Natera (NTRA) 28 Feb 222022 Q4 Earnings call transcript

Welcome to Natera's 2022 Fourth Quarter Financial Results Conference Call. [Operator Instructions]

[Technical Difficulty]

Chief Financial Officer. Please go ahead.

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

Chief Oncology; On the Solomon John of CEO; Chapman, Steve Fesko, and line, I'm Moshkevich, joined General by Business Officer. our Manager

conference webcast. live is broadcast Today's call via being

referring at slide presentation be investor.natera.com. to been that will call a of replay A this to also will has posted We investor.natera.com. be available

Slide X. on Starting

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

XX-Q such refer best known or differ XX-K We reflect contained SEC, or risks that and and suggested Please cause materially. to the caution documents factors time including time Form with our and results the to based currently results that us, with statements you actual events today's we X-K or file those to press identify release. on differ other factors from recent most may actual forward-looking statements. our important materially filed from Those to documents that the our the by could in judgment

or call the as not being during today, accurate current replayed presented If are Forward-looking XX, call reviewed call made of or information statements during information. may today, made the the contain is this February after XXXX.

or revise to obligation forward-looking any any update statements. disclaims Natera

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

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

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

both of XX% year-on-year XXXX, $XX the execution of year XX% up milestones. XXXX had $XXX.X X.X is for were Mike. million achieving key Revenues We QIAGEN processed great in revenue. XXXX We than growth when and commercial XX%. terms guidance, initial excluding and year, higher our which from up Thanks, midpoint the in the a full onetime million of tests, million

growth Business strong continue a This and tests off XXX,XXX bigger XXX% continued growth strong with growth in revenue in sequential of comparison or QX a We QX an increase growth QX XX,XXX of XX,XXX momentum of demonstrates XX% with difficult volume representing and product XXXX. performed of of even in a XXXX. of very with year-over-year performed base after XXXX, growth year-over-year, versus XX% QX. oncology tests units XX%

more several even XX% ordering our JPMorgan of at We milestones estimate earlier the conference than that presentation oncologists key We've the States United now Signatera. year. achieved are in this since

strong, First, predictive sense we Nature in was the Consistent other CIRCULATE in showed that January were of data very out some excitement on post-surgery. of prognostic types, of you published our and pleased to colorectal both study cover which field. publications the gives cancer in the see months and generating our Medicine, prospective is value the tumor XX with Signatera data earlier multisite

these into topics in the later deeper dive will call. Solomon

already all met received account higher IIb or IIb coverage adjuvant monitoring a confirmation Stage that breast cancer in We Stage patients MolDx of Signatera Signatera represent portion higher could million roughly per X we year, that from recurrence and subtypes. in with for volume. had growing population Second, across patients our requirements and breast estimate tests for cancer

designed in utility further to coverage, and pipeline In got addition to coverage Signatera's expand the a current cancer. data we've breast highlight of

we this each plasma year, expect studies with samples. publish approximately cancer X,XXX breast fact, to In large-scale X

Genetics issue for to results the XXq XXq and they guideline referenced Medical encouraged very study. were all include individuals In offered the later findings achieved recommendation we hope that a women's digest we ACMG's in health, updated College syndrome. pregnant screening societies see performance year guidance deletion of to SMART and American the be of by to study, incorporate this that as strong other see medical the action

strong expanded We to another Counselors guideline adoption see offered were also pleased National a screening Genetic recently Society for as the carrier of very endorsement.

this We later detail will get more in call. in the into

of Oregon donor-derived Class Society Level and Lung with new a the recognizing Transplantation for International Heart the X cell-free B In Health, recommendation. issued guidelines DNA value

to for Medicare Prospera coverage continue towards work We our heart test.

study, publication RenaCARE which In the of evaluated our heart, chronic addition perspective await disease in we Renasight real-world kidney patients. to eagerly

first study that expect We year. half to the this publish of in

guidance. to XXXX Moving

We guidance to $X a in billion. $XXX range are million our setting of initial XXXX revenue

We top from momentum line as expenses expect continued we burn. this reduce to our even and dramatically level XXXX reduce generate operating cash

are to that cash XXXX, I'm million flow reiterating a cash to a path to of guiding in burn $XXX really XXXX. will be breakeven pleased we compared to inform everyone our quarter we roughly hitting and reduction

we budget. include study, in expense PMA doesn't As cancer level which estimate $XX we the previously, would about million $X required. if our This for detection we've of years, million cost mentioned annual early prospective over in X of be included new about all a

further wouldn't feedback the results FDA hand, awaiting we Once and proof-of-concept we the the As in necessary our investment. study. pull proof-of-concept without it's results said trial. having from of can the favorable we the goes we of whether saying on very and It decide trigger we're feedback on results [indiscernible] a from the then have before, do level study without that to stepped-up

Permanente our states, a of health decades of is with executive serves health X systems at leadership in Ruth announce Ruth Kaiser large care to seasoned Mid-Atlantic currently industry her career. are she She experience. She as earlier Health roles also President Board of we operations. Finally, pleased Williams-Brinkley to oversees appointment of the regional held very Directors. of Plan the where

her. to with thrilled Ruth we working We to look welcome are the and Board, to forward

Great. Okay.

