Guardant Health (GH) 10 May 192019 Q1 Earnings call transcript

Good afternoon and welcome to Guardant Health's First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode.

We will be facilitating a question-and-answer session towards the end of today’s call.

As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Carrie Mendivil from the Gilmartin Group for a few introductory comments.

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

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

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

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

otherwise. XX-K, description, of with file the Securities a any complete quarter to Company and quarter] fourth forward-looking I'd statements Officer. Helmy call May the Co-Founder For disclaims turn Guardant because revise Exchange or information, Guardant's obligation information the of XXXX. financial contains live Form Risk new [first or please are call over events the Executive whether projections the to Eltoukhy, list any which and is that, only With Company’s Helmy? update Factors intention section the as This and X, Chief will time-sensitive broadcast of (sic) more conference like and Commission. on see report accurate to or future

Earnings am Thanks, Carrie XXXX and welcome to pleased I to us everyone you Health's for afternoon. thank Quarter Call. you, this Guardant First joining

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developments Looking ahead catalysts. advantage working potential hard positive XXXX, and in to these we of upcoming take are

team approximately in investments clinical XX nearly have of of sales on our and early are pickup to terms volumes. we in expansion We there completed our the commercial representatives, seeing return

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relationships to new Our in our both deepening significant progress ones. make continues adding biopharma and business partners current with

continues programs in surpass development across our the expectations. business. to we pipeline very In relating Finally, to our are our the technical encouraged LUNAR R&D rate sum, our strong growth by of

now to progress of LUNAR guidance and a our for to that, in -- updated the our biopharma million for $XXX now we from million. AmirAli? of $XXX With the this forecast details range will program. year-over-year. of be XX% call to progress, of more to in AmirAli up $XXX growth our over million, As million turn XXXX business our This previous to result $XXX previous revenue XX% expect reflects with I

parallel In clinical partnering with Guardant the more programs. biopharma accelerate adoption, Helmy. and to drug discovery with using are their XX than for assay development support efforts we to companies Thanks, our

between tumor our We highly only as those the clinical other approaches performance is a TMB. performance liquid mutational further by are XXX-gene believe when the partners, that and markers large GuardantOMNI broad the differentiated We immuno-oncology. driven such biopsy for strong platform biopharma for magnified partners burden, panel. also applied a increasing offers, and demand in encouraged range analytical from biospecific even large The to or but by is especially of from around genotyping, GuardantOMNI gap demand not our

patients. some recently our exceeding detect the the believe in GuardantOMNI, screening cancer data as sets, developing version shared assay around detection generation this are rates The treatment AACR breakthrough review quite early shows to progress changes of biology into to upon helping year able device a high cancer We received submission our in cancer cancer. program, asymptomatic individuals. identify the cell for enable from will LUNAR commercial for colorectal a positioning for the mix the This detection FDA. and GuardantOMNI data blood-based screening the encouraging, in in for using This most assay we assay of the engine of stages the has management, advanced as mid-XXs this early more the to survivors annual methylation DNA. looked and compelling represents GuardantXXX genomic and performance and success a colorectal to-date which nucleosomal cancer patients. potential us demonstrated is approach into oncology data to risk colorectal of accelerated data sensitivity exploratory average diagnostic of deeper insights individual. with and cancer specificity LUNAR recently to test of of of diagnosed massive LUNAR an at of it simultaneously detection process The cancer precision are use We and TMB in meeting, cohort patients with initial companion which their This free variations asymptomatic designation, data alteration with of fragmented epigenomic such for detecting early XXX aims XX% signatures. fuels of This expand presented surveillance develop

