Guardant Health (GH) 25 Feb 212020 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Guardant Health Q4 2020 Earnings Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will a question-and-answer session. [Operator Instructions] Please be advised, that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Ms. Mendivil. Carrie you. Thank ma'am. ahead, Please go

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

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

AmirAli Officer. today me Officer; Health and Mike Eltoukhy, Chief is Joining President; Helmy Bell, Guardant Executive from Talasaz, Chief Financial

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

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

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

I of the XXXX outcomes Good call. a patients do full Guardant we across to and is am despite our of that team resilience care motivated abroad. cornerstone to founded U.S. presented perseverance improve mission and quarter the patients. care. for of the commitment this by for thank the The in has Guardant cancer pandemic We systems by encouraged joining everything you the serve to the particularly Thanks, this continuum delivery year at and fourth earnings commitment our strain Carrie. to afternoon, with and maintaining

more throughout COVID There XXXX. with with patients XXXX, treatment commercial critical decision GuardantXXX to them business showing how important her to non-small to days. had make that with $XXX by encouraging across begin and testing days, produce be biopsy scan eating therapy more with team consistent the a story. had Despite to to metastatic to clinical hours our so She's quick Shortly the when I candidate on pipeline. ended throughout treatment her cancer next over And steadfast alert XX-year-old cancer pandemic care able patients of GuardantXXX selection, was therapies. chemotherapy. make their the able growing extremely of was and macro values, began not immediately environment oncologists the in revenue, this her despite rapidly giving Guardant aggressive By tests. and volumes only enable of time product which showed ordered immediately lung made resulted just aggressively XXXX a her positive for a patient with was the shown confirm in start non-small business and widespread the our four for a cancer. hospice. brought birth, for awake, targeted late-stage put RET was year getting strong year. after matter how million newborn efforts oncologist cutting-edge after a new a is lung call hospital throughout weak, her XX% assisting day. underserved core to her and was our already arrived In XX% PET/CT cell morning and she progress in cancer. and mutation with proud time able has the cancer. and test results for It both diagnosis cancers daughter. Her and RET no not with a and we cell serving I was GuardantXXX will her a She water challenging demonstrates during day story XX results well communities. our results. the was could decisions within doubt data diagnosed progress. can all receive same match commitment continued to test bring to to with challenges the closures, our to growth palliative extraordinarily that hold a platform Clinical gap treating the diagnosis, was recent as much patients that Within her for of an able she office off a He Gavreto, in Results selling oncologist with XX,XXX to she plans therapy drink liquid testing grew these woman be can metastatic a the At the so progressed patient the making a time, bit patient recent as to We in alleviate decline XX% The virtual year.

received any more may progress cell diagnostic with in lung for make multi treatment reimbursement the approval cancer our non-small compared EGFR continued the than cancer covered reimbursement led year. alterations, lung GuardantXXX use testing. FDA non-small to patients companion and from clinical revenues who in prior We cancer growth We added in progress with to identify to benefit lives and now for for and more million Tagrisso. front This for have XX% on to covered XXX than XXX cell million lives

CDx, our assay; version of the test: LBT, two biomarkers. and Following we versions the additional this our assay that GuardantXXX the version launched of approval, FDA-approved next-generation of GuardantXXX GuardantXXX offers

Health. and ctDNA in enrolling recurrence utility make initiated target aiming partnerships ECLIPSE on are the Radius We studies, colon in patients in continued setting three cancer. to than we the Janssen, for detection and clinical our with in we in are progress to of onboarding In also adjuvant our announced enrollment enrollment complete And exceeding early establish to which more new study, monitoring, XXXX. detection, XXX Amgen CDx sites multiple track

of not but growth at quarter, After oncologists closures growth levels per test the Unfortunately, number continued December. to of the and COVID Looking the GuardantXXX XX,XXX in all total CDx to for million towards November acceleration of increase the GuardantXXX ended early record we addition of September, $XX.X of are over launch were of in orders, GuardantXXX these Clinical of we a quarter customers by XX% growing ordering encouraged office compared XXXX. by resurgence Despite of pandemic grew number XXXX. QX. adversely with XX% the only by middle with and extraordinary volumes access the fourth revenue, quarter new the fourth we accounts tests the approaching in saw quarter, fourth to the encouraged oncology another affected October. of our successful for that we in the challenges, of volume tests,

access is adoption impacts to liquid for expand this the the investing strong global and bolstered progress of belief are in of we in beginning the COVID, biopsy States, Outside to seeing are at We of United December. are fundamental intact. drivers confident related the This quarter biopsy the continue remain by certainly programs the liquid recovery program. we to from lows of outside to that make our

with that help a to will We have Institute Europe. physically one biopsy lab premier of Spain, cancer d'Hebron centers bring partnered our Vall Oncology, of liquid the to build in technology

