Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Thank you for standing by, and welcome to the Guardant Health Fourth Quarter and Full Year 2022 Financial Results Call. My name is Sam, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call. [Operator Instructions]

I'll now turn the call over to Alex Kleban. ahead. go please Alex,

Alex Kleban

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

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

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

regarding and the section release risks information entitled forward-looking Guardant the Additional appears in these uncertainties today. statements press in issued

a please year with and Exchange section on Factors For in December list complete annual XX-K the Securities Form more and and filings ended see the report other company's the description, Commission. XX, Risk the for XXXX of its

any include intention or forward-looking earnings contains submitted This revise Reconciliations with or accordance discussion financial information measure found call call calculated by required financial may directly GAAP projections of SEC. GAAP. not of are This accurate law, disclaims measures whether is as comparable release of also be otherwise. broadcast, update only live February to and XX, because or financial information, statements, a any to today's new will time-sensitive the that Except or conference in the as future obligation to events Guardant most the certain XXXX. in

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

Helmy Eltoukhy

into outlook over over for screening thank an more go then for call afternoon, finally, will providing earnings will Good business. Alex. to and today fourth more at AmirAli for and our our progress a update across detail an you I XXXX. oncology our I look XXXX financials on and our provide off turn Mike call. our full our update quarter start Thanks, And on detailed XXXX the business. call joining and will year by

on area as selection, our of unmet Slide and a was now vision monitoring in whereby our pivotal we revolutionizing X. Throughout Guardant areas of therapy year fruition, progress noted XXXX significant the made to significant care, for recurrence of business, cancer three each year, Indeed, brought screening. in need we

across position current with a quite But would for standard a cancer tests our data positioned advanced of our today, enviable. are be to breakthrough these of exciting. to the we be just areas truly where am portfolio live Our of team's average using new tests survivors for mission is cancer cancer proud one individuals our powerful and of risk in from I dedication defining healthier longer care and of and all of stages help patients lives. blood so to commitment patients,

Building had earlier the rounds therapeutic liver successful with that another of unfortunately, She after to having ORSERDU. the approval treatment, detection two but share for patient had undergone and symptomatic on the FDA become options. this XXs year. cancer breast this, to spine, breast an A cancer, excited in receiving to first mutation CDx story ESRX just of our weeks patient GuardantXXX of of cancer I'm related had without spread she her in occurrence

in only a mutations, ordered targetable seven doctor which detected but alterations. no Her of GuardantXXX, historically number tumor days

qualify at in is their of greatest wishes us chance this one therapy. HERX-negative affected after finding first With of now targeted occurrence, the an this up critical lives treatment, However, the ESRX marker, ORSERDU, her to ESRX motivates has treatment the attend impact enabled wedding patients' Guardant. breast what able emerging being way all are her son's mutations This here XX% is in patient mutations spring, this the to for these cancers. targeted ESRX. one of present advanced ER-positive to with of to patient

X. to turning performance on Slide Now our

fourth the our prior year. with pleased full the growth ended million in over with year XX% quarter revenue year. to We representing $XXX bringing are of to We million $XXX strong revenue, our finish the

Slide year depth This quarter ordering reached products. compared fourth year-over-year new fueled by revenue tests volume quarter, XX% to with resulted and by Clinical quarter, prior Moving GuardantXXX. on of over in contribution X. test in of in the which was XX,XXX in increased the fourth XX% GuardantXXX growth to clinical the from up led increasing

X. growing the ever GuardantXXX I'm Turning about to Slide franchise. of more our than potential excited

with of liquid in some form days diagnosed the of than biopsy of every metastatic more non-small being early tests newly patients established therapy comprehensive less are liquid this market, biopsy of genomic cell still half billion building $XX with GuardantXXX leader We two three GuardantXXX. is selection receiving cancer than profiling. lung

In fact, have continued new expanded, to field, market entrants despite over we the share. not if in the maintain, past our year,

Our breast of for be and used companion number a a a hundreds first-of-its-kind high ESRX best-in-class commercial to as have GuardantXXX in be including with treatment to continues milestones of diagnostic team significant for CDx cancer proven approvals Progress for barriers. our patients first competitive approval CDx GuardantXXX with alongside publications, mutations. recently,

biomarker clinical Following to after cross impact the AI-enabled, a covered portfolio seeing volumes, Galaxy, Guardant tissue-based UnitedHealthcare coverage breast recent this for cancer enhance in we the XXX are portfolio lives testing reimbursement approval, discovery. and million with and of our expanded positive introduction lung accelerate already the platform and more than

PD-LX the XX% Galaxy gains an the will detection. Importantly, improvement in market. accelerate has tissue this think further making We over are we shown in

our we through multiple as therapy streamline reimbursement Epic, fueling our strong of comprehensiveness with we this later we look to XXXX, expected drivers and breakeven approach drivers partnership ordering expanded to growth utility continue as and Japan therapy we include in in deployment year integrations portfolio. our EMR our of the business. have These customers trajectory selection As ahead selection with

to X. Turning Slide

our and companion have expected key sales billion CDx a Japan. is strength approved We companion U.S. the differentiators surpass regulatory One to of in coverage of of of and the the we are covering diagnostic $XX of biomarkers where CDx types offering. tumor in Global have the both now therapies, XXXX. and seven diagnostics breadth range GuardantXXX therapeutics