Jay content program. Shendure, privately our of Guardant on make of to April, oncology exciting patient who this LUNAR to pioneering into seek Advisor Bio, and Dr. DNA. study with market includes acquisition patients held We a of through planning our the a further accelerate epigenomic the encouraged to we Bellwether are pursue their care Scientific improving team technology the to closed a Bellwether as to The start end, team we Health. platform are second company, by free and screening of To on technology will our the advance we addition investments efforts, of in focused will of the In XXXX. the this to research our progress continue as XX,XXX cell over enhance We opportunity. continue half the prospective believe act we further colorectal

our She both currently publications Chief Finally, than I Executive Dr. leader a to AstraZeneca Bahija Directors. welcome with more Dr. Immunocore XX experience operational like talented and is immuno-oncology leadership Jallal therapeutics. and scientific Board previously has deep would authored serves at patents. than Jallal of more and to XX She Officer peer-reviewed roles as the MedImmune. holds in held and of

In mission help Jallal also Guardant, conquering the patient addition University Board I more Bertocci to of Research a now will care Sciences the to sits detail Board our guidance, and of and as to of with that, and UMB president cancer Her Association Derek? call Guardant, of With Health past She's Trustees Women for financials. Derek of John Park data. Dr. the Science. over on in for member Anthem. advance Immunocore Hopkins commitment and turn of on our expertise will we deep strengthen the Corporation

first pharmaceutical million driven per the in by Thank clinical increased million overall revenue totaled same and Revenue in higher totaled the up $XX.X tests from period $XX.X This you, quarter million, quarter customers for AmirAli. the quarter XXXX test. growth for due and Precision and prior increased the for prior-year oncology from to testing $X.X million, demand the first revenue higher ASP. XXX% from of year. clinical volume XXX% was up both $XX.X of the

in volume Access commercial Medicare XX% higher $XX.X Average first prior up million in affected due First of patients oncology quarter. revenue the increases tests was to quarter for to quarter the of payments totaled Act $X.X in $X,XXX, from cancer XX% year and for to precision Precision the up ASP. and earnings from first year increased from tests demand X,XXX in XXXX the prior were revenue tests recognized of Protecting in oncology quarter X,XXX XX% preclinical that revenue Medicare year lung totaled test $X,XXX by quarter XXXX. beneficially QX payer most the from starting biopharmaceutical up prior in the million, due clinical tests quarter overall

from in in prospective and variability primarily to profit oncology due revenue XX.X% year first for total services precision up totaled support to development compared the period of testing development programs for $X,XXX subject revenue of higher as development in from and first XXXX, ASP margin profit margin to first volume GuardantOMNI cost the XXXX and profit as companion Gross XXXX. biopharmaceutical services biopharmaceutical $XX.X using tests, quarter-to-quarter in million was an growth programs first to activities X,XXX Gross is test. prior complete. quarter $X,XXX, a XXXX. up million, was GuardantXXX to quarter due diagnostic December compared revenue $X.X development improvement discovery oncology development Gross the quarter was XX.X% remember precision The in to less first up is year. tests First the the up of quarter AstraZeneca, start drug services per clinical the to which in in in quarter, million, and of gross biopharmaceutical from ramp the totaled of cost revenue prior from for the demand was higher same Please the the prior-year in was during due quarter for and the priced quarter announced of prior-year $X.X revenue. services. customers gross in due the increase XX% quarter quarter and X,XXX a recognized CDx customers introduction the to increased Average Development the GuardantOMNI X% of retrospective test late testing. XXX%