on very strong This more a for over growth. year. XX% slide. growth the continued businesses, strong processed tests, across think we traction details positioned are XXXX into I get we well a the X.X represents XXXX, increase In and million next Let's approximately

off I'm that estimate getting eligible talking of about are patients NIPT. States going start health. in Today, the women's we roughly an the half United to

While market market to to grow, that underlying we've share. continued consolidate continues

adoption and discussed, see areas. also And patients. screening help expanded to additional both guideline access more we've for are are in carrier further XXq pleased As to opportunities and expand recent traction we

some it John, of over Chief to Let these to latest me John? the Business turn topics. Officer, on updates discuss our

specifically of screening and method year Obstetrics prenatal deletion The which XXq Gynecology. last profiled published our screening December, XX,XXX-patient the Natera College Thanks, offering Steve. noninvasive SMART Medical of and that syndrome In referenced in recommended SNP-based Genetics the developed American Journal a of all the patients. guideline guideline American practice in published study, to

such XXq recommended other XX, microdeletion common screening deletion for in routine most muscular genetic about affecting cystic trisomy and humans, live common XX, is the than syndrome X trisomy conditions in fibrosis syndrome It's more births. as XX atrophy. spinal

syndrome specialties of diagnose a heart median is Patients immunodeficiencies, deletion with of neurological average different issues, X.X XXq clinical palate prior cause challenging and be seeing issues. endocrine congenital age on a defects, years diagnosis after born very at to dysfunction leading molecular deletion XXq diagnosis. syndrome to X may with

a In XXq a ACMG's X.XX% XX%. damage resulting and of can offered about very prevent sensitivity study, by from positive seizures of hypocalcemia. created recommendation that Treatment the with false We're dilution rate, be predictive birth SMART by caused high in screening. all in value brain momentum the SMART our and we calcium positive publication excited XX% new saw patients

we will region can These be fetal deletion targeted XXq that for cost PPV. simply Because massively deeper sequence a signature screening we at contribute maternal believe XXq differentiate a much doing Natera. labs from parallel runs Natera We SNPs significant the versus and specificity of high DNA, across to sensitivity, and can our sequencing. differences differentiator level effectively sequencing

deletions XXq labs not way. because major today, our only is XXq SMART is of below megabases. Natera were This a Additionally, in X.X XX% limitation most megabases. in limited above X.X this touched results high-risk study for

data. a a study multisite genetic screening created is who's the our with XXq prospective competitive the significant of lab published confirmation we've our subjects. knowledge, of Finally, lead only Natera majority published in To with

likely complete recommending will differences be which our data other and given for To in X cases a took The physicians, performance will again. done SMART ongoing, be years long there important all trials persist prospective will women. no study especially significant to lead offered are to never guideline knowledge, these pregnant and no time. to published is XXq think We be there

been have may XXq payers going to see coverage performance believe place differentiators plans These health will [expense]. be into those forward. tests start believe XXq more to possible will their to as We happen. important only we its also place It's as we coverage for value that come will that limit on physicians validated

guidelines patients. this Beyond follows month, recommendation carrier offered seeing available carrier change be screening recommend screening of Counselors all reproduction. for guidelines a being from a considering expanded Earlier the should Society that made all National NIPT, in individuals practice ACMG This expanded to expanded a Genetic carrier XXXX to also we're screening. published to pregnant

seeing medical policy changes We're at guideline changes these also lead health to plans.

commercial carrier screening. policy done progress we large In now with that important. seeing of but a fact, that be covered here, that expanded one just work covers lives fact XX% There the still month, the benefit new of this supports manager use to are is is

Steve to to I'll discuss organ Okay. health. back turn Steve? it

Great. Thanks, John.

are going well. health Our initiatives organ in

benefit were received The prospective out continue fall. been to appear the multisite kidney community. publication well last from of the transplant, that Trifecta result excellent and study We which large-scale have to of the came by in trial

we sites of greater of DTRT In with to most XXX biopsy years. soon. this excited trials one we believe published match tested readout the date for from DTRT, transplant XXX heart results than significant academic clinical in In samples the forward X investigators and plasma field, the across to heart look led We of greater and top are recipients being transplant, follow-up is independent the than academically study. the samples X.X to up

just heart the include guidelines Renasight donor-derived main call. at testing in momentum mentioned heart updated is to transplant I recipients. in body, for cell-free top ISHLT, DNA Our also because its the of the timely governing surveillance

they a cause kidney diagnosed genetic patients Renasight of test that their previously genetic with is a chronic whether The disease. have for determine As have may been reminder, can disease. kidney our chronic test

XX can this disease. testing. million million We chronic living being of of care having we think year think be and about of patients for more with and per with genetic kidney diagnosed the CKD the than improved areas that testing, With than United more in health one the X population there eligible is XX% States are patients newly largest

than more Columbia, design to in the Clinic, others, patients X NYU, over definitive with Clinic Mayo in leading among August, study. having RenaCARE years world's enrolled Cleveland completed UPenn, Yale, UPMC, from RenaCARE worked X,XXX enrollment the ago, investigators we We from centers. XX and

study management designed assess genetic is may Renasight's to the impact findings care. how The patient clinical of

