GH - Earnings call transcript Q4 2024

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Operator

Thank you for attending today's Guardant Health Q4 2024 Earnings Call. My name is Tamia, and I will be your moderator for today's call. [Operator Instructions] I would now like to pass the conference over to your host, Zarak Khurshid, VP of Investor Relations.

You may proceed.

Zarak Khurshid

Thank you. Earlier today, Guardant Health released financial results for the quarter and year ended December 31, 2024.

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

will measures, within be Before remind we involve financial from actual specified of forward-looking material will could uncertainties These materially differ results you to discussion adjusted of call statements making are non-GAAP cause that during items. risks those securities begin, this also call, statements I'd laws. a the which to meaning like or include exclude that to federal and management anticipated. This events certain

call information as directly financial the SEC. Guardant Additional and regarding are release statements, as to material update because intention in financial well any except required or turn GAAP disclaims today uncertainties risks by whether available most law. XX-K obligation or over well as would to issued the of like filings the that, to our press of to and I Guardant other reconciliation new with conference accurate and financial measures information otherwise, or projections in future events non-GAAP comparable the live as as is in call revise The broadcast. With Helmy. only as forward-looking information, this

Helmy Eltoukhy

number increasing growing generating and liquid all volumes across upgrade while test proud quarter continued and the selection and our evidence of for we of their thank business. major new MRD. biopsy hard profitability Reveal our portfolio. In so Zarak. milestones flagship completed our record smart and onto therapy a our volumes generating both we Starting execution for Thanks, afternoon, our test team Good year And expanding CRC, GuardantXXX joining platform, and our for Shield, key for strides this opening we screening We blood an on positioning and of in year. In coverage XXXX Slide made for for XXXX received test of of MRD selection you enormous for was therapy work early delivering cancer. on market our Oncology, our and I'm year for significant approval Guardant. inflection Medicare a well fourth detection Screening, up business, X, an full on us revenue, call. earnings an outstanding FDA

on to all excited impact on we in terms I'm of XXXX Our and the innovation, have even the growth, importantly, team more in patients for cylinders and XXXX, cancer world. come fired product around accelerated volume what's most will in

get breast they XXXX, her start for a The As with to non-invasive confirmed next the pathogenic in woman a our and oncologists a her for GuardantXXX importance cancer move we patient that to metastatic, was Reveal can considered patient work back and triple-negative Guardant outcomes. The to cancer the improve to In I how with synergistically was test. a story typically Reveal ordered test. do, would nodules recurrence PARP being of highlights was like quickly today together ability to helped tests triple-negative effortlessly crucial diagnosed treatment. and call confirming XX-year-old is our a completing whether determine Guardant reflex inhibitor. nodules. To in to for a breast the cancer. standard-of-care the her came oncologist BRCAX to reflexed to be information ctDNA indeed she lung and GuardantXXX identified mutation. also automatically was then were some germline negative. metastatic GuardantXXX test imaging positive time, to nodules her steps after or predisposition imaging Her therapy, identified monitor was these not for tested oncologist Unfortunately, recurrence. After and on were used more

QX our revenue to growing increase year-over-year. XX% $XXX to finish revenue million, $XXX line year performance year Turning on excellent bringing full- year-over-year an X. million, Slide to the We to top of had total an XX% with

XX% grew driven total XXXX. clinical was performance revenue, our growth This XX% saw increased oncology which by ASP and bringing GuardantXXX, supported year clinical year-over-year, year-over-year, volumes was the in XXXX. volume double-digit Turning to This to volume quarter the tailwinds. X. which XX% in Slide largely driven incredibly fourth by growth by Total reimbursement clinical for strong full

closer XXXX, of reach target to XXXX. of $X,XXX to wins, increase the the ASP now Slide our of Turning We of reimbursement a ASP goal significant number $X,XXX. X years At We an year. our by Day $X,XXX for therapy the achieved to GuardantXXX reimbursement including X stated goal in Investor selection. take supporting due improvement rate LDT of to look the this roughly September a from at to saw GuardantXXX over Medicare was ahead tailwinds course our of we

significant We tests have and in we the payers. been for been both also our amounts paid which at we by paid saw speed commercial improvements have the

addition GuardantXXX, pricing important creating year, another wins X Tissue In to our from effective increased to selection therapy $X,XXX Medicare business. for this of $X,XXX January for tailwind

state improve therapy coverage laws further continued biomarker to Looking commercial ASP products. are ahead from opportunities for the there and expansion year, this our selection additional

the Moving Slide July, smart in a The X. of transitioned most improve CGP. genomic product. incredibly detection test GuardantXXX called leading upgraded biopsy representing well of resonating by to onto reinforces nearly is the experience for factor frequency depth LDT platform, liquid by physicians Precision sensitivity is XX. GuardantXXX capabilities the solid to GuardantXXX liquid guideline-recommended significant our and GuardantXXX's upgraded and all firsthand. platform we Oncology orderings Liquid on the Liquid Liquid to including upgrade for testing number position of tenfold, greater Last as drive increase tumor GuardantXXX of our the our and burden genes expands flagship markers tumors helping

by detailed as of for effects the provide information much, leveraging tests, CGP and to have current and much patients more. therapies Importantly, apps a generate These histology undetectable believe pipeline about harmful number tumor detect differentiated smart of existing are chemotherapy Liquid that features, applications. identify phenotypic a adverse platform, will limitless our allow of additional which will GuardantXXX such rich more we we help subtype

