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. At this time, all participants are in a listen-only mode.

We will be facilitating a question-and-answer session towards the end of today’s call. 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. ahead. go please Sir,

Peter DeNardo

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

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

predictions will to or guidance. these revenue that or and from growth COVID-XX statements. on expectations, cost uncertainties anticipated implied expectations strategic government outcomes, optimize and plans, to actual patient projections hiring, and the delivery chronic Before Examples market we to decisions with of of by future physicians results and statements forward-looking these will and statements opportunities care potential during world made risks receive like FDA, statements reimbursement benefits, curtail other of and XXXX. begin, and the impact KidneyIntelX including forward-looking partnerships this kidney of distributed studies expectations for and end-stage prospects Private call our reimbursement our forward-looking materially product include regulatory that the improve Reform disease, in the economic events during make Act include, regulatory of future KidneyIntelX KidneyIntelX our Any or potential without change, collaborations, intellect, that that kidney business benefits of commercial financing successfully operations, from and policy of results our and expectations remind our this of our within by performance differ statements whether business, cause regarding the you and limitation, statements. clinical and I'd or the management relate the meaning strategies be Securities and call events savings trends events, development, KidneyIntelX Litigation adopted for submissions, statements of to involve marketed, decisions, clearance those including could for to ability and These potential material of are including

should you reliance undue statements. not these on place Accordingly,

assumptions. June please October This refer projections our on the XX, law and or any or and For on of estimates on forward-looking risks All made various update and Renalytix description are of intention Risk a Form Commission. the is current the future X, except was Report based call because to XXXX. with obligation Exchange live information, business, conference on as XX-F filed required disclaims statements that the XXXX with time-sensitive whether contains of this Factors statements any call our revise today, and Securities section uncertainties information management’s associated of or as accurate broadcast new otherwise. financial forward-looking events, by or to only Annual

turn I'll to the call now James over James? McCullough.

James McCullough

good and morning. Peter, you, Thank

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

adoption anticipation are providers KidneyIntelX across the trifecta, disease. patients in care with footprint and kidney who groups to diagnostic commercial And securing advance primary of moving are helping of we this diabetes large win to

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

understand goal create a can at care risk keep intelligence-enabled easily to is the been early test healthy a the This Our prognostic involvement better developing validated safe primary a productive. modifications when patient's to used provider artificial greatest therapy, by that behavior and be the can clinically results specialist of very has have important is at effect and people stages failure because early it stage. to and kidney

evidence Medicare believe regulated We a to of that clinical powerful best-performing, and also data and KidneyIntelX’s by algorithms intelligence insurance, responsible harnessed artificial product the provides for development KidneyIntelX as safest FDA, devices. us capable biological future be validation. in create to and reimbursed with Exhibit ethically being the to product A using electronic how clinical and by important can real-world features medical rigorous uses data blueprint biomarkers, including subject

data definitive strategy insight, insurance outcomes broad reimbursement, our an and pathway FDA is regulatory clear. With commercial

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

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

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

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

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

to with accelerate expect conclusion with We momentum anticipated successful FDA. an contracts with this insurance

training launch we to commercial To field its summer. our beginning the life global cost-effectively States, selection to expand this of KidneyIntelX. accelerate is EVERSANA model key build adoption This EVERSANA-Renalytix the commercialization of in deployment a United May, EVERSANA, across parts awareness with footprint, Renalytix solutions will expected the services. of leader and in science announced

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

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

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

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

do from the the important given will positive results body real-world of health positive additional systems the expect likely same growing We evidence.

Health studies care drug an Spring versus Kidney addressing assesses System risk Two of the presented health improved inequalities patient black Notably, following: at in for races. to demonstrated of therapy chronic progression Foundation is care precursor this the This KidneyIntelX to important population. patients increased other for a SGLTX result Atrium, the Conference illustrate prescription access kidney accurately within black within provide inhibitor in testing test recent higher led First, National KidneyIntelX disease Atrium Clinical patients.

type sessions the demonstrated University significant the recommended scientific at kidney titled Early Diabetes directive the at risk XXrd Management. X Prevention, Utah Health versus The for American of Chicago Association to veteran Please XXrd population of June higher from disease of for this a researchers and University assessment Kidney is analysis Recognition Administration released Veterans contemporary presented outcomes in care Second, real-world the the evidence disease U.S. large, and need Disease early-stage to in incidences by the population. from XXth population data VA's in poor diabetes the month. and kidney the and Chronic look new be June Illinois,

aspects our over to commercial progress. discuss to our additional now will of Tom? McLain, I turn President, Tom

Tom McLain

Thank you, James.

to be City in conversion we've most KidneyIntelX, test With New preparation payers. benefits testing metro payment expansion KidneyIntelX commercial anticipated of for of to the the study in U.S. of Having commercialization a for Sinai, significant we're opportunity real-world focused demonstrated evidence KidneyIntelX area at the continues Renalytix. The the FDA our completed Mount market clinical of approval in for the York

initiated KidneyIntelX the success, to a system groups engage to payers large Metro and with the York time provide accelerate opportunities the that added the many clinical of program. in into on into support to Building area. lines same health They launching of expansion we've practice New benefits

area expect also to health fiscal year focus the We Metro Advocate A the add during additional XXXX. for second in area of York Health including the and Carolinas, system is Wisconsin. New partnerships in Georgia, Illinois regions, commercialization expanded

