CDNA - Earnings call transcript Q2 2021

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Operator

Greetings, and welcome to the CareDx, Inc.

Second Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ian Cooney, Vice President of Investor Relations. Please go ahead.

Ian Cooney

you us thank and afternoon, for today. joining Good results quarter ended today, CareDx XX, the financial released Earlier June for XXXX. The the release company's on website at is www.caredx.com. currently available and Officer; Reg Dhingra, call. Executive and Seeto, Officer; President Chief host will Financial this afternoon's Chief Ankur

historical of I the get to like securities made which should Act Any the meaning and pricing expectations coverage statements, These trends, those be operating not statements. upon Private including, of to started, place to Securities are in on without the and assumptions. call management could that statements be matters risks should not statements. financial cause include pursuant undue future remind safe this material expectations implied that estimates harbor decisions, are statements federal this statements. you results Reform limitation, forward-looking during and or our Before call results these anticipated contained that provisions of to statements these actual current Litigation uncertainties of Accordingly, forward-looking statements involve be from forward-looking will XXXX. reliance and based of that are would we forward-looking examination materially everyone making various statements historical enrollment regarding within laws, differ All facts and by our deemed

over update our CareDx any or obligation, Commission. associated today's events by Reg. July to For our principles. the measure only the that information, comparable Exchange I new as not will broadcast intention the a with disclaims calculated in with accordance projections whether earnings today, of information, list call the and revise be SEC. This business, to measures discussion call other accounting any or a provided information The XX, in turn most please see Reconciliation may financial or statements, with in descriptions will GAAP call live forward-looking generally are and financial of release certain law, uncertainties required to risks with financial Securities this the filed to now directly of otherwise. or speaks XXXX. because except found and include filings the accepted conference also future

Reg Seeto

to to and and joining thank guidance CareDx's both conference the innovation year CareDx. second call. excellent and revenue quarter: financial the journey; you our quarter welcome I'll our five leadership from patient external record testing Ankur. is by covered theme the with partnerships; afternoon, across is from for as part XXXX is growth on Ian, second us new key the position expanding highlight Good full to everyone, Today, organ increase the fifth for focus is the building on first pipeline Thanks, of driven highlights the earnings is internal services; leadership third of our continued the fourth our the of by XXXX from connecting patient and our our be areas;

had On another quarter topic, growth. we the first of stellar

from Our was new hires testing year volume outpatient quarter XX% total by driven in of revenue services. growth record last ago

outcomes we because on innovation is the patients. bringing success transplant Our focus leading mainly sustained improve of to

Our and call to XXX% patient over focus on X the transplant led company. decades the many to us has transplant consider

of transplantation. the leader the to being leading this, on every on As part of in in each thank I and delivering vision want one team our -- CareDx partner

services increased revenue, to increasing was compared quarter. XX% which second ago the the our in million. testing was the quarter year of main driver results, $XX.X total XX% quarter from million, to For $XX.X revenue The growth

is as the contributed like the at pandemic. launch addition, and was start the performance from million top of the in a well results these XXXX. launch $X.X to In improved mode AlloMap the excited in the business digital our second again. I'd of increased line. The conditions deliver. Approximately quarter business to XXXX ex-U.S. global for growing patients, second tests team X,XXX revenues In reflection of as is we revenue to demand HeartCare. products transplant from and highlight NGS be and that XX,XXX of to $X.X to were mode test AlloSure products XXX% XXX% products products The quarter, other the HX million strong part CareDx provided of

expression Our assessment DNA donor-derived and cell-free comprehensive rejection. of graft gene

XXX of heart offerings. June, now adopted more kidney protocol. XXX centers testing kidney transplant using community our an greater and centers more of than end Notably, centers than the States As AlloSure the XX and practices have were in United than

to are care our nephrology term by this moat could patient, the and presence. In nephrologists increasing We're to play the from setup. Our uniquely approach take a AlloSure on service role connecting our transplant of their in core remains of direct protocols. to focus number where we in building transplant building team portfolio way, an patients has started within replicate community expanded of transferred patient the centers the transplant been as through testing we long community our effective strategy, also to the a We've unique model be once our center focused on transplant connecting and the the especially positioned more journey. offerings

MAPLE status patient In innovation of a on study. the areas. continue multi-modal a allografts. the to we assess is leadership first approach During expand our of multi-center multi-modality patient to liver in we study our to liver, X,XXX MAPLE enrollment new QX, prospective announced through using

by for are very XX% X innovation as especially patients, excited Lung For as of lung, we within new transplant allografts fail lung AlloSure years.

