Natera (NTRA) 9 May 232023 Q1 Earnings call transcript

Hello. Welcome to Natera's 2023 First Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, May 9, 2023. I would now like to turn the call -- conference call over to Mike Brophy, Chief Financial Officer. Please go ahead.

operator. Thanks, afternoon. Good joining of for call discuss to Thank first our quarter results our of the you conference XXXX.

Solomon Officer, On being webcast. the CEO; in to Medical our John call business; is today Chief Steve by wasn't due for join stepping to the line, I call Alex Business via am Aleshin, Officer. broadcast joined conference Moshkevich, live able who and company Chapman, Fesko, Chief Today's

investor.natera.com. A will IR has to We it's referring been also will slide to site as our of that presentation replay be be a soon available. to call the posted close as

Starting on Slide two.

and clinical the regarding results. studies, expect capabilities, our outlook, product that conference future During performance and related effects assumptions financial call, statements our opportunities and make products, outlook expectations anticipated future on forward-looking operational reimbursement this and strategies projections, we of future hiring events our for coverage size, such our market for operating we partnerships, course as various will financial including to dates, release and and and

factors contained time most the the those on we that statements. differ with you that based from other the suggested identify better may recent materially. results today's our it differ results and risks or a factors refer events Form materially currently filed important cause XX-K Form reflect by SEC, press not and X-K or Please including to our XX-Q our documents release. Those caution such in to forward-looking actual and from could with statements file actual We to the time or documents

to this today, call or or not information revise forward-looking today, call as the presented during or obligation Natera reviewed current any update during after made made the of statements replayed May contain information. any If X, XXXX. is being statements. disclaims call accurate the may Forward-looking are

a not updates quarter, public on we do but further form on in provide provide call, so unless will will We the during guidance any forum. today's guidance or

We each performance. we of growth noted, comparison. numerical as will number reference changes our a such discuss year-on-year quote otherwise financial unless represents a And

And to call over now Steve? I'd like to turn the Steve.

Great. Thanks, Mike.

are financial in see As start robust up important QX our the you to leadership performance drive as in highlights, business. a DNA strong tests year XX% and maintain versus continue milestones quarter, we off analysis and from to the We position can QX. roughly very the cell-free across process XX% of last achieve XXX,XXX sequentially from we

was the revenues major We year-on-year. generated which increase, quarter, million $XXX in a and in versus QX both

is Signatera spring. strong last of the very strong clinical Altera growth. saw and growth We year. in volumes over also this generating in We step-up quarter, volume of continued test XXX% XX,XXX year momentum versus a performed We saw which more QX last is QX and than

that pleased to we guide revenue result, As raising are just a our set ago. be we two months annual

We are for $X.XXX rest to $XXX will The remain guide same moving to a of billion million elements the new the the range now. the of for of year.

$XXX to of to million our burn to and hit cash pace are We of our million. on reduced target target XX% hit $XXX margin XX%

You flow cash will our in previously breakeven announced. XXXX, QX goal burn we feel quarterly half we in almost QX for on see and cash track XXXX we're cut that our versus

necessary Note been goals. financial are conservative testing MRD we've In screening our not of expanded in addition, guidelines XXq to and that with carrier our these achieve impact guidelines forecast. for the and ASP

SMART of for including has our been health We third landmark accepted Panorama paper the position continue the to publication. in study. women's in have significant extend two papers our more NIPT than that highlighting published now We publications NIPT XX leadership peer-reviewed a with performance

differentiation as NIPT grow. the driver be market volume We continues continues to to think important this clinical an

wins for of well. course, had string Of a this as we've Signatera spring

with presentations presentations leadership this to that data we several out are announce XX and AACR, of our poster June. very at and two continued are oral excited We

Signatera's three in think value neoadjuvant new melanoma into will setting call. breast Stages a that Signatera expanded the addition, cancer demonstrated In and important, we of performance We study the I-SPY in for neoadjuvant setting. later dig in study X patients four and and breast is demonstrated the the the

Health, After from securing commercial Medicare for coverage we to breast we transplantation. for Blue Prospera in reimbursement cancer In were the heart for Shield tumor Medicare with pleased coverage of major pan policy receive Signatera decision March, a California. in coverage Oregon secured

this We included guidance the in originally. haven't

So this is a nice win.

the in kidney, the in from impact details I'll of updated are the modest from isn't seeing guide, reimbursement Medicare with especially in upside our get now as some the in. line of later we can our in call. But making context overall this the expectations, more policy. disruption coming a you see business. bit In with results heart the into an

Okay, great.