Health. Advocate Health Aurora with Advocate form to Health December, Last Atrium merged

With the it's the and the X health -- in largest health combined system million nearly integrated nation. patients serves system fifth annually, non-profit the combined

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

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

Third, over number opportunities have represent Texas practice. can We terms summer. of markets? and EVERSANA drive to clinical care apply the months, and knowledge successful and intelligence the on in beginning Florida, e-marketing partnership the XX in states what developed access new eligible past care expansion of with sales, will in primary office These significant in we this that in patients primary

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

become provides EVERSANA future updating transition you look salespeople forward advances that on to with Renalytix can our these over during to I earnings calls. agreement Our employees.

Sterling, financial for call over now James? the to the quarter. who like James our turn I'd will to discuss results

James Sterling

Thanks, Tom.

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

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

highlighted transition are earlier, impacted at revenue now Mount the noted quarter testing As the in has restored and was testing system to payment hospital at commercial the James we Order resumed quarter's in call, for last our there. mechanisms which Sinai. and by

through last volumes $XX in vendor maintaining on reductions period. reflects cost expenses This of the reduced from prior year revenue employee program, the and to and testing GAAP the and took lower over million were ramping. controls $XX.X on an result prior we actions expenses operating focus ongoing to Operating million a year basis,

was for Net March XXXX third XX, the fiscal $XX.X quarter from for XXXX. million down share We of ended or with $XX.X third the share. of per million in $X.XX fiscal loss quarter $X.XX quarter $XX per XXXX. or of the as was million cash This

now call Operator, we the can open questions. for

Operator

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

Your open. line is

Dan Arias

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

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

James McCullough

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

the The new it technology winding Sinai to really get a and we're an complex. learned of have electronic the it with the action enormous of road. able into about physician the system, complexities interpretation issues record has with been advanced care. and amount with behavioral think a and been throughout And long working associated ordering system, medical in closely intricacies primary integrating associated Mount is introducing prognostic in we advantage deploying understand I of all all quite medical the understanding has and

than that in good is been doing of making the significant we easier know-how, did have which past, other news think amount accumulated. we've first we when time substantially a we're mentioned Sinai. And deployments I has in it the The this is this

pay that very care. and is a was That nice very see it's see getting how we've done nice a road and coverage goes. an in. we've to system buy works, cautious could that had commercial But obviously the a the huge clearer. major transition something So, that road That's over, to be now coming clinical that the to We're full it canyon to that primary And to evidence I that. switch awful there needed of diversity by used get lot into to been think trivial. about It's of humble And was predicting show validation. able model. to works it and insurance, is the be commercial well, not KidneyIntelX to

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

Tom McLain

James. Thanks,

on But through an with I on, that them. in quarter building payment Dan, system -- things out to at James system very significant point the what they during are of to because Sinai accomplished agreed how the seriously we went like Sinai were Just, Mount Mount third significant and conversion a commented evidence that commercial want to that. the development the quarter, the within health program model that two a takes was

systems. James that very KidneyIntelX have clinical with population not secondly, there, to And that health their and said, It's significant, medicine bulletin for testing. update work as guideline issue health only other to but incorporates into

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

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

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

Dan Arias

Okay.

a phone on and thoughts of Sinai of an FDA ask combine So progression if that Mount you of then, at path upward time on the at next system that, Where sort will XXXX, is the shock will And those the just two of quarterly could volumes thinking follow-up should in sort sounds people you see the give or you'll I O.J., circumstance, to that least end confidence approval. the barring for some revenues, it, KidneyIntelX? models volumes that if we have unique presumably, I'm with if the could, I a to natural about able or have associated think just Do year. here 'XX, on we're here point. It not to outlook have of you people like will calendar be be revenues inform wondering their sort for this and think -- about ability do fiscal at just are but trying what to to there.

James McCullough

Yes.

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

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

O.J.? But,

James Sterling

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

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

Operator

next of Titania [Operator come question will Instructions] Our Galia H.C. Wainwright. Kota from

Your line is open.

Chait G.

forward know Chait Hey. volume test growth in on key This testing But, and well? volume you. -- moving you Yi volume the previous could I is you've remarks. question, following behalf just drive as summarize addressed from up required subsequently, factors of Chan. your Thank to this as And prepared well and the

James Sterling

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

authorization is marketing novo de a It is unique. seeking. are this So, we that

drive and really data validating rapidly. you everything. looks growth, obviously foundation for reimbursement to need legs reimbursement great. of regulatory, to have so The We're stool, And That's the all data. scaled quite the three

importantly, with one Shield, diversity coverage look payment not insurance pattern It's diversity. Medicare, and is contract. Cross most other Blue groups. Medicaid, Blue It depth contracts to -- This And coverage across payment. universe the here, validating of we're you the a reimbursement establish private of payment payers established long-term is that

course, of all $XXX with reportable Medicare pricing And, at result. KidneyIntelX off started

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

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

stool, have you advantage So de once legs the novo through especially competitive now set with have with those you you've barriers to long-term a very three marketing in high FDA. entry, a because substantial authorization bar,

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

us And room. gives so, that

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

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

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

adoption. So, in that But start this to to in start rare in trifecta wide near the well to without direct threat a generate positions it's And to summer drive in in term. results. really that such a large to market us place the lean effectively should competitive have open

that. you to know to don't if I want Tom, add

Tom McLain

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

Operator

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

Mark Massaro

the guys. Hey, Thanks questions. Good for morning.