process. the MolDx by under Our as submission of is LCD technical part new review

innovation offerings enrolled has the the was space. scientific in driving been especially X-year that management transplant X,XXX because first outcomes and to to graft This ISHLT We reporting significantly As two among investing Again, also those clinician and announcement as in of workflow, the transplant use groups. survival focus with transplant a to by XX an in latest of by surveillance more AlloSure. technological of key and delivering are proven We're serum leading our The on companies. or innovation, from also we safety longer-term lung and broader It solutions significant the findings preferences growth of services monitored patients study kidney middle on With in of study, hyper-focused cell routine focused these therapy innovative continue conferences ACROBAT recently testing record than previously possible support record a the able ecosystem to new develop in body post-transplant capabilities. needs, of understand data, support by KOAR-XXXX, clinical XXXX, transplant to biopsies In biopsies and our transplant AlloSure conference were we're to the designed creatinine Registry both scientific our in patient was substantial higher ATC, innovative reduces efficacy with track the and no from XXX% broad rejection and and XX build patients introducing opportunities prospective ATC UNOS evaluate takes were partnering data year. leveraging compared are patients one and and managed in than only are incredible AlloSure testing highlight and cell the diagnostic leadership, than analysis included national centers pipeline and services we're more In AlloSure the our transplant the abstracts. the of commitment Data. in space. using the in KOAR the the driving cell Study. is mentioned, At such stem center our generation. was announced for-cause first X,XXX executing launch testing guided innovation of to patient. The stem recipients this of performed we from care discriminates patients. with number AlloSure whose innovation our last rejection the had the acquiring in patients the in data patient we submitted largest from we AlloHeme noteworthy test These against.

app novel and provide pioneering manage clinical With investment XXX,XXX to believe transplantable app the to We've close theme will mobile sciences Miromatrix, is augmented novel in their medication OrganX organs added This on the an have will agreement, May, organ augmented have designed this appointments to pipeline provider technology on use early per mobile results. available the platforms. availability cloud-based patient which advanced management of journey. help patients medications, We've part in digital we XX,XXX our through availability to Today, a transplant announced strategic our in transplant we and year, with lab investing for also people schedule view value care addressing as patient the solutions. application AI and in for app innovations. and in we to Transplant example, connecting the an easy solutions to patient key analytics integrate that of novel through now shared databases their transplant strengthen In fully We large XXXX, interaction. June, of only AlloCare managers acquisition patients. companies Hero, life strategic test organs. data a our For recognized by AlloSure waitlist be develop of expanded of human a bioengineering, organ also with to the platforms data Android company, patients for U.S. a we

transplant than from the to more on and now dialysis connect than patients centers. waitlist XX,XXX centers more to continue As we we the practices the patient, transplant manage referrals X,XXX at

patients also for signed up that than have We RemoTraC. more have X,XXX

discuss to Health all our Diversity of pleased call to join Dr.Valantine Chief join to Stanford to learning forward and over turning Before Workforce have her at the Scientific Board, Ankur am Dr. at like excited Scientific Valantine I our and I'd Officer with and from For say NIH. Hannah financials, her. is Institutes, we how to National We're working have Professor Valantine Dr. Medicine the look former Board. our to

Now handing over Ankur. to

Ankur Dhingra

performance I'm fiscal you, with the of pleased Reg. our very the for year results financial business and quarter XXXX. second Thank

Let me provide more you details.

the Turning statement. to first income

record year-over-year XX% second -- driven XX% grew $XX strong year-over-year. million demand very services revenues million, Our revenues our to $X.X to year-over-year NGS adoption We across to driven growing for the in continued quarter, XX% for kidney and three $XX heart business both revenues on regions. Product and XX strong volume for million. our $X.X products. services growth Testing by by see were quarter patient grew XXX% revenues basis increased million, strong results. all Digital products year-over-year testing

margins. Moving to gross

of XX% of gross year's compared of in for quarter. margins second the the was compared was non-GAAP gross the to margin quarter a XX% gross XXXX, prior period For XX% the margin in same The the second quarter to XX% XXXX.

and patients our for to scale current operations. quarter for both investing new we also expenses and were for lab productivity heart and capacity driving are kidney At for efficiency our are volumes, $XX the We also in time, for same the higher upcoming Operating million. services. services

continue We to development both transplant to also invest services on clinical R&D and of provide data new trials pipeline, outcomes. in in patients clinical for

mentioned, organs capabilities across the Reg term also reported term Similarly, Study, for recently benefits we patient our we build continue commercial transplant As long our data to patients. kidney for the long journey. demonstrating KOAR across multiple and

second year. the last period loss $X.X of quarter, a net same For net million million loss $X.X compared to was in the