since Let and business scale me XXXX in the despite the volume significant in get beginning remain increase We've mid-XXs growth rates some into of the of a business. tripled the more our the quarterly trends. of than the

sense critical very commercial large populations. patient that shows is record that services think and execution we in I the track a of gives are offering

to also can see year be no XXXX prior big You step and QX over has that up a different. represents historically the proven

of the serum share the shows broader of taking represents favor This our seasonal QX, from is to by and also screening market NIPT continuation in a driven NIPT. in ongoing in shift success part but patterns maternal

is we only margins our a This amplified this further penetrated term the reminder, year. XX% increased we was QX year, volume long it three strategies have NIPT but gross about been expect impact pursuing that today. by think would we growth for volume As

for and access provide this California decision the continue providers the into and of lab the NIPT screening our limited important last state offering, when participate fall participate. was through California low to patient Despite most required state's to in thought program effect to margin to program. operating in the opted not was we patients population. One go prenatal initially it to

offered courts some to enabling program, regain However, allowed to state the challenge, outside volumes. after the a increasing while margin legal the have lost of be of us NIPT now our

optimistic decision we're made So stay. we that to right the

competitors We new fall. Many many for screening profile. panels serve exited customers to take customers opted XXXX. high-volume margin because carrier hope see last improve of is after guideline low on go rates decision support our are screening accounts that the we carrier preference strong, broad reimbursement many have currently clinical a very into space was a and as to broader the second to utility have of these these feel and screening we accounts the they and for The we

continue lower company than because profile the margin. Signature's is our margin decision volumes expense, The to of ramp and our overall third driving Signatera is the upfront growth

the However, expect lower decision Obviously, the increase ASP as COGS narrow through delta that we to we are initiatives. Signatera to is various growing still in very we as days right early in continue and oncology.

short-term revenue much data and these advantage improved leading our particularly the between peer uptake have with potential. strategies, volume each line Despite body continuing there of of margins lower trajectory grow top gross trade-off review future coverage. is cash a Signatera, now competitive top extensive We established operating generated, now to strong was these bets, to by for on the expenses. upside of a burn we've significantly we which strong and more With

cash our burn this in happening QX. see reduction with You net

upside potential future further. again, slide XXq think The Signatera pace. broad we guidance aggressive revenue into the XX% strong of guidelines, gross for trends mentioned, we've the same volumes. things volume on Our remaining next intact with just boost And roughly which the conservative is translating is there to And burn demonstrates and year. XX% been we carrier upside the could cash are goal our margin society for and panel screening at as clinical strong

seeing updates their to QX. a in don't on progress XXq. but think see Signatera think start to oncology, screening the ACMG see to a update off the moving With On ACOG which ASPs we the direct in QX our back March, sequential in described In SMART we we're for of low published compelling. are very the in in ACMG we pleased the policies, favorable We're carrier payers ACOG the mid-XXXs guidelines, change pleased detail we very guidelines of from positive guidelines, we sign. insight guideline good course, is to XXXs clinical existing soon, data into As have in process. were hopeful are to strong we

driven benefit coming incremental smaller with trend progress breast This from largely monitoring recurrence by in a was mix our Medicare coverage. and

So schedule the we ahead for on that we improvement 'XX. Signatera, continued optimistic remain of are our see trajectory, we course of and reimbursement over can

we a on guidelines give we expect a fact improvements to exome, offset year we're ASP signatory to haven't tissue full is benefit which this stronger the benefit on the benefit COGS from For gross progresses. place not that the by the margin the was in Also, much ASP to gotten NCCN realize yet clarity, dependent

our compelling Panorama new The NIPT. into gets next on slide the publications

with a supported the over all around with for reminder, States XX,XXX SMART, the XX% of than outcomes in represents differentiated performance in multicenter United includes As clinically Panorama's Panorama prospective NIPT capabilities, publications. samples the the pregnancies market study, This peer-reviewed they're by XX we where largest study. validated NIPT genetic confirmed analyzed more in

With recent publications, we the to of add evidence. body to are continuing

obstetrics result PPV rare of rare We are The information important extremely the than malignancy. cancer. Panorama third to potentially quite their high, evaluated of is sees these of clinical that receive DNA who life-saving that show but this advised very these more patients specific Panorama patients maternal could in and pattern, investigate further. that a doctors and patients and gynecology finding doctors. an type seeing so one have material The indicate a first suspected could provide published when It's XX% two result time, for

help have high likely publication for The were XXx XXX determine provide information these SMART at pregnancy This patients, panorama outcome which ultimately second manage preeclampsia in In published to about of was closely adverse risk more preterm a significantly from increased may to about Xx risk increased new Xx more to These important these likely birth. Panorama to in a able [indiscernible]. doctors have adverse to risk. subcategory that X is outcomes. pregnancies could more patients, a and patients of in publication found

another learned excellent. SMART XX,XXX we real-world the across in screening with was clinical of chromosome accepted is employees screening was and NIPT genetics setting, chromosome a in performance that over validation from sex pregnancies prospective for when by medicine. Panorama's for Finally, largest This aneuploidies publication sex

continues study insights SMART seeing, As and yield the performance NIPT to Panorama. we of critical real-world about the are new

to other market NIPTs. strong we data from As the Panorama think leadership our expands, continue differentiate

Okay.

