RENX.L - Earnings call transcript Q3 2023

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Operator

Good morning, and welcome to the Renalytix conference call to review third quarter fiscal year 2023 Financial Results. [Operator Instructions] And as a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DeNardo of CapComm Partners for a few introductory comments. Sir, please go ahead.

Peter DeNardo

Thank you, Chris. participating call. for all you in today's Thank

Joining James McLain, McCullough, from Renalytix President; remarks are provide formal Chief Officer. James Chief me Sterling, today and Financial Executive Officer; Tom

you uncertainties forward-looking not operations strategies on or materially and and future cause or projections undue by you implied statements. chronic and world in our could revenue by submissions, of or and to improve we statements or curtail this optimize guidance. These from statements. studies that benefits our results potential of this Before and future these made are expectations our patient Accordingly, that receive for statements cost should opportunities care Private during plans, with on without be KidneyIntelX of forward-looking of the COVID-XX expectations regulatory decisions physicians, hiring, limitation, other call and reimbursement involve statements. of differ Examples expectations statements the include business, whether regarding like for financing regulatory and strategic development, adopted growth, to commercial events events, collaborations, anticipated product Act and Securities I'd to Litigation the reimbursement events call management make include, benefits, risks the these delivery distributed the Reform that and of or including decisions, KidneyIntelX impact statements reliance our forward-looking and including spends including ability market, FDA potential the begin, actual predictions our economic will for those performance during meaning disease, the of expectations outcomes, savings will relate KidneyIntelX, within that remind end-stage KidneyIntelX of partnerships XXXX. Any and marketed, statements clearance material these and prospects of place the and from policy KidneyIntelX to potential results successfully government change, of kidney clinical business

For Risk made our XXXX, uncertainties risks of that are All report associated this to refer and with the sections on a on XX, Factors current our on based estimates XX-F Securities management's the statements various and the annual with Commission. description Exchange October filed Form forward-looking and call of was business, assumptions. please on

Renalytix live projections disclaims X, any or James or required information whether XXXX, only turn any by update conference June because and contains time-sensitive revise over intention accurate of financial This obligation, broadcast statements to James? today, future information, call as McCullough. forward-looking and except new or is of I'll the or now otherwise. call as to events law, the

James McCullough

and you, morning. Thank Peter, good

market untapped across achieved and are the advance primary who moving product disease. And Americans commercial diabetes kidney primary proposition KidneyIntelX. are and close product, XXXX, use for be it; year and millions helping the with providers of KidneyIntelX our to accessible across our assure trifecta, KidneyIntelX securing disease. X a three, diagnostic of are diabetes message as win footprint lead would be and we'll accept groups providers to patients to outcomes will when largely anticipation all insurance; care a could approaching we powerful that and distinct have this KidneyIntelX care As all two, patient benefit approved. these fiscal will kidney care Completing of a pillars country adoption we is in what FDA of we we across simple improve primary in One, large anticipated, you with

record, all institutions. the offices systems blood-based that a through key with combines medical intelligence-enabled in proves in multimodal independent and and evidence by Our algorithm. device get health government patients KidneyIntelX to access equal can expanding processed need more an through the features real-world these the unique they biomarkers practice is better care medical artificial patient's electronic care

for electronic is capable uses using blueprint when Our an clinical goal rigorous reimbursed developing easily risk behavior therapy, stages people development how safest primary result be by us and artificial validated that and to it believe early in healthy because involvement and is has FDA definitive a and provides intelligence as have can at A devices. With at insurance, by our insight, including KidneyIntelX a FDA, keep of algorithms being care biological prognostic best-performing, by a product harnessed important broad test strategy responsible a clinically can kidney also with regulated greatest pathway medical subject real-world been data be ethically future clinical the failure Medicare a and data This can modifications and to patient's reimbursement, validation. to Exhibit and powerful stage. features data regulatory understand outcomes KidneyIntelX's used early product and commercial artificial effect important of productive. We the biomarkers, clear. the is specialist intelligence-enabled to that very create safe the insurance evidence provider create to to better

of reimbursement large We fast and are KidneyIntelX focusing individuals there for States United on regions kidney is of approaching super a disease diabetes populations status. with and where majority the are where insurance