Our second for $X.X per per $X.X quarter quarter a $X.XX period quarter the was for $X.XX the of was income in million the to year. in income net million the non-GAAP last net year. last net share same of Non-GAAP of compared net to a loss share compared loss

in diluted of the non-GAAP XXXX and and share same quarter non-GAAP diluted $X.XX per period income $X.XX basic the was net a last in net year. Our basic second to income compared of

income As net other non-GAAP a define EBITDA interest, adjusted and expenses. before as tax, we amortization depreciation, income reminder,

June of and we $XXX in an at For revenue equivalents X% quarter XXXX an XX, generated was quarter of recorded cash and the in last $X.X million to million On second adjusted we XXXX, million. Cash adjusted operating year. from marketable basis, operations EBITDA record cash of the $X.X quarter. securities the second $X.X of second compared loss or EBITDA positive of million

analytics ecosystem. of our portfolio the to to continuing expansion deployment at capital offerings. expand medication the capital journey. transplant strengthen transplant. actively We advanced in We invested to to management we patient organs Hero in support partnered bring develop side, invested OrganX patient transplant to with direct in Transplant And in deployed for available On our we aimed Miromatrix and capability to

guidance. to Turning

our our testing updating to our continued the reflect We United are for strong the second quarter and results in revenue demand XXXX expectations services States.

$XXX we million As of in today, to revenue year. $XXX for million anticipate the

continuation see ongoing great Our variance from of guidance products and services very continued patients. penetration around balances services. the demand We our uncertainty of positive and and for our market includes COVID response

We clinical partner the us for opportunity. to on choice, innovative patient tremendous in and offerings As call With the of open focused of front transplant provide transplant journey. I'll that, have a digital we the that across opportunity realizing remain questions.

Operator

Our first Andrew Raymond question Cooper [Operator James. Instructions] with from comes

Andrew Cooper

first, I trajectory any you about update kind guess, that could conversations getting payers as with can with attachment we forward? an Heart the and for here AlloSure give tests rate -- think HeartCare AlloMap? like on from the on paid maybe And the commercial of look us what updates X,XXX for with

RegSeeto

Thanks, about the about attachment Andrew. the Ankur I'll take rate let the Yes. XX%. question, about I'll is coverage. yes, first But talk

And And think the seen this and company the think clinical and in attachment. obviously, clinical XX% I benefits, that, be to evidenced quarter, with unmet approach. we're to of by we real this. multi-modality I really some see achieve last what proud we've so XX%. utility the this talked and the first about rapid excited with truly need between we is incredible And only

So want comment commercial a Ankur, bit on do to the coverage? you

Ankur Dhingra

Yes. A general the ongoing coverage. update on

across So of continue did the as We And discussions, our some adoption AlloSure. the portfolio the discussions covered bit going are -- lives with some well. coverage such, we and our quite -- but get both commercial payers. little additional in with

Andrew Cooper

Okay. the your just as think guess, the bigger Appreciate resilient side. COVID one maybe raise. impact of with I product Great. the XXXX, face the just But to I volumes back the pretty guide. really on were in And on

we when the rate some folks about run puts help the little of hoped. a saw the just second raising the here to about kind modestly takes relative we quarter just guide think So more in maybe and think me bit might than have

Ankur Dhingra

This Andrew. Ankur. question, the is for Thanks Yes.

pleased midpoint also for The So QX performance the yes, with midpoint. the strong QX million raising reflects increasing the at and overall well. at as pleased $XX and business the about here, performance. the QX the very guidance we're Very at increase for includes the guidance momentum

in relative So last million But we're to for year. the raised half that also back would first the by in said half, X the now raising we've like quarter. what we to the guidance first quarters you I the combined, $XX remind

either. good seeing good momentum Probably very our one-time seen our We're might So of we're QX overall. people pleased in in business, in ask adoption no some we've kind business. performance

And and market the look to to guidance, our keep is to we driving the continue to expect forward intent that. we drive As drive our penetration model.

product not are COVID are the and the risks all that, we today been would past we ramifications some variants side. testing the term. beneficial has for in given on only discussions was -- the put place, that RemoTraC pretty structurally are where it Given where on environment. services felt be the us once ignore the side, see in the COVID prudent the to in But in short did we

would happening be like anything that seen now. felt not not discussions it the ignore we are have now, We prudent that right right but to

Andrew Cooper

one me. last just maybe for And one Great. Okay.

