Natera (NTRA) 8 Aug 242024 Q2 Earnings call transcript

Good afternoon, and welcome to Natera, Inc.'s Q2 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the call over to Mike Brophy, Chief Financial Officer. Thank you. Please go ahead.

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

Manager and On the Solomon Aleshin, Medical Diagnostics; CEO; call via is Chapman, Steve and being General Officer. Today's Alexey broadcast conference line, I'm Moshkevich, joined President, by of Chief Oncology webcast. live our Clinical

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

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

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

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

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

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

Great. Thanks, Mike.

highlights health new we QX QX. volume another units what COGS organ Signatera accounts and grew versus of Let's quarter had board. sequentially quarter on of versus We by health, year. We of had seasonal I'll and grew last another posted was trends were a headwinds, the gross winning We of Volumes up were strong to a very QX driven a delivered women's another and to next was up get excellent quarter last up in record XX,XXX into QX. quarter. to Revenues And quarter In across over XX% QX growth. strong in the shortly. slide. QX typical over XX% the oncology, volume despite XXXX This ASP another great margin and roughly strong excellent year. sequentially get volumes compared XX% clinical ASP the strong compared we that with

the All we means margin of gross and our revenues raise for full that can in guidance year.

points growth margins centering of the an year. we gross now our At guide XX margin midpoint, in from margin. We're transformational posted the are XX% a and XX% We our gross annual and implies continues. guide in gross $X.X revenue last increase the around roughly year about and the revenue new nearly excited billion roughly progress of percentage XX%

clinical developments and positive on that discuss today's the many also product on side we'll call. We had

for make the are ALTAIR ESMO the not line First, going I us want know the time in they to flag let to investigators submission to mid-September. that that

the results GI huge current we'll their there's As and target done. CIRCULATE by [ to ASCO investigator the is data ] everything January, and plan stand to more get presentation, generate Their patient do and time let review a analysis work. them in needs to so team for of amount know, ready you them and

in extremely which colorectal critical spend have time important will and significant the believe These survival GALAXY we ESMO. study, data calendar meantime, and full the today. we'll shared readout we because it in the XX-month for from results cancers, overall of data readouts an first other be is marks importance of at reviewing includes prospective This cancer. readout the In very Signatera that colorectal

new by recommends a genetic will the patients with update Solomon on news Kidney disease. organ the testing addition, on win kidney paper will and provide Prospera recent major National an published for majority the some He health discuss In consensus with Renasight. that and Foundation of

feature preliminary differentiated the the detection and that upheld rejection new across of a Court to launched both MRD also percentage heart enhances the Federal made our NeoGenomics. and for test allows more with front, Prospera by patients for of us cellular RaDaR antibody-mediated a transplant July Heart organ cell-free rejection, We on acute in then rejection assay legal accurate donor-derived alone. And the injunction Appeals assessment deliver risk finally, the DNA

first reminder, the a last issued As the Court late year. preliminary by District injunction was

decision this assay that of borrowing recent limited So upholds the order, with sales exceptions.

our case pleased jury the year. look are the to with outcome to We forward and next presenting

Okay.

drivers the the into next business on some get Let's slide. of

in unit shows volume absolute slide and time, over progression growth had both growth. of rates year-over-year the terms The we've first

quarter results This of like looks the we've the had last years. one X QX in best

declined to see from volumes women's health reminder, existing new customers QX. clinics because QX pregnancies fewer our compared X% a to in usually XX% As

same-store account that sales Given hard business is the wins. in overcome existing to drag new women's with of large book volume health, we of have

today. our industry the product growth analysis, particularly enabled in see was the partly midst nationwide volume quarter a to in which shortage outperformance women's QX. The new continues RhD to May noninvasive launched was especially of health beyond Rhogam in strong the in our we pleased new above by differentiated I of the and Fetal So features, that affect

strong Horizon, market see and NIPT the leader our we're screening. in products, the carrier expanded very where to continue health market interest where leader women's in core we're in We Panorama,

deal addition growth to full which In we organic the quarter. in in got the from our that Invitae announced contribution we boosted January, that growth, a further quarter

We both great also another quarter for Renasight. Prospera saw and

to and We here growth perform accelerating. is well continue

course, and Signatera the outstanding The ] slide. trial major metric always total we had a [ Of pharma growth volumes orders the next on of as as units. shown, in well chart in in another the you is was Signatera we've see Altera which quarter, clinical clinical clinical result oncology volume source as can includes left-hand

setting of The right-hand the clinical the over chart quarterly progression volume time. shows

units about big step-up a see QX, We in X,XXX X,XXX the that You had we and per past, in quarter. XX,XXX have can typically we roughly followed in units now QX. sequential added or with

of quarterly adoption. is expectation think we Clearly, baseline experience While the right continues are XX,XXX to to roughly still the drive going Signatera growth with units and physicians meaningful forward. X,XXX having patients

drive that us to of QX growth all helped volume best growth So revenue recent in one performances the memory.