As it's put the important readout, results context. to in them

is a a high pathogenic XX.X% I published think patients Oncology, hereditary patients In of nearly resulting cancer patients had modifications. of indicating variant cancer an with study large X,XXX XX.X% comparison. hereditary those And a in treatment cancer. of instructive JAMA variant, had germline

looking panel. with fraction their CKD As participants in We of RenaCARE will guideline with pathogenic we patients the discovered modified after study out, what positive pathogenic was study the RenaCARE future. the be have and the variant position metrics, for what Renasight fraction the the associated inclusion at a of us treatment read think was the same could variant

our distribution tuned a through This updates point. and have a on already large is important channel opportunity. in more nephrology this Stay place very opportunity, for existing we call

now that, I to to over more results our turn review detail. With will in Solomon it oncology

Solomon?

today data made volume colorectal In stories adoption since volume and we in Thanks, months, coverage Steve. progress big cancer. few publication growth, great our are in observed XXXX. excellent oncology. breast past launch in and the We've Medicare growth The

deliver communicated follow-on and to providers. XXX,XXX. expectations patients new had new growth can tests At XXXX. units in with than ordering existing patients XXX,XXX see, more end as we QX, we've is by for exceeded This And the of you our by by expectation driven

with back the the now at that ordering in test negative get is is Signatera of Steve testing becoming early an standard more positive. this When XX% United shows chance part the is gain combined patients than are of strong when helping Signatera. or States, the think many reassurance intervention to care volume mentioned in when rapidly growth, of their I oncologists U.S. that

XX% volume that In XX%. to of immunotherapy of about to volume from And and it colorectal, that think about the is is list XX% mix, monitoring. to terms adding way bladder roughly breast now cancer makes the

as need, well. our and we and today progress unmet core magnitude by the commercial clinical with Medicare, but of As also and to and gotten of a commercial reminder, point We've reimbursement largely our medical because are status driven strong types. the and is build technology based test across utility plans the team reimbursement making lab diagnostic of we've industry-leading on to scale an validity been clinical lab disease because momentum and advanced able with this evidence

clinical have believe to regular benefits Since it think bring the practice, test. We has into a switch more industry. in MRD providers important a MRD Natera competitive unlikely advantage the blood unique ongoing lab of MRD which existing challenging our ordering doing creates Signatera cohort another field. from That a who with existing are patient ripple to a with draws, first-mover usually advantage makes patients the an it in lab monitoring unseen physician's is Signatera personalized another effect. assay an to will We

working in XX publications have X dozen in Signatera across than significant competitive is more advantage we generation, We XXXX. types. cancer where peer-reviewed now Another started back data roughly

able across excellent fact the pan adoption generate that think I and for types we've us Signatera. in tumor to the cancer gives confidence been reimbursement consistently results eventual

now of of Medicine, our a of journal patients. XX study X,XXX XX.X% publication turn clinical with CIRCULATE we across rate the to Stage study colorectal featuring The colorectal announced strong II over detection and in progress cancer. follow-up months demonstrated our in for patients. III In the presurgical Let's performance Signatera mid-January, Nature in

this whereas or significant benefits the implications not Signatera may whom get negative not. positive benefited did In CRC has in treated addition, do significantly adjuvant we from We showed patients need think who patients, the of of chemotherapy, CRC, for many patients Signatera strong where they chemotherapy today predictive be Signatera others unnecessarily.

sensitivity the the physicians nature receiving of the The the prospective results key beyond specificity cancer. outcomes. bar study and the predictive field, and for the the in Signatera evidence with evidence utility raises takes distinction here real which and of into improved is element, in also time strengthens patients colorectal whole and it This

NCCN We it as expect the next the in adoption Committee. well will Guidelines us help physician reach that influencing level as

still We from XXXX. been not near yet anticipating since in the annual of the committee guideline August are an in it published meeting updated future has NCCN

if in our it this the have timing will this we the by next publication Given In we round. of expect the would committee know evidence be case, NCCN been January, in do not considered the round. incorporated that

evidence Altera for future minute, cancer trial and expected CIRCULATE the Also, readouts creates with a from back for including adoption is the ongoing step map VEGA. road arms, X the our to To in new randomized strengthen further, Signatera indications. colorectal a journey replicable in

consortia the that drive with evidence with in then change initial monitoring coverage repeat First, or prospective cancer. and the academic guidelines. that plan cohort We Medicare partnered biobank adoption confirmed either immunotherapy aim and validity enabled cancer, that definitive an pharma trials, to to more bladder breast and clinical journey

for cancer monitoring coverage patients for cover breast approved all was adjuvant at model recurrence the Signatera Signatera of advanced across to types. in and disease is MolDx both decision The in this latest work. example cancer breast

suffering the coverage from U.S., Given critical we as Medicare the cancer people of in breast milestone. number a view

breast are Looking newly XX% with at to XXX,XXX with approximately higher. XX% resectable approximately there the of Stage cancer these IIb every patients addressable and patients market, diagnosed year

future the For to we X population, an and opportunities addressable our disease. setting and expand market coverage of potential neoadjuvant million into we tests, estimate stages see in earlier this approximately of patient the

strong monitor already difficult that of patients clinical and their cancer decisions and demand mentioned our physicians disease. from sign Steve existing a to of an XX%, inform Signatera early This treatment better approximately patients. is from volumes, chunk meaningful coming breast are the

was organized including cancer is one see America. we that breast from of come feet. our community making Morning this patients strongest on indication self-empowered, with patients Good voting The highly with and breast Many featured cancer, testimonials an where their

to XXXX, reimbursed rapidly growing expand we data our to expands it breast pipeline. translating coverage CRC and cancer well effort our forward tests deliver focusing decision This publishing and team cancer addressable looking per be breast and expanded monitoring, our as more our coverage market evidence into as on million We're immunotherapy year. In from in X.X adoption. growth clinical bladder will approximately and commercial in and new we cancer as

slide remains this strong pipeline some with key data clinical highlights. showing Our

