Natera (NTRA) 28 Feb 242023 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by. My name is Desiree, and I will be your conference operator today. At this time, I would like to welcome everyone to the Natera, Inc. Fourth Quarter 2023 Earnings Call. [Operator Instructions]

to Officer. conference like Brophy, to now Financial Chief would turn over the Michael I ahead. go Please

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

Q&A. Today's on line, be President Moshkevich, Clinical call of and webcast. Officer, Solomon conference Oncology Chief the CEO; General Medical available Chief also Al President, I'm Chapman, Business Diagnostics; Steve On broadcast our the by being Officer; will and live and Aleshin, for and line and Manager joined is John is Fesko, via

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

our studies products, expectations file this factors regarding materially call, forward-looking contained press suggested Those time and that coverage effects and outlook, expected results, known for factors and our current statements. on other future conference could XX-K reflect dates, we you forward-looking make to market actual cause financial the or and to to Form risks operational anticipated from our our important or such our results XX-Q product documents assumptions that operating partnerships, identify and best with of statements those judgment expected future time including based and on the such and and the filed differ reimbursement related release. that recent and events from including clinical will by X-K may actual refer statements SEC, as performance financial documents and currently most our the that release size, outlook various for or to us and differ Please with we Form caution materially. today's the results During capabilities, results. We opportunities our events and projections, course strategies future

XX, not current XXXX. to revise today, If being day, the claims presented may obligation to information. Natera Forward-looking any reviewed after accurate made information this call the statements. contain during as replay or are or forward-looking call statements call's February update of any made the during

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

We call each our or of such quote performance. will a numeric like changes year-on-year growth I'd over we number Steve? a Steve. comparison. And represents otherwise to unless turn as now the noted, reference to discuss and financial

is Great. on transforming worldwide. diagnosis Thanks, disease the Natera management Mike. focused of and

X,XXX guide. XXX to in volumes, top health came oncology organ units to year in QX end highlights. We pre-announcement. XX.X% XX.X%. significant by at to innovative presentation clinical conference, health. Gross metrics of We've year-over-year driven we the at year of evidence with is news great $X.XX revenues in the also more XXX,XXX at was and we're finished in XX% of JPMorgan and QX pre-announcement utility the in we growth margin and full increase finished that and over which our women's represents growth strong growth million lot XX.X%, XX.X%, revenue, of than roughly margins is the combining of the compared peer-reviewed processed tests technology of the had ahead the January compared our XXXX, saw into supports the X,XXX in representing growth XXXX. On million were since of processed QX of QX We billion, products. which with Our get our We a above ahead of of excited $XX $XXX QX our made XXXX. we XX% Full tests an XXXX,

QX every quarter. were later reducing conference, true-ups roughly lab $XXX that of XXXX a in revenues in XXXX. The great burn and revenue call, savings and JPMorgan ultimately course the by still improvement which were we don't some that the cash we reflects the at estimate As also results very quarters. And XXXX. made to represents versus in our in QX million previous momentum million burn the significant strong roughly throughout XXXX Mike in progress as compared $XXX cash had roughly in business guidance discussed year, gross generated the repeat these margins will organic cover on XX%, for continued we the We

impressive XX% we $X.XXX of billion, estimate We year XX%, are by QX the flow business. revenues cash $XX of flow burn cash million. On still core investments most million our while $X.XXX guiding into quarter cash, will we of will be or cash and to What's gross significant to full we billion making margins sooner. breakeven $XX is be breakeven for to achieving this very

We margin can volume ASP expanding fundamentals expanding so more is do is our plus in strong. we large, You'll that We're with before XXXX. we robust in and in includes benefit investment go patients come. growing potentially clinical later into enabling and details our that COGS few on increasing in core in guidance highlights to hit remains see This and investments research this down. I'll development because rapidly, are believe now extensions other commercial the going markets, the in in trials core our guideline enhancements operations product each. a and years our could line major

We'll and of innovative Invitae's prospective and clinical our [indiscernible] trends we cell-free there, the acquisition First, seeing some in on big we're read donor of we're impact positively far. In our and care. positive screening women's feeling carrier are value think health first-of-their-kind patient major clinical complete DNA they we progress well thus about assets may organ the and how is health, building studies we given momentum today the as trials. be talking acquisition strong about enrollment expanded out recent timed

which and We've drum separately monitoring we Finally, oncology, range to patient coverage CRC, cancer breast a ago. cancer including were recurrence its developments MRD bladder neoadjuvant week, just modern variant breast enrolled the that excited has few for expanded to also clinical cancer. in and weeks bladder a for talk mosunvasive indications, announce pleased Alex beat the study in exciting cancer. I'm MolDX this earlier first of cancer, about Signatera for monitoring of and to across had in of a

results front Finally, beyond. of we've think us good position that I and the had in a IP puts XXXX on string an excellent in

Great. Okay.

QX traction to oncology Let's strong ASPs of results get oncology. our excellent million the on room indications. think exceeded driven and we news the because execute above at on the of volume goal great had $XX level full another and higher particularly now $X,XXX drive get currently clinical ASPs year's we a higher by XXXX, by next to by We that of we into hit actually details in $XXX in of think get we slide. to Revenues women's in $XX Signatera still to ASP ASPs the XXXX. That's there's covered XXXX, health business, a continued continuing end and expectations across can growth the previously and benefit just

performance XXXX. the slide. preliminary we on the this track new can commentary as saw so the throughout you volume Volume XXXX, QX as Medicare QX is course, annual see are for driver well, in announcement trends next of that progress in We was analysis sequential us far help women's and improvement trend coverage on well. The a strong suggest continued on will encouraging of Of of quarterly week's ASPs and broadly course health similar.