South Our regional for Carolina remainder is the Carolina, XXXX Illinois, Texas in and New calendar York, focus of and North Florida.

estimated population. New XX% of private insurance payers testing and a like and quarter, in Metro eligible already the the for groups area, combination of Chicago, payment Medicaid Medicare, KidneyIntelX KidneyIntelX from this of our have As York Illinois exceeded

largest members in plan million third administered X In serves well covered estimated million by total, EmblemHealth, secured covering X.X New Blue Shield insurance Northern health CareFirst. with with and BlueShield over CareFirst already Blue an Iowa, Program, contracts estimated Maryland, million more in coverage as This South During Federal FEP, with with lives. Shield lives Employee and X as complements in BlueShield with the Illinois, and Blue Connecticut Cross the million BlueCross agreement X care Blue Virginia covered region. is BlueCross Wellmark in Mid-Atlantic secured York of and Washington, D.C. we lives CareFirst recently U.S. the quarter, which the Dakota, an Cross

the Our insurance economic health recent are groups with kidney coverage of and evidence use. wins uncontrolled to KidneyIntelX data consequences our real-world contract approach validating defining developing leading in reinforcing disease strong

momentum this the conclusion an of this we will EVERSANA contracts cost-effectively its build of deployment parts FDA. expand to the May, in beginning with commercial solutions United field expect across anticipated training announced To States Renalytix in summer. commercialization with accelerate a footprint, awareness with global successful key services. We EVERSANA, our selection science insurance to with life leader launch and

Renalytix EVERSANA model This is to KidneyIntelX. accelerate the adoption of expected

in Tom shortly. this President, McLain, discuss will more detail Our

transitioning last payments the insurance we Sinai signaled we to milestone for tested Health at commercial patients quarter, As completed long-term Mount system. of the

During testing short-term volumes. there adverse a this transition, was impact on

include issued Importantly, Mount evidence. the this to Sinai month kidney based KidneyIntelX has population testing diabetes care all the in on their KidneyIntelX pathway physicians health to disease update newly utility a published

patient an for SGLTX-inhibitor black results patients. health to likely health black Conference disease body Two important care of races. access within population. Notably, given Foundation a therapy same Health risk the of led this patients Spring National First, the to within is presented positive from systems will increased result testing positive additional the of This kidney other KidneyIntelX illustrate System chronic test real-world precursor addressing Atrium, the KidneyIntelX important evidence. improved following: Clinical the prescription higher Kidney the assesses Atrium do expect versus care We drug growing recent in studies at accurately demonstrated in for inequalities progression provide

Administration June titled aspects Utah XXrd recognition look researchers The and U.S. chronic the real-world President, our the kidney additional early-stage new data Second, commercial in population to discuss American early I higher prevention, University by Tom? kidney in Diabetes the directive contemporary of type the will this disease Chicago demonstrated X in turn disease risk veteran population. sessions versus Illinois, management. Please as the at and and Health analysis be month. for Veterans need Tom scientific to from of University XX McLain, and to Association presented Care XX of outcomes incidences disease VA's progress. large of the now significant poor for June our to over population a kidney assessment released at evidence from recommended diabetes the the

Thomas McLain

Thank in market test commercialization testing New York to focused of KidneyIntelX we're Metro of to payment groups expansion They into commercial conversion the and added provide area. the benefits benefits the the we've the study you, with New many of City support be Metro completed York approval FDA real-world payers expansion a launching same in into preparation the the success, accelerate Renalytix. Having James. program. to of health on KidneyIntelX KidneyIntelX to in opportunity lines clinical The that system opportunities large initiated time our of KidneyIntelX, in for engage significant to evidence most U.S. practice With payers. Building for continues we've anticipated of clinical Sinai, the area the for Mount a demonstrated at

Aurora add also system in Wisconsin. Last largest New expect A second nearly commercialization Metro form Carolinas, Advocate combined Health The health Health area fifth is Advocate We the for area including integrated in Georgia, additional expanded merged focus Atrium nonprofit to serves it's fiscal York annually, nation. with patients Health the to system and Advocate Illinois system million December, in health the Health. health during regions, year partnerships the X and of XXXX. the

groups combination the evidence on of produced testing southeastern Health Atrium expand utility in large study has systems. practice real-world with that and other focused health can Forest evidence Wake Our commercial locations, Atrium a U.S.,