Let me Oregon transition Health. to over

Medicare mentioned, that ahead were we of secure will to always for launched reimbursement. Many in. originally guidance can't included we you this recall come of predict our I because As transplant. will heart Prospera we when in in coverage heart pleased reimbursement hadn't Prospera in We

we're with already a So now volume running we're that start covered, to a nice ramp. off

NIH-sponsored prospective think will study, year. the from also We count DTRT which have later this data additional be published we

really we're parts. our about in good So feeling trajectory

Also pleased donor-derived extending further in ESOT. basis addition endorsements in heart, but statements the were cell-free to as These and ISHLT ASTS testing to growth today, see for serve the as are DNA of very we AST well, and markets could and recent from where underpenetrated. from endorsements the volume guidelines to society kidney medical

On kidney, policy. physicians how we've worked volumes out Medicare seen modest to in the transplant as disruption implement new

is the our the policy, confusion magnitude line from will addition patterns. disruption based slight somewhat itself offset with of shift which represents we the our resolve upside of Some heart some and and think in in coverage. by over the surrounding ordering it's a is time expectations on The

material guidance, revenue impact can you raised As our this on a our isn't overall from making trajectory. see

access. recent a enrolled Plus, help we data potential we've think Looking and could expand further got society the penetration. provide trial from access increase new fully ahead, to proactive patient that now path expand the endorsements

in with of community. look will the We impressive ATC sharing The be it in to June. donor-derived think data cell-free testing, can industry forward so first readout support that DNA at benefit it's entire we the

it turn to John? Officer, few kidney over Business disease me chronic Fesko, on in John to additional Chief give let Now oncology. a updates

Steve. Thanks,

patients been like Renasight patients every the patients with patient million could living line, think Alport As disease, diagnosed who germline the about get a one those XX diagnosed diagnosed the The have at we in In very are in DNA in who CKD. year, because polycystic U.S. opportunity conditions market is or we each reminder, genetic Renasight. also is future, testing there product CKD potentially U.S. genetic with are testing. kidney already looks have syndrome, and kidney disease chronic million a with of CKD. large over

Clinic Yale, help from in clinical We year Colombia, and centers. XX the this utility context, the than Mayo, of this the from enrollment with We started patients over To others study. X,XXX investigators leading RenaCARE Natera definitive more sponsored NYU, define genetic collaborated with Cleveland Penn, and UPMC, working study. in testing design on XXXX to last completed

designed RenaCARE could CKD population management. of incidence to study importantly, Renasight's the how in genetic findings is and The genetic the eases conditions clinical then impact

Some have asked the in RenaCARE state. success what like us looks

While waiting the about talked to I we're We testing. we instructive quarter, results, proxy found best but cancer think it's publish the an this hereditary is comparison. last

XX.X% will for variant metrics, previous cancer who germline tuned associated study discovered X,XXX as as be a study with modifications. large test patients oncology, information CKD variant in high those had general of fraction modified of hereditary time. At the Renasight, had indicating The a treatment pathogenic pathogenic same with of pathogenic fraction variant participants at these positive reached their RenaCARE more stay patients including the nearly have looking patients of cancer. resulting published over variants who had penetrance is out, well we what after treatment patients with a Of

Okay.

they the trends in actually strong volume our a year. dive larger a into covered will the pharma as on clinical pharma number of growth QX oncology tests The the budget favor need overall excess for in our by in lumpiness QX slide. call. QX. Let's volumes some of of somewhat that oncology Typically, the growth We masked the next in utilize is order top to volumes companies the and at

actually far since XXXX, up we've sequentially were of QX seen volumes QX. XX% clinical Our roughly strong just momentum continued so in and

step of More time reimbursement. of the of XXXs, ordered reimbursement. meaningful volumes a XX% by our where continuing covered mid-XXXs was core ASPs coming make from pleased low are up indications. driven in some the really indications Medicare also on the the have were QX are incremental We now to we points to mix than which We from see breast and we estimate concentrate benefit to

new are of more year, rest as drive expanded well. we covered the coverage commercial to think the indications opportunities within forward indications, improve Looking to collections there to some our and

On that we is a Shield Signatera utility plans progress for differentiator. pan-tumor highlights is of kind The in from March. think clinical and a policy the the a that our are with we are a note, for making policies offers. of that which appreciating fact coverage economic types, increasingly the The Blue our key data of first across study was coverage breadth commercial decision recent good number case of this commercial cancer California

of with California, Shield bladder from seeing for there's Louisiana look momentum to think progress. monitoring. Shield cancer also we coverage on Blue therapy coverage, to cancer, We Cross pan and colorectal Blue with cancer addition forward In Signatera members secured and of Blue for commercial we things muscle-invasive and testing diagnosed how serial IO plan

touch Right I on turn portfolio. to before to I IP over briefly our Alex, it want

assess in been only as discussed we past, a IP, has play is broad things how we've As not the have yet which portfolio litigation. of of small we deployed MRD The remainder portion in in a evolve.

turn more over Alex? review in detail. to Alex now will I our oncology that, to data With it

Thanks, John.