the X,XXX in we came saw on units I'll we As January. I oncology on mentioned and full of where XXXX. our a earlier, coming here have so ahead growth strong women's separate in health health in preannouncement up, slide focus organ year

units where As acquisition volume the the just year receiving of per in This sell-through business come the in. In we see to record we into strong now day that January pullback initial women's donor-derived the to prior health acceleration a we're as was progressed, a December. in as year ended, organ return including hitting momentum starting well, D&A carried in of and tests. we the women's saw health after fast compete to to to Also, Renasight due strong women's the generated publication. Invitae's positioned assets saw interest going growth is health, we're body organ This [indiscernible] in derived features the We momentum and see and significant our of across the oncology. of think peer-reviewed a unique self-free in well XXXX great, early coverage RenaCARE the donor that off we're evidence to we start health, forward continue after changes. given and health, to

over On the QX, oncology In next of our QX ramp did we strong units we're sequential showing slide, another to continues by the XXXX. of clinical business, X,XXX outperform. units, quarter, increasing XX,XXX which

breast clinical Signatera strong into the see utility year Roughly full indications. over we the continuing XXXX. We're XX% cancer monitoring which the even the core colorectal as and we including shows cancer to and strong cancer, strong growth was immunotherapy XX.X% of of muscle-invasive in momentum use QX, add bladder For the test, have oncologists rate XXXX. going new indications, of growth across and XXXX,

Just as the critical volume seeing. and growth gross margin traction as we revenue is are

think I good snapshot of the is maturing. slide business a this

of Signatera, the COGS, over in above which course ASP course and of the ASP particularly XXXX. our the COGS Over expectations, and initiatives our year, improved delivered both of

the the the roughly mentioned I margin the quarter at As top think XX%. was underlying of repeatable gross we in call,

implies that drivers guide within ASPs continued are gross based meaningful Our control. improvements cost and margin XXXX our on

in in both got our are that also the we've gross addition, to later and upside drivers discuss number that revenue potential of margins In included a guide. we'll call

margins expanding stable reduction with in net This operating essentially the on So growth, line burn January. in expenses data in revenue is is achieved cash dramatic of result we we in released XXXX. a strong the

And XXXX of an target ago, QX, milestone based discounts, we year-end QX not As large are helped in if breakeven of advantage far can seeing reach a sooner. are years these flow by discussed scheduled quarter so up to some to XXXX. X previously, we set we December plus that year cash this a chunk long-term data accelerated get which a year, efficient in of this results, CapEx early set we we year. take confident the has in for us on that

payer dependent in the in flows basis. and this to course, a Of is are achieving cash confidence is to build our we're momentum and claims, point inherently continuing with part so But times difficult precision forecast on than submitted response on ever. quarterly are stronger to goal

violating awarded. And ARCHER Gen about respectfully be Rob on set to Gen was to of these of of for trial notable generated jury And results entered in patents was enjoying our conclusion trial. injunction the now DS sizable the each NeoGenomics. One our whether the point then these were against willfully in injunction both of infringement had obviously what IP. cases IP damages demonstrates is issue than the against another and of not this on of I for outcomes that to and good appeal patents. preliminary different that are an The point we strength ordered will The us we Since different the that X to our Rob still we've awarded results the Finally, note IP think IP damages a is anyone future we MRD lower ongoing IP certain The our into taken think jury enforce royalties of litigation which rulings. companies in verdict was Care plan has estate follow which our the the and requiring to follows space the the infringe attempt news still we against process technology. disagree category case protects us only they've that I XXXX, created the tumor-informed subsequently, of space, them. a determine after [indiscernible], The with based a been much of on front. past core found permit is were but and Invitae judges requesting, offers

Okay.

in Solomon updates over discuss it Now health. hand let and to Women's me organ to Health

Solomon?

Steve. Thanks,

deal. Let's the start with Invitae

recall that in collect judgment difficult their on anticipated $XX be Invita amount First, our that We IP we of it litigation given secured from past ARCHER financial million. issues. roughly could damages a to

deal. we in of that applied part consideration So amount the judgment as this

would be would that also Invitae payment of Invitae's can it $XX.X $XX mean that We make to milestone have there's for make the million extremely paid accounts, well deal very of we because payment us. million. happy a working we that to potential excellent up retention upfront. if is We And

lab transition it's products. hire As we reps, physical in Vita our health goal products, to nor We to XX assets. a did on Panorama and Horizon did seamless their Invitae's its a those and provide sales women's is reminder, not take Natera's of accounts of any roughly of operations

Our team and as well. retain volume is we working hard much doing can to we're as

to to We at increase think year. upside that to as on $XX these guidelines we expect to $XX think potential practice $XX recurring depending to come million retain how high-quality which we will provide numbers. million $XX soon up XXq, if least million, things spring revenue carrier go. see million But a in there's we and as could this or expanded Especially clinical for screening to per

the So the rationale forward more and year we deal we to progresses. strong, look providing updates think is as

our of XXq One keys health women's in screening microdeletion. highly the the to differentiated is test our for offering

XXq into megabases. Natera we in a us creates translated going societal guidelines SMART demonstrated has region clinical of common in test X.X small X believe As technical This test, that very clinical to it interest over the become trial run region the our as and standard is that differentiation goes SMART to increasingly would validation allows XXq shutdown us place that repeat. using think which gold excellent core to our this the is will, performance than into technology that this becomes around particular represents valuable. When get genome advantage in its we're trial. We of doing the more allows parallel has very SNP-based massively which observations to companies target as hard be sequencing, significant in to XXx the we

blood was overall SMART of a collected cases to XX.XX%, and demonstrated and overall trial newborn XXX% patients prospective more that of and enrolled spots. In Panorama reminder, a anomalies. a specificity sensitivity clinical prenatal, specimens ultrasound outcomes genetic multicenter translates XX,XXX of XX.X% than trial, from this As which PPV PPV of in with XX% X-year and

wake ACOG. attention and from strong of more gotten guideline ACMG from have XXq guidelines the anticipated As in a

effective or X to than rates in shutdown they approximately competitors have positive sets the sequencing. The of just report starting Xx unreported, X,XXX, present might completely from lab We pregnancies. significant but with doing and that high, screen with that Xx number a positive was population look missing are rate data PPV low screen be expected or metrics a that incidents, noticed lower X suggesting