expect seeing see we acceleration Liquid, are XXXX. GuardantXXX to an traction from to growth GuardantXXX positive volume in continue in the Given we

for early late-stage and settings growth cases to few continue product business the selection the over and oncology major will strong I'm next Turning to growing both with confident Slide opportunities our international X, more that very see upgrades, our ever years. of than portion therapy expansion, in use

and shifting surveillance which expectations. Utilizing the to received molecular intent potential for X Biopsy Reveal for where recently setting Now Smart imaging. the were in CRC, treatment recurrence leader Liquid standard-of-care in gears CT on in Slide that ahead testing, to the through reimbursement testing of for after We alongside surveillance such as X, CA Reveal Reveal, Stages of MRD. our coverage has curative is platform, identify X. we per Medicare CRC Medicare prior testing tissue-free Guardant with scans are test, ctDNA thrilled consistent $X,XXX traditional monitoring runs

Now, Reveal decisions. be therapeutic informed more will available making in to widely more and patients support oncologists

encouraged MRD. of view the NCCN further increasing guideline related represent as testing reflect to commercial updates recent value of strategy. are our and clinical changes opportunity we as practice what are see the of the of recurrence beginning recognition and guideline are We well only reinforce our updates The monitoring. to NCCN of ctDNA the an attractiveness to seeing in The

Turning to XX. Slide

pipeline validity in breast Reveal. for monitoring. for extensive an for and have supporting and submitted data clinical potential Medicare recently Guardant cancer therapy further We coverage of utility we publications surveillance, CRC cohorts Beyond to support reimbursement

of cancers, a we their for throughout number have ahead, sharing forward updates ongoing look and the clinical progress to Looking validity year. additional studies on we

to Slide on XX. Moving

transition to platform. dollars is Biopsy in XXXX This the This to the made the our a year. by team's and well. Smart During execute critical supported the XX% our we to accomplishment reduce of an XXXX, exiting than a course achieved ability more for reduction tens incredible to was millions is save COGS largely reduction of progress of testament Liquid and Reveal and will

to Turning is Reveal point XX. XXXX. to important on track reach in Slide an inflection

managing we Reveal to despite in As Medicare burn. ahead our very volumes reimbursement demand, manage a order strong of reminder, been cash have

tissue-free executing test. our a level. Now for oncology market with demand key ASP our This the our the reduction making year reimbursement improving milestone margin in in on meet CRC positive, this is us commercial for at surveillance COGS, long-awaited gross channel to meaningful and be to Reveal achieving we'll push robust high test market to leveraging ahead a unlocks with a and the team a focused commercial MRD place,

had fueled by XX% very was Turning year-over-year. strong to growing of our samples for mix Liquid XX. reported of contracts. now year We more Slide biopharma growing than partnerships growing represents This XX% a now of Smart and number Biopsy biopharma and with which revenue the XXXX platform, new our XXX above

companies. is well Biopsy offering Smart was biomarker supporting offer partnerships catalyst development. Our in improved XX key global top and biopharma XXXX major growth a such as products with performance and This signature novel Liquid as discovery strategic as applications

on more us of well recently diagnostic recent Biopharma specific Data we advanced detection Looking robust & lung Slide for closely We mutations companion Ingelheim of some within a Boehringer announced diagnostic this partnerships, collaboration at and other with positioning a pipeline of in a highlights XX. for the to companion the have year. cancer, our develop business

epigenomic biopharma early cancer January, evidence partners. with million Moving ConcertAI's GuardantINFORM to genomic a announced EMR that X.X tumor XX collaboration to from platform a therapy ConcertAI than and more platform create real-world to records tumor we patient and differentiated augments clinical data. with our platform types. combined on data. In of and both comprehensive integrates across help insights development with data profiling This research national records accelerate for profiling database This will data-as-a-service

will cancer an this collaboration Screening. to achieving update I that, one to call AmirAli step now data, this to is for with conquer over goal. With turn the mission closer and us Our brings on

AmirAli Talasaz

Helmy. Thanks,

Turning to Slide XX.

always progress covered with CRC becoming identify early FDA-approved established detection treatable. they first selected our indication of a Our most it indications. We Shield for for a primary has capable when test of XXXX developed range many CRC multi-cancer platform first given goal as the reimbursement as an made been assay catch blood has types incredible and Medicare regulatory in cancer pathway. across are screening. We and Shield, our We've and Shield to

FDA at for XX. approval, Shield Slide million average of beneficiaries risk Upon was to covered CRC. XX Turning our Medicare

rates Shield very important the will $X,XXX. and are securing received for of $XXX. PLA recognized was Medicare of Medicare received as a unique Shield, to or and code that even designation advanced increase of upon class laboratory price Shield that favorable an more favorable status expect new We test an diagnostic CRC ADLT screening a price pleased for We recently

on Slide IVD after Shield August, Moving were to In few we FDA a launch approval, XX. early thrilled days assay. our to just

We screened are our from have patients seeing using excited been that thousands of patients test. and physician reception outstanding are and

our We are looking impact forward to quickly. scaling

beneficiaries. Medicare to Shield majority of testing delivered million Our mix revenue of covered samples covered strategy QX, coming from $X.X of focus drive covered by tests. We the high population the in on a to patient is driven reimbursable

In to happy addition, first COGS launch, margin breakeven [ achieved ] of we quarter in our Shield report of gross ASP I'm for approximately that with full and $XXX.