data provide the me cancer. detail colorectal let some map road First, in on

that pleased the section vote. XX-month that discussion merit and therefore, included we spring. updated guidelines committee prognostic predictive the is inclusion NCCN not occurred the and review predicted, As meeting the data in was in the an included having Signatera the Signatera and and this as in was This that Galaxy was prospective unavailable the see we was CIRCULATE are January Nevertheless, guidelines because not to that prior were for to the acknowledged in published real-world August NCCN paper systemic process evidence value. updated of published

to systemic we GALAXY and cover the has in of data data reviewed that on Medicine, highlighted the the peer review. plan been for Nature time evidence the CIRCULATE XXXX submit published Now

the referenced the it's that change data more and randomized is which be a the we GALAXY the surveillance The to followed later While need possible the read NCCN news out is both setting that good this and prospective biobank know data study guidelines, questions. already adjuvant committee adjuvant is address Altera that surveillance XXXX, may coming. sufficient by to expected both year, for study data adjuvant There's NCCN would this the in in in expected that study. the

and commercial will trial has BESPOKE and be later surveillance U.S. enrollment follow-up that arms in currently the and that nonrandomized settings. expect experience Furthermore, study, complete continue plus Japan including will be of GALAXY to There several the is with from anticipated for endpoints study XXXX. readouts we now this the randomized both in are the submitted field, the also enroll publication the CIRCULATE de-escalation large year, out. relevant extended trials which where adjuvant at a

believe With we these good we're goal, many position. shots in a on

noting list is worth this it's that expensive. far Additionally, from

not by out. beginning it conducted independent other include multiple to Signatera studies institutions As being does now on clinical are read that utility

ago, started this these we or forward. a working as six we competitive dating far that think trials Given going back some on years significant pipeline as advantage seven creates years,

While advancing. the has pipeline CRC data been

make continue across We progress indications. significant multiple other to

large patient think each, Here, as road cohorts clinical on support basis studies adoption you points near-term additional studies to could recently see the submissions than map. and the plasma the with Medicare. or that and more time six XXX published from We serve data for either these

The managing Data This we order who true to that Signatera GI points. CRC. highly gastroesophageal avenues oncologists risk X,XXX stratifying and study cancer where with is these and new for are more a opens planning patients real-world and for anal submit are papers relevant to XXX also pancreatic for than patients. in cancer, publication time

surgical either or faired -- can pancreatic allow the more patients extremely selection more and may Signatera be surgery medical our that suggests for data for cancer disease. that For example, of for personalized management

the need. in developing had of scale also a on the focus breast data unmet given particular cancer We've

has course, I'll or data. for our examining represents are published a significantly XXXX more on and this breast we in been Building with the following case on ASCO achieved the detail coverage BLISS very an more was cancer we which patients with use is for for cancer data of longer slide. presented submitted ISPY-X CCR, at think strong We neoadjuvant points win histology So landmark breast and major plasma to Signatera, Xx already now in in out publication. more in expanded cohort, us. up in XXXX And we neoadjuvant the recent follow-up. decision Xx next cover and a pleased This get expanded study are the time publication

systemic tell the all about and neoadjuvant XX% get Up of is First, how you treatment, The treatment are that let include neoadjuvant rendered purpose setting therapy, neoadjuvant me is therapy. any therapy can therapy which surgery. following: cancer any This patients today. or is the and treated before now it to three. trend, of immune chemotherapy, growing patients breast combination a endocrine definitive describes targeted of

is to allow downstage The the response order first recurrence; to for of therapy. to second tumor decrease is surgery; adjuvant more the and the third in guide the distant effective risk is treatment to to assess

clinical response and Namely, working that therapy toxic The adjuvant there several difficult. the of if certain NCCN chemotherapy. if themselves therapy hard in explicitly to is unmet new needs avoid the setting. adjuvant assessment know are state it's is However, the or accurate shorten to of neoadjuvant patients duration guidelines can

opportunity to fundamentally an for is Signatera here. change management there So

metastatic points were therapy and Now significant HR-positive, as to during plasma TTA predictors over HERX-negative trajectory in with as were the over or data. recurrence death analyzed. let's the time patients. status found XX In X,XXX go patients of triple-negative well neoadjuvant study, be

even at a after regimen, in is on CTA are disease which therapy, a patients of deal. improved patients detected postoperative has This setting, negative these when not time with residual survival adjuvant the Since was big being necessary. see aggressive treated have neoadjuvant can the slide, you who be may a As the surgery.

effect Additionally, in observed this cancer, triple-negative could even breast be earlier.

eligible cycles, was few of CKA avoid As may weeks their chemotherapy. potentially one a additional soon be they suggesting initiated, certain patient was neoadjuvant deescalation or and adjuvant as for therapy just of neoadjuvant their forms regimen after if after clear a two just that to

tZERO. that point. terms or therapy be favorable at powerful, chemotherapy, long-term finding The time are was were compared a a initiated, managed time This improved second very before exceptionally CTA who free intensity recurrence is relative favorable the their survival patients negative point significantly that patients Signatera-positive had outcome of new at that of surgery indicating diagnosis negativity much adjuvant is CTA This to distant that significant identify was may patients their in the in subgroup radiation of may less future and treatments. with aggressively

seeing reimbursement enables at the for neoadjuvant the an data patients. also this Signatera believe earlier We patients cancer breast and monitoring incredible Consortium the we of for relationship these point can of in and It effort which treatment entry I-SPY in neoadjuvant general accelerate right help allows adoption The data back today as you're setting after patients into seamlessly an the result way ecosystem, support diagnosis, surgery. with then for is XXXX. initiated time our of amount