During cancers, and QX, key gastroesophageal we continued study. in with peer-reviewed our publications publication anal with the progress our CIRCULATE along of

III come. to the good of in cancer. with a publication. our had set studies At neoadjuvant cancers, data colon, CDX remain conferences, the new also focused partnerships We on we side here anal data accepted that right melanoma and in medical our time, shown more Phase for page was colorectal, and at breast key the we And and presented bladder in esophagogastric, on same breast

Now Mike? Mike over to I'd to to like cover hand it the financials.

summarizes position The growth, the growth performance we in given rates, in Solomon. leadership driving Thanks, just several covered care. underpenetrated feel our like to and Steve financials. and slide we areas our and Great. next are of large revenue XXXX and position great continue a

the a comparison just XXXX you'll $XX QIAGEN a XXXX margins, That from with wind down Steve QIAGEN close elevated to. in of onetime note of on the our gross million the affects and recognition little against skewed were revenue alluded that comparison in had true-ups. us recall which would revenue the growth we other is to I also little versus that because XXXX, partnership

Operating balance in year, our Signatera pressure clinical headwinds the line this growth how expenses original to volumes our in with from germline with guide landed P&S program sought and described ending cash expectations. we as reimbursement. we've last in temporarily course, and our would is of margins line And ASPs, California in expand time

Okay.

the get into Let's guide.

revenue in all deliver of areas advancing for caution million As prices. strong to volume guiding selling average focus require Steve to This some include our to us on mentioned, XXXX. across but continue billion are will growth $X we $XXX

described in we As Signatera through volumes. feel make past, guide. the the clinical progress And evolution and our on mix of volume meaningful ASPs women's progress modest on in just we've the fronts health for like in can these included execution we natural we've

benefit And details cancer experience expect very gain I the including to we We breast reimbursement. breast more decision. are recent the also once the coverage we of be from a more cancer coverage impact on modest with will able give

ACCN cancer. guidelines health included to our our these addition or with have profile don't X expanded changes we outcome just timing. from typical in efforts, approach, in can haven't guidelines we colorectal any impact potential In reimbursement change we screening and major really our the XXq and because guideline those carrier that Consistent forecast control the with women's the in

are and We reimbursement cautious guide taking this limited a presumes on similarly hitting gross projects essentially line This our COGS on progress margins. year.

longer execution beyond the inclusion clear as in study gross past. reimbursement term, us we guideline just give mid-XXs described would the sight Over margin the of and and to continued line in have

more bit this cash and On want Okay. a guidance. to I on OpEx time slide, the spend burn

decline versus You'll we note $XX to see XXXX. growth, expect million roughly despite operating continued this guiding that to by year expenses to

could In performance COGS investing in leadership cash continuing areas without we've this large scale substantial business while described, we've each now health to improving product increase executed by years projects to when focus pledged future we platform strong growth middle in flow positions with our a Many in breakeven of to instance, our drive playbook building reduction built a increases. executing get can Steve of commercial will that that large of before you volume clinical channel, user As that that of spent we once trials, experience women's and operating large running recall the have expenses. XXXX.

trials our the stable We big health-related as then held women's expenses concluded.

year, to leverage. focus. We've the our we operating start continue guideline. in this leadership XXXX newer demonstrate same of can strong in, our now we volumes established And to areas the While pour met positions

million we As burned We've by and amount of alone. 'XX, a the that we decline million in meaningful roughly of burn already in where QX. expect our over now demonstrated roughly to in XXXX reductions QX cash result, approximately $XXX half burn cash we're at year this $XXX quarterly course

during called also the accounts collecting cash of collection out to collected date. the QX, good experienced roughly receivable $XX generated estimate million last we making in we've rapid progress some growth we that in year. million cash backlog I been about in and We've on $XX of

a QX cash think our year. Signatera in DSOs in to position also a muscle declined progress revenue we this flow set And all lot of growth. volume good and reimbursement strong we've put the accelerating pursue last us despite We modestly puts breakeven behind processes continued target sequential recently.

X If fully guidelines the a still with previously we we are we've get we flow delayed when you quarter great guidelines, as to we in cost expect I position to in described. good news those If on are goal cash any reach breakeven hit the think mentioned, mid-XXXX we of a discipline.

our objectives us So of ahead allow cash balance we current us. meet expect existing will to the

we these So today. very with are share results you pleased to

let Operator? now over operator the the call hand to questions. And me for

line Savant [Operator Morgan with Instructions] will the Tejas first Our question come of from Stanley.

of So talk just a there's a in quick I Can Mike, follow-ups terms decision Signatera obviously, the of bit And cited of comes about some both couple your that little you've a about impact? in XX% chance volume for from know breast breast. here, you. near-term payment. look-back you more current of coverage the detail,

of specifics perhaps the So year from as some here. half to there in the contribution back the just Signatera curious around

But is as And sort sequential gross then making and bunch a any second in. on here some trajectory, the gross would upon color reproductive indications well. the based the you are margins commercial of year the noncovered ASP of recovery a for on margin push on Signatera through helpful other follow-up that puts trajectory takes of health guys totally and my the I be understand

I the first. yes, I Tejas, questions. the take appreciate last one And I'll do.