high mentioned on previously. In In ultrasound that market view, addition, cohorts of know new population clinical don't are the patient for are you of I and appropriate screening very have saw the rates test from few [indiscernible] also finding quite late had trial, findings other And Invitae we labs transitioning where a sensitivity that is SMART in XXXX. the if making claims PPV comparative we in a broad strong the mix based accounts of panels. XXX% as our not of a

we XXX to options gene where in So addition be launching ones genes, high totally a custom provides and including all detection are pleased Horizon to new portfolio, our really challenging other to panel, flexible a across struggle. existing the lots panel serve these customers. may

is in is panels positioned investments with think ACOG, curation, a team to hot variance and expanded guideline field. Broad we in remain carrier topic the an leader automation, these With in new genetic expect our lab our panel we Horizon a XXXX. well together screening also counselor where to see for

the property data, the this beyond. our to commercial us strength for Turning and think We intellectual where now about estate, our and the for compete of enables our in are to execution prospects leadership position Oregon excited Health we space. XXXX clinical

do aims performance the data trifecta has for randomized been years, data the where Our had foundation X across in to papers we or that XX top area trial an a now first with centers between third accepted these most compared controlled the which in in generation assessed basis noninferiority the see to journals. the the monthly after a us transplant. ACIS In heart biopsy publication in study. organ have their on year paper with clinical in the prodigious health the curve of Prospera the indication, assisted we our molecular show which page, recently the X can of sets ROC summer. in surveillance to published preparing for under biopsies Trifecta demonstrated for heart are [indiscernible] This correlation you this strong Prospera on Sites laid and microscope. Reporting X.X, first endomyocardial high-quality accepted performance start heart the last surveillance using enrollment

space, X ProActive, and the enrollment in PEDAL transplant major we have Now kidney of Motor. finished trials:

accepted, think has ahead time cell-free that lab been No study paper Prospera up X biopsy. detect showing can active DNA from data other surveillance now We lead look forward working setting. rejection like on this. support months in first of we're the additional to publication, this this Our we the payer And readouts study. might from ProActive has data coverage already and to this

can aiming Moving event This is on value this for to can to study predict We important the XXX over important PANEL Prospera serially field the prospective indication. trial, therapeutic to believe after sites. a how show rejection patients response study this be utility from XX enrolled to bring and used different outcomes. with significant an

motor showing kidney the pancreas performance and generating in novel study transplantation, of liver. heart, of the clinical see is Finally, multi-organ kidney, including Prospera validity cases data

meaningful these key our to leadership trials data We expect way. extend a in

So we're excited about XXXX.

continues Moving Signatera multiple significant benefit oncology. areas. across to advantage from now to a first-mover

is first exemplified recent significant and X IP by injunction our our portfolio and decisions. as leadership favorable innovation, strong technology in The

projects multiple plan and We continue new XXXX to to invest with products that in in innovation we launch XXXX. MRD-related

continue We to invest expanding our in portfolio.Now market-leading also clinical

with and the cancer, bladder years that this ongoing, coming were and Signatera XX generating can monitoring. pan-cancer immunotherapy today, and over in cancer in changing. In to trials test is by We number data prospective many peer-reviewed reimbursement, years breast payers which oncology practice market a of access cancer, pipeline private randomized Medicare become the publications growing will designed covered multiple believe several continue ago. date of colorectal

cover Alex moment. greater use ovarian detail their a majority across We oncologists patients. to cancer to have added in allows coverage now Signatera broad which list, This in that of will the

over to experience. a in to results the decade complexity physicians a tumor-informed experience developed we've that here, in the nearly capabilities delivering of operational easy personalized and patients and which the of believe many is timely highlight is discount back manner to and at scale. There MRD I curve real half replicate. want field I Finally, a not

expand digital physicians. We of and launch records, turnaround our the mobile and through phlebotomy refine services, and into integration the industry-leading improvements capabilities these to medical continue patients to for electronic of solutions expansion time,

I Alex? recent want updates. Now call to clinical cover to the over hand Alex to

Great. Thanks, Solomon.

reported which results cancer, XXX study's to from prior noting. States. worth showed initial are multiple with In than United this presented more performance and registry the events GI at now the colorectal CRC data across year indications. study, asset in We first exceptional consistent our key enrolled readouts. centers were patients BESPOKE Turning The there ASCO

was the testing reduced patient for Additionally, first of anxiety time, it respondents. Signatera that shown over markedly and XX%

Additionally, participants component substudy, around TAS-XXX since X.X the had able patients an sample suggests exciting population, which X% wanted impact being result. reported continue X%. presented I the XX on also has of investigators was based the the same The at characterize untreated receive this to a Signatera tested patients X to TAS-XXX Signatera forward. The XX% enrolled highlight study patients our on testing clinical to Compared INTERCEPT with randomized study should the to over TAS-XXX spontaneous CK patient of Signatera routine notable is of approximately the showed of II they months study. The population. Cancer where small DFS practice wanted done a by clearance perspective Signatera finding in used was high next X,XXX is is positive results that months, the Signatera. clearance this ALTAIR be suggesting in commercial preliminary Despite trial that single Phase freight agent was data XX% positive the drug of activity using TAS-XXX size, Signatera relapse. Interestingly, observational Center that Anderson to clinical using and positivity MD median study of between to going and a from

study a median ALTAIR this from believe ago X broader which months We positive of reported Additionally, signal presented randomized. survival observational compares study. a for I this months, favorably a not the the cohort. Though X X.X know study all disease-free to provides the to moment the we was

it If in countries. We published expect of presented the perhaps U.S., QX and positive, in to ALTAIR in is the QX. we expect study trial being results readout be from practice this Japan concomitantly with full in the top the likely, changing line and other many year