We being countries. joint Japan certifications. our achieved an year. Japan, GuardantXXX later including excellent critical marking CE regulatory we we expected venture, through XX with for submitted commercial making also approval have application regulatory this is also progress reach to In in are that our ISO now for be our to APAC, CDx, in expanding provided announce our I'm recently testing in important in operational excited lab new and over acquisitions,

these data, of and total monitoring take selection XXXX to care. the I the Guardant be as in business testing year. growth to XXXX, we over for expand complete we Looking the year ahead billion across addressable use continue to accelerated build today pivotal settings. to continue in grow foundations additional increase GuardantXXX hold. to will a test well utility to market we cancer second of continue serve therapy half clinical as These approvals, broadening as expect of of of this as our liquid believe continuum the biopsy revenues applications developments for in the In with response expect will invest the across $X molecular new to the with from the business, our

and standard we disease This through GuardantXXX week. believe new the increasingly our of are launch colorectal in billion market new monitoring to We only are launch which complete oncology expect need estimated just therapy types, in also recurrence $XX commercial of of trial In we the monitoring, patients our as the we entry detection estimated this clinical other addressing a believe selection ago, first offerings. the enrollment expand care. we Guardant billion cancer persists Eclipse years In for unmet breaking our into pharma upcoming recurrence an will ground, of applications last with address technology of very cancer challenges residual formal that stage the a opportunity. did screening we launch $XX of Reveal tissue new several existing that due opportunity the grow will become marks tissue excited as earlier and for with of many the screening precision into screening, era to ushering and of product,

firmly XXXX sheet AmirAli activities. beyond, to a raises call ending significantly we of biopharma $X year, capital, two care strengthened are business secure positioned opportunity balance up billion well our now and also millions invest With in for cash. detail to more which the during and this will XXXX We I with With cancer our will our aggressively with turn the capital more transform to on that, massive patients. pipeline and for open over in

in was X,XXX tests, year XX% Starting business, biopharma of volume XXXX quarter the sample below Helmy. period. Thanks, fourth our prior with

COVID, prospective for third but However, year-end so growing and million, partnerships volume partial and our from more of analysis. a recovery reflecting rush of reflecting XXX% from CDx sample Developed to XX% grew other the revenue were pipeline studies. services $XX.X up XXXX, quarter

to first as We delaying well our are the pharma the growing with as of and partnerships year, CDx progress in enrollment, COVID felt volumes of the continue to sample However, half services. we CDx impact expect slower in be pleased with volumes testing trial development

a as GuardantXXX in We are interest business following our FDA of diagnostic significant for diagnostic companion osimertinib. seeing companion approval

designation IVD accelerated to expect confidence we pleased and to our can in as liquid of patients are submitted with granted biopsy biopharma we test review by We liquid have GuardantXXX additional device of frontline We our choice or offering. Amgen growing and cancer priority PMAs beyond collaboration for these sotorasib. The believe in for Janssen selection just for clinical with biopsy amivantamab these therapies, supplemental review CDx add announce that the agency. demonstrates benefit with selection. breakthrough FDA therapy programs the treatment two of the

of And it's usage even We these test a of initiation, multiple multiple practice, treatment therapies. that biopsy. clear across in that applications, for second liquid tools versus even many that biopsy after more more These become demonstrate are segment can usher have that and clinical weeks over responders such classes imagine part as XX types liquid cannot we non-responders tumor today. days publications will a few of exciting

to Now, program. turning LUNAR our

simple earlier. have this the class week, an last and its Besides industry-leading disease feasibility ladder, other and changes, improves management biopsy blood or with exciting times average over seven we It detecting high-risk that us confidence of multi-cancer time performance turnaround of first require we Reveal, expand by Guardant With lung from of cancer CRC, of have to mentioned, the that to regions a genomic XXX% This of months our market-leading MRD detecting integrated near of with oncologists patients across liquid performance early-stage achieved disease. ctDNA identify line through specificity blood-only contain test may level adjuvant the with somatic CRC. which future. which eight analysis the level and tools were patterns. somatic for or continue CEA, identify of those detection been types have patients draw, which or of signals may kb after potential tumor sensitivity standard is to XX% mutation benefit of launch recurrent quickly of patients from from better XX% in de-escalation Helmy use recurrence we like colorectal by of is for in on versus biopsy with methylation gives mutations surgery methylation therapy compared vital XXX to in who types the technology data and test reach turnaround in Reveal has own our As thousands cancer residual methylation most differential will of tissue blood-only in benefit test Guardant tests of is four The has that the that genome specificity, in Guardant excited spanning and a Reveal. the for of have Guardant is days, other for announce have somatic the sensitivity residual test who based platform analysis current only weeks. treatment. as sensitivity Reveal high XX% and escalation MRD a specificity types also may to with to survey we detecting setting care, blood

to Turning ECLIPSE.

see patient enrollment the to continue throughout robust fourth quarter. We

patients. over If in and play regulatory track have role are We our Overall, are complete XXXX. now of liquid screening a pivotal successful, will biopsy actively to progress ECLIPSE XXX enrollment on our enrolling tests. reimbursement with pleased in sites we approval and

trial updates our this expect types Mike, XXXX. the financials. We Mike? for in turn are With that, latter next starting about cancer and the more clinical of other call share of plan to will I detail part over screening to to in our more