Signatera that question in in the all discussed is year over you variables mean, the I and we've to for call of inferred more just expect course the kick right. improve past. you've gross to I trajectory have the what do on in. reimbursement I margin the think time your for

continue to to us our in to have improve Signatera. evolve more for time mix ASPs into -- for the You

also projects more some of of other through in year. health working have the progress bear fruit the as some we're channel women's that to the the you time then And

of do margin through I the that's progression course year. think So the kind of steady

the And getting contribution, we're bad and this we and just call, just the I we yes, just erred short decision the terms we just got side the guide. to On given breast very cancer about on news excited -- positive as obviously, kind from the between usual, the MolDx, of caution look, -- mean, timing we contribution of in of that.

of things that couple the looking our us map kind will from in we're the is the more for that with the can through A And we're the give the quarters going year. -- and on Noridian happen exactly details timeline, on to contribution how get be on pricing. clarity need engage will just to and that typical what that of

also to kind of back-end expect that would I be weighted.

to variable, other can breast the I call just cancer. think, there what volumes out is The in be

like I quite channel. on think volume has cancer to our the come through in call. organically Steve this breast The alluded

significantly us the this for on our reimbursed of coverage to now And heels a there's volume. decision, expand cancer potential breast

we to it a got chance before us you So incorporate that to in a execute on and guide. go give

mean, decisions end look there up -- be effective submission some. the are the on to these expect MolDx. finally, as And payments, back I of the things Typically, being to coverage I

year. going more let into we'll And look I back So back last as that, clarity some be on have think you we there there'll know.

on question. commentary that pause Steve, have any me Let there, you other if

you I thoroughly Mike. covered Thanks, things. think No,

with Your Julia next the line of Qin question JPMorgan. from comes

then versus I guideline that. looking 'XX, margin obviously, and XX% somewhere that piece moving inflection? dependent within And is not like the a follow-up. to the your of levers see or revenue at more how guideline the mean, see do margin XXXX, guidelines And the costs is that much guidance. in a before the kind mid-XXXX flexibility just follow-up operations? improvement And lowering if have on is -- big costs? gross on materialize of and then do understanding lab what kind growth of do a you of any how But that down further you sequencing to So mid-XX% to take gross much I the where your control XX%

kind on of COGS Yes. me some first these Mike, just let comment of projects.

over our So done the of we've years good rallying a on straightforward. projects. are pretty these these big cost really job And reduction resources

have NovaSeq to capacity do the versus expanding NextSeq, example, mean, in to facilities. versioning in our the I or these with certain -- for

So these complex projects, really they're like aren't technically straightforward.

have high pretty confidence think I so them. in hitting we And

We've I margin are progression up really COGS move comment bit as here future reduction out of But what big want handful a like a do making chunk got the little into projects on a that significant the showing we to Mike, you think of we're guidance. further?

a I you that's Steve. clearly a think just I lead-in, margin is No, I Yes. project. good COGS mean, that the I touched within progression control. of think that there's lot on our mean,

think to I ASPs. the ASP we expect mean we that see in detail Signatera on front, I in also talked about the evolution

Signatera commercial of mix our were reimbursement coverage kind change evolve kind continue from that as now Just we're and which seen as some in started, we've on of And Medicare also real we in from in to seeing favor to the in already mid-XXXs ASPs ASPs mid-XXXs. and the just sea now, well. expanding launch a reminder, increasing based and is they're a as the

those think all I are our levers are that So in favor.

right the think leverage us on I pulling And operating we you expense other now. terms then our And levers of we just that is part these of I that base. mean, the of get this kind some of pull, can can in levers see

to to think, simplified the by platform, the on drive I cash continue I current this, ability So is our revenues burn guide. think

delayed. that think that they're the are delayed, I guidelines permanently in And that event I that don't means think

OpEx our still means in just to And meet talked about think, prepared get them. got that we scope us, can we've I think as I remarks. discipline with we for the goals continuing

Yes. to to need get any And we don't of guidelines that those to be to clear, XX% come -- target. in margin just those

then I guidelines. nearest can helpful. terms seems Super is MRD, when Got term the side and may. in like the if on of one ECS And microdeletion health microdeletion, women's more we it. expect It between

XXq. for prepared You mentioned that your evidence strongest in is remarks the

and So how for can to the is to much subsequent guideline health ASP we women's see limited expect XXq, lift your payer volume? coverage

that. take I'll Yes,

XXq, really game whole think, I testing. ball So is the for [microlesion]

that's submission started, the was have I we sort Other of today, the that coding growing in are when the base deletions code that into included, XXq but led actually So of CMS XXXX, infrastructure. in think, is contracts XXq. AMA, the we payer is the to microdeletion which pricing XXXX. for in And part

where be And guidelines XXq as or go most pricing whether we the will think the the it's focused. XXq that's the is I where forward. microdeletion. We are to payers broad So think from same, whether is it's a going be of interest