Guardant for incremental administrative U.S. a quarter customers net $XX.X a in clinical the focused to [Technical non-controlling and joint our in The teams $XX.X common quarter loss commercial Health Net value Guardant to litigation and A the was were would is in Difficulty] have reported due samples of quarter As our of as in the a of using million results We for interest ASC first to XXXX Health's for U.S. on by million, required net impacted first force the of of patients. of common expenses was revenue from of Form attributable retrospective XX.X the of which PMA Total U.S. promotional the teams for XXX of per This million, $X.X being to testing for first compared related revenue release. our GuardantXXX reminder, QX first cash, for activities bringing XXXX payers $XX.X claims in XX% XXXX, prior was recognition to in cash of resulting is $X.X were attributable incurred this effective million were by in the the marketable standard ended precision in without $XXX.X million R&D restated due as new million XXXX company company's primarily XXXX. Sales first FDA expansion adopted to quarter January governmental $XX.X Net quarter million of to XXXX. was XXXX. modified January was programs compared the completed the primarily $XX.X the related testing increase oncology to of the standard which the the our was million our XX-Q adoption from to and million accounting to precision was first a contracts commercial change the the compared the clinical applying to that The the million at under our financial XXXX support $XXX.X third-party expenses. X, compared corresponding stockholders public stockholders to XXXX, was decrease revenue $X.X and revenues of clinical ASC difference XXXX oncology marketing -- adoption to program. quarter work quarter the $XX.X $XXX,XXX premarket compared revenue in primarily to method, expansion increase the of press and revenue change expenses the biopharmaceutical all We in to to million in the development for the LUNAR of operating XXXX adopted standard prior The quarter XXXX. fair not from first of outside or and the that to we in and quarter expenses $XX.X to first Instead approval SoftBank loss charge were that of reported increase QX, redeemable of recorded XXXX. General share XXX, XXX. quarter $X.XX markets first not period sales ASC and to new compared XXXX. the statements. costs means quarter to opening of year. earnings and expenses our disclosed submissions of due the been testing loss $X.XX equivalents X, increased an venture the effect retained in to accumulated of attributable addition first first $XX.X our quarter our million XXXX million and loss was to paid for first with as well as the increase of The new end of effect in increase million. securities in assays quarter. as testing with compared in the

year our $XXX revenue previous range As million This XX% revenue of the of XXXX. million to million. Helmy XX% representing to mentioned, $XXX to updating we for full to over million of the guidance growth $XXX compares XXXX are expectations to $XXX our

previous clinical be XX,XXX tests the of compared expect also We XXXX XX,XXX XX,XXX of for to expectations to to our sample range XX,XXX. in to volume

testing to We timetables, on expect of half biopharmaceutical steadily while more should clinical across grow year. continue first particularly in be XXXX customers the strong from to program the revenue based

million. of investment in continue impact the to expect planned million large prospective clinical for trial the we the in $XXX LUNAR program, $XXX Excluding net loss to range our of

phase prospective earnings turn of loss like are and this large the able this clinical At the Helmy. the call. be for to planning guidance update trial we'll We to net impact I'd to for QX in call point, our on the trial back our

access Derek. you, we closing, throughout Thank Guardant to In unprecedented have the decease. of a opportunity information unique molecular at all stages we believe to cancer's expand

making week will up now forward Conference some on important and are Bank Operator? seeing in of Vegas. that, America headway Healthcare With at you it the questions. to of our We next open to we look goals Las

And with Thank our you. Tycho from Instructions] comes of [Operator first question Peterson JPMorgan.

Your is line now open.

thanks. Hey,

wondering, I'm you assay? study, just for can bit screening might little be the CRC talk what for about the On if the success goalpost a

Hi, Yeah. Tycho.

So…

Hi.

the call CRC as we issue. mentioned Yeah, believe as that's rate potentially average-risk we in liquid big patient stay grow. -- in the big is planning are non-invasive during And as biopsy very really earnings assay can our We a study. that compliance know, screening we market phase of low population for

we more And are in about study, of planning and about next we'll We our when it. guys have in can information that posted. earnings call hopefully provide details you keep we more phase definitely it, prospective the

And fraction this this paid guidance? is finalized? accounted will curious Medicare in And what you Okay. of for then draft on just did get volumes the once how LCD,

we've So it's shared. what we've not in reported our what of in or current terms guidance

that to of types. because but that's kind QNS coverage. the cancer of And XX% we cancer of about XX% volume. the to you how our draft LCD overall of lung or LCD, as terms of terms multiple LCD the This In our lung in-availability current coverage about volume same of remember, Medicare requirement think tissue for about Medicare draft expands our in covers and

would if you Medicare NCD our to coverage the XX%. -- bump about As recall,

some XX% have inavailability tissue samples tissue percentage that will percentage -- And access. similar number so a cancer, issues of there will that of significant -- given or be in of samples we lung fairly expect that we

that the in it's in but hope XX%, maybe be up we Medicare of above going of as to most as significant so, not XX% and likely terms samples we're between XX%. bump seeing, much And certainly somewhere