Next, let cancer. us review our catalysts progress bladder towards in key

both have currently spondering Just everyone, to remind neoadjuvant reimbursement, Medicare and settings. the in we recurrent

become around do on of XX,XXX year, we well indication the not highly cancer highlighted the While X pending studies with readout and every bladder penetrated new believe talk reimbursed we diagnosed this patients slide. about often being this could

collaboration with We believe our have with in that the Signatera status continues previously study an the The of the FDA our work gives is would and the if well, of readout in first likely FDA We randomized, global advantage. IMvigorXXX placebo-controlled advanced basis is form submission, study to it us enroll positive, discussed being the for done second half XXXX. Genentech. the

of the the find to create tailwind Signatera convincing this patients prospective later of beyond already great format is negative presented Signatera it data be We nonrandomized that European and in this saw also an DFS shows Conference that may we outcomes, is in IMvigorXXX study will data an especially the the set arm Urology the noted at if interim results have want negative from Association data oral published XXXX. in commercial good improvement year, it

We Matthew is leadership PI the of with in funded a are Alliance's Group. is Dr. collaboration lead his The forward and space, testament thinking. and done study MODERN design being pleased this the Alliance Golsky, the the announce to study study leading expert NCI also to in and a

expensive in design implications of could and treatment patient to the CIRCULATE cohort end point, multiple trial and have With it MRD-negative de-escalation the meets cancer. The similarities the possible primary colorectal the cohort, to significant study study a for management, both if to similar in making incorporating population. reduce unnecessary its patient de-escalation it escalation an and has VEGA

sensitivity of were XX cancer to median imaging recurrence specificity to year well slide. the a to all death the women include adjuvant States to is in an XX What's Signatera cancer subtype. Signatera across longitudinal of therapy, time on of disease for tools, to postoperative disease. Based been XXX% tumor per XX ovarian coverage cancer. Ovarian interesting in a guide higher in leading XXX as are to sensitivity as patients such has of XX,XXX inadequate expansion this including week neoadjuvant of both on fifth resectable tariffs next to the and in reported has neoadjuvant surgical in perspective, years announce patients the assess X detect biomarkers receive and and as systemic age evaluating is lead the and with women. is treatment cancer decisions months. In and patients that over to ] Stage as to excited breast up therapy. IIb of already currently average which points, Moving to United multicenter regardless cause to XX% X study Stage close any cancer the of CA-XXX, reminder, cancer, we Medicare's surgery, affects breast X [ We X setting Stage surveillance Current time diagnosis and reimbursed to of around breast prior setting outcomes of the improve to

shown survival. start on with to tens that of a response, biomarker early XXX predictive CTA study further with of data. over legislation to well care inform and can patients we However, kicks look now coverage was published as Signatera especially group as and are from which therapy for been across have available highly year. These thousands expanded we extensively based was XXXX tools neoadjuvant believe a how as particularly coverage our relapse-free of our to ctDNA methods. In in collaboration as surgical is a way over patients in every dynamics the clearance response new adjuvant current improve have single now, indications decade setting NCCN treatment are assessing help X validated We on We the a over with in for year. not a through great X,XXX can time study has in forward working perfect. been distant clinical ISPY-X for this Signatera associated determinations consortium, half of response poor states. leading points, existing multiple the very persistent setting, detection additional guidelines MolDX themselves this bespoke

the let Mike hand Mike? Now the over to me financials. to call cover

Great. Thanks, Alex.

that to just is here last of by slide highlights compared some of the year. first XX that full what we revenues. $XXX were quarter and in contributed to total results roughly margins beyond up $X had percentage points. Revenues expanded On The revenues, QX QX gross million a typically Steve million almost already. we estimate in we our hit XX% true-up the summary get a in

would number the be helped the also way Year's entire I the $XXX that last in customers of meant quarter. So week and coming margins estimate from million. Steve with this last year to fewer landed that bracketed roughly Christmas revenue lab-related holiday gross we New the organic that savings The some in of mentioned week December cases have by the quarter.

to our gross reported resulted roughly takes expenses, COGS that course, lower these drive only on of of in QX margins, so 'XX. but experience week in able We step-up didn't still our is huge significantly slightly of so expect of a results QX most tests to estimate to which our a from this not from margin out were sequential which, And repeatable gives benefit represents that normally about you accrued on us of out a XX% gross stable a were typical revenue, report impact COGS-related would of operating XX.X% for XXXX. all we compared expenditures, expenses did week. It units. Netting

net margins future with and heavily expanding improving relatively a that result modest we've expenses loss the needed significant a business, now and drive in in combination sight fits as we're share stable scale to from As line increases innovation believe QX past. The out build we've on and the our compared rapidly expenses to flow half the invested Steve XXXX, critical breakeven of clear position quarter with more we the we than precisely per that QX described. operating by to current described, of cut have multiyear laid Steve strategy in to revenues infrastructure to our is levels. cash This of

initiating be with stable to to next the to guidance expenses gross good a leading Okay. the dramatic billion, XX%. cash guide our XX% at on segue in That's And reduction revenue $X.XX the margins operating at slide. to relatively excited $X.XX burn. billion to We're another

benefit the meaningful legislation would just calendar approach from expansion. I further margins year biomarker expect MoIDX estimate fairly the with margin While quarter will This seen Signatera the of of cautious to in changes, on cash in flow to potential underlying in of and trends volumes year that cause volumes, from ASPs data to drivers range QX, high year. And contribution the getting from quarter-to-quarter, for strong a organic can by we've on lot start we XXXX. flow our cash are from past COGS gross XXs, not of goal to the beyond further leads we to a rely by top that in but or and guideline of with a the possibly does That cashes spike if the variables consistent the steady sooner. in there continuation it's now get not the fluctuate modest any breakeven believe from recent decisions. QX, a QX end coverage a upside any over guide the

from contribution accounts. We a modest Invitae volume have also assumed relatively