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

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

James McCullough

the June. Yes. I very think very the at FDA, me is we pleased been remind But market where and will That's expect moment. it. is the continue FDA. you moment, the say This we're with Thanks, It let I you process productive run. we the careful. very a a a we're be has to very let have iterative decision at Mark. process. communication time. have to are that optimistic. to And by we going moment, just we end market, that until the we're the At just And don't with sensitive disclosed our of have it to

Mark Massaro

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

James Sterling

two-thirds [Technical Difficulty] the which of quarter, are roughly So, for volumes billable. were

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

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

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

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

Mark Massaro

Okay.

Sorry.

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

James Sterling

about X,XXX, billable. is Just of two-thirds that about X,XXX, over and

Mark Massaro

Okay. that. appreciate I

at think the to So, payment March. Sinai Mount at Mount completed. transition testing Sinai that indicated you I I commercial Is in paused know that that right? was was

Mount it Given that or a volume Sinai, we is of a cadence sort away? normal going right work to expect bit is more growth get of the at that do there squared should of still transition of to forward, little

James Sterling

the volumes $X forward, at are study those back, Mount Total but third less billable, ongoing we moment. tests is for were million under when longer -- a impact those. the third, we No. -- are getting that the contract of paid not are a billable are that no going were hopefully, whereas currently Sinai, we commercially at were Those

are while back, them So, volumes of not a generating. third are revenue

Mark Massaro

of Okay. EVERSANA them. if sales have just the Maybe How that forward. Renalytix you organization expect you become ground, folks sense. update do know a me think way employees curious -- access many like indicated you characterize it makes walk you to a that's get an I just to contract would they through seems boots many sales going be transition that how out. on type the Maybe fair And That on it's could to of how partnership. play I to And reps?

James McCullough

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

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

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

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

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

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

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

you comment want to further? do Tom,

Tom McLain

Thanks, Yes. James.

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

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

force KidneyIntelX are be sales We value a of partnership is day. combined This it contract a These a synergistic. here. is a the and EVERSANA a from from highly get true end Renalytix they to as or commercialization. will bring the the that and where not is at in both can EVERSANA It's going this execs, account whether paycheck paycheck relationship. Renalytix So, this one sales think of

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

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

Mark Massaro

all for the it That's Thanks great. for color. me. Okay,

James McCullough

Thanks, Mark.

Operator

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

is line open. Your

Randy Baron

questions. Hi, guys. Good morning. I have two

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

James Sterling

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

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

Randy Baron

right. All

always in of always -- ever I number year this range? does question that be it or is Is you to kind there's of two, I Let the tests, studies -- out, enough or just thousands going of become, as those study it that tests, me current don't know get XXX model ask the of So, kind be tests? a that a is kind of about I constant rate XX,XXX way. don't ever know, studies, is

James Sterling

developing. If means a It future set. necessarily depends. we're products with have wouldn't it and tests that study or That we be working iterations up, go

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

continues work So, the there.

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

Randy Baron

it the And will -- of generate upfront? would Is kind cash that trade-off? study

James Sterling

It’s they're It's the not varies. upfront. not They're lot test there’s run. awful of cash an as just case really a billable. just It where

we absorb tests. of these cost the So,

Randy Baron

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

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

James McCullough

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

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

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

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

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

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

say to matters, kidney got here's new very we You now drugs really simple, on And really that work, here. focus have disease with need way solution a rapid because simple there's I a them. patient to that a

higher both does growth, optimistic very we which with one of of can to reasons they're EVERSANA, it deploy future And confidence target got And resources we investing have an are a can these IRR. worked am of in make return we past. us effective to message. ROI, resources I that we So, with can in Tom a the sure to give the this drive going who where with that and about that hold really the the generate target simple is resources and I an degree

we bit. year a of the going I a into I'm Randy, of being half get delighted up what yes, to now. incredibly And the was second it with also real, Mount this we am KidneyIntelX. Sinai that -- because confident partnering ton in-the-world happens did we come And previous and that with are mean, a have, the I use little So and done in seas valuable. wild KidneyIntelX companies. going able experience early to with in experience I'm haven't now in I very getting

other gives the becomes product that messaging. draw we when more territories, the set the much a clear out got can from, that capacity we and now into move we've data So of great us in terms

trifecta. So, Dan the earlier, three ours this long it's think point. that has I but stool, lose winding with the to the the legs at And arriving we're think, trifecta as a said I having road, station at of been,

Randy Baron

Good luck.

Operator

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

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

Renalytix (RENX) 9 Jun 232023 Q3 Earnings call transcript