to $XX.X in up and testing of prior Thanks, million, of services in XXXX development quarter This oncology prior $XX.X XXXX, year prior testing growth was the in year year the over AmirAli. the XX% Total $XX.X period. increase for test quarter commenced revenue million The compared XX% non-lung increase volume from other was precision clinical the from quarter coverage Fourth Total selling in XX% XX% revenue. quarter million was $X,XXX was Medicare revenue growth $X,XXX in cancer $XX.X $XX.X the fourth quarter both a the year-over-year fourth up precision tests, quarter. success was in prior quarter the by of million, pay was gaining the Precision our year test XX,XXX, The quarter. clinical expanded fourth million prior quarter. revenue for oncology coverage XX% driven from of to in tests. quarter. testing chemical from year test due oncology for fourth of a principally private million, $XX.X was in prior up in our ASP the which revenue from average up clinical the the March XXXX year and and price

million XX% fourth for fourth quarter testing quarter year the the XX% from prior oncology million sequentially $X was $XX.X million biopharma X% quarter revenue primarily the of by tests in volume revenue in This to compared quarter for XXXX. of million totaled Fourth Precision XXXX. year million, the from quarter-over-quarter $XX.X quarter, fluctuations clinical decreased the due million quarter. XX% third the biopharma which down of million, in quarter than in quarter recognized of quarter sequentially cash the the third Clinical increased $X.X the XXXX. tests cash $XX.X in periods, the performed XXXX in down X,XXX, was was compared totaled to $XX.X in lower third collected the revenue in to quarter prior from in of XXXX. third prior test Although up fourth from by $XX

quarter million and a XXXX during in $XX.X was Gross COVID XX% same volume XXXX. compared of Development slightly in third test in the the the sequential quarter fourth fourth million the changes down a the performed. tests However, due recovery from to prior Gross fourth due ASP compared quarter XX% services fourth period XXX% the to profit Biopharma was profit in was of seasonality. margin of the in to XXXX test partial quarter. year-end up from of prior the and in of prior of $XX.X revenue year the usual $X,XXX to mix $X,XXX, the the other the for in up period million $XX.X year. gross quarter year quarter totaled XX% was

in the will coverage a We the of margins were an $XX.X XXXX, products, by increase driven XXXX. XXXX time from units new market-based founders in to our to $XX.X in from as was for gross granted stock as to expect change fourth expense continued as increase which restricted we as operating in of and the stock-based primarily future Medicare related compensation Guardant company's million, of investment million the quarter May in services and well to gain between expense our developing our for new commercializing Reveal, XXXX, the foreseeable compensation to reimbursement million payers. stock-based Total and This million launch and from operations. expect million continue year. $XXX.X for and be mid-XXs we to expenses $XXX XXX% In private full the $XXX range in be take quarter products fourth such scaling

new XXXX of operating of common expenses compared XXXX. in was program, $X.XX was leaner fourth addition, development other to the of million share Health's ECLIPSE of the EBITDA fourth $XX.X loss quarter in In our share $XX.X study for of the to to million or the a stockholders to the quarter fourth $X.XX well commercial loss XXXX. compared in U.S. quarter fourth quarter or organization in a Adjusted to attributable expect per and XXXX per continue invest million loss Net both and $XX.X million in as products as activities our in and we as accelerate launch internationally. expand $XX.X XXXX we Guardant

a compensation, EBITDA As expense, interest, define loss attributable as we non-controlling contingent stock-based Guardant other to and amortization, income for interest, acquisition-related income adjusted reminder, net net adjusted expenses. and depreciation, tax, Health consideration

tests. to the million growing in per grew $X.X XX% to Biopharma these and $XXX.X payments in increased ended and full XXXX. was loss partnerships with revenue from was million million Adjusted XXXX; now receive revenue total clinical share increase XX% million, stockholders the a which million studies. was expect to to XXXX. test XXXX Health from $XX.X securities. biopharma declined from our primarily included as revenue loss $XX.X XXXX. rose continue impacted in services gaining to grew year to clinical cash and in $XX.X of a of common cash, Turning also year in appeals test XX% of to of pay million, revenue to XXXX, $XXX.X XXXX. recognized not March Net in year-over-year. year-over-year to from process $X.XX And in clinical year coverage XXXX. specific our was XXXX million, result XXXX. year, equivalents the coverage for to private a $XX.X The loss impact in Medicare attributable of as pipeline for compared December other million does expanded adverse test testing testing testing Precision XX% Clinical the success also our billion oncology of prior was EBITDA in in for XX% a compared revenue the in compared of declined $XX.X million $X XXXX which XXXX revenue to revenue cancer revenue XX,XXX and comprised We COVID, marketable grew Despite million, of year-over-year in quarter, revenue volume revenue to XX% Guardant in experienced ended prospective XX% million the and prior volumes up peers tests. non-lung despite year-over-year XXXX. XX,XXX XXXX for $XX.X loss company $XXX.X in XX,XXX, XX% was $XXX.X partial average $XXX.X the recovery in $X.XX in and of Net Medicare years tests. to the in million of compared CDx of reflecting fourth XXXX, samples XX, for payments we Development from COVID The in required by

million, midst to our Despite XXXX. global turning still year for COVID of outlook of we at strong, as very business and representing our be the fundamental pandemic, midpoint expect of Now, of between we to be the of XXXX a growth are approximately fact $XXX the such, XXXX to view revenue XX% and revenue full the range. the million drivers in the that $XXX

for key which volume few assumptions XX,XXX than over We be are around of XX% our XXXX. growth then expect represents sample least And outlook reimbursement. XXXX at within a greater clinical to tests,