to it's Transplant in are when there, about balance, sheet? what necessarily does it of we given you're considering, with of are think think cash Hero. needing go of to bit little the generating clean things work kind there in positive more how some a Miromatrix size And trending look as to see a pipeline out just to Just do about and and terms cash like? and again pretty quarter maybe of that attractive nice But opposed EBITDA you towards use in we more balance bigger that the cash

Ankur Dhingra

Yes.

within the to continuing remains still transplant on journey. add patient focus Our assets

seen continue. portfolio general, offerings. In assets several you’ve the opportunities within towards the to a the of has offerings sizes, approach That take various of continue our and where whole plethora will last us add remains. the is but – taken approach funnel quarters, You’ve add over approach we adding approach that

Operator

Sykes Matt from Goldman comes question next Our with Sachs.

Matt Sykes

being, second one patient just your you metrics we one and journey. use cetera, on that, with community maybe get Any of on past, patient? we et on about picture on pushing today nephrology, the see the for on the then, patients, calls key progress update that bigger one, past to there? the the I that sort the which mentioned the you're of some the question. growth, appreciate can the color developing you've Just of see And which things and Reg, can success into. you're technology to any on drivers on engagement the patients. Any an apps all to the talked downloads, in making like to are of impact

Reg Seeto

Yes. Thanks again, Matt.

an On start the up. we're us and I for the ahead had year, of firstly, team the expectations. certainly focus one first the well of nephrology, it mean, we on since been has of community ramped area

eventually in XXX really community nice we nephrology making growth quarter, and are we nephrology happen and the and using additions QX. see well to in involve The centers, us plan, moving think shared have space during the key that really prior to offerings some I AlloSure as as to protocols, continue we've which well. for that the that additional community QX who long-term QX setting, movement during a will actually in more potentially now than as now is of sure seen

continuation and transitioning is we play role really a incredible So the when are And to the that unique community a position they of point from back patient we in have. go transplant center to nephrology of this community.

well exciting and our of So expectations. ahead really

the getting well been that is of our on whether some the pre, some now we every post-transplant I single X,XXX pivotal transplant sharing or referrals, in one we've a as the the peri, patients think this themselves. this adding, post-transplant or And the from on those from journey, from kidney getting BD as then into do patients, digital what external to actual really, dialysis our journey. transplant moving two as focus actually And centers on one and patient the to receive actual in the of then is and piece moving the On it's journey. those of and XX,XXX what really partnerships company. center, example, connection the pipeline internal offerings transplant active waitlist, The -- moving on to who for patients three of heart

you digital, really of heart really post. key as app, thousands when progressing manager. look it's app plays as the We're obviously, whether on we measures pre, or our care improved, seeing peri download that, that mentioned, We've performance had patient are patients as as patients the and part a well of well. at So it's using the some

to exciting the bring have a really last not X we of months. So and lot of to see just continue offerings type as accelerated but course also incremental platform during excitement, this value. from patients, the of centers they what see from And the we as

Matt Sykes

Reg, very helpful color.

more me. one for Just

Just now is -- going bit. down we it's very see case curious, stayed to I'm transition high mobile as well do do in you to using back little has asset, much here? with it pretty got phlebotomy fairly sure have unpredictable, that utilization, in in better things will But feel obviously, And or obviously, from like developed. you're indeed I'd love idea But you've with probably you actually the a come utilization RemoTraC? strong, wrong to the things worsen now, clearly, position from was the COVID to be as direction. get you to this is obviously RemoTraC and but seem an patients a

Reg Seeto

out. that offering Yes. was And RemoTraC last think XX%. I quarter, shared, has the built it itself we’ve we on been mobile around phlebotomy exceptional

to continues quarter This XX%. around be

for patient, to the you business we about growth, increased – strong access again, look So we the this this we even of we direct beginning volume as to interface the mobile we’ve is this how continue consent. with And how with had the support where built. at and patient, just talk that see, the really

prior So terms again, in really that consistent with what quarters usage. of we’ve seen in

Operator

Sandler. Our with next question comes Piper from Steven Mah

Steven Mah

Congrats on the quarter.

think you and get So max Heart. attachment for can now? on attachment rate the the do maybe question a XX% you rate you're What AlloSure right approximately follow-up

Reg Seeto

I was moment. the at think, incredible I And even think us, XX% level exceeded, above I get anyone's this we We're certainly you clinical mean, expectations. this be achieve. utility, there has a for knew the to to one projections I if but think predicted I test at or think being of that of sort do think could it'll any level, envy multi-modal of Yes.