first we while anticipated. rate annual be infrastructure are maintain to than With positive in the its in we $XXX current Screening us gives XXXX, margin flexibility reinvest gross cash in burn commercial year post improvement, million. full to launch, Shield originally target much of sooner our expecting our This we of

Turning XX. now Slide to

XX,XXX boost are are XX%, strategic of colorectal modalities, encourage in majority of may option than of with detection focused CRC. introduction our some compliance phases. exploring the Shield later in overall at This later in our Abu Dhabi early were in Abu to to including greater that announce may we region screen tests initially on screening as While their the FIT scale-up the and Recently, to participation in surrounding blood international a a XXX,XXX screening getting Health is Currently, of first are regions the we Department part and year, of Screening more its be aims to selected a and Dhabi excited we colorectal current in UAE cancers in test scale and approximately screening stages. The approximately less screening colonoscopy, pleasant and to the the platform. cancer patients diagnosed annual program, program. interests the in non-invasive U.S., the

as Shield XX. for Vanguard NIH in Slide process through a study. has competitive field decision leader announced to the the a of We sensitivity, select Shield as on by MCD highly a disease for to NIH's the and recently Detection or especially to Moving been Guardant that of of selected of recognizes MCD types The predict origin. Multi-Cancer cancers good cancer cancer detect validates of early-stage as needed detection MCD our the across technology. variety with site well accurately test presence the

scientific cancer approximately across We in types conference will XX in of that Shield are XXXX. the data patients be pleased presented to performance a of MCD quarter the announce in XXX second

or the are in of our and milestones which American ASP. data, we XXXX, enables potential ADLT of excited upcoming presentation guidelines, status, including Cancer multi-cancer ahead, Society Looking about inclusion our improved Shield in ACS securing

with are to I call turn planning CRC that, upgrade over our detail more We the for now our will financials. Mike Shield to also screening test on VX. With

Michael Bell

AmirAli. Thanks,

I'll unless XX, million. also primarily year Slide revenue Oncology for XX% sequentially to otherwise XX% primarily record to QX test XXXX and the increased highlights the Precision volume revenue tests to to Precision total by XX% increased now grew rates, discuss in select by in driven Turning was Clinical to GuardantXXX, refer $XXX digits. mid-single $XXX million. grew clinical grew which some $XXX XX,XXX from XX, driven a XX% XXXX. ended quarter which revenue, financial growth December year-over-year quarter million, to I'll noted. Fourth Oncology and tests

our We platform start continue at in Smart Liquid we which GuardantXXX launched strong upgraded of of to the Liquid, uptake Biopsy see our QX. very

growth also during continued strong fourth GuardantXXX in the Tissue was quarter XXXX fourth of We and of saw XXXX. $X,XXX. the Reveal approximately ASP of quarter

year, incredibly fourth million quarter, which quarter, above As biopharma quarter, another up revenue very led performed seen totaling our XX%. $XX growth This tests fueled to strong of we increasing strong we well throughout have fourth tests had with approximately record in which Precision in revenue the out-of-period our of Oncology in the expectations. Once by commercial XX,XXX, quarter million, fourth was XX%. was from also upside business again, collections $X payer biopharma the an the

revenue from Finally, Other generated million the Development we totaled that quarter. & million in reported and $X.X Screening the includes X,XXX $XX.X QX Shield revenue tests XXXX Services in

being Precision test XX% XXX,XXX, from million. Clinical growth For increased was Oncology tests XXXX which total again of by volume with XX%. revenue, $XXX the growth revenue grew Precision revenue million. driven Oncology full-year $XXX to XXXX, million, XX% increased XX% primarily which $XXX represents to clinical in to

driven which, volume, despite As fastest-growing our in managing digits XXXX. increase continued an Helmy year, was surveillance in clinical by of mentioned, ahead test reimbursement, throughout clinical volume saw We growth of Reveal test XXXX. double was grew GuardantXXX growth largely strong the us Medicare in which volumes

second was approximately Finally, test growth to ASP, of also XXXX. XXXX. grew GuardantXXX $X,XXX throughout in approximately Tissue improvement Clinical by the from XXXX strongly our revenue also which $X,XXX in fourth driven significant increased to a of the half quarter

our year reimbursement in tailwind, led in this collect more to had than addition we improvement In the upside tests significant accrued the us to trends which throughout previously for cash throughout the for, resulted out-of-period revenue year.

for approximately year expectations For was with million trends. the performed in revenue based years on approximately $XX and million, recorded Of historical consistent prior experience full million. XXXX, $XX payment $XX tests was our this

result a However, the the upside we revenue as collections remaining this of was million better-than-expected $XX for cash out-of-period non-recurring XXXX. and view

Turning biopharma. to

XX,XXX biopharma well XX% year As XXXX. to during tests mentioned tests business revenue growing and from during biopharma Oncology earlier, full test our totaling incredibly biopharma with performed million, XXXX, increasing XX% $XXX volume Precision the

year Development that from for Other of the at of Screening between and $XX.X full and & revenue were Shield million includes the the XXXX launch revenue generated tests the end August Services reported of the $X.X Finally, start million year. totaled IVD

to Slide XX. on Moving

the Our quarter non-GAAP margin in of continues and very XXXX in XX% to XXXX. to XX% gross of compared quarter be fourth fourth the was strong

