submitted we then details that fall. Reveal, And markets. will as smart final to about later that more we a and from With hope very feedback for has forth launch be thereafter, still are to it there and platform about the details been the So liquid

thank Okay, you.

you, Yes. Thank Tycho.

ahead. William go Our Blair. comes next from from Brian question Please Weinstein

made kind guess build I more bringing you I’m around as move yourself in other about of about a kind talked were how here. the just an liquid Can questions. positioning investor importance especially guys. Hi, beyond talk about you’re your and out genomics? you curious of smart but about biopsy, AI you’ve in kind technologies. of utilizing of you approach starting unit earlier. curious types you’re taking that my to out, of You imaging different Thanks longer of multimodal I’m capabilities, of that for just term technologies kinds thinking kind of

AmirAli you that. want to take

sure. Yes,

excited on of to very this stack ventilation. that can figure based on that technologies we unmet way. That’s you bunch unmet on use are some really clinical why names in the meaningful what open and instance, for are epigenomic are yet. So Brian, on actually, we a that have at about very up take out at front, like, need way our we Guardant Yes, general, that working with the have Guardant, and mentality in have that obviously we talked that impactful

We of in We over many epigenomic we performance players we the on and technology detail that assay a off-the-shelf stack again, and that maturation the there that time, of novel would best. reagents had terms we novel talk on other mentality, our have like think are who never second are field contributions front, how in fragmentation for works. and the hoping there built using a just none to side, about hopefully, I assay

definitely, with I, working Regarding that’s that our we radiology mainly are something partners.

are like talked And go fall it details have, the into we we maybe of these that LUNAR Day about to One can that more. hopefully, some we in over of future, them before. in going is near Analyst

where you time that how stool terms gets there there in out Great. that product playing fit comes and folks. unscreened colonoscopy, launched. product as I’m Obviously, CRC, see curious is over on of just the And volume is then is There then DNA FOBT. from?

especially of but to anyway. seeing is kind kind don’t those interact patients, system of most on much you’re there think leaning what on-screen those the of just side, really curious that very potentially I healthcare the really with the I’m target plan

the do really you And how people? So come go volumes do from? you unscreened will think after where your

patient need in the XX by of about that unmet population, we Really million that of I to on total think screen our play. what and XX, the really of patient XX million, which that at is the mean are screening liking new to big. age population XX to initially them

on the you the kind fraction really look basically, devices or at them stool-based of through patient how really with doing touch good preference and patients they workflow they screening when like cancer those just a fact, follow tests actually of In at much or just is the based in it’s want colorectal then say, of yes, of lot tested are health not. a submit system kind their needed people who by to of get never samples

about are test superior that is hopefully they So fact, And a PCPs going like we health system, are, – comps. and confirmation think with as close see feel And bunch get readouts experienced really good and really we the hopefully it. expect our really them I and ECLIPSE it. for in very our connected with performance a of to

of blood, pre think to initial our covered we the to ECLIPSE out. experience toward blood-based fronts, be the But what be. a blood bunch the see potential those that get doctors patient testing I would see, which a It screening. a to is of based they test with a have would as how CRC have on

Okay, thank so much. you

to turn Tejas Morgan from now Stanley. We Savant

is line Your open.

I’ll evening. switch Good guys. and on Hi, to MRD with start one then talk biopharma.

in guide clinical color to it so on can what you Is adoption And terms into but for it’s quantitative your you’re and of not revenue sort to of contribution expecting exactly me, much embedded volumes, fair Reveal is any to Response? this help your share year? So assume contributing far?

Yes.

We see pleased So shows technology that patient how exciting we Reveal. think, be applications mentioned, around the of project, that we think adoption very story impact to I it’s and robust having continue the really I very the today. that with progress of of some

a of we’re kind – out have core – of do products individual volume would GuardantXXX in – point. in the into are reasons, clinical In of longer for that’s with and Medicare being in in kind I likely aggregated in of near-term. we’re take we I terms I again, reimbursement breaking on this certainly terms a that opportunity, private also we approach our puts bulk revenue tissue, will the of the not the with side volume. terms to guidance terms mean We products. risk-based our that much near-term of terms will a once things the reveal contributing be of contribution, remain response deal. say at takes payer and of not reimbursement. keeping opportunity in necessarily Obviously, terms competitive the future, of we’re but more similar think, think think

more that be expect on one you pharma any being pharma, Got seeing That’s cancellations of replacement impact we price it. you for positioned backlog? a basis spoke to essentially for Omni on here point follow-up to about LB launch a at your fair customers, a tell? early loaded is on And then too as or year that go-forward to similar it be ‘XX? in Or in terms are And from expecting helpful. should the back-end Smart a