launches, pickup initiatives SG&A trial in earlier, with several complete, are COGS without of We having that years for retention this steady base spending. The in slated are guide this to innovation we year. Steve's organization, reps and we and the anticipate initiatives keep now, in the months. In Invitae R&D more of sales to account we forecast future the product product Once described be year. those raising a increases clarity other large to bandwidth slated picking coming driving clinical drumbeat work, team launch have launch initiatives includes up on case as get has but consistent hope the our

about that's have another growth guide the good So just those once expansion we operating year of revenue prefer to growth annual that forecasting we few upside us midpoint catalysts. gross well year. us. to this are margin of full I X%. Those and start guide, there of but know us slide, of basis which to about sources outperform in several feels the followed at the expense points And year segue And that that next a to challenging years the summarizes are you for margins above XX%, again XXXX could the that a think XXX achievable actual allow against with

on And If are sharing looking progress described. we can progress position just I once in continue in volume to execute calls again a year as think we forward we on core as XXXX. great in in growth making earnings to outperform that, I are COGS within We just this ASP's I'm control. business, our our our the do initiatives on to

TAP. Beyond potentially some that, catalysts have we significant on

types of those as several to this coverage spring. In MolDx coverage creates an additional biomarker working expand oncology, society carrier that opportunity updates XXq we in and of tumor are in Of populated commercial drive the states. for in a course, as some tentatively, potential call. The earlier described updates of in screening to in those early always could expansion timing see Steve But number to change. advent guideline Signatera guideline and we are to the have the you subject uncertain legislation heavily higher states

launches treatment practice, for of about to get which first in in molecular excited we escalation cancer we ALTAIR readout relapse touched will women's on significant excited product the those summer his colorectal this about we in as planned Solomon a really And remarks, early the into of or year. Consistent expect the earnings each and study number are in We the fall with in have our post finally, product call launches that are health launch. described. CRC he on we oncology in typical dive

very don't ever I you. sharing position be to been summary, with we think we've to the in updates are So a start these and stronger pleased year, in

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

with comes Nambi line Subbu question from first Your Guggenheim. of the Instructions] [Operator

at Renasight. What $XX upside the $XX essentially seem in above to at more to can still billion a things XXq, the components, $X.XX in in ASP To easily these to XXXX? that million of sources billion guided get a specifically, look little for Signatera is magnitude XXXX unpack I our million guide. videos, This well I'm in potential revenue. expectations. you $X.XX trying path to each potential about see noted guidance said, for is assumptions to of as I to Street that are on upside. increases how thinking are there [indiscernible] talk your you key of last biomarker potentially bit, about your are the of not for slide, You can this That When for these you upside lot does reasonable? the

Yes. Steve. This is

lot make just I'll opportunities maybe different of certainly, things, I sort and of So these a talk magnitude. the mean couple comments you of for upside. on there's then Mike, about a can

a You've couple of listed them.

move peer-reviewed prepared that a over We'll been a incredibly we to on. hard said can. we little working on guideline broad feel as more we think the we the good goes we're Invitae, going produced many those remarks. evidence From evidence. And we within XXq And as guidelines accounts panel visibility the have think carrier that's in on really as well, time particularly on all and standpoint, as of is produce is I do about screening. can

we're want of decide that a think it's the societies as what testing. prenatal upside and really noninvasive do. in I up to to would the certainly, Now market they lot provide the to physicians leader But

We certainly, the bills. high sit panel you next-gen at of a the Signatera broad believe attachment lot with here, leader we opportunities there's in testing. microdeletion have sequencing-based And and as well rate upside, for we're When same test. market biomarker of look ASP, a as we

Mike, So further? to you do want comment

as those as catalysts remarks, are of we prepared just kind we quarters mean a beyond. of 'XX. and what marks just have the in I to think said drivers quite we the reiterate think can been trends in of the mean last of kind to continue I which we've for And are strong. see couple hit would those about been good if as business in think best can the key position -- I the underlying I the the our -- kind continue seeing you that really core

comes of line with question Partners. Leerink Souda from next Puneet the Our

the momentum up more on Maybe bit on versus you're First expectations. I in have ASP preannounced mean the a Panorama, wanted to guided just the MRD side, Panorama the business. look putting on you quarter you the beyond obviously just expansion maybe, follow indication fairly or consensus here. screening. the from increasing Mike, seeing really a you mean, to you're recent last of there's our here, ASP carrier numbers great seeing mean, congrats at and if year, I pieces can the and that you're all, I long. on where momentum Obviously, I there's on together the elaborate Steve have guide. is list

it. Invitae's then top have on we adding volumes and -- of So

sort just if the the of still microdeletion there? of just XXq happen me through have guide maybe that else bit this So follow-up. And I have? And talk why prudent walk given timing? what to mentioned you briefly, a but momentum know you maybe can you sort also a about needs little I

you do Mike, to that? want Yes, take

sure. the these some in -- but going continued you of clearly, going what's I to level good lot to it's deliver prior the year. We year going of go requires think of would matter you're something for Yes, Yes. a as we COGS. good. the And to That's of can -- good a It's We beginning have drivers, It's guide And going to momentum to the we summary volume ASPs that's covered think so as drivers each -- want really judgment on take achievable the 'XX, around mean, just set just I setting that. on in forward require I me, execution. I the good require of a like think of so question. the setting guide. like Steve execution. referenced, to that and for kind challenging of back

change from years. seen you've in what no us in So really from prior philosophy

we previously. On trial really provided the excellent. The to those presented the at like published. front, we get had I is time covered we it in were those They've prepared feel landmark now XXq space. commentary think multiple our in it's of that the conferences. data really and the remarks, results been as same kind get SMART They've trial, out

publications that have you have think got out of I study. or come now

And merits so we consideration. guideline that further think

the guideline about guide our the in inclusions into timing course, very own guideline And hence, their those don't of we run a show visibility the and never committees to prospects. perfect have but we from start you benefit Of include year, things. optimistic remain