XXXX with non-GAAP gross an XX% We in basis also compared annual improvement an on of to XX% saw XXXX. margin

range million the was for full-year an quarter to fourth on operating in XX% year of year we and margin were of XX% the million year in an improvement XXXX, X%. of provided gross and from non-GAAP above XXXX, that and Screening, full period XX% prior Excluding the increase call. Non-GAAP the fourth XXXX, quarter for XX% increase both XX% of earnings full an $XXX expenses our the QX $XXX guidance

of non-GAAP one-time Our full $XXX in range operating was a expense year of million million couple fourth guidance of XXXX. due above our to $XXX the items to quarter

false $XXX advertising Health of related expense sounded us claims the to Guardant jury at significant million. its the incurred and on favor all which in litigation we November Firstly, unanimously trial, awarded

company in-line the bonus we Shield top approval the components, respect payout bottom and for plan, Secondly, level, accrual launch as with of FDA a QX, Board products. successful performance XXXX to with in and reflects year which the financial measures, of line year bonus full increased the the approved such new

for gross XXXX, increased As EBITDA of and revenue, million of $XXX in our EBITDA $XX million an full our a XXXX. was improved leverage, adjusted loss improvement flow the profit of year cash year-over-year free result million operating in $XXX XXXX. Adjusted loss to a both compared and full year

burn the to in million our target XXXX I'm of on Free line we positive focused be was represents and in burn QX we in flow $XXX core provided of in XXXX with burn business and $XXX materially Screening of XXXX. managed that reduced line approximately million therapy call for was to year in also compared cash to guidance cash an with $XX $XXX our report to XXXX. continue earnings cash pleased We improvement million the successfully and full our be million. selection guidance for our our free-cash that flow on

maturity represents $XX.XX. potential is greater million a the optionality sheet conversion comes coupon in and convertible XXXX time, and X.XX% of Turning we cash a in favorable while we optimize $XXX and million successfully year to Earlier month, mitigate premium, Slide sheet the on a future. The debt now this risk, due of at restricted We we terms, XX% with convertible annual with completed debt structure the with provides private $XXX exchange to believe marketable ended balance debt capital in which balance XX. a to helps where cash the $XXX convertible cash, which conversion securities. our equivalents, on extended same price million approximately the new debt of

reduced November total was $X.XX billion, our convertible transaction, As billion coupon $X.XX debt of debt, of $XXX which result million is is in the a which to from XXXX. X due our

a concurrent also mitigate $XX stock help million of repurchase to We structured dilution.

Following these was approximately position million. transactions, forma pro our cash $XXX

We with million to $XXX we continue cash cumulative breakeven to million the $XXX flow XXXX cash reach next expect free in outflow of will years. over that X

XX. Slide to Turning

better Before revenue different discussing business to Oncology our provide moment and Services want to for going Other, take than to performance how XXXX, reflect to Rather assumptions revenue the we Shield. and clarity Development changing splitting outlook & the preview presentation Precision intend of we to our our into on a lines and forward. we're present

revenue for start revenue slide with which shown break which As we are Data, the numbers. In & Oncology development clinical we'll companion revenue and components, line; revenues. we and are: will XXXX, components out such, that from previously full that and we which total X in testing biopharma as MRD testing testing the reported we was revenue, to well the reported selection our clinical, revenue biopharma Oncology represents and new Precision previously the within year as as previously finally, represent to testing reported services reported XXXX which Biopharma previously services; summary, other XXXX which Shield therapy which revenue represents Other, data & Precision generate namely Licensing customers, in revenue revenue; sample Screening, biopharma Oncology, diagnostic as as

full for year assumptions our Slide outlook to Moving for XX XXXX. and

revenue compared in to of XX% the We to to year approximately million, XX% expect full XXXX. growth $XXX of range million to $XXX be representing XXXX

XXXX. upside in growth XXXX, total implies to XX% non-recurring revenue million Excluding XX% range the in out-of-period this $XX of

assumptions our down revenue in the Now, key guidance. breaking

XX%. oncology of expect revenue this in non-recurring represents upside year-over-year in growth XXXX, the to excluding XXXX. Oncology grow approximately out-of-period approximately Again, We revenue XX%

upgrades to our we Smart all LDT positive of be Biopsy, Medicare and expect our we're and we're in making XX%. GuardantXXX total to coverage surveillance clinical to our oncology growth CRC test, the products Reveal for tissue across clinical XXXX launch traction accelerate seeing oncology volumes recent approximately volume Given the from on Liquid

well growth Data forecasting We and revenue. to & expect are our Biopharma double-digit biopharma perform business to low for continue in XXXX

$XX into want tests. which driven million, of we million revenue, for Finally, by be to the to launch, initial still expect some Screening very $XX in early the to although Shield to XX,XXX it's XX,XXX we guidance provide range

expect back-end the include from will loaded, productivity our does ASP throughout to full reps significantly the receiving year impact due We year. Also, volume it to guidance be ADLT hired the this time not ramp up designation. take of to newly any

occur over accordingly guidance made to and this and in both last expect our Reveal update our gross in Shield We've to few COGS appropriate continue months reaching margin at We progress great XXXX, reducing we'll breakeven. the with the time.

full For the in during XXXX, year. XX% impact year we're XX%, we margin the mix of the in range confident deliver that changes that gross to of product expect despite can we non-GAAP

continue expenses expect expect an total to in be operating during XXXX, G&A We we increase, XXXX. We'll to and be efforts X% continue significant R&D $XXX operating expense investments to X% coming the operating and the leverage for relatively in Screening flat representing mainly from as range $XXX to compared sales increase non-GAAP expenses with XXXX ramp million, to of to commercial gain to million and to in compared Shield. our marketing up

to reducing each in flow to continue reach we cash committed company-wide be in year to order our cash breakeven Lastly, XXXX. burn