Yes.

the typically the clinical and fine-tune to around and maybe With maybe we think, speak biopharma initially, Mike, really It setting. important start us smart liquid smart allows start, especially launch I’ll data. So test liquid question. that to in with collaborations to first can REVO a biopsy collecting you biopsy, I

really no other the as it smart liquid GuardantXXX We products customer see segmenting different do between our launched that past. So than we’ve it’s biopsy CDx. in on base the

a think, entire future provide see so I the at tests gamut be for that opportunity it of the of as spectrum smart GuardantXXX biopharma But some applications we of point. certainly, will And segment will and really, full have. another biopsy liquid to

flowing we’ve closeout second biopharma And into definitely real on we of in always the strongest the rebound by QX or strong really any healthy seen that on had see loaded of the half always sort any side. XXXX. business. We’ve quarter. that to Maybe XXXX. volume, back-end the a is impacted add on very It’s of impact been not the cancellations we the and year, by biopharma far

we growth ended. forecasting it greater volume So although back of biopharma than be will are XX%,

get QX, again, we that So see XX% to will plus sequentially lower and think throughout XXXX, in starts I that to volume. up growth to ramp volumes on then

Very that. appreciate helpful. the Thanks I time for guys.

Thanks.

next from comes Leerink. Our from question Souda go SVB ahead. Puneet Please

question. Yes. Hi, taking thanks the for

– advanced stand? event the nearing So reaching first if with XX,XXX CRC XX,XXX where Could desired ask? you you colonoscopies maybe of ECLIPSE, still already. good completion screening mentioned one you feel do enrolled you rate we the could you enrollment are I that view? that in should And on elaborate is just for that any there, And about investors this adenomas. question around Anything have ECLIPSE your expect from then trial? can to see to they important get would helpful. And readout? want be is a data before we pivotal How provide the in

Sure. asking for Thanks, Puneet, question. the

enrollment, So of in terms now. we that of actually at the the December middle reached XX,XXX

the the in additional some workflow of So find in out diagnostic ECLIPSE journey them is the to are biopsies stage colonoscopy patients additional that through imaging terms active. The patients of are involves of getting really typically in the the and the something tests colonoscopy figure staging, and going whole for through which patients then disease.

phases population patient journey. different different in is of So, that

into bunch going we a even get the are have reports, confirmation ones colonoscopy have the over have. by that central really until of diagnostic the But far, into So we pathology the of phases for we XX,XXX we them CRC identification reports. colonoscopy the that next and

a So, more read see and year, are middle excited timeline, that’s we happen. and this takes out into ECLIPSE eminent still of going why are to in of to that, all-in, of this around we without few a what’s thing are terms months going expecting we sometime lot details the hopefully,

we available the it’s verify that, market as coming it kind we our the adenoma could competitive and education messaging from earlier, focus there of and look get there detailing When and differentiation of is mainly done. see tests to lot that advance that, so we advanced worked PCPs and Having PCP the to mid-term I kind adenoma, long-term, and about going a advanced talked their on The It’s field based why at distinguish of survey in a a too, of of the finding generation. are Regarding cannot a still around lot of these a different the believe far have CRC over to data be fronts performance interesting. not that – sensitivity. physician in this factor mid still. are we performance we XXX long-term, lot and adenoma on of said performance development would across adenoma advance really

ECLIPSE disclosed terms line which they without data is collaborators, have In we and get readouts, basically, full any it’s have presented get linked whenever are put it, that we the bonds the in of our timeline disclosure data conferences, obviously. control data top conferences, and to going quickly to of out that obviously. with we there, to partners to have published of very the going data,

we But time of terms going think part in line, to ahead. readout as to is data presented So, be be I ECLIPSE of to see, have which that is main going one

out looking the of helpful. an trials of of And it. readouts then when a Reveal Got data actionability smart And Thank terms Super me, around monitoring, and more liquid size we get maybe early follow-up larger performance? recurrence MRD just the you. glimpse in can patient we Reveal? and biopsy sort or help quick or should what on be prospective other for

We Yes. analysis hopeful that presented some breast of that. by we interim. the some in recently, a and of Obviously, data fuller data at that we are some – updated presented are we new at JPMorgan, present data we can No, kind questions. excited on ASCO great GI and very

have over So, are and some the largest Difficulty] studies readouts continue two studies trials, quarters. year I of interim. besides I There out to [Technical would other few say the on COBRA will likely throughout are read will we working that and and those next the think data that the

a and biopsy the be expensive kind deepest at liquid in is where Investor So, give fall. just Day imagine will that steady it’s the there working, that indications. the smart and I platform, would of across probably be this preview are of we probably CRC, something not stream we other engine maybe data, but our hopeful most would would