As make a next Signatera are team. with now studies. integrated step, prospectively a their the coordinating I-SPY to biomarker we future in

a Finally, ASCO last a being presented studies presented being and AACR conference to more at at season this of key we've with be academic kept in schedule month, busy June. planned number

in sets importance including esophogastric Let presentations data particular a significant have for as few five new of be going me AACR, that well At forward. program highlight our may poster we data utility significant data will adjuvant spanning across At XX leadings. cancer, the two and Signatera be of highlighting as neoadjuvant at muscle-invasive bladder ASCO, in and presentations. poster oral the least new there

a of want these to few just I studies. highlight

discussion in conducted the program poster Anderson. clinical INTERCEPT CRC. the reports the of of on The surveillance a setting first This MD being by Signatera poster being utility

cell of predictive dynamics Additionally, the nature receiving lung study with sponsored cell we XX% demonstrate upwards We use of readout by Empower regimen. containing we patients. which the non-small cancer, the patients being think in from immune to cancer cancer X CTA lung largest non-small the remains Regeneron receiving that IO therapy. for cell non-small will know of market in lung an immune therapy look forward

recurrence CTA including risk dynamics also Japan, benefit predicting be adjuvant of in and therapy role data a will on of focus an the updated from present. Lastly, CIRCULATE

update on ECD to brief Finally, I provide want our program. a

detection for colorectal We and continue make to blood-only first cancer cancer developing progress early multi-cancer. for good in assay, later

that should provide to investment inflection out updates year a We this if said prudent as when completing into before, in significant are spending by read thereafter. the a case-control with a is presentation to remain we've end program, and the will committed We of follow warranted. we study

With financial that, let to review hand me the Mike call to the Mike? results. over

brought are This we expected last the versus Average in across and those Alex. of encouraging year. ramp, Even per get Thanks, in modestly volume QX next expect cost up initiatives the Steve business last quarterly at covered of volume revenue line slide quarter progress underway, financials some and summary with later the to exome The been growth a to margins. cost is particularly up our unit just continues the volume future average as this significate in those prices trends year. was growth, growth cost and business, from was I of more be continued of the share to Signatera of which additional to the the making given selling to Signatera. see that COGS speaks gross tracking with versus short-term set our in savings we the in-house. we've sold the taking picked with three some initiatives pleased goods market revenue volume year

year past, growth half we of last QX usually strongest screening in case is and I excellent emphasize and the health made down volume I our was second something earlier wanted in been have has really trend big and to a year. the this returned these be had QX health position on to in would with quarter, the for think then still sequential California When respect XXXX the year. gains an was great call the that that amplified overall. Steve we November December really to flat volume off taken to business. quarters sequentially NIPT carrier and in year, the women's first point with If in seasonality in this

in secular in phase be as about Of ramp growth course, continue Signatera a in we appears as call. we earlier volume significant to talked a growth, the

are make out that here strategy, base and of noticeable then I'd steady and a between spent the we to laying scale expense We've that this a revenue We've done few expense gap before growth that women's just point organ channels after prior that building win on channels. pleased scale. growth. are oncology calls to of while we business, when lot Last commercial the really be health is really now hold best-in-class years once can showing achieving continue again a and revenues build health and time and was volumes Natera the

other factors. swings million will in working the CapEx you think, and QX in is capital, slide, than in to gives more I we of year. some year, a little about to burned that that this and leverage next $XX QX starting down The of We've $XXX have in sense I operating caution a business. you are cash last see the the will million burn

may simple, just after investments. and linear to cash equivalents this have cash cash keep we burn quarter change a is in just and not quarter. short-term things And So downward just metric on progression burn the

of impact investment and gains unrealized portfolio. our includes it modest from some losses So

nuances very is growth The revenue on my the clear is to us revenue or Advantage trajectory on Medicare overall flat from collection operating despite continue down view. second key The robust the we quite driving in growth. quarter once trend also my expenses. strong for with further see low experience consecutive perspective pleased DSOs operations and I cash a to focus. revenue cycle shorten our cycle Signatera function getting That's reimbursement. Medicare plans of as the We to hope of gain growth return some again was

win. traction by reimbursement broader for gross driven opportunity Another upside is margin

performance fact the operating the some about Even clinical year, we stated cash the talked progress screening improved I we to our next Steve and previously are see Signatera without for think think breakeven we based hit some . ASP. showing carrier on rest now, QX movement flow significant benefit very given from and target encouraging the and track this which scale could year. volume we of our would wins significant on outlook to be that year on we continue our the yet practice XXq in are are guidelines, that on

Okay.