For an full $XXX expect we flow of million million range burn improvement in XXXX. to free cash be for million, the compared $XXX to to $XXX XXXX, year

we and the Screening, the XXXX quarter million to maximize in the reach $XXX our the we Screening will first-mover Our during consist business million million remainder fourth scale as breakeven approximately related to of to Shield XXXX. and cash approximately of flow expect in Significantly, $XX burn our to excluding business burn $XX of advantage. year

that, turning rich of Finally, are ahead. With pipeline will about business to opportunities open and call the segments now questions. excited have we our we to XX Slide across a the catalysts

Operator

Leerink from The Puneet with first comes Souda Partners.

Puneet Souda

you that Street Reveal half feedback one that field expect are believe I this wrap well. us, to the you're But the drivers on to what in upper-end? the well the on million of second And as gives the on against surveillance. going you it's ahead guide But maybe and you $XX the you I'll contribute for Shield appreciate as congrats that force could one getting of you on expansion and million sales to NCCN? was First Any second million can square for recommended I here the $XX on $XX is coverage. well. the NCCN lower-end? And Unfortunately, loaded. Screening, contemplating half? confidence try Reveal, about from talk other surveillance and the

could balance you of the it's know I you X? as result How expect those go in this days So early still market. of to that? Reveal adoption do a

AmirAli Talasaz

Thank with give Shield you, start Puneet. Maybe Helmy question, and I to Reveal. about the it I'll

So, we continue to be very pleased with what response, we are hearing response. patient in the field, physician

Now few Vast XX field. our as is, the to connecting it very came increased the people test to the they majority productivity. the fact, in of to year, guidance, last August make in in contribute XXXX ended in some launched them and we points. One we time going in I added, a take it's back reps late XXX we with We it to XXXX. late,

more rate As to going believe be a back-ended. -- ramp result, that actually we our we is are

our to The full is is, consider this other year thing first launch. of

of this is it years, always, obviously, it's back-ended just when more launch So in the at too. kind growth numerically, look you

reps we about by are maybe our going field to we of people terms XXXX. end planning in 'XX Day have, of to number of are total that we XXX In mentioned Investor call have of in the that

mainly what Medicare Some stuff better pricing. expected, than we the went

it going not leave after Helmy date. maybe I'll hire have will we But to like these Maybe X a contribute result, a people months little bit meaningfully more like their till that newly Reveal. again, reps in X, a are for field. bunch the it and give As hired of

Helmy Eltoukhy

question. saw Thanks, a actually Puneet. NCCN the We were Yes, fairly encouraged update guidelines. we when good in

given of of a I utility guidelines years is that where bit testing. direction, And terms of in the really all-in-all, behind not cadence ctDNA but in very right terms and with sort dissimilar in the as the testing right in of practice of the this the too this liquid we're clinical forward sort we get for a I encouraged The adjuvant moving biopsy with see to XXX think little with saw actually from and tend guidelines perspective. Reveal confident place testing coming terms a of in on the a think in the whole setting. we're to whole, value from is, step especially be it's the recognizing we'll surveillance we NCCN guideline

Operator

The next question Capital comes Craig-Hallum Group. from Bill Bonello

William Bonello

of mean, one has if any have Shield. to having I preliminary whatnot. just you there sure USPSTF commercial accomplish obviously, of wasn't trying if payers on outside might with kinds about But I'm Medicare wait activity the Shield? thinking on been, Another to of I discussions ahead that? you be payers curious are you and was

AmirAli Talasaz

[ kind in Yes, from like very feedback are ] of initial terms getting saw we in Bill, conversation boards, them. early we some advisory mainly of having

of in after mean are guidelines We inclusion go happen are we planning I those XXXX. to ramp into ACS right up some could after guideline engagements it that we optimistic. Hopefully,

activities those up ramp will We

Operator

Jefferies. comes Peterson The question with from next Tycho

Tycho Peterson

Shield. on couple A

So risk ADLT and status? to to lastly, can Medicare Dhabi? the at the And into quarter? just confirm then any then a in versus that maybe in the that think how do ACS move just you expect guidelines, not lower $XXX the for do whether about quarter. Dhabi the I Abu fourth lift dynamics Is the midpoint Abu bit includes guide? baked here, guide that fee-for-service you subsidized And or is And assume second that's And could volume come? just little you're ASPs guiding Shield $XXX samples? you maybe that

AmirAli Talasaz

Yes.