And I John differentiators. these big this know think of with lot really it's be sort both to a payers. interesting pans got highlighted out how those, we make also future. differentiators a see I but to with in going some of think mean, and physicians we've I And the of difference,

mentioned carrier on also expanded screening. I

today, of from And guideline it's, ACAR have payers coverage actually fact, expanded one issue strong. guideline the seeing we ACMG. screening. a in And why think guideline NSGC. carrier of We positive supportive So you're strong in There's to pretty policies. a from that's good place reasons the is starting

lives positive of one covered that just United the a covers that screening. issued expanded So last all we States of the commercial in call for XX% the lab on managers week benefit mentioned carrier guideline the

incremental new that's the not in model. so And upside that's

of margin recently. sort as of reduction And you've why your the slight seen in the one mentioned, think product mix I reasons Mike is

right Some comes idea turns out thought guidelines to us knew of low-margin proactive we were that, of of a that and to the went business. it was they because we some decision. as the business out these [Semaphore] a And good from that was that do coming, on take decision that making

Now seen this of a since out and out we NSGC we've chunk going the screening. and company, significant lab they're went business we've to management carrier We've that seen of picked they seen guidelines expanded volume, up they'll big covering out. come benefit say be come

collect screening to larger a the on coming, that but take the are a that know have of decision the margin, think guidelines carrier able sort overall of in So I and we're that temporarily reduction book be go right in on is going future. the was volume, slight to expanded

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

what one in year? on in then Can I biopharma a clarify volumes that follow-ups. have few from contribution clinical And you saw you Signatera. the just first So versus the

Yes. comment? ahead. you contribution go the expect. want pharma, you'd But Solomon, as to versus from clinical Do Overwhelming the

think I Steve, was you want Steve. did comment? to that

to going I No, you want to say ahead. go if on color just more make any that,

retrospective committed now Yes. as business reviewed the for from steady. looking well. prospective partnerships as Pharma Look, a trials. we And diagnostic And right both to have remarks. new well major seeing is III accelerating the our is during strong multiple and I the we've pretty as business pipeline we're reasons studies as got my remain growth companion well, clinical Phase

trying Solomon accessible maybe that expanding. at this the IO then Okay. on are Signatera, Helpful. and you And Got inaccessible and are is well as point and for congrats for already CRC it. the to that already TAM overall indications understand that. in given monitoring, breast,

How or inaccessible the the tissue-based tissue. the approach? tumor-informed so to can the because as maybe of market you with to talk sort approach that portion billion And So it's $XX of remains sort market of what of capture? much us

Sure. Thanks inaccessible tissue-informed approach. think a of question. because for the being the major I of of portions don't market

the tissue-informed cancer if product across can -- terms gives I in be think of applied anything, disease. of advantage an single a that and approach pan the stages

that's story out. think play And the how seeing we're I

who many cancer X.X or of are question there for significant. breast breast by per your suffering the cancer and to Medicare is TAM, was addressable out milestone a survivors. now of are year significant covered So million patients very cancer from us, given tests really penetration how breast

terms in expanding for at slide in that, focused breast there additional coverage we're this that the addition indications point, to indications cancer, immunotherapy see already growth, Medicare. really with I colorectal multiple that think we But bladder, expand on on monitoring. cancer you and the are in for opportunity of saw coverage to So private the

we've studies a for shown and the I several more. and that have Hopefully So neoadjuvant from good GI there's evidence ones think in growth from cancer growing ton answers on where table of other breast to setting your in the X cancers that those categories question. new validity

that's competitors. the of market one one an I very saw Mike, Last exit helpful, Mike carrier Yes, your may. from if for testing Solomon.

And we 'XX are how that could about should volume, of then to that in coming market sort And beyond? Natera. wondering thinking us you ASPs how of to that think So some volume about pricing in you market? commercial in the talk that about and

that take Mike. me Let one,

screening. of mentioned I'll in done actually, think, Natera's well and -- business previously, And I exit the of comment. see pretty largely there, the So gained I carrier we think that did pretty some competitor. a I sizable

that's in an business outlined, that think opportunity significantly ASP relatively that as near Now volume of And in. increase there's low-margin today. we've we coming future to the the that's a

covers as you from And saw guideline week. just wouldn't on changed commercial a carrier of benefit that their expanded we screening coverage Whereas gotten have management will. company just covered last you now large We previously of XX% saw a lives coverage, NSGC.

us, on it's So and bet of even we turn can take for low right was further what business we let's makes looks going upside comment saying, and landscape that a of think of that that to the lot like? there's bet. that think, out you the on on Mike, we though into look, it want I but initially, sort sort made something do this margin sense

that think it I covers well. No,

Max from Masucci line Your with Company. question Cowen come will the of next and

another on great Congrats year.

essentially risk testing. CEA the So Signatera prior for subtype. pegged the it's CRC to varies X-year breast, in recurrence by surveillance But periods, recommendations of

more CMS about across X ideal you've or Is So say, the you breast? vary are likely subtypes? just by be Signatera subtype? conversations thinking how any it on years to others, period could static, with it based surveillance for all Or had

a couple you of let jump just comments could in. Yes, add so that me

done of look we've that about X if clinical those -- I years we're you done, think to back I on patients. follow-up we've think trials the

And so it, waiting clinical We're using sort in a to back of trial. kind MolDx, we got the of what's the that for more of benchmark. still but we billing revert letter will as bit little detail which I kind final we're think to kind in just have come from of the

Solomon?