And you process? Okay. timelines submission just that talk maybe are front, in and for timeline lastly have just the changed XXX all? at about the you then OMNI, a on regulatory G Can where

Yeah, sure.

we our last of we CDx impact our on GuardantXXX as as are on IVD on of to our timeline, decided work QX call, as we projects mentioned like terms In in and working timelines we programs multiple late And minimally. especially only this of initial GuardantOMNI. believe parallel XXXX and two before, we mentioned should

As package our GuardantXXX the of to now, time submit frame. some we summertime expect FDA for the time in QX in

specific still the progress For haven't program, in it's program. and we you posted will timeline we we GuardantOMNI for days any make the early keep GuardantOMNI, mentioned as but GuardantOMNI, of

Okay. quarter. Thanks. the on Congrats

Okay. Thank you.

Thank from comes Bank of the De you. question Bruin Derik America next of And Lynch. Merrill

is line now Your open.

taking quarter, Hi. you thank Derik for This my on the is today. question. Congrats Ivy on for and Ma

think about you question, comment we how first that? expanded Thank AP Can trends on should the the just coverage? So given you.

expect the showing significantly we're coverage we mentioned. that if this commercial modest continued get to that able in getting effective continue a that insurance at it draft the expect also ASP. Medicare. LCD are make larger as significantly We LCD could we So driven progress with decisions. coverage progress that including payers are is we the that private became payers in We this improvement proposed by would not add the would gotten here with our to time. We've But in our first fall some from we forecast for quarter as to ASP

so design this. Thank you. helpful. we're on about the know thinking cancer the still very That's then for And I study, colorectal

be Just to think year recruit take we to see fully design about patients. available? would X.X it trials years take to will those long wanted previous or -- to one patients? when XX,XXX would how it recruit how to up should long And the for At

Yeah.

to planning who or going we mentioned we performance we have early I a as hopefully, colonoscopy, we what blood study, the for on through in duration idea have And biopsy for check that study going in we planning when exactly draw for the information to that going us do in earnings we blood terms during of to So good would a so and to still the be for of referred that phase we to question FDA call study your liquid believe, do. are the study. the earnings comment. of of phase It's prospective go this have the is them patients earlier are observational are draw. Actually, call. And for our QX timing more it's of about you and next the

right. All

forward Looking the than to prospective finally, that. And the of earlier study kind large is plan for expected. we

the what's next get Just plan in Is your to guideline? wanted to you considered get the thoughts USPSTF on the circle something would targeting? be

to us comment I earlier that. for think So, about

maybe it's clear. maybe phase going more this through to planning become and go us Let

be is just starting that what progress before this statement I'd planned would made this study in And much due to the data data study. the of start our reason some after we doing start focus Our seen data are this additional prospective AACR maybe earlier make this we've at think to and time we that that than we study. some some that we and that investment it's early platform prospective right presented this technology to and the observational going the we

Great. Okay.

week. Looking you. you at forward guys Thank next Vegas to seeing

Thank you.

you. question our Schenkel comes And Doug next Cowen. Thank from from

open. is now Your line

$XX increase I Hey, is it's services? good a guidance. full on -- guidance. Derek, revenue How bridge and biopharma clinical my much development think you of you versus million this Starting taking for testing in year can afternoon, guys questions. versus thank testing

on is and to that million critical that X,XXX $X.X volume. increase samples we're So, And so our of the million see indicated we pharma XXXX the And correct. million. sample And $XX to is at the on continue $XX an that average clinical we looking ASP that's side.

move equally to both increase revenue. development so there up the would approximately them modest expect be services roughly We and for over a left

expecting And on there based the biopharma within mix to year what that in impacting date, of you're is change any you're seeing Okay. the change? there guidance that's any OMNI testing is

has OMNI continue We but and both product. OMNI There being be it strong some a will to strong from see volume them continues this we -- good GXXX saw to variability quarter-to-quarter, quarter. be -- from biopharma. be

Okay.