limit I numbers if we'll XXX%, mean, happy very get I see is So that the But we think as we're to we upper So the think, shared. with there. right? have utility, I continue we've clearly, just clinical

Steven Mah

Obviously, a strategies, this on you then, Okay. guys made Great. and in to that follow-up is patient direct to then, have And and Transplant expect a we any the you for of years which investment the continue significant part point strategy? continue strategy. another patient Hero. maybe you driving -- volume to example, those one question to investments, guys second make direct the Can over And patient this question, should growth into to adherence? to invest to

Reg Seeto

always care it's management one have how mean, firstly, patients. strategy, patient with to our thing. which I Yes. single of companies it I think be in COVID started did mean, folks there, I one incredible we the offering. from not would the we're to to direct managers, -- strategic involved And our the the these have accelerate had and was these of with realize patient basis first RemoTraC

of the patient to continual with think offerings, our with incredible moving potentially of really you so stickiness app, core help drive has if care an products. there's addition also rate we managers, and on other it with do then adherence the And now what

but single of all thing, I that. one see think not more I think I think and it's additive, you'll So

So of increase. again, to offerings can brought the and combination we're that really patient excited only by we've the

to being it invest transplant. add pieces are continue for direct to connect to ecosystem us, think, the entire all being it's makes and we because patient question care company pre, second the I or we're company an for we is, your post XXX% see and to focused important we'll to and do, on and other the the this it in so to is continue journey transplant us there, out there from think What peri things outpatient easy and offerings. may I that to continue going

and us I and found think to up everyone looks expects lead far. us up so -- what to and we've that's looks way, the

Steven Mah

Okay. And just question. maybe a it. Got then follow-up

So peak Connect, transplant quarter, dialysis XXX the to dialysis that last over from you've engagement? really got referrals really to it it centers to looks what yes, XX,XXX, waitlist went XX. centers talked What's good XXX from on Is really transplant about, we've like growth XX,XXX went driving or... fantastic

RegSeeto

And -- When there's that it's realized whether yes, it's parts Yes. we nephrologists. think, kidney initiative. or the dialysis mean, whether changes I I in that some or of ecosystem, we've from been there OPOs community it involves multiple it's centers whether

centers think, to So an more those seeing. macro I one transplant centers. to there's macro -- the changes all of anticipated dialysis we patients to these progress more patients impact intent refer changes we're was of And have

So we believe we and EMR one with have our that as which the that, in offering, TransChart. best-in-class of Ottr is leverages both part and an developed platforms, of terms we what

and good that trusted really way us to helps really, unmet which in market. need, introduce solution And attraction electronic we're a unmet at. something ensure to there's we're do this an what we've is you the in transplant And referrals how an to And secondly, is, created you how been address which so what's is way the addresses centers? able do here bring need, being seamless has two, helped seeing the communication? then really us get wafer that bringing we're to really So a that a

Steven Mah

AlloHeme. transplant not similar confirm And it's LCD? covered going And one that's you then for umbrella last you you for AlloSure? that me, to similar to multi-test sort on of just Great. about AlloHeme? under do how Can And protocol think reimbursement surveillance Okay. the do the envision a be

Reg Seeto

Yes.

saw we stem you it's the the with study enrolled solid I first for So not AlloHeme, had for think universal patient ACROBAT is organ of the part release transplant, recent LCDs. and the cell

the first So thing. that's

obviously, and look is, cell at we is do how used look itself measure is itself the is the before. stem second it's of is which has at -- being measure AlloHeme, done engraftment. trying we in as never do But relapse, study next-generation The to study what believe thing we is chimerism. looking staff What been the at what

future or there are But So is of existing want I here is what we we innovation. the reimbursement innovation that which to a and is drive hallmark think, stand the reimbursement. as approaches important out the to multiple thing saying different company, for

is been relapse done so they at which trying to measure And can hasn't is a before, with providing now test approach. we're this do and in thing, which look the

So that's what we're there options of but sort multiple of coverage. avenues for yes, are taking

Ankur Dhingra

your just universal And Steven, to around organ the solid reimbursement, I current clarify transplant. covered LCD think there, on question

get that's our does So certainly expectation work AlloHeme through, that. as we as not in covered

Steven Mah

that or Yes. Yes, that -- that's assume sense is you can of once do be wanted us going a and do multiple -- year question, not year? be this right. Or part of Yes. the multi-test I you of And a tests it's protocol testing covered. you maybe? just frequency as going the the to multi second you look There's per to to confirm my of kind tests for relapse? give a

Reg Seeto

fields. a patient in It's as be that longitudinal important have we've monitored actually well, transplant Yes, no, so this management will other similar done what to to longitudinally. patient test

longitudinal. but shared on would We the haven't yet frequency, be yes, it a

Steven Mah

longitudinal. It’d be

Operator

question next Couillard from Our comes Jefferies. Brandon with

Brandon Couillard

spend the share year. you kind it OpEx full the Ankur, Reg, about Can your would quarter sales you could of pretty investing and marketing up update then, you're the talk the considerably areas And on just for great be most heavily? outlook where an in if second jumped sequentially.