change This next slide last the the alongside QX in years, in QX XXXX revenue shows to results. X the

major as over In the strong some across the engineering appeals been which volume reimbursement Even upside projects new reimbursed. a can continued trends, ASPs we're on, upside to and that year. Women's cases again tailwind seen a very we to the biomarker potential source we That without them. that the we modestly rest the that substantial of the year of a additional getting to the both be has and may modeling ASPs positive provide of improvements guidelines, of trends some we're for were on and once to make remaining Advantage as were through work analysis, state addition still make continue made that the up investments and this persistent of growth through undertaking data positive are health ASPs continue we payer really year happen. We ASPs model we've Medicare the positive women's but see businesses. Signatera outreach quarter. of stable in momentum QX, very through very fraction list plans rest from we have in but internally, ASPs health

year, will we accruals include we true-ups do our is seeing prior execution we set lumpy, but above cash true-ups expectations. last These so of this in of be collections excess in don't they effort these is why future the represent XXXX. All guidance, driving which our true-ups in and revenue revenue are

grew improve, of goods we had we cost benefit reduce from Signatera now is modestly the prior just sold. our in remained net achieved metrics trajectory stand continue the quarter. This about result ASPs burn the well the over underlying to next the another gross margin efforts same gross While we the QX range again gross above our story. in to team total both tell in full XX%. The of and both quarters. shows above and slide declined women's revenue gross as R&D now and true-ups COGS points record Underlying COGS are organic cash percentage that our margins our margins slide health The results time. $XXX, quarter as margins the above net the X of shows and

you you while investments that launch that historically, newer story, to operational continues on generate are substantial women's and of commercial to can getting we health to the now made see those And base, initial For we that Signatera. are cash. scale

for for We above is cash in QX. pleased seasonal consecutive expectations potential are very the given headwinds flow second breakeven the to be which our quarter,

even cash say flashing the well Looking breakeven future. the incorporating I'll by when We year, into of we stepped investment we R&D the get cash not our year are second half again. to flow in for hit of and this breakeven into May. full in the announced positioned sales, investments did the flow to up guide

foot to make over the is fantastic from commercial need organ health products the our updates everything patients. With on to deliver our call to strategy let we're to hand gas oncology. we me and that, to doing Our for Solomon keep cover and sure

Solomon?

guidelines chronic affected in renal key start reinforced importance Good for of organ testing with CKD. on afternoon, now for genetic the kidney Steve. we everyone. Thanks, Renasight disease patients data and test U.S. health. the XXXX trial I'll launched updates XX in million have by or society the the Since genetics,

paper choice addition the across showed as testing diagnosis that testing. strong clearly genetic out and X a range National genetic with positive and with agrees our in the cases NKF and out of in also in in a paper counseling of We, and patients change nephrology, primary genes. in conditions and our positive We recommended NKF that The majority of about for a paper position covers CKD. strong test of therapy. The too, pathology multi-gene trial, Natera NKF patients comprehensive a that which lab patient broad pleased KDIGO, to in X reported last with X share testing wide are of paper a consensus a experts which Renasight panel for X and the characteristics. X their of clinical the utility the positives new a genetic clinical May. on endorsement input benefits RenaCARE in recognized to utility Foundation change kidney week who patients perspectives. The from XXX Kidney renal published genetic out recent from diagnosis, included call leading recent genetics, to follows we leading our also consensus on to X update guideline earnings spoke with provided

support impact Renasight means this a of on have to now the the these positive recommendations X We for genetic of So nephrology. in adoption testing will major from continue believe organizations clinical test. we have

Prospera, heart and are seeing multiple account wins in Moving kidney, where lung. on we to

Quantity the a and of and disproportionate a see turbulence the we out reported some heart rebounded in cell-free a like trajectory, year the Score. DNA. can for fully we Prospera be Previously, to transplant growth DNA donor-derived changes has product Prospera of recently the total enhancement is by or cfDNA, the would cell-free believe the in last Heart growth. I fluctuations donor test highlight Following compared influenced to share in that taking but market Donor launched called reimbursement, our on blood we after fraction fraction positive background Medicare DQS

we can false of previously those to by submit in clear levels. background now too. In Prospera publication the surgery, study just of improved For approximately background have for this to This example, introduced second DQS, the and new a it showed which to of transplant Heart patients positives biopsies, available vary. for DNA at cause all from presented those is and levels using who Prospera's underwent threshold, later cell-free study are XX%. We or who malignancy and Transplantation Heart, infection, year. all clinical addition reduced XX% a was fighting and test cell-free plan fewer peer-reviewed decisions unnecessary the it's a enables off Prospera This dd-cfDNA. for Society an we for feature sensitivity the of independent DNA heart to April, increased International that DQS rejection With in XX%, also Kidney Lung

oncology. to now Turning

On was standard observed conjunction indications led another inform driven in setting after excellent growth Signatera with monitor breast number strong especially commercial saw Signatera new which in to in factors. the major ordering volumes by value front, multiple we impressive adjuvant was ordering in the oncologists cancer core enabling the surgery, colorectal This initiation, recurrence patient clinical in interventions. of disease the driven noted, the by earlier across cancer. U.S. is X XX% all increase the decisions over for to being by proposition physicians risk-based treatment imaging, and for as with growth growth Steve Signatera during of quarter. There of test We saw also at least all

cancer caught approach. over late for XX% surgery, which colorectal the historically too are curative-intent example, preferred is of treatment For recurrences

And to for to experience. and numbers mobile user are And We're week response and for from time the through neoadjuvant investing portals of therapy also being and specimen phlebotomy cases. with heavily and delivered EMR X monitor test digital are initial reliably three, Natera our of number choosing for subsequent in customers X results cases under under Record immunotherapy. in weeks engaging receipt integrations.