Yeah.

think I around is clinical guidance pretty and pharma. equal

is of helpful. Super developments, you the months there Avacor I got of on you I part business, then that and this clinical Is just And expectations X.X data the say for guess, bump early decision. of year? guess meaning or remarks, reimbursement the to as the what's past, it's you're QX in an your impact -- positive seeing in in NILE kind driving noted was up strong over so volume on quarter? Okay. that a it recent second presentation And prepared top too on the

little certainly think it's think by to I But force being we catalyzed NILE. medical with bit affairs early on NILE are as and from resonating out that sales seeing said, our -- from anecdotal I comment So, uptake is a team that evidence our physicians there.

that and important adoption we important And there's really to that and do pre-messaged continued it is and that have the nothing XXX our as clinical continued an going we of seen XXXX it in so into uptake was XXXX. we changes year view -- throughout be something catalyst to

to one take want I cancer the shot question. colorectal more at And Okay.

that you on call. So, you I it in fair, a point the you to the sense But made in this stages. of just emphasis hear are be planning also,

to need as Sciences and cancer advance product to a market, approval, baseline recommendations. favorable a garner if required colorectal It need back really use USPSTF I seems to to what's development FDA you're of I you're an need guidelines, Exact you're going go in get the screening example there. to going to and successful a as to into So, to for going that mean tool. we want

all question with agree? because doing needed successfully the and you what that with you study this to on to DeeP-C really do first loaded Exact second that Two, than dollars. combination more get study And in in then be finish line. third, Alaska a could Native plan would today's Exact that are out prospective guess for it more the I So be budgeting DeeP-C on Because that's there $XX about would spend you fully million study? than

Yes. I question. the appreciate

are guys are details about about what planning would study. going mentioned, to to we the in the Exact progress of as and keep the some you do posted are and So, going the we in -- we that make we this of phase

I share give for it's we through Regarding we in concrete to are go hoping requirement as process. the a this us early But that we think information can study, earnings next call for budget answer. our too detailed this more

is terms most what which commercially required in Now, successful such of question. out could agree a test. remembering plan imagine, Yes, going the of we have kind for scope that you required that to I we in FDA test laid And as of study paid. probably to kind of get you of with terms approval is is study. your a did

that consideration. have in our We

still reimbursement early think of reimbursement comment too terms to it's I for In us strategy. about the

Okay. Thank you.

you. next from your Leerink. from Thank And question Souda comes Puneet

now is line Your open.

Yes, Congrats quarter. Helmy. on the hi,

first question recurrence an monitoring. Just maybe important around market. That's

that or with for had of and sense product GXXXs just in give are had that sort product that going here are OMNI a how then early you've us conversations give the products. much of the versus the initial how ones and conversations with us you've the sense you companies. the modeling and And year biopharma how of terms of Just initial with your

Yes, very good question.

-- are by the how about and of we're move are having I today. with those in they setting them conversations, very started. conversations would existing of first I GuardantXXX testing similarly adjuvant companies early involved those -- when of of going And also also well. thinking samples many many phases even and think many so There it's we're the those perhaps can or of pipelines terms in of in their better we're very say their than they well. drugs encouraged into involved conversations pharma going as involved

think that's the earlier I and component the innovation is assay say of field. would one differentiating new for factors there the of the the epigenomics I

by that And in the be kind don't significant will seen. so it very But encouraged XXXX. we've But tires it's contributor we a think something on. companies I that kick said, certainly the pharma progress want being we're of to

that the -- your some Okay. I of to if us obviously, given the indication. But reached I understand of preparedness where -- sense this going And of conduct average phases. the of studies and Just this a Or in preparedness second into time? -- have are the a just us really just give reached assay wanted your point laid also need sort us where point you have have out that there sense you are risk before of CRC path before here? terms this appreciate in into sense -- -- know prior half have there's study immediate planning if for you the a screening trial? comments you there a that give have lock around you you you in could point around an market, the completely get you give starting questions I the to you and at