Ankur Dhingra

Yes, sure.

going are focused and sequential your question sales primarily, the investments R&D heavily into you see is more marketing, and the investments, our latter. So on the

back then, we've the upcoming team approval where -- team, sales perspective. has within has for invest towards step thematically investment is channel, you been another developing organ general, from we've after and our the to for side especially commercial nephrology been things that potentially marketing solid one been But about we our our those area the continuing transplant launch, on So lung direction. area, commercial details, us heart on in heard to preparing continue you've where the work kidney been of where our if capabilities a investing. multi-organ, that which And

you forward, in invest about side will we our where the direction side the the of as sales LCD, If pipeline on we and will new Under the and have going the to then a because thematically, as R&D -- that on have. more opportunity lot marketing we think pull remain well.

our So of our pipeline trial in as side enrich on the so investments original direction, we've than that the that side we our of both on clinical increasing as development well sooner things, been plans. things can

Brandon Couillard

in of Could Got AlloSure good when when you. you some terms about new test able block you AlloSure transplant got to a protocols? center impact And And adopts. center sort just number then, you've establishing new the of competition Reg, extent, centers of talk protocols. are and to to, out volumes progress -- a adopting the obviously,

RegSeeto

it. no, done center to real a get for a has that it is we're us, think, the effort on standard those Yes, gold To into protocols, lot to from takes be -- of the the certainly, now but have innovator once get don't space. to in you multiple from think, early year X. year data It I comes have in adopters clinical sharing there's name like protocol. word almost unless first you're experience, clinical count engagements, and also the showing it the that getting AlloSure it and that earned, use And leading get protocol I we the

uses on protocol, either. if just a it's would a -- DNA, a but regular not frequency, center don't cell-free we it that count for example, So high have or

the And of to important over So which relationship, put think with continue it's privilege do we've years, as -- once have a XX to this built on they and real honor on protocols it's part that. us these centers. we

And protocol that So adopted. implicit the developed. strategy increase there's we we've to do a yes, nice as once core with consistent it's the -- it's yes,

Brandon Couillard

one Last future on for proxy you. for update Got a for rollout? HeartCare? capture launch? look be for it KidneyCare me. at And KidneyCare that Any is that you've timing would experienced to And as the rate unreasonable

Reg Seeto

actually where that think and an through truly by. Yes. that KidneyCare And I that I organs, excited it we’re care LiverCare. and HeartCare. we’re mean, one is KidneyCare, lung multi-modality area now validated across all doing was It’s

by lung, we the for a putting which we’d clear us, that. in are specifically, going the the kidney But the AlloMap through validation place, have of process end example, we’re terms there’s for learning setup lab for mean, for we’re In and clearly, year. we process I of from mentioned

on that to to be putting the guide in with LCD, on clear place. things But apart of sort we when in from – new of think, based expect of timing so that. we’re we I And and continue no track just sharing other terms have validation,

see an sort that’s want extremely what But we’re area on to So track we exciting. for again, of that we do.

Operator

with Craig-Hallum Nowak question comes next Group. from Capital Our Alex

Alex Nowak

going What's utilization can had months they're protocol, this Reg, get changes if out about a the follow AlloSure's do doctors initial feedback to doctors? now X the the you've KOAR the how that you think graft less word to results. about they have And transplant now from see failure?

Reg Seeto

the country. of that's calls phone of Alex, rolled KOAR announced I really mean, ATC had first think sort sort question. had we Yes. a across multiple out, we've good at I as at and

also I think validation. strong there's excitement, level but a of

in of So I think, the had utility, that by centers been real-time from study. shared for ways, we some of the results sort of example, the seen the many ADMIRAL in some

we're only anything, I data, study and term if so getting long further And the established. validation have think, company which to it's just