In demand Cross the generating coverage, Metro Blue area. practice of test addition, and in Blue and we the of in Illinois are large initial benefit hospitals with Shield groups Chicago

on drive new successful months, we intelligence the Third, past developed office and over XX care can sales, expansion what markets. clinical e-marketing the in have in primary

terms in significant eligible beginning in the of of apply will access states partnership knowledge opportunities in Florida to that and primary EVERSANA this care and summer. practice. These Texas number patients with represent We

and and materials, program will markets, support effectiveness will those programs. force hiring of through comprehensive and reps effectiveness also a dedicated our KidneyIntelX us along EVERSANA state training sales with sales sales the they improve in combining employee sales disease XXX% their help

on over employees. provides future I'd now to the James? updating earnings to EVERSANA agreement Sterling, the become James can Our look calls. salespeople advances to our turn who call results quarter. that during these will I'll with like for to forward over financial Renalytix's transition discuss you our

Oliver Sterling

which quarterly our March to of issued reporting dollars, third financials U.S. in Tom. which that under XXXX, GAAP we corresponds the I will results period is our SEC on financial quarter the here for X-month Figures ending are discuss fiscal XX, X- quoted filing and our Thanks, and Today, based GAAP U.S. our year. includes currency.

For we the reported quarter year. to of revenue recorded prior for fiscal the of third $XXX,XXX $XXX,XXX quarter, compared the

quarter's commercial to payment by transition James in for the quarter highlighted and at the earlier, call, Sinai. impacted our revenue last we testing which As in noted Mount was

employee Operating expenses there. last million system now restored on quarter third quarter to of prior were and we took are reduced expenses third has reductions resumed Net million of mechanisms at controls of fiscal ongoing hospital year This from Order cost the XXXX. $X.XX prior testing an share. result through fiscal year in basis, lower $X.XX reflects XXXX the down million focus This on operating or over $XX.X maintaining GAAP revenue vendor per $XX or loss from and program, share per to and ramping. the testing million the $XX.X was the actions a period. $XX.X the volumes for and was for

cash XX, questions. we open million the We $XX Operator, for can as quarter with call in XXXX. the of March now ended

Operator

Stifel. of [Operator come Arias Our Dan question Instructions] first will from

Daniel Arias

importance can exist. ramp path and or Tom or long that usage road relates maybe a to not the area, the York And New and about this at it been it's the talk winding New point as for James, may may the on headwinds just here, City forward area. point York least obviously, Tom's at to you the of Metro

when extent increases perhaps? what how we expect just that the about you're that institutions past to work things do encountered various could successive at to the you issues like do Mount the heading So we volume way think like comes you've And feel Sinai? XXXX, it into

James McCullough

Thanks, answer most Dan. Tom this. I'll of let

the has substantially medical learned the other primary have the care. behavioral enormous with and closely with complexities good physician interpretation we're the doing of first know-how, than think easier get this and integrating issues in associated and been with did significant able advanced in technology and it time has the I have into prognostic associated intricacies to working throughout we been road, news The and this which of been think amount electronic long a accumulated introducing when Mount new of I the amount really we winding record all mentioned we've at system we're understanding we in it and -- of is understand a past, system, advantage in medical Sinai deploying is it a deployments that making ordering complex. The Sinai. quite has all about the action is and

been we've a full the nice buy to transition to I It's clearer. in. getting We're not trivial. switch obviously insurance commercial system think get model. about we've was that was now very huge see major needed the That But diversity nice coming humble able see pay done and predicting that. That's So of a that it's that And to very coverage road to how is to canyon commercial to clinical over, road a into cautious validation. the goes. the and

It works. be by it to there works to lot be is care. evidence and could that well, KidneyIntelX that had primary an awful used And something of show

lot this please comment But a points validation there around coming the which Tom, So are are future. further. of for