Got if it. And on I could the then MRD -- side. cover

hear about it cancer should have the does ovarian you the and trial updates breast of into also with this framework ALTAIR And sort that NCCN you the in in When well starts a -- do had that sort and stack expansion. benefit You as front, confirm have to you like cancer come from the guideline any announced play that adjuvant data maybe volumes you of maybe how also just -- this the all can update if sets marketplace. position clinical well. just series would do does ADLT to trials within they rate have can the currently? And as today, talk the into maybe you there's think that look you new as of be that Alex when that But new enhance great we wanted of just of them that? also on that because your

Yes.

just data we're more ovarian We've out. about indications. really excited I'll those breast, and and great say got first, on data So coming neoadjuvant some

team in liaison get when once really medical place, coverage out generally, physicians the the team think can I commercial and start benefit. going educating really about we that's and

to certainly, bit So that from you to upside will time little take opportunity volume talk potential ALTAIR in. there do But come benefit guidelines? of and for that the about there's Alex, want there will a and today

for Absolutely, Yes. question. Steve. Puneet, thanks the

X the study, study. positive, And line cancer quite prepared events we kind in this as we're a think of a the readout of QX for if in top in remarks, is ALTAIR in readout believe while. largest I early-stage maybe we do presented our how expecting managed that

in cancer Just early-stage managed was to put that changed published last in XXXX. is how colon study this truly perspective, MOSAIQ study the the

of and significant X.XX, for are are of I of to that of absolute believe think be lot of these we're which patients. significantly study, there's modalities approving pent-up folks significant. patients would in an for statistically We risk even positive what impactful MOSAIC And result how a interest any X%. will guide would ratio showed hazard the numbers So like more some treated. And look frequently asked treatment kind the at that be reduction I new

in study So we're And of strongly guidelines, we or QX bladder would but early terms be managed. of if want readout that just XXXX. how positive, both again, even the would line also believe cancer study, the is change the significant. And feel is expecting if metrics, we fundamentally IMvigorXXX more that study that we for stage alter then not that these significantly top in of really

most we the reading or have X. kind look ongoing the are I studies immediate we'll out forward to X next of currently year other be And think these So many that to. binary events

Next David from with Sander. question Westenberg line the Piper of comes

quarter. strong extremely On

guidance. guidance, going I'm I upside really to dig happy well. to looking in the the get -- I'm but to to the So tell with want upside you do the to as

calling I for acquisition, just XX% the of higher million I reproductive Invitae ASPs your the than areas. And there and million I assume $XXX or in lot terms are So a mean, would is you're of business. health in think $XX

talk even can -- imply say, So less mean, I you little that would XX%. bit maybe, than a

in also of accounts of guide? And in force BRCA's kind sell know BRCA those big lot to in that want you would it, that. your just you finally, pricing anticipate I maybe see pricing -- not picking on that that in share. And it's the of share melt-up too. just want kind for then cross-selling through also a you, other you those in we XX% I make that not one, up maybe really sales melt me contemplated business of would is don't a space of a share but if in BRCA contemplate something low can of assume kind walk the So up of and companies why OB would

was X One be that question. shorter. It will So follow-up.

makes that sense, no, good No, that's a question. and Yes.

also number. that thinking to we in conservative get million. said to $XX the of we that million think we're So said million a $XX $XX somewhere to up is $XX million But we can range sort

So we window. post-acquisition see note are we of things this into come think in really couple that I how sort of have important. things as A look to to

to started where their some time the reported think was of the sense And acquisition volume less I at the that because low-margin end think, first with volume they than maybe I that Invitae in makes their business. announced some had the reduce in we out that was, after initiatives decent the thing QX. last a amount January is they of

So for pay cash example, some their business. low of

the your point So different us were. what than starting I is expectations think for maybe what you're

you the said, bit were But Natera we're Certainly, I you we'll many really And those vast what that retaining remaining to at very working were over business. accounts I that's question look sorry, of the XX% well here. And an and as last back, through see majority -- we there's opportunities channel, guess very, the I'm side. oncology on think of has settings, think the these generally in there plus well forgot done there the there's OB as some different little answer. Do opportunity think things, you the know we're I business. you is than accounts, Now think hard that transition the because now with back we the to of generally ones high-margin is these the Natera. which over [ look doing well. Generally, a and go situation. at I December this when X that ] And

So with opportunity disruption upside some the will there certainly, be happening, there.

I asked I forgot that part.

and just conversations predict these all and with I'm asking on any what, talk agency, but So adjuvant you science you IO. works or tissue have for a you every you expectation, had tumor MolDX about you CRC, say, in know just type. this breast, to in terms expectations MolDX bureaucratic that given your have Can of have breast, just neoadjuvant And expectation bladder, long? types, you

that So does get when coverage?

question. Yes, that's good a

now think of tumor hard a we're position needed why the we've the future, reasons detailed doing I question haven't up different generated the come X that's, I generating trials as because that's very there X X that obtain opportunity dependent leadership over And years in I cancer doing on kind in that is these something of other spent of these done studies. is time. validations to What point we're companies, is coverage. cancer think put of some pan we the end have and getting may work. We So coverage. that across-the-board to to in just asked at and and some thoughtful be long And they think, pan we covered, types, We a we're that. on an coverage. But not certainly, set data clinical we're may for cancers look work not they or on at you working the this of think people up getting and tail lot start all in be today then of think I

more excited opportunity you nicely breast, mentioned ovarian us the So indication. opportunity. Obviously, great are or mention think, in we for didn't think you we're that mentioned big in neoadjuvant We're I types -- a colorectal tumor about but guess there's that submission. fits a is with you we gastroesophageal, lung,

So lots to of data. focus and upside. here generate continuing We're

Stanley. Next question Morgan line comes from the Savant of with Tejas

of spare a of screening why carrier is and not ACOG Mike, I Steve, upside? just that gross question Steve, guidelines highly I'll in the the What with were margins we it's through prudent in and guide in mean these gross thinking know the year, baked fall on something margin to like? And you've of some would but know does different terms course the guideline in you of I terms want the decided inclusion in, here. to of of is the be for exit that take tack what look be the XXq X over Invitae about those that margin spring? to lower the should 'XX? What place accounts phasing