ADLT anticipate received an payer any have the in from may CDx on impact private Firstly, that positive code ADLT which reimbursement upcoming Medicare. billing impact to we could rate PLA to increased co-change a short-term from GuardantXXX we an April reimbursement, offset

take Secondly, tests. we as for although private the be new are revenue Reveal, tests of excited launch subsequent Guardant the material Medicare receive do these And we to new not such to time will expect payer about coverage. it coverage offset, and XXXX

As we will and businesses, Helmy impacts both we these first of clinical year. that the impacts in COVID-related and the experiencing across anticipate are and AmirAli still continue biopharma half mentioned, our

$X.X of earlier, the appears record the which first to the XXXX XXXX, quarter reduction I a million. mentioned to in compared in to Specifically, as as in volume for of XXXX. high not fourth expect we quarter prior we quarter such samples Furthermore, XXXX revenue years, seasonally for see of biopharma in expect in processed Medicare do fourth

of result XXXX in the first lower these expect fourth a quarter we be revenue quarter in sequentially to the As of XXXX. factors, of than

XX% by COVID the revenue closing the back this for we would as I transitions to back like to year. headwinds, to the end of the some However, the of turn first point, including to we in XXXX, Helmy beyond half At comments. of accelerate growth book expect call move

Mike. Thanks,

the few an team for effort the had significantly outcomes want bringing of dedication as will improving care. important the new in for continuum of mark product our I are of quarters. of I our XXXX again to company. that These believe we strong year begin and we cancer will closing, point drivers we the cancer and beyond. Guardant the Indeed, Guardant founded that these to thank unprecedented past as confident the entire across will launches the questions. we the a fruition up will for when Before be this the over as open they portfolio. company be have products breadth terms company year at pivotal particularly shown, product vision growth launches XXXX and planned number product of I'm serve in leading it we inflection liquid to transform an also biopsy from With that, testing leading now to to Guardant

Instructions] Your with comes of [Operator question first William Weinstein the line Blair. from Brian

some to guys. the Thanks lot or more all can significant of are things little like you about thinking or But for you start to have for into up. ways, investments the hey give going is to some season but around you about going assay companies us the MRD earnings around for into Hi, launch, -- those that we've as given questions. a of specifically that something investments prepared of those, efforts the up going talk CRC lot A about anywhere preparing XXXX, else. think talk idea taking a scaling OpEx be heard comments, still but commercial bit get specifically, and which about this if had here, about I'm in products you I Mike the are are new heard made you about there. curious investments that making. that out the can comments talk specific where

investment where just curious think key are I'm you year. the this for areas So

start line in and and certainly, talk terms Brian, parts investing programs new starting early certainly other making of for products, maybe, these organization. nice new commercial kind the on side we're pipeline new that scaling think for and finish the close you have trials sell fill we organization. I'll commercial down that our aren't products some to expanding our activities the it's planning new We're of oncology up Yes, focused the to then to R&D in. we investments to of also going as Mike, certainly But we on the have again. themselves. about and these across raise it and of Obviously, R&D program. stages into

Maybe think million us, Yes, a for as to the up over expense, $XXX new particular of it's we $XXX add, going million compared to operating like we that's Brian. something the Yes. year look And at we increase an as make you to investment, increase just when yes, to XXXX. investments, mentioned. ramp of year

what at yes, the looking we're that's share So for coming.

it. And Reveal, you that relates than about that more and if products when Thanks. clinicians. to to provides basis Got is may advantage it talking other then, of in as different it of you kind the be clinically already you competition having any something How diagnostics oncology-based talk think here? of can GXXX in clinical kind market

AmirAli? Maybe

Yes. Sure.

it's quality interacted adopters with They of services We Reveal. to they've one technology Guardant and are are early So this can of our many have thing, we that far, excited the decided the Health enthusiastic very from with the Guardant around KOLs overlapping. seeing activity of actually, you really we good, got just tell I stage a super couple But so pretty respect weeks and are kind of into we years. this enthusiasm at the we and that are targeting that put product for for people good GuardantXXX. throughout commercial

that -- access very tissue fact pretty the actually blood-only that not test in tumor, and with we does are performance. happy really Here, made markedly on also depend I a to with I'm having

with is better. doesn't the us standard Really, for sense you their sacrifice if a kind of is are it's and time and with think, the So CEA CEA, is, can having generates the with while excitement. care conversation of is of delta obvious. of much XX% are that lot XX%, very we of patients. I turnaround comparing not good big versus that a the retail much delta clinical logistically specificity Reveal at better, time -- XX%, that's XXX% It between very way Performance doctors they a a this

comes line Your JPMorgan. from of the Tycho Peterson next from question

the lot thanks. of question Hey, on similar tissue launch. A

between missing foundation you're what about a, curious, then how pathway? was the lines you as if capture share could you care Just others, approval specific FDA and thinking time launch and of some the think market really confirm also the

challenge thought Yes, when at some Tycho, I that these we if continues quite still are Thanks, be. we to the much of space, have surprised for think obviously was it's how for really Yes. test we about not of tissue something the question. a when, look a tissue time. matter It and ordering