Thomas McLain

James. Thanks,

on Just have in the systems. that evidence and clinical building want not into third that the -- Mount a are other James I health they payment guideline that. And to program very X health model but said, during takes within with the what secondly, very that development But incorporates went for seriously were update there, James testing. because point quarter, Mount on, of Sinai population quarter system them. we and Sinai commercial the to that medicine, was significant, agreed KidneyIntelX significant to to stand their system issue like conversion things at commented through an the only with significant out to as that work It's bulletin health a how accomplished

amassing also diverse for Mount real-world population. because second often of The lost a the point be that can is in population course that Sinai evidence have a is they the payer diverse

City hundreds that members and can area. down them of amassed the study members. in we of to talk their on of health the York outcome metro power data for plans And another in we that major So have is benefits New about specifics sit

be large also And confident payers groups into benefits KidneyIntelX the practice ability of health to bring and so to as care who testing we forward. those that Sinai that outcome a in we implications with lot And that of off as from for look is an other are expand about Sinai sales we begin across the to into area. incorporating whole as having of wind their is broad go that Mount our Mount going work to build metro the successes recommendations systems, has members

Daniel Arias

Okay.

X just system it sort confidence on O.J., of like could those have sounds FDA natural follow-up of then patch if KidneyIntelX. there. And or time people we'll approval. year, a next have I at the here about the a the that, upward if should of ask calendar thinking XXXX, So to the on we're Sinai could, volumes associated sort I for on the with barring at of progression end Mount in be the the quarterly presumably, is combine will will that some phone you unique least that Where thoughts circumstance, you shock

that if at Do we revenues be outlook think volumes ramping. to you just to are ability -- fiscal a revenues, do have inform this wondering able an about you'll of here on to their think not 'XX, models what give and to I'm just point? people for sort or trying

James McCullough

Yes.

this in reimbursement consistently. And data, as and that are and Let's be that grow mean market cautious growth forward, of that's that should this remain get with environment, obviously, over want to make again, We're cautious. going moving And And assertively see think going you're we trifecta continuum. that we there. delivering to able But hopefully, regulatory under we operationally. especially we're the we doesn't I diversity. when the promising We're operationally. we what and after see That we of summer to in I emerge, think, is important. sure emergence

different just for really categories, testing physician, see But to success care develop That's Sinai. Mount start on example, volume relying for to systems. exclusively as the other metric So O.J.? to we're to in health going direct opposed

Oliver Sterling

see bit full to -- time development I'd to to have No, build volume which we provide need on guidance correct. confidence. and some see a consistent with like a basis That's to more

And sure ahead, that provide need guidance quarters recognize the we and a to building. we of desire do trends to that basis we'll strong some consistently when so we all make be the so, I can want the in that see just and we on so do confidence,

Operator

next question from come Chaitanya [ HC Wainwright. Our Galiakota [Operator Instructions] ] will of

Unknown Analyst

know but following I test in subsequently, the This forward on Chen. and this remarks, of factors volume your Chaith drive addressed from and ] question, you key up Yi is [ you've growth well? And summarize previous to the required just behalf volume could as moving prepared

James McCullough

outcomes it's States In we trifecta have the a which in So disease the and kidney that standard patients the is great is of And set felt legs to the early-stage with United FDA the this X diabetic data, And stool. figures. runs market, reimbursement we into from approval. the diabetes for -- and well needed prognosis. baseline disease, a kidney X was diverse It regulatory process so new. large, particular order to in beginning an

is is seeking. It that unique. we marketing this are a De So authorization Novo

the the It's And most stool, validating obviously everything. importantly, growth, That's so course, really pricing establish coverage Medicare diversity pattern across long-term regulatory -- reimbursement at depth groups. $XXX you the diversity. It coverage payment. And started and data. payers The Blue And that not off all contracts private Medicaid, to looks with KidneyIntelX validating reportable result. of with Medicare, Cross scaled drive a you we're all Blue of have We're the is payment quite legs Shield, universe a for to reimbursement payment to of look need here, established X reimbursement This of is insurance foundation contract. great. one other data rapidly. and