our the signed deal note comment in partnership summer. I for to on was on renewal up and Foundation this was final A commercial Medicine. One with XXXX want side. Foundation originally with

growing maintain and agreement. the and Signatera, oncology Empower focus our to products and business the new to adding have Natera For cutting-edge Altera portfolio. not allows on reasons, services to our companies decided renew This

For continuity monitoring services we any for of continue care, FX patients. Tracker will existing

oncology. map Now over in road I'll Alex to turn discuss it clinical to our

the multi-institutional traction volume Thanks, Signatera the utility Solomon. value and in clinical clinical Operational that wanted this to business meeting gain slide. At highlight of ASCO the other delineates UCLA core the proposition June, oncology particular based in And in continues I institutions over a academic one to nicely to Signatera growth featured was dozen publications. on from and and previous study from continued expectations, the outperform utility. improvements our really

who study reported majority this that negative, with III time vast of And high I resulted Signatera in valuable anxiety. Signatera-positive, the on treatment highlighted breast slide, outcome. reassurance patients Stage XX% cancer. of in XXX of with tested treatment examined to of offering change As this the a The evidence investigators possibly a improved change patients patients tested patients XX% in these

breast INTERCEPT This of you country. impact Some colorectal patients will the in very remember the is being but and a study how study cancer Anderson. in practice from a clinical across into of for great having This is adopted is positive similar cancer. showcase MD Signatera

and both we areas of pancreatic Merkel indications, disease clinical Signatera in have for study, need. several latter We these publications cancer first-time they the But cancer, believe peer-reviewed unmet are also discussed quarter, carcinoma. The new pleased muscle-invasive significant bladder during EBLIS in call. expanded and publish this publications then, two studies including which we in been represent there new since the cell are to QX also

review, carcinoma example, significantly under curative this by in risk after being multiple to in submissions For recurrence. The the forward paper, Merkel the Signatera new clinicians. submissions that outperformed with X.X. provide an higher year are treatment ratio established indications these will Merkel look carcinoma and hazard presenting This to later of cell on was Medicare cell adding was risk reported factors future. currently update utilized to currently We these the we testing associated

to future ahead readouts. Looking data

United further of pipeline successful, strong clinical States could, randomized believe we in globally. a and that trials have the prospective change We practice if

for for more interpretation. time notified As investigators Steve and us the review, analysis of the mentioned, data need Altera

to in reported PIs that we to to be cancer So being new study colorectal of at delay the presented. in the in overall and XX-month survival data they will announcing plan to survival forward ASCO September with overall January. We look the prospective presented defer GI be time to in the at and readout the the time. disease-free data on will ESMO first looking the forward being data. are addition to timing over results data readout Conference X,XXX patients, GALAXY outcomes Meanwhile, survival these in mature This

XXXX, the trial focused on opened. trial span after expecting being the out including indications. In recently XXXX studies Phase in breast escalation de-escalation colorectal IMvigorXXX III with a and bladder and in treatment to cancer, and suite to and we forward of some studies. continuing trials XXXX both trials both bladder cancer enroll that to Looking we're of beyond, cancer, also have recurrence molecular have these full cancer, we on Furthermore, MODERN read well

that We invest and update just I Signatera an trials a also early in of want we on. This we've continue clinical cancer snapshot have on program. is our as cancer standard pipeline, important clinical detection achieve high-quality vision practice. generating our to of evidence data part of previously presented breast to our to also provide

We make to blood-based detect colorectal a continue assay developing progress cancer. to in differentiated

collected finishing colonoscopy to that at in by samples. samples matched results future, I utilizing a on colorectal are We cancer prospectively average-risk provide near blood and will plans study the look forward time. these further sharing our details We supplemented

Mike? Mike turn over will the to I Now cover financials. to it

margins. Great. covered and the points The just year-over-year summary Steve in Thanks, the a the P&L next slide on progress. QX Alex. of key revenues is and

SG&A expense a lines, we've just the On over made several the growth-oriented as reminder, past year. investments in

women's Invitae, sales working the up is which from well. very taking team example, For health out

maximize a indicative the holding QX These are would I what investments and we grew modest achieved our clinical measured time and cash interest able like proceed balance increases revenues are second in and the step consistent we to had constant. to think we're despite described, income. in for trials. in how actually and headwinds up also here the slightly with being. We'd OpEx that balance of grow quarter guide, That's to to in Steve We breakeven cash seasonal R&D our like relatively with margins the while

Okay.

Let's $XX good slide. $X.XX million when removing the talked about. at to the On to This get guidance of the in roughly the on are bump represents expect true-ups now annual and versus QX implies billion. volumes implies bullish compared about are growth in beat revenue QX. the pacing, second far quarter steady The revenue $X.XX to next guide revenue so off XX% a revised growth expecting we billion midpoint also in the $XX revenue revenues, of QX. On million we we now sequential XXXX. we on and the guide half The financial are as and to a Steve year, start in

periods. true-ups guide always we upside future would generate our any assumes in revenues to $X expectations to continue second above the our guidance. Our half, And in true-up if in cash represent

are the second We largely for overall the ASPs stable in modeling half also business.