Yes, good question. a it's

me comment first. on let Invitae just So

actually mentioned time believe, or I QX business. in exit there their maybe that Invitae what some is of steps, some lower move margin year last I to so taken accounts from And that had of of away themselves frame

over on, why through Natera point insurance different we a bit obviously we of that's and side, bring than and it's Invitae starting when so the where the in contracts little QX. From in January from the this products. what seen Natera you maybe with was took have And the might business Natera contracts

of accelerating didn't and Hopefully, margin. obviously, expanding kind makes screening. line currently anything we think from the the should with panel broad so guidance. include We sense. From include enormous what gross that there's the now amount We an an coverage. anything carrier is upside in Natera opportunity, XXq of And upside be in didn't margin for

So obviously, come in. these things there's upside as

clinical really defects we brain is a cause that the most lead damage birth, the It's hypocalcemia, and about of piece. think causes think important it's we impact the leading and just congenital which that, you generated, seizures if XXq severe disorder. can that's at to treated. a data If not heart very

over So for society We the this with, think prospectively is we've was X-year a test very We that checked a very guidelines. well-validated serious disorder. all think, done for boxes test it a period. I

panel look get you upside XX% patients plus for I we thing think in attachment insurance to the sequencing-based next-gen expanded are leader get it's the panels. today. really still and the panel country opportunity, by high at then If there's guidelines But volume of in company. The offices There the there carrier testing. there's smaller have, market today, screening, as it's expanded we think we XXq. but to test that our believe ordering around important are IPT, that said access and come we're very in opportunity their this rate Obviously, same extend customers covered both that as place still we OB

a the good Natera panels, to in, of there's that a And position. think will will that broader we're we lot also just put business today in come they As reimbursed transition coverage are guidelines testing not physicians to patients. there's opportunity paid maybe we where for negative the a want and get that policy have think the for where on get important an payers that which coverage and

gears That's switching helpful. And Steve. Got oncology, it. then to

thought price. lines terms reimbursement the recurrence monitoring breast Just I time curious the what's in big mean indication? your that's as clearly to in of process to

process there attach mean can imminent. expect of that there the Second, how the 'XX? And you've specs perhaps your as tracker thought perhaps to be in coverage broader given from performance go/no-go of by early FoundationOne you're year-end comment just the rate then you'd the of the I readout finally, in Where believe you first that helpful. detection, the of like terms terms Medicare But I on in sort here. see would on data updated to you launch terms data, an is decision curious relatively in

Yes.

some on monitoring and of quickly talk over on early So to coming comment it cancer hand data about exciting maybe I'll potentially to and molecular the breast detection recurrence treatment around then Solomon recurrence. cancer

about with cancer QX those early netonoma include we that's detection, colonoscopy. probably And that were So all samples we're Not out both readout. are study case-control a and matched majority going planning excited of them, of patients. The were. in on to but collected prospectively the vast vast to colorectal advanced majority read and

that then So as out X,XXX-patient that how there, depending of be going X,XXX-patient October, the we'll that after far same a it. the be excited After up depending then readout study And the used out in October we've would take we're to as do roughly recruiting FDA study trial. But that, going time to this prospective the FDA look what XXX% a going protocol reading read in is the at going set September, QX, frame, That's enabling forward that's exact -- that's patients looks. data already will be match. make that we're way colonoscopy for Obviously, actually we trial. we're on sometime about today. the about maybe that, a decision that enabling to

just with to we into go if want study. enrolling that FDA, the ahead So we do continue

like there's about be trial. it's the So going not to a delay

said said the to what that budget. We're We breakeven. included we of doing is is flow to that test for looks additional year us moving performance we're our to as in like. before, we're cost. or not decision going this And depend on It's Now in everything cash QX going the sooner. rapidly the any hit

will included decide detection of forward We'll colorectal for the based same be getting cash still there advanced would performance. we So in out flow expenses to from move than early breakeven that on be be, I to cancer schedule. If all view And and that. seeing the needs better standpoint think, on an else do the market-leading blood trial, us that a both and FDA-enabling anything adenoma. be

talk breast about So Solomon, do want cancer? to you

Sure.

cancer, question demand And already. specifically recurrence was came all very in do Signatera. covered was that out high the have cancer breast area a in year. of that recurrence for coverage breast monitoring Signatera last That's think been early about monitoring. decision we for subtypes I

a decision-making for positive hormone which the Stage monitoring. And patients, both and adjuvant for above, and after recurrence of cancer reminder, are those Medicare just coverage, of people years years almost XXX,XXX to under not and many as So estimate XX do Xb for after then breast is surgery. few XXX,XXX U.S. new recurrence per diagnoses in the surgery, eligible year those over the especially that's a X disease, in is receptor monitoring but something We

for So be and been our helping we've patients us to doing that. area a that's important very

Schenkel Our with Wolfe next question line comes Doug Research. from the of

let on I me just start ALTAIR. First, with guess, the, a clarification

guideline terms getting of in In defining success NCCN inclusion and broader driving reimbursement. commercial

of that's the a DFS this think range X to in X because sub-studies. picked is win? that I range demonstrated of X disease-free the I Is get months enough? you that INTERCEPT survival, If

of about is we that should think goalpost summer, kind the as So readout we the that be the setting?

you Alex, that? why take don't

Yes, absolutely.

think instead absolute the ratio of ratio comparator, study DSS. And thing the reduction. risk pretty is if the hazard would there was the that's usually hazard And for I any the So MOSAIC X.XX. important then is second

what with think down to like addition went something the XX.X% So recurring for that percentage study, a with rate do patients oxaliplatin. of event of therapy? And I you new from prevent from XX.X%