So Where that's utilization side. could I pay probably more terms come the this been commercial is good. in of think really from

where sort think team. and is bit used requested a payer this being information by our of further I that's

think and come interim in I further the came I come. mean, further only that studies. there's so we're from. for data, we're just that formation, what again, it. to experience, obviously, more And upside data But done And have DeNovo was so And was this DSA. ones adds their I -- they've this long where would some centers, studies. insights prediction got through think, these long well-established term term of to and But we also the were from the DSAs earlier that advance, useful example, many there of in so show that that's

insights. repeatedly been their ADMIRAL these And seeing and that centers studies biopsies, -- first as think, as in shown term in of that users really It outcomes now part experience. well and compelling just were reduction own that overall the was increase seeing powerful. with at length. the I I have two think, So long that, like reinforces in in and the KOAR, really things now which But

Alex Nowak

that Okay. the Understood. tech you do expect where When when stands? And study you there? can clarify to would expect to with you then, And OKRA the AlloSure what update along just assessment, said you be that on finalized? Any out? read

Ankur Dhingra

Okay. I'll OKRA. cover the part lung part, and then on Reg cover the second

-- expect dossier of are requested details all with technical has we been X this LCD half on the filed. year. the change. status, under as in been MolDx, based the of we the on overall, the And sometime before, So would that assessment new under no we've in results MolDx that has side, The communicated, lung the have process the the said

RegSeeto

future and consistently, work that leaders we’ve very still of crave complete getting track this includes quickly OKRA by start the taken OKRA, end enrollment the – has with of just end really of really mean, we’re because no clear the KidneyCare, place process take the and year. multi-modal before plus, to on the day I we innovation. need that right has On year. approach drive shared and unmet Into surprise completion Alex, which I of really think, What’s iBox, I of generating innovation. will centers of to enrollment And OKRA then future. on so the think, in we’ve XXXX as the with to And AlloSure, that moved strengthened, AlloMap is, been

leader, finish as more So we to to OKRA, come we’ve long the The transplant coming. sort term with Clearly, develop of the We’re we the thing. known just continue have the is with that. we got innovation, we’re enrolling next do people us then in to right? on data moving will expect market so innovation, to and and to bring innovation, keep needle goal that once KOAR-XXXX studies so be well continue

Operator

question comes Massaro next Mark BTIG. from with Our

Mark Massaro

Congrats a strong quarter. on Yes.

line, year. guide $XX we should million beat so million could do I by $X.X you the and think weighted or QX? QX for top about and by raised QX of you you each mean, it X% on $X.X to think the be So it, million for the more or the delta call or

Ankur Dhingra

probably between with model adoption The earlier QX -- the it very overall working the would side and the as penetration was to the business the we're drive saying fundamental around and equal model with. to I trying keep continuing on momentum -- pleased Yes. guidance, is QX. on the I -- we're market this

that, use half you would it take so if X. So across I

Mark Massaro

double consecutive volume sequentially. growth and Okay. both of like your revenue fifth it's And this looks digit quarter

obviously, might when out higher continue on the rate about digit to trajectory greater nephrologists. RemoTraC, care, in think business, Are reasons community an so basis? types a look on that on Allo growth things I -- double to I this increase that of there that growth unsustainable? think And attach rate your utilization with could heart outreach guess, what type you sequential for can't we render any

Ankur Dhingra

Yes.

we I large think attractive pointing, have the us in as of you're market where of and in front a Mark, stages penetration. fairly we're where very early market

So to to in quarters, in of to year. X the adoptions. ways over products the starting we success nephrology the go. And and setting both model the and around as introduce well. had start last We've to business going on X biggest Greg or continues. their the center described still have our centers remains this as just our that where focus tremendous as model drive at continue well the we're long that forward into add continue working side, protocols that That We direct centers to

of now, of the haven't is range keep prudent anything, good. point side, we in guidance, us there. the services product momentum whatever of business The would quite change eyes COVID any variants, to as the especially would cetera, in side the earlier, our adoption I going for that momentum core our it relative to or on was on to be talking seen off about right, was et not also business. But As

Mark Massaro

That's curious if And how is the us cell you're about Atara kind have would And you been -- then the and can to just learn activity if for you there? great. getting a of work there's your allogeneic and product on what customer new sense feedback any Biotherapeutics with AlloCell business. give be any more therapy update