the So expect the Steve improvement sequential momentum do current continued we given Signatera modest that see to ASP, described. in

leaving track and burn. for repeat the guide investments are We we have cash this are necessary guide disclaimer all still QX, my planned unchanged the to growth cash versus year. I'll OpEx on we and make on the

breakeven we a timing in easily it's capital. expect are to in important have quarter. and at operating given level, of that burn reimbursement expenditures Now to due of this can fluctuations understand from vary The capital payers timing to that cash working quarterly we

less represents are So flow year where results. The a just prone these to guide swings. positive and the I statement, is be have quarter of wouldn't the full course, surprised we to we others income negative where have and cash

I expect narrow the gradually of losses course through our so continue year. to the And to

Okay.

your that, the happy quarter with with and we're very to pleased take questions. So

it to hand Operator? operator. the Let me

Our Dan Cowen. Brennan comes from question from first

needing of I -- an PFS trial, quarter. be on given then into to ALTAIR understand anything the readouts the read either the But or Congrats that on is they ALTAIR from out either PIs would at OS GALAXY, appreciate readouts delayed there to observational you time due time. I something, this on randomized the need trial that and see more OS Maybe GALAXY. from trial? And coming trial. not a might all the this is just on the just clinical the this

OS we how the benefit, of mean think So that doctor see here NCCN? about usage for if either expectation an what actually could do and/or we kind

Yes. Thanks, question. Dan. Good

get leading I ALTAIR, I work data to and patient a on together do line just the analysis. time too And obviously into ESMO yes, So lot mean complete think tight. of little to was the there's the bit a

which I support the move conference, want next PIs the large-scale excited that. But we about ASCO out So And excited And to think readout and really GI. the that of to milestone, about. perspective, first reading Signatera for big data survival of at it's kind the on to is we're we're course, definitely XX-month having something GALAXY be going is data a ESMO. overall

bit coming want you to more this readout ESMO? think, a talk do about, little Alex, at I So up

question. Yes, the definitely, Steve. Thanks for

X-year For think gold in the usually DFS the that is think colorectal predicting now maturing survival. cancer X-month it timing and GALAXY is adjuvant kind standard also we And perfect overall of considered setting the overall and about the from out. as read -- I cohort we're data able to is survival

X big that we provides of So kind upsides. think

I with think for predict outcomes, DFS shows Signatera builds for it ctDNA And possible clinical the as how kind dynamics surrogates also and it both development. at framework a trial results of future looking OS. long-term first

call, True-ups driver in Maybe assuming were I that. Mike, that discuss here if X last changed if to back of you price from a don't now And just just for been pricing, I opportunity the then then sounds look know quarters. in Signatera characterize follow-up big on on maybe there? think last guide a half in like? up a you're Great. Any have like I step the pricing. And price. way it the could obviously have what flat assuming anything the year, you

question. the for Thanks Yes.

collections months moderate. very better them. I up last to we that do the we've surprise I to seen ASPs reason wouldn't again, it expect to they're that some mean, to they're true-ups, over or see us additional the cash we really stepped But XX the meaningfully why more in hard so. because don't guide me -- how just the is true-ups. to on yes, response So forecast

as to will think we've revenue I ASPs nonetheless, up hopefully, that's that So rather I on accrual pricing, seen process go mean, showing year think, up, of But more the a the kind a true-ups. On is so than a be I continued of true later. the Signatera. progress presumes we And we think the in based that, second with heroic is ASP some can not ups reimbursement guide the beyond -- in step reimbursement imminently from modest on just and Advantage think payers. Medicare that Medicare for some half yield something what look, but yes. I achievable the mean, this

question JPMorgan. comes Vatnsdal from next Our Rachel from

So see first this typical continued up on especially women's health, the there quarter, given seasonality the progress great to dynamics.

you can the talked test you You highlighted? up the sales guys us about some -- the walk also did for force of side, on Invitae can And break benefit? from much us how was through So then Invitae of fetal what you contribution there. the increasing that

should how about that we the think So contribution back in half?

Yes. Thanks a lot.

organic this of QX, that the QX and we the growth from an that QX. of increase need. of of leading we've are the we as yes, business. is came like seemed we be test. a meeting continuing significant interest excited -- particularly, RhD And to continues were a us launch in one And think, women's to what lot I new really in health a customers. And closing -- continued new that seen to things drove is on in unmet customers in It fetal then of the was So out interest, very outperformance lot

course, made a of Invitae So contribution.

interest of full for women's and Invitae new we just And health XX% in growth growth think continuing or like in that Invitae now coming organic range. quarter the that the the coming something of a prenatal said think was maybe -- I I Natera portfolio. we're QX of it's getting as volume similar in QX the in. we're volume a see is to But lot in in

follow-up, just Great. solid front. had And gross margin really on the then quarter another on you my

how back So this kind can for side. half the guess, about the of down think into Signatera especially on us, progress of should I you the we year? break And continuing

versus How on the of -- of Signatera dynamics. sequencing much into operational really COGS versus margin mentioned patient was where for the You've test that back further And half? the that test gross due think some whole about efficiencies? on getting the you subsequent we first patients progression that do into to do how the

to do that? Mike, you want take

sure. Yes,

the you're of in right. that course, as are gross improvement women's health continued strong, margin Steve is But yes, gross So also by the looking in margin. see mentioned I'd to very quite we're kind The Signatera call, that. guide ASPs of influenced, the highlight gratified

in Austin that that associated Specifically, to the on we seeing. There's get lab still, COGS kind I and really Signatera that dynamics. We we're in And saw gross up the COGS versus the volume another scale of in the terms think, of is kind room a lot step -- scale with sequentially margin is reducing down think, facility. to particularly running the of I run Signatera tissue really for QX. of in-house, kind that, where to as the modest we of stand related

the think of just of just we've that's of progression kind positive if kind you of I for the the a driver think back underlying seen here. about you non-true-up think progression, gross I margin terms if So kind half. And in --

see underlying still of trend modest could in you sequentially kind QX. think in that of I kind model improvement That's QX sequential implies. what and the