Building U.S., efforts such approval cancer, and solid and the look in expect first breast our increasingly entrust and the The in Japan. with have track established as UnitedHealthcare over our cancer in to becoming colorectal gain we as to partners lung in is value in our records. apparent CDx on both approval recently increasingly tumors Keytruda we with and programs Opdivo of investments metastatic strong biopharma CDx success in received payers to cancer CDx independent players years coverage our critical approval

on up Slide X. Biopharma volumes quarter record year-over-year. with to XX% Moving finished We the

restrictive Biopsy volume mix. Despite a funding many our from pressures, years. Because of XX% strong low over our smaller expect see conservatively platform environment now over double-digit for XXX to volumes have and GuardantINFINITY these from growth Act to in growth. partners, Inflation to of represents pressures has partners biopharma led impact We our supporting for which delays biopharma now the and test XXXX, Reduction biopharma the the more budgets we Smart in we our in growth seen not Liquid cost expect XXXX.

with trend biomarker-driven That near-term our said, these biopharma we business more steady longer-term growth do the not headwinds towards structural dampen expect of a therapies. to

and forming all in opening Infinity ramp large XXXX beyond. in Our foundation market of the a further the for China, and opportunity platform growth

Reveal Slide gears X. to on Now Guardant shifting

to XXX% is and in company just growth validated CRC, In with is in commercial tumor in With the the driven Our strong year be breast technology in scratching in turnaround year-over-year industry-leading this Smart traction XXXX, clinically infrastructure XXXX. opportunity. Biopsy increasing and time, we $XX growth lung existing expect second CRC XXXX, billion upgrade tissue-free in key a including we our only Liquid patients and rapidly are asset. to of post the MRD surface franchise market the with its by platform. Guardant types, growing our launch and MRD is growth

expanding making power use chemotherapy than into patients decisions studies surgery Based to based also are and progress for disease showed in We predictive a in the of residual results, TRACC test from XX% greater MRD residual B Part X,XXX in The and CRC two-year ctDNA results Reveal. supporting for with chemotherapy which evaluate our guide exciting study settings. for number ctDNA-negative of than disease-free include our of Recent adjuvant TRACC value C, results treatment the our great patients negative study will demonstrate is patients. clinical designed significantly following Part survival clinical will on trial these II/III avoidance. Stage the more to patients the on platform

The chemotherapy study holds use the of care and quality potential patient to unnecessary life improve through MRD. reducing by of

start. have and aspects but the and COSMOS excellent are to of look part of from Overall, off we a or substantial to also XXXX across year business, through this We of the is a results we development had year early later in great next. progress all our PEGASUS making

come. for relationships, customer growth coverage, payer will and upgrades oncology towards partnerships efforts to in our technology Our clinical fuel years

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

AmirAli Talasaz

Helmy. you, Thank

meet setting. first the a believe XX. year specificity. Slide with pinnacle was in seeing results XX% guideline millions CRC Moreover, XXXX adherence are and our Medicare approval, the just become these preferred to adherence criteria detecting exciting the to for XX% with option in Shield screening business the sensitivity individuals FIT being XX% screening ECLIPSE with coverage, patients. needed over FDA patients obtain recommendation for test, We of real-world of CRC XX,XXX demonstrated compared to ECLIPSE, to readout. trial Turning XX% In our LDT with we rates for an in our

The which our of When test testing effective test sensitivity colonoscopy driven stool the true by completed. respectively. the complete and not remain and are effectiveness cancers more XX% modalities FIT at ordinary the is both and clinical do tests, screening XX%, of undetected. are rate sensitivity The individuals or

complete and for Shield indication, for anticipate of As we XXXX. quarter detection submission a CRC FDA FDA in our PMA approval and approval this to IVD expect launch reminder,

to ACS FDA get We ADLT obtain included Medicare receive coverage, approval. in status guidelines and expect following

blended be We of a expect ADLT private payer ahead approximately pricing to $XXX with Medicare coverage. of Shield $XXX ASP

Slide to XX. Turning

believe overwhelmingly shared the unmet of As the of feedback and positive These in above testing Conference cancer patient screening receiving the the JPMorgan understand test leaders the modality. been field January, adherence a These leaders from era completing the and top at foresee beginning disruptive we new sensitivity the and need, advocates. blood in importance a with bar. was observed the the leaders we've

We've Slide XX. best said the step to often the gets test that done. is turning Now

cancer of of is this sensitivity in other than screening. the effective detecting in modalities shown CRC As higher Shield all graph,

As in saving testing compliance millions current the increase years a a will life care. of as over option overall standard of and screening result, adding Shield potentially result

the real-world underserved in on populations. the overall a This Chicago screening announced CRC improves with adherence tests. failed to Moving have study, complete studies prospective Slide with CRC that Shield We will the in for partnership prospective of will who whether combination to observed USPSTF rate patients like University medically will from X,XXX enroll in to examine up evidence XX. screening Shield. support U-Screen our recently this, study inclusion initiation of guideline The

the future excited beginning of the In new summary, in I'm the of era screening field. the cancer and about Shield