very compromised not We have that. important. That's

regulatory. then, FDA and course, -- of So

those stool, So to entry. legs in substantial X once barriers with you have

have long-term the set marketing with De advantage you've FDA. a especially very You competitive bar, a Novo because authorization through high now

going a there, get compete regulated around be we reimbursed validated to it's with product to to difficult Assuming KidneyIntelX. create turn very and

back room does been question happens? is what wild. experience How that the in are has the over very it gives happen? last What months XX in doing to [ majority to our generating simple real-world primary KidneyIntelX And so ]. we've yours, a with us And What is defining the goes become points? a what physician, clear, of message of the the into objections? this What are All support market. care Dan's which

the primary we said and arriving So FDA them patients, that looks costs in early you difficulty it's and in is to care. treat all as we know the insurance. The are disease then it's terrific before disease benefits great in We we develops, say diabetes you with a more early it, tipping kidney stage, And of published be into very use data before very to the spiral. But the of to getting start XX% stage, at to accept call, people on which And if the it shortly is simplicity. now you effectively that message greater able than can we're point. to and course, hope approved. because have simple early need

anticipating becomes with program given we're So putting diabetes that disease. And focused there in looking in place, patients trifecta directly those a list the are. -- and the with majority country now with and where sales we've insurance commercial on regions -- when where large we're we populations at that and very of we're have where we've marketing of are trifecta kidney in place, of now and strong now super coverage that

add to really in wide adoption. to to well don't this near I market to threat to term place start that in drive us Tom, without to have competitive open want to So summer know effectively But lean a generate rare it's results. a you trifecta if that and in such that? in the in should positions large, start direct the

Thomas McLain

approach patients expect I well, majority seen to with anticipated the that primary is -- think today. be And at you straightforward are eliminates Renalytix And limit And X those pillars point for point the simple, are soon be that like answers a success. James, primary the is achieved really the care. that to of has at we're today. will approval barriers introducing innovative that on novel that very we FDA we very clearly that these that very KidneyIntelX very at often covered necessary care into excited show where

Operator

Instructions] [Operator of from come Mark BTIG. will question Our Massaro next

Mark Massaro

received I'd indicated know first by The June, FDA. can you this perhaps an hopeful you've is, of the to of obtain provide approval that one you're know back curious -- hear, you talked then month. communications having are I the be from update you've its provide James, on order you But end end dialogue reclassification how plans complete to the still the to about prepare some review. you've like, agency and to and between forth I agency? And

Just there, any provide would helpful? I update be could you think,

James McCullough

pleased we I productive by we think is be end very been me with moment. the disclosed of the It FDA. a is where with the June. very let decision very are moment, Yes. a iterative market, at the we That's At to that process. expect we to communication it careful. have time. and Thanks, has we're This our just a say Mark. sensitive And

continue run. until FDA, I you at But we're very just have don't the to let will the that going market you process remind optimistic. it. moment, the we're have And to

Mark Massaro

for question, Maybe the the up be Hopefully, think maybe reasonable were we that the sense in the Okay. didn't down it. might for transition in indicated comes quarter. or the missed quarter, see back next volumes you assume as they quarter, tick Great. give in quarter? And us Sinai. to can what O.J. volumes I then that in it about the prior another you on to have sequentially Mount due few next moving to the volumes months. would But know be can just sequentially? at a would I the weeks I reported

Oliver Sterling

which the volumes billable. X/X So just of roughly quarter, for were -- are

that still Forest, example, tests not there. for of of Wake tests a So part that are billable. study set Atrium in are there's

by indicated currently. of in and volumes call, Mount to it the represents improving bit be now or So quarter, we Sinai billable the offsets reimbursed the this about commercial traditional are but under used that a Sinai in tests model, something at pay are test not from X/X Mount

headwind have the growth. at moment, we against So that

expect current Mount as care quarter, total we doctor, the do as going up, that also to increasing, seeing Sinai, away growth ramp of down percentage et Sinai and For continued tests go from primary a are Mount commercial tests forward diversification tests but the the independent PCP cetera.

we So have impact encouraged that overall, from but transition. Mount short-term the do Sinai

Mark Massaro

Okay.