slide, on about revised in Steve be that while versus that we know of So ago. the that are the to with you we revenues prefer Those outlook. months followed we let's guidance the have these up two mentioned our company razors for provided earlier talk a next year. the cautious expectations moving for

as going driven mentioned, we're up helped I especially. strong the account seasonality to sets months, for monitor QX, us summer by of win think wins, impact has a I the -- in the year but performance in great

in steady year, guide That for transplant plenty erosion over these appropriate Signatera ASPs improvements of assumptions assumes ASPs for be and conservative of forecast modest from in kidney leaves in the and to that's reimbursement. the screening course now. the clinical NIPT, but The scope the carrier for here the some ASPs we continued think

change. We are the leading and element the rest of guide

we cash of for gross burn and year plan expected range full XX% us year come remains for. want there that outperform, in comfortable revenue our XX% are to On certainly will is the similar to trajectory getting margins, The on the to of on see to scope bring progress this concept track, this in and a more ASP expense on year. into really the think cost We couple initiatives savings a is we operating guided guidance. and the aggressive before

to strong a year Operator? we look start taking think this your forward are questions. So we in and off to summary,

the comes line first Savant. Your Instructions] Tejas of [Operator question from

Signatera I'll commentary guideline start Maybe X the decision here, with on Steve.

some Can for swing about talked fully inclusion importantly, on And time viewing estimates? degree as of sort data. to the sort of committee not considering more that? the confidence lines Signatera your you you're that share sort in the what around guideline which drives You of color factor your medium-term just the CIRCULATE a CRC

Yes. Thanks, Tejas.

first, to So cash guidance. deadline for our CRC. that in really includes breakeven in we're to flow nothing get our NCCN We're an path going

on lot without got in. momentum on So we're I ASP both having trucking of mean, and We've ahead. a upside that volume

of here Now said, a the up we in with ourselves really, Alex data that very I of that with outlined. position set course, nice all think,

randomized I trial, trials a have going the be we of then put very, reading position. very end going out of us strong that that we realize didn't in in probably Altera And to are people of reading this is XXXX. that be lot a towards the certainly, year. mean, think which out to think sort will I

far CIRCULATE vote the as XXXX of study GALAXY discussion months it concerned, included which at considered section, not in we've the As occurred. is the time vote but that confirmed the written after was the several was the study, was

be published think, the of realized study August we XXXX that's that in saying, with think I now been timing. going calls as we sort last So in . with line we've the before to to expected that's I X what meeting, respect GALAXY wasn't what the earnings

out randomized meeting here? data going do and that's exactly of out there, trials. We backstopped there's from considered. published good forward the another coming is know going the happen to all what's We happens meaning of be what formally it's we've certainly, Now suite decisions in new GALAXY now say can't with August. But and that future can

Your line next Puneet from the comes of question Souda.

one ASP is the little some well you this. first on side a health Signatera. ASP on of talk about both Mike, Mike bit and maybe as could of as the can address business So women's

here impact the were terms trend what lines on Sort some of are carrier improvements? of testing. seeing sort of We in

And talk we So ASP how think maybe the just overall? should about that. about

question. the for Thanks Yes.

early So that so being the we of ahead the quite about that on for product schedule a Signatera a that product. simply to We've Signatera, function price what the of pretty are points past days the talked the it's first relative being ASP and put for and -- launch of immature in always components in clinical the drivers ASPs. lot we're on ASP

set Steve for think expectation prepared we We this would exit that had will as of I Signatera I front the in his QX, kind the XXXs actually be ASP year an us. mentioned in in with we there clinical of previously, got So remarks. in or think

not mind So see retrench. really why a it's we from here, in not reason that our would

that kind improvement contemplates And can have for call these colorectal the previously. the from about here. guide principally traction increased speechead, volume that in the initial of on and time our Medicare we patients, think point. this And reimbursed all concentration reimbursed keep we from increasing particularly traction business of we've cancer. volumes we types that between a tumor recurring but modest I mix reasons it's coming talked hope of and Medicare in billing

types a to new name some reimbursed to commercial kind Just tumor coverage. addition getting in the few, now of and

good drivers lots of So there.

On the in them women health were ASPs strong. grew think side, ex quarter. California, and sequentially I -- They were the we

California, rationale in the remarks -- this penalty was we We take prepared for business. and state to on feel that. So we stay both knew talked in like because a clinically blended that there, the there, would long-term the encouraged stay by about take being but in we order wanted Steve we I to would for ASP and

be on that way this talked Steve mentioned, the fact screen we've cautiously about as of far. so And that care we're the that to The erosion contemplates trended on goes little the to a have bit kind guide reimbursement. front. actually leaned just the has off previously into we're seeing that back more that taken And care headwind

exited we've opted guidelines year. that to have there And quite clinical strong competitors share improve the the it's profile few the that see take because a the here the As in business. to think that's us for are something we we'd market, actually actually progress table like calendar and utility in on reimbursement and to

as this [indiscernible] I I'm So business those the lot, are into in 'XX. look ASP 'XX out of Overall, kind that's about know main trajectory a Natera. in drivers but the encouraged of you

very keeping margin, is year sort even XX%, our for of the in too, with that volume I'll margins strong. we of off add best we're which some still the the of temporary just intact for guidance initiatives taken we for XX% we've to think traded where

looking So very things are actually positive.