Yes.

let So chime maybe I'll and in. then say a AmirAli few words

justified data gotten technical the the technology we presented. feel development and in internal I think as alternative test if that we terms the to this the But well for we a screening planning of trigger doing we provide and we where both to wouldn't we've we that on assay, wasn't it's doing an has market. are are point extensive of as study compelling the have confident that from data that be case. now We the existing believe to pulling that the that ability

Some aspects are would really time tell.

terms and that going to philosophy had readout products our to we we committed the would make But we a get do is, develop that see what's happen. and are always are committed the we this difference value one of would at Guardant that at thing launching add study We technologies have to end the when patient care. study would as field works what the issues But or we that asset test of to due role. compliance the a believe screening be us and outcome can have we and significant not? simple study see an would as study. we this of hopefully do CRC tell And blood add study then And this a in let start us to to

that -- and sort getting That's could one, monitoring I helpful. both you for technology? a Bellwether of That's Okay. How recurrence what the in around could of term? do And from technology you. your expectations market asymptomatic last near-term if what's Thank this great. do what's sort you employed? And that screening see Bio longer squeeze

to basic interesting and a We've material I with of the free kind the was the it epigenomics circulation. the talking we into we us That could so and with at amounts we Bellwether Bellwether and about the are epigenomic and oncology So of space. between that gone alteration and mix, was And and signal DNA fragmented tiny technology acquisition. potential what cell team we saw DNA evidence was integration have especially included years of information the earlier, in when synergistic in biomarkers have, ratio tumor-ship are fragment of there closed mentioned that. team the on to early have value-add we helps kind process. kind which see through somatic to that parallel in kind an technologies about can and are about of some which signal mix methylation showed asset. that That's In fact that have fragmented of mix very say for relationship technology some AACR noise that to to where we increase that detecting they we looking those kept looked that that circling data we the we as genomic at interesting

Thank Great. you.

comes from Brian Weinstein And the Blair. question from next William

is line now open. Your

actually well. will that Bryan. need that? bit can to I order as be is then have on broadly for on Thanks. competitive sensitivity more commercially remind CRC specificity And the specific internally When a on more I'll the at Andrew data and little you we Brackmann of be you that Could you level trial in confidence here? some guess add here? you you speaking, This see gives maybe us what questions you think

the you AACR. what that the -- in data guys know So public data showed yes about we

lines to AACR. two that we we're more Stage and thought we increase our the signatures to than X some we could in population -- was potentially that's been have with population efforts the that materials remarks generated could additional level data at showed in have of mid-XXs the about data those confidence that sensitivity of assay. mentioned AACR XX% of specificity share, in You we with our imagine in that going patients we in prepared colorectal control of more and as some who and recently in we And have those interfere diagnosed patient of some what data that showed detecting some continued tumorship at the cancer material kind looking patient

prospective earnings have the completely the more for that of study. in primary guys we terms our would call in you for frozen of endpoint next Now field hopefully endpoint is data we talk about primary protocol can when the our and the study, in

what read between the to and questions we've And you us presented. data gotten it. abstract guess relates what understand difference of guys of Can and that better on formally led that help you you Got the the then I out, AACR just to as it sort differences? lot Thanks. data a those

the got before Oh abstract The published presentation. that yes.

very patient’s samples And of end with size. have data number it’s which of covered to best patient a that of small patient and increase presentation. was strong number actually So continue size my we data, the abstract memory oral number the should higher in the

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open. Your line now is

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guys. Great. Thanks

question-and-answer conclude a program our concludes participating may all session. you that thank Everyone conference. And does in and you. for you have disconnect. today's day. Thank This the gentlemen, great and Ladies