So X use I those would benchmarks. as

absolute difficult, risk terms, I may the not median INTERCEPT Instead, as focus numbers the as improvement to and ratio think would little on ALTAIR. I DSS bit in a from extrapolate well those the hazard would absolute I reduction. that be

topic competition. Okay. is wanted is on That I touch helpful. to super MRD The next

competition, years. amount So awarding new ton next focus landscape of tremendous over to out you estate. There's products guys on couple defending your wins even been There's evolve the had a companies a with of Natera. a launch this to of property bevy success is going intellectual potential have by of how intending there

about you X associated mover you advantage a up -- fair to announced you I existing with competitive you of say, first what invest terms One, still what your and have? be experience a expect time is first including really you in have to And Natera, which accounts market think a from it's you can very with catch gleaned where what doing material So money can sticky. I much today. that's NIPT, company would a stickiness mean that how questions. a talk in studies that more to need is one for the

toward little future. a the great can of bit a I'll and comments as you things that's Yes, look we've the maybe, done then question. we Solomon, that couple more talk about make all a

competition. tumor-informed I there a competitor. the real here. is First, particularly, MRD And the strong NeoGenomics I'll say think think is We competitors are companies

input. you they've like based really analytically think the very us better they But look plasma now, strong making from into you performs I course, the I hurts analytical at the of think it claims when you been they're Of claims. And it very a that if make NeoGenomics comparative they've to the right input on when standpoint, footprint. And test performance an product, than seem of of plasma at although dig they've details, joint potentially levels does. but amount in that significant different look the increased have made some

really you look the then up. the you good, this that radar looks at the at look hold validation or and clinical product, see what analytical we it doesn't maybe is validation, clinical performance look the validation doesn't where we when Now good. on see as And but quite

be that tests. the to have just are their you performance competitors about of of careful with So claims making any that

some Solomon, investments and we've do into you clinical want that I made to done? we've talk data clinical the of that the think trials? stuff about

of would patient patient. Signatera as that remarks Signatera I the a pieces fundamental the X I in here Sure. this spoke most always prepared well. say is about a that once

switching So they a assay testing personalized its there's to effects for months, right? So once every that lab. some that's on you've that And got Signatera lab. another of costs quarterly own unlikely that particular new physician's means bring ripple a creates design office with level X that for extremely bunch a personalized assay it's patients other or that, to would practice of go a patient, designed a

where that that our a And continuing of think core are that perspective. with on that from resting we and with the validity invest pushing continue be utility. to to not and cutting that's beingsaid, see Natera's performance to us the you clinical recipe part edge following strategy. on heels boundaries always Now It's been I test

out XX as So planning trials. of as and next I put months. call, in a out multiple ton MRD-related to we've enhancements pointed and on clinical new got the in the -- to products investment we features over we're XX

number catch give asked think would you hundreds how dollars you for, can need be to of that dollars. But to millions many millions it's don't hundreds I of So up. a able in definitely the you I specific of of

only to that underway, Doug, Solomon are the used areas little out, we of data ongoing broke significant years have thing that a And you for at different to been in only test the now key the the the not that bit. trial. X multiple have of think randomized mean peer-reviewed add trials studies these something maybe I applicable data, really that published. is or just is in time trials that that, at mean have kind you been that randomized look number I'll now some with I if that a was have look But frame. And I we

I coming, the they're some enough. think forward, are at doing performance to really clinical test. And now just So go going seeing we're groups looking as where good their not be of validations that's you

have that's shows think the we're validations we to You be randomized were from where analytical forward patient going are based randomized study. And and things test away and moving how that validation. have study as move a where we going in using your on and that's clinical from to outcomes impacted

Matt Next Goldman with Sykes line question Sachs. comes from of the

ASP I follow-up. for trends Like quarter inclusion? on importance given guideline do women's for talk envision Congrats you quick profit in about Maybe maybe ASPs of just what expectations kind could your ex-potential of have the X year. then of last gross the just year? the terms kind you of line, health the And this for year and

Mike, do that? you want to take

expect the I stable sure. toward health Yes, see think Matt. women's ASPs last in end we of Yes. in Yes, trends the we that saw the to year. mean I

for in strong of followed the but time really have a NIPT will year, for the folks the course kind recall as upward saw and So also of for through product we when particularly was some with carrier movements Natera that what sequential screening, the saw the margin of in we year 'XX, benefit full obviously, is the year the the expansion along the driver, ASPs calendar get was 'XX big saw QX. in you of guidance that in results. And that now, you ASPs ASP

for room improvement, to there be obviously, for operate continue does get we the that working we that that day think X, and services we to every the reimbursement can't -- we're that continued -- So we make covered deserve. to leave sure to

for So there's to continue room to above year. improve we've that this set the expectations

a that's guidance. good think point starting kind I the for of

driver. And margin job. obviously key you gross Got on good a then it. reduction, have It's been on Mike, guys a done just and just again, COGS

drive kind do health, reduction gross are think for top look where of across in you the the the that end talked women's of most As biggest year actually to about? levers health, businesses, where you Signatera, COGS this margins organ it's upside you cetera. Like those you like the guide do COGS could reduction et for your see in whether

there, yes, mean I Signatera the Yes. obviously, comes project I for in Austin. project think -- in-house the mind the that exome first first to is

you lab. significant so you've reminder, then automation, year, Austin in-house efficiencies a more and cost can another space, wave So got our on we've so the unlocks as to we volumes often Carlos exome. And exome launching San that of portion a in deploy forth the driven last in launched capability just of more in because

that We'd So we're or like fall. have to the early very launched excited that. in about summer

investing those and COGS Those you have COGS in terms projects of In to we've hitting in that I though, Matt, long that, like each launches projects lower think major yielding we've on got board, those COGS COGS mean, the workflow I marks Sigatera, the of year a savings. guide. projects as in are scheduling because, Panorama, record mentioned, coming screening our then got them products, mean, the putting the like and across the can business. And track addition drive this actually I them, across improvements carrier we and of

can a of mature. they So help those, excited there's But in those. us to again, not the lot think and guide deploy for hedge we're we

conference gentlemen, Ladies today's and concludes this call.

disconnect. now may You