from question Catherine Schulte. next Our comes

actually payers made hear This on genetic in remainder additional we've States Good you additional commercial past? testing legislation And is progress year? on Peterson with any Catherine. about where what for front. the of have contemplating Tom in to for guess seen I you progress the progress are Signatera the

Yes.

peer-reviewed more of one with -- we think strong expansion where I long showed Alex have see coverage can you I It going is And having come some really leadership but from have So data. all we into we there's think to commercial commercial an papers. extensive over slides colorectal, for just for with very XX of definitely that in that a program than And not now that's MolDX Medicare. to the way time. peer-reviewed and -- a starts position, Signatera the payers big in still think, it's go with opportunity with

do be of new submissions we've we're that strength we eight to seven on I this year or based out. said might think MolDX data able the the putting

certainly, well commercial that's side. on expansion as seeing as an So opportunity the what we're

supporting great of side, that commercial place. we traction the states now legislation seen some we're the everyone. in put for and I access think seeing seeing this it's legislation sort this We've several more are expanded On bipartisan of

kind the stages. back filing the of the and appeals very early think I of at end paid is getting still us

legislation it's hard at But is impact point on commercial the in continues. news, So to really this the to plans. the be the comment overall what going good

we're seeing progress. I think

determined there'll be coverage positive have well. little is as it their see of led number plans own sense that makes a solution. increased Blue that which analysis done that to the Shield of states and add for great, think economic adopting and then Signatera, an again, we seeing We're I more bit And like

line Our of next from comes question Qin. Julia the

the breast, got And about you from for meaningful Marta to we for of the year? you impact of Signatera volume ask, not, do terms be is think expect that uptick have testing Julia. extension? This to the in? when CMS if on coverage for recently And you I how seen it in rest should in any just wanted

Yes, a great question. that's

the because opportunity. breast breast look of at very we've a first is of kind actually the that been big available. When seeing number an of just are while business So there's proportion increase you in patients the at for a

there's clinical utility. Second, high very we think

data patients those And that data, set, we with and initially time points. now setting those of both all followed we and include breast data smaller X,XXX and in those monitoring performance incredible now well of a third have neoadjuvant we've very, both settings, or very is the adjuvant data publications roughly setting in than recurrence performance strong in more initial have sets published in extensive XXX up settings and

So this to combined strong are number with data, of increase the operational coverage, execution tests the very combined in. in coming an is leading that with the

sign. that's think very a good I

from line the Dan of Our next question Brennan. comes

Great. Maybe two parter.

also Signatera in prospective I-SPY data, studies. there but make coordinating like with your Just generate sounded kind cited future on the the biomarker the of could you neoadjuvant opportunity, it you reimbursement, know commented I to team

neoadjuvant us the So impact women's happens? through, assuming on for like the just side, just but think when And for screening, a in know XXq be? not just kind how that and in what impact then in to I can they're in plans give you the kind of timing you we potential sense carrier us finally of come of about coverage were -- just the can if secondly, what remind they are guidance, do and terms of on data could

Yes.

in we with utility data points. and we X,XXX neoadjuvant plasmic a high that publication of settings where the study I think on the I-SPY now clinical patients have So has with setting, new very is one strong the think it definitely very time XXX

cell-free breast of donor-derived the read patients. one it for opportunities future. for at to we near studies biggest to submitting When is MolDx out in we this to do as look, think So and opportunity this comes plan expand sort in health, this an the on to ever coverage the of women's I that's look DNA, access very more

in predicted pregnancies. very showed and high sort example, the SMART you And of that for range, that we any sensitivity, shows could could Like, which roughly value, high for disorder incredible utility very affects we to with test one that was X,XXX really high data a tests. positive specificity for this XX% the XXq, of exceptionally clinical in time generated generate study for that type we we've

it any that guideline that not the time to that's And access of type test the look going that type think helps to and patients for access. . otherwise generating may is have So I thing we great you're those patients bring committees expands it are think data because of at.

line from the Alex comes Nowak. question next of Our

expand could you coverage headwinds the a more the facing hoping on you're MolDx was I Great. right. kidney bit All change.

said The tracking to are headwind You working physicians through it. is expectations. your

And how testing on of been then, just have guidance on field? would expand viability long the impacting to just is term how headwind? in testing your the change guess does the transplant market? just I the that So reimbursement change this What without the outlook

So I a Do do? just I misinformation any all. to change with coming it out It Medicare? And of causes there. they need a think physicians sort or should to from actually what clarification there's respect what swirl confusion there's of think anytime of at change means, some sort make

reimbursed Of various we're the working we're through just think have things And in for think biggest of thing at us misinterpreted as the of RNA been that causes can't some good is, places. I seeing one on the volume the that DNA time was that I same guess, same patient. you maybe get changes for that kind was I And cell-free testing course, and that disruption. announced

that And has strategy. that's biggest think that never probably of And I Natera's change was part the occurred.