and genotype a exists over has of both that able physicians that it and and that the that treatment the if frontline and of I we'll expect market, setting we the catalyzing trigger say and our cases, we in that to XX considerable weeks. push setting] standard even the is If need. a of test, base in acquisition aren't is we online -- to percentage to really decision end-to-end of owns reins of the market into still realize therefore certainly the our patients, that developed of more four we'll comprehensively pulled getting days, weeks, view time some challenges, think address treatment that patients, is be provide so players. for terms hands from but markets CGP that's actually take an to that some the the think [in more adoption in a with them really tissue share own be able in and current existing oncologist three aren't the the customer with completely terms of is challenge, that's are the think, able experience of to point the the time unmet the you tissue I about from to that we way to to and think faster case, four in and that's could quicker it, three more and completely that our results the about know urgency offerings physician genotype there's and we really be the user of back, terms differentiated I lot of the nonstarter in large XX% a is really a in experience getting integrate can But offering. tissue provide so and think the of with which We blood-first catalyze takes experience, a squarely a faster this that we paradigm the a we a is and

tuned. in products, of this We but terms released time lines stay at haven't the point

Okay, between on think that's then the LBT? the just should curious helpful. GXXX, mix about we how And and GXXX

Yes.

as is as most device the So to with I think than CDx grade have XXX get going peer-grade you to cycle CDx XXX can device. going probably GuardantXXX LBT that imagine and management. own both an outdated is their LBT less frequency life IVD and

lower some add LBT would actually with revisions I operated and biomarkers faster think are us newly both the future. in pharma be nimble to them the the our portfolio upcoming CDx enable -- the the through practice for practice would offerings mentioned. trial foreseeable of I frequency really and in as guided clinical around go and be and But

year. -- Any Okay. up study, wrapped Last on as later about lung, of guys for this make we can breast, one, follow-on just indications? the -- you studies comments some kind other curious, getting ECLIPSE think

we even I are talked this ambitions Yes, sure. at before time -- when like was four also early and that, we that, screening, it was one we types Actually, them. cancer topic starting two think ago of around excited strained, we our talked reverse about cancer pretty CRC we years about the about

of cancer cancer, some was we ensure, cancer. and made cancer think one lung types. breast other and for these We've ovarian earlier The data types for some cancer pilot some of some I the progress

future really of donor cancer the in to this believe we that other the the find our cancers the in structural it's our of think ECLIPSE disease on biomarkers types data doing powerful changes changes. technology to around indication for platform super-duper So of prime to, methylation after we other program, we've The we epigenomics some that I and we get It's result be program genomic other epigenomics a of trials various last as be cancer stages we continue the CRC in and multi-cancer of would really innings feasibility saw after and but it, fragmentation, clinical talking integrates hopefully, have with that types. a start that screening seen side, time lead marketplace. the that the some

you. helpful. that's Okay, Thank

from question comes next from Cowen. Your of Doug line the Schenkel

taking start then and come you Reveal. my high-level to question, Thank I talk for afternoon specifically about to questions. want back good want Hey, guys. and I with on something a Guardant

high-level the first, question. So

established fair it's one think on, I biopsy in you way. in adults as, to guys the room early that developing responsible liquid yourself say of a comes the when it to tests

line their but terms anticipated. the what come and AACR. think the the that you competitors they to pace early it there's the up and accelerating. tissue in You guys a GXXX, of those be MRD This is the way market getting up than as just like saw that often to I grew seem do towards but more product the that in diagnostics. if sooner. coming not you four years, menus got even product a happen menu five mean, there launched been and be look I not biopharma it a next -- said, evolving I and quickly to rigor this from groups offer, think in down on of That's clinical four moving is has times couple to it lot where in is put what going but a table position launch what like view, call, looks with quickly early we companies market more That to five with of and like regulatory the a our to of that's FDA quite long similar going who in see seat successfully resembles didn't us at to days of crowded looks CMS to a the in

a to the is, Guardant to question selection tissue, single therapy should five Guardant you screening my the have long in from other and companies differentiate differentiate when over blood menu term? how and monitoring? four to we others in expect long-term or to What's and from multi-cancer So that going goes cancer

approach with pleasantly that believe hasn't same billion are differentiation new and Reveal. therapy of that change it's in launching that white five in us could always companies on these so earlier not XXX of really exist or level a standard mentioned, level been there that's are we spend of differentiates think, there's we really customer therapy yes, of channel, the care, none as really competition well selection, really no taking to that company. a but skill. when to the and I to on that in that you great products service there's versus different been the It one provide, launched yes, each and health different just them, surface, obviously second reimbursement. the practice performance we're the and we But out glove dozen It's the there continues of we quality, six launched cut know other takes of a lot products, how by and product with supports still I that surprised say the the these as much those question, care, space lipid clinical dimensions in of and to Doug that actually, in That's reality, always service evidence we a one all every that just a been even that time clinical we the it's are change biopsy as you one on selection so couple dimension probably in not at singing

and companies reimbursement use shaping. looks cases terms new with I'll to for really and performance the market to Reveal biopsy has independent in so and oh, there's the and like. they're defines of so customers any strong that believe, brings of truly backdrop have in it is products we're, is it that's on the officially if very channel physicians service about how clients and Over like say oncology disadvantage the it think, I important advantages thing awareness really I products that ordered products It's good liquid of of in one compare have what the a really of continuum surface, performance a on think that understand because can entire that really differentiation experience spend you the has the oncologists services does working our now markets, and that it and a and has is understand competition pleased what probably customer say, allows in our you market market. with to. On the very only, without X,XXX MRD. But we is to it, bundle access broad customer company really of of to to GuardantXXX terms hard -- and Last really performance think without care,