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

Mike Bell

AmirAli. Thanks,

Turning Total results. the was quarter to sample financial compared million, revenue and in volumes. $XXX.X both up the was by prior biopharma of to quarter. XX% year-over-year review precision to quarter was $XX.X fourth from the the XXXX for revenue million increase year This million our growth year for prior XX% million, testing Slide increasing in driven in quarter. $XXX.X XX clinical fourth Total oncology $XXX.X

quarter from the was same from prior from and growth million, an year for products, increase period test million from tests revenue volume Reveal, new strong XX% of clinical X,XXX the TissueNext our $XX.X as oncology was from of Response. well clinical This quarter. Fourth by the increase Precision up GuardantXXX approximately prior as the was tests year XX,XXX, quarter. driven contribution increasing XX% of increase an $XX.X and previous

consistent of $X,XXX, quarter The ASP For ASP range the quarters. few in was XXXX, of fourth with the the approximately $X,XXX. was blended last clinical GuardantXXX $X,XXX to

will as and previously have products well amounts we clinical stated, the the products. volume new the GuardantXXX blended the received as of for to be both ASP continue As reimbursement new mix influenced by

from in tests was quarter. the test million, year biopharma fourth the prior the Precision quarter Biopharma prior up $X,XXX. XX% totaled from X,XXX tests, year $XX.X oncology from totaling the fourth in approximately quarter. quarter $XX.X fourth strong was ASP million quarter XX% the revenue up in with volume Biopharma

received the in revenue totaled year from catch-up million, to fourth due other quarter onetime XX% increased payment comparison in the prior which XXXX, and quarter royalty primarily services the a was quarter, that the fourth Development base. down $XX.X of

of margin same Gross in period XX% $XX.X XXXX line continues quarter. profit fourth our for in target main the The year. to difference compared driver XX% the of year just was quarter as fourth gross million of the to prior quarter be the to mentioned. prior revenue, with year-over-year $XX.X Gross in the change profit at million royalty was a of mid-XXs coming this compared in in

XXXX Operating quarter $X.XX loss XX% quarter was fourth the fourth XXXX fourth the for increase million per or in or of of were expenses for XXXX. $XXX.X an the compared million quarter of compared XXXX. of fourth million $XXX.X quarter per $XXX.X million, $XX.X the $X.XX Net share in to to share

which XX% to increased the million XX% biopharma comprised million revenue and full of grew oncology revenue year. year-over-year revenue Precision revenue testing of was in XX% Turning clinical XX% year. increased testing up to of $XXX.X the million, $XXX.X Total prior and $XXX.X million, which year-over-year. $XXX.X from million, $XX.X was

XXX,XXX, The than for which from up clinical was ASP clinical year-over-year blended was the ASP Clinical XXXX. to test XX% in blended approximately year for $X,XXX grew tests. of $X,XXX lower volumes XX,XXX the XXXX,

consistently XXXX, change ASP and GuardantXXX $X,XXX the TissueNext mid-XXXX, $X,XXX both has Response. between While mix lower cash the blended the in due in the to XXXX the and since to for of Reveal, GuardantXXX, versus been range was ASP in true-ups change in

the testing full revenues in related and $X,XXX increased projects due and in progress year-over-year mix. customer XX% changes Biopharma prior XX,XXX approximately the services $XX.X in other the third to due milestones volume to to million with and Development year down of to parties. was XX% timing primarily slightly tests. $X,XXX XXXX, approximately Biopharma product declined ASP in from variable to year

as loss XX% in $X.XX $XXX.X to XXXX. in was year Net Gross margin to the million compared to year XXXX. full XXXX share million was Operating million, in in $X.XX expenses million $XXX.X the $XXX.X loss full Net XX% compared to an increase in was compared were for XXXX XX% XXXX. for $XXX.X XXXX. XXXX XXXX in compared per of

Non-GAAP clinical the of of per Non-GAAP over and fourth Moving months $XXX.X from past investments exclude of XXXX tax prior XX $XX.X product on assets non-GAAP our both infrastructure was to for pipeline primarily increase our a payments, million the XXXX. screening financial consideration. operating were increase compensation XX% businesses, commercial operating loss expenses Slide $XXX.X fourth intangible quarter. made million of measures primarily $XXX.X continued net an the Non-GAAP $X.XX and year oncology across in quarter compared amortization payroll million in XX. our employer stock-based contingent This the driven for and per on and development expenses quarter the and quarter million, the related $X.XX XXXX to share data. was fourth or or share for of by

define adjusted quarter compared amortization $XXX.X as XXXX the We income million depreciation, was tax, in EBITDA of net a and of XXXX. to in quarter million and interest, $XX.X Adjusted income loss of the fourth fourth adjusted other loss loss EBITDA non-GAAP for

expense.

from million prior prior million year compared a as XXXX Non-GAAP per loss Non-GAAP million was loss corresponding XXXX $XXX.X year compared $XXX.X $X.XX net for year for million, period. the in was $XXX.X to Non-GAAP XXXX $X.XX was corresponding quarter. increase XX% for as prior period. operating the to the $XXX.X for expenses net full year for share the

cash, cash used joint of purchase was approximately billion payments with our We $XXX that marketable million equivalents EBITDA loss related and $XXX.X million to consisted million $XXX compared year primarily million of approximately free onetime in to the cash debt cash a venture. reflecting Adjusted million in a a $XXX in outflow EMEA totaling a of loss XXXX. securities, ended $XXX.X in $X XXXX of and of the

the large operating activities levels, In we Slide and cash to will strongest investing infrastructure our in take and operations, opportunities XXXX, start cash diagnostics. $XXX XXXX continue our year million support front years. peak as believe gaining to is But burn now research the in our oncology completed three XXXX maximize as organization. lower can material development very and us. below beyond our now was is Turning to leverage we establish of actions what to to core expenses of investments place our in terms to firmly rate run significant commercial we will XX. platform We cash extend our in burn reduce