Thanks. Okay. Alright. Fabulous guys.

you. Thank Yes.

turn from of America. Derik to Bank We now Bruin De

Your is open. line

questions. you for Hello. A of afternoon and taking call. couple Good thank my

really going a are of is partners the that think biopharma. that that the in there talk dynamic a into your Can how just about space, about little first one there, I on investors is clearly market. on bit competitive go companies lot you to trying by Getting asked choosing of they with gives are are and helpful. because other this? running and a of dynamic things the some flavor trials of this in head-to-head like that XXX with the there be some studies what of Just would and going the competitive Guardant? Reveal And some like are on

selection few do that’s extremely and good we area an OMNI, years a therapy I would that ago. No, around well. Yes. for are say a question. was XXX market that’s that phase. past mean I that that we And head-to-head

so I think cost don’t end their if we the win, in largely it’s terms of bank on. broken someone’s on or because maybe

and our costs We prices of to margins line. make we remain want that stable. keep kind our sure want to So, obviously in

And so we compromise typically on. it’s not something

feel And there. win we excellent like so we rates have had yes,

with XXX biopharma now We working over are growing. and companies

all we are see positive. churn We much side. the very So, on don’t biopharma metrics the track

very in been are head-to-head that new pleased we of. of products, we have terms head-to-head all phase been we also results of And companies doing analyses. In with studies have pharma part often are where that a the

we smart are see OMNI. days biopsy some so the And areas of And early products. liquid other of very and are GuardantXXX we we as much it on, the interest and from newer seeing working

that for the and only demand But products an more with now is we done not we that’s see And grow, that from demand can launching new existing products strong that sort so are like something the – very seeing of well. approved we demand that. are really as be de-risked as of analysis some platform are CDx to continuing are seeing is we GuardantXXX nicely, only growing even exist not that

with are frankly, – around are very and create as a breadth relationships we it’s engagement we moat stronger So, seeing our getting able pleased of clients. to and stronger broader, are we portfolio biopharma with the

in what’s one, be enhanced? is technologies, they IPO focus one of to what’s just it when protocols? how a the that’s you out going lot in on some history over perhaps mean in we look how guess Thank with there just cancer. new the what’s And assay. more and shifted ancient were glance, next-generation really lung using any that and I compare changed you on it time then a of of first smart and biopsy on like but been digging some during space doing have market Is for And similar reasons and Thanks helpful? that. I they But up evolved discussions on our company also, another evolved like obvious got lung has the at so in liquid CRC there mean assay. the other are realized would you. was XXXX, the sort I for looking that’s sort contrast there lung

do AmirAli, you to? want

Yes, of versus the question, terms around lung CRC it’s so in nearly screening.

think and started those lung since of that during I days, and multi-cancer added there So, our about time, and screening I the understanding ovarian visibility of XXXX exciting got cancer, other we talked is publicly for And which we biology a were types believe thing that talking data. kind non-air around we years started generating the cancer the our cancers few cancer, same MRD, and at about colorectal breast cancer over initiatives. program, in the terms is cancer

actually really pathway And our really FDA-approved age regulatory is for years majority indication top at a And above. once people including other Medicare a that’s very became CRC CMS our XX factors, reimbursement really us at to why the other anchor in we for pathway. and covered on have indication test of Now, that. anchor it cancer has indicated or types way now of vast this of is looking good of add because this that lead fact,

has I from you indication. XXXX, cancer seen, So, that’s have data And as the CRC we are to types. But throughout see become a our why you going other are like lung. think anchor adding few

see already bladder, those. you some of data So, in we types, in are going couple I but pancreatic to a think conferences, cancer of shown have more maybe other

for with us really indication. anchor lead our as a been multi-cancer journey screening CRCs it’s So,

Max Please go turn ahead. and now from We Masucci Company. Cowen to

Thanks the for question. taking

setting rough test you do then expect how that idea what do split cancer a the event? to And between recurrence in have MRD, on Is quickly cancer or the volumes from adjuvant First XXXX monitoring used favor coming monitoring mix that shift volume for will of of in XXXX? a MRD you be recurrence? expectation versus clinical

mean monitoring out test kind in You are of subsequent first for test like to it after versus of that kind just the to adjuvant setting test? first break that

Yes. Yes, exactly.