Right. Yes.

testing So just was we to the cancer of months. up paper, presented echo that Steve's comments, published the X conservative -- to view is every trial follow-up in which to clinical what research, and X had years look cancer the in at

your Max, disease their subtype the differently their on depending very and patients to question, are treated stage. But

to So earlier recur, of triple-negative HR-positive they post-definitive we with and is tend for a years. treatment to steady know XX X recurrence cancer post-surgery more going up kind over than HERX-negative that patient, compared of to years to if example, even patient recur a breast is whose chance

it's little variation do I a to early see some see across And bit expect so still really subtypes. days those patterns we the usage that But out. think in plays to how

also, during where feet. number we see decisions. mentioned, initial I And the their just with Signatera think of we're want tough of to pretty surveillance significant some well information patients are as And treatment period as voting really to uptake they cancer pleased that breast in the help as inform

one Absolutely. Super helpful. And my just then I'll -- ask more.

win beyond? that note, patients IO So win each in a came the expect in Medicare the or coverage of similar Signatera acceleration any cancer just Medicare ordering Signatera breast on and to number win do ordering And year for IO? you 'XX breast MIBC in sheer July. given operable coverage diagnosed accelerate trigger trigger then coverage that for the Did newly Signatera test of Signatera

Yes.

Let me there. just comment

it think, endorsement team sort and of think do to about getting they be ordering, think may a I is us our And affairs but coverage medical an the Medicare definitely additional So indication. educating allows our mean, I it coverage, feel the I I think review. necessarily that triggers commercial thoroughly of physicians physicians a rigorous data. very have very out of out sort that team comfortable I educating to not

record when bladder, does look increased in and at at any gotten look we're particular that's the invasive indication really medical out has coverage, you record numbers. seeing IO, that triggered, look you And utilization. seeing numbers around which I type, think, education you when tumor education we're So at additional and mean, muscle come When I and growth. result

So the think behind well certainly, organic going the of we've powerful. breast we're our on interest. power seeing to once educate we as to it's done, physicians studies show the that put data team But and we really strong that be

question -- is I just see to increased your in one add was usage coverage This or of coverage I think cancer to monitoring. IO bladder that breast the about going we trigger in nuances. that, do in

was an that interesting So question.

practice. could that we've and do so And natural see of the extent over one benefits physicians seen that start that that to of start patient more a the is that patients then We using many and may applied across their over particular test type type again, be in step. the to realize and in

with to patients number Puneet's new and immune that time eligible for top The immunotherapy. population to out of our other sort who are the to that continues And is inhibitor grow thing manufacturers. the from read related earlier, continues as mention every more of on just eligible I'll checkpoint question patients well immunotherapy and more expand trials

Your next of line Catherine with question will come Baird. the Schulte from

that we have testing payer in your guess we what other or Signatera, assume Signatera, Louisiana expectations saw first there inclusion? states on commercial last like just for for NPCN genetic no for year? similar any if are what the are covering to on XXXX Are side guideline legislation I working

that? to you take want Solomon,

houses. passed state who there There a already their are -- legislation think whole lot viewing are Sure. X and are I legislation more states in who've

we're actively that. And really though don't we so monitoring control that,

are involved a the lot But in of discussions. we

across of I John lawmakers think have XX his educating states. and done the team job a great

So the more and we more continues do now payers and evidence continues their increase. our see strengthen with commercial progress to also to as covered among patients adoption as

want biomarker add I don't -- if be further that? we So hopefully, this do we anything some expect see year to of the of adoption some And legislation. John, we making coverage. to you expect know, to announcements commercial

Solomon. Thanks,

this has big X some other like legislation to Island, Illinois, Arizona. the Florida, Just states, states year, legislation states Cancer New beyond including by championed expand, in effect There's in passed XX Texas, now including least Louisiana, Society, at in pending York. Rhode American

for it's payer about we patients. actually It's as confident policy that, great on great the quite And that's commercial and feel the So space. pushing side well. for

program? for Are study from that Okay. path one forward Super FDA feedback know those helpful. the expect detection. should hear And just events? on to XXXX early proof-of-concept we the When to the maybe then and results

will Yes. be. They definitely

say So able the announce there'll hope hundred proof that of to study. has will X smaller One phases. a probably then be we follow-on be be study several be from. which results to I concept will would slightly patients, And like

I 'XX definitely be think those will events.

back million investment very We're We've this strong to And additional some some initial we're But is I to feedback then year. feedback. to do have. that a the on of now the low. FDA goes, as as year. we previously up the get that a right $X key which crank in hope of expect at is described that around already stable the keeping far we And position think results, proof-of-concept