Reg Seeto

transplant the by we're mean, excited very to. I Mark, different we're areas of going Yes,

on asking moving we TCD other the solid into about partnerships had therapy Atara have clearly Atara, cell us not were role So public from AlloCell. actually with can to offering disclosed our until them they kept conference. showing the cell stem we because space briefly okay is with at the we The us allowed organ only and -- and even mention just disclose those. mention to And to talked finally we with space the we that

do So interest share at bit we'd we about more allow area partnerships that on it's at think potentially love some continue an and I really across to in others see us strong a to dependent Day. Investor companies. point to It's so. And

helpful. the think a sensitive is having I feedback really here key the thing of for sort being is, is standardized really test

because real from no different As we've feedback today. got standard there's companies the

go, as of from amplified okay, had what hearing they have to well, been as across even think samples well, I this other so a there's the if standard reference they're multiple have us I using rules, partnering and boards own developed We've the And AlloCell, a work couple that some their had with today. and ad of every using home they level and use they companies as of a think excitement is but a great, wanting way really as strong partner of well. result now

to obviously, some think, decided just thing some these because deprioritize interest. we I some studies continue as strong, of as I think, in long where our inside had So or to of secondly, showing partners are, hands it's positive examples, programs. sort partners terms the those discontinue decided who of And only the and

I whims growing. to development. in invest drug to subject strong again, we that this is continue So sign the But sometimes is think and of interest,

Mark Massaro

for and And the the guess the transplant any any characterize maybe kidney can Great. have nearing I three Okay. with opportunity of is specialty as the you that heart? lung, on working determination versus number with synergistic transplant centers? all a Medicare centers final are really you how you're statistics lung

Reg Seeto

you approach and have into and I centers that's XXX months, And you've as I've us, the each plus, over different or you of the attended, seen pretty been last is that, a cover is -- different center kidney What really pan Venn the of think couple above it's say you expand all for this to centers, below much don't go everything the they I experiences. organ think meetings pan mean, I that. cover can and result of that's diaphragm. these I diagram, Yes. organ think of the if special. having I out I field are

increasing recognition, it there's the kidney think and do particularly So diaphragm, as sort think but and present those of well the already diaphragm. below above heart-lung along, above which and it's story is And were I I liver. two I think ways, efficiencies bring below existing in as diaphragm, we synergies an certainly, the we had as now there's because

development that Ottr, deploy cross well. And the so portfolio as way such that it's the we to that other have more whether a high-efficient very offerings we whether team, allow Management, presence the it's whether the importantly, we it's have usage offerings our a it makes the Waitlist just it's and it for but it's TransChart, have strong AlloCare, whether whether in

absolutely concentrated places of very been upon. we've pool There's you're that able to a right. build centers So and

Mark Massaro

we And question final and and Great. when could those talk products? your work about to there you see Can with from HistoMap development me. just expect UroMap and progress

Reg Seeto

UroMap mean, really nice I development I progress. both as making in they’re as HistoMap. is well Yes. think

HistoMap UroMap place both had are multimodal we have our lab the lines. on in side these we of in and already from looking on terms are this our the study. clear in internally at have track at offerings of development but But stage on think I that exciting still more what in sort time stage,

approach example, multimodal different for as used being that in studies couple well. of of that using HistoMap, a is we’re as part So

Operator

question Our Yi Chen H.C. comes Wainwright. from next with

Yi Chen

the of XX% of half first the and of of at revenue XXXX represent XXXX, total represents Looking first of guidance. revenue the XX% already revenue midpoint your the XXXX the half about

So there is being revenue this slow potentially them growth? should guidance second half can or you we other you're the year that elements conservative some about consider comment now in whether of your with

Ankur Dhingra

observation good yes, Chen, there. Yi

nice we impact, business then year, thing half, last the year gave was It only half us. the in COVID in the patients which second think beneficial seasonality of the the and a I and I would say hugely pickup the built both and RemoTraC, second the for out rolled for in first half. had as is

in being, for the it last point half year will unique X the that its This play year's versus seasonality year the was. So X seasonality. half was on quite own out

Yi Chen

covered are comment And could patients percentage you Medicare? of on by what lung it. Got also, transplant

Ankur Dhingra

About XX% to XX%.

Operator

and back Ladies question-and-answer reached Reg to the would of our call turn gentlemen, for we to have I the like now end closing session. remarks.

Reg Seeto

real today, for covering also do Thanks taking as taking a do do very transplant mean, I one for thank on call really how thank of you privilege honor, we is much. is and who’s analysts time. and we want patients, of to help and everyone to each I we interest investors the in really listening and I what want interest essence, at a the and having to think but what we company. take every just the who what I do us,

patients, help We really our support company to we’re think can a the the goal overall and have that we – a we more more contributing that in important as mission.

So of again, now. you thank and you. all Bye rest have Thank you I a hope the day. great

Operator

conference. today's concludes This

time. participation. disconnect your may lines at You this Thank for you your

CareDx (CDNA) 30 Jul 212021 Q2 Earnings call transcript