Our next Puneet from Leerink question Partners. Souda comes from

overall right that understand benchmark us X.XX. on about patients there don't the -- talked question getting I maybe at the ask consider? here. appreciate I just margin to of together out. trial but Mike before there them tell this But you a XXX behind wasn't for involved, wanted to true-up in pushed gross that, difference anything terms from You've benchmarking mean appreciate Is a to MOSAIC follow-up XX% XX% ALTAIR, of benchmark? XX% second margin. need gross is Natera then estimate? What's beyond should we powered this? And a I to perspective DFS on I But Alex. both I'll where trial, the how that it's we of is is should that How -- deliver just mind, just ratio of of If we hazard else

don't you what and Yes. good to Thanks, ahead can looks like Mike. you Puneet. Alex, go talk about Yes, hand then it and why

Yes. Thanks, Puneet, for the question.

guidelines that think, best study benchmark. as to it the to we and and kind is, the think change in was the adjuvant of last that study previously we've I a X.X we setting. showed MOSAIC -- DFS And stand really that a led discussed think treatment by target DFS X.XX. of number in

reported right forward we we are to out think I continue we the those available. number. awaiting generated when the and to they're look results to still final So be that's And just and think the by investigators,

margin, gross I I mean, right? is kind that as true-ups, second half. half delta do underlying yes, the key difference margin. and out mentioned, just of the the the it's X in half gross me of first that to think I've the I think organic I backing think that's presume could On second true-ups, the So between kind just key

think room the improvement I for there's QX. in both QX and sequential

the is of blend a so guide couple And of those variables.

So organic gross progression. pretty the margin of bullish on underlying kind

a one around I Got And FMI. Okay. squeeze if it. quick just could

impact that does growth termination, volume your any Altera change expectation on Signatera? for partnership the With or

way. forecast doesn't the a not we're at Yes, partnership thanks. good That's it all mentioned or any and continuing question. our guidance going in our change volume No, forward, we

Our Tejas Morgan Stanley. Savant question comes next from from

some from of still analysis sort should Sticking Do of hazard expect a next we the when as So that trial in then Signatera can with performed the it's delay should time And drug that light think XX. demonstrate evidence from guys? Jan right get Signatera in of and the bar. GI, here terms frame color framing you it right? line share year top think I it theme, Is can subgroup you readout readout, early ASCO the the ratio for you the Alex, just meet meet X.XX was to talked bar, that you that we the level failed about. to could not enough and

Just points would any X be color those on great.

Yes.

maybe the readout can Alex, So the comment then, performance. on talk I'll about you and

kind is now next think as here ways So discuss from get yes, there, quite the plan. we've major we'll ASCO we I a which as out got closer And the communication of conference. GI,

available to want and GI. Alex, were read weeks closer ASCO the couple the the a a results decide subgroup we want to some conference, I line analyses? PIs we we'll with think they meet do out -- to little top what you as of we with about talk do get were planning before of if but to

definitely. Yes,

the We published. assay estimates being portion first ESMO, performance performance. about GALAXY. at that updating also used think be is is in obviously I of performance will that study. assay the a Altera So Signatera on GALAXY. We're question and in published

So think I the published, think out terms concerns, I is we it's performance there expect. assay in and data what that's of been and

here I analyses, to in of don't even Now just speculate. subgroup want terms

results we're think analyses results. They're on show, may I be the prespecified. important, And depending the subgroup important. final be awaiting what may not

data us as a as we'll is to soon that available well. look at So take those as

competitors greater Got it. one as the follow-up, just of tumor-naive physician That's a helpful. your for recently And talked then in about approaches surveillance preference setting.

that time apparently tumor-informed Just continue relevant given can conviction the approach due lack since to diagnosis. of to a provide results

And look pipeline, approach either via a a as that. naive an informed you've as will your a to in take curious hopper aspect own? you version here. that got few one just to we of Signatera, address tumor of So panel your improved MRD about perhaps tumor or your the Is on that think broader things I'm

Yes.

we decision at is whether think to informed tumor tumor more on this successful. going the or naive So point, be

tumor you pretty not really question interest look the volume at and the in it's that's the right? If clear, over think just physician dynamics a about kind And marketplace. time, relevant. I of

are mutations if at even looking time. in clonal over generally, we're the I tumor there's think present that developments

the we eye is and in obviously, the happening always products we've successful marketplace. are continue approach the out been So market Look, clearly tumor-informed doing what's on keep innovative with the I don't described that and pretty innovating happening by it the But our over do we'll what's relevant. And time, things is really being way and competition, to evolving I is point, things that think approach at physician. this chosen as evolves. clear, think

one final One Super it. for helpful, guys. me. Got

think that XXXX? Steve, you and year-end? think ACOG, just framework, -- to now I a there's do it and as it's still Or in happens you mean, this don't between possibility slip about as but could it's on that a Just know catalyst, you the