So, maybe in remission percentage that tests used adjuvant using just in window cancer are monitoring that come the MRD test XXXX, months on versus patients what and recurrence? across that vendors those volumes of in are all are from six will

Yes.

early are call oncologist. our still the mostly to obviously, in And is points We days. the

lot those up we that are given time still of a are so ramping And strongly, we getting initial very points.

recurring that in and And point. But growth be into sort ‘XX, continue so time the are throughout seeing certainly strong of stream will think as we initial that the ‘XX to majority of that well. testing tests we

blood-only So, we we time Well, that of are to monitoring being the both it’s over test population. one are mix, advantages your prevalent that with something pleased sides, a I think and of think very access seeing progress. able point, the really that is I to

adjuvant survivors kind If their XX majority them, are you period. a think cancer year out about with the million than more of from XX% are, an there the resection curative of

lot population, that so interplay have on in the side, a before there synergistic primary out see our build us we an is franchise, opportunity And terms for there position as in even of setting. really the we care can to primary screening as continue that we accessing we instance, our have care even prevalent build of that enormous is we

of very holds are by we future what excited for the kind So, us.

after be reps potential for XXX-plus built today? XXXX approval? plate their team. primary FDA and sales much LDT on time they and preparing a versus responsibilities, effort to to of have the care hear initiatives great How the are you a broader person Guardant in sales And sort sense. rollout launch SHIELD dedicating It would Makes what PCP have

tell well mentioned scheduling bunch the are in a fact, I feedback you to the looking the happen, in as is Actually, I the of terms awareness peers, our remarks bringing to are the pleased screening feedbacks prepared Yes, the of started margin. field, and sure. PC got that we blood-based are trained, setting to at deployed cancer early we from getting very way can bunch of them on-boarded, that team in maybe, the well and the targeted from terms of And a with in we these market. getting now

have for fact, In SHIELD Guardant they already the them that live. were of come want waiting patients mind we of to many using to test. LDT Many if live, in start them are

So, very bunch assumptions really that encouraging it’s of us, for had. and we contract

So, all launch us half with the this expand getting launch then for LDT tracking successful they the a at a IVD activities the team And launch. XXXX of to us. support successful their first focus is busy LDT this in ‘XX. time But as to launch going – would actually in very be the are and for

Please Nephron Meehan to ahead. from turn now We go Research. Jack

for question Thanks. had I a Mike.

G&A, cost into marketing, sales business. maybe XXXX. just maybe the You give talked some color you investments the could going statement, I just the down walk us about and margin, income for on gross R&D, was hoping guidance

the On margins, XX% at Jack. for margins were talk had we XX%. to very of we sure, this always we full for year XXXX, we target. Target gross about though successful sort XX% have that about Yes, gross

some expect fact to take that products, the starting will we have get we from new reimbursement. on margins to but mainly it’s the pressures going coming up, see XXXX, ramp think gross I to time volumes to got in

in this heavy increased on R&D growth the on expect OpEx, gross about remarks the sales and investments XXXX. OpEx our XX%, talked again, then we we And low-XXs. probably from XX% most We side, there. and the we that OpEx the earlier. coming margins And prepared be to So, investments and is marketing yes, of non-GAAP in sort about the of made about in was the

a hired to the think roughly the lower. look screening people growth year. going XXXX, be the XXX to business be we end commercial be is growth about of that probably growth side of of going at of most We on probably side. It’s I when will towards on level the last and that XX%,

those are into all expenses So, XXXX. of to flow going

develop growth of business, portfolio and to still pushing will And the the on development on and that of coming the that most and generating side, the on device. sales continuing think I multi-cancer then we the So, data oncology screening marketing side products screening and side. on research are be for product and

OpEx the in expect XX% to about we XXXX. again, grow So

We now go Sykes Please turn to Sachs. Matt from Goldman ahead.

squeezing for I just will Thanks Hi. it question one time. me. leave given to

community XXX. clinical given oncology commercial the Just the importance think your – in market, volumes, your the you on that mentioned just team around to I is

the person, of of stays the Just been size the terms of that level there or your that? right to throughout could XX% expectations if reps have of plans growth? you that have year? of in the are And oncologists XX% like a on have now are got doing feel course that good some volume increases, drive that offset sort the same digital what are Do engagements interactions growing in then you with that just your that

questions. Good Yes.

think on. I getting hirings best of have terms reps we really come we to that terms of speed the the in room grow some up have I some Obviously, have, reps XXX hopeful the been made. when access is think still those there are to of terms that essentially of new in in hasn’t we the

lifted a room potentially as opened to see we restrictions and access grow up. has So, lot of are

There information that on decision many actually of downsized teams companies their We because more – more do especially are much hopeful have pharma and support we there engagement, this of the to I is a the to digital know behind it. some lot side. help a of test the support going are that – physicians, lot is sort

see really for we opportunity close investments very increasing the on That as said, that So, we our an being with and side. are – engagement physicians. digital

adept think a channels of – think now. has those engagement are but opened open of there where gone, there the to more not is and I technology physicians, that much lot up, think some I I opportunities have just more

of definitely and us an for that’s opportunity growth. So, area

question? of part second the The

Yes. Thank you.