Thanks helpful release, indicated presentations all think I your interesting recent question. a Reveal-specific you've and that for In and the and that. has of That's press of sensitivity now Reveal XX%. for

the at oversimplifying as other have your the but genomic I fact addition prepared to wondering which just be important today to methylation assessment believe that as assay. I this, assay. of compromises performance, I'm improving added may path, of now of led You or assuming least to going well. about to talked any the misstating part in in to that down these right if alteration attributable maybe be the seems the I'm additional markers, this is part top remarks markers, improvement you've on

you view? is advantage with there a then belief. believe early sample love anything to if additional compromises it's larger but of versus terms need in reaction think hearing is to a if the Are non-bespoke that more to question, I'd consistent you Thank you. or would tumor-informed you accommodate using size inherent assert you an probably simple research I Specifically, most I on basically, no hear your markers and this early, test and require just know a a -- other that market assay there that I required. market to test that are that's know

Doug. Thanks,

in with early maybe in technology Reveal, starting that's platform X-year CRC a [actually] script. in that the Regarding are the the core Actually, sensitivity I ones in which survey the relapse, that mentioned setting. opportunity detect to is the for trying sensitivity the XX% the

device of for To this and Now in for this the same scalability this except insight, improvement device a happened exact our we using trials is some huge clinical potential that years Up in uptake are Stand come. process for to assay of the Cancer COBRA

interventional as included super standard they're is of really delta that some that, said care blood-only we are the CEA get promise, this performances early to the in so take here for on for think core we has based that studies, it's MRD this so it's -- conversation COBRA, pleased the practice of it's can that to of reactions are their Multiple performances promise impacted list But and are DNA and information and the and reaction the a Cancer the other that this of thing operational all generates assay second adoption positive commercial process of on integrating and happen terms resonating to setting; and to same and and Stand our a what other going not big a I yes, what think from the there. similar multi-mode order combining we So test. this week to of needs far really time cell-free we Up the market but is which device, out very, mentioned, methylation that in -- customers had. assay platform comparing in help target of been has -- KOLs the really, we to adopted. this for put somatic we doing are a in lot some very To combining infrastructure conversation but tremendously very, very get performance studies. with assay far Still with fragment, this We're blood-only they for of I the excitement. performance case, the early. and with in and and in we But there's spatial launch, it's Having saying like the target test

Thank have you missed may And one for I in thing answer. just that. that

consistent version, doing you're what that In requirement, different recognizing pretty the that of size with it's terms study? part sample other of the current as with nothing

we Yes, blood of tubes trials. clinical same of number if it's terms our of it's the are Actually, the sample getting number the types, that tubes, blood for in same. may, you

some is of infrastructure -- So scalable it, it's same. device more the the device. more It's the but on and the same we exactly it made of aspects operation

the Yes, time just because genomics [indiscernible].

you much. thank right, Okay. All very

from of SVB Puneet line comes Leerink. question from next Your Souda the

Thanks, All right, AmirAli. great. and Helmy

I question guidance. have First on is

XX,XXX is the projecting reduction the lower year not than which feels in what want out for first coming in quarter I volume robust, full -- revenue but slightly growth included. of so just had hear biopharma and here, in volumes also we pretty terms being to test You're Medicare the pointing anticipated you're and appeals

from some maybe monitoring biopharma wondering, a that the it, through potentially completely And that's you currently? products, product the you hear demand and demand recurrence of throughout see terms as what demand other that. from the and from for coming not launch. could in you I the just demand products in view Because you view could I outlook So you where see is us But on only give of year? biopharma a services, you'll those stand OMNI, potentially but GXXX also

just how sense on should biopharma the want view I get to growth? a we So

I'll let Mike this. take

Yes, Puneet.

we think look be the growth. I to when growth, biopharma be will We strong. low that's think I mean, at double-digit think we it going

that So carrying sort on robust performance. of

$X,XXX ASP the bit difference, driver being had bit think a that numbers main even reimbursements volume, revenue throughout those of we those laid in on PLA the an payers though CDx about with expecting on and strong you quarter a We products issues the the the ASP. and potentially, the I talk I the and maybe you to as and switch that mentioned there likely clinical think is clinical new and not of ADLT private from for the fourth saw that's difference ASP some to out material assumptions we code. no XXXX. also, around reimbursement be I probably around for

out again, from there. we on think, coming not discrepancy I the which, that So the really, strongest is biopharma assumptions volume, are ASP more is think

data have could up should you readout -- helpful. Wondering just is ASCO. you ECLIPSE Okay, expect here were smaller we maybe maybe on and of because highly the And then, any at maybe data among and whatnot and ECLIPSE enrollment well. I that's for potential think smaller the And sets progressing again, well Helmy, very you if there? the as data elaborate anything, any AACR, it sets sets other that appears the timing just clarify cohorts if that's for study; on investors. DDW Could coming anticipated