by we all. weren't that at so impacted And

accounts to kind really stopped So just temporarily sort or of XX% sort kind push impacted maybe of by range I don't the of of they through say slight have we're of just while things. work of ordering this I'd where pause know XX% in volume sort disruption,

mid-single business. digits Now to sort when of for overall the of us, book cell-free from I kidney of kind revenue it the business, donor-derived is DNA testing, think comes

very have things. not is you're that's helping completely we offset in offset that revenue do I but Prospera disruption to think overall seeing new now by raised ways, heart a our in heart that revenue. fraction we tiny coming that it's in is So our of that offset, nice many the now ramp seeing reimbursed a of And But we're from that guidance. course,

of the growing is So sort company kidney XX% overall, see claims. even in the nicely broader did to we XX% pullback the though

Great.

Sorry, there's there. a part second

a we we that health organ opportunities have we think different of positive. think lot business. I about are what very do overall think the Look,

I out is think trial June. in the proactive reading

think I going DNA, overall. going be that support to that's there. the There's great be information some industry. entire cell-free to good donor-derived for

four last strong I think guidelines like in out now seen six that all the guidelines have society we've before. these really come that exist new months, didn't

kidney in maybe that in couple sort of calls, commercial creates the opportunity great study chronic into that's really could We patients and volume, clinical a are RenaCARE change readout get that we've to have the talking last coverage an then, think about how looking expand I think this treated, forward I potentially utility, the potentially opportunity to think, the course, to reassessed future. Renasight. of more And of and very of coverage high we're we And of been disease think and later summer.

comes the Westenberg. Our next question from David of line

any Can California for have Hi is for Dave. on the expanded comment and NIPT on Johan[ph] carrier screening been you gross if accounting what give this the margin might headwinds? the

Mike, that? do you take want to

sure. Yes

yes, that think marketplace in of because leaders I just two -- market two we those is events the I So a hard going a would disruption little those, but think without some gross margins the also is to bit it's caused out kind share. think to take at I temporary, as into one are those things have leaning of have separate been least higher and

well, a you gotten have it's take mean margin? gross there's then to of yes, account say, and would So some the around for hard there. wins I and to the credit penalty turn be

and going year. we we're can as that think were year so longer-term And a they to you for return going to benefit in that next now have as early this see into

the those we of and good about include without the play. I So onwards with I'll mean really to kind think impair kind I third continues of growth. press feel just maybe that

been us. have you've last that the year gross range from so the margins seen in in kind I would of think

intentional part, and the think So it's it's move we long on quite business. of our very term for the constructive

of next the comes Our from question Garcia. line Liza

So another volume Signatera. for on congratulations great print

It volumes another that, obviously But exome I guys really, indications, doing kind been of plans Signatera you. new ad for you think, So have testing. of well. question with more kind which drive really to

and on how the still to kind be from of kind the you're really can benefit, there kind in And getting about of of really your to shift so doing that qualitatively how kind the exome and XXXX if think side, you not bit. of margins that into to right, you margin how side? see alluded great, just how of the in obviously, about And little think kind would exon to heading XXXX on kind that testing oncology you're of a

Yes.

comment first then Yes. So can in. I'll you jump maybe, Mike, and

on protocol And of the kind more midstream the we've and to So get underway reduce And expensive exome to deliver for the patient we of new side, had still on we're an physicians. exome that's time that same for the we've Signatera, the COGS does of that. very any run information projects high-quality increased COGS. lead parts one but various a

some of beyond there 'XX is time I in be we think sort still going most as be of there the the expand there's opportunity to to going executed frame, but that. work

applied are Panorama X on to per sample Panorama the of I that a insight more I tabs look, And time, whole, on underway. have some moving on million I'll same a one is just growing NovaSeq, basis. have the as give focus COGS now across is as than on the very also run. a that right? decent volume project COGS mean, obviously quickly. you So you're But NextSeq these. tests to you projects we scaling the be amount is amount an from extensive to saves that simple going up, sort being the And That's at are the focusing some reduction company a while as basic Across that of reduction. mean,

sort costs base as do per NIPT samples. large obviously, sample of very get we applied savings because the sequencing that's So across we of

types there's of So projects all like that.

they or kind those part amount studies in an big getting X which those, annualized research, of of all the development LIMS business doing extreme million basis. in We validation COGS just to million require of within require of cash kind on standard work really the executing $X things and of verification of of the breakeven. are road flow new to of system, to launching, integrating then sort like are our the that really projects an X have each savings pretty $XX of the sort none range And

side, then the hitting XX% how getting sort by to end margin projects COGS for seeing that's are are some of us And on the or of out can we're we big kind and don't hitting as guidance the XX% for just colorectal And XXq see really from really a and ACOG some of it's the into order the ASP. year, that range card ASP of shrink. like getting or on projects that this you year. of these that reminder, both of to milestones Again, year of are the drastic a this there expanded hit guidelines any in NCCN of getting carrier need sort improvements

all time for to your have thank you. and And a would today is that their we of everyone We the pleasant for have day. questions. time like Thank rest