Yes.

looking the ACOG physician screening at have the for at been still and in we I XXq, done. on about guidelines, positive data, very really looking studies feel carrier and that at both and grounded that's looking think preferences

So we are will strongly and this expect coming. I you see that we year, think well, very to -- things something feel

from comes question next from Goldman Sachs. Our ] Matt Sykes [ (sic) Prashant

second Congrats mentioned stable step-up with health be in for you women's will on second sequential the the the ASPs, the ASPs quarter. all ASPs? Signatera assuming My in first decline one is, in do at half you half, to expect

half. one. ASPs of model I'll question. second take health Thanks actually for kind that space the kind stable women's Mike. No, the for the we in It's of

So the the payers we a women's do historically across that with erosion long which inconsistent the a progress seen in reimburse [indiscernible] that health continued that not followers long-term momentum particularly of just deviation just just guide. We've expect the guided little seen the in that's in board that of getting from space. way some but a really to typically NIPT. in recalcitrant We've that's bit decline, the as we've for ASPs, the tail

Now been few tail and of definitely the of seeing long you kind years this a conversion of standard that that care that for of of kind payers, of get we're now. it's kind now,

the about good women's ASPs health this very at feeling time. So

And incrementally Got you're it. de-escalation you there the that and study? an Is the data to is similar does from Japan And expecting CIRCULATE-Japan potentially that study then study, expecting from shortly? the also what different are arm? escalation have that's it CIRCULATE-France

do Alex, take to you Yes. want that?

Yes, absolutely.

these [ recur. the of The in are majority at the stage patient hotly chemotherapy we're the probably patients -- giving is looking X adjuvant world patients where So of the debated. of still chemotherapy, not lower-risk, but CIRCULATE-France, population benefit many ] adjuvant

that's patient patients So population of that observation. randomizing a of standard is that which kind is narrow follow surgery defined the or study care, stage receive after in of kind chemotherapy adjuvant Signatera-positive either to

different again, of So adjuvant is standard would question. There getting a deescalation arm no usually kind in than postoperative it's since, asking I was ways, and care I pretty of adjuvant Altera say are part not many these of chemotherapy. patients as

are Signatera followed So are just no their there being is the outcomes deescalation and observed, component. but randomized patients negative

I this for for to Matt. And Sean mention forgot Got on it.

from Our Schenkel Research. Doug next question Wolfe comes from

go just to through few a loose ends want on I Signatera.

let So want to for of a back the to topic competition, you mix second. of here the but me independent improvement, -- put today? about first-time assuming come What's COGS I sit actually, side I'm that's mix. When we that tests as the to talk of versus surveillance

of been of think mix more towards of keeping Signatera so how then that So the off first-time this, on XX% track more you've time tracking over to we in mind that surveillance. And and year revenue kind shifts even over If tests, X year, seem Doesn't gets on better grow first-time building stack as that be more you tail to per growth. you more ahead? the and year in that annual of the on outlook purposes test an of surveillance think tests maybe then for XX% then following growth sustained about new the mathematically predictable for volume support year-over-year. top

there and time. It's like of majority quite to very of I it's kind product setting. mature cohort. first, we historically, there's still characterize setting. few balance, into XX%, probably Altera, that first you the state, has the compliance staying of And been of in the Then would Yes, in launched but Mike. surveillance for kind time, patients kind volume, broadly. I of your where volumes, that's it patients would of high with Signatera very think in the for surveilled tail steady getting been where recurrence be gotten of XX% monitoring over obviously, look, of zone to surveillance like It's have a very your that some evolve, stable vast It's kind Doug. to grown when it of continued Thanks is, seen tests kind we've the question, we've what XX-XX

might top of adopting progression seen you physicians of test, continue account I happen funnel getting new that the new be of the because as the top coming mean to just keeps they funnel. as the expect haven't the in patients just rapidly We kind when filled.

to I stay two smart a that excited stack potential parter, fact more kept where enough you of that's so up be ongoing useful it's of It And outlook have time. And think, extremely okay? And I kind can one longer-term the of that got that part. we to unique with relationship long-term quite the patient that think with you've your balanced, dynamic, about you of that much classes this -- so kind because and think do I'm patients the that does growth remember patients kind point, the test. support, over for we're mix a to only

the second one ask I So again.

talked of just mix think I at So you COGS stable mean I that's essentially just it you I improvements your is answered of think And because independent that the kind was mix. about, XX-XX. that

was equivalent seeing have to potentially more better the in make is This think once that asserting So convenience clearly think studies XX. performance an going Are study is competition. seen moderation contemplate than would any view below may was like out actually I'm important for in as seems done studies market it's study performance. what be suggests said, the yesterday, than certainly over to with was on we've a hard -- is better you specificity positioning their that -- what at folks from seen I what's based more to you data perfect standpoint, exactly. especially these to where what Yes, -- way yes, presented me, data or at we're looks sensitivity, to well follow-up you we Guardant contemplating apples-to-apples that Guardant on to anything it comparisons. I study, assay Signatera. is which be guys you from should is a part this have growth what like and there, least risk than Recognizing and are be yes. My XX%, again which, XX be we've points shifting convenient. a sorry, that from lower. That that reported of you'd COSMOS sensitivity But in

thanks. Yes,

since, guess, in maybe Guardant promoting think, seen field. out and we've We've announced, their I'll And they accounts. seen January them been I I So, has the XXXX I them tests, year. COSMOS this the results of in say in think,

paper dynamic the published. they've for gotten out It's changes that while. a So don't good We much. think really there that's been the

-- out months had been now. they've data out for They've the X

feel oncologists of Great seeing good So the in will plus performance. the think use it further about publications We're really XX operations. peer-reviewed I We don't well. product. our going XX% much. really test multiple studies are impact Things pipeline.