James. Our next line the with Raymond will of come Andrew Cooper question from

on Can you've for to actions give and outcome of the in going the in Maybe legal the or of guide start, quo the the there past sort sort you some are what metrics given and California the there? the expectations greatest potential from on us dynamics. status latest some assumed of

take to that? want do Mike, you

we've mean, still in relates is fairly that is to in headwind margins. a basically California, -- the in I 'XX I it this allows assumed in sure. to there, which We're an -- injunction we've there's great. as to mean, to Yes, meaningful which just place customers recap, yes, Panorama our now offer guide, us

But that I think there's there. upside do

an time. increasing As customers get fraction to we to will progress kind Panorama the give continue over of who of migrate through to updates year, we'll you our

that's tend for And a things, to hard cautious. -- reasons. all the be we think one look, one another those I and types model So it's when to obvious conservative with where that's faced of

beat. kind we So hope a can scenario we there modest we've basically modeled of to very which

the Okay. around on made you to to maybe comment Great. And then breakeven. want one I focus path

before health. I women's in done you said think this we've

about does coming, some women's think to are us health? believe OpEx of coming outside lead we that So when cuts they're I of that guess these

reductions actual are actually sort there dollar do perspective. the you're there? of that tell think more the Just where from from they and Is some about going those meat about of where and stemming on us how and bone we business the what

Yes.

Sorry.

a when been focusing look, then trials. sort a to that in we've a been and really in. time. of I'll I I operation And feel of a in make the spending at we've long me think -- for you lot jump clinical comments, mean, you of of free Let doing efficient on the an lot the couple R&D, can -- that's running look

give read as think to to start example, you these operating and of you I'll the studies one SMART of some I to trials start out so start off, can phase the get expenses. some And in study. reduction

X that million study. we to $XX no longer done. the and we spent results is out, because for a million running $X year So years and have a done. in have study between continue making now row, And it's that read The anymore investment

that's a the think right trial, we've of and example up. wrapped trial it's completed, I the So investments. great where We funded made the now is and

of lot We've the that sort publications. work. of seen. a took mean, completing got really across sort lot the it's you've on of efficiency a focus trials board. I XX of of there's on some now But So

last think, Okay. you mid-XXX clinical the Mike, in one said I Great. Signatera. side Maybe ASP for one.

quarter, XXX. last over think I said you

dilutive margin more think that bit how there, detail the focusing to So like sort in of want happy just a you indications, I to in guide a give ancillary little the can which growth and to you and just of take, versus you're just kind degree but the trajectory make certainly the on noncovered sure covered growth about seems you're in side?

good oncology another quarter in progression. steady this just ASP of quarter kind Yes. of clinical We saw terms

we're it. the kind So we're I the I characterize way think I'd there along same humming on -- of is just -- would

we like covered aside, recurrence volume about setting. getting of more the in the guidelines kind mix, universe, on just talked the in leave kind of people fewer to think previously And things the and monitoring bundle expansions that I

the the year, on clear over right I get the like think with we're there's and trajectory for track XXXs a into to us pretty of course looks that.

from come Massaro will BTIG. question Mark line of with final Our the

Congrats XXXX. on excellent an

to publications. add reasonable you if this more you a And of guess coverage be it's a couple I'd wins curious year. peer-reviewed So Medicare expect number to have I

determinations? melanoma, think and that to have would decision? submitted you timing some lung, for have of Medicare how how head of on should but And we waiting type MolDx we been esophageal, the data Obviously, coverage many about neck, potential pancreatic, ovarian, be roughly

Thanks, Mark. Yes.

flow So -- I data. that of go not we we we're steady time. have not that peer-reviewed we're I fact of cannot the get deal exact without is competitive coverage any you sort having a the outlining because a reasons, have publications But submissions big at on mean, peer-reviewed mean, for strategy. particular XX

our moat differentiator without do for getting the which our think eligible ability leverage go from a for on point. out publications FDA right? get for no ADLT based It's to going big a path coverage is very approval, to Natera. else actually these one and So and ADLT big status, with same go to the So is we is and view, others an a starting their difficult

think So another we reimbursement again, we that's have. big that

definitely see submissions, additional expect out the pipeline of can competitive for updates strategy just through going to kind exact kind the this as but You year of crank we work reasons. we're not to of

then Okay. And just question. last my

solid in some like Medicine, some of other tumor of at covers with Health, kind the indications bunch decision. space Foundation for pan Guardant a pioneers we saw determinations, one Looking which example,

Medicare think of curious guys a solid showing to having you. done and you communicating with be determination? great do if may might job in tumor coverage You what type but I'm framework the you're lot conversation have pan see Medicare data, of to future, be we a that able of a they

Yes.

really have a it where cancer So There's think tipping to a indication a that I by go sort sort sort we indication point becomes of always pan certain that hit a more of think you've we've threshold. said until of of you view.

through moving we're and I coverage. And think getting really fast indication-by-indication the

job. evidence, delivering for think We're the that's we're going a great everything. to foundation I doing be the So and

about I is We all to The have the tumor-informed that redesign go across the platform and run just it's enables that pan the think thing don't to same assay. approach cancer. different path Signatera out and types, pan cancer. and great this We of kind tumor

So stay tuned.

pan But it's pan how to to see have on going some future. things out. possible cancer we're think momentum I in be there could the

today's that conclude We Ladies for joining. meeting. thank you and all will gentlemen,

disconnect. You may now