In X%, our areas we recent all addition, begun by across including operational $XX our translating efficiencies to reduction in of implement million the to have workforce business, of approximately savings. annualized

to and For reimbursement revenue track our our in therapy be in breakeven continue clinical abroad, XXXX, remaining for will and on penetration. aggressively business XXXX, selection market to to data spend in the simultaneously continue U.S. we time. be development GuardantXXX both In about MRD will growth, focused XX months' increasing on target while

will technical a other for lung CRC market development strong activities and select screening, to launch resources following commercial fund while and data cancers FDA reserving continuing with For as necessary continue as we in well the development approval.

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

We in to to expect precision we expect more grow growth full key revenue $XXX XXXX the by approximately The year range XXXX. growth of of $XXX compared revenue to representing will which XXXX. million, of driver XX% XX% to be than oncology, XX% be million over to

ASPs and drive expected products volumes be for than more Clinical additional upside dependent XX% MolDX commercial increase from all are product by potential mix growth. reimbursement on continuing continue GuardantXXX Response. to with to will this for and to TissueNext Clinical coverage with

volume from budgets Reduction While be conservatively the to we we for expect the biopharma environment resulting Inflation the expand smaller of our double impact partners. the from growth funding in reduced continue low partnerships, biopharma more restrictive our to and our biopharma digits, biopharma Act

of dependent milestones revenue on and of of expect in revenue partnerships, the with above amount to signing other services received. revenue and the be million timing project quarterly royalty ramp-up and the development new XXXX, We existing $XX

full improve to below increased previously to operating XXXX This XXXX our expectations XXXX, from departure to as previous year outflow and and focus the further expenses to a represents burn. significant $XXX improve discussed, cash in following expenses million in years. free expect cash on we be operating and reflects and Finally,

to XX. turning Slide finally, And

a vision cutting-edge technology, is consistent diagnostics on Our long-term transform opportunities focus to through cancer high-impact and execution.

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

Operator

question Dan Instructions] Stifel. line your from Arias is open. the now [Operator with you. line of Our Thank first Dan comes

Dan Arias

shorter in help getting guide more think guys. makes for between you that the just Thanks familiar for you and as or you commented Helmy you you assay guys? question. short contributions the data then reimbursement think between tests, the CMS in Reveal payers is with for one the on and with cancer? us get of Helmy, like just the And differences for afternoon colorectal just coverage lines coverage decisions MRD and the assumptions can breast way feels other new I'm it underneath can revenue for XXXX? maybe on be types performance decision words, time saw you increasing than time Good and from a do what Mike, process, Reveal the Reveal anything terms curious for presumably whether about In that

Helmy Eltoukhy

Yes.

mean, we with market head I I and which education, market. I ultimately a CRC. that has are there. assay start like and think, tissue to of, I went I is second product advanced in lot fit to think with you around. think, It's more in think disruptive a start this a forth I'll the technology yes, in have that It's many I'll back get in is through where have, So ways. your getting that But part. something we harder also when certainly, we free understand

that we'll that we more fashion. -- data as go indications, additional think supporting fairly that timely we be I optimistic So, able have sets in process are be to a through we'll to able subsequent

double-digit is that we're insignificant almost I going in we've something I'll to excited thing add with mean XXXX. XXXX about Reveal, going to I we other The increased or millions we're think in very progress in be made the -- that the from revenue low XXXX is

with sort we we're that saw engine we just when seeing XXX on of really so And kick started. like

ultimately, for. And we and a us going in one that a is believe, to business will be whole division so be this big for

Operator

The you. Masucci Max next of the with from line question Thank Max? comes Cowen.

Max Masucci

questions great Hi, progress. on the thanks year for taking of congrats and another

contributions So, some looking ramp the I was MRD seen for CRC could would for in I going competitive to we've test. revenue Reveal range imagine at the wide. be ask, quite just

curious free factors hear generally, you then just more was it your great I outflow that to million for the cash how to would guide. And So, maybe key rank accounting the be meet order you're ability how will that? determine $XXX

Mike Bell

Yes, sure.

I the Medicare year yes. Reveal think currently see volumes, size, revenue -- more the think, on in from because [ph], Reveal of is we I adjuvant than I the really, get, setting. really it's mean that we'll drives reimbursement and this the the from which just CRC

surveillance year, driving there. we setting. And so still good the we've really last also, And lung breast I think we're seen in volumes launched and and CRC traction in

I that So, feeds think into

said to be our clinical volume going over we growth, is which XX% XXXX. in

to And mentioned, this but that from help to levels just mean, profit. reduction, And margins some with our to to going And we XXXX. and then revenue than increase growth, and flow see dependent the this to of in I free be it's as to reimbursement. going the lower it's drivers obviously, in longer the about we'll to then cash in the from which revenue XXs Helmy start managing that's on gross that the to gross It's OpEx we've still expect take we year. going see, the that come be talked drive going year

already can that so in can revenue, we taken actions can do and operating And manage then that's to if drive achieve that, we gross the if free cash and to margins expenses we the that, do reduction flow. the going absolutely, we've

we've the that within out times Guardant. few now a a built infrastructure of lot mentioned we've obviously, And

XXXX. sort last significantly marketing our now of And been that's us that the to sales in the CapEx couple on to side. it's even which operations, and really for spend, going the the and level come so down across leverage in to years, And R&D $XX of has million

Max Masucci

Thanks. Great.