Sorry.

you might I out. gone quarter? were volumes the think What have in the

Oliver Sterling

over X,XXX. of billable. Just that X/X X,XXX, about And is about

Mark Massaro

that. Okay. I appreciate

do little Mount that I Mount should at bit think Sinai, the get that you you Is testing Do Sinai work in completed. still payment to going that March. growth of that was a Sinai right? expect I is given that paused away. the know transition forward? -- squared Mount transition a was So to at right at indicated is we sort it Or more normal of volume there of of to cadence commercial

Oliver Sterling

for of ongoing -- million those. billable, paid getting when back, volumes $X we X/X, forward were is Mount contract were whereas under are that but Total we are X/X No. less hopefully, no longer we -- currently impact Sinai, going were at the the those

commercially Those tests are at the moment. not that study billable are

So X/X revenue back, are volumes are of while them not generating.

Mark Massaro

how like think fair How sales -- sales curious an contract the many seems them. characterize the on just be would get ground, you folks reps? you to to way it's a have Maybe sense. if it update partnership. to, organization That that's makes And on access boots do many a Okay. EVERSANA I

Maybe become you how out? expect that play know going to me forward. indicated transition type through walk of they could that of I you employees And Renalytix just

James McCullough

glad I'm It you up, brought a sales is contract this organization. Mark. not

way, In specific negative And a needs way, specific over be product to dedicated new very like very had especially reaction you marketed a are a KidneyIntelX, simple which way, looking those a sales have our you contract resources. to to need when at a fact, in relatively but we've to careers.

of us So EVERSANA for couple a allows things.

we significant in One, to in could infrastructure all the qualified us that because and are evaluate are quickly characterize to field they and the to XXX% salespeople to they dedicated before salespeople a a people But sales these our than a the access sophisticated which in allows on Renalytix. those salespeople have we us get put way. screen more them to network, them It very allows understand our in own. ability bring much place

a sales carrying So as is in anticipation W-X things KidneyIntelX it's Renalytix. and These people not that's convert will employees actually bag. they multiple the are that dedicated into contract in coming the folks for force of

a So out EVERSANA put so developing looking deploy. allows there's we're it. of X us significant populations hiring do diabetes insurance at sense small, have to in We're where kidney lot us starting regions supermajority for and to and accelerate now resources we made where that process a and and coverage, to concept disease, it just

out wild Tom I a the going we're not think comment -- starting here. on but scope, -- total it's it's we're with let of -- I'll

model insurance model the specific we and to achieve works. a Let's that then start rapidly and and a more ROI you do get want resources in scaling to increasing coverage, sure with place we demonstrate have it. now And expanding comment show that Tom, we're further. can

Thomas McLain

James. Thanks, Yes.

a So to these the options of offering into of and whether appropriate this recruiting Renalytix, director, without we report Mark, the the part the And companies. of EVERSANA of business a sales the the account and territories. they in is will leader leader to continuum execs execs EVERSANA are the for regional area, team. are in Renalytix the they as be We that of didn't process. a case hiring Renalytix get involved is have. for decision account worldwide make members are to Those EVERSANA they in

entire company everything the years, going X we're bigger sales gives Renalytix X be in terms that we and that power force. brings management our learning much that's company And very made of able for small years EVERSANA to capabilities so other available another of when or to into a afford be to us that a wouldn't

So this relationship. in and highly that This going it combined is synergistic. be bring EVERSANA to and can sales of Renalytix contract one is will this both a where We as not value the a sales commercialization. think is force

true partnership execs, Renalytix a the the paycheck a of It's day. here. or KidneyIntelX EVERSANA These a from are get end whether account paycheck at from they

showing for of X repeatable identified regulatory in Texas we to and that Renalytix key everything outcomes it accelerate reliable, into a we the Florida KidneyIntelX can learned focus, that all key terms we markets position all our those of with bring, evidence, commitment, will tools the have now messaging, of In with and in EVERSANA markets development is be payer can, X that our have that the that with markets. the a demonstration we of with in that that markets we launch key new are technology,

so EVERSANA practice accelerate that will the you that we and the to parameters better So we successful of a as the in with other gives is care that rapidly and them, hope successful, it a phase, evidence that working we it of first markets be proves or first very area. that be we KidneyIntelX in have know understanding can scope phase with this primary