Tycho Jefferies. comes Our from Peterson next from question

here. cleanups couple to going I ALTAIR to guess, pacing A sure I make want just of back I kind the of here. understand

and ALTAIR. incorporating I previously committee the CRC meeting summer this NCCN about you talked think for

do pushed strictly you to NCCN? So about first how year, that's this think U.S.? think that's still Now out timing versus And question. of a next the of you do kind driver is

Yes, that. take I'll

we overall there. is survival on data I said testing ESMO, were has data incorporated we and this Signatera be footnote overall MRD in think as that's being think, first, see for a prospective thing. The which that's they're going out a at very NCCN positive manner. XX-month previously looking based survival And data so out look, committee, in the to we're already read to a about happy So perspective excited

as that's data of we're randomized for these randomized all looking doing what we're trials. course, and Of clinical well,

in So positive But studies, we NCCN certainly, these think, doing going puts can't the important also remember, to Solomon described. all a I position. It's committee. with what's us as predict to always happen

today. that's really sort of of looking indication necessarily ALTAIR then that surveillance a I the things driving his the but then paradigm a lot today. with of at it's different the -- curative have adjuvant if you utilization So those of we've study, Signatera, molecular X recurrence. And growth find recurrence, decision-making, driving have we on section, notion is think, cases right? are doing largely is of And of GALAXY with use you intent surgery have covered that's We the which the the new treatment a in all been by seen not the study. which

and over time. but guidelines see, in to have studies putting ourselves impact we'll look, by we're doing We're doing position to we right see see everything can. So the these

kind guess, I on then, use cases. And of

development you of anything some little cancer. bit I you those coverage. ovarian Medicare of market if and just on in think some cancer, last quarter, talk bumps newer you're talked bladder doing around indications about a kind there? of Ovarian back maybe about the Can

Yes.

we've about Signatera had actually we're is seeing the these of that So I one things in And in able And other just areas. cell peer cancer. is indications Merkel as a great fact, been the strategy review generate on data to coverage now. lot of interest and that get think in announced, this Alex in data we quarter, now different multiple and last pancreatic

So all we're new for and MolDX. continuing be types, to will tumor those generate evidence submitted in

when indications. think, a out go results And coverage, XXXX, read is of starts the sales we've being gotten potentially the out So bladder look with cancer actually those exciting areas, IMvigorXXX team we and promoting one I XXXX. definitely as see in as bump we then in towards we the

and So of we to interest a the right we strong continue lot board, across data see the think approach. clinical the that approach is pan-cancer by backed is

a Is it tumor then bit naive a change little strategy MRD. And for of on one. in Great. last

maybe talked you somewhere you but the the tumor Understanding, this think on part about not past, spending of a about naive. it's in about $XX obviously, on think just fall. in I a the some huge previously smaller I and sets data focus, spending readouts market, year talked million

Yes.

in of definitely that we is tumor what's understand certainly, We I types winning think what are we've the before said the what's physicians we're think, looking of what the happening, test competition, marketplace I But kind are is, aware of using. approach at So informed at what -- physicians in. understanding point. think we've definitely interested and are this happening

extensions and I we're and we've have we'll what different future. different are. innovating see those And product of we wait enhancements line MRD said just kind think doing and in the things, to think announce to expect we're and some I

As later that's having some we've $XX that where $XX talked are million those as and range having the this detection, coming spend far early generally about to on million think and cancer actually of I like year, in readouts track.

excited very detection, in readout we're about. the able in give on expect early cancer be future to to we progress our which So a near

from Baird. Our Catherine next comes Schulte question from

paid of improved was hold carrier improving collections comment? guidelines. get that of on on ASPs, your that health more you Maybe you fraction regarding screening tests first Does Or comments on women's the seeing a true microdels? just on without there? Are even

case Yes, Catherine, the microdels. good say that's on question. I'd not

to -- I think really is the going come a from improvement there guideline change.

we're payers the think I test supposed is maybe where and they're covered paying what there's to. when talking a aren't about

need make we're really getting payer get on after more. something things just microdeletions still do that paid, with as unjust doesn't with place. And And that. the like records, coverage that we certainly, guidelines you appealing to the to on getting and denial, time you coverage try sure goes in collecting better rests generally like example, medical But to things for like, at and have learn upside an

it accounts? And And ordered mentioned, in Okay. of cumulatively over portion your was since What at from then of it ordering volume the oncologists Got you existing it. Signatera, think, launch? new growth I sequential second ordered all quarter. percent XX% penetrating have what physicians for versus

Yes.