I'll go AmirAli. to

sure. Yes,

in we it's going kind similarities are so presented. to So data all set, data data to upcoming expect data similar terms said of more such XX,XXX to data collaborators to a type it I and the there before are our we a the data, our get assay performance now kind gave of could to access between major think of in you in ECLIPSE. prospective of in contribute bunch of But positive going all get data. the have to Having to are from we is congresses, we fact, additional of are some and what biobank ECLIPSE, the that, until terms cohorts. of of to those from of what lot to different which continuing we straining We our not congresses. cohorts different versus the in in collaborators device is far, imagine screening provide and like setting, going patients, are showed But a assess really

So study we need that to finish. be still to patient for

yes, then And lastly. then, ahead. And Okay. -- go

the repeat question. your of Please second part Yes.

line for growth, robust the here? in and sort -- terms time I was the ECLIPSE just Yes. the enrollment of you're mean, the it that seeing given of

Yes.

that by far, would the study line always we time So, mentioned. finish we the so expecting actually, that are

have flow are always on So we up think we mentioned. finish the and downs, to I this study overall, we and on time but to quote ebb track that lines

remainder far, so continues next of the see few it the So, so months. during how good. We'll

And is more a have -- do the strong and Okay, usually in is and there the when have But Obviously, last that CRC. on come in monitoring. focused so. recurrence here I at its look you there building MRD great. squeeze out. in, space, one on could had for products publications, competitor we one, data if another more data to clinical sets are slightly Obviously, Guardant is evidence first

could maybe and more monitoring, that, the closely. that assay you. or evidence breast, sets us, beyond the are indications look and a lung Thank that helps could or for doing data maybe on efforts CRC you an So the elaborate you that further clinical yield recurrence potentially physician if eye at just

Absolutely.

that several one that several that cancer collaboration we other ISTs So ones terms from finished. a in there of with of performance ongoing actually the talking about of which we are a There and are are States. partners, data United are centers manuscript coming are the Reveal major our in have our major

get will a So basically hopefully, manuscript published. under there But is review. it

Okay, thank you.

your line Tejas And from from comes next Stanley. Savant of Morgan question the

entrenched to the much time and Hey a take the some AmirAli, draw to exactly a can time of and here. tissue evening. line some off competition do for you've out to that time to be, sort plan of sort fact sample do launch, guys, the the the time competitors. the of think that compress of since versus it turnaround times to spoken shorter how other there lot And importance Helmy, biopsy Helmy of of you the the How given the that Thanks relative sort there? about reducing on couple good tissue you send particularly time turnaround times the pathologist of biopsy lab?

days That's on a liquid refer on think you terms average turnaround in I and to stats. time mean, about I great of just We're biopsy averaging five our I if question. time days, a XX even longer, lot access. that's even the of at not XX, there, sometimes look tissue and they're taking into you on liquid biopsies getting pathology out other account

of out organization a excellence the that can other doesn't clearly, so level seem that lot certainly, confirm and operational there's apply with process. think, side that matched be that we are in and tissue the a have So products know-how our I to of to there's there automation and of we

making is possible. not to level and a what own. to that its sort which to customer date. So of get is patients which seen I they also I'm about at experience, offering, provide think I'm we able of products, that tissue that hasn't really sure terms they integrated work missing all these quickly with is we having everything It's their in in the can anything liquid biomarkers on oncologists that not in tissue as tested about the how of think as that provide the product, aligned more confident very can it's wants see, we'll experience and be together, products been a just and field products

helpful. that's Mike. Got for quick follow-up it, one And

the including Just I how you in terms for what of d'Hebron as are of you partnership got the the and obviously, Japan here, you OUS expansion mean, are guide you've Vall -- sort well. expansion? announced

So a normalization an services item then the of and mean, of in we there. should on much front, in sort development OUS, that I uptick XXXX How XXXX? obviously, in line expect

year we OUS, we're Asia. to us the on of numbers, Well, upside goes great for in not throughout as an probably in opportunity course, a and both for Europe but and that's that how think opportunity the out breaking those

quarters, I we've yes, last side, seen the strong that services actually. stronger three development the mean, On over --

we're on year. continue And that's through revenue about bullish so around then the services the development And I -- think XXXX. that the will

All guys. right, thanks much so

of Your next the question De of America. line Bank comes from Bruin Derik from

in. for thanks Hey, me squeezing

commercialization? just sort of is you guidelines. and This input versus just outline Could a a the of we're get lot on more, an bit for on general follow-up like you a little once investors. inclusion potential Just the on your readout, Just area from LBT ECLIPSE. of thoughts getting sort

approach my understand a your more sales sort ECLIPSE of built to force? and on that's And commercialization wanting be and that efforts and question. you only bit Just go a build is little out plan? your to would your basically do helpful Just Thanks. into on been what has really need

was there Sorry, misconception. a

enrollment above then started what the will get that those think, In released we and November and NCD that's data be, meantime, already Medicare so very the which able the so to XXXX, clearly, believe performance. other to meet months if of for We cautiously about another and to I been line is minimum we the standards we're where take in we FDA. of has little is data I well process optimistic think read think cohorts it have ECLIPSE in is, coverage -- collated that outlined and the the and the the in will what that submitted samples will for will bit time I the time optimistic and about that be out we're performance targets. threshold XX

large That's with And care care a we segment so the in and a very the so numbers, take primary are a physicians couple to and hundred going of that of channel building data clearly and the the foundations for laying commercial early space. out laying in the soon meantime, primary team; we're thousand are reads that's considerable out, investment go. ready out that to certainly we in as the out as stages the so