Operator

[Operator Randy next Instructions] question The Pinnacle. Baron come from of will

Randy Baron

questions. X have I

the billable? year, we're Like totally this first for glide that by billable of directionally, And model the on The percentage? just Do XXX% the XX% get end out? we calendar when not how we're towards guidance but that kind giving the about is of for on do get curious we I'm think tests, really O.J. you should path I tests? billable

Oliver Sterling

tests moment, billable of billable. doing And future as we we're should studies commercially, and a as be constant. develop are tests As will grow the relatively long of always some see so and the tests not business But total, forth, that the increasing portion there on products are study certainly. the at we as percentage

So commercial approval. the let's the sales taking hopefully, new build see as, how in side expect are continue to months quarters would positive well around ahead messaging things. the And as hold to that I and initiatives FDA of

Randy Baron

right. All

it always way. kind thousands question the of constant -- Or the be tests? a of is ask going kind range. XXX to be rate number me tests, Let of that is study studies in of Is is that this ever current

just of there's to it model kind you know, -- don't XX,XXX X, studies become, or I this that year get Does tests? enough always I about as So a out, ever know know. don't I

Oliver Sterling

up. depends. or working have upset means iterations that and I It products study be developing. tests It we we're future if with wouldn't necessarily go

at R&D So what all study there's concrete assessing future. additional It active those like forth. build. volumes biomarkers, The the will the and plan in team forecast things is how indications no so depends look or moment on in for test

continues there. work the So

in So that ahead many an should have years on. impact

Randy Baron

cash kind the that generally we're Is And what of study trade-off? upfront?

Oliver Sterling

is of the billable. It a it's lot They're cash varies. where as This case an upfront. not run. just not really awful tests they're It's just

tests. these absorbed we of cost the So

Randy Baron

I us release, high you outlook can year? of mean, that the know I is from on looking comes milestones is Washington. optimistic obviously, just Okay. your who And the of today weeks, out you cautiously tone you're you give for And positive, FDA the sounds think get and press couple great. next James, very positive level you're But this what is which regulatory what in which later assuming like it knows what

it mean there's like seems a thunder I horizon. the on cloud

rest this ramp rate? the for out approval, looking the force business we exponential got like just got You've could how and of about at an you evolve insurance get assuming evolve should think really FDA, sales calendar the how year, and you've

James McCullough

validation, FDA and the conversation office does it's authorized. especially a into out now of Yes. it's obviously with and us authorization. can to It with and FDA simplify De an say, Novo, Novo Physicians allow is walk marketing major payers It new. we change is physicians. coming De

AI environment from any experience effective especially than to simplicity, else the message, are messages et the more is of a going simpler around the the enablement, sales difficult. The the difficult, often and easier devices And complex to getting in we're how clinical especially the anything huge the cetera. coming as outcomes, the all data that experimental. So KidneyIntelX simplest relate medical it is learning off of of is time more does know, thing And the power and the ramp this have coming doubt adoption. regulatory and to again, with of off we that with removes we're

say, here's is to And simply worry overwhelmed, message boy, so a they're That's patient very get physician with better. message. thing, oh, that dealing insurance. who getting care So can I FDA that my disease going primary very approved. the to a often simple data have use complex about don't to pretty simple if is okay, this I a

you course, this Of legitimately get and multiple years it to can and the millions complexity takes you point to tens that. say dollars of where all of

back powerful unmet because physician us, into very the clear end this, incredibly we need large to need. and No office, to way think high a where optimistic this to among care. Everybody So especially need We the able this back is, to message able nice. setup are of for it's identify one in risk populations. there's primary needs but the I has simple a at very fascinating, say, to carry who's year we're be I us don't come these it. for

There treat who too we can are them understand and we because kidney with So diabetes can't treat all. people you disease. many

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Operator

Instructions] [Operator call. am in seeing you. will questions Thank no this means Speakers, conclude all This Thank further I the queue. conference that you today's for participating.

enjoy pleasant disconnect. day, and may You now weekend. Have your a

Renalytix (RTNXF) 9 Jun 232023 Q3 Earnings call transcript