So Tycho, great thanks for questions.

first with That really very to the we the are the first that launch. want full thoughtful of the that that get are don't with skis. and we We full ASPs in was ASP printed going our had just ahead to We we put QX. pleased data the for be to quarter year very of we want

are would We continuing monitor impact to mix our are we the payer ASP. going to -- that

of -- improved in kind of this bump again, Medicare emphasize not I guide. I think rates embedded that is ADLT our

the that get at this then are know, that's point We of and very confident us. accordingly. Based everything it payer that guidance just how know to mix It's the and to exactly going We we going look It's very our for activated It's to at mechanics timing. we are something process, time a when get clear. works. process. not the on about revise of ADLT a the it's quarterly matter then

to it's So Dhabi, make And upside very sure guidance we derisk want it we include ASP. our to not for just ASP. before our on we that quickly, dilutive Abu

Department into engagement it, with details that going are with there. the more without Health we pleased So, very we of have of

Operator

The next Cowen. from TD Dan comes with question Brennan

Daniel Brennan

the in do what how additional to to I when think we maybe ramping sure on through could in us you We're baked like 'XX. and give help us think going be? could breast to color surveillance hear you XX,XXX but then that? I'm Could b, what's about in timelines of you focus give the us not on on know 'XX? think might for 'XX, XX,XXX guys specifics, like back tests Reveal. you're some going kind impact you And about of monitoring, when we just about indications, did

Helmy Eltoukhy

last Mike very And product additional of accepted data both Reveal, for we that prepared across then But oncology growth. to and but published terms are each not of on breast MolDX. of of products. That in remarks, submitted to lines I'll see monitoring respective of the for acceleration be publication Maybe late in with wants and said, has some year as our kind we start as maybe soon year. fill sort pleased volume in sort cadence we'll submitting and of as we for all as said, terms being in we how we're And the journals, those in certainly, just started, of our volumes. said there indications, for the in

expansion half second this earliest, could sometime potential for think we Reveal. of indication so see year the we at And

Michael Bell

add. I'll volume Maybe we Yes, acceleration. Helmy Yes. for Reveal expect as mentioned,

getting up think the of across Reveal not for focused acceleration right, clinical You're going Dan, out lines. expect field because just again, the this all ramped much Reveal more, breaking be we're really volumes or the will on year. And the volumes that's the increase to time But CRC. yes, and will be loaded during It we're to oncology we the accelerate. some take sort we of back-end now is very

CRC, looking just The throughout to traction to offs hold. weeks out accelerating the and year. is it's kick- that the Reveal and X or our volumes yes, sell ago. X had take So go team But we're forward for take meeting we very time much very energized but going to national excited to sales

Operator

Subbu following Nambi Guggenheim. question comes from The with

Subhalaxmi Nambi

ADLT fair questions. the guidance approach COGS that Reveal? Shield, ramp, have been Reveal, what Is like And impressive. embedded your a achieving in timing? ASP Shield Two to via reductions embedded for it what XXXX is similar guide? mix, is you're the in already On the Shield reduction respect to COGS with And assume

AmirAli Talasaz

Yes.

especially of bunch doing activities that lot is Guardant there the a of platforms actually, on we are highly leveraged are synergy. for mainly, a is So, and based epigenomics, at R&D that

are LDT is through which the the of some COGS Reveal, cross-deployment Reveal. that doing an technology by learning, of seen IVD these process you Shield some a but that have is both we takes product, across implementing guys bunch improvements reducing we changes cross- on and achieved on is product, synergy and So, improvements what bit and have we so stack an Shield had. of longer, there

Helmy Eltoukhy

the Yes, pleased coverage of the of very the I'll were CRC we so at Medicare Reveal Yes. ASP. course, surveillance And year. start to get at $X,XXX maybe take the

positive roughly to with on going So between a ASP have that's $XXX ended and XXXX $XXX. an ASP. We impact

coverage. have adjuvant mix of course, there's have then, And all big a so the positive Medicare then a we're CRC, and of of we sort and we going There in have Medicare Medicare Advantage impact, impact because Reveal is lung, breast to of in surveillance an CRC, and and commercial. impact

have a yes, mix something roughly to guide like we increase $XXX. to a would our perspective. ASP from we of So But expect lot with deal to the sort there's in that

apply included in any that impact haven't intention $XXX. our to It's ADLT ADLT for for We rate.

line And to on the Medicare our would that, if guidance change we so Shield, similar and and when we increase receiving we that. an rate, with would expect get in

Operator

Mark from comes BTIG. next The Massaro with

Mark Massaro

a strong Congrats on XXXX.

one first The Helmy. is for you,

GXXX today, your either plan to volumes [ your business a to about prepared I saturating you or misconception think was was T-cell ago, probably there you year this But year. that investor products in indicated your ]. into comments go across about accelerate all an

that liquid majority you're could in the just Medicare revenue came was the the I about field anecdotes one then GXXX you give some products? And of recognize if for I So with upgraded AmirAli. seeing level curious seeing your would those you us interest a addressed what think of you're equip payer not from be be about whether to population in what well curious coverage build QX, non-Medicare or but and commercial I when you'll orders in? comes from

Helmy Eltoukhy

obviously some is especially been given I've the every to XXX and and upcoming, with products have smart sort out tissue. liquid Thanks, question. going our that have year. in excited most we've we can you This there ones sales Mark. then seen them of the at I probably the the with team, tell I Reveal the appreciate we biopsy of meeting, national

We on since physicians in launched really features biopsy, been a so, lot really a are momentum existing nice of momentum. haven't it's we we alike. And And uptake even that exciting saw new from liquid and smart that seeing XXX we yet. turned physicians

can confidence And this to continue XXX at terms the not liquid the the penetration, going increased sort is year going each over growth in the just types year of of ended few tail in really of we lot of next growth some so we I as drivers. the years for where progression. more new as do long a patients will it's have high sort testing well, how this the just have epigenomics given extremely of some tumor has applications room last that outlined only how address, and in findings started, market. of of field that there's It's well

innings cell the liquid there of so for sort -- therapy biopsy where are terms early selection in very we of at can And grow. really