Operator

with Tejas, Thank line line your question Stanley. the from Savant of next open. is now The Tejas you. Morgan comes

Tejas Savant

the for Good thanks guys. evening Hey and time.

a ask parter, I’ll So, screening. on one one MRD two and on

with MRD, chime think market the Mike, could about of balance generation newer ahead control Helmy So indications this making and revenue expanding the how priming push. reimbursement near-term between you versus or a starting getting and into you cost and perhaps bigger in on

changed any share the protein you on markers marker perhaps on is tell? choice Or too can AmirAli, on a non-proteomics classifier the there. it adding data, that’s the insight performance the situation then Was weighted still ECLIPSE those already the way markers Any perspective that of there? the to sort was marker? Or related degradation it And so it more to far? of early

Helmy Eltoukhy

Hey. Great. Thanks, Tejas. Good question.

about that’s the market, about exactly to the essentially share, we products, of we we develop new sort spend or launch think So take framework some sort that the is wait versus we competitive do do as how of only until which the of balance where are we know much product think free. given is we comes the reimbursement that share market how environment one in we we much tissue the and kind market of see,

so the And that ultimately think, that required over take sort the, I markets of MRD product market. to is is

that where move that luxury we that reimbursed really on of pendulum can believe towards essentially that. engineer tests the try balance have We demand to concentrate and we move to and sort

overall term. I would that’s MRD market. that is excited say, And demand, the on I for thing, why mentioned I of in CRC so should this the guess we’re terms other we’re concentrating very

obviously just clearly flip give we the there it’s like But cameras. Smart It’s tests you Liquid and to a opportunity. moved XXXXs our on functionality it. and like taught in in out that quickly. a Biopsy. everyone to help video Well, ultimately see think the it major going smartphones product the be came very back how another fit to improved use cam as about were we co-opted And didn’t I talked analogy market

that AmirAli, smartphone MRD do in you… are market. We

AmirAli Talasaz

screening take I maybe the then And CRC question.

of learning terms still happened. learning from in – data, just kind we the proteomics So has of they already some are

so some kind go the lessons like oscillation sites some reasons, temperature multiyear of there similar hundreds at through, use are variables forth, and this us competitors including these chest some that contribute of many For we’ll of time. tubes some there But coming biomarkers, kind learnings the themselves. – but interesting are maybe that of studies, those [ph] you of of some shipment, lack Infinity performance are close the samples keep learn performance the like in to samples and competitive of factors kind of proteomics, our from learnings different of in or for we our could

In of CRC saw to in what just this terms I’d degradation, know performance like we terms sensitivity. XX% of

on the some On the interesting detecting of of control main of of level stack developed just that of XX%. in details patient, case which line, colonoscopy. tech are post side, and higher that of those is is have CRC, a performance learning end patients when last some is really XX lower month and a so the early like said the actually asymptomatic perspective gets from through training small intervals; are cases the XX% study cases the one also we CRCs, this reason kind actually and with my algorithms go stage removed, tumor fraction these that confidence Having of the we that, observation are border lessons stage early those kind colonoscopy of and

So seeing. we of have bunch that is would learnings explain some are this delta point a good But of samples, the these from of these we bunch samples. that now

us there improved over that are even this potential can path get further time, from XX%. probably So performance the for

see. we’ll So

Tejas Savant

guys. time Appreciate the Very helpful.

Operator

the Derik Bank Bruin America. with you. comes line from of question Thank Derik? of De next The

Derik De Bruin

Thank that really commented been have Hi, on they There the this been dynamics? some – the Could have biopharma I you call. calls we’ve for good any on into impact haven’t have or some market more my other we were you IRA afternoon. the taking companies from that. that go a mean of bit little CRO suggested that seen

biopsy little a that guess, now companies about or products there’s the bit talk also lot on from And liquid a going I offering more just – you the a there? can dynamics are fact So products. there similar is biopsy liquid here of competitive now competing dynamic any

Then more volume a standpoint? versus you’re little competitive have bit Just what a from a seeing I follow-up. on

Helmy Eltoukhy

of Yes, I where of to and lot of value difficult CROs enterprise aren’t some maybe lot and the the Okay. a companies can biotech over biopharma that that. a with are bread-and-butter potential kind do I it’s them sort A we’re respect and headwinds trials, take I IRA XXX testing trading seeing, would of the below conditions. and say think, companies macro are we necessarily we just doing. work with obviously frankly,

follow-on analysis, for research, doing of research We’re lot targets. retrospective a

obviously, a bread-and-butter business is and the good type mean, part selection business. I our the patient of