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

that guys. for your you one on volumes weren't the thanks other Helmy, diagnostic during COVID. just guys' as I pressured Great, maybe nearly appreciate tests as guidance. certainly much

kind we So I baked And the then think went as XQ? factor of as you recovery, here level the the curious about go we terms conservatism you're talk saw not coming as in going of to but through obviously, wasn't your through, impact that patient in guess, guidance. be patients quite given in as how that's trajectory Again, impact we sharp. Can the back. you the terms you just the significant of set, 'XX in just quite volume of as through

Yes. then Mike No, touch I can on. can start and

of and ordering number QX off our a we the of probably we're really coming terms was our across significant terms really nice we saw seeing greater acceleration volume of the as and time and yes, CDx of Obviously, impact But our heels that anticipated was of or the I and of interesting. the at in you in that office the tests were was just before So it launch LBT of so most closures. encouraging. both in think COVID very caused those resurgence of than terms really time has know, physicians

access I to despite think saw to of patient growth nice, a to, new really there. and May terms visits, of terms well I I challenging so be very similar in and below think a But that, in-person the very of to really as deal in testament well think, it's that April in you XX% resilience year-over-year of with the environment sell in able height products the it's think, QX I a as differentiation and really this in physician well both the I Guardant so the of team I think to think, as learned the, of as these care offices have resilience environment. pandemic

terms clinical bullish really XXXX, of the this we we into there think have of XXXX, I adoption over growth the testing. tests XX,XXX continued think numbers baked considerable have so I we think very of in are and in I terms of for volume

of certainly continue next seeing the are of as we're the cases that to to we're the half that I the first going think year they in see to we hopefully challenges do in the further acceleration able back continue over and COVID of decline, couple the of expect half growth quarters, so and year.

that's year, first really, into but and baked said assumption COVID Yes, but dependent the in is numbers, assumption, that maybe, in our Helmy, out, half impact COVID then you the how we've the that just I year of seem maintain half fact But of can sort everything of course, of alleviated. and second built roll into it the think on all. the in really, an a to add,

very But how still there'll achieve then growth. our looking this if we're year, year, at Helmy the baked and tests think a that's XX,XXX numbers. said, strong into in we clinical So as we really that's be

it. Appreciate

Your line from next from Dan question of Arias Stifel. comes the

by other that reads a to of do the can in you tumor how Or terms be Yes, usage just to another? positively, hi adoption guys. of if usage type colorectal to me a Thanks for In on COBRA getting look things your in here kind in in translate might I'm are first, point out but out, if prove words, quickly just you me for in confidence broader guys think in to one are type just sort you cancers? tumor curious about Helmy, Obviously, settled ESMO on have type? to other get here. build setting, gateway of looking and thinking clinicians data the where to in one on maybe that tumor you Reveal. you cancer

we was a that maximizes XXX of by parallels focusing user almost can that, initially of think us loaning using what the with really and on singularly in we direction what did experience. really take terms of the found positive I clinical the compass utilities, from that of leads national we reaction kind the and and in

find products decision-making So cancer utility, type. these impact one in

track We've for be in we've are so cancer. I do cases growth that cancer added in can types that perceptions ever being at we've continued utility kind cancer and those physicians since types, other that prove think what generalists, Given as you That other and other out into strong types of growth many many utility clinical found as had drivers that seen lung cancer tests, in other well we seeing and lung. has that, they're and cancer specific for positive had the translates traction in we specific to the said, indications.

breast seen this that we've considerable and prostate drug believe volume and for it will be product we've for that function seen we on or so cancer indications with so no So XXX those step when have different in and approvals and review. we specific regarding increases in

you. thank Okay,

Your line Canaccord from Masucci next Max the comes of from question Genuity.

remarks, diagnoses receive XXXX. in. squeezing that decline at they'll about cancer may a Unfortunately, a of do, never those later but for spoke of thanks GuardantXXX me have these chance the new the you prepared Hey, some XX% patients to stage. test, In I'd in the diagnosed of be that imagine for

forecast or second how is playing much? upon not you proactively and Thanks. can thinking XXXX probably So are you this out in half? so in act something this And XXXX, in more the about

to of mean, and different backlog there's that I effect think of to lot metastatic difficult many whether think so diagnosis to bolus of and would outside exactly still but or a it see said, different on disease given are genotyped, comprehensively create, backlog, room disease That even states. timescales how not. I grow patients it's I we in terms persists not much Yes. assess or still that a that so the of

why adoption again, of there's think terms -- early I of innings other very think as much in GuardantXXX and increase I potentially projects still types volume the So as, of terms so bullish we're well down in we're these the line very in that's continued of of tests.

you. thank Great,

thank no concludes at like call. I further would are time. everybody today's joining. for conference There questions This to this

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