AmirAli Talasaz

are during our younger proactive on we adjustment focus we Shield regarding patients, commercial experience And on on didn't experiencing side, to Shield when have the LDT covered workflow really patient that.

reimbursable assuming In volume there get feedback market to this covered the of that year, take we fact, the get data XX what's we and on opportunity, maybe patients. huge Having and answer our patient access that until and patient. But more Medicare, to of said like that, are exactly needs is and of Right and worked changes forgot about X assumption expanded majority time, ramp of have our that that this tested Abu partnership. focused get Shield from has was there some go vast, since vast to demand the population, through have contribution those Dhabi. I our logistics, to just though, first are payer ramp. that cover was mix. to now, a now initiatives of And this Department coming actually know program totally, an by of of we XX,XXX program our workflow how about internationally in At going the a over younger level test this I of and get younger for expanded fraction Shield patients case who'd the the a we they're we go expectation coverage of patients. just we in minority earlier above quickly ordering ramp. opportunity once the Abu this That Dhabi don't is visibility Health question, to to there

Operator

Donnelly Patrick with from Citi. comes question next The

Patrick Donnelly

Helmy, Reveal. maybe one on

change as Can should we the catalyst how one the little ramp just will AmirAli, Can talk the [ be just go reimbursement, bit And pursuing ] talk on volumes. you about a in expectations know VX that. Just through of through a mentioned a in front back there what then maybe little quick you're half Shield. holding for kind for go? strategy, just the the I on I second a Mike know VX? for you that before more of

Helmy Eltoukhy

Yes.

year kind As we we are demand at ways really they sort have Reveal, really lot of sales meeting was efforts And were out accelerate very initiatives big some sales our I said on and how in really motivated, sales that we a being exciting team excited of had there now in training think, sort able this product national of, of the limiting from the the one this of much servicing to before, terms getting there. our and sort team. our we're of of more -- was offer robustly

the is. market, And out most the of to room MRD, with So, we especially where where the tissue-free really fact targeting the there. and have given you not opportunity didn't a juice lot been surveillance the yes, reimbursement we've get most there's of sort of area that that's grow, been of really setting, an it's of

oncology go team very, and excited And very business. our ready means for is for so, the to what this

AmirAli Talasaz

that planning have Regarding to right of and it's hopefully Shield active tuned. program of version end the to have year. by Stay us VX, -- for the test of now. are we approval launch And

Operator

with Arias The Stifel. Dan following comes from

Daniel Arias

comment Help for companies there. shooting piggybacking me your and The maybe and here approaches. is the as that tumor-naive just tumor-informed field last MRD increasingly on way off evolving both

your early, And think the considered you are the idea and test whether XX,XXX As had in serve to I a just how in interested way to community, that volumes Abu both? about outlook for Dhabi own are question, you quickly; Tycho's in portfolio volumes? best XX,XXX clarification for ask on then the just having someone

Helmy Eltoukhy

think XX X use. cancer fit XX survivors It's that the from product market. tissue-free a the portion to ultimately mean, the is the look, well. years some that that I we that market. million market than point doesn't at It be Yes. simplest as addresses MRD our largest of would But be the of product going to out, part the in are mean portfolio more million not out tumor-informed a of

We to we'll listen have to TissueNext market, and the to of We couple our are understand what the of GuardantXXX a needs customers, that. obviously years launched do continue ago.

that major this a have upgrade We of year. test

going we're market of to needs the required. the and listen so to adapt as And continue to

AmirAli Talasaz

At patients said over first all, the within program don't are screen the can this this how we Having so they have time, not. aim year. really they assuming visibility approximately is test XX,XXX ramp we that. quickly just of Dhabi, it Abu the fraction to at or if can and approximately that, up since contract a XX,XXX and patients About

a material really a that not included. of effectively, is So just guide, our fraction XX,XXX part of

Operator

Morgan comes question Stanley. Tejas from with next The Savant

Tejas Savant

there's energy of offsets And decision you situation. know you case you sort of talked Court Shield gating is So, just a states there Supreme perhaps I looming ACS against follow-up that or second rejigging via opportunity for effort inclusion quick one be and with decision on 'XX -- questions. Tycho's USPSTS? the ACS sort half phenomenon. activation AmirAli? Is sort the on insulated still the a earlier Medicare past, a here, factor catalyst of on then from would Will your that to But with that need this in about obviously of that guideline go require any commercial for bigger

AmirAli Talasaz

Okay.

little So, more, [ maybe I start that guidelines ACS a maybe Tejas. clarify I'll to bit with need ],

optimistic we would in pleased So, are terms are started consider team, with in that working have Shield to of guidance review with continue that the they CRC they we ACS, that on. conversation that we and the

but So, are we know, exact not we it sure, in we confident, timing, are XXXX. be what should based on sometime

we focused are the impacted population, population patient In terms to going Medicare right Supreme mainly which and covered now not get of case. on the case, is by patient that

opposite of that on. fact the It's kind us are and to move administration question. waiting We while be in what to we we'll a against pathway of for Yes. of patient closely. see access is that not sure very Medicare on mind, There population are for happens. future. field, just the the monitoring case, Trump kind success of if younger lot for got the Maybe, kind of actually for business that but I I'm it building is good we law actually last the side on continuing work

Operator

Vatnsdal The JPMorgan. from following Rachel with comes

Rachel Vatnsdal Olson

assumptions ASP year, So, I into GXXX. dig wanted to this specifically on

the walk are for ASP front levers for that traction for can given throughout on And XXXX, can what So, see through the embedded that growth you assumptions selection? this therapy year you that in continued us you saw your core XXXX?