And we’re whole mix a of things. so seeing –

were We’re doing on. who being and is quarter a seeing strong they very said, some with We lot more delayed sort into a That one into a strong. so where came and of defense, our they’re pipeline – do order for others XXXX. very clients book

kind these upcoming question. some hopeful we’re There’s part don’t how the want that so And But materialize. second hopefully headwinds of prudent look be in at of a obviously, to year. of we terms we

Derik De Bruin

Yes. Yes.

without… assays, with if had on presubmission a you different meeting the so, run feedback two what’s FDA? having with proteomics trial, the one And and have the variable Just been the

AmirAli Talasaz

different are devices screening There sites. two configuration on

we started and – the before, then proteomics. we DNA configuration, only as added with we So mentioned the cell-free

device, that of which terms was got we before actually threshold, DNA any clinical in in data parameters, base of only of everything So had kind cell-free unblinded. configuration was clinical frozen device

of terms a proper a we statistical way we’re and So in the in doing believe way. clinical planning, in planning this – proper not

a meetings kind we’ve line launch again done testing. of In conversation discussion do with it CDx before pre-alignment of studies. these of that, configuration deprioritized a other has IVD other of pre-sub, COVID terms testing pre-sub to multi-device that the have kind go some have in FDA, with multi-month of manufacturers multi-configuration in and kind Having a plan this was to coordination time of it of not FDA possible within post said been we kind on such done of and the and terms have our to kind

see a as in that We way. FDA believe when done review. So we’ll through proper go we’ve we

Derik De Bruin

Thank you.

Operator

with comes proceed. Thank next please of you. Nephron. line Jack, Meehan The the question from Jack

Jack Meehan

continue screening. on to wanted Thanks. Good afternoon. AmirAli, I

the to medical And of any then kind time thoughts FDA expected in journal. on second, process. First, on continuing publish ECLIPSE a line leading

could quarter, Just potential you line panel? a is And approval? after what time the do think you they the submission do this think commission for

AmirAli Talasaz

Yes.

this in before quarter, imminent process submission the like of going out terms to PMA end we’re FDA to planning So is this go now, like it’s of the that agency.

we is In line, that submission. judgment FDA review get those time from to be for XXXX our specifically after days a line approval. FDA, time like from appropriate FDA, would early of XXX have better initial feedback terms it are we understanding which before we have of after Based of a going expect kind times which on feedback some our

to a But once kind of a understanding. better have that port, through backhand going we are we go

we some review of that to for line. panel In the want of to terms up both of make Cologuard, call it’s They’ve put cycle. conversation, those and during done downs definitely, they Epi decision done first [ph]. were and if review kind them that for that for devices FDA’s devices they’ve proColon its But

experienced, are So but choice again, a call not. want they now it’s panel to if discussion or for they their more

Jack Meehan

journal? medical the on And

AmirAli Talasaz

journal. Medical

and an of a of take. on is So review factor line internal publication some based of time would paper submission. long having ready for external our like kind the activities aspects how But

We the continue throughout in a good review publication expect XXXX. have peer journal to to

Jack Meehan

Helmy. decision great to means And get what If follow-up more What for UnitedHealth would for financially, GXXX competitively this this could your I Awesome. be thoughts. think CDx? just you one This do can mean? ask

Helmy Eltoukhy

terms FDA financial But of approval to know, think process. high space not the have pressure. approval. easy many one is get And but competitive test in you side hard moats on It’s bar. easy NGS or And talk to has side gave PMA CDx in extremely about submit, diagnostic Maybe the And and in as of the that the entire very approvals. tests an I of very talked tissue about to through companion of Derik are There to coverage our go only that’s few business. we Mike the even that’s that has it. they with might competitively,

frankly that it is of even number there’s newer And over We’re entrants, if the seeing – the on our maintaining clinical of as XX remarks, the in not share we seeing market not we on the XX prepared entrants despite expanding years. hasn’t the pharmaside. or entrants eight and are any said last mattered side,

to the of in not command GXXX them yet spend of could therapy had crack continues essentially dollars that billions market Some to selection.

Mike Bell

it in and a the were news a quantify we start this. still of And Yes. to It’s a $XX to to our for the assumptions the add we guide over going increase of if our from of in timing then XXXX. on positive stay GuardantXXX going increase it’s a if And can – any see recognize increased perspective. bit backed payments revenue revenue. X,XXX to time financial from Maybe I don’t have maybe the get impact. X,XXX can $XXX with that’s same to to take ASP, And because ASP range. United. We to But we to our million in our payer, into is GuardantXXX way assumptions getting our

we’re So we’re looking that traction with closely, payers. seeing potentially and other

into upside, for not baked but it’s at room moment. there’s our So numbers the

Jack Meehan

Awesome. Thank you.

Mike Bell

Thanks.

Operator

Thank the from of with you. JPMorgan. next question is Qin Julia? line Julia The

Julia Qin

Good taking for a Thanks afternoon. question. Hi.