there's to then And So test. actually expanding ordering tumor we they like different they then would But other of they trial start ordering on say the couple the other the the maybe typical pattern doctors once and across the start practice, into would a clinical it other they practice utility into have start colorectal, move types. patients. Maybe doctors their within breast -- see beyond experience, But be see using they're board is groups patterns. generally the consistent. They Signatera, on patients. that pretty out obviously, I

within get And practices. orders strong on generally, so those I a would of say there's and people once recurrent board, that very expansion rate

to maybe said, we of out, with coming physicians for track in that there maybe on more were we with data interest new pipeline waiting and come a definitely new they healthy board, physicians see very Now to -- coming they that the of timing yet, within in use it on but to that using. currently people seeing right expansion them addition physicians are certainly come they new just in, a lot we're for the hadn't decided

comes next Subbu Nambi Guggenheim. from Our from question

in any off think that I were the signs clinicians adopting readout impact ALTAIR on on pending believe so, readout? demand. but the have any you Do confirm don't to will just delay market that wanted the holding

a question. that's Yes, good

this approval of sort a is a would So clinical need to on new reminder, which particular is treatment without molecular to go paradigm, what for where be used get studying recurrence is ALTAIR relapse. as you just drug

just significant indications do adjuvant the or we're make and not the monitoring whether cancer, just so doctor to in growth And surgery those cured or and That's the many chemotherapy colorectal in we're the intent is patients early, adjuvant of where alone. based not. portion if a doing cancer actually that indications. And on cases, majority recurrence today seeing catch standard the patients, surgery. And that vast, vast ALTAIR in decision-making, from the because is are surveillance trying being decision to seeing different about be surgery usage in that a studied for of of the you can the can you give

are So those being indications in of neither ALTAIR. studied X

further. opportunity we out into market the impact remain any So the XXXX the corner about delay, think quo. won't status obviously, excited on the potentially I have current we the And reading results and expanding as turn

in the there think and out ordering it just is consistently how could if new be changing trial, appears you super a our what Signatera ALTAIR Okay. negative, it And be on even multiple checks helpful. Is I this because if they thinking design behavior it But positive, internally? reads practice impacted it That's it case. complicated point trial wouldn't like you're said, subgroups. reads about that use are out out

area and how adjuvant we're the think or are I And at monitoring about look, Yes. recurrence recurrence. today we're the the thought view intent sort on I the molecular the utilization with underpenetrated, volume I growth. as surgery. really very things. very, This And we're opening of it of looking seeing. up treatment on mean, utilization growth of majority potentially that's a of think, idea of do we've that core to still new course, decision-making all and vast And

data out So additional go uptake reads how from we'll and have things get we to the see this. after what

next question from Eve Bernstein. from Our comes Burstein

Two you. Great. for

row had case X,XXX X tests quarter. well a quarters clearly, you above in to Signatera one, XX,XXX you've said to First is per though, that growth, At test with that. this add point, base your

don't parts clearly on increase So is sales from given market. One X,XXX reason of you've this. the seeing to because that part to you're interest plan the XX,XXX force. But you to for your anchoring members two

force, increase why you'll this given strong if from then increase your surveillance, even sales working that two, that don't not in at have sales So force tailwind favor. point? And you

case it's reasonable So at base don't you increase this to point? think the

And a very demand we've There's Yes, growing. that's a good market. underpenetrated lots question. look, we're of in been

growth. just as strong seen kind a think to have have a very are try stay generally really we with which do. them, we expectations look, volume outperform We in of But able and to to solid we normally row, X I our conservative have quarters been

-- hard But to look, there's you can't a judge it's receiving days. -- quarter-to-quarter because a on there's different things number sometimes basis of

holidays. there's Sometimes

big are major where at. there's Sometimes conferences doctors

we've before look reiterated probably of is QX, reiterating course, X,XXX, back, of XX,XXX to And given point the think can of things the then annual a I of of the better basis, just to units growth. X,XXX we look you at just fluctuate kind of so and same I the things. But every a because at delivered pitch step part kind in think, But that's when sort you about take that case we I quarter. way think of base an

a particular has standard is how going. sort just with of So that exactly reiterating do the quarter baseline kind next our it's keep and on views nothing to of we a

it. Got

follow-up doing way. any with your forecast guidance or below off -- because said clearly XXX,XXX they that. partnership were lot strategically isn't therapy a the the that ALTAIR could and well partnership or That that piggyback you up changing As in a XXX,XXX deciding of following tests sense you is renew to Foundation, on made selection not

Why you're not? And changing forward if in anything, for I that of of we volumes marketing they, change volumes drive think the right the forecast, sort could about why you? imagine if partnership not really for your So a Because going not Altera to delivering turn, wasn't Signatera. ton that things then try to to me value. weren't plan makes it And drive going that your what, there? really fix

just challenging back And when would think think grown test, So And mean, like in you opportunity as be a different say, reminder, we're quite in we but business sides didn't Signatera, have since decided I be we're I distribution. XXXX, And We're Signatera commercial and Altera, really that that situation things started on. we partnership our laboratory immensely. for to running when with we that bit I plasma it we look, I focusing Yes, which very a accelerated in. back right? the And then, were the responsible than changed back for well reasons, that place to both the growth we continue. But have I make when on can said, it signed sense was forecast. look partnership. partner a a has the were doesn't doing to impact really

continue a Altera to well immunotherapy ordered data We where very really do had the being patients. we've immunotherapy in see monitoring strong alongside where monitoring times, lot those of we

the sense -- that yes, anymore a it forward lot move but make doesn't of of continuing partnership. just it move continue along. sort we're to indication, in So to It's we'll

of out conclude will Thank for questions for participation. today. are We call. This your you today's time conference

disconnect. now may You