Michael Bell

ASP main driver And very, we rate. that just a to GuardantXXX No, the we very of our think sort saw in reiterate, of start one. the from of Yes. at Yes. throughout LDT impressive increasing bringing Rachel, XXXX. was I'll to had then $X,XXX. GuardantXXX Mike. up year, take Advantage I them The year in pull-through that the Medicare increase the to $X,XXX it's rate the

top went GuardantXXX of to a lot in the because that, than we of from cash ASP previously also, on we out $X,XXX of more 'XX period receiving half And $X,XXX just And getting so QX were accrued -- yes, back for. upsides at our 'XX. we have these

the I definitely, commercial over on XX when have is $X,XXX of ASP, to here that sort GuardantXXX. expanding next XXXX, the we payers stay. for months we we for think the is the focus us the believe, and opportunity really And at to and look longer coverage

we've GuardantXXX, good that now. So, we national very the All coverage cover run got payers time don't every cover the test. they but

the version, lung LDT in And types some certain for or like So, cancer indications. for only some the cover for cases, and CDx-only versa. breast certain vice FDA-approved

over $X,XXX And ASP so, yes, coverage time. the is expand our that's really for to focus really going us to just for built guidance the What's be into GuardantXXX.

we continue incremental would expectations, our if above again, with to about our So upsides an be of to and get more bullish ASPs yes, got GuardantXXX where we're out-of-period expansion But can we've we any be forward. If that will upside. accelerate these the looking to feeling then our the that coverage, guidance. of

Operator

comes with question Mikson next The Canaccord. Kyle from

Kyle Mikson

'XX? be in runway could in your and insurance? from lengthen and different that important the in competitive could year enhance you talk Is Shield that Tissue Helmy, to contribution could in terms you for position about expand XXXX be the GXXX? AmirAli, that's given for how under the just franchise that portfolio, your of And this maybe demographics just the clarify volume secondly, longer-term is to opportunity, going going of patients GXXX from

Helmy Eltoukhy

think bar -- we've since resonate going with We offerings launched upgrade think, think, be, I this But that it. is a this most going be that from competitive I sort and significant growth view capabilities one our last years none, I really for to in pretty it'll of few space we of seen, to of is test. one point the a physicians. over the from Tissue strong Yes. mean, franchise

use and the we think our major contributor a so very tests upfront to is monitor patient business pillar XXX of they're -- to important a to for that really really then I it's is that couple product what this patient, the with expecting both forward. pillar seeing And as next sort going selection yes, doing physicians a years. sort important continuing And of of be therapy a are over a of when going and

AmirAli Talasaz

Shield the assume volume of Medicare majority we volume XXXX vast majority from come from meaning the beneficiaries, in beneficiaries. would was patients, what covered Medicare and still targeted is QX in

the commercial So, a insurance volume. our are of like patients younger minority

Operator

The comes with from Stephens. next question Mason Carrico

Mason Carrico

where the seeing an has incremental growth helpful. with this that was in accounts? incremental tonight. some higher you're U.S., would Is utilization is into types But been Is share Any a color where I'm just the if give capturing few for could coming insight competitors? between penetration from us exactly jumping be asked, you Sorry GXXX tumor new growth in lower it there from? it on

Helmy Eltoukhy

from [ greater accounts. ] largely from would I existing it's adopts say

we you majority GuardantXXX have U.S. oncologists know, that order As today. of

And so about it's getting depths. a greater more lot

So lot the has as apps see it been been capabilities is think, of of with some that lot a applications, of more platform. of a go that physicians their are a taking of test, resonating has lot of we still come as just this I there, a these of with physicians. to exciting, like we and greater these genomic competitors onto roll patients genomic There a sort test from has having some that comprehensive beyond the And standard that back just but out test share it's utilization profiling also don't well. a all test out

Operator

final Sykes Sachs. Matt with Our from comes question Goldman

Matthew Sykes

on just for Maybe quickly, expansion force just sales AmirAli, Shield.

you're those out. Could launches investment walk that the that being this gating X in consider expected. little today how about factors or than earlier year call maybe are? the sizing of ACS of it you what at and in future? But bigger you into talked originally building bit in Just little thinking maybe what through a bit 'XX? about point ago, you guidelines, competitive year any over would a terms Is that gating a talked kind you about You just factors given maybe

AmirAli Talasaz

at to that Guardant terms huge opportunity this Health. for believe everything us investment by of execution Yes, is is brand are continuing we going talking about to Shield a in continued have gated and

constant. remains that So

burn constant some that annual to at mentioned like part, our now around this $XXX is going The million. what which is be time, net is other we ring-fenced for

So we execute are continuing that to based discipline. financial on

it sense. on is just than because X.X fact ago, the reasons. we was that about the main So more ago. to point versus today And And embedded of is $XXX didn't volume economics pricing commercial Medicare with be X.X continued price. based going pay favorable ago, The ADLT makes the years I showing years there years X.X that the multiple what's what P&L made earlier lower economics coming, be assumed commercial, to on factor, going what was are expansion is expect expect $X,XXX the is unit cash execution we we to unit

give would commercial this can reinvest gross profit some So additional a us building into we infrastructure. that

Operator

your you This Thank call. participation. for concludes you. today's Thank conference

You disconnect your may now lines.

Guardant Health (GH) 20 Feb 252024 Q4 Earnings call transcript