So faster whether of term? off, best you lung you’ve up to breast a in today. just years mix? drive penetration What And like lessons curve patient to experience are taken any XX% penetration cancer compared to the longer lung your [ph] there from breast, many payer expect GXXX lung for terms look potentially following the do it’s reach adoption in to that breast or learned first on

XX% seen that inclusion understand that inclusion, question includes is guideline support goalposts versus given second only for achieve regarding launch your to Thanks. And of is setting Shield? AmirAli in what my early new to you’ve scope the kind study U-Screen can on this you real-world a guideline for the how of hope the will important help do currently you scope experience. of in then limit that And the compliance us study compliance, noncompliant be population,

Helmy Eltoukhy

Okay, good question.

what in be that cancer to the adoption mind needs making essentially fact the In advanced to access of top drives and breast options is that those really is order cancer patients. of approval, the life-saving terms therapeutic for testing patients options for

a host genomic cancer had is often breast the need coal in an of cancer resistance the to in kind and the what’s breast but approval, Lung is many really mutations, therapeutic that for mine, testing of about hasn’t others, ESRX canary see upfront. mutation. this though, with traditionally, options. of But we’re unique require PIKXCA now is fact this so sort emergent And the starting

of primary it’s the to inherent So kind tumor. not often

to way in therapies. is through the for of diagnostic blood. access feasible therapy, type class that are that a means only that new And the the really manner companion only we And this mutation-driven ESRX

a very it’s it’s exciting. why so big It’s And opportunity.

that breast this already seeing adoption you’ve really of a hopeful of said, cancer. faster And cancer for way because nice in volume approval. increases kind We’re as types, additional paves we’re including

AmirAli Talasaz

the And actually cancer test. to regarding that and the screen show U-Screen adherence we improved to doing the colorectal studies using blood are

a such inclusion, really of and Guardant other also of U-Screen going doing, So pave are guideline generate puzzle of that for a would commercial the to the time. over other some path series the adoption but to combination is piece systems of be only of generate prospective we with all that are would not which, studies – partners in terms tests and evidence health going for it’s one in

expect guideline going inclusion the about, in U-Screen updated, evidence, series I guidelines are get a XX% this first talked study of than that is more adherence rate. are of we to kind have to these kind USPSTF a that sense we as field. expect a supporting. a real-world prospective we it’s of that data have before And I coming we

this population, that just the we hardest are of the this one. those impact fact of who and time, patient noncompliant at terms which are In the testing the patients are are the

patients, showing high of compliant. to show blood and compliance fraction fact, of us some even between current to when health those patients a they that for tests, if actual the XX% of a imagine test, rate kind talking those about we huge system compliance the of in that of good patients So value that access get very even in those pockets they’re which blood are are generate we conflict are, is XX% the

Julia Qin

it. Got

AmirAli Talasaz

you. Thank

Operator

line question next The Souda you. comes the of Puneet? from SVB Thank with Puneet Securities.

Puneet Souda

Yes. Hi, Helmy AmirAli. and

I Reveal. of appreciate on readouts data, of one here. – the TRACC, PEGASUS, the the look growth COSMOS, first XXX% as trials I mean are in you at the here, most as So But we the XXXX.

these to how Reveal for Do about how have incorporate that So that on trials? indications? thinking you for And mostly Or ongoing generate into data? reimbursement Biopsy, should we XXXX Liquid you then new do do in be these Smart into you insert Reveal?

Helmy Eltoukhy

great Yes, question.

I highlights largely sense they’re just would of the, are these in interventional. are trials. the pivotal These So more some that of say, pivotal

in So haven’t the been data of really of for these establishing kind of in clinical fashion sets this sort the that are utilities, really really private seen in payers. field prospective terms especially

highlighted know that about I terms to of we some the validity In be sets presented around this not them data have thinking will reimbursement, and that Medicare are hopefully, or second be don’t of year able many published here other clinical part.

Puneet Souda

Reveal X.X

Helmy Eltoukhy

Yes. then And Reveal the transition.

in obviously some been for that’s time. something yes, has the works that So

going Liquid version either the carried have be or Reveal bridging very sort And kind Smart studies of That Biopsy. been a these mapped points we of to it can using out in sometimes has graceful of the so confident new we’re many and essentially make transition. are out, of

Puneet Souda

Got the think you your position types? what just on CRC should on here, indication detection. it. just on into working given sort other the reduction have? expansion early And and tumor focus side. then multi-cancer can potential ask the other we screening should How the think are cash mean, about given beyond And we you priorities burn Shield that I investments and of if there how I about for competitors could on cost your outline

AmirAli Talasaz

very So indication lung we CRC first was pursuing well. are mentioned seriously the cancer our we’ve indication, before, as actually, as

screening XX,XXX patients high-risk screening. should study, So patients we are our for go lung cancer study doing registrational who through

XXXX. three of since with done in our SFA the we’ve it mentioned we enrollment; UCSF that probably second cancer presentation, some be of year actually prior actually study lung around in study. in to addition And kind we are should year and are of expecting get enrollment visibility as data We

of early to readout year be that this sometime later expect [ph]. We XXXX or part

Puneet Souda

it. Got

guys. thanks Okay,

Operator

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

Matt Sykes

my taking you. for one Mike, Hey, maybe quick one good afternoon. for questions. just Thanks

in reduction in we talk maybe Could are should sort and SG&A levers where and particularly that of we of of workforce the XXXX. reduction, XXXX. workforce think Just talk done about split XXXX move you how versus as side, the of see kind drop OpEx as what over some you into in implementing efficiencies about big the in about the R&D and you’ve kind

Mike Bell

reduction, the on pretty say would workforce I areas it’s Yes. of much business. all the across

not weighted in areas. really any So specific it’s

So the of each of we bit across a lines. impact see that

year flat line. primarily especially be how the the on we still the on side, I and the rate sort really on I’d bring overall the OpEx think on to down bring oncology say year-over-year, commercial relatively invest continue is going and we to below to drive the SG&A have. focused side full the how run of opportunities we’re XXXX, side we moreover, that it’s probably R&D

we’ll be been going months, to half of off, ECLIPSE year, start the drop of for as next XXXX, of continue doing few first probably then start the least similar we’re build the come and a we for at biobank. side, But spend expense as a down. see up the R&D significantly see the we’ll the as half the that studies by on I to on to to with R&D carrying the the lot think second But think I half last year. latter in of we’ve

And so that’s as how we look well. at OpEx our

second I of in think the off the room rate really dropping half year.

Matt Sykes

very it. Thanks much. Got

Operator

The line Leonard Dan Dan? you. comes with Thank from of Credit next Suisse. question the

Dan Leonard

Thank you. Two questions.

to that if how trial sales interventional an Thank there’s want Puneet’s assay? guidance, you’ve the you like to Reveal in what logistics left question, I’d that. potential already tried do upgrade. And has question answer be for characterize are trials follow-up into how sure helpful a flight you understand a I trends to to you’ve my could your made on then physician upside? decision, the versus do your and what Like the therapeutic just work you. change those I Helmy, on understand off, for would First make bake outlook as if it

Mike Bell

the that. mean, going I we think Yes, driver few a I definitely GuardantXXX. revenue there’s there that trends start am volume. I to the baked think in into clinical I real while is the And trends. off on mentioned we’ve

with so continue consistent to strong year-over-year we And GuardantXXX. make growth in

mentioned real revenue just that GuardantXXX, driver that the that’s So I in the of assuming ASP point from with stays constant we’re view, and

last year to to X,XXX X,XXX range.

think But improve. half ASP with on year there’s to board, in commercial coming the of the opportunity latter start sort maybe I payers the to of for

drive think upside, an could Japan. and I other also there’s would reimbursement things that that be in

for we We’re be some Response, this expecting reimbursement positive a will have Guardant for to that. If year that point that us. still and in was that come,

think I the just then saw side. And biopharma, talked growth as biopharma we the in We’ve XX% last about we’ve on well year-over-year low growth quarter. mentioned double-digit

about we of guide, that our want biopharma into customers. the obviously, the we’re baking spend conservative be to because revenue So

improve that over expectations. a to for there’s potential So our again,

last biopharma We a And with also over book timing that that were lumpy the think things That’s, depends see the similar be continue at we’ve to $XX partnerships. of how again, here, quarter, we’re to then looking And upside. we lot line, would accelerate we book to order a be if how conservative business. mentioned want what we at we did could the in then conservative a upwards. an very – a good looking planning, that see we on in again but be trend development the rate obviously, above I services, we’re And on again, And will just said as million. a – growth that and the were it’s way. quite I think

Helmy Eltoukhy

Yes.

of already from was knew in results haven’t trial raise enrollment, not you’re We There mean, we new shown for that’s But going the one. cutover, early absolutely enrolled terms the target be to right. this the the a platform, transition that innings, cut started. happening. quite to obviously that over and I trials we In and patients, the old we’re are will

it ensure until on trials. those biopsy start those with Liquid platform we’re waited So Smart where clinical those trials already validation we We number of testing sets. data that a to was ready

Dan Leonard

both. you Thank That’s helpful.

Operator

Thank you.

Patrick? today line Donnelly Patrick question last the with Citi. of Our comes from

Patrick Donnelly

growth me guys, on squeezing just Maybe the Hey here. side. profitable for thanks in one another

think have – PMA similarly, you there. on then the pipeline one you of to it’s changed And on build piece? of just kind do screening the earlier the the And think As of opportunity the the other a trajectory the screening on and that you the of the about follow-up again, that AmirAli, investments side, and following Helmy, for quick out, opportunities on then some about some both about up submission. then international of funnel just kind of how questions

talking Just early you guys know I initially XQ. were

XQ confidence in it Just what that happen you. to get it done. Thank the happens and to has

Helmy Eltoukhy

and years. to area the not Just is save think of establishing therapy the standard driver is that in obviously, international. us, It’s going coming on big but lives Obviously, just a the U.S. for of we in big first screening with are us and that an the U.S., we’re Japan care growth outside a opportunity globally, selection, to MRD establish really for market

and our there. set both excited up be biopharma that really We’re to access the able about being with partnership in lab China patients eventually is to Adicon and

And then number Europe, we have in labs obviously, there. of a

think the to and I very that systematic each gross – possible would get margin in investing So us approach a in where revenue as of activities we’re reimbursement quickly doing I or as I kind localities. of say, those think, to will disciplined taking, we’re public investment one positive the

AmirAli Talasaz

be to line, QX. PMA Regarding time it’s going

done. imminent. this going almost to So it’s be done quarter. It’s by It’s

Patrick Donnelly

guys. you thank Okay,

Operator

Q&A Thank Year well all as Full and you. Call. for as Guardant Fourth Results Quarter you Thank our the XXXX your Health That concludes session Financial participation.

You lines. may now disconnect your

Guardant Health (GH) 23 Feb 232022 Q4 Earnings call transcript