Bye-bye. Welcome.

We from now go turn ahead. to Leonard Fargo. Please Dan Wells

you Another I is framing for with revenue you sales there opportunity on material framed? if launch. are hoping you. for could How Thank Hi. XXXX. was test screening are LDT not market than elaborate could expectations a more success planning just And be you you the SHIELD revenue of blood the XXXX? in on some healthy

and your So, you. perhaps you could opportunity. contrast compare Thank

Yes, sure.

is our the tens to make need win LDT engagement really in down of here, can people through of and is get IVD for TAM of sure strategy or billion millions and in tests. unlocking road we order our securing general, $XX go commercialization with payers through reimbursement So, long-term go this to screening for classical the of which access routes SHIELD to pathways

the contribute in in have to line coverage Guardant’s top very as materially And days, So kind the way policies, any by result, we meaningful payments result, cannot don’t a of since a revenue. we minimal expect any we of ASP, obviously, a payers, as like low. early very, very

decision. on review But time, early in come that are are Medicare hopefully post expecting that is The the FDA board would after Medicare we XXXX if planning expecting hopefully and approval, post goes be would following of be well. reimbursement first followed this the FDA a and bunch Advantage up which, in now that would at coverage payers, like and approval, by that Medicare we major

XXXX not any main at in this projecting because that’s we ASP. are material that very So, of reason the revenue contribution low time,

We now turn Citi. to ahead. Patrick Donnelly Please from go

you the you catalyst me set you, guys What a we think side, even squeezing some there? for expand be maybe Thanks just lot you in guys. side it’s Japan I JV. kind for international should groundwork in build? here. that building keeping guys volume should international know How the we or on have whether about a maybe laid there Europe, Hi the ‘XX, on an of of one on to Helmy, have eye as continue

great No, question. Yes.

approval of couple catalyst, nearing the made about we excited is progress the we very are last We important GuardantXXX. over I an are regulatory In have think of Japan, years. which

XXX,XXX rates will around rates patients, it’s that reimbursement as opportunity the mentioned, reimbursement months. And that we coming a market very to are in U.S. hopeful in genomic similar late-stage large profiling. are the with We come comprehensive

are and a nice team gearing we I up launch up building that are for, So, product. very we that of think

its be to unlikely it’s of think could in contribution. I but nice ‘XX be in terms very something times, ramp in ‘XX, it significant Given

and In to terms we so also with labs in in XX that UK Spain. be we groundwork those can should are the work we partnerships, laying and hopeful months will very those and Europe, KOLs of horizon, the up running those hopefully with academic significant up together centers and there that That that think and or are two very next but nice the in a really be us really a longer unlocks really is a running. secure labs event it’s public once something the are right in that do reimbursement revenue to way international a I setup opportunity. for way term And

Canaccord to Genuity. For Mikson go our ahead. final Kyle from turn Please we question,

Thanks. Hi.

for So, back want I SHIELD to lung though. to go

presumably So, let’s say CRC two launch, a faring And do to reimbursement there tests actually that the being market where approval maybe already the you in that for assays of have first wanted the you cancer after your the you kind of just XX you XX launched is help I SHIELD case? envision at for lung CRC years, cancer few maybe and like do like point. market, cancer, to one already you ask, relatively have established? How can disadvantages think

Yes.

So, we going upgrades FDA And IVD basically for LDT approval. approval. device have and is Guardant time that horizon And innovation route, have cycle of SHIELD SHIELD an Guardant the IVD SHIELD an IVD route expect have to would it. faster behind can Guardant you after and longer LDT LDT so

really upgrade upgrade cycle be much indication faster we lung, LUNG FDA device submission include to should for a FDA through few SHIELD able that at the instance, going in to take expect review years I to readout going us. to we have much, that For time for and case of that’s than SHIELD Guardant the LDT lung

device So, panel your answered types. that can faster to much to attacks those hope cancer claim applied other similar of types. than the getting cancer question. LDT story IVD get added cancer for get I A can

of disconnect you to and you lines. joining Q&A. thank to come We the our would have